Confirmation Number:370870
Event Started: 6/15/2005
Have done over the life of this committee, having been -- much more work having to do with today and tomorrow. The meeting would make well as announcements on the SACGHS website. Today is going to Indiscernible ] Three of our key members are leaving us and their official commit -- capacity ofas members. Hopefully we will have access to their input informally and formally on a regular basis. Our colleagues Indiscernible ] For all that they have done and had ab opportunity to make -- an opportunity to make -- watch out.
We want to avoid that. We're appreciative for everything they have done. We're also happy to -- today that there are new members joining us. Let's welcome Indiscernible ] Joining us from the department of health where she has been the last four years. Indiscernible ] Second,. And she is going to -- a large suburban national laboratory. The representatives of the San Francisco advocacy for a volunteer group and patients group with breast cancer research. -- Indiscernible ] From the university of North Carolina. The department of genetics and the director of the cancer Indiscernible ] And finally, Dr. Indiscernible ] Joins us from California, Los Angeles, where he is an associate program director of the ucla Indiscernible ] Research director and the Euro psychiatric -- he's the network financier research network nationwide research response order by NIDMS and other NIH components, to Sylvia, tiara, Jim and h -- julio, please pre--- feel free -- you're not expected to knock our socks off the first half hour of the meeting. Don't know anxious if you're wondering how can -- did it get on this committee and what ary that expecting from me. How they got to where they are today, the history of all of this. That's wen fine. Wan Cory, it took him and I don't think he understands any of this.
He was on the last committee, to. That's fine. The one -- one thing that Ed taught me many things, he's that time this committee and the predecessor that what is important for us is to develop a relationship between all of us because we have to depend on each other for judging guidance inside the meeting and outside of the meeting. Take your time and relax on what this could be an enjoyable meeting and thank you all for joinings -- joining the committee. Our new members, by the weigh, will partic58 as ad hoc members whole the processing of the members is completed. Their complete biosketches can be found in the folders, but you're still her on. What does that mean? All right. Good. Indiscernible ] Joan will be joining us tomorrow, Chris Hook and John are inable had -- able to denned attend this edition of the meeting. We have new faces, Dr. Barry Straub, the ex officio from CMS.
Ellen barry joins us from the representative of commerce. Julian gory presents us from the office human resource protection, and let me now acknowledge is the outside activities of two of our members, join Reid, represented SACGHS at the NH/NCH here in Bethesda in January and covered the training and we thank Joan for that extra effort and Cindy Barry represented the insurance plan commit -- committee last week and covered our work on coverage and the re-- reimbursement on genetic discrimination. Cindy, thank you for your important work there. We have a bit of housekeeping I need to go through formally. Last, at the end of the last meeting, Dr. Joe Boone and Steven Indiscernible ] Gave us a presentation. Unfortunately, there was not a choirom by the -- qo -- quorom by the time their presenting are given. As much, I need us here to review by a couple of views of points made. At the end of the meeting, we heard about ongoing efforts to improve access to quality care. Here's what they had to say. Whole individually Indiscernible ] Rare diseases and conditions, collectively affect a significant portion of our population. The majority of the six to 7,000 known rare diseases are considered genetic, making it, the testing essential to the diagnosis of the condition. How far, the development of the test for rare genetic diseases has not kept pace with the plogress of our knowledge -- progress of the our knowledge of the genetic bases of our disease -- diseases. Were told about the conferences being pland in September of 2005 in D.C., the goals of the conditions are to raise national array -- awareness the growing public meeting to improve the availability, equality and acceptability of genetic testing for rare diseases and promote development of multiple process ease and models to an end of the translation of the recoach -- research and Cripical practice. The announcement multiple goals are for outcomes for individuals and families to access tests, ease of access and third-party depine de10ment, usefulness of test results, adequate followup systems and education and support of testing after it's a completed. The conference in September will build on a acceptness of an earlier meeting held in may of 2004, called promoing testing of rare diseases key to ensuring quality subject to rare diseases of the at that poet -- meeting, recommendations were were developed by many to address this important aspect in healthcare W. that as a summary, are there any questions for further discussions on that bit of past history before we provide to pre-- review this meeting's agent -- a jpd A. having read that into record of what happened is a very important presentation. This is what we intend to accomplish today and tomorrow. I want you to -- if you recall and as you see on the following slide on -- I keep going back to the slide of our list of the 12 issues that when we first organized ourselves with the committee on, we identified and priority eased as devoting priority eased as devoting the attention in -- for knows where we are now and the process and this is especially useful not only for the new members but for all of us. Are we offensive to your behavior. Welcome aboard. We have introduced you and how terrific and wonder 68 you are. The -- wonderful you are. The first questions are going right to you. No,.
The into yourself; this, again s our road map. As your mare -- chairman, I want to make sure that we're all aware of where we are on the road map and whether we're meeting our targets and deadlones. Let's make it -- to read, feel free to up and look at it more carefully. What that take -- basically says is in keeping with our can you rent plan, we'll be considered in-depth in this meeting, two of our high-priority issue. Coverage of the acceptance services and form of genomics. We will hear updates on three other up--tonics important to us: Discremeination, direct consumer marketing of direct test observances and large population studies. You will recall the committee deferred considerations of the patent -- use this one?
May be. I was working awfully hard. Thank god. Catch my breath, I can -- in keeping with our, so where we are, we that remember we deferred consideration of the patents and access until the national academies committee on intellectual property rights in genomic and protein-related interventions issues its report. That report is expected to become completed later this summer. The committee will receive that report as possible and then we willp vote a representative from the NAS committee to update us on the findings and recommendations at our October meeting. This issue is being dealt with safely in the process, and we need to do nothing further until October. We will start this meeting, our 7th w an update on the genetic discrimination package transmitd to the secretary and a briefing on the status of pending legislation in congress, related materials can be found in Tab 3 of your briefing books. Following the genetic cis discrimination update this morning, we'll be briefed about the secretary's response to the committee's let or director consumer marketing of genetic tests and services relevant to agency opportunities and f -- FDA AS --s role in the overseat of genetic tests found in Tab 5. We'll consider next steps taken with regard the issues of large population study. That's going be a very, very important and interesting conversation. It's unfortunateom a half hour, so one eng I want to make one thing I want to make sure is if any of you have something you may have to do, step out or something, don't mess that half because on miss that half hour. It's a key one. We're going to need you focussed on that. have to be specific about guidance and we have a load a lot of time to give that guidance to the task force. I -- highlight this as an important part of the meeting. We will spend this afternoon completing our work on coverage and reimbursement which we have spent a substantial amount of time over the past year. We will consider the numerous public comments received and we will finalize the report and recommendation. We will finalize the report and recommendation. We will finalize. Because Cindy Barry will lead us through that. Let me tell you on this one. We're going to be focused in our conversation. We're going to listen consider -- very carefully to each other. We practice this a lot last tight -- time. We're really good at listening to each other and not going off the roar, off into the wild blue yonder painting outside of the lines with all sorts of intellectual discourse. We're going to stay in the lines and run this thing through and get through a consensus. I'm about this one. Tomorrow, em we will focus on another one of our high-priority issues, pharmacogenomics. Thepharmaco jep onlyics task force with excellent -- from SACGHS task, has put an outstanding job of putting's session tomorrow giving us a solid foundation work -- moving forward with the work on the topic. Our goal will be how to determine how to provide the development of report and recommendation to the secretary on this public. Football public commentsar are scheduled for both days. One of the things our new members will fine find, this is a relentlessly open process and we benefit from significant input always from the public, and we're always plaid to be able to take time -- glad be able to take time to do that. At 1:00 after lunch, we'll hear from the public. Individuals who would like to provide testimony and have not already signed up should do so at the registration take -- desk. A final reminder, members and exo fishios who would who want to lunch, do so no later than 9:00 a.m. at the registration disk or else. Finally issue as I turn to Sarah for a few reminders about the rules of governing us as special government employees, let me say one thing, Sarah. You and your team are performing speck tool spectacularly. The amount of effort that goes into staffing this committee is extraordinary and the number of late-night phone calls, where people can't get home and the number of hours that we're pulling staff and teen team is just extraordinary. I want the committee to be well aware and hopefully who Jeff your boss is who is lessen -- whoever your boss is who is listening, I will make sure they find out. That is this is an extraordinary staff and we're well-served by you and all of them.
very much for that and I can't take any credit. I don't do any of the worked, actually. A mand accusan and f -- Faye do it all. We valuesa -- have a summer intern, abby is here with us. We're putting her to work as well. very much, Reed. I'm going to remind the committee about the conflicts of interest rules that you all have to follow. Because you're appointed as special government employees. And even though you're special, you, you're o bleejd to follow the rule -- oblige -- obleged to follow the rules of conduct. They're outline today in the document, the standards ofco -- conduct employees. You received one of these books. I will highlight three of the rules today. The first one is conflicts of interest. Before every meeting, you provide us with information about your personal, professional and financial interests and information we use to determine whether you have any real potential or apparent conflicts of interest that could compromise your ability to be objective in giving advice during committee meetings. While we wave comflicks of interest for general matters, because we believe your ability to be objective will not be afternoon -- affected by your interest in some -- in such matters, we rely to a great degree to be attentive during our meetings to a possibility that an issue could a rise that could a -- affect or appear to affect your interest in a specific way. We have provided you with a list of your financial interests and relationships that could pose a conflict to you if you're a -- they're a focal point in our deliberations. If this happens, we ask you to recuse yourself. The other rule is the emolients clause. It prohibits you from being employed by or accepting e mole -- emolients from a federal government including from foreign universities that are government-operated. An e mole ument includes salary, honoraria, transportation and per dieem. The prescription on accepting gifts extends to your spouse independence and yet also applies at all times during your appointment, not just during our meetings, these restrictions are constitutional and are not matters of policy that can be waved or reconsidered. The last rule I want to talk about is lobbying. Government employees are prohibitd from lobbying and us this, we May not lobe as individualors a committee. If you lobby in your professional come -- capacity or as a private citizen, it's important that you keep activity, this activity separate from the activities associated with our committee. in mind that we advise the secretary of health and human services. Not the congress. And I want to thank you for being so attentive to the rules. It's very important that we do so, and I appreciate it.
Great. Thank you. By the way, in that emolument part, was that about travel?
Yes, I should have said that. In your table folders is a little summary of the emoluments clays. If you have questions on clause. If you have questions about it, can you before -- refer to that. If you have questions answerd to, that we are committee management expert, David Alpern is here and he can answer questions of a more specific nature. Don't spend a lot of time on it this sec, but I was caught offguard on this -- it as l the foreign travel business. I didn't know about it until I -- until I did foreign travel and was paid for by or requested to be paid for by another government, and I know, you know, there is a very technical part to this rule and you have to be careful about it. I want to make sure that you all saw that. But we'll look at it and not now. Now we're into the heart of the meeting, and for those now members of the committee on, the number onesh that we have -- one issue that we have identified as being most important for the life of this committee has been the effort around the appropriate protections of genetics discrimination in employment and health insurance. This has been's real key focus. We put a tremendous amount of our energy on that. To give us an update on genetic non-discrimination legislation and where the efforts are, let me turn to Agnes Masny.
