Confirmation Number:222761 Event Started: 6/15/2004 5:29:49 PM Event Ended: 1/1/0001 12:00:00 AM

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U.S. MANY ARE NOT TRIND IN PUBLIC HEALTH, BUT NEFLS, THEY ARE PUBLIC HEALTH PROFESSIONALS. AS TOBY MENTIONED YESTERDAY, THE IOM MADE THE ANNOUNCEMENT LAST YEAR THAT THE PUBLIC HEALTH PROFESSIONALS OF THE 21st CENTURY WILL HAVE TO BE -- DEAL WITH CRITICAL AREAS IN TRAINING . IT'S AN APPROACH TO TRANSLATE ALL OF THIS NEW SCIENCE INTO ACTIVITIES THAT IMPROVE EVERYBODY'S HEALTH AND THE WAY I HAVE CACHTURED IT HERE IS THAT I THINK ABOUT PUBLIC HEALTH AS CONTRIBUTING IN THREE MAJOR AREAS. OR THREE BOXES, IF YOU WILL. I THREE MAJOR GAPS WE'RE TRYING TO FILL. THE FIRST ONE IS PROBABLY THE MOST IMPORTANT ONE AT THIS POINT. IT'S FIGURING OUT WHAT DOES IT MEAN TO HAVE GENETIC VARIATION WHAT. -- WHAT IS GENOMIC POPULATION HEALTH. MANY, MANY PROTEINS AND PROTEIN VARIANTS THAT ARE GOING TO BE DISCOVERED AND WE ARE JUST SKIMMING THE SURFACE RIGHT NOW OF WHAT THAT INFORMATION MEANS TO THE BURDEN OF DISEASE AND THIS ABILITY IN DIFFERENT COMMUNITIES AND HOW THIS GENETIC VARIATION INTERACTS WITH ENVIRONMENT. AND ENVIRONMENT, IF I DIDN'T SAY IT SO FAR, HAS BEEN THE MAJOR ON POINT OF INTERVENTION FOR PUBLIC HEALTH SO FAR IN OUR QUEST. SO THAT'S AN IMPORTANT ROLE TO CONSIDER, AND THAT'S A POPULATION RESEARCH AGENDA. THE SECOND ROLE AND THIS IS TO FIGURE OUT, REALLY TRULY THE VALUE ADDED OF GENETIC INFORMATION IN BOTH TREATMENT BECAUSE RIGHT NOW, WE HAVE A ONE-SIZE-FITS-ALL PUBLIC APPROACH TO THE MAJOR COMMON CHRONIC DISEASES THAT INVOLVES BEHAVIOR MODIFICATION, YOU KNOW, DIET, EXERCISE, SMOKING CESSATION ON, ET CETERA, AND WE HAVE TO FIGURE OUT STEFCKALLY BASED ON THE BEST AVAILABLE SCIENCE WHY SHOULD WE CHANGE THAT APPROACH AND IN FAVE OF A PERSONALIZED PREVENTION MEDICAL APPROACH. THEN THE ISSUE OF IMPLEMENTATION IS REALLY CRUCIAL BECAUSE YOU CAN DISCOVER ALL THE GENES AND FIGURE OUT WHAT THEY DO. CAN YOU FIGURE OUT THAT THEY'RE GOOD TO BE USED IN A GENETIC TEST, BUT THE IMPLEMENTATION CAN BE MESSY IN A HEALTHCARE SYSTEM THAT IS REALLY NOT PREPARED FOR GENETICS, AND I WILL LIKE TO RECITE TO YOU WHAT CLAUDE SAID LAST YEAR. HE WAS THE OUTGOING DIRECTOR ON OF NHLBI, AND HAD A NICE PIECE CALLED LOST IN TRANSLATION. NOT THE TITLE OF THE MOVIE, BY THE WAY, AND HE BASICALLY IN THE AREAS OF THE HEART, LUNG AND BLOOD AREA WHERE BASIC RESEARCH -- THE ISSUE OF ACCIDENT THAT LESS THAN A THIRD OF PATIENTS THAT NEED ASPIRIN FOR THE PREVENTION OF COERO NAIR ARTERY DISEASE ARE USING ASPIRIN. I DON'T PRESCRIBE NECESSARILY TO A PESSIMISTIC VIEW OF THE WORLD, BUT MORE OF AN OPTIMIST IN THIS DEPARTMENT. CDC AND MANY PARTNERS HAVE BEGUN THINKING ABOUT THESE ISSUES AND DRAWING A ROAD MAP. IT'S A BIT TORTUREOUS RIGHT NOW, HAVING LAND MARKS AS WE MOVE FORWARD FROM THIS ONE BOX TO ANOTHER. A POPULATION HEALTH RESEARCH BOX, BUILDING AN EVIDENCE-BASED FOR PREVENTION AND THEN MOVING GENOMICS INTO PRACTICE. THEY'RE NOT SEQUENTIAL. MANY GENES ARE ON DIFFERENT PARTS OF THIS CONTINUUM, CERTAINLY FOR GENETIC DISEASES AND NEWBORN SCREENING, WE'RE ALREADY IN PRACTICE. FOR MANY OF THE COMMON CHRONIC DISEASES, WE ARE SOMEWHERE AT THE BEGINNING OF THIS MAP WHERE GENES ARE COMING OUT OF THE TEST TUBE, IF YOU WILL, AND BEING, GOING DOWN THE TRANSLATION HIGHWAY. SINCE I DON'T HAVE THAT MUCH TIME, I WANT TO GIVE YOU A BRIEF OVERVIEW OF THE KIND OF INITIATIVES THAT CDC AND OTHERS ARE DEVELOPING AND THEN WE CAN HAVE SOME MORE DISCUSSION. IN THE DEPARTMENT OF GENOMICS AND POPULATION HEALTH RESEARCH ARENA, WE HAVE THREE MAJOR INITIATIVES GOING ON ON. THE HUMAN GENOME NET WORK, THE HANES PROJECT AND GENOMICS AND ACUTE PUBLIC HEALTH INVESTIGATIONS AND FOR MANY OF, I MEAN THE HUMAN GENOME 'TEED 'TIMIOLOGY HAS BEEN WATCHING OVER EPIDEMIOLOYGY HAS BEEN WATCHING OVER THE GENE STUDY. WEMA HAVE MANY AROUND THE WORLD THAT USE IT AS A BASIC SCIENCE OF PUBLIC HEALTH, AND THOSE PEOPLE ARE ENGAGED IN METHODS DEVELOPMENTS, TRAINING AND KNOWLEDGE-BASED DEVELOPMENT, AND WE'RE ALSO WORKING WITH NIH AND OTHERS ON THE PULLING AND SIN THEGHTIS OF THE MANY -- SYNTHESIS STUDIES GOING ON AROUND THE WORLD. YOU WILL HAD HEAR MORE FROM FRANCIS COLINS ABOUT THE U.S. STUDY LATER ON. AS OF MAY 1st, WE HAVE HAD A NUMBER OF PRODUCTS THAT ARE ON LINE. WE DON'T HAVE TIME TO GO THROUGH THIS, BUT A KNOWLEDGE-BASED AND A SEARCHABLE DATA BASE IS SORT OF WHAT I WOULD LIKE TO SHOW YOU HERE BRIEFLY AND YOU CAN ALL GO ON LINE AND FIGURE IT OUT. THIS IS SORT OF AN, A RUNNING DATA BASE THAT CHANGES FROM WEEK TO WEEK THAT CAN YOU SEARCH BY EITHER GENE. WE USE -- [ INDISCERNIBLE ] WE USE ICD CLAUS OR INTERACTING FACTOR ONS LIKE SMOKING AND DRUGS, ET CETERA, THAT SUMMARIZES THE STATUS OF THE EPIDEMIOLOGIC GENE, GENE INTERACTION, AND I'M TOLD THAT THIS IS IS A GOOD ADJUNCT FOR MANY RESEARCHERS WHO ARE TRYING TO FIGURE OUT HOW TO GET GENES OUT OF THE TEST TUBE INTO POPULATION-BASED WORLD. TO SUMMARIZE, THIS IS THE, SORT OF THE LITERATURE OVER THE LASTY THREE YEARS. THIS -- LAST THREE YEARS, THIS HAS BEEN GOING UP, OBVIOUSLY. EVERY DAY THERE IS MORE PAPERS IN THIS REGARD AND WE CAPTAIN UR ABOUT 50 TO 100 ARTICLES EVERY WEEK. THESE ARE YOUR TOP-10 GENES. H, FR, HLA. WE DON'T HAVE TIME TO GO THROUGH THEM, BUT THIS IS SORT OF -- THESE ARE THE MOST EPIDEMILOLOGICALLY-STUDIED GENES. THE SECOND IS THE NHA BANK. THIS IS IMPORTANT. WE DON'T KNOW THE PREVALENCE OF THE MAJOR VARY YAUNS VARIANCE OF PUBLIC HEALTH SIGNIFICANCE IN THE U.S. AND AROUND THE WORLD. HA, INES IS A NATIONAL SURVEY CDC DOES ON A BASIS. -- REGULAR BASIS. DNA WAS IMMORTALLIZED IN 8 THOUTH -- 8,000 NATIONALLY REPRESENTATIVE SAMPLE FROM THE U.S. AND WE'RE CURRENTLY IN COLLABORATION WITH NCI LOOKING AT THE PREVALENCE OF THE TOP 57 GENES OF PUBLIC HEALTH SIGNIFICANCE. I WILL LEAVE IT AT THAT FOR NOW. THE INITIATIVE WE STARTED LAST YEAR IS FIGURING OUT HOW HUMAN GENETICS AND GENETIC VARIATION CAN EXPLAIN OUTBREAK INVESTIGATIONS, AND WE'RE CURRENTLY IN THE MIDST OF EVALUATING WHICH OUTBREAK INVESTIGATIONS, WHICH IS THE BREAD AND BUTTER OF MANY PUBLIC HEALTH ACTIVITIES BOTH IN ENVIRONMENTAL HEALTH AND INFECTIOUS DISEASE OUTBREAKS, FIGURING OUT WHY SOME PEOPLE GET SICK BUT NOT OTHERS WHEN EXPOSED TO THE SAME VIRUS BACTERIA OR ENVIRONMENTAL AGENT. AND THE SECOND AREA ALONG THIS CONTINUUM OF BUILDING THE EVIDENCE-BASED, WE HAVE TWO MAJOR INITIATIVES. THE GENETIC TESTING EVALUATION AND FAMILY HISTORY, FOR THOSE OF YOU WHO HAVE BEEN AROUND FROM SAGDT, YOU MAY RECOGNIZE -- SAGDT RECOMPDD THAT GENETIC TESTS NEEDED TO -- TO BE EVALUATED ALONG THE CONTINUUM FROM THE VALIDITY TO LEGAL AND SOCIAL IMPLICATIONS. FOR THE LAST THREE YEARS, WE HAVE BEEN ENGAGED IN FLUSHING THIS OUT A LITTLE BIT MORE AND THROUGH THE COLLABORATION WITH THE FOUNDATION FOR BLOOD RESEARCH USING FIVE GENETIC TESTS AS EXAMPLES, WE HAVE ESSENTIALLY DEVELOPED THE METHODOLOGY FOR HOW YOU CAN BEGIN TO EVALUATE GENETIC TESTS AS THEY MOVE FROM RESEARCH TO PRACTICE. AT THE END OF THE YEAR, WE'RE GOING TO HAVE A METHODOLOGY MEETING WHERE WE COMPARED THIS METHODOLOGY WITH OTHER METHOD LOGIC TECHNOLOGY ASSESSMENTS THAT EXIST BOTH IN THIS COUNTRY AND AROUND THE WORLD, AND HOPEFULLY COMING UP WITH A CONSENSUS WAY OF EJAUL EVALUATING GENETIC TESTS, AND WE'RE USING THIS INFORMATION INTO THE NEXT INITIATIVE, WHICH WILL BE A COLLABORATIVE INITIATIVE BOTH WITHIN THE GOVERNMENT AND THE PRIVATE SECTOR. WE CALL IT EGAT. THE EVALUATION OF GENOMIC APPLICATIONS AND GENETIC APPLICATIONS -- APPLICATIONS. WE'RE GOING TO BE EXPERIMENTING WITH A NONFEDERAL MULTIDISCIPLINARY INDEPENDENT WORKING GROUP THAT WILL BE, WILL BEGIN TO USE THE TOOLS OF METHODOLOGY ASSESSMENT, EVALUATE GENETIC TESTS WITH THE PRIORITY FOR THE ONES THAT WILL BE USED FOR PREVENTION AND POPULATION HEALTH, EVALUATE THEM ONE AT A TIME, USING A STAKEHOLDER GROUP FOR INPUT, AND THEN COMMISSIONING REVIEWS THROUGH EVIDENCE-BASED CENTERS OF THE KINDS THAT ARC SUPPORTS, AND THEN COMING UP WITH SUMMARY STATEMENTS AND RECOMPLENDATIONS AND THE GOOD THING ABOUT THIS PROJECT THAT IT NOT ONLY INVOLVES PRONOUNCEMENTS, BUT THERE WILL BE FUNDING FOR PILOT DATA COLLECTION PROJECTS TO FILL SOME OF THE GAPS THAT THE GROUP WILL IDENTIFY, AND I'LL BE HAPPY TO TALK MORE ABOUT THIS. FAMILY HISTORY IS A BIG ONE. AS WE TALKED YESTERDAY, IT'S SORT OF THE INITIAL GENOMIC TEST, IF YOU WILL, THAT WE ALL HAVE, AND WE DON'T NECESSARILY HAVE TO HAVE A LAB TEST FOR, AND WE KNOW THAT FAMILY HISTORY IS UNDERUTILIZED IN PREVENTIVE MEDICINE AND IT'S A RISK FACTOR FOR MOST CHRONIC COMMON DISEASES OF PUBLIC HEALTH SIGNIFICANCE AND IT'S FREQUENT. IF YOU LOOK AT THE MAJOR FIVE OR SIX COMMON CHRONIC DISEASES, HALF THE POPULATION HAS A FIRST-DEGREE RELATIVE WITH EITHER CANCER, HEART DISEASE OR DIABETES. AND IT'S A RISK FACTOR FOR ALMOST ALL OF THESE DISEASES DEPENDING ON THE NUMBER OF RELATIVES AND THE AGE OF ANCESTORS. THE REL ATIVE RISKS CHANGE. IT'S THE MOST CONSISTENT RISK FACTOR FOR ALL COMMON CHRONIC DISEASES AND YET VERY FEW PEOPLE ACTUALLY NEED A GENETIC WORKUP AS A RESULT OF FAMILY HISTORY. SO THE INITIATIVE THAT WAS STARTED TWO YEARS AGO IS NOW FULLY UNDERWAY. WE'RE USING THE SIMPLE CLASSIFICATION SCHEME THAT DR. SHUMER FROM CEDAR SINAI AT THE TIME, AND NOW AT UCLA PROPOSED A FEW YEARS AGO TO CLASSIFY PEOPLE INTO EQUAL TATIVE RISK CLASSIFICATIONS SCHEME FOR ANY DISEASE DEPENDING ON THE FAMILY HISTORY. IN AVERAGE RISK, MODERATELY INCREASED RISK AND HIGH RISK, AND WE'RE CURRENTLY DEVELOPING A FAMILY HEALTHWEAR TOOL FOR FIVE OR SIX COMMON CHRONIC DISEASES, TWO, THREE CANCERS, HEART DISEASE, DIABETES AND USING A COMPLEX ALGORITHM TO CLASSIFY PEOPLE INTO THIS GROUP. THE THREE GROUPS AND WE'LL BE CONDUCTING A CONTROLLED CLINICAL TRIAL TO EVALUATE THE CLINIC AND UTILITY OF THIS TOOL IN ORDER TO CHANGE PEOPLE'S BEHAVIOR, AND THE GOOD THING ABOUT THIS TOOL IS IT BRIDGES THE GAP BETWEEN GENETICS AND PUBLIC HEALTH. IN PUBLIC HEALTH, WE LIVE IN THIS AVERAGE SCHEME. WE TREAT EVERYONE IN THE POPULATION AS AN AVERAGE PERSON FOR ANY GIVEN DISEASE, AND WE GIVE EVERYONE THE SAME RECOMMENDATION FOR DISEASE PREVENTION. GENNETTIVITY ISS, ON THE OTHER HAND ON, ARE ALWAYS LOOKING FOR PEOPLE AND FAMILIES WITH SINGLE GENE DISORDERS, BUT THESE ARE ONLY A FEW IN THE GENERAL POPULATION, AND MOST OF US, IF NOT ALL OF US, ARE NOT AVERAGE. WE FALL IN THIS MODERATE RISK GROUP FOR MOST DISEASES, AND TODAY WE DON'T KNOW WHAT THE GENETIC BASIS FOR THE GROUP IS. 10 YEARS FROM NOW, THERE MIGHT BE ENOUGH GENETIC DISCOVERIES TO FIND OUT THERE COULD BE A GENETIC, MAYBE A GENOMIC PROFILE TEST THAT WILL DISECT THE MODERATE GROUP. THE GOOD THING ABOUT FAMILY HISTORY, IT'S MORE THAN GENETICS, INVOLVING SHARED BEHAVIOR, SHARED CULTURES, SHARED DIET AND A FAMILY CENTER PREVENTION APPROACH. SO FINALLY, SINCE I'M RUNNING OUT OF TIME, I WANTED TO MENTION THREE INITIATIVES IN BUILDING THE CAPACITY AND PRACTICE, BUILDING A PUBLIC HEALTH CAPACITY, DEVELOPING APPROACHES FOR POPULATION-BASED MONITORINGS AND OUTCOMES RESEARCH AND I'LL MENTION ALL THE EFFORTS THAT CDC IS DOING IN ENSURING THE LAB QUALITY OF GENETIC TESTING AND PRACTICE. THE CLEAR EFFORTS THAT YOU ALL KNOW ABOUT, ET CETERA, BUT IN TERMS OF BUILDING THE PUBLIC HEALTH CAPACITIES, WE SEE ACTIVITIES BRIEFLY. BACK IN 2001 AS NICHE PEG WAS DEVELOPING THE GENOME ONIC COMPETENCIES FOR HEALTHCARE PROFESSIONALS DOCTOR, C AND MANY PARTNERS DEVELOPED IT FOR THE PUBLIC HEALTH WORKFORCE THERE. IS QUITE A BIT OF OVERLAP BETWEEN THE TWO. YOU HEARD FROM TOBY YESTERDAY ABOUT THE DEVELOPMENT FOR CENTERS OF GENOMICS AND PUBLIC HEALTH. THERE WERE THREE FUNDED OVER THE LAST THREE YEARS AND HOPEFULLY THERE WILL BE MANY MORE, BOTH IN SCHOOLS OF PUBLIC HEALTH AND MEDICINE ACROSS THE COUNTRY. AND LAST YEAR, CDC BEGAN, ACTUALLY, FUNDING STATE CHRONIC DISEASE CAPACITY GRANTS TO SUPPLEMENT WHAT THEY'RE DOING ON THE MATERNAL AND CHILD HEALTH SIDE WITH RESPECT TO GENETICS AND PUBLIC HEALTH. LAST BUT NOT LEAST NEXT TERMS OF OUTCOMES AND MONITORING, YOU WILL HEAR MORE ABOUT THE DIRECT CONSUMER CAMPAIGN, BUT LAST YEAR AS YOU KNOW, MANY A GENETICS HAD THE CAMPAIGN IN 2 TEST CITIES, ATLANTA AND DENVER, AND THE PUBLIC HEALTH RESPONSE TO THIS WAS TO DO A SUHAVE A OR A SERIES OF SURVEYS WITH HEALTH DEPARTMENTS IN THE TWO EXPOSED CITIES TO THE CAMPAIGN, ATLANTA AND DENVER, AND WE HAD TWO CONTROLLED CITIES, RALEIGH AND SEATTLE IN WHICH WE HAD SURVEYS OF WOMEN IN, WHAT TARGET BY THE CAMPAIGN, 450 AND THE HEALTHCARE PROVIDER, 250 IN EACH CITY, AND I DON'T HAVE TIME TO PRESENT THE RESULTS OF THIS SINCE I AM RUNNING OUT OF TIME, BUT HERE THEY ARE AND WE CAN DISCUSS THEM LATER ON. AND SO IN CLOSING, I WOULD LIKE TO KIND OF REITERATE THIS LONG AND WINDY ROAD BEYOND THE BEFEN TO THE BEST SIDE -- BENCH TO THE BEST-SIDE CONCEPT, AND REALLY AS WE ALL ENGAGE IN WHAT I CALL ACTIVITIES IN IMPROVING THE PUBLIC'S HEALTH, WE HAVE TO REALIZE THAT WHAT WE DO ON THE POPULATION LEVEL REALLY INFLUENCES TO A MAJOR EXTENT WHAT IS DONE AT THE BEST SITE LEVEL AND POPULATION LEVEL INFORMATION ON EITHER THE THE EPIDME -- EPIDEMIOLOGY GENE OR THE TEST ON HOW WE SHOULD USE THE PRACTICE AND ENSURE THE QUALITY OF THE DELIVERY OF THE SERVICES IS REALLY IMPACTING IN A MAJOR WAY ON THE PRACTICE OF MEDICINE. SO I WOULD LIKE TO CLOSE HERE AND IF YOU HAVE ANY COMMENTS, I'LL BE GLAD TO TAKE THEM. ING THATS.