Thank you, Rhode. -- Reed. I would like to take this opportunity to once again thank the committee on gent -- genetic antidiscrimination and to all the committee members for all of their input, and most specifically, to Sarah and to her staff and Amanda Sarata who has beenkceptionally opinion -- helpful in pulling all of these materials together you will be hearing about and most importantly, to thank the public for your continued input that has been so helpful in directing us on this important issue. So what I'm just going to, do we're briefly going go over sort of where we are to date with what has been happening in this whole area of genetic discremeination. I'll give you an update on of the recent developments that include the correspondence and what has been said to the secretary Leavitt, well as to a brief legislative updating what have is happening in the house. Then we're going to have a presentation by Peter Gray on the legal analysis that was requestedby this committee to loca requested by this committee to look at the current registration, what is the system where there are potentially gaps and we'll have a legislative briefing from Jamie Vickery from -- he's from the staff representative Judy Biggert's office, and we'll have a committee discussion to see what further things we need to do as a committee to move this forward. The task force members have been myself, Cindy Barry, Barbara Harrison, Leonard, reed tuckson, joann, Peter Gray, Tim leshan and Mildred Rivera. With regards to the congressional developments, thegenel -- genetic information and non-discrimination act was introduced to the house in March, and this was a bill sponsored by representative Judy Biggert and co-sponsored by bob Na where, Anna issue and Lee Slaughter and has a total of 101 co-responsers. What happened is after The bill was introduced, it was referred to three subcommittees. One to the energy and commerce committee, second to the education and workforce committee and third to the ways and means committee and the education and workforce committee has always life -- referred us to a subcommittee on employer and employee relations. The bill that was introduced into the house is very, very similar to that of what was passed by the senate, but it differd in only one way. And there were some provisions in the senate bill that addressed and potentially would amend the internal revenue code so those have been omitted from the house bill, and these were measures, though, that only affected church been plans, so there are some thinks that thea -- that at in the future, they could be put back in but currently, they have been admitted. We'll hear from, more detail, of course, from Mr. Vickery regarding the legislative update. So on to the correspondence that has been sent on to Secretary Leavitt is that after our last meeting, we drafted an encent on another -- incent on to another letter to the secretary, included in your briefing book and there were also four enclash ears support on. Once -- enclosures sent on. Was one was the compilation of the public minute. wanted to make a telephone book and received our own telephone books in the male, long with a dvd, that was a compillition of the public comments, summarized, though n a bridge that was not a total version. We're going to view that in a few minutes and there was a copy of the American health insurance plans letter of February 22nd to representative Been Booneer and an analysis we'll be hearing about shortly of the current law. So this was all transmitted to the secretary by the NIH director. So all of the public comments that had been received other by e-mail or mail or people that presented here to the committee between September 24th and November well as any research articles that were also sent to the committee. All of these were compoled in the book that was -- compiled in the book sent to the secretary. The content of the letter -- letter, we were urging the secretary, of course, to exert his influence and leadership to bring about an enactment of federal genetic non-discrimination legislation and in the letter, we reviewed of the stakeholders' perspectives. That was the perspectives of the patients, the general public and the coalition for genetic fareness, and it, in brief, we summarized the fears that the public has of the potential dis-- use of the genetic discrimination, healthcare decisions being shaped by fear rather than by best medical practice. Patients who are soaking Jeanetteic seeking genetic testing outside the formal health care system, patients anything that the results be captain out of medical records and opting for anonymous testing or foregoing testing that could actually prevent disease. There will be concerns about the lack of specific federal protection against genetic discrimination was also summarized in that letter.
O also pointed out the perspective of of the other stakeholders and consumers such as can A HIP and the chamber of commerce noting that these are complex issues and deserve further analysis. We recommend the secretary meet with any key stakeholders and groups that were interested in advancing this consensus building regarding genetic legislation.
Lastly, the secretary's letter gave a summary conclusion about the analysis of the current law and the goal for including in -- this of the law was to inform the secretary and provide a debate around the claims that the current law provides adequate protection against genetic discrimination. We specifically wanted to look at and analyze the law and identify if there were and point out where there were potential gaps. To date in summary, what was said to the secretary was that no federal law directly addresses the issues raised by the use of genetic information. The current law and court decisions does leave substantial gaps in coverage and offers inquest and certain safeguards and the current Avenues for relief were uncertainty -- uncertain and likely to lead to confusion and well, maybe costly litigation.
From the perspectives of the public regarding genetic discrimination, we put together the compelling testimony in an a bridged version for the public in our October 2004 meeting and we are actually going to view that now. Of about we do, I wanted to credit and thank those people who were instrumental in putting this DVD together and that is Scott and Peter from webconferences.com. Larry Thompson from the national human January only -- Gene and research institute and from the medical art NIH.
As I see it, genetic is the weather-tracking device of health. What if people were given the knowledge of a potential storms in their lives? How would they believe to protect themes? What would serve as the plywood for theuento windows and what evacuation routes would be made available to them. More fortunate -- importantly, how many lives would be save the -- saved. That's rate -- really the question, isn't it? Gene -- genetic testing as a disease-forecasting tool a potential to revolutionize medicine. The health benefits promes to be significant, but genetic information request also have serious implications for individuals, families and society. Many people are concerned about the possibility that genetic information will be misused in health insurance and employment. When people think that genetic information can harm them or their family members, they may decide to Gore go genet -- forego genetic testing that could benefit them. The committee produced this video to document the compelling testimonies of seven individuals whose lives were affected by the fire of genetic discrimination. They reflect a deep public concern about genetic discremeination and point out a need for federal legislation that would reassure the public that the misuse of predictive genetic information is prohibited.
Today, there is a current of fear reverberating throughout the genetic community. Not a fear of loss but Ritz -- retribution.
Fear and inuendo surround the world. People are afraid. Their fear keeps -- keeps them from being tested even when the test make the difference between whether they live or die. We put off being tested because of what the physicians recommended because of potential discrimination. Countless women in my family the last years have been diagnosed with breast cancer and several have lost their battle to breast cancer. could have all been prevented if we had pursued testing them -- then that. Griefs me thinking the loss of there that could have been avoided. I've decided that knowledge about my health is a gift. I want everyone to feel the freedom to have that gift.
After carefully way -- weighing the potential benefits and harms of disbren -- genetic testing, I decided not to undergo testing for consequences to my daughter. My fears are twofold. First, the information may not be protected and might even be misused. I also worry that if I test positive, my daughter might be obligated to disclose the perhaps of a judgeetic mutation and she might suffer future discrimination and health insurance and employment as a consequence.
As it stands now, if my children undergo genetic testing for human chromo-- chromatosis, they risk not be believe beingably to obtain health epshoorns when they're no longer covered under my husband's insurance. We're given a choice: Protect their health or livelihood? It's troubling to me as Americans we're placed in a position where we have to make a terrible choice. had a hysterectomy in October of 2003 and the proof Lake -- proof lactic mastectomy in March of this year and I'm still in the middle of reconstruction. It seems unfair to me that I am taking steps to keep myself healthy and to cancer in the future, and I'm being singled out and made to feel I am a liability. If someone in the company were diagnosed with cancer or some other disease, they mold not have been asked to switch -- they would not have been asked to switch insurance companies as I was asked. No one should have to force an insurance company to cover perfectly healthy children. In fact, I don't believe it should have mattered what their genetic status was to begin with. We're havable members of the community with contributions to make and shouldn't have to afraid our genetic anomalies, whatever form they a rise, will be held against us. I should not have had to spend a better part of six months wondering whether decision to have my genetic's verified by their pediatrician was a huge mistake. I shouldn't have to wonder if my children's genetic status is going to follow them into the workforce and render them unable to become employd in their chosen fields.
The reality is knowledge inage that you're carrying any particular genetic desorder, in my case, hemophilia and HD is just as devastating to you, your children and your grandchildren as the disease will be later. Open communication is almost non-existent between parents and their at-risk children regarding how they can better prepare to minimize the destruction of HD if they do have it. HD must be sequent -- scent shrouded in Chrissie to protect -- in Chrissie to protect everyone.
My mother had breast cancer at 35. Her mother died of ovarian againster at 41. Her sister had breast cancer at 42. I was 31 when was diagnosed with stage 3 breast cancer. My daughter, a 21-year-old s in this line, too. She, like me, and like another everyone in our family with this mouthing a, hide, that is hide, caps -- him. I.D.I., her genetic information even and especially from the healthcare providers likely to help her manage her lifelong predisposition to disease. Hiding integeral health information is the home -- only fail safe way to avoid discriminatory pro -- practices such as the loss or denial of health insurance or loss or denial of employment because there is no comprehensive federal legislation that patently forbids insurance or employment discrimination on the basis of genetic information.
Many people are afraid to come forward and fight for their rights to employment and health insurance which can -- coverage because they're afraid of the retribution that may not only be taken against them but could be -- taken against their families as L.
It's remark official -- artificial -- remarkable for me to realize the work my Parrot -- parents did in the civil rights the '60s was cot not completed then. Here I am working on the same issue, no matter the genetic makeup of a person.
In my opinion, genetic information is no different from any other essential KPC ting wishing distinguishing information about any human being, all of which, all of which is, by law, kept off the bargaining table that bares up this human rights based society.
We want to be heard, want to be protected, and we don't want to set in the back of the bus anymore.
National legislation that would make it illegal for insurance companies and employers to use someone's genetic status against them has, indeed, been drafted. As each day passes and the genetic common etwaits out for the house to bring this bill to a vote, scores of people across this nation are being persecuted on a basis of their genetic status.
Finding out your genetic status is p.m -- permanent. You can't take it back, and it's not something that you can change your mind on and what I really need is what we all need is a law that clearly defines the safety and the fact that you can't be discriminated against genetically.
Knowledge of our genetic risk poses many challenges for visits, families and society. These public testimonies reflect a deep anxiety about genetic discrimination and illustrate the problems that can result when genetic information is misunderstood and when people fear its misuse. the comb -- coming years, broader efforts will be needed to educate society to ensure that information about genetics is conveyd clearly and accurately. Although solutions to those challenges will take time, enacting federal genetic antidiscrimination slings something we can and should do right now. To address public fears about the potential misuse of genetic information in health insurance and employment. As these public testimonies make clear, federal legislate -- legislation will go far in providing Americans with needed assurance that their genetic be used inappropriately. Federal genetic antidiscrimination legislation is in the public and the nation's interest.
Reporter: Think that this DVD is as compelling as in its shorter version than for the testimony that we heard that day, and I think it was done extremely well. We will later in our discussion could actually look at what we'll be able toda -- to do even with the DVDs. More than one copy of course, sent to the committee members, there were 150 copies that will, the same number that matches all the numbers of the house that -- so that we can look at what we meet want to do with the DVDs. Okay. So, again, I want to just thank the committee because I think this sort of shows almost the fulfillment and the culmination of so much hard work regarding this issue, and I think it's very compelling and it says that we are moving this issue on and it hopefully will have some positive outcomes from all of the work of the committee. So next what I'm going do is turn the podium over to Peter Gray who is going give us the summary of the legal analysis and this was the analysis that was support on to Secretary Had sent on to Secretary Leavitt.