THANK YOU VERY MUCH. ANY QUESTIONS OR COMMENTS FOR DR. KHOURY ? I HAVE SEEN A PUBLIC LISHED REPORT FROM THE MARRIOTT EXPERIENCE WHICH, OR MAYBE IT WAS JUST SOME PRELAME PRELIMINARY DATA SUGGESTING THAT THERE HAD NOT KNOW MUCH INCREASE WHILE PEOPLE WERE AWARE OFS ADS AWARE OF THE ADS AND NOT REALLY CHANGED PRACTICES. FROM LOOKING AT YOUR DATA, IT LOOKS LIKE IT DID CHANGE PRACTICES. IS THAT THE CASE?

WELL, I MEAN, WE HAVE SOME LIMITATIONS TO THIS DATA. WE DON'T HAVE ACTUAL UTILIZATION BASE. WE HAVE WHAT PHYSICIANS TOLD US IN TERMS OF THE INTEREST AND THEIR OWN PRACTICES AND IT DOES LOOK LIKE THERE WAS A BIT OF AN INCREASE. WE ARE ALSO WORKING WITH MIRIAD TO ANALYZE THEIR OWN UTILIZATION DATA TO RELATED TO THE COUNTRY AND THE DENOMINATORS, THE WHOLE U.S. SINCEUS. I DON'T HAVE THE -- CENSUS. I DON'T HAVE THE FINAL WORD TO THIS BUT IN THE NEXT FEW MONTHS, WE SHOULD BE ABLE TO MAP IT OUT.

DID THEY CONTINUE THEIR AD CAMPAIGN?

NOT TO MY KNOWLEDGE. THEY'RE PONDERING WHETHER TO GO NATIONAL OR NOT RIGHT NOW.

OTHER QUESTIONS OR COMMENTS FOR DR. KHOURY. YES. AGNES.

IN YOUR SYSTEMATIC REVIEW OF GENETIC TESTS, YOU SHOWED THE WHEEL, AND I DON'T KNOW IF THAT'S IN YOUR NEW BOOK. YOUR REPORT IS IF YOU WOULD THINK THAT ANY OF THE MATERIALS FROM THERE COULD BE UTILIZED AS GUIDELINES FOR US IN THE WORK THAT WE'LL BE DOING TO TRY TO BOTH CATEGORIZE AND GIVE GUIDANCE FOR THE COVERAGE AND REIMBURSEMENT.

ABSOLUTELY. ANY OF THE STUFF I MENTIONED THIS MORNING, WHICH WAS A HIGH-LEVEL DISCUSSION, THERE IS PLENTY OF MATERIAL AND BACKUP, SO YOU GUYS TELL ME WHAT YOU NEED AND I'LL BE HAPPY TO GIVE IT TO YOU.

OKAY. THANK YOU VERY MUCH FOR THAT VERY INTERESTING PRESENTATION. IT LEADS NICELY TO THE NEXT ISSUE ON OUR AGENDA. IN MARCH, WE DECIDED TO PREPARE A SUMMARY OF OUR SYSTEMATIC PRIORITIZATION PROCESS IN LIEU OF A VISION REPORT OF THE CHARTER DESCRIBES A VISION ENROLL AND ROLE FOR THIS COMMITTEE. WE THOUGHT A SUMMARY OF THE PROCESS AND THE ISSUE THEMSELVES WOULD BE OF USE TO THE SECRETARY. I WOULD LIKE TO, AGAIN, THANK EMILY WYNN DEAN FOR HER LEADERSHIP THROUGHOUT THE PRIORITIZATION PROCESS AND HER ASSISTANTS IN DEVELOPING THE DRAFT VISION REPORT. I WILL NOW TURN TO ELLY TO FACILITATE -- EMILY TO FACILITATE THE STUGZ OF THE REPORT.

THANKS, -- THE DISCUSSION OF THE REPORT.

THANKS, ED. WE HAVE TO BE CLEAR IN ACKNOWLEDGING WHO REALLY DID THE WORK ON THIS REPORT, WHO WAS THE STAFF FOR THIS COMMITTEE, SPECIFICALLY SAGE MANSKY LED THATTY EFFORT AND I WANT TO ACKNOWLEDGE HER EFFORT -- EFFORTS AND THE FACT THAT SHE WAS VERY APT GHOST WRITER FOR THE COMMITTEE. WHAT I WOULD LIKE TO DO THIS MORNING IS TO JUST SORT OF GO THROUGH WHAT I BELIEVE IS PRETTY MUCH JUST A RECAP OF OUR DISCUSSION AT THE MARCH MEETING. MAKE SURE THAT EVERYBODY HAS HAD A CHANCE TO LOOK AT THIS SUMMARY, AGREES WITH IT IF WE HAVE ANY DISCUSSION GRMS -- ITEMS, WE SHOULD PUT THEM ON ON THE TABLE NOW. I KNOW THAT ONE OF OUR GOALS IS TO PUT THIS WHOLE SET OF ISSUE BRIEFS, AS WELL AS THE SUMMARY UP AS A PUBLIC DOCUMENT AND ONE OF OUR WORK PRODUCTS. SO, I GUESS THE FIRST THING I WOULD LIKE TO ASK IS JUST, YOU KNOW, IF EVERYBODY'S HAD A CHANCE TO READ IT AND AGREES THAT THE SUMMARY IS, THE WRITTEN SUMMARY IS A CORRECT REPRESENTATION OF OUR THOUGHT PROCESS AND OUR CONCLUSIONS FROM THE DISCUSSION. I KNOW I I HAD A CHANCE TO DO A LITTLE BIT OF PROOF READING, BUT I DON'T KNOW IF THERE ARE ANY OTHER COMMENTS THAT PEOPLE WOULD LIKE TO MAKE AT THIS TIME. SO I WANT TO TO THAT FIRST . NO? SORRY, HON ON.

A POINT I MADE BEFORE AS WELL, I THINK IT'S IMPORTANT FOR, ESPECIALLY WRITTEN DOCUMENTS THAT COME FROM THIS COMMITTEE, THAT THIS, EVEN THOUGH OUR NAME IS THE ADVISORY COMMITTEE FOR GENETICS HEALTH AND SOCIETY, THAT WE GET THE WORD "GENOMICS" IF THERE AS WELL PERIODICALLY IN EXECUTIVE SUMMARY SECTIONS. THERE WILL BE SOME OF THE AUDIENCE WHO WILL THINK WHAT WE'RE SAYING IS RELATIVE TO GENETICS. THE LAST 20 YEARS, I.E., BUT NOT NECESSARILY-IN-ONLYICS IN THE NEXT 20 YEARS. I KNOW WHAT WE ALL MEAN, BUT I THINK WE SHOULD BE CAREFUL IN CHOOSING LANGUAGE CONVEYING THAT TO OUR AUDIENCES.

SO WOULD YOU LIKE TO SEE EVERYWHERE THAT IT SAYS GENNIETICS CHANGED TO GENETICS AND GENOMICS?

Reporter: WOULDN'T DO IT EVERYWHERE. THAT WOULD GET TEDIOUS TO THE EXTREME. BUT I THINK IN, YOU KNOW, EVEN IN THAT VERY FIRST SENTENCE, FOR EXAMPLE, WOULD NOT -- IT WOULD BROADEN THE SENSE OF OF THAT SENTENCE AND NOT HURT IT A BIT TO SAY ADVANCES IN GENETICS AND GENOMICS PROMISE TO HUMAN HEALTH, ET CETERA. JUST PICKING A FEW SPOTS THROUGHOUT, AND ESPECIALLY SUMMARY SECTIONS, I THINK, THAT HAD AN AFFECT AND BE MORE INCLUSIVE.

WE CAN EVEN CHANGE IT IN THE TITLE TO GENETICS AND GENOMICS SO IT'S RIGHT UP FRONT, TOWARD THE INTEGRATION AND DIVISION OF GENETICS AND GENOMICS IN SOCIETY. THAT'S ACCEPTABLE.

OKAY. YES.

WHY WOULD WE KEE JEBETICS -- [ INDISCERNIBLE ] -- GENETICS -- SORRY. WHY WOULD WE KEEP BOTH. WHY NOT JUST GENOMICS. WHAT WOULD WE LOSE BY DROPPING GENETICS.

I'LL GIVE YOU MY ANSWER.

SURE.

TO THE DIFFERENCE BETWEEN GENETICS AND GENOMICS.

UH-HUH.

GENETICS LOOKS JUST AT GERM LINE DNA WHEREAS GENOMICS CAN ALSO ENCOMPASS EXPRESSION ANALYSIS AND THEY'RE QUITE DIFFERENT THINGS. ONE IS WHAT'S THE BASIC PROGRAM AND THE SECOND IS HOW IS THAT PROGRAM EXPRESSED AT DIFFERENT POINTS AND DIFFERENT DISEASE STATES.

RIGHT, BUT FOR THE PURPOSE OF THIS GROUP, I KNOW THOSE ARE THE TECHNICAL DIFFERENCES, BUT FOR THE PURPOSES OF THIS GROUP AND THE WORK THAT YOU DO, I MEAN, I'M ASKING A QUESTION TO THIS GREW, WHAT WOULD WE LOSE BY, INSTEAD OF HAVING GENETICS/GENOME ONICS, FOCUSING ON JUST GENOMICS?

I ALSO THINK THE PRACTICE, THE CLINICAL PRACTICE OF THIS DISCIPLINE IS GENETICS AS OPPOSED TO GENOMICS, WHICH I THINK OF MORE ON THE ANALYTICAL SIDE, BUT THE MEDICAL PRACTICE IS THE PRACTICE OF GENETICS. SO TAKING IT A LITTLE BIT FURTHER. I THINK IT'S A SUBTLE DIFFERENCE, BUT I THINK THAT IF WE WANT TO HAVE CREDIBILITY WITHIN THE GENETICS/GENOMICS COMMUNITIES, WE NEED TO TRY AND USE THE TWO TERMS. IF WE WENT JUST WITH GENOMICS, I THINK IT WOULD BE LEAVING, LEAVING BEHIND THE MEDICAL PRACTICE AND SOME OF THE ISSUES ABOUT GERM LINE INHERITANCE.

OKAY. SO THEN I THINK THE NEXT THING WHAT WE WANTED TO DO WAS TO GO THROUGH WHETHER THE REPORT ACTUALLY ACCURATELY REPRESENTED OUR WHOLE PROCESS FOR GOING THROUGH A LARGE SET OF POSSIBLE TOPICS AND SORT OF THE VOTING PROCESS AND TRIAGING AND PRIORITIZATION PROCESS THAT WE WENT THROUGH WITH THE MAIN COMMITTEE WITH THE EX ON OFFICIOS AND THE COURSE OF OUR DISCUSSION AT THE MARCH MEETING. I WANT TO ASK IF THERE IS ANY DISCUSSION OR -- IF ANYONE FEELS THAT WE HAVE FAILED TO CAPTURE THAT IN AN ACCURATE REPRESENTATION . WOW. I AM REALLY EXCITED BECAUSE AFTER WE HAD ALL THAT DISCUSSION ON WHEREASES YESTERDAY, I WAS AFRAID THIS MIGHT REALLY TAKE A LONG TIME. OKAY. SO I WILL TAKE THE SILENCE AS EVERYBODY'S -- THAT THIS IS AN ACCURATE REPRESENTATION OF THE PROCESS AND THE CONCLUSIONS OF THAT PROCESS. SO THE THIRD THING I WANTED TO DO WAS TO, YOU KNOW, IF WE FEEL THAT OVERALL SUMMARY REPORT TOWARD DIVISION OF INTEGRATION OF GENETICS AND GENOMICS AND HEALTH IN SOCIETY IS A GOOD REPRESENTATION OF ON OUR STOCK PROCESS, I JUST WANT TO GIVE PEOPLE A CHANCE, IF THERE IS ANY COMMENTS ON ANY OF THE ISSUE BRIEFS, WHICH I THINK WE HAD A FEW COMMENTS ON AT THE LAST MEETING AND I THINK MOST OF THE COMMENTS HAVE BEEN INCORPORATED. IF ANYONE HAS ANY FURTHER THOUGHTS OR, UM, CORRECTIONS, COMMENTS, WHATEVER ON ANY OF THE ISSUE BRIEFS, I WOULD LIKE TO OPEN THOSE UP AS WELL FOR ANY RECOMMENT -- RECOMMENDING AS. ED.