As Peter gets ready, let me introduce him. On Peter is from the equal employment opportunity commission, and he's, you heard, will review the legal analysis we commission. Now, understand and remind you all that there was a very important point that Agnes made, and that was that we have had some pretty intense discussions with all of the stakehold -- stakeholders who care about this issue, and one of the elements that really kept popping out from some constituencies was do you really need new legislation? Why doesn't the existing legislation solve the problem? Why reinvent all of this. I want you as a committee to also understand. Not did you see the video here, which we're doing, but this is -- we're an advisory committee, but we are an active advisory committee. We are engaged and so the conversations that we have had with different stakeholders in this have been to elicit an -- a date, positions and quite frankly, they have been trying to quite hard to tree to see if there was common ground and so where that common ground is. I want to be very clear to the committee. This is -- we're not sort of sitting back on this. We're trying to find common ground. Out of that need for trying to determine common ground comes this idea of, well, is it adequate s current legislation adequate? That's the context for this analysis, which was prepared by Mr -- Mr. Robert Landman, a consultant on biotechnology activities, he's sub squintly retired from HHS after three decades of service. He's not able to be here today, but we're glad that Peter consentd to prevent the analysis on his behalf. About the -- let me also acknowledge the agencies with jurisdictions over the laws analyzed, EOC, DOG -- DOJ department of labor and SACGHS and the office of civil rights reviewd this analysis for technical accuracy. We thank all of you around the table who had a role in that also. Thank you, Pete jeer. Yeah, good morning. Let me start right at the outset with a couple of little caveats. As Reed mentioned, was asked to present the report that Mr. Landman had prepared because he was be here. What I know about the health insurance part of this, what I know about health insurance is that I have don't know that much. are folks here who can provide you with some assistance if have questions following my presentation. S sec, let me note neither the contents of my report, the presentation of it or concerning it, especially during employment discrimination should be in any way seen as the EEOCs endorsement of the report's conclusions and during the question-and-answer, I can explain it and during the course of the presenting a, the report does reflect the commission's views on the legislation and I will reflect those at that time.
The report begins by noting at that the beat the Encinitasa senate and the house in the areas of insurance and employ hem. These gaps have become significant in the last few years because of the genetics in the science of and the what the areas of medical prodisbre.ses the deciphering of the human genome opened now opportunities for medical progress. The bill, the report reflects The bill's concern among the public, the fear regarding the loss of privacy with respect to quarterback isetic information and the -- genetic information. We curet sort of saw him drive home that point, and in this regard, I would note that some of you may have a couple of weeks ago, there was a new study for printd in the May-June Japetsics -- genetics, reported that 45,000 participants in this particular study raised concerns about po-- the ability to raise health insurance as a key concerns. The scope of the report, the report itself, if you look at it, contains discrete sections addressing federal law on health insurance, privacy of medical information, state law, federal appointment non-discrimination law, constitutional protections and protections geared toward federal employees contained in executive order 134145 that President Clinton seend in FebruaryThe security act entitled 3 ADA on HIPAA, and title of the ADA well as title of the civil rights acts of 1964. We're going to first move the hillk insurance part of -- the health insurance part of this. One of the interesting facts noted in that recent genetics and medicine study regarding the concerns of the public relative to genetic information in health insurance is that the fear of discrimination is lower among persons in the U.S. over 65 and among Canadians, generally. One segment of the study large number of Canadians. The authors of the study scug -- suggested that might be, because of Medicare for U.S. seniors and national health insurance for Canadians, where coverage is not at issue. For most the race -- rest of us as at -- as a report and this sleet note, health insurance is employment's bias. The report notes 60% of the U.S. population is covered by employer-provided health insurance and those insured by employers, most of these plans are covered by arisa and the health insurance portable and accountability act. The report notes that one basic purpose of HIPAA was to ensure that in some circumstances, individuals who change employers in -- and health coverage shouldn't have new coverage denied or Restricted because of a condition. An employer would be performed to impose error error limited re-- impose limited restrictions on coverage, based on conditions in certain parameters. The report further makes claim that under HIPAA, group health plans and group health insurance issuers can not impose a pre-existing condition exclusion the basis of genetic information unless there is an actual diagnosis of the condition reality -- related to the information. And the example noted in the report, an individual who tests period -- positive for the mutation in a Gene linked to breast cancer would not be deemed to have a pre-existing Dean in the absence of a diagnosis of breast cancer. As this slide notes, report includes a reference to the HIPAA rule limiting coverage plans on eligibility requirement or charging specific individuals more based on genetic information, so nothing bars the establishment of a group rate based on or in part on genetics information. The report states the HIPAA provision and the small group market prohibit an employer from refusing to renew a policy based on genetic information about an I'll enrollee or potential enrollee, but it would not restrict an issuer from taking genetic information into account when determining the employer -- employer's leave all premium and, the -- overall premium, and the report said a state could require an individual to take a genetic test as a edition of coverage, not to deny coverage, but for the purpose of determining the premium -- premium to charge the group and its members. In the individual mask -- market, HIPAA guarantees certain individuals who lost group coverage has the opportunity to purse -- purchase individual coverage without an exclusion based on geep -- genetic information. As I noted before with regards to the individual market report indicates although it can't deny or issue a policy, you can't have the premium based on whatever genetic information it obtained. 1346 -- some of what HIPAA does now, the report focuses on gaps or protection in the coverage. First as noted here, HIPAA doesn't promote a group health plan from requesting, purchasing or otherwise obtaining genetic information about an individual or require angindividual to submit on a genetic test as a submotion of coverage and on the basis of genetic information, the information obtained charging all members of the group higher premiums and the report states that charging higher premiums could make health insurance too lost -- costly for health employers and has the same effect for denying coverage. Other against noted, chording to the report, HIPAA protects don't -- don't apply to small groups. From what the report knows, these are plans with fewer than two per pace -- participants in the first district attorney of the plan year. Nor does HIPAA apply to plans that cover retirees only or to plans that elect under HIPAA to be exempt from the non-discrimination requirement, and I'm going leave it tokings to explain later if you need or want the explanations, what plans may make this elections to be e -- exE. from these particular -- exempt from these particular rainstorms. The report identifies as a significant gap the fact that HEPA non-discrimination -- HIPAA non-discrimination provisions don't apply to health insurance policies, even though then 10 to 15% much -- of those covered has such policies and even though the number much Americans seeking insurance outside of employment is locally to increase rather than decrease in the future. Hep, although HIPAA does guarantee certainly individuals who lose group health coverage have the opportunity to purchase individual coverage without any pre-existing condition or exclusion that I mentioned earlier. As I always mentioned, it doesn't prohibit issuers from taking health factors including genetic information to account when setting premiums. The report looks at the social security act and notes that federal law sets national standards for medicare supplemental or medicap policies, which are health insurance policy covering out-of-pocket costs in medicare, including insurance and deductibles and other costs not covered by medy carry. The supports state that medigap issues are prohinted from issuing the issuance or effectiveness of a Medicare supplemental policies or disium -- descrit -- discriminating because of health status claims experience relative humidity of health care or medical condition of the applicant, but, the report notes, that unlike HIPAA which exPressley includes genetic information win the coverage of the term "health information," that is not the report here. The report suggests there is ambiguity as to whether and to which extent a medigap policy might limit access to the use of genetic information. Title of the Americans with disabilities act provides that no individuals shall be discriminated against on the bases of disability and the full enjoyment of the goods, services, facilities, privileges, v or accommodations or any place of public accommodation by any person who opens or operates the place of a -- a public commodation. Places of public accommodation enshrewd -- include insurance offices. Chording to the report, the issue is not Little too of the physical application where the insurance is written, but rather the content of the insurance policies,ha what is covered by the policies and although there are federal court cases and some comments by legal scholars arguing that Title 3 rears equal ac-- requires equal access not only to insurance offices but the terms included in insurance policies for prevailing sense is that a ADA didn't -- doesn't cover the insurance policy. Most have ruled against coverage in this issue, and specifically, those include decisions from the third, fifth, sixth, seventh, 9th and tenth srkt. Only the first and second ruled the other way, and apparently the fourth and 11th and D.C. circuit have not yet ruled. The trend is clearly against coverage. The report notes that even if coverage might be included within title thirty twos protection -- title 3s protection, there is a separate provision in the ADA called the safe -- safe harbor provision that would limit the reach of the ADA. According to the report, the safe harbor provision means that Titles 1-4 of the ADA knar -- are not to be construed to prohibit or center -- restrict an issuer from classifying risks limiting risks based on or consistent with state law. A key of the safe harbor provision is that the term at issue not be deemed a subterfuge to evade the purposes of the ADA and most courts, deciding case -- cases under the safe harbor provision have take know a broad view of what it means. Some parts have even allowed you issuers of insurance, the use of insurance provisions that even lack actuariual justification, and the argument is so long as the provision in the insurance policy was adopted before passage of the ADA, one can't argue that the of that particular provision was, constitutes a subterfuge to evade the purposes of the act. On the flipside, the contrary argument is that the current use of a provision that evades the purposes of the act should be deemed or violated because of the presence -- present use of that provision. That argument has yet, has not gained currency with the courts. The report looks at the HIPAA privacy rule. It's relatively new rule, final regulations issued a couple of years ago. The rule establishes the minimum national stand fard -- stand tarred -- standard for protect the national health privacy information. The deafsition -- definition is quite broad, carrying all individual identifiable information which encompasses genetic information, including family history, and the covered entity is fined as including the health plan, health-care clearing house, health care providers and whoever transmits any health information in the electronic forum with the -- in a transaction covered by the HIPAA regulations. The reports suggest there are gaps in the coverage of the HIPAA privacy riew. basically, the privacy rule doesn't bar the use including genetic information, rather it merely sets the standards for getting access to the information. In this regard, the report notes that health information that could include genetic information is available for use in underwriting premium rating and other activities rating to the creation-or--- or renewal of the a health insurance and health benefit, and the report notes the privacy rule doesn't limit employer access to ole -- health a half -- information or genetic information and under the privacy rule, once -- once-protected health information is lawfully provided to an employer. It becomes an employment record and no longer considered to be protected health information. The support -- report looks at state law and it notes that there are many different state laws providing all sorts of differing levels of protect. The report identifies 47 states in the of Columbia that restrict the use, restrict or limit the use of genetic information determine how health insurance rates or individualil -- or group insurance rate plans. They vary in scope and genetic information. Some states, for, exclude family medical history from their definition of genetic information. to the reports, the three states without specific health insurance protection are Mississippi, Pennsylvania, and Washington. The report notes some states have enacted widely varying laws dealing with genetic information generally, and of these laws, the report notes that they treat genetic information differently, many of them, or most fright it from other medical roars, they folk -- records, they focus on the medical information rather -- rather than user or use, they safeguard information at different stages of the acquisition and retention -- retention and provide greater individual control through area -- varying means such as concept requirements, rights acts and civil remedies and property rights. The bottom line -- before I get to the bottom line. One of the report -- points to remember is with respect to the state law, regards to the laws that act the insurance is that they also contain different definitions what have copscouts en constitutes genetic information. Again, many of the statutes will cover genetic information resulting from tests and won't include family medical history -- history. So the bottom line is that different las provide different scopes of coverage and protection and allow different enforcement manages. We could have 20 state laws and 20 different ways of enforcing, different levels of protection and enforcing the law. I'm going move into the area of genetic discrimination employment, and re-- repeat my earlier caveat that I merely, the presenter and not speaking as if I could, officially, as an employee, the equal employment opportunity commission. The report notes as that as of August 32 states have enacted laws restricting the use of genetic information in the workplace and that nine states are considering such legislation. Most of these state laws establish greater protection for genetic information than for medical information generally and again, as I have said now, a couple of times, while the statutes do offer some protections in the workplace, there remains the problems that they, again v widely differing scopes of protection and definitions. And many of these laws do not prohibit or do not encompass genetic, a family medical history within the definition of genetic information. As the report notes and as we have heard earlier, there is no specific one federal law that directly prohits or protects against genetic discrimination employment. The main federal law addressing issues relating to genetic information is the Americans with disabilities act, specifically title of theThis slide sets forth the basic coverage of the statute. The three prongs of coverage. Prong 1 is, is -- covers the person with an actual disability. Someone who is major in life activity. Prong 2 is somebody who has a record of a disability and that'll be called Prong 3 as an individual who is regarded as disabled. Now, the report notes, and the slide notes, that the commission, the EEOC has interpretd the ADA as protecting against genetic discrimination. In the regard, the report cites to a 1995 EEOC compliance manual chapter in which the commission elaborate on the term "disability." In the compliant manual, we included an example of, regarded as discrimination that includes the following facts: An individual applied for and was conditionally offered a job and then given an -- a medical examination at which time it was revealed a genetic profile -- profile re-- profile revealed a susceptibility to colon cancer. It was a symptomatic. The employers saw the report and withdrew the job offer based on concerns of productivity and insurance cost and attendance. The compliance manual notes this would be considered a violation of the ADA under record -- regarded as prong of the statute of the were the commission's view, the person, employer was regarding the person as disabled. The report also notes that the commission settled its first case addressing genetic discrimination in 2002. And this is in reference to a case that started in 2001 involving the burlington-northing -- worthington railroad. Suffice to say it involved employers secretly testing employees to see if they had a genetic predisposition to carpal tunnel system. As it turned out, the test the employ ear was -- prom-- employer was using determined if the individual had a rare genetic condition acting one in 50,000 persons called heredtary neuropathy with palsy. Apparently carpal tunnel syndrome and one form of that share certain Kirk -- characteristics. There was a condition that it was not job-related. The standard that is to be used when conducting a medical exam of a current employee, and as the slide notes, the EEOC and bullington-northern e sent are you -- e -- eventually settled the place. No court was roard to look at, address the commission's view about regard with regard with regard to the ADAs coverage. Limitation, the slide discusses of the limiting as. Specifically, it notes the scope of the ADA has been narrowed since 1995, and particularly ge-- beginning in 1999, with respect to how the term "disability" has been defined. In particular, the report knows three cases and decided in 1999 and one case decided in in which the court said that employers, courts, excuse me, courts need to play, pay very special or careful attention to the person at the moment the employer makes an employment decision. Specifically it noted the ADA uses the present tense to determine whether an individual is impaird and if so, whether that person's impairment rises to a level of substantial limit on a major life activity. The key is that the language-defining disability should be read as requiring that a person presently, not potentially or hypoet thatically, can be substantially -- in order to demonstrate disability and the report suggests the upshot of the cases makes it unlikely the supreme court would fond a mere genetic predisposition to disease or disorder would constitute the disability. A person who is a symptomatic would beup to establish the disability under Prong 1 actual or Prong flight recorder -- record and, in fact, might be hard for the person to further establish a Prong 3 violation of regarded as. As an employer would certainly argue, they were not discriminating, that they were taking actions against the non-disabled individual who meet develop a future impairment, but they had no dis-- misconception with regard to his current status. Other limitations, the ADA doesn't prevent an employer from gaping access to your genetic information. -- gaining access to your gentic information. Specifically and in this context, the employer is permitted when, in the hiring process, to get information. Once an employer makes a condition offer of employment to an individual, the employer's permitd to conduct a medical examination of that employee, and there is no limit at that point on the information the employer is allowed to obtain. No limit. So if an employer wants to spend lots of money, you can get every genetic test available there. Is a limit presently with respect to what an employer can do with that information. Under the statute, an employer's limited to -- with respect to making employment decisions based on medical information conducted in the post offer phase of employment, but I will noise note this again, where an employer makes, withdraws' job offer to someone who is a simpom matic based on a genetic predisposition, it's at least questionable, according to the report, whether the individual would have a case, would be able to argue that he or she, whether the employer considered that person, regardd that person as disabled when are -- withdrawing the offer based on fear of future imper ma'ems. impairments. As for current employees, the standard that exists to conduct a medical exam is that the ems -- exam has been to be job related and consistent with thises int. Although it might be less locally the employer be able to meet the standard with respect to ordering a genetic tests, not outside the realm of the possible, for example, during the discuss -- discussions that led to the adoption of the federal executive order for federal workers, some agencies argued they should be to conduct a genetic test of current employees if they plan to assign an employee to a remote look. For example, to do a BRCA-1 test e even on an a symptomatic employee before Sonia Bittoning her a place where it would be hard story -- for her to getmed -- medical care. -- this situation could a rise in the post employment skinario, and an employer gets genetic information. And based on that genetic information, the -- before -- before it could sign to someone elsewhere it wanted to do a followup exam, and it mean hard to argue that moo might be hard to argue that that might not be job-related. The report addresses the more traditional defenses available to employers in 88 case, reflected on this slide. The report notes the EEOC expressed support for legislation addressing genetic discrimination and even though the commission has and continues to argue the ADA offers protection against the genetic discrimination, doingez who sends her -- dominguez testified before the senate health committee in 2002 noting that the application of the ADA to genetic information is less than clear and because it's less than clear, both individuals and employers need understandable rules. So -- so that they can be guided in the future with respect to how they am and use such information handle and use is such information. The report looks at Title of the civil rights act, prohibiting discrimination as note on the slide. It reports notes that if an employer discriminates on the condition of a descrate protected group and -- discrete protected grief -- group, and here, for example, those of Jewish-Egyptian background Indiscernible ] If a employer were to select a specific for genetic testing, say women werum, only for -- women were only for BRACA testing would violate title 7. Title 7 doesn't bar use of genetic information or testing. It just prohibits treating discrete groups differently with respect to that testing. This slide on protection references a case that is discussed in your material called blood cell force the Lawrence Berkeley lab, it's on pack 20, and in that case, talked about federal constitutional protections, um, but again, you you should night that federal constitutional protections are eliminated in that it only applies to governmental action and that there is a way -- weighing in that goes on between individual rights against the public health or, interests of the government in taking action. So it's quite limited. Protection for federal employees I referenced earlier, executive order 13145, applies to federal workers butp forcement of the executive order requires use of the rehab act in that the, there's no remedy for a violation of the executive order itself. So, unless the conduct also is deemed to violate the rehabilitation act, um, the protections included in the executive order are not enforceable in a court. And in the report's conclusions, um, that the report notes there is no one federal law addressing access to and usage of genetic information, but the laws out there that might be used have significant weaknesses and gaps in their coverage and in the ob-- absence of a federal law, we may enterad about -- period of litigation, using the different and divergent federal and state laws, spending a lot money and time trying to figure out what kinds of protections the laws offer, and at the end of the day, finding out for all the cause and cost and time, there is little that -- cost and time and there is little that protects the use of genetic inform aismghtzy believe after the next presentation, there will be an opportunity for committee comment and discussion of the report. Thank you.
Thank you. very much. very much for a very excellent presentation and for a significant body of very great work. So the next, sir, we're going to.
We're happy we're able to be joined today by Mrs. Jamie Vickery, who is a legislative assistant from the office of the honorable Judy bigert of, U.S. of Representatives. As you heard, representative Biggert is the original sponsor of the house bill and it's very timely that we hear some perspectives from some sort of, from the Hill and how you all see where the status is. free to present either from your chair there or from the podium. you very much for taking the time to join us.
Good morning, thank you for giving me this opportunity. I'm pleased to be here this morning and it's nice to be able to get off the Hill. I feel like I have been chaind to my desk and forgot what fresh air and sunshine feels like. Let me warn you, of all, I'm not a scientist. There is a reason I was a political science major and not a hard science major, so I'll leave the nitty gritty details of genetics to you, all the scientists and researchers in the room and focus on the political efforts prevent genetic desitemination. Now, as you know, my boss, congresswoman Judy Biggert, along with Lo -- Luis Slaughter of New York, Bob May and have introduced HR 27, the genetic non-discrimination act of 1995. Congresswoman Biggert is the of the subcommittee on energy, the subcommittee with jurisdiction over the human genome project. I don't have to tell you all the sequencing of the human genome was one of the most excuse me -- significant scientific break-throughs of the past century. The implication of the of the brackthrough are mind-boggling. Because of the genetic testing made possible by the discovery, individuals can, for the first time, know their risk of developing more than 1,000 genetic disorders. They can adopt better habits such as exercising, eating better, going to the doctor or going to the Jim -- gem to lessen the impact of their condition, and they can mentally prepare themes and their families for what may happen down the road. However, as we -- have heard today, the ability to protect excuse me, to predict disease through genetic testing and family history opens the door for terrorist-- discrimination, particularly in the employment and health em-- insurance field. When individuals are afraid this information be used against them or their families, they will not be tested and the research is not being used to its full advantage. Some people have said they won't want to know. No doubt, finding out that you or your child could suffer from a debilitating disease could be disconcerting, but this should be an individual's choice to make for themselves. The fear of losing their job or health insurance shouldn't be a factor. As we just heard existing laws, including arisa and HIPAA are unclear on the topic and are no more -- more than a patchwork. To be frank, they're Swiss cheese. This means in order to protect -- protect an individual's privacy, we have to enact legislation prohibiting specifically treatment the basis of genetic information. That's why it's important to get HR 1227 passed. O Pope -- opponents say it's not necessary but the solution and need of the problem. No one should lose their job or health insurance before we enact legislation. Specifically, the bill prohibits employers ear health insurance from making employment or coverage decisions based solely on someone's genetic information. The bill's very, very similar to the bill, Luis Slaughters introduced into congress. However, we realized that given the current political climate, a bill introduced was probably not going to go very far. So she and her staff graciously let Congresswoman Biggert take the bill N. keeping with the current political environment, we have made a couple of little changes to make the bill more business friendly and make make it easier for republicans to get on board. None of these changes substantially change the bill or take away any of the enforcement make nisms. The bill places limitd limbs on the amount of damages a employee can see based on the sides of the company, and contains protection against frivolous or opportune lawsuits. It includes so-called water excuse me -- watercooler gossip. If your office is anything like mine, everybody knows everybody's business and it's not always true, and there is nothing your boss, much as they try to control it k do about it. This is the exact same legislation that passed unanimous lein the senate, and it's strongly supported by the bash administration. So what is happening with theble? Unless -- unlike the senate bill that went through the health, education and labors and pension committee, the house has been there through three committees: Education in the workforce, energy in commerce and ways and means. Because the non-terrorist -- nap discrimination provisions apply to the medigap insurance people can by to cover -- buy what medicare doesn't cover, ways and means needs to soon off on this bill. One tiny provision the bill and it goes to a separate committee. However, the ranking member the exul -- full committee, Charlie Rangell from New York, and the chair of the house subcommittee Nancy Johnson from Connecticut are both cosponsors the bill. I don't think we'll have a problem in ways and means. I'll be honest with you. Like I said before, there are some in business community that are opposed to this bill. Andol the education and workforce committee held a hearing on non-genetic, non-discrimination in July of last year, nothing -- nothing more came out of it. The business groups are afraid this new legislation the set up a new regulation on how they do business or that it will create an administrative burden. Let me assure you, this is the last we want to do. This is -- Mrs. Biggert is a member of the education and workforce committee and a member of the employer/employee relations subcommittee that has discuss -- jersey deck over this bill. -- jurisdiction over the bill. She understands the concerns. We're trying to work with the business groups to address their concerns -- concerns without taking away any of the guarantees of genetic privacy. Although the groups are still opposed, they're not as adamantly a -- opposed as they once were. Some cautiously optimistic they will drop a neutral stance and not work against the HR-1227. Right now, we have 105 co-sponsors. When you consider there are 435 members of congress, means we have gotten a quarter of them on this bill. However, the problem is that a majority of the cosponsors are democrats. We have 74 democrats to only 31 republicans. The republican-controlled congress, that is not all that helpful. This is a bipartisan bill, and we need the cosponsorship to reflect this fact. So right now, we're focussing on getting republicans cosponsors. For a lot of members, it's a good way to show that you are pro-patient, pro-medical research without having to deal with the sticky stem cell issue. It's also a good weigh for members with large genetic labs or biotech companies to show their report -- support for their constituency in their district. Ideally, you would hope number -- members would get the bill because it's a good think this to do. In reality, you have to sell a bill for what it can do for a member. That's what we're trying to do. Here's where you all come in. Now, I know it's sort a delicate position because working for the administration you can't really lobby for the bill even though the White House does support it. I would encourage you to let agency leaders, including Secretary Leavitt how important this bill is, and encourage them to encourage house leadership to get the ball rolling. I know the President strongly supported, there has been several excuse me, there has been two statements of administrative policy in 10 8th and 109th congress, but we haven't heard much from the White House other than that. They're not being, getting role involved. Anything that the administration can do to sort of kick leadership in the pants on this would be very helpful. As you know, this issue's been around for quite sometime, and, in fact, congresswoman Slaughter's introduced this bill or something similar to it in every congress since 1997. This is theeing for thest we have ever come in the legislative process but we still a long -- a long way to go. I'm confidents this the year we can finally do it and protect individual's genetic privacy. We all know those provisions are long overdue. I know you have a lot to fit in today, so I'll wrap it up. Once again, thank you so much for this opportunity to be here with you today and thank you for all that you have done on this issue in bringing it to the forefront. I look forward to working with all of you and getting this bill passed. Thank you.