BEFORE MOVING ON ON TO THAT, WE WERE JUST HAVING A LITTLE BIT OF A SIDE BAR HERE, AND ONE OF THE THINGS, BECAUSE OF THIS DISCUSSION ABOUT GENETICS VERSUS GENOMICS, THAT WE MIGHT TRY AND DO IS IS A FAIRLY BRIEF GLOSSARY BUT OF SOME OF THE KEY TERMS THAT WE COULD WORK ON IF THAT'S ACCEPTABLE TO EVERYONE.

YEAH, CLEARLY I THINK THAT WOULD BE A USEFUL, YOU KNOW, I DON'T KNOW IF IT NEEDS TO BE IN THE BODY TOWARDS THE DIVISION STATEMENT, BUT JUST AS PART OF THE APPENDIX COULD BE A GLOTSSARY OF TERMS.

RIGHT. -- GLOSSARY OF TERMIES.

IT'S NOT GOING TO BE AN EXTENSIVE 30-PAGE GLOSSARY.

I KNOW.

BUT PICKING UP THE KEY TERMS AS WE DISCUSSED WOULD BE IMPORTANT FOR PEOPLE TO UNDERSTAND WHAT THE REAL ISSUES ARE.

I ACTUALLY THINK THERE ARE A LOT OF THOSE THINGS THE PREVIOUS COMMITTEE WORKED ON, THE DEFINITIONS AND SO WE CAN JUST PULL THOSE TOGETHER.

YEAH, THAT'S WHERE I WAS REALLY THINKING WE HAD THE GLOSSARIES, PROBABLY LARGELY IN HAND AND CAN EXTRACT FROM THE --

ANY DISSENTING THOUGHTS ON THAT? OKAY, LET'S ASK STAFF TO ADD THAT TO THE APPENDIX AS WELL . OKAY. SO CAN WE TURN TO THE ISSUE BRIEFS?

I JUST HAVE ENOUGH TO DO REVISION, BUT THE BULLET ON THE FIRST PAGE OF THE SUMMARY, MY RECALL FROM THE DISCUSSIONS ON THE THIRD BULLET THAT WE TALKED ABOUT, AGAIN, TO BE CONSISTENT WITH THE NAME OF THIS COMMITTEE, OF THE ETHICAL-LEGAL OF HEALTH. IT'S -- WHICH TO ME IS BROADER THAN MEDICAL, AND ALSO, THERE WAS, AS I RECALL, PART OF THE DISCUSSION ON THE LARGE POPULATION STUDY, SUPPOSED TO BE ECONOMIC AND I, I MEAN, I JUST BRING THAT UP BECAUSE I THINK THAT'S WHAT I RECALL FROM OUR DISCUSSIONS, WHICH IS A BROADER THAN WHAT THAT IS.

OKAY. SO TO ECONOMIC YOU'RE TALKING ABOUT SORT OF WHO WOULD FUND THE LARGE POPULATION STUDIES?

I THOUGHT THAT WAS PART OF THE IMPLICATION.

RIGHT.

ITS EFFECT ON HEALTH BUT ALSO THERE IS THE COST BENEFIT, WHICH WAS PART OF THE DISCUSSION AS I RECALL IT. THAT WAS MY THINKING.

SO JUST -- SO WE HAVE IT FOR THE RECORD, INVESTIGATIONS OF THE ETHICAL-LEGAL, HEALTH, ECONOMIC AND SOCIAL IMPLICATIONS. IS THAT THE WAY IT WOULD READ?

THAT'S, I MEAN AGAIN --

OR HEALTH, MAYBE WE COULD PUT HEALTH FIRST, SARAH SUGGESTING, WHICH I THINK IS A GOOD IDEA .

THANK YOU. IT'S GOOD TO HAVE A FEW COMMENTS. ALL RIGHTY. WELL, I'M UNDERCHEMD BY THE -- UNDERWHELMED BY THE RESPONSE RIGHT HERE. OKAY, SO I THINK THAT THESE ISSUE BRIEFS, I THINK, ARE ALSO QUITE IMPORTANT FOR US TO HAVE OFFICIALLY BLESSED AS PART OF THIS COMMITTEE BECAUSE THEY ARE GOING TO IN SOME WAYS, FRAME THE ISSUES, BUT ALSO DIRECT THE WAY THAT WE THINK ABOUT SOME OF THE ONES THAT WE HAVE PUT ON OF PRIVATIZATIONS PAST. -- SO I WOULD LIKE TO TAKE COMMENTS. DEB IF YOU HAVE SOME.

IN JUST LOOKING AT THE BULLET POINTS, CAN WE ALSO, ENHANCEMENT OF OVERSIGHT OF GENETIC TECHNOLOGIES AND SERVICES. THIS MAKES IT SOUND AS IF THERE IS A NEED FOR ENHANCEMENT AS OPPOSED TO ASSESSING THE OVERSIGHT. I MEAN IT'S -- IT'S PUT IN ALMOST A NEGATIVE LIGHT, AND WE DID HEAR WHAT CLEA AND FDA AND CAP -- THERE IS A LOT -- A LOT OF OVERSIGHT OF GENETIC TESTING SERVICES NOW. COULD WE CHANGE ENHANCEMENT TO ASSESSING THE OVERSIGHTS BECAUSE THAT'S REALLY THE PROCESS THAT WE DID. WE LOOKED AT WHAT WAS BEING DONE AND NOT NECESSARILY ENHANCING IT, BUT EVALUATING AND --

SO WOULD YOU SAY ASSESSMENT OF THE NEED FOR ENHANCEMENT OR SHOULD WE JUST SAY ASSESSMENT?

I THINK IT'S JUST WHAT WE DID WAS TO ASSESS THE OVERSIGHT. IT'S JUST ENHANCEMENT MAKES IT SOUND LIKE THERE IS A DEFICIENCY IN THE OVERSIGHT OF GENETICS TEST, WHICH I DON'T THINK CURRENTLY EXISTS FOR MOST AREAS.

ISN'T THIS WHERE WE GOT INTO THE TESTING THAT YOU CAN ORDER ON ONLINE BY SENDING IN MOUTH SWABS AND WE HAD THAT DISCUSSION ABOUT ALL THE DIFFERENT WAYS THAT TESTING, THAT MAYBE WE WOULDN'T BLESS AS OFFICIAL TESTYING, BUT THE COMMUNITY AT LARGE SEES AS AN OPPORTUNITY FOR TESTING.

THAT'S THE FINAL BULLET, ASSESSING THE PROS ANDCONS OF -- AND CONS. I THINK THAT'S BEEN SEPARATED AS A SEPARATE BULLET.

OKAY.

SO, IT MIGHT BE A FINE POINT. BUT JUST LOOKING AT HOW ALL OF THESE OTHERS ARE STATED, THIS IS STATED IN SUCH A WAY THAT IT SOUNDS AS IF THEIR NEED -- THERE NEEDS TO BE MORE OVERSIGHT, RATHER THAN WE ARE ASSESSING WHETHER --

RIGHT.

-- THE CURRENT OVERSIGHT IS OUT --

OKAY. I THINK THAT'S FINE. CAN YOU MAKE THAT CHANGE.

OKAY.

GOING ONCE. WE HAVE ANOTHER RED LIGHT ON OVER THERE.

I HAVE NOT BEEN INVOLVED IN THESE DISCUSSIONS. THIS MY FIRST TIME HERE, BUT I NOTICED THAT IN DR. MURRAY'S PRESENTATION, HE ADDED AN ITEM INTEREST HIS PRESENTATION THAT WAS NOT IN THE PRINTED VERSION ABOUT THE QUALITY ASSURANCE OF GENETIC TESTING, ET CETERA. WHICH SORT OF RELATEDS TO THE SAME ISSUE. -- RELATES TO THE SAME ISSUE. PERHAPS THE TENSE TIST HERE IS WITH REGARD TO THE WORD "OVERSIGHT." NO? BECAUSE I THINK THAT THERE IS ROOM FOR IMPROVEMENT IN TERMS OF THE QUALITY OF MEASUREMENTS. THE TRACEABILITY OF MEASUREMENTS TO NATIONAL STANDARDS, ET CETERA. I THINK THIS IS A VERY DIFFERENT TESTING ISSUE WITH REGARD TO GENETICS VERSUS SORT OF THE RUN-OF-THE-MILL CLINICAL PLEASUREMENTS WHERE WE -- MEASUREMENTS WHERE WE HAVE OUR CHOLESTEROL TESTED MANY, MANY TIMES WHEREAS GENETIC TESTING, PERHAPS, WILL BE DONE ONCE IN SOME CASES AND YOU RELY ON THAT INFORMATION FOR MANY DECISIONS THAT YOU NEED A DIFFERENT LEVEL OF QUALITY ASSURANCE, RELIABILITY OF THOSE MEASUREMENTS, AND I'M NOT SURE THAT WE ARE AT THAT POINT. I THOUGHT THIS WAS, PERHAPS, -- [ INDISCERNIBLE ] BUT I THOUGHT MAYBE THE ISSUE WAS DO WE REALLY WANT TO SAY LEAVE SIGHT OR DO YOU WANT TO SAY ENHANCEMENT OF QUALITY ASSURANCE MEASUREMENTS OR QUALITY ASSURANCE EFFORTS OR SOMETHING LIKE THAT. BUT I THINK THERE IS ROOM FOR IMPROVEMENT IN THAT REGARD IN TERMS OF QUALITY ASSURANCE.

ED.

WHAT IF WE STATED IT ASSESSMENT OF QUALITY ASSURANCE AND OVERSIGHT. WOULD THAT BE A WAY OF GETTING THAT POINT IN THERE? BECAUSE I THINK THAT WAS PART OF THE DISCUSSION IN POINT OF FACT . YES, THERE IS -- SARAH A -- SARAH'S COMMENTING DOES THIS GET THE CLINICAL VALIDITY OR IS QUALITY ASSURANCE MORE ANALITICAL VALIDITY.

I THINK QUALITY ASSURANCE IS MORE GETTING AT WHETHER THE ANSWER YOU GAVE, GIVEN WHAT YOU TESTED WAS THE CORRECT ANSWER, WHICH IS DIFFERENT THAN WHETHER THAT ANSWER HAS ANY MEDICAL UTILITY. I THINK THERE ARE TWO SEPARATE THINGS AND I THINK THE POINT THAT WAS JUST MADE, IF I MISSED, IS THAT, YOU KNOW, BECAUSE THINGS ARE POTENTIALLY ONCE-IN-A-LIFETIME TEST WHERE YOU DON'T HAVE A CHANCE THROUGH REPEATED TESTING TO CATCH AN ERROR, DO WE HAVE SOME HIGHER OBLIGATIONFO PROVIDE -- OBLIGATION TO PROVIDE QA, QG C KIND OF -- ON QC KIND OF MECHANISMS TO ASSURE THE TEST RESULT IS ACTUALLY A CORRECT RESULT.

I'M JUST TRYING TO FIGURE OUT HOW TO WORD IT TO ASSIST STAFF . WHAT -- WHAT IF WE MADE IT, I MEAN IF WE DON'T MAKE QUALITY ASSURANCE, IF WE LEAVE IT A QUALITY, ASSESSMENT OF THE QUALITY AND LEAVE SIGHT OF --

THINK IT MIGHT BE USEFUL TO ACTUALLY LOOK AT THE ISSUE BRIEF THAT GOES WITH THAT BULLET POINT. WHICH IS IN THE APPENDIX OVERSIGHT OF GENETIC TECHNOLOGIES ISSUE BRIEF. I THINK THERE IS A LOT OF DISCUSSION ABOUT WHO, WHO HAS OVERSIGHT OR RESPONSIBILITIES WHAT THE CURRENT STATUS IS, BUT THERE NOT REALLY A SEPARATE DISCUSSION IN THAT BRIEF ON QA AND STANDARDIZATION OF METHODS AS MUCH AS JUST IN THE CURRENT MEDICAL SYSTEM, YOU KNOW, WHAT GROUPS ARE RESPONSIBLE FOR TRYING TO PROVIDE THE OVERSIGHT FOR, YOU KNOW, THAT WOULD BE RELEVANT FOR GENETIC TESTS.

WHAT IF WE JUST SAID ASSESSMENT OF THE OVERSIGHT BLAH, BLAH, BLAH, AND REFINEMENT WHERE APPROPRIATE. SO WE ARE NOT MAKING A JUDGEMENT ABOUT WHETHER WE'RE DEFINITELY GOING TO IMPROVE SOMETHING OR THAT THERE IS SOMETHING IN NEED OF IMPROVEMENT, BUT WE'RE RECOGNIZING THE FACT THAT WE'RE ALWAYS GOING TO HAVE TO REFINE THINGS, EVEN CHANGING CIRCUMSTANCES. I DON'T KNOW IF THAT DOES THE TRICK.

TURN TO THE PEOPLE WHO BROUGHT THE QUESTION UP? ED, IF YOU WANT TO COMMENT.

I WAS JUST LOOKING AND IF ONE READS THE ISSUE BRIEF THE ISSUE BRIEF PRETTY CLEARLY SAYS NEED FOR ENHANCED OVERSIGHT. OF GENETIC TESTS AND LEADS LOGICALLY TO THAT POINT ALSO. AND ITA -- IT'S ABOUT PROTECTING THE THE PUBLIC AND CUTTING-EDGE TECHNOLOGIES, BUT I THINK THE WAY IT WAS STATED, PERHAPS THE WAY YOU ORIGINALLY SAID IT, ASSESSMENT OF THE NEED FOR ENHANCEMENT OF OVERSIGHTS SINCE THAT'S CLEAR, THAT CLEARLY IS IN THE ISSUE BRIEFS AND BY STATING IT THAT WAY, IT DOESN'T PRESUME A CONCLUSION.

OKAY.

I WAS JUST GOING TO POINT OUT THAT IN AN EXECUTIVE SUMMARY LIKE THIS, ALL OF THE OTHER TERMS ARE VERY NEUTRAL. THEY DON'T TIP OUR HAND ONE WAY OR ANOTHER. IT'S JUST WE LIST OPPORTUNITIES N.THAT SENSE, DEBRA'S POINT IS ABSOLUTELY RIGHT ON TIRE MARKET. I DON'T THINK WE HAVE TO SORT OF LENGTHEN THE BULLET POINT TO COVER ALL CONTINGENCIS.

UH-HUH.

WE'RE SIMPLY SAYING WE WERE NOT A -- EVALUIATING IT AND READ FURTHER IF YOU WANT TO KNOW WHAT WE DECIDED. IN THAT SENSE, I WOULD TIP MORE TOWARDS NEUTRAL TERMS AS MUCH AS WE CAN.

IN NEED OF A VOTE FOR OVERSIGHT OR NEED FOR ENHANCEMENT?

I DON'T THINK WE WANT TO SAY ASSESSING THE NEED FOR OVERSIGHT. THAT WOULD SUGGEST WE CONSIDER THE POSSIBILITY. NO ONE NEEDS TO HAVE OVERSIGHT.

NO. NO. SO ASSESSMENT OF THE NEED FOR ENHANCEMENT OF OVERSIGHT OF GENETIC TESTING OR GENETIC TECHNOLOGIES AND SERVICES.

I'M NOT A BIG FAN OF THE WORD ENHANCEMENT. I THINK I'M WITH DEBRA ON THAT ONE.

OKAY.