Well, very much. We very much appreciate your taking the time and also your offer that be able to continue to be connected to not only to the congresswoman as well.
Yes.
I think now with that, and if can you still please join us at the table still, we would appreciate it. The prior -- floor is open for some discussion. By the way, I want to say that we, we actually don't quite work for the administration. We are ad-- advisory to the secretary, so that gives us a little more latitude and I'm glad you that sort of put that there so we can underscore, particularly for the new members of the committee on, again, that we're an advisory group to the secretary and there are certainly some constraints there, but there are multiple opportunities there. -- floor is now open. Ed, I so in our rand -- hand.
First, I want to thank you for coming and and presenting and please take our thanks to your boss as well f -- for sponsoring this something that has in the six years I have been involved on advisory commitos, it's been one of the top issues for both administrations and each of the secretaries, or at least we have take know it to each of the secretaries. Please, please thank your boss for response organization this. You gave us some guidance in terms of how we could help. How do you think -- the opposition is, is the opposition, you oon use said, you think they may go neutral on this. Is there anything that needs to be done in terms of getting more support from appropriate business-friendly groups to help with is -- with this.
We are actually working with those groups, like I said before, and they probably have about 10 concerns. And, you know, there are certain things we're happy to set down and negotiate with them. There are some things that are not negoteable and, it's a matter of finding something that people can live with on both sides of the aisle. Basically our strategy root now is to get as many people on as we possibly can. The harder, excuse me, the more people have supporting the bill, the harder it is for groups to oppose it. Politically and PRwise. So, at that, that is our strategy right now and focussing on republicans, focussing in on bringing people in any constituency, people affected by this, think this of the -- it's hard to say no to people from your district and hard to say no to sec people.
Yes.
As a follow-up to, that those of us Tateing -- rotating off the committee, when is the last day of the service, the end of the meet something okay, you very much. I'm taking a mini sabatical, and the, I meant representatives in the,who is a republican for the district in which I have a small business in Colorado. And so I may pay him a visit then as I am -- .
We'll get you everything you need to go
Excuse me?
Come see us and we'll get you everything you need to go in and meet with hep.
very much.
Agnes.
As I mentioned earlier that one of the options that we have is we actually have 150 of the CD-ROMs, of the testimony the public and maybe what we can do is to identify the people that were previewd in this public comment, what areas they came from and specific local -- specifically, Sunday it to those representative -- send it to those republicans and, of course, may be to the, all the house members as well. We can't send it, of course, but we can recommend the secretary, of course, send it on to them. we could highlight what areas those people who spoke, what areas they came from.
Great. We've got in the queue, Francis, Emily and julio. I want to make sure, though, that Jaimie been given a copy of the lead -- letters we have sent to the secretary already, and if we have not, Jamie, iffy -- you don't have those, I will see someone who has a handy copy around, they can handle -- hand it to you to take it with you when you go. Obviously now, we're thinking about the next step. I want you to know we're pushing hard in that regard. Francis.
I would also like to express my thanks to representative Biggert and to you, Jamie, for being here today to stall -- tell us about the status of this. Having worked on this issue, some of us for more than a decade, it's gratifying to see the activity that is going on this year with the unanimous vote in the senate and now The bill being introduced in the house and at least assign to committees, although I guess I would like to hear more about yourm pregs about whether hearings are likely to happen. Because without them, it's generally the conclusion that not much forward motion is going to be occurring. I mist -- I must say I'm deeply disappointd to see the opposition that. Seems to be largely responsible for the current logjam coming from the business community. After all, as pointed out in the 19 error-- nice presentation by Peter, a very large number of states have passed investigation -- legislation that prohibit the use of genetic information in hearing and firing and promotion and to our knowledge, there has been not a single instance that legislation has led to frivolous I think has been one the communities concern's coming from the chamber of commerce and the national -- national -- facial association of manufacturers. The evidence for this being a risk to the business practices doesn't appear to be very compelling, and the argument the need for this is night -- nicely outlined in the democrats we heard here and reproduced on the DVD are from the public's perspectef and iseral very compelling. So, I guess I had two is what is your estimate about the likelihood of hearings and the second relates to rumors that one has heard that perhaps the bill would have a chance if the employment provisions were stripd out it was reduced simply to health insurance protect. I want to comment I don't think that isma -- what the public is looking for. If people are anxious about genetic information and how it mean used against them, employment is clearly a serious issue. It's not just about health insurance, and I think that would be in unfortunate to see that particular the bill lost in this particular shuffle. May be can you comment on whether that particular idea of recrafting the bill it only to health insurance is something that is likely to have any legs at the moment, and as well if you could comment about the hearings.
To answer your second question first, you know, there has been legislation introduced previously that was just healthI am not entirely sure that that is something that Mrs. Bigert and Mrs. Slatter are amendable to, from what we have heard. The insurance excuse me, the insurance industry is not nearly as opposed to it as the business community. So would be easier to do, but I guess -- guess it comes down to something, or to the question of do we want what we need or do we want what we can do and I think that, you know, from everything we have heard, the employment Aron Katzmana s where the problems seem to be cropping up. And that, I think, that's, we need these, the employment issue as well. To answer your first question about committees, from what I can tell, the committees are more opened than they ever have been. Certainly any workforce had's hearing in July on had a hearing in July. It's hard to say what committees are going toco -- to do and what they're not going to do. It did pends on what sells on the sleight on this timing and we have had a schedule of congress and all I say is we're working on this and they seem to be more amendable to moving this bill than they have in the past.
Good. Thank you, and let me make sure that I understand also, Jamie n this regard, the -- is there any active discussion with the employment community around, are there ways in which the bill can deal with their concerns regarding frivolous or unnecessary lawsuits. It's not even, as I understand their position from, we did a lot of work with listening to them very carefully, and they were generous about their time and helping us to understand it. It's just, as I understand their position, it's just as the public is concerned about the potential fear and misuse. They're concerned about the potential of frivolous lawsuits which, is important to their conduct or their opportunity -- activities. Are there any, is there any sense offence is tist to the concerns, there any way in which The bill might modify, when someone takes into account those concerns. That was something that was brought up with the SlaughterBle in the 10 8th congress. If you look at the, excuse me, the current bill, 1227, there are some provision -- provisions in there. Yes, the exhaust administrative, excuse me, there are certain steps that have to be followed before you can take a claim to court. And also, it's broken down into three categories, the amount of reward that can be a -- received. There is a limitation on awards based on the size of company. So, obviously, if you have a problem with birks -- ibm, ibm is going be able to take care of that claim more than a mom-or-pop Goldman Sacher -- bakery, or something. We're still open to negotiating with them to, like I said before, it's a matter of finding the balance between still having affected enforcement mechanic theming mechanisms and the same time, finding a way for you to make it work for business people. Thank you. Emily.
I think one of the things this committee has tried to do in the past to move the legislation forward was to understand what the objections were. And what we had heard previously was that there were two objections. One was that it's not really happening. We have testimony. We have a dvd. -- a DVD. Please use these tools. The other comment -- comment we heard was there is adequate protection under the law. We commissioned a report to really review that in a very analytical way to look at what actually are the existing protections and to create a set of data that could be presented again in a very analytical way to individuals who are making those kind of, just brush it off kind of comments. We don't need to be wasting our time with this. There are other things that have taken care of. Are there any additional points that we could address very specifically through the mechanism this committee has, which is basically public comment and the ability to commission special reports of the state-of-the-state that would be helpful at this pot in time to move the legislation forward.
I think the report is going to be phenominally helpful. Again, like you said again and again, people are saying oh, there is existing protects in law is HIPAA. HIPAA taking care of it. Arisa is fine. There are already pro10s in the law. To be able to present them in a precise and say, you know, this doesn't cover this, this doesn't cover this, this doesn't cover this, it's going to be tremendously helpful. As there was some way to Sunday that out to the hill and in a very concise, very format that staphers could at and we could use could be incredibly helpful, getting people to understand there is really no legal protection.
Okay, and the other question I had for you is of the individuals who have not yet signed on, havey that not yet seened on because they just have not yet really been educated and come to a decision decision oh -- or they have not signed on because they're opposed to specific reasons.
I think it's a combination of both. We have certainly health, staffers are overwhelmed. The stem cell issue on the hill consouped everyone for the past -- consumed everyone for the last three months, it feels like. Sos that -- settles down and people are starting to move on from that, I think this is people time to educate members on the importance of the legislation. Reporter: Just want to clarify one thing that I think you just said in responsibility-- response to Emily. Sarah, let me just make soar. Sarah, let me make sure. I want to make sure you heard year -- clearly. I think you alluded to it, but I want to make sure you're specific. Did you actually request we send your office a copy of the analysis that we have done?
That would be incredibly helpful. I would very much appreciate's copy.
I just wanted, for the record to note, that we have been asked to Sunday a copy of the report to the congressman's office, and we'll be happy to do so. Thank you for the clarite. Julio.
I have a question on the same issue, which is whether it's been abrupt or become problematic, kind of where does, um, like a pre-existing condition, you know, where does that begin and and what is left over with actual to nextitiving. other words, can you get genetically tested and be shown to have a predisposition to a disease you kept have yet, or -- you or you can already have the disease and also have the Gene. And for pre-existing conditions, it's traditionally, healthcare has been tradition problematic, and that is the genetic testing that is discussd in the legislation overlap with this wish issue of pre-existing condition. other wordsia, we talking about only the tests for someone who is healthy, or a test with someone who may already have a condition.
I'm from the labor department. Maybeec speak up. Writ -- it may seem random a labor department person is speaking up, when Peter talked about the HEPA probable provisions and protects they have against sort of in health insurance and health insured based coverage, plans, restricting coverage based on the fact that a condition is pre-existing, I think the analysis that we have done supports the finding that pre-existing conditions, once you hull -- actually have a condition, I think you're pretty clearly within the HIPAA protects. What is unclear is if you don't have a diagnosis of a condition and there is just genetic information, there are still a lot of gaps there and I think that's what the legislation is looking to address. There is a question whether or not a attending provider or a licensed medical professional has diagnosed the condition, then I think you close -- cross the line into a pre-existing condition and start where proy thees apply. It's up until that point there are a lot of gaps that I think the legislation is trying to address.
Our ex officio is terrific. Yes. I can clarify whether the request is for the legal assessment report or whether you're also requesting our telephone book of the public comments. And whether you have that already and whether that would be useful for distribution?
I would actually like both if you could -- I, I -- we appreciate both of them.
We appreciate -- appreciate. We're very clear on what the request is. Thank you. Any -- yes.