ACTUALLY IF YOU LOOK AT THE BRIEF, THE NEXT TO THE LAST PARAGRAPH SAID WHILE THERE SEEMS TO BE A CONVINCE -- CONSENSUS OF THE NEED FOR GENETIC TESTS, THE BEGINNING OF THE NEXT PARAGRAPH STATES A QUESTION: HAS A BALANCE BETWEEN PROTECTING THE PUBLIC AND ACCESS TO NEW CUTTING-EDGE TECHNOLOGIES BEEN ACHIEVED, DO CURRENT MECHANISMS STRIKE A BALANCE BETWEEN ACCESS, SAFETY, AND MEDICAL PRACTICE, SO THOSE ARE THE QUESTIONS THAT WE'RE LOOKING AT.

UH-HUH.

AS TO, I MEAN, THAT STATEMENT AT THE FIRST SENTENCE OF THE PREVIOUS PARAGRAPH IS PRETTY STRONG, TUMLY, AND I NEVER REALLY -- ACTUALLY SCOM, I NEVER REALLY CAUGHT IT -- ACTUALLY, AND I NEVER REALLY CAUGHT IT BEFORE THIS POINT BECAUSE THAT'S SAYING THERE IS A NEED FOR ENHANCED OVERSIGHT, WHEREAS THE QUESTIONS BEING ASKED AT THE END ARE REALLY MORE BALANCED AND -- AND SO I WOULD JUST BE HAPPY WITH CHANGING IT TO ASSESSMENT OF OVERSIGHT OF GENETIC TECHNOLOGIES AND SERVICES OR ASSESSMENT OF QUALITY AND OVERSIGHT OF GENNIETIC TECHNOLOGIES AND SERVICES. BECAUSE IT IS IS AS IS POINTED OUT, MORE NEUTRAL AND CONSISTENT WITH THE OTHER BULLET POINTS AS SOMETHING WE'RE GOING TO LOOK AT WITHOUT A PRECONCLUSION ABOUT WHAT NEEDS TO BE DONE.

OKAY. SO I'M GOING TO ASK THE -- OOPS, WE HAVE JUDY.

YES. I JUST HAVE A COMMENT AND MAYBE IT A A -- ON IT'S A VERY SUBTLE POINT, BECAUSE I THINK WE'VE HAD THIS DISCUSSION ONCE BEFORE ABOUT THE TERMINOLOGY WHEN REFERRING TO THIS. MY CONCERN, AGAIN, AND MAYBE IT'S NOT LEGITIMATE, BUT I THINK I NEED TO BRING IT FORWARD, IS THAT THAT ASSESSMENT, JUST LEAVING IT AS IS, I REALIZE YOU'RE NEED FOR NUTRALITY IN AN EXECUTIVE SUMMARY, HOW FAR, WHEN YOU'RE SAYING THAT, IT SOUNDS LIKE AN ACTIVE, ONGOING MONITORING OF WHAT THE LEAVE SIGHT IS. LIKE YOU'RE ACTUALLY DOING, YOU KNOW WHAT I MEAN, TAKING AN ACTIVE PART IN THAT OVERSIGHT, AND I DON'T THINK THAT IS WHAT IS INTENDED BY THIS, THE ROLE AS OF THE -- AS THE ROLE OF THIS COMMITTEE, FRANKLY.

I THINK WHAT WE DECIDED AS A COMMITTEE WAS THAT WE WOULD TRY AND JUST KEEPY THIS ON A RADAR SCREEN SO THAT WE WOULD HAVE PERIODIC REPORTS.

RIGHT.

FROM THE DIFFERENT BODIES LIKE CLIAC ABOUT WHERE THINGS ARE.

THAT'S FINE. ABSOLUTELY. THAT'S FINE BUT AT THAT LEVEL.

YEAH.

BARBARA.

I'M THINKING MAYBE A COMPROMISE WOULD BE TO SAY ASSESSING THE CURRENT STATE OF OVERSIGHT OR DISCUSSING THE STATE OR THE STATUS OR, YOU KNOW, SO YOU IMPLY IT'S JUST A ONE-TIME, YOU KNOW, LOOKING AT IT.

AND SINCE WE WERE PLANNING TO MONITOR THE OCCASIONALLY AS WE CONCLUDED, I THINK ASSESSING THE STATUS RATHER THAN CURRENT STATUS WOULD BE THE APPROPRIATE --

I'M GOING TO ASK FAYE TO READ BACK WHAT SHE THINKS THAT BULLET POINT SAYS NO SO WE CAN SEE IF WE HAVE CONSENSUS.

ASSESSMENT OF THE STATUS OF OVERSIGHT QUALITY AND OVERSIGHT OF GENETIC TECHNOLOGIES AND SERVICES.

OKAY. IS EVERYBODY HAPPY WITH THAT AS THE BULLETY? ALL RIGHT. I'LL TAKE SILENCE AS A YES. QUICKLY. TURN OFF ALL THE MICS. JOAN.

AND ANOTHER AREA, LOOKING AT THE ISSUE BRIEF OF GENETIC EDUCATION AND TRAINING AND GIVEN OUR LONG CONVERSATIONS YESTERDAY, IT REALLY DOESN'T ADDRESS ISSUES OF DIVERSITY IN THE WORKFORCE OR CULTURAL COMPETENCY, AND I THINK THOSE WORDS NEED TO BE INCORPORATED WITHIN THE ISSUE BRIEF.

DO YOU MEAN WITH AN ISSUE BRIEF OR WITHIN THE REPORT ITSELF?

I THINK AT LEAST WITHIN THE ISSUE BRIEF SO THAT WHEN IT ASKS ABOUT ADEQUACY OF GENETICS WORKFORCE, THERE IS NO MENTION OF DIVERSITY THERE. THERE IS NO MENTION OF CULTURAL CONFIDENCE.

SO, JOAN DO YOU WANT TO SUGGEST A PLACE WHERE THAT MIGHT GO. SHOULD IT GO SOMEWHERE IN THE FIRST PARAGRAPH OR --

OR IT COULD, IF YOU LOOK AT THE NEXT TO LAST PARAGRAPH, IT SAYS THERE ARE QUESTIONS OF THE ADEQUACY OF THE GENETICS WOKFORCE, AND THEN IT SPEAKS ABOUT THE SPECIALISTS AND GENERALISTS AND I THINK IN THERE TO TALK ABOUT ADEQUACY AND TALK ABOUT ADEQUACY IN TERMS OF REPRESENTATION, WHEN DIVERSITY OF OF GROUPS WOULD BE A LOGICAL PLACE TO PUT THAT .

OKAY. ANY DISSENTING VOTES ON ADDING THOSE TWO POINTS TO THE WORKFORCE ISSUE BRIEF?

NO, I THINK THOSE ARE REALLY GOOD POINTS AND THEY WERE CLEARLY BROUGHT UP AS IMPORTANT PARTS OF THE TRAINING AND EDUCATION OF OUR WORKFORCE THAT'S GOING TO BE DEALING WITH GENETIC ISSUES IN THE FUTURE. ALL RIGHT. ARE THERE OTHER COMMENTS ON ISSUE BRIEFS THAT WE SHOULD TAKE UP? FAYE.

I JUST WANTED TO POINT OUT THAT WE DID GET SOME PUBLIC COMMENTS ON THE ISSUE BRIEFS, AND I THINK THE COMMITTEE NEEDS TO TALK ABOUT WHETHER WE'RE GOING TO SEND THOSE OUT FOR PUBLIC COMMENTS, AND I JUST WANT TO REMIND YOU WHEN WE -- [ INDISCERNIBLE ] WROTE THEM, IT WAS JUST TO PRESENT A BALANCED VIEW OF THE ISSUES NOT TO PRESENT THE COMMITTEE'S POSITION ON THE ISSUES, BUT RATHER JUST TO GIVE ALL THE BACKGROUND INFORMATION ON WHICH TO BASE YOUR DECISIONS. SO THE QUESTIONS -- QUESTION'S WHETHER YOU WANT TO SEND THOSE OUT FOR A PUBLIC COMMENTS AND WHETHER WE WANT TO CHANGE THEM FURTHERO OR DO ON WE WANT TO KEEP THEM IN THE CURRENT STATE THAT WE HAD DETERMINED PREVIOUSLY.

IN THE TABLE FOLDER OF THE RESPONSE FROM AHEP, SO THE AMERICAN, AMERICA'S HEALTH INSURANCE PLANS AND BASICALLY SAYS WE BELIEVE CONCERNS AND THERE ARE A NUMBER OF THINGS HERE, BUT I'LL SUMMARIZE. WE BELIEVE CONCERNS ABOUT POSSIBLE GENETIC DISCRIMINATION BY HEALTH INSURANCE PLANS ARE LARGELY UNFOUNDD. AND CONTINUES ON THEY MAKE SARAH'S SAYING THAT THEY POINT OUT A FACTUAL DISAGREEMENT AND PROBABLY WE SHOULD RESTATE HOW WE SPOKE OF ARIIS, A. SAYS WE SHOULD ALSO NOTE THAT THE DISCUSSION ON PAGE 3 OF GENETIC EXCEPTIONS, ON PAGE 3 OF THE GENETIC EXCEPTIONALISM CORRECTLY STATES THE IMPACT OF RISKS ON STATE LAWS DEALING WITH GENETIC PRIVACY AND GENETIC DISCRIMINATION AND HEALTH INSURANCE AND EMPLOYMENT. RISA DOESN'T IMPLY -- APPLY TO INSURANCE OR HEALTH INFORMATION PRIVACIES. EMPLOYMENT, RATHER RESTS AS A FEDERAL STATUTE AND WELFARE AND BENEFIT PLANS INCLUDING HEALTH AND DISABILITY. WE CAN MAKE THAT FACTUAL CHANGE.

RIGHT. SO I MEAN I THINK WHAT WE SHOULD DO WITH THE PUBLIC COMMENTS, THIS MY OPINION, WE CAN GET A COMMITTEE CONSENSUS, IS TO TAKE THIS, THE PLACES WHERE WE HAVE GOTTEN COMMENTS LIKE THIS THAT ARE RELATED TO FACTUAL THINGS AND JUST DO A FACT CHECK, YOU KNOW, BECAUSE OBVIOUSLY YOU DO YOUR -- DREW YOUR INFORMATION FROM SOME SOURCE AND THEY'RE DRAWING FROM SOME SOURCE. LET'S TRY AND FACT CHECK IT AND NOT JUST BLANKETLY TAKE THE PUBLIC COMMENT AS THE CORRECT INFORMATION, BUT DO OUR DUE DILIGENCE ON THAT AND THEN I THINK THAT WOULD BE HIGHLY APPROPRIATE TO MAKE ANY FACTUAL CORRECTIONS. I GUESS FROM THE POINT OF VIEW OF THE ISSUE BRIEFS, I AGREE THAT THE POINT OF THEM WAS TO TRY AND JUST GIVE A BALANCED VIEW OF WHAT, WHAT THE ISSUE IS AND WHAT SORT OF THINGS ARE UNDER DISCUSSION OR THAT MIGHT REQUIRE FURTHER DISCUSSION AND TO TRY AND MAKE SURE THAT WE HAVE CAPTURED THOSE THINGS AS WELL. WITHOUT DRAWING A COMMITTEE CONCLUSION IN ANY WAY. I THINK THAT THESE WERE INTENDED TO FRAME THE ISSUES SO THAT WE COULD, UM, GO THROUGH EACH ISSUE AND AS WE DID YESTERDAY WITH THE EDUCATION, NOW WE'RE GOING TO MAKE A SPECIFIC RECOMMENDATION IN OUR ON RESOLUTION ABOUT WHAT WE BELIEVE SHOULD BE DONE. AND I THINK THAT'S COMPLETELY DIFFERENT THAN JUST DIFFEY EVERY -- DIFFERING THE ISSUE BRIEFS, WHICH WERE WHAT THESE WERE INTENDED TO BE.

I THINK CLEARLY FROM DISCUSSIONS THAT HAVE BEEN HELD AT EVERY ONE OF OUR MEETINGS, THE CONCERNS ABOUT POSSIBLE GENETIC DISCRIMINATION BY HEALTH INSURANCE PLANS ARE LARGELY UNFOUNDED. I THINK THIS AND THE PREVIOUS COMMITTEE HAS DISAGREED WITH US, THE PUBLIC DISAGREES AND WE HAVE, IN FACT WILL TRY TO BRING THE PUBLIC TO THE NEXT MEETING TO DISCUSS THAT PUBLIC WHERE THERE HAS BEEN DISCRIMINATION.

I MEAN I THINK IT'S COMPLETELY LEGITIMATE TO SAY THAT THERE IS A DEBATE ON WHETHER OR NOT IT IS OR ISN'T THAT CERTAIN STAKEHOLTIER -- STAKEHOLDERS FEEL THERE NO NEED FOR LEGISLATION BECAUSE THERE HAVE AN BEEN THE ANY MAJOR ABUSES, AND THEN THERE ARE OTHER LINES OF EVIDENCE THAT SAY DESPITE FACT THAT MAYBE THERE HAVEN'T BEEN ERROR MANY HIGHLY-PUBLICIZED CASES OF ABUSE, THERE IS STILL, WHEN DO YOU PUBLIC OPINION SURVEYS, A FEELING AMONG THE PUBLIC THAT THERE A FEAR AND, YOU KNOW, SO HOW DO YOU RESOLVE THAT IN ITSELF. IT'S A DILEMMA, YOU KNOW, HOW DO YOU RESOLVE THE ISSUE OF OVERCOMING PUBLIC FEAR WHEN THERE NOT ACTUALLY TOO MUCH DOCUMENTATION THAT THAT FEAR HAS A RATIONALE BASIS. BUT WE -- I MEAN WE STILL HAVE TO DEAL WITH IT. IT'S STILL A BARRIER TO IMPLEMENTATION OF THIS INTO THE PRACTICE OF MEDICINE.

OKAY. OTHER COMMENTS ON ANY OF THE ISSUE BRIEFS IN.

IT MIGHT BE SINCE IT'S INTENDED TO BECOME A PUBLIC DOCUMENT THAT AT THE BEGINNING OF THE APPENDIX WHERE IT SIMPLY SAYS ISSUE BRIEFS ON 12 PRIORITY ISSUES THAT WE ADD A BRIEF PARAGRAPH EXPLAINING WHAT WE MEAN BY ISSUE BRIEFS TO ESSENTIALLY ARGUE WHAT YOU JUST SAID. THEY'RE NOT DESIGNED TO GIVE AN ANSWER. THEY'RE DESIGNED TO LAY OUT THE ISSUES FOR THE COMMITTEE AND BY EXTENSION FOR THE PUBLIC. SO THAT PEOPLE DON'T READ THESE AND BELIEVE THAT WE'RE SOMEHOW EITHER TRYING TO MAKE A RECOMMENDATION OR REFUSING TO TRY TO MAKE A RECOMMENDATION.

RIGHT. THAT'S SOMETHING STAFF COULD DO, IS WRITE A SUMMARY PARAGRAPH WITH THAT.

THAT IS KIND OF EXPLAINED AT THE TOP OF THE BRIEF. IN THAT STATEMENT THAT'S ON EVERY PAGE, SO SOMETHING SIMILAR TO THAT PUT AT THE BEGINNING IN BIGGER LETTERS SO YOU NOTICE IT MORE.

YES. I MEAN WE WANT TO MAKE SURE THAT WE CAPTURE THESE ARE INTENDED TO FRAME THE ISSUES RATHER THAN REFLECT ANY STATEMENT OF WHAT THIS COMMITTEE HAS ARRIVED AT AS A CONCLUSION ON THAT PARTICULAR ISSUE.

I WOULD POINT OUT, THOUGH, IF WE FINALIZE IT HERE THEN IT DOES BECOME THE OFFICIAL VIEW OF THE SECRETARY'S ADVISOR ON COMMITTEE ON GENETICS.

RIGHT. IT'S A VIEW BASICALLY THAT THIS IS AN ISSUE AND HERE ARE THE QUESTIONS THAT REMAIN TO BE ANSWERED RATHER THAN HERE IS OUR RECOMMENDATION FOR WHAT TO DO ABOUT IT. WHICH I THINK ARE QUITE DIFFERENT THINGS AND I DON'T THINK, FOR MOST OF THESE ISSUES WE'RE QUITE READY TO PUT OUR STAKE IN THE GROUND AND SAY THIS IS IT. WE KNOW EXACTLY WHAT WE WANT TO DO. GO FOR IT. WE'RE FRAMING WHAT WE WANT TO DO FOR THE NEXT COUPLE OF YEARS OF THIS COMMITTEE'S LIFE.