I would just encourage those who are, speak on this issue, include in your talks. One of the first things I did when I received the telephone back in my office was take a picture of it so that one could see the thickness of it. Because I think this has been an issue that why, why develop budget legislation when there is no discrimination. I was on record at the last meeting for saying that the individuals who have written and their judgeetivity iss, they're -- and their genecitists, my colleagues, have wren this is not a problem and should be a shamed from of themselves, and I have -- have received comments back from them arguing I should not say that. I'll go record saying they be ashamed. It's when you catch the fox and hen and him doing this he he's visiting, and why he have blood on his and he said cut myself shaving. you know, you don't ask, you don't ask the insurance companies whether they're discriminating. were going to say?
Um, let's do couple of folks here sort of wanting your picture. Not your picture, but -- [ Laughter ] -- the picture you took. They probably want your picture, too. If you would Sunday that around to the team, I think everyone would appreciate it. As we bring this portion of the meeting to closure, let me just try to get, again, we have a couple of seconds before the break, but I want to make sure that we are clear on the next steps here. I think the committee has gone pretty far in terms what have it can do. The secretary now has the materials that have been referenced, he has the letter. We will, of course, use every mechanism to keep that in front of him from moving forward. And what I want to sort of get a sense of is is there anything else left? I still would say to you, Mrs. Vickery, that if there is any role that we can play to, and I don't think that that's -- I'm volunteering it or saying I think there is, to help try, to again, look at whether -- where of the opposition, quote, unquote, is, and common ground trying to, grape, get -- again, get language that helps to met date -- mitigate of the concerns they have that are not related perhaps to the issue, but more of the unintended consequences of the issue, and that's really what I think, I'm hearing a large part on that community. It's the -- it's the unintended concerns about the legislation. If there is a role that we can play in terms of brokering, talking, clarifying, mean I think we really want to get there and so no -- know that the committee is open to whatever role we can appropriate lay play within the confines of of our charter and responsibility. A couple of quick thoughts to get us, we have other next steps and only that. One, two?
Did we specifically, from Agnes' comments d we specifically ask the secretary to do a broad disk of the public comments and of the public comments and the legal analysis.
Let me read the letter we'll quick.
Can we do that or recommend it, ask it of the secretary?
Actually Dr. Zahoney in transmitting the recommending as the committee, suggested that that the secretary do that. So.
Good and --
Just a point of clarification. Can we or can we not as individuals contact our representatives, especially those who might be on the wrong side of the picture -- particular issue, long as soon as we don't make fact that we're members of the advisory committee?
Yes, as long as you don't do it today or tomorrow.
All right. Yet -- yes. Last comment.
And in our last summary, we had made a recommendation to the secretary that they pull together the stakeholders to actually analyze of the disconcerns from the business community and I don't know if that's been moved on or we can say something to the effect. To mention in the reports in the public comments we have had when the coverage and reimburse issue -- reimbursement issues, there were several organizations that voiced their support for the antigenetic discrimination legislation. One of which was the American academy of actualaries, the other the American association for clinical chemistry and I'm just wondering whether we should, you know, kind of go through that report and pull out even some of those comments and if we were going to send on another report from this meeting, to sort of e keep say that we have received further comment from the business commune -- community and that maybe some of these organizations could be included in the steak stackholder meeting, if, market that's where that would go. [pausing to switch captioners][ Captioner needs audio. Please hang up the phone so the captioner can dial in. Thank you.
Captioner needs audio. The audio is ringing busy. Please hang up the phone so the captioner can gain audio access. Thank you[ No audio [
Captioner has no audio. Please reset the audio line so the captioner may gain access. Thank you.
Captioner has no audio. Please reset the audio line so the captioner may gain access. Thank you.
On the role of fda and monitoring such marketing and third that recommending that hhs collect data on the public health impact and collaborate with the federal trade commission on the monitoring of such advertising. In march, we received a response and you can five that in brief five of your briefing book. Since that time, there have been some efforts to address our concerns. During an interagency conference call on this topic in April, two working groups were established to respond to our recommendations. We will be hearing updates on those working groups shortly. Following the working group updates, Deborah wolf from fda's center for devices, office of compliance is with us, and we are happy that she is able to prie provide an update on fda's role in monitoring marketing of genetic tests and services. Before we hear Deb fwra's formal presentation, I'd like to ask Matt Danerd and Deborah wolf to update us on collaborative efforts to monitor such advertising. So Matt and Deborah, can you give us that update, please?
Thank you. Yes. Matt Danerd. I'm happy to report that the fda, etc NIH task force is up and running and working well. Due in large part to the people sitting next to and Faye of NIH. What they have done is put together a wonderful chart that has potential targets on the left side. There claims somewhere in the middle a synopsis of the science supporting those claims potential consequences both health wise and economic and they presented that to me and we had a telephone conference about that. I comments on -- commented on those on what was good and what we needed. What the FTC needs in this area since a lawsuit here, if this is what we're looking at down the road, would be an entirely new application of the FTC act, we need the proverbial slam dunk. We don't want any scientific issues anybody on the other side could debate. So this is what we're looking at. The nda and -- fda and NIH are going back to doing a little more work which I am eternally grateful. They're going to come back to me after this committee meeting sometime in the very near future and discuss it again. And when we have a consensus on good targets, I'm going to take that to my folks in advertising practices and say, listen, I've told you about this. You've been a bit excited. Here are the potential targets. Hopefully I'll be able to say this is a good case, and if they agree, we'll take this to a bureau of consumer protection folks and get their head's up sort of agreement and we'll take it from there. You have to realize that unlike the fda, our hook is not simply the public health, although that's an enormous criteria in our case selection. Our hook is advertising. We've got to find a strong claim, which is not supported by competent, reliable scientific evidence and then we take it either to court or administrative law judge. Part of that, of course, scenario is, well, when's the potential public health consequence? What's the economic consequence? How strong is the claim and is the science? What we're looking at are claims that some of these tests can help you lose weight over the long term or can help you determine whether you are susceptible to serious diseases like cancer or that they can prescribe a nutritional diet for you in the future that, in fact, will help you avoid some of these diseases or avoid obesity and we're fda in particular is checking into the science on these and how the tests are performed because that does make a difference as to whether they are -- how predictable or projectable they are. So they are doing all this work, and it's quite wonderful. I think we're off to a good start.
Matt, thank you. Let me ask one quick question. Given the ones we've seen in terms of facial cleaning or this addictive behavior, does your child suffer from the predisposition to alcoholism, drug abuse or learning disabilities, just send in your swab and we will give you the right nutra suiticals based on this genetic profile solve the problem. There are interesting examples out there. I guess where I'm sort of struggling with is wondering why you are having such a hard time finding or narrowing down on the right test case.
Because what we're talking about are specific facts. What is the exact claim? What is the science supporting that claim? How serious is the condition that the test that the advertiser purports to claim that test is going to show you? An addictive behavior that affects us all and we're all concerned about that, but the kind of claims that we deal with on a daily basis are cancer cures. Aids cures. Bogus HIV test kits, which we just did with the five-dayhat's the kind of claim that gets our attention.
Again, I'm glad you are moving forward. of the things I must say as we list ton Maureen who's coming next, and then we have questions after that, is apparently observers in prominent scientific publications in commenting on this process have decided to label our activity moving at a glacial pace. While they are pleased we are doing things, apparently we are characterized as moving at a glacial pace. Hopefully, whatever commentator that wrote this after this meeting decide that maybe we are at least moving at a more aggressive glacial pace, but that we are trying to do this seriously. Let me also take this opportunity again, for the new members to remind you, there are a lot of people that pay attention to what we do. We may not always agree with how they interpret our activity, but we are being interpreted. Be mindful there is a lot of scrutiny what we are doing as it should be. Newing from cdc. Thank you, Reid, very much. Actually, in that same article, I was quoted as saying that my friends at the fda are doing nothing, so that tells you how your words can be distorted. So my apologies to the fda if my words did not -- said the wrong thing at the wrong time. Anyway, we had a conference call last week to begin the process of discussion of how hhs is going to respond to kind of collect data on the public health impact of the act consumer marketing of genetic tests. And we have a working group that has a representative from nhgri, fda Joe Hackett serves on that. A few folks from the cdc and I would welcome any of the new members on this effort because our work has just gotten started, and I want to thank Sarah and the SACGHS staff for keeping us on target. Our job is not as easy as it seems measuring public health impact has multiple facets to it because you have to define what that means. And as I said, we had a brainstorming session, and at the outset, we kind of decided to break into two groups. The two types of tests, if you will. The ones that are squarely within the health care dliivery systems where you have direct to consumer advertisement that is done within the context of health care providers examples of this is the back to one analysis campaign that many did a couple of years ago. Then the other ones are the ones that are outside that system because it impacts how we can measure impact if something is in the health care system as you mentioned with the public health response with the back to one analysis campaign. Presumably, if people do this outside the system, then there is really not too many immediate ways of finding the outcomes or impact of such advertisement. But we kind of began to kick around a few questions. Obviously, the ultimate impact is find out the outcome of people are tested, not tested, whether people are being helped or served by such ddc targeting. And I think it may, as I said, it would be a few steps before we can devise the kind of data collection instruments to get there. There are a few more, I guess, what I call process measures that one can use. One consumer's knowledge, attitudes and behaviors. Whether people have heard about these things, and whether it's affected their knowledge or their behavior in seeking them and why they seek them and who are they, and or not the outcomes have changed. So we started that discussion, and let me just give you a quick summary of, in your tab, I there is an example of a public health response to the back to one campaign that was an actual experiment. It happened in an intensive way in six-month period in two cities in U.S. in Denver and Atlanta. At that time there were at least two responses that happened. We partnered with health departments Colorado and Georgia to mount surveys to health care providers, and women of the right age group. Random surveys to find out what's going on. There is an mmwr article in there and a peer reviewed publication on its way. same time, Keyser in Colorado did a similar are analysis in the Keyser community, and they have the advantage of using hmo is that you have a closed system and it may not be representative of the population, but you know referral patterns and the paper and genetics and medicine just appeared in March this year. You guys can peruse it. And at both of these surveys showed an impact of such campaigns. I mean, it's a no-brainer advertisement works. It makes people think. It makes people act. Whether it changes outcomes or appropriateness of referrals, that's something to be looked at, but during our discussion last week on the phone, we kind of began think about the ways to essentially tackle the problem. One way, and I'd be curious to get some more input from the committee here. One is to partner directly with these companies. And we were cautioned to work more with the other subgroup here because on the one hand, if some other part of the government is pursuing them, I think partnering with them to seek data on who uses their services and obviously there are privacy concerns and business practices that may not allow to us do this, but for us, I think finding out why people use these services and what the impact of these services are on their own health is what we're after to try to document these things. So we decided to shelf it for the moment until we figure out what the other group is doing. We talked about networks as a good place to do these kinds of activities and surveys, and would be trying to pursue this. But of course, this methodology would miss outof pocket purchases and direct access. other words if it doesn't come back through the health care providers and be in the chart, there's no way you can capture the impact of such a practice. The third methodology is to piggyback on existing surveys that cdc and state health departments do on an ongoing basis. of the surveys cdc does on a yearly basis is the health star survey, which is a random sample of a representative sample of the U.S. population about 45,000 people, and we're going to be adding dock styles this year, which is a random sample of physicians to find out what people do and what practices look like. And again, if the magnitude of the issue is small, I mean, 4,000 people may not to pick up if it's only one person in 5,000 that use these services, it would be very difficult to pick up. But at least establishing baseline rates of different things will be important and you can track it over time. Now, of course, states have different surveys. One of them is the behavioral risk factor surveillance system which is faith-based survey, and we will be looking to part with several states to evaluate that data collection systems as long as we are able to devise sort of minimum sort of co-elements for how we can do this. So anyway, we are going to be exploring different things over the next few months, adding questions to existing surveys, both state and federal, and working with hmo's and I look forward to working more with different members of this committee and trying to get a better handle on this public health issue.