AND THEN THIS PARTICULAR ISSUE, GO TO THE VISION STATEMENT ISSUE BRIEF. MOST PEOPLE WOULD GO THERE THINKING OH, THIS IS WHERE I'M GOING TO SEE THE VISION AND, IN FACT, WHAT YOU GET IS A LOT OF QUESTIONS THAT SAY SHOULD WE HAVE A VISION. SHOULD WE ASK SOMEONE ELSE TO HAVE A VISION. AND IT DOESN'T DECLARE THE VISION. SO I THINK IT'S IMPORTANT THAT PEOPLE KNOW WHAT THESE ARE AND WHAT, IN PARTICULAR WHAT THEY'RE NOT.

OKAY. OTHER DISCUSSIONS? ANY OF THE EX OFFICIOS? WAYNE'S REACHING.

I'M NOT SURE WHAT I'M GOING TO SAY MIGHT SOUND A BIT TOO HARSH. I MISSED THE LAST MEETING. I'M NOT SURE HOW YOU GOT WHERE TOWHERE YOU ARE RIGHT NOW, BUT I THINK THIS COMMITTEE SHOULD BE MORE BOLD OR BOLDER AND I AGREE WITH HUNT HERE. I WAS READING THE DOCUMENT HERE AND IT MEANDERS ALONG AND I THINK YOU NEED TO BE BOLD AND ESTABLISH A VISION FOR HOW THIS STUFF IS GOING TO HAPPEN. I MEAN YOU HAVE HEARD, I MEAN PEOPLE KNOW ABOUT THE ISSUES RELATED TO GENETICS. I WAS HOPING MY COMMENTS THIS MORNING MIGHT ELICIT SOME REACTION, BUT I GUESS WE HAVE ALL EATEN TOO MUCH PROTEIN LAST NIGHT AND SO JUST TO ENCOURAGE YOU TO BE BOLD. I THINK THE COUNTRY NEEDS HELP IN THE, IN USING GENETICS TO IMPROVE HELP AND HELP SOCIETY. SO IF THIS THE PLACE TO COME, JUST BE BOLD.

I WOULD JUST POINT OUT THAT AS SOME STATED, THESE REALLY ARE BRIEFS THAT WE HAVE DONE, PRIORITIZED IN TERMS OF HOW WE WOULD MOVE FORWARD, SO THEY'RE NOT THE ANSWER, THEY WERE THE BEGINNING AND I WOULD ARGUE IT'S NOT THAT WE DON'T HAVE A VISION, THAT WE VOTED NOT TO HAVE A VISION, BUT WE VOTED THAT PERHAPS THAT'S NOT WHERE WE SHOULD SPEND OUR TIME IN CRAFTING A VISION BUT RATHER TO GET DOWN TO SOME SPECIFIC, SOME SPECIFIC APPROACH S.

SO MY RECOLLECTION ON THE RANKING OF THESE VARIOUS THINKS -- THINGS WAS SINCE I PUT THE DIVISION STATEMENT ON THE TABLE, I SORT OF PAID ATTENTION TO HOW IT FELL OUT IN THE RANKING, AND IT DIDN'T GET RANKED VERY HIGHLY BY MOST OF THE PEOPLE WHO VOTED ON THE ISSUE. THEY -- I THINK PEOPLE WERE MORE CONCERNED WITH US SPENDING OUR TIME ON THE ACTUAL ISSUES THAN, YOU KNOW, MEND ISING -- SPENDING HOWEVER MANY HOURS WRITING THE DIVISION STATEMENT, WHICH, YOU KNOW, WE COULD HAVE POTENTIALLY GONE TO THE DILBERT VISION STATEMENT BUILDER WEBSITE AND, YOU KNOW, PICKED OUT THE RIGHT KEY WORDS AND HAD ONE CREATED FOR US. SO I THINK OUR VISION IS GOING TO COME FROM THE ISSUES THAT WE HAVE CHOSENY TO PRIORITIZE AND TRYING TO, TO TAKE SPECIFIC ACTION ON THOSE ISSUES SO BEING BOLD IN A SPECIFIC WAY RATHER THAN IN A MORE GENERAL WAY.

IS VISION THE RIGHT WORD? I -- I JUST WONDER IF VISION, I MEAN MAYBE THIS IS MORE OUR ROAD MAP RATHER THAN OUR VISION. BECAUSE WE'RE GOING TO BE CREATING THE VISION OF WHAT WE WANT TO TO AND ACTIONS TO TAKE THINGS AS WE WORK THROUGH THESE DIFFERENT ISSUES. THIS IS NOT REALLY -- YOU'RE RIGHT. ONE OF THE THIGS, ONE OF THE ISSUES WAS TO CREATE A VITIONZ STATEMENT. WHAT WE -- VISION STATEMENT WHAT. WE ENDED UP DOING IS CREATING A ROAD MAP.

YEAH, SO I WOULD BE OKAY WITH A SHIFT IN THE SUMMARY BRIEF TO ROAD MAP INSTEAD OF VISION, BUT HUNT, LET'S HEAR FROM YOU.

TWO POINTS. ONE IS THE UNFORTUNATE CONFLUENCE OF TERMS, SO WE END UP WITH AN ISSUE BRIEF AND A VISION STAGE. CONCLUDE THAT WE AREN'T GOING TO SPEND OUR TIME ON THAT AND THEN WRITE A DOCUMENT THAT'S ENTITLED TOWARDS A VISION SUGGESTING THAT, IN FACT, DESPITE OUR VOTE, WE'RE GOING AHEAD AND DOING THAT. SO IN POST OF CHANGES -- CHANGING THE TERM MIGHT BE OF SOME VALUE. THE OTHER SPECIFIC SUGGESTION I WOULD HAVE JUST TO AGAIN REMIND READERS AND AVOID POTENTIAL MISINTERPRETATION OF WHAT THESE ISSUE BRIEFS ARE IS PERHAPS PUT AS THE LAST ENTRY FOR EACH OF THE ISSUE BRIEFS COMMITTEE OUTCOME OR SOMETHING LIKE THAT THAT REMINDS THE READER HOW THESE WERE THEN PRIORITIZED. THIS ISSUE BECAME ONE OF THE TOP PRIORITIES FOR -- PRIORITIES FOR 2004 OR THIS ISSUE WAS DETERMINED TO BE AN OVERARCHING ISSUE, AND THEN UNDER THE VISION ONE, IT COULD SAY WHAT WE JUST ALL SAID. THAT RATHER THAN THE COMMITTEE, RATHER THAN HAVING THE COMMITTEE DELIBERATE ON THE NEED FOR A GUIDING VISION STATEMENT, THE COMMITTEE INSTEAD DECIDED TO DO SOMETHING ELSE. IT JUST WOULD CLARIFY AND ALLOW READERS SIX MONTHS LATER TO ACTUALLY UNDERSTAND WHAT THOUGHT PROCESS WE WENT THROUGH.

IT MIGHT ACTUALLY BE WORTHWHILE, SAY, EVEN ORDERING THE ISSUE BRIEFS INSTEAD OF ALPHABETICALLY. AT THIS POINT, I MEAN ALPHABETICALLY WAS COMPLETELY APPROPRIATE WHEN WE HADN'T RANKED THEM. AT THIS POINT, IT WOULD HELP ALSO IN THE TABLE OF CONTENTS AND THEN IN THE ORDER THAT THEY'RE PRESENTED TO THE READER ON THE WEBSITE OR WHATEVER, UM, MECHANISM TO PUT THATHEM IN THE PRIORITY ORDER THAT WE HAVE -- TO PUT THEM IN THE PRIORITY THARD WE HAVE ESTABLISHED NOW SO IT'S VERY CLEAR, YOU KNOW, TO SOMEONE SCANNING IT, WHAT THE PRIORITY IS AND, YOU KNOW, THEN OUR MINUTES AS WE GO THROUGH OUR SUBSEQUENT TASK FORCE MEETINGS WILL HAVE A REAL CLEAR WAY OF CAPTURING. OKAY, WE SAID THESE WERE THE TOP PRIORITIES. THEY WERE PRESENTED AT THIS MEETING. THEY WERE, YOU KNOW, THE OUTCOME WAS A SPECIFIC RECOMMENDATION, YOU KNOW, COVERAGE AND REBIM REIMBURSEMENT WE DECIDE SIDE GOING TO TAKE SEVERAL MEETINGS BEFORE WE'RE READY TO PUT OUT A COMMITTEE STATEMENT. BUT OTHERS, YOU KNOW, WE HOPEFULLY AT THE END OF THIS MEETING WILL HAVE TWO MEETING RESOLUTIONS. I THINK THAT WILL ALSO HELP CLARIFY TO PEOPLE FOLLOWING OUR PROGRESS THAT THE PRIORITY ISSUES ARE BEING DEALT WITH AND THAT THERE ARE OUTCOMES.

LET ME ASK IT, THOUGH NEXT TERMS OF A SUMMARY STATEMENT, THERE ARE FIVE -- WE TOOK THESE 12, UM, PRIORITIES AND PUT THEM INTO FIVE DIFFERENT CATEGORIES, AND TWO SUGGESTIONS. IN THE SUMMARY STATEMENT, I WOULD TWID THEM UP, BE A LITTLE MORE TELEGRAPHIC. DIVIDE THEM INTO THE FIVE SECS, USE BULLET POINTS, HELP THE READER UNDERSTAND. THAT'S WHAT AN EXECUTIVE SUMMARY IS SUPPOSED TO BE FOR, AND THEN I WOULD AGREE WITH EMA -- EMILY TO ORGANIZE THE TABLE OF CONFERENCE IN THOSE FIVE CATEGORIYS WITHIN EACH ONE CAN YOU ALPHABETIZE. THEN IT'S CLEAR WHERE ONE IS IN TERMS OF THOSE FIVE.

SO JUST TO HELP STAFF ON, ON THE OUTCOMES SECTION, AND I'M LOOKING FOR IT UNDER TAB 2.

I WAS JUST RAISING A QUESTION ABOUT THE 5 CATEGORIES. WE STARTED WITH FOUR, I THINK. AND THEN --

THEN WE HAVE TO WRITE THE EXECUTIVE SUMMARY. THAT PARAGRAPH DIVIDES INTO FIVE. SO YOU HAVE TWO ISSUES THAT ARE THE HIGHEST PRIORITY. THEN YOU HAVE TWO OTHER ISSUES THAT ARE, SORRY, THREE OTHER ISSUES THAT ARE, QUOTE, UNDERTAKEN, DEPTH EXPLORATION. THEN WE HAVE TWO OTHERS SHORT ACTION, TWO OTHERS MONITORING AND THREE OTHERS THAT ARE OVERARCHING.

OKAY, SO RATHER THAN THE WAY WE HAD SET UP THE PRIORITYIZATION INITIALLY, WE COULD TAKE THAT PENULTIMATE PARAGRAPH OF THE SUMMARY AND JUST MAKE IT A LITTLE EASIER TO DISERN WHAT THE REAL OUTCOME ON OF THAT DISCUSSION WAS.

I THINK JUST, YOU KNOW, SOME BULLET POINTS AND PULLING THINGS TOGETHER SO THAT IT'S ALL INTERNALLY CONSISTENT SO THE WAY WE CATEGORIZE THINGS, THEY'RE LISTED THAT WAY IN THE TABLE OF CONTENTS. THEY'RE LISTED THAT WAY IN THE BODY, THE SUMMARY, AND THEN THERE ARE SUBGROUPS IN THE APPENDIX AS WELL THAT WAY. YES.

JUST TO GO BACK TO THE POINT ABOUT VISION BEING ONE OF OUR LOWER PRIORITIES AND YET THE TITLE OF THE DOCUMENT. WHAT IF WE MADE IT RATHER THAN TOWARD A VISION, WHICH WAS HOW WE GOT THERE, UM, WITHOUT BEING A VISION STATEMENT, AND I THINK THAT WAS THE SUBTLETY, BUT IF WE MADE IT MAPPING THE INTEGRATION OF GENETICS AND HEALTH IN SOCIETY OR A ROAD MAP FOR THE INTEGRATION. I WAS THINKING WITH THE MAPPING BEING A LITTLE BIT OF THE GENOME ONIC ILLUSION THERE.

THE QUESTION IS CAN WE STILL -- WITH THE CDC ROAD LOGO IN HELIX FORM.

PUBLIC DOMAIN. GO AHEAD. [ LAUGHTER ]

SO MAPPING THE INTEGRATION OF GENETICS, UM.

AND GENOMICS.

I ACTUALLY LIKE THE INTEGRATION. I THINK THE ROAD MAP FOR THE INTEGRATION OF GENETICS AND GENOMICS IN HEALTH AND SOCIETY OR SOMETHING ALONG THOSE LINES WOULD BE --

OKAY. WE JUST WANT TO GET IT SPECIFIC.

YEAH, I WOULD LIKE TO KEEP THE WORD "INTEGRATION" THERE BECAUSE I THINK THAT'S REALLY THE KEY THING. THERE'S A LOT OF ACTIVITIES AND THEY NEED TO ALL BE SOMEHOW THE COMING TOGETHER IN CONFLUENCE SO THAT THIS CAN TELLLY HAPPEN. -- ACTUALLY HAPPEN.

COULD YOU JUST REVIEW FOR ME WHAT YOU DECIDED ON FOR THE TITLE. SORRY.

I THINK IT'S A ROAD MAP FOR THE INTEGRATION OF GENNETICS AND GENOME ONICS AND HEALTH AND SOCIETY. IS THAT CORRECT?

THAT WAS MY RECOMMENDATION. IS EVERYBODY OKAY WITH THAT?

YOU'RE GOING TO CALL IT ROAD MAP? IT'S NOT THE ROAD MAP. IT'S JUST DEVELOPING A ROAD MAP WHERE THE PRIORITIZATION OF THE ISSUES WE'RE NOW GOING TO HAVE TO REVIEW TO COME UP WITH THE ROAD MAP. IT'S NOT ACTUALLY THE ROAD MAP, IS IT ?

COMMENTS.

CORRECT. GOING BACK TO MAPPING, I THINK IT COVERS THAT CONCERN.

BRAD, WHY IS A ROAD MAP NOT OKAY BECAUSE WE HAVE SET OUT WHERE WE'RE GOING TO GO AND THEN WE'RE GOING TO GO DOWN THE ROAD TO DO IT. SO, IN THAT SENSE, THIS IS OUR ROAD MAP OF WHAT WE'RE GOING TO BE WORKING ON.

THE ROAD MAP, I GET IT. I THOUGHT YOU MEANT A ROAD MAP IN THE WAY --

I THINK WE USE ROAD MAP FOR IT US, FOR THE COMMITTEE.

OKAY.

SO.

YES. COMPLETELY I CAVE. USE IT.

SO DO WE NEED TO SAYA IS SAGHS, ROAD MAP.

IT SAYS THE SUBTITLE IS A REPORT OF THE SACGHS. I THINK THAT'S CLEAR.

OKAY. ALL RIGHTY. NOW, DON'T FEEL COMPELLED TO FILL THE TIME JUST BECAUSE THERE IS TIME. IF WE HAVE --

WE HAVE PLENTY OF TIME. PLENTIY OF THINGS TO DO TODAY.

YES, SO I WANT TO MAKE SURE THAT WE'VE CAPTURED EVERYBODY'S COMMENTS, BUT WE DON'T HAVE TO SIT HERE AND WORDSMITHS MINUTIA TO FILL THE TIME UNTIL 10:00. DEB.

JUST ONE QUICK POINT. HEALTHCARE IS SOMETIMES HYPHEN EIGHTED, SOMETIMES SPLIT. COULD WE BE CONSISTENT THROUGHOUT THE -- .

OKAY. SO -- SORRY. AND JUST A QUESTION. DID WE FINALIZE THE QUESTION WE HAD EARLIER ABOUT HAVING THIS GO TO THE PUBLIC FOR COMMENT?

I'M ECHO ON WHAT I THINK WE HEARD. THAT WAS -- WE HAVE SPENT THE LAST YEAR COMING UP WITH ONLY TRYING TO GO THROUGH THE ISSUES TO GO FIGURE OUT WHICH ISSUES YOU WANT TO FOCUS ON. DURING THAT TIME, IF SOMEONE WANTED TO MAKE A PUBLIC COMMENT, IT WOULDN'T BE ABOUT ANY STANCE TO TAKE TO THOSE ISSUES BUT WITH WITH ABOUT WHETHER THOSE ISSUES ARE IMPORTANT FOR US TO THEN PURSUE, AND WHILE I GUESS THEY COULD MAKE A COMMENT ON THIS ABOUT NOT -- WHAT PARTICULAR ISSUES, BUT WHETHER THEY'RE IMPORTANT OR NOT, THEY HAVE HAD THE LAST YEAR TO DO THAT, AND WE HAVE HEARD FROM A LOT OF PUBLIC COMMENT. SO I DON'T THINK, IT FEELS TO ME WE NEED TO DO THAT NOW.

I WAS GOING TO ASK THAT AT THE CONCLUSION OF THIS SESSION THAT WE THEN NAKE A DECISION. I WAS GOING TO PROPOSE WE MAKE A DECISION TO FINALIZE THE DOCUMENT WITH THE CHANGES RECOMMENDED. AND THAT BE THE FINALIZED DOCUMENT. IT WILL THEN GO PUBLIC. OBVIOUSLY THE PUBLIC CAN MAKE COMMENTS THEN, BUT IT'S MORE, I THINK, AS BRAD HAS SUGGESTED, IT WILL BE COMMENT TO HELP GUIDE US IN OUR FUTURE DELIBERATIONS ON THESE ISSUES, BUT I DON'T -- IN TERMS OF WHAT THIS DOCUMENT SETS FORTH PER SAY, WE HAVE HAD IT OUT THERE, WE HAVE VOTED UPON IT, PEOPLE MAY DISAGREE WITH OUR PRIORITIZATION, BUT I THINK IT WILL BE IMPORTANT TO MOVE THIS FORWARDED TO THE SECRETARY.

RIGHT, SO I WOULD AGREE WITH THAT. I THINK THAT WE CERTAINLY ARE INTERESTED, ALWAYS INTERESTED IN COMMENTS FROM THE PUBLIC ON ANY OF THESE ISSUES, AND AS I MENTIONED BEFORE, I THINK THE IMPORTANT PUBLIC COMMENTS TO INCORPORATE HERE ARE THE FACTUAL COMMENTS SO WE'RE NOT MISSTATING FACTS. BUT AT THIS POINT, YOU KNOW, UNLESS THERE ARE SOME OTHER ASPECT TO AN ISSUE THAT WE HAVEN'T CONSIDERED, I GUESS THAT WOULD ALSO BE A LENIT -- LEGITIMATE THING TO ADD TO AN ISSUE BRIEF THERE. IS ONE MORE QUESTION THAT SHOULD BE ON THAT LIST OF QUESTIONS TO CONSIDER, BUT BEYOND THAT, I THINK WE SHOULD TRY AND FINALIZE THESE TODAY AND THEN SEEK THE PUBLIC COMMENT AS WE GET TO EACH ISSUE AND REALLY WANT TO DELVE INTO IT AND GET ALL OF THE PUBLIC INPUT ON THAT ISSUE PRIOR TO MAKING A SPECIFIC RECOMMENDATION BY THE COMMITTEE. EDA.

AND PART OF MY CONCERN -- ED.

AND PART OF MY CONCERN IS IF WE CONSIDER THE CALENDARED, IT'S IMPORTANT TO MOVE THIS FORWARD WITH SOME DISPATCH.

AT THE RISK OF WORDSMITHING, JUST A SMALL POINT ON PAGE 5 OF THE ROAD MAP, UM, THE TOP PARAGRAPH IS A REFERENCE THAT SAID KLIA CERTIFIED LABORATORIES. I THINK THAT'S THE FIRST REFERENCE TO KLIA THAT CAN YOU USE THE FULL NAME THERE.

RIGHT. SO I THINK PART OF THE APPENDIX OF DEAF NIGDS MIGHT BE ALSO -- DEFINITIONS MIGHT BE A LISTING OF ALL THE KEY ACRONYMS AND, YOU KNOW, WHAT THEY ACTUALLY MEAN.

THAT WOULD NOW MAKE IT 30 PAGES LONG. BUT WE'LL DO OUR BEST. [ LAUGHTER ]

SARAH ALSO HAD A SUGGESTION IN THE SPIRIT OF TRYING TO, OF TRUTH IN ADVERTISING FROM THE TITLE, I GUESS IT COULD BE. SO USING THE -- THE TITLE WE DECIDED UPON, BUT THEN, UM, THE STUDY PRIORITIES OF THE SECRETARY, RATHER THAN A AND SOCIETY. IT MAKES IT A LITTLE CLEARER IN THE SUBTITLE EXACTLY WHAT, CAN WE GET -- ON OH, SORRY. ALLEN.

AGAIN, AT THE RISK OF BEING WORDSMITHING, I THINK IT MIGHT BE AN IMPORTANT CONCEPT. I HAVE A QUESTION ON PAGE 1, THE EXECUTIVE SUMMARY. THE SECOND BULLET. CONCEPTUALIZES GENETIC CONCEPTION, END PARENEXT. IS THAT TO SUGGEST GENETIC THAT WAS -- THAT WE'RE REFERRING TO.

THE NATURE OF GENETIC INFORMATION.

IS IT UNIQUE OR IS IT UNIQUE IN SOME WAYS FROM OTHER TYPES OF INFORMATION.

I THINK WE SHOULD BE CLEAR IF THAT'S WHAT WE MEAN. PUBLIC DISCUSSION OF WHETHER OR NOT GENETIC INFORMATION, YOU KNOW, IS UNIQUE OR HOW OR SOMETHING LIKE THAT. THERE'S MUCH TO BE DISCUSSED

WHY DON'T WE STATE THAT PUBLIC DISCUSSION OF WHETHER REASON WE WERE -- THE GENETIC EXCEPTIONALISM TERM IS NOT EXACTLY, UM, -- I MEAN IT'S SORT OF ESO TERIC, I THINK, WHAT THE COMMUNITY KNOWS.

NO, NO.

SURE.

USING BOTH TERMS IS FINE. I WANTED TO MAKE IT CLEAR. THE MEDICAL TREATMENT OF THE GENETIC INFORMATION. I MEAN IT'S PERSONAL INFORMATION AS WELL, BUT CAN WE SAY MEDICAL AND PERSONAL INFORMATION BECAUSE IT'S THE, THE ISSUES SURROUNDING HOW YOU TREAT THAT MEDICALLY AND WHETHER IT GOES IN THE MILLION RECORD AND -- ON THE MEDICAL RECORD AND THINGS LIKE THAT.

ISN'T IT A QUESTION WHETHER GENETIC INFORMATION IS DIFFERENT FROM OTHER MEDICAL INFORMATION.

IT GOES BEYOND THAT BECAUSE WE'RE GOING TO -- OUR DECISION IN THE END WAS TO LOOK AT GENETIC EXCEPTIONS EXCEPTIONALAISM GOES, I THINK, MAYBE BEYOND THE INFORMATION, SO MAYBE WE NEED TO WORK WITH THAT WORDING A BIT MORE.

WHY TONIGHT WE INCLUDE THAT IN THE PRO SIDE AS AN OVERARCHAING THAT GENETIC EXCEPTIONALISM IS AN OVERARCHING.

OKAY.

OKAY. GOING ONCE. GOING TWICE.

I'M -- I APPRECIATE YOUR DISCUSSION. ON THE MEDICAL, BUT I REALLY, AGAIN, I GO ALONG WITH ITS, THE INDIVIDUAL'S INFORMATION AND ITS HEALTH INFORMATION. IT'S MEDICAL -- ITS MEDICAL TO ME IS MORE NARROWY AND IT'S REALLY THROUGH HEALTH INFORMATION. IT'S THAT, YOU KNOW, MOVING TOWARDS ELECTRONIC COUNTS RECORD. I JUST THINK IT'S CONCEPTUALLY IT'S MUCH BROADERY THAN MEDICAL.

IF WE SAID PERSONAL HEALTH INFORMATION, WOULD THAT CAPTURE IT? OKAY . [ LAUGHTER ]

ALL RIGHT. SO I THINK WHAT I WOULD LIKE TO DO UNLESS ED HAS OTHER COMMENTS.

WELL, SARAHA POINTS OUT, THAT YOU KNOW, WE NEED TO BE, WE NEED TO BE ACCURATE ALSO AND GENETIC INFORMATION IS, IN FACT, UNIQUE PERSONAL INFORMATION. WE ARE UNIQUE GENNETICALLY .

PERSONAL AND HEALTH ?

COULD WE SAY PUBLIC DISCUSSION OF WHETHER GENETIC INFORMATION IS DIFFERENT FROM OTHER PERSONAL HEALTH INFORMATION. BECAUSE IT'S REALLY THE DIFFERENCE BETWEEN IS THERE A DIFFERENCEO OR SHOULD IT BE TREATED JUST LIKE ALL OTHER

I WOULD SUGGEST A FAIRLY SMALL GROUP TO WORK ON THIS. WHY DON'T IT BE YOU AND ME, ELLY.

OKAY.

IF THAT'S ACCEPTABLE TO THE

DO WE NEED TO GET THE SECRETARY'S APPROVAL BEFORE WE WOULD POST THESE OR WHAT WOULD WE DO IN TERMS OF PUBLIC ACCESS?

WELL, THE PROCESS WILL BE THAT WE WILL SEND IT FORWARD TO THE SECRETARY AND ONCE IT'S RECEIVED, WE CAN POST IT ON OUR WEBSITE. SO WE WANT TO MAKE SURE THE SECRETARY HAS IT OF ABOUT WE MAKE IT PUBLIC AS A FINAL DOCUMENT.

THAT'S PROBABLY A GOOD ORDER. [ LAUGHTER ]

OKAY.

JUST TO POINT OUT, THAT'S A TERM OF ART RECEIVED BY THE RECEIVED BY THE SECRETARY JUST TO MAKE IT CLEAR. BUT THAT'S WHY I WOULD LIKE TO MOVE FORWARD BECAUSE, AGAIN, LOOKING AT THE CALENDAR, I THINK IT WILL BE GOOD TO GET IT TO THE SECRETARY AS SOON AS POSSIBLE.

ALL RIGHT, ED DO YOU WANT TO GO AHEAD AND TAKE OUR BREAK NOW OR DO YOU WANT TO GO AHEAD AND START THE NEXT DISCUSSION AREA?

DO I HAVE A SENSE FROM THE COMMITTEE. THERE ANYONE WHO DISAGREES WITH THIS PROCESS, THEN, AS OUTLINED TO THE COMMITTEE? IF ANYONE, IF I DO NOT HEAR ANY DISAGREEMENT, THEN WE WILL MOVE FORWARD WITH THAT PROCESS, MAKE THE CHANGES WITH SOME DISPATCH ANDSOME SEND THEM TO ON TO THE SECRETARY. SEND THE REPORT ON TO THE SECRETARY. THANK YOU VERY MUCH. THIS HAS BEEN A HUGE AMOUNT OF WORK BUT I THINK A VERY IMPORTANT PRIORITY SETTING EXERCISE THAT WE WENT THROUGH, AND I THINK IT'S A GOOD SUMMARY OF THE THINKING OF THIS COMMITTEE WILL BE USEFUL IN A LOT OF DIFFERENT VENUES .

WE ACTUALLY, WE HAD THE BREAK SCHEDULED FOR -- WHY DON'T WE -- I THINK THAT'S A GOOD IDEA. WHY DON'T WE TAKE A BREAK NOW, ELLY -- EMILY AND THEN WE'LL HAVE THE PUBLIC COMMENT AFTER THE BREAK. DEBRA.

CAN I HAVE A QUESTION, THE EDUCATION RESOLUTION WAS THAT REVISED AND WILL WE SEE THAT THIS AFTERNOON DURING THE WORKING SESSION AT LUNCH OR -- .

UM --

JUST FOR INFORMATION.

WHAT -- WHY DON'T WE TAKE A BREAK NOW AND -- YEAH, I THINK WE WILL HAVE TIME, BUT LET'S KEEP THIS TO A 15-MINUTE BREAK AND WE WILL.

YES, IT'S BEEN REVISED AND I THINK THE PLAN WAS TO BRING IT BACK TO THE COMMITTEE TO SHOW THE REVISIONS WHILE AT SOME POINT DURING THE THREE-HOUR OPEN SESSION, I THINK AND THEN THERE MAY ALSO BE SOME ADDITIONAL DISCUSSION IN THE COVERAGE AND REIMBURSEMENT REPORT. IS THAT CORRECT?

YEAH. YEAH.

LET'S TAKE A 15-MINUTE BREAK AND WE WILL RESUME THEN ABOUT 10:50. [ FROM THE CAPTIONER: IF YOU CAN READ THIS MESSAGE, WOULD YOU PLEASE HAVE SOMEONE RESET THE AUDIO LINE SO I CAN GET AUDIO TO THE CONFERENCE ]

JUST RECENTLY ON MAY 11th, 2004, THE "WALL STREET JOURNAL" RAN AN ARTICLE ABOUT SEVERAL OF THE COMPANIES THAT OFFER DIRECT-TO-CONSUMER MARKETING OF GENETIC TESTS. IN THE ARTICLE, DRUG METABOLISM TESTS ARE LINKED FOR NUTRITION AND TOXINS AND THE AUTHOR DESCRIBES THE VALIDITY OF ALL THE TESTS AS "THE SCIENCE BEHIND MANY SUCH TESTS IS SHAKY". OBVIOUSLY, IT IT'S DISAPPOINTING THAT ON THE ONE HAND WE HAVE MADE SUCH GREAT PROGRESS TOWARDS TESTING PATIENTS FOR THESE CLINICAL -- CRITICAL FARM COULD NOTEIC TESTS AND AT THE SAME TIME HAVE THEY POSSIBLY P ERR SEVED AS UNRELIABLE OR UNIMPORTANT. HAD JEN SIFTS AND OTHERS HAVE WORKED TO BRING THESE NEW TESTS TO MARKET. THEY HAVE THE POTENTIAL TO DECREASE SERIOUS ADVERSE ETCHES AND ALLOW FOR A MORE RATIONAL PRACTICE OF MEDICINE. MOST IN OUR INDUSTRY BELIEVE THAT THESE TESTS LIKE OTHER DIAGNOSTIC TESTS ARE BEST CONDUCTED IN CLEAR CERTIFIED LABORATORYS. WE URGE THE COMMITTEE TO RECOMMEND THE NECESSARY LEGAL AND REGULATORY CHANGES TO MAKE SURE THAT PROGRESS IS NOT LOST SO WE CAN CONTINUE PROGRESS TOWARDS OFFERING THESE POTENTIALLY LIFE SAVING TASKS AND THE BEST MEDICAL SETTING POSSIBLE. THANK YOU.

THANK YOU VERY MUCH. IF YOU HAVE THAT TYPED UP, IF YOU COULD PROVIDE IT TO THE STAFF, ALONG WITH THE COPY THAT YOU HAD FROM THE READER'S DIGEST, ANY OF THAT MATERIAL, WE WOULD APPRECIATE FOR OUR RECORD. ANY QUESTIONS OR COMMENTS FOR MR. MURPHY? YES? EMILY?

SO I WAS WONDERING WHAT YOUR RECOMMENDATION IS FOR THE CERTIFIED LABS WHO ARE ALSO MARKETING DIRECTLY TO CONSUMERS. I MEAN, BECAUSE, JUST BECAUSE YOU ARE A CLEO CERTIFIED LAB DOESN'T BASICALLY KEEP YOU FROM UNSCRUPULOUS MARKETING PRACTICES. IT JUST MEANS THAT YOU ARE PERFORMING THE TEST CORRECTLY BUT NOT THAT THE TEST HAS ANY REAL UTILITY. SO IS YOUR ACC COMMITTEE WORKING ON SOME RECOMMENDATIONS IN THAT REGARD?

NO, THAT COMMITTEE IS ACTUALLY JUST WORKING ON ISSUES ABOUT REIMBURSEMENTS, CDT CODES, ET CETERA. WE UNDERSTAND THAT SOME C LERKZO CLABS MIGHT OFFER TESTS THAT HAVE -- CLEO LABS MIGHT OFFER TESTS THAT HAVE LITTLE OR NO MEDICAL ADVICE. AND WE SHOW THEY ARE USING THOSE TO ORDER AND REPORT THOSE RESULTS. I THINK WHAT IS IMPORTANT IS THAT THE MARKETING BE HONEST AND FAIR TO THE CONSUMER, AND THAT THEY REALLY KNOW THE CONSUMER BUYING THOSE TESTS THROUGH A PHYSICIAN, WE KNOW THAT CONSUMERS WILL ASK PHYSICIANS TO DO THESE TESTS. WE GET CALLS EVERY DAY. WE ARE A CLEO REGISTERED LAB AND WE GET CALLS EVERY DAY FROM PATIENTS WHO WANT GD-6 TESTING AND WE HAVE TO REFER THEM BACK TO THEIR PHYSICIAN FOLLOWING CLEA. THE BENEFIT THE PATIENT WILL GET NEEDS TO BE HONESTLY AND FAIRLY DESCRIBED TO THE CONSUMER AND IT IS NOT BEING DONE SO. AND MORE IMPORTANTLY, WELL-ESTABLISHED MEDICAL UTILITY TESTS LIKE SOME OF THE ONES THAT ARE COMING OUT NOW FOR PREDICTING ADVERSE DRUG REACTIONS ARE BEING MIXED WITH THESE OTHERS. SO I THINK THAT'S THE REAL ISSUE.