Great.
Thanks.
Let me just march into the presentation and can I come back we'll do the questions at the end? Is that all right or do you have something that's really
It's very brief and it's appropriate now. I would suggest that Emma Maris who wrote the piece you commented on before for nature and genetics, that you contact her, Mr. chairman, about the genetic nondiscrimination since this seems interested in genetics.
Good. Thank you for connecting the dots. That's great. Let's move now, then, to Deborah Wolfe's presentation. Deborah is going to update us on the fda's role in the oversight of direct genetic market with tests. She's with the office for compliance at fda and then after Deborah's comment, we'll come back and put all of the pieces together and determine, as you listen to what she has to say and what you heard, how we might move forward in terms of our agenda in this regard. Deborah, thank you so much.
You are welcome. to be here. Good morning, everybody. I want to make a couple of quick points before I start my slides. One is that I would acknowledge that we do work slowly in general, and I think in part that's because of the bureaucracy itself and the way government works in general. Part of it has to do with resources and part of it has to do with these issues being complicated, and there's not always consistent opinion or agreement inside the agency or within the department. So these things just require a great deal of discussion before there's really a movement. The other thing I want to say is that my presentation including a lot -- includes a lot of references for statutory and regulatory provisions. I hope that you don't find that off-putting. I think here, a lot of the specific language in the statute and the regs is important, and why I did it this kind of legalistic way. Okay. Direct to consumer marketing of genetic testing is taking place in a much larger context of direct to Conner -- consumer marketing of all kinds of medical products and services. So I think that's one part of how you look at the entire field of, you know, consumer reaction, what prompts consumers to go have a specific test done? There have been a number of studies done on the impact of different aspects of dtc marketing of drugs especially, and there really are a lot of mixed opinions in the consumer and medical communities. The advertising and access of genetic testing raised concerns that are different from those of advertising direct access of drugs and medical devices. Some of them are the same in terms of who is making certain decisions, what kind of guidance they have, but they're also, as we heard, a lot of much larger consequences. And fda's role is uncertain. Inveet troa diagnostics provide information rather than treatment, so when the agency approves or clears a diagnostic test, the safety and efficacy are reviewed in a different way or viewed differently from the way that they would be viewed for drugs and devices that are used in therapy. The consequences are the ones, you know, remove the test itself, generally isn't causing any sort of danger. It's what happens with how good a test is, how reliable it is, and what happens with the information you glean from it. Okay. These are kind of the basic aspects of promotion and advertising medical devices that we look at. Premarket notification, premarket approval are the two ways that medical devices get to market. Whether it's the labeling and advertising authority the mda has over medical devices, intended use has to do the kinds of claims that a company makes for the use of its products. All of this touches the practice of medicine, which fda doesn't regulate, and I'm going to touch with our work with the federal trade commission. Premarket notification, these are generally lower-risk devices. Essentially, these are devices that are cleared for marketing based on being equivalent to a part that either is on the or was on the market prior to the date that the medical device amendments were enacted in 1976. For the most part, general controls and special controls apply to these devices and they don't get the same rigorous review that products that require approval do. Company submits a premarket approval application and the product will be approved if the way that the conditions of use are presented in the labeling provide that reasonable assurance that the product, if it's used according to the label, is generally safe and effective. Okay. Central to our regulation of analyze specific free agents and how that affects genetic testing, an approval order granted to a class three device that requires premarket approval. The approval can restrict the sale or the use and distribution of the device. To the same extent that it's permitted by section 520-e of the statute, which basically says that if fda believes it's necessary, they can require that the sale, distribution and use of a device be redistrict -- restricted by regulation so that it's either made into a prescription product or upon any other kinds of conditions that fda thinks are necessary to provide safety and effectiveness. 520-e referred to restricting devices through regulation. There are only three devices currently clear, restricted by regulation. All of the other ones -- any other restricted devices are restricted through its approval order. Those are all of the class three more rigorously reviewed devices. The only three that are restricted by regulation are analyze specific free agents, and hearing aids. Most restricted devices are class three that require premarket approval and are restricted through their approval order. Okay. Section 502-q provides that a restrictive device and restrictive either by regulation or approval order that a restricted device in its branding if the advertising is false or misleading in any particular or used in violation of any regs prescribed under section 520-e, so for analyzed specific free agents restricted by regulation,502-q would be restricted if it's false or misleading or sold in of the restriction captured in the regulations, which I'm going to mention in a minute. Section 502-r is false if it doesn't include the intended use summary of relevant risk information. And device labeling, which is a broad category of material that includes any sort of handout, glossy brochure, any piece of material, essentially that a contribute distributes is labeling. A device is misbrand fd it's labeling or false or md leading in any -- misleading or any particular. That applies to all devices. The advertising limitations that I talked about were for only the restrictive devices but fda has labeling authority over all devices. Labeling, as I said,interpreted broadly. The material doesn't have to be physically with the product to be considered labeling. It can be as long as it is textually related, it's been determined through case law that essentially if it's about the product, it's labeling. Advertising is not really defined in the food, drug and cosmetic act. It's mentioned but it isn't defined. So the center for drug evaluation and research has regulations, and the way that they define advertisements, basically, is, and adds that think about sort of intuitively as an ad in published journal magazines, other periodicals and broadcast ads. Our review of advertising as opposed to labeling brings us closely in to working with the federal trade commission. In 1971, there was a memorandum of understanding between the two agencies that essentially decided that fda would have primary jurisdiction over the advertising of prescription drugs and of restrictive devices. Those devices restricted by approval order or by regulation and over the labeling of all prakts. And the federal trade commission has primary jurisdiction over advertising of other than restricted devices and over-the-counter drugs. One thing that's very important in terms of the genetic testing issue is that fda hasn't really clearly defined the Internet as either labeling or advertising, so while we do apply our jurisdiction, it's not clear for the most part whether we are actually defining it as labeling or advertising. And it's the in general, the substance of the claim that we look at. We did have an Internet working group a number of years ago that was attempting to make that determination. It was, in fact that group was disbanded. The federal trade commission has a broader authority over advertising in general, which is why their role is very important in this area. Okay. Analyze specific reagents used in idt testing are restricted, as I said, by regulation under the authority of 520-e. This is the regulation that I've shown here 809.30, which restricts the sale of sar's. They can be sold to ivd manufacturers, they can be sold to labs granted high complexity determination and then they can be sold to organizations that use the reagents for other than medical diagnostic purposes. The labeling for asr's is limited as well. The labeling has to make clear that analytical and performance experts are not established, and for class two and class three, the higher review amize specific reagent except as a component of a specific test analytical and performance characteristics are not established. The reason that's important is that when the tests are marketed and they are marketed only to labs, they're not allowed to make a claim for the intended use of the asr. Once they do that, it becomes a device subject to the claim becomes subject to fda's jurisdiction. Okay. The advertising, the regs on asr's require that the advertising promotion, which includes their labeling and their advertising include the identity of the analite and again the limitations. For class two and class three, as I said, they are limited to whatever test they have been shown to be used for. Class two and class three are higher risk uses, essentially class two are mostly blood bank kind of analyze and class three are HIV tests and tb test and a number of others. Okay. Ordering -- this is also in the regs. Ordering in-house tests is limited under section 520-e of the act restriction to physicians and other persons authorized by applicable state law to order such tests, unless, as I said it's sold to ivd manufacturers for other than diagnostic purposes. what happens here is that in all of this direct marketing to consumers, the testers used in labs that are developed using the analite specific reagents are technically limited by regulation. No one should be ordering the tests except physicians. You do have the way that a lot of the medical device contact lenses or a lot of prescription drugs, a lot of the web sites that sell those will have a physician on their staff that's perfectly willing to write you a prescription. Whether that's valid, the prescription itself in that setting where you have no relationship with the physician depends mostly on state law. So the state's regulate pharmacy and the boards of medicine. So who can actually prescribe a test is up to the states. But this would be helpful in terms of our regulation of tests used developed by labs using asr's if we knew how to apply this, and if there was support in the agency to enforce it. It's not clear here, actually, who -- whether this would restrict the lab from accepting an order. I mean, the problem here, this doesn't really discuss who comes under the jurisdiction and who would be responsible for basically not ordering in-house tests. So the question where this genetic testing involving laboratory developed testing is really whether the of the asr, which we do regulate and the lab process become a device, you know, conjunction of those two things become a device. That would limit the reordering of those things to physicians fist establishing whether it is a device and then as I said, this issue of Internet prescribers. Limiting access to the tests, even if we could enforce that of the regulation, wouldn't prevent labs from advertising the test, and then the question is, whether advertising a specific use for asr by the lab creates a device that requires premarket approval because generally what starts fda jurisdiction over the product is the claim the company's making for it. So if a lab is establishing a use, then they could misbrand the device if that were an inappropriate claim for the asr. Okay. When we look at enforcement as a whole, and with specific reference to ivd's and tests, we're -- fda is focussing right now on risk-based reviews both in terms of public health priorities and in terms of resources. Here for asr's and laboratory tests, you know, there are a lot offish b shoes about whether the tests are valid, whether they've been shown to provide the information that they really claim to provide, look at the consequences of false negative and false positives. Several viewers talked about the kinds of health care decisions people make or employment decisions or all sorts of thing maz may -- that may result in an incorrect answer. We would at the seriousness of the disease or condition, the role of the genetic counseling and then, you know, the issue about whether genetic information places a certain burden on people that they may not want. All of these things are, you know, broader issues that fda really can't decide itself but that go into our Cal cue louse. The agency has cleared about 12 Nen netic test kits. These last three are among the more recent. Dr. Joe Hackett, who heas here, can speak for peiveg about she's tests if anybody has specific questions. I'm not a sigh enterive. I don't really know what exactly they do. These are some of the kinds of claims that we are worried about, and as Matt said, you know, we need a slam dunk. It's not -- there are a lot of claims out there, but in trying to identify -- here we talked about the impact of wrong information or the seriousness of the disease. We need to put all of those together when we're looking at how to best use resources. So these are the ones that we've identified as Matt said, a chart with a number of Internet companies. These are the kinds of claims that we've sent for now, companies are claiming that their tests can predict how someone will met tab lies drugs or have adverse drug reactses, nutritional counseling, tendencies toward obesity and detecting sus Septemberibility sus Septemberability, auto immune diseases, chronic fatigue and a number of infectious diseases. As we've said, fda and FTC are working now together to coordinate some of the information we've collected. The comftion on the -- the information on the web site. I want to sort of point out right now we're focussed on Internet web sites. There are other kinds of advertising for these products. I haven't actually seen of it, but because the of the Internet has become so widespread and it's national, this is a good place for us to start. Okay. Thank you.
Thank you very much. Why don't you, just because I know we'll have a lot of questions. It will probably be easier to take it from your seat. The other comments that were made by Matt and Maureen as well. So the floor is now open. Let's start with Emily.
Deborah, I had a question for you because I'm concerned that your use of analite specific reagents, which my understanding for that there a very specific claim made by the manufacturer of an asr that is T. is an asr and can be used as a component of a home brewed test. is that most of the labs we're concerned about are not buying analite-specific reagents from a certified manufacturer, they're just going to a regular research supply house and buying a component the components they need. Does that mean the fda really doesn't have any control over what's going on there?
It would be the same type of situation where we're not looking at the laboratory offering of services. Only if they were selling that test to another laboratory. So whether it's an ss -- asr or not, that doesn't make a difference.
So let's just take a concrete example, one of these Internet companies that's offering to test for risk of future development of osteoporosis. They make up everything completely in house, home brew, does that constitute any kind of an asr that fda woulden able to regulate?