OTHER QUESTIONS OR COMMENTS? IF NOT, THANK YOU VERY MUCH. AND CAN WE HAVE KELLY ORMOND COME TO THE TABLE AND THEN ALSO GAIL JABBIT IF YOU COULD COME TO ONE OF THE OTHER MICROPHONES AT THE TABLE. KELLY ORMOND IS FROM THE NATIONAL SOCIETY OF GENETIC COUNCILS. YOU ARE THE INCOMING PRESIDENT; IS THAT CORRECT?

YES THAT'S CORRECT. THANK YOU. GOOD MORNING. I'M KELLY ORMOND PRESIDENT-ELECT OF THE NATIONAL SOCIETY JOINT VENTURE GENETIC COUNSELORS AS YOU ARE AWARE, NCSC PRACTICE REPRESENTS A NUMBER OF PHYSICIANS. AND SGC IS THE LEADING VOICE, AUTHORITY AND ADVOCATE FOR THE GENETIC COUNSELING PROFESSION. NSCC THANKS SACGHS FOR TAKING OUR PRIOR TESTIMONY AND SUPPORT MATERIALS WHEN DEVELOPING THE DRAFT RESOLUTIONS AND REPORTS. NSGC FEELS WITH UNEXCEPTION WHICH WE WILL DISCUSS TODAY THAT THE VISION REPORT, ACCURATE REFLECT OUR UNDERSTANDING OF THE ISSUES WE ENCOURAGE SACGHS TO DISCUSS THESE ISSUES. WE WOULD LIKE TO ADDRESS THREE AREAS, THE DRAFT RESOLUTION ON DIRECT-TO-CONSUMER ADVERTISING, THE DRAFT REPORT ON COVERAGE AND REIMBURSEMENT OF GENETIC SERVICES AND OUR CONCERN CERTAINING THE DRAFT RESOLUTION ON GENETIC EDUCATION AND TRAINING OF HEALTHCARE PROVIDERS. FIRST WITH REGARDS WITH DIRECT-TO-CONSUMER OR DTC, IT STATES THAT GENETIC COUNSELORS WILL STRIVE TO ENABLE CLIENTS TO MAKE INFORMED DECISIONS BY PROVIDING NATIONAL FACTS REGARDING GENETIC TESTING. AS DISCUSSED IN THE ISSUE BRIEF, SACGHS DIRECT-TO-CONSUMER MARKETING MANY CONSUMERS VIEW DTC AS PROVIDING THEM WITH ADDITIONAL INFORMATION AND OPTIONS REGARDING THEIR GENETIC HEALTHCARE BUT WE MUST BE CAUTIOUS ABOUT DTC EFFORTS THAT PROVIDE MISLEADING OR INACCURATE INFORMATION. NSGC SUPPORTS AN INDIVIDUAL'S RIGHT TO FULL DISCLOSURE OF ALL APPROPRIATE INFORMATION, AND THAT GENETIC COUNSELING SERVICES BY A BOARD CERTIFIED GENETICS PROFESSIONAL SHOULD BE AN ESSENTIAL COMPONENT OF ANY GENETIC TESTING PROGRAM THAT'S MARKETED DIRECTLY TO CONSUMERS. SECOND, NSGC AGREES WITH SACGHS'S STATEMENTS IN THE DRAFT COVERAGE AND REIMBURSEMENT REPORT THAT GENETIC COUNSELOR BILLING IS LIMITED BY THE CURRENT LAKT OF CPT CODES FOR GENETIC COUNSELING AND BY THE LACK OF INCLUSION OF GENETIC COUNSELOR AS NON-PHYSICIAN MEDICARE PROVIDERS. WHILE WE RECOGNIZE THE CHALLENGES IN DOING SO NSGC ENCOURAGES SACGHS AND THE SECRETARY'S OFFICE TO CONSIDER WAYS TO ADDRESS THESE TWO ISSUES. WE ALSO ASK THAT SACGHS PROMOTE FEDERAL FUNDING TO PROVIDE EVIDENCE-BASED STUDIES OF GENETIC TECHNOLOGIES AND CLINICAL GENETIC SERVICES AS WAS DISCUSSED YESTERDAY, THIS TATE, ACAN BE USED WITH PURCHASERS OF BENEFIT PACKAGES SUCH AS EMPLOYERS TO SUPPORT THE INCLUSION OF GENETIC SERVICES AND TESTING AS A REIMBURSABLE OPTION WITHIN HEALTH PLANS. NSGC HAS PRIORITIZED AS ONE OF THE THREE PRIMARY PRIORITIES IN OUR PLAN AND WORKING ON ADDRESSING THESE ISSUES. FINALLY AND MOST IMPORTANTLY, NSGC WOULD LIKE TO ADDRESS THE DRAFT RESOLUTION AND ISSUE BRIEFS ON GENETIC EDUCATION OF HEALTHCARE PROVIDERS FIRST WE APPLAUD SACGHS EFFORTS TO ACTIVELY CONSIDER THE ISSUES THAT IMPACT THE GENETICS WORK FORCE AND HEALTHCARE AND TO RECOGNIZE THE EDUCATIONAL EFFORTS WHICH ARE ALREADY OCCURRING. OUR GREATEST CONCERN, WHICH WAS NOT THE FOCUS OF YESTERDAY'S ROUND TABLE DISCUSSION IS THAT THIS DRAFT RESOLUTION DOES NOT ADDRESS THE NEED FOR ADDITIONAL TRAINING OF GENETIC SPECIALISTS. NSGC STRONGLY BELIEVES THAT THE QUALITY OF GENETIC MEDICINE REQUIRES THE INVOLVEMENT OF HEALTHCARE PROVIDER OF ALL SPECIALTIES. MEMBERS OF NSGC AND OTHER PROFESSIONAL SCRI NETICS ORGANIZATIONS HAVE BEEN INSTRUMENTAL IN DEVELOPING AND IMPLEMENT EDUCATIONAL INITIATIVE FOR OTHER HEALTHCARE PROVIDERS AND WE EXPECT THAT THEY WILL REMAIN THE DRIVING FORCE TOWARDS A BROADER GENETICS COMPETENCE IN MEDICINE. WHILE NSGC DOES NOT WISH TO PROMOTE THAT ONLY GENETICS PROFESSIONALS ADDRESS THESE ISSUES IN HEALTHCARE IT IS CLEAR THAT ANY FUTURE MODELS IT WILL REQUIRE THE INPUT OF INDIVIDUALS WITH SPECIALTY TRAINING IN GENETICS AND GENOMICS. THE NICHE PEG CONFIDENCE STATES THAT EACH HEALTHCARE PROFESSIONAL SHOULD AT A MINIMUM, NUMBER ONE APPRECIATE LIMITATIONS OF HIS OR HER GENETIC EXPERTISE, NUMBER TWO, UNDERSTAND THE SOCIAL AND PSYCHOLOGICAL IMPLICATIONS OF GENETIC SERVICES AND NUMBER THREE, KNOW HOW AND WHEN TO MAKE A REFERRAL TO A GENETICS PROFESSIONAL. THESE COMPETENCEIES MAKE IT CLEAR THAT NON-GENETIC HEALTHCARE PROFESSIONALS SHOULD NOT BE EXPECTED TO PROVIDE COMPREHENSIVE CLINICAL CARE BUT TO WORK IN CONJUNCTION WITH GENETIC SPECIALISTS WHEN ONE ADDS TO THIS THE FACT THAT MOST HEALTHCARE PROVIDERS ARE NOT COMFORTABLE WITH GENETIC INFORMATION, PARTICULARLY IN THE AREAS OF ORDERING AND INTERPRETING GENETIC TESTS, IT BECOMES CLEAR THAT IF CONSUMERS OF GENETIC SERVICES ARE TO OBTAIN HIGH-QUALITY HEALTHCARE WE MUST ENSURE THAT SPECIALISTS ARE AVAILABLE TO SUPPORT THE PRIMARY CARE GIVERS AND REFERRING SPECIALISTS. TO ECHO THE STATEMENTS MADE YESTERDAY BY THE AMERICAN BOARD OF GENETIC COUNSELING, THE RECOMMENDATIONS TO ENSURE THAT GENETICS EDUCATION AND TRAINING OF ALL HEALTHCARE PROFESSIONALS IS ADEQUATE, WILL ONLY BE SUCCESSFUL IF THERE IS AN ADEQUATE GENETICS WORK FORCE TO IMPLEMENT THESE RECOMMENDATIONS. IT IS ALSO CLEAR THAT THE CURRENT NUMBER OF CERTIFIED GENETICS PROVIDERS NEEDS TO BE EXPANDED. ADDITIONALLY, IF WE ARE TO ADDRESS THE ISH ISSUES AND HEALTH DISPARITYED RAISED BY HEALTHY PEOPLES 2010, SACGHS MUST CONSIDER THE LIMIT CULTURAL AND ETHNIC DIVERSITY AND MOST OF THESE GENETIC SPECIALISTS CURRENTLY WORK AT ACADEMIC MEDICAL CENTERS OFTEN LIMITED IN THEIR ABILITY TO PROVIDE OUTREACH TO UNDERSERVED REGIONS OR PP LATIONS. FURTHERMORE THERE CONTINUE TO BE MULTIPLE IMPEDIMENTS TO INCREASING THE TRAIN PIPELINE. AN INFUSION OF FEDERAL FUNDING WOULD INCREASE THE NUMBER OF QUALITY GENETIC TRAINING PROGRAMS IN A SHORT TIME FRAME. GENETICS PROFESSIONALS WITH THEIR EXPERIENCE ACROSS VARIOUS AREAS OF MEDICAL SPECIALIZATION, AND ABILITY TO TRANSLATE COMPLICATED GENETIC INFORMATION INTO NON-MEDICAL TERMS ARE THE IDEAL PROFESSIONALS TO HELP BRIDGE THESE TRAINING GAPS. AS NSGC PROVIDED AT PRIOR SACGHS MEETINGS TO MEET THE INCREASING NEEDS OF GENETIC MEDICINE A TWO-PRONGED APPROACH IS NECESSARY. FIRST WE MUST INCREASE THE NUMBER OF DIVERSITY OF PRACTICING GENETIC SPECIALISTS TRAINED IN THE UNITED STATES, SECOND, AS SACGHS HAS RECOMMENDED IN THE DRAFT RESOLUTIONS, WE MUST INCREASE THE KNOWLEDGE OF HEALTHCARE PROFESSIONALS SUCH THAT THEY CAN PERFORM BASIC COMPONENTS OF GENETIC MEDICINE AND DEVELOP KNOWLEDGE OF GENERAL GENETIC CONCEPTS AND REFERRAL RESOURCES. TO REACH THE GOALS OF AN EDUCATED POPULATION, WE MUST ACTIVELY WORK TO REDUCE THE BARRIERS TO TRAIN GENETIC SPESHISTS AT THE SAME TIME WE ARE WORKING TO INCREASE THE GENETICS COMPETENTS OF NON-SPECIALISTS IN CONCLUSION NSGC ENCOURAGES TO ACTIVELY LOOK AT THE NEEDS FOR SPECIALISTS AND NON-SPECIALISTS TO ENSURE COMPETENT GENETIC WORK FORCES. WE'RE WILLING TO DEVELOP AN ISSUE BRIEF AND DRAFT RESOLUTION REFLECTING THIS APPROACH AND I WILL PROVIDE A WRITTEN PORTION OF THESE COMMENTS FOR YOUR REFERENCE.

THANK YOU VERY MUCH. ANY QUESTIONS FOR MS. ORMOND? COMMENTS? YES? DEBRA?

SO IF THERE IS A RECOMMENDATION TO INCREASE THE NUMBER OF PEOPLE TRAINED AS GENETIC COUNSELORS, ARE THERE TRAINING PROGRAMS IN EXISTENCE THAT COULD EXPAND TO ACCOMMODATE THAT EXTRA TRAINING?

I BELIEVE THAT THIS ISSUE WAS COVERED WHEN ROBIN BENNETT CAME AND PRESENTED TO THE COMMITTEE SEVERAL MONTHS AGO AND THERE ARE PROGRAMS WHICH ARE WILLING TO CONSIDER EXPANSION, IF THERE'S FUNDING TO SUPPORT THAT. AS WELL AS A NUMBER OF PROGRAMS WHICH ARE IN DEVELOPMENT, AND TRYING TO ESTABLISH THE FUNDING TO GET THOSE PROGRAMS UNDERWAY AND I BELIEVE THERE WERE ALSO SIMILAR ISSUES FACING MEDICAL GENETICIST TRAINING.

QUINN AND THEN AGNES.

I WOULD LIKE TO APPLAUD THE EFFORTS OF NSGC, OVER TIME YOU HAVE BEEN A GOOD VOICE IN THIS DISCUSSION.

THANK YOU.

IN TERMS OF THIS EVOLVING NATURE OF GENETICS AND GENOMICS IN THE 21st CENTURY, I'M WONDERING WHETHER NSGC HAS DISCUSSED OR CONSIDERED THE TRAINING NEEDS OF ITS OWN WORK FORCE, IN THE SENSE THAT AS WE WORK THROUGH THIS CONTINUUM FROM A GENETIC DISEASE FOCUS, WHERE WE FOCUSING ON GENETICISTS AND THEIR FAMILY AND TRYING TO CONVERT INFORMATION FOR THEIR PSYCHOSOCIAL SUPPORT AND DECISION MAKING TO INFORMATION THAT WILL BE USED IN THE DAILY PRACTICE OF MEDICINE, I'M WONDERING, THERE IS THAT TENSION. BECAUSE ON THE ONE HAND I DO APPRECIATE AND THINK THAT THERE IS A BIG ROLE FOR THE PRACTITIONER, GENETICIST COMMUNITY, BUT IN THE FINAL ANALYSIS, THE NUMBER OF CONDITIONS FOR WHICH THIS KIND OF PRACTICE WILL BE NEEDED WILL PROBABLY BE NO MORE THAN 10% OF HUMAN DIS50 EASE. SO HOW IS NSGC GOING TO -- OR HAS BEGUN TO ADDRESS THIS RANGE OF GENOMIC INFORMATION FROM SOMATIC TELL TO POLYMORPHISMS AND IS IT SOMETHING THAT WE MIGHT CALL GENOMIC COUNSELING AND WITH GENOMIC COUNSELING END AND HEALTH EDUCATION START? AND THE PRACTICE OF MEDICINE? SO I MEAN THERE'S THAT TENSION BETWEEN HAVING MORE SPECIALISTS VERSUS INTEGRATING THE GENOMICS KNOWLEDGE INTO THE PRACTICE OF DAILY MEDICINE. SO YOUR THOUGHTS ON THIS WILL BE APPRECIATED.

SURE. MY PLEASURE. I THINK THAT GENETIC COUNSELORS HAVE ALWAYS BEEN A VERY FLEXIBLE GROUP IN FINDING WAYS TO TAKE THE SKILLS THAT WE ARE TRAINED IN, AND APPLYING THEM TO THE VARIOUS CLINICAL SITUATIONS. AND I THINK THAT A PERFECT EXAMPLE OF THAT IS OUR INTEGRATION INTO THE CANCER GENETICS SETTING, OVER THE PAST DECADE OR SO. GENETIC COUNSELORS ARE CERTAINLY AWARE OF THIS ISSUE THAT YOU ARE ARAISING AND CONSIDERING IT ACTIVELY WITHIN OUR MOST RECENT STRATEGIC PLAN, WE HAVE RAISED THE IDEA OF ADDRESSING SCOPE OF PRACTICE, AND HAVE SET UP COMMITTEES THAT INCLUDE MEDICAL GENETICISTS AS WELL AS MANY OF OUR MEMBERS PRACTICING IN DIFFERENT CLINICAL AREAS, TO LOOK AT HOW WE MAY BECOME INTEGRATED INTO THESE VARIOUS AREAS OF GENOMIC MEDICINE, ALSO LOOKING AT GENETIC SERVICE DELIVERY AS WE DO RECOGNIZE THAT MANY OF OUR MORE TRADITIONAL APPROACHES TO GENETIC COUNSELING MAY NOT BE AS APPLICABLE TO THE NEW MODE GENOMIC MEDICINE SO WE ARE ACTIVELY TRYING TO INCORPORATE THAT WITH DIFFERENT VIEWS INTO THESE COMMITTEES.