Not if they do everything in house.
Okay.
If they buy the Regis outside, then they come under asr concernsp.
So if they buy from xyz house, does that fall under fda?
If the -- the asr would. This is of the problem. of the problem is or mean, whether the combination of an asr that's sold to a lab and what goes on in the lab can be regulated by fda. The other question is whether the home brew, which is where they do everything, whether that can be regulated?
Right. My big concern is that most of these folks, asr's are made in general by legitimate gmp manufacturers who are making them with the knowledge that there is a real medical utility for them. And that the plateses that we're primarily concerned about are doing it totally home brewed. They are not using anything that's any component that's marketed as an asr. So what can we do to control the proliferation of those kind of assets?
That aspect is not my strength, actually. I don't work in the ivd group. I think they are probably in a better position and they can look into that sort of how widespread, you know that is. I don't know enough about
It's very widespread even in clinical laboratories. They are offering legitimate tests. So my guess is it's there in the ones that are not offering legitimate tests as well.
We don't know for sure none of these tests are legit in the, either.
Right. But I mean, with the assumption that some of them might not be, my guess is that they are not getting components from a legitimate ivd manufacturer or gmp manufacturer, I guess. I don't knowp. You know, we can talk about that at fda. We can get but I don't know how else to answer.
That's good. I think if you can look into that, that would be terrific. We've got in the list, Julio, Ed and Deborah. One comment is that this issue of trying to control something seldom works. If there is a need for something, people will jump through whatever hoop to fill that need. There is a need for workers in one area. It can put any type of immigration barrier, people will jump to get the job. The situation the way I see it, the taxpayers pay the tax, the money to the research. The research is done. The results are published in the scientific literature. Stories are reaching the covers of the York Times," anything you open there is something about the yen netic risk for this, for that, for the next thing. Then you go to a doctor or traditional medical institution and try to get a seft test. Even when you can talk about, you know, risk for, you know, impulsivity, which there are genes related to that, but I'm not even talking like that. So let's say in my own area from a genetics, the oldest thing in the world like a field [ ] 50% of the best selling drugs in the country. About just under of the average Caucasian population has a variant of the gene that has no [ ] Another same number 10% have multiple copies of the gene that give the dprug drug that met tab lies very fast. There's no effect. So it is a real concern in the clinic. Some people go to the doctor, they have side effect. After test they have several patients like that. They go to the doctor like in the mayo clinic's beginning to test for that. You go to your average like ivy league medical clinic and say, you know, can I get tested for this in the hospital lab? They say no. You enthusiasm come up with a test people have a hard time finding a doctor who can understand that. So we fund the research, we let it be done. The results are there. Some are them are more controversial. Some are not so controversial. People go to regular health care, you know, system. Nobody uses the test. Nobody can handle it. There is a need. They going to find something. You can put every regulation you want, you can prohibit things from United States, people will send it to Canada. It will be done in Europe, someplace. As long as we say that the issue is important, advertise the results and in the traditional health care system cannot hand tl at all there's going to be a gap and the gam is going to be -- gap is going to be sealed. I'm against people saying send your test here and we'll tell if your son will become a drug addict. I don't think you can make that kind of claim. We should watch for blatantly false claims, which I think you are very correct in trying to do, but this kind of a marginal or questionable predisposition risk, as long as we say that we try to justify the funding that saying that the issue is important and then don't offer people anything, you know? So there is a need, it's going to be soon.
Thank you. Ed?
Yes. One of your comments that the fda is not clearly define the Internet promotion of labeling and advertising was interesting. I thought, is there something that this committee could do, at least in this context, to try and help the decision be made there is of such a big issue that would be spitting in the ocean for to us do anything?
My guess is that it wouldn't be very helpful. I mean, I think that this is something that just has a lot to do with fda's variously evolving thedes about promotion and how to regulate it. And I think it's been an issue for so long, and it is dealt with on a case by case basis a lot of times that you can certainly, you know, comment on it. My guess is that it's not something that is going to get a lot of concrete action.
Well, I think that if we should write to skttry Levitt about direct to consumer marketing and make a recommendation to the secretary that we might wish to include in there this issue that I would certainly. I don't know, maybe there are people on the committee who would not feel that the Internet is a legitimate source of information, but given how often I use it every day, I certainly think it is a la jt mitt -- legitimate source of information. My guess is that it's more powerful than most other media these days for public. So I would hope that we could include at least a sentence or brief pair are a graph saying -- pair are a graph saying that this should not be an impediment to pursuing these companies. One of the things, by the way that I do hope that the people in line, Deborah, hung and James as you start to question but also given that we're getting near the 11:30 hour, I want to make sure you start to do what Ed did is start to formulate what see as being next steps if any. I think Ed is starting to push some of that together. Julio had his comments about what we ought not be doing. Just think of action steps as you ask your questions. Deborah dism. I would like to follow up on Emily's comment because I was taken aback by the inclusion of asr's in the discussion because I see asr's as part of the regularry framework in which laboratories were set up by the fda to allow types of testing in a regulated fashion that are not necessarily able to be brought as pma or 510-k approved full device test kits. And I don't think that's what the committee was asking about or targeting when they were looking at the direct to consumer marketing that was being done. I don't know how they're doing their testing, but I doubt it is using asr's that are manufactured. Well, I think that's -- I mean, I think that's what I would discuss and get back to you about, right.
Hunt? I wanted to raise another area is whether this falls in of the groups or whether this is of the things you should not worry about or worry about in his own time. In addition to direct to consumer marketing for tests for trade predispositions, there's also a growing number of tests that are much more frivolous in their intent. Or they have no intent at all. It's more like sport. So you can, for example, any member of the public can get for $29.95, a little kit, take a swab, send it off and get some genotyping done or sequencing done. Depending on how you read the inserts on these packages, either to be the first in the neighborhood to have a little bit of your genome done which could be cool in some neighborhoods or because it actually is sort of telling you something that might be important in a very vague and unstated way. You can imagine some of these could be for paternity issues, parental issues that come up in some households or markers that are prescribed and could become linked to some trade predisposition. This is widespread. I tripped -- sorry, a family member of mine tripped over the target web site. I don't spend a lot of time there myself. But for $29.95, you can get this. The question is, I guess my concern on why this might not be the best possible testing to be out there is that most members of the public, notwithstanding my desire to have the public think it's cool to have perhaps bits of their genome sequenced, they're not prepared to know how to interpret the information. Either in terms of the genetic makeup of a y chromosome that's floating around the family or in terms of mini satellite repeats or tri-nuclear repeats so they'll read something and then see in the newspaper in which the expansion has been connected to some disease. Who knows who's connecting the dots between those even if that's an unintended consequence. So my question is, is anyone looking at this kind of direct to consumer marketing or is that something we should just let go because there's far bigger fish to fry? My concern is the public education is just not at the level where we're quite ready to have potentially millions of people having a little bit of their genome sequenced or Gino typed and have that information in front of them.
Do you send that tissue to a lab
Yes. You send this swab off somewhere and three to six weeks later, the test result comes back with a suitable for fraisming little certificate that says, you know, this is what you've got.
I'd be continuing our work with FTC trying to find the slam dunk case if that would fit in. I don't think that's a slam dunk for the FTC. you have to decide what's deceptive about it and what the injury is and how serious the injury is. And I think on our scale, you know, case selection cry tier yarks the case where the test purr reportedly determines your susceptiblity of conser would be far higher than that would on the case selection. I'm not going to eliminate it if you want to talk further about it.
I mean, if you want to send the name of it to us, we can look into it and see what it is. I mean, there are products out there that shouldn't be there. I don't know enough about that one to know exactly but I'd be happy to look at it.
Clerveerly marketed tcag, g as in gee whiz.
Thank you. James some.
I want to emphasize that when we're talking about tests, I'm being obtained some way or another, they are fairly restrictive in the expertise or the availability, that's one thing, but I we should also remember that the entire intent of advertising oftentimes is to create a need where there hasn't been a need. While advertisers are certainly able to do that and free to do that, it seems to me that the interest that we have is to make sure that they aren't creating a need that's harmful to people or using blatant misinformation to mislead an uneducated and unsuspecting public. And I think that perhaps with one of the roles of the expertise of this committee can be to try to help find those tips of slam dunk cases that are clearly not supported by science, that could have potential harm to people. As opposed to those types of advertise types of activities that, well, you know, they backed up by good sigh Epps and may not be available. Let me, as we start in the five minutes that remain to try to sort of where we come out on this, first is, I think that the committee has grappled, I think, responsibly with our obligation to the public. We are raising this as an issue of concern. And we have because of our efforts caused the creation of several task forces within government that are looking to how they can do their job appropriately. We don't want to cause problems in what we're trying to do. We're trying to act appropriately, finding the right cases where there really is egregious behavior. Let me ask because of the recommendations I'm going to make is that we respond to the secretary saying that we are gratifyd that there are these committees formed, these interagency activities that are ongoing and that we are they are seeking out appropriate cases for review. And we will say in our letter that we, I'm suggesting, in our letter, we would sort of say that our members are willing to find or recommend jam am -- examples that are of particular concern to us from our experience for the committee's consideration. I wonder or not there is any experience with just the fact that you all have targeted an area, you know, just generically, that you have targeted an area and made it widely known you are looking carefully at bad behavior. Does that in and of itself have a chilling effect on egregious activity? The fact that manufacturers or advertisers know that you are looking to take somebody to the hoop, as it were, basketball playoffs right now. That you are willing to look at it. Does that start to in and of itself have people start to behave a little more responsibly? Do you have any experience in that regard?
The FTC does, but because we're a law enforcement agency, we a very fine line between what's appropriate and what isn't, and we don't want to chill legitimate businesses from doing their jobs so typically, we have a law enforcement matter that we make public same time that we, for example, issue a consumer brochure or alert saying watch out for this kind of advertising because, you know, the only disease that's going to cure is too much money in your wallet or whatever. So, yes, it does have an effect, and for that very reason, we're very caution about doing that.
And
Please finish.
No, that's okay. , no I like what you areGo ahead.
So in some cases, we might issue a brochure, for example, I did in the we hadn't brought a case yet but there was a lot of bad advertising going around, and so we issued a brochure saying go into this with your eyes because there's some problems. Now you still will need reading glasses and there are side effects. We did that and I brought a case later. It's very for the FTC to do that. It's possible that no one other than myself at the federal trade commission has made nigh official statement about our interest in this area. So we have to be very cautious. I really think that's a very balanced and appropriate statement, Matt. Deborah, just real quick in terms of fda. Same thing, I assume? I think with some industries it does. With others it probably doesn't. There are times when we have sent, you know, 30 letters to same kind of industry, and they, some of it, companies that were making SARS claims for masks. There were about 30 letters sent to these web sites. You know, I don't know how many more were outWe get -- we'll take an action against one company and then that company will send a letter about its competitor two weeks letter. So I think it depends, really. I don't think it's consistent. One thing I just want to make do at least, is I think and Matt's point is important. We're not looking, and it's April Po -- apropos, I assume committee is not looking to chill or have a neglect-effect on appropriate behavior. What we're trying to do is make sure that the public is not being preyed upon by inappropriate people who are attempting to do things to them in an area that has special significance. And to the extent that we can make it be known that we're -- that this is being looked at carefully, I think is important. Deb brarks you wanted to make one more comment?
Yeah. Fda in addition to the enforcement actions provides some educational information on the web site. I mean, there's an area for hot topics where it talks about breast cancer, other things. We recently as of a couple of years ago, all of the full-body scans that are being advertised where it's not really thought to be, you know, necessarily safe and effective, the tradeoff in terms of finding things that may be ben