AGNES?

MY QUESTION WAS VERY SIMILAR TO MUIN'S. I'M WONDERING IF YOU HAVE BEGUN TO LOOK AT INNOVATIVE WAYS AND HAVE DIFFERENT TRACKS MAYBE AS A GENETIC EDUCATOR AND A SPECIALIST WHO WOULD THEN TRAIN THE TRAINER SO THERE COULD BE MORE PEOPLE IN THE HEALTH PROFESSION, IN GENERAL THAT THEN COULD HAVE ACCESS TO THIS INFORMATION, AND THEN LASTLY, HISTORICALLY I KNOW THAT THE GENETIC COUNSELING PROFESSION DID HAVE OPTIONS FOR PEOPLE WITH PUBLIC HEALTH BACKGROUND, NURSING BACKGROUND TO BE ABLE TO SIT FOR THE GENETIC COUNSELING EXAM AND THEN THAT -- THEN THERE WAS SPECIFIC REQUIREMENTS, OF COURSE, JUST TO HAVE THE GENETIC COUNSELING BACKGROUND AND WOULD THERE BE ANY OPPORTUNITIES TO HAVE A SEPARATE KIND OF TRACK, WHERE WE COULD MAKE USE OF OTHER HEALTH PROFESSIONALS, THAT ALREADY EXIST TO ACTUALLY EXPAND THE -- THE AMOUNT OF GENETIC COUNSELORS THAT ARE OUT THERE VIA DIFFERENT MECHANISMS OF EITHER CERTIFICATION, MAYBE NOT NECESSARILY GENETIC COUNSELOR NAMED BUT SOMETHING GENETIC COUNSELOR ASSOCIATE OR SOMETHING, BUT THAT WOULD RECOGNIZE OTHER HEALTH PROFESSIONALS, WHO THEN WOULD HAVE SPECIFIC TRAINING IN GENETICS AND THEN COULD SIT FOR THE BOARD?

MM-HMM. I THINK SOME OF THOSE QUESTIONS WOULD NEED TO BE REDIRECTED TO THE AMERICAN BOARD OF GENETIC COUNSELING, WHO DOES TAKE CARE OF ALL THE PROFESSIONAL CERTIFICATION. I KNOW THAT THEY DID CHANGE THEIR CERTIFICATION PROCESSES, I BELIEVE IN 1999, WAS THE LAST YEAR THAT INDIVIDUALS WHO DID NOT GRADUATE FROM AN CREDITED PROGRAM COULD SIT FOR THE ABGC BOARD EXAM. BUT CERTAINLY, THE TRAINING PROGRAMS ARE COGNIZANT OF THE CHANGING NEEDS, AND WE'RE ALWAYS TRYING TO READDRESS CURRICULUM TO BE TRAINING FOR FIVE TO TEN YEARS DOWN THE ROAD, INCORPORATING MANY OF THESE NEW SPECIALTY AREAS, AND CERTAINLY EDUCATING OUR NEW STUDENTS IN AREAS OF THINGS LIKE BILLING AND REIMBURSEMENT, HEALTH EDUCATION, PREVENTATIVE SERVICES. I'M NOT AWARE OF ANY PROGRAMS THAT HAVE SPECIFIC TRACKS ESTABLISHED, NOR DOES THE CERTIFICATION EXAM CURRENTLY HAVE TRACKS BUT I KNOW THAT THESE ISSUES IS HAVE BEEN DISCUSSED AND I'M SURE WILL CONTINUE TO BE RAISED. DOES THAT ANSWER YOUR QUESTION? OKAY.

ONE LAST QUESTION, BRIEF QUESTION AND BRIEF COMMENT FROM HUNT.

YOUR CALL FOR INCREASED SPECIALTY TRAINING IN GENETICS AND GENOMICS IS CLEAR. WHAT ISN'T CLEAR TO ME IS WHETHER IT'S YOUR RECOMMENDATION THAT THAT BE DONE ONLY IN THE SPECIALTY OF MEDICAL GENETICS, CAPITAL M, CAPITAL G OR WHETHER YOU CAN GET TRAINING IN GENETICS AND GENOMICS IN ALL TYPES OF SPECIALTIES.

I THINK BOTH NEEDS TO HAPPEN. I THINK THERE ARE HISTORICALLY A DIFFERENCE IN THE APPROACH TO PGMENT AND ASSESSMENT IN MEDICAL -- MANAGEMENT AND ASSESSMENT IN GENOMICS AND I THINK WE CAN BENEFIT HAVE HAVING A LITTLE BIT OF BOTH.

THANK YOU VERY MUCH.

THANK YOU. OUR NEXT PRESENTATION OR COMMENTOR IS GAIL B -- JABBIT WITH JOHNS HOPKINS UNIVERSITY.

I ACTUALLY HAVE SOME POWERPOINTS SO IF I COULD APPROACH THE PODIUM, THAT WILL BE HELPFUL.

AS THOSE ARE GOING UP, I WOULD ALSO POINT OUT THAT THERE IS A MATERIAL ON YOUR TABLE FOLDER OF COMMENTS ON THE DRAFT RESOLUTION ON DTC MARKETING, GENETIC TESTS.

GOOD MORNING. MY NAME IS GAIL JAVIT AND I'M A POLICY ANALYST AT JOHNS HOPKINS UFER. THANK YOU FOR THE OPPORTUNITY TO PRESENT THESE COMMENTS THIS MORNING. ON BEHALF OF THE CENTER AND ITS DIRECTOR, DR. KATHY HUDSON. WE SPECIFICALLY WOULD LIKE TO ADDRESS THE DRAFT RESOLUTIONS CONCERNING DIRECT-TO-CONSUMER ON DTC MARKETING OF GENETIC TESTS. THE ANALYSIS OF DTC MARKETING OF GENETIC TESTING MUST CLEARLY DISTINGUISH BETWEEN ADVERTISING OF GENETIC TESTS ON THE ONE HAND AND COMMERCIAL AVAILABILITY OF THESE TESTS ON THE OTHER. EACH OF THESE ACTIVITIES IS SUBJECT TO DISTINCT SYSTEMS OF REGULATORY OVERSIGHT AND IS AMENABLE TO DIFFERENT POLICY SOLUTIONS. WITH RESPECT TO ADVERTISING, THE DRAFT RESOLUTION RIGHTLY IDENTIFIES THE FTC AS POTENTIALLY PLAYING A KEY ROLE IN PREVENTING COMPANIES FROM MAKING MISLEADING CLAIMS ABOUT GENETIC TESTS. BUT WHILE FTC HAS A BROAD MANDATORY MANDATE TO PROTECT CONSUMERS IT'S DESCRIBED FIRST FTC MAY PREVENT ONLY ADVERTISING THAT'S FALSE OR MISLEADING. WHILE ESTABLISHING THE FALSITY OF SOME GENETIC TEST ADS HOUT THERE TODAY, WOULD LIKELY BE NEITHER DIFFICULT NOR CONTROVERSIAL. THE OTHERS AMBIGUITY AND DISAGREEMENT CAN BE EXPECTED. CONCERNS ABOUT THE IMPACT OF DTC ADS ON CONSUMERS THAT ARE UNRELATED TO THEIR TRUTH OR FALSITY WOULD NOT LIKELY PROVIDE A BASIS FOR FTC INTERVENTION. INDEED THE GOVERNMENT IS SIGNIFICANTLY CONSTRAINED BY THE FIRST AMENDMENT IN REGULATING FOOUTFUL COMMERCIAL SPEECH. SECOND FTC MUST CHOOSE ITS ENFORCEMENT BASED ON THE HARM CAUSED BY THE ADVERTISING IN QUESTION. EVIDENCE OF THIS NATURE DOES NOT CURRENTLY EXIST, WITH RESPECT TO DFC GENETIC TESTING. WE THEREFORE RECOMMEND THAT COMMITTEE CONSIDER WAYS TO FOSTER DATA GATHERING CONCERNING THE HARMS OF DTC ADVERTISING. THIS DATA COULD BE PROVIDED TO FTC AND USED AS A BASIS FOR THAT AGENCY'S INVOLVEMENT. WITH RESPECT TO COMMERCIAL DISTRIBUTION, THE DRAFT RESOLUTION RECOMMENDS THAT GENETIC TESTS SHOULD NOT BE SOLD IT DIRECTLY TO CONSUMERS WITHOUT THE INFORMED GUIDANCE. AN APPROPRIATELY TRAINED HEALTHCARE PROFESSIONAL. SOME WILL VIEW THIS AS UNDOLY RESTRICTING PATIENT CHOICE. OTHERS MAY FEEL SUCH GUIDANCE SHOULD BE REQUIRED ONLY FOR CERTAIN TYPES OF TESTS SUCH AS THOSE THAT PREDICT SERIOUS DISEASE. SOME MAY QUESTION WHETHER HEALTHCARE PROFESSIONALS ARE ADEQUATELY ABLE TO PROVIDE GUIDANCE AND INTERPRETATION OF THESE TESTS. THESE ARE ALL IMPORTANT ISSUES FOR THE COMMITTEE TO CONSIDER. BUT THESE COMMENTS ARE INTENDED TO ADDRESS WHETHER AS A PRACTICAL MATTER THERE IS A MEANS OF EFFECTIVELY IMPLEMENTING THE COMMITTEE'S RECOMMENDATION. CURRENTLY NO FEDERAL OR STATE ENTITY REGULATES WHEN OR UNDER WHAT CIRCUMSTANCES, GENETIC TESTING SERVICES MAY BE COMMERCIALLY OFFERED TO CONSUMERS ARE HEALTHCARE PROVIDERS. IT IS THEREFORE, UNCLEAR WHAT ENTITY WOULD NOW HAVE THE AUTHORITY TO IMPLEMENT THE RECOMMENDATION. THE DRAFT RESOLUTION RECOMMENDATIONS THAT FDA ENHANCE OVERSIGHT OF GENETIC TESTS WHILE ACKNOWLEDGING THAT AGENCY'S LIMITED OVERSIGHT FOR MOST GENETIC TESTING. FDA REGULATES GENETIC TEST KITS THAT ARE SOLD AS FRE FREE STANDING PRODUCTS AND NOT GENETIC TESTING PROVIDED IN-HOUSE BY CLINICAL LABORATORIES. FDA HAS LIMITED OPPORTUNITY TO REVIEW ONLY A FEW DNA-BASED GENETIC TESTS EVEN THOUGH THERE ARE GENETIC TESTS FOR OVER 700 GENETIC DISEASES. THIS IS NOT FIRST COMMITTEE TO IDENTIFY FDA AS AN APPROPRIATE BODY TO PROVIDE MORE SUBSTANTIAL OVERSIGHT, AND WE DO NOT DISAGREE THAT FDA INVOLVEMENT COULD BE BOTH BENEFICIAL AND CONSISTENT WITH THAT AGENCY'S BROAD PUBLIC HEALTH MISSION. WE GE FDA'S WILLINGNESS TO STEP THIS ARENA WITHOUT A CLEAR MANDATE TO DO SO, PARTICULARLY IN THE ABSENCE OF MORE CONCREED EVIDENCE OF CONSUMER HARM. -- CONCRETE EVIDENCE OF CONSUMER HARM T. FAILS TO MENTION ANOTHER KEY PLAYER IN GENETIC TEST OVERSIGHT THE CENTER FOR MEDICARE AND MEDICAID SERVICES ADMINISTERED THE CLININGAL LABORATORY OR CLEA. LABORATORIES ARE COVERED BY THIS STATUTE. DESPITE RECOMMENDATIONS FROM ADVISORY GROUPS CMS HAS NOT YET ISSUED PROFICIENCY STANDARDS FOR MOST TESTING. IN AN ACT OF CLEA CONGRESS RECOGNIZED THE CRUCIAL ROLE THAT THEY PLAY IN LABORATORYS. GENETIC TESTING LABORATORIES IN ARE CLEA COULD ENHANCE PUBLIC HEALTH PROTECTION. THE FEDERAL GOVERNMENT HAS NOT INVESTED IN ANY ENTITY AS AN ABILITY TO SERVE AS A GATEKEEPER MEANING TO DECIDE WHEN AND IF THEY PROVIDE SUFFICIENT VALIDITY TO BE USED IN THE CLINICAL SETTING. THIS IS IN CONTRAST TO THE SITUATION WITH MANY OTHER CLINICAL COOLS USED BY HEALTHCARE PROVIDERS TO DIAGNOSE AND TREAT PATIENTS. SOME WOULD ARGUE THAT INCREASED GOVERNMENT INVOLVEMENT IS NEITHER NECESSARY OR DESIRABLE. OTHERS BELIEVE THAT GIVEN THE INCREASING IMPORTANCE THAT GENETIC TESTING IS ASSUMING HEALTHCARE THIS GAP IN OVERSIGHT COULD THREATEN PUBLIC HEALTH THIS COMMITTEE COULD PLAY AN IMPORTANT ROLE IN IDENTIFYING THE BENEFITS AND DRAWBACKS OF A MORE RIGOROUS SYSTEM OF OVERSIGHT. THE DRAFT RESOLUTION RIGHTLY IDENTIFIES SEVERAL AREAS OF POTENTIAL CONCERN RELATED TO DTC GENETIC TESTING. MUCH REMAINS UNKNOWN ABOUT THIS ENTERPRISE. IS THIS A TREND THAT WILL CONTINUE TO GROW? WHAT IS THE IMPACT OF SUCH TESTING TODAY? AND WHAT CAN WE PREDICT ABOUT ITS UNITEURE IMPACT ON CONSUMERS? SOUND POLICY FORMULATION IN THE MONTHS AND YEARS AHEAD ON THIS ISSUE WILL BE GREATLY NEEDED FOR SOUND EMPIRICAL EVIDENCE. IT IS IMPORTANT THAT THIS COMMITTEE IDENTIFY THE ENTITIES BEST EQUIPPED TO GATHER THIS MECHANISM AND TO STUDY THESE ISH ISSUES N. SUMMARY, WE RECOMMEND THAT ATTENTION BE GIVEN NOT ONLY TO THE DUBIOUS CLAIMS MADE SOME GENETIC TESTS BUT E TO THAT END WE OFFER THE FOLLOWING SUGGESTIONS. FIRST, THE COMMITTEE SHOULD FOSTER DATA COLLECTION CONCERNING CONSUMER IMPACT OF DTC GENETIC TESTING, INCLUDING WHETHER AND TO WHAT EXTENT CONSUMERS ARE OBTAINING GENETIC TESTING THROUGH THESE MEANS. WHETHER SUCH TESTS ARE CAUSING HARM OR PROVIDING BENEFITS. AND THE NATURE AND THE MAGNITUDE OF SUCH HARMS OR BENEFITS. SECOND THE COMMITTEE SHOULD CONSIDER HOW CLEA COULD BE HORNESSS TO PROVIDE GREATER OVERSIGHT OF LABS PROVIDING SERVICES. AND CONSIDER FDA INVOLVEMENT AND CONSIDER MEANS TO OVERCOME THESE BARRIERS. FINALLY THE COMMITTEE SHOULD CONSIDER THE MERITS AND DRAWBACKS OF A FEDERAL OVERSIGHT COMMITTEE THAT WOULD SET STANDARDS THAT GENETIC TESTS MUST MEET BEFORE THEY ARE MADE COMMERCIALLY AVAILABLE. THANK YOU VERY MUCH.

THANK YOU VERY MUCH. ANY QUESTIONS OR COMMENTS? YES? CHRIS?

JUST A COUPLE OF OBSERVATIONS AND OPEN QUESTIONS THAT YOU RAISE. YOU'VE MENTIONED THE TERM "THE IMPORTANCE FOR CONSUMER FREEDOM OR CONSUMER ACCESS TO INFORMATION". YET, IN THE VAST MAJORITY OF OTHER MEDICAL TESTS THAT ARE AVAILABLE CONSUMERS DO NOT HAVE DIRECT ACCESS TO THOSE. THE REASON GENETIC TESTING IS BEING MARKETING IN THIS WAY IS IT CAN BE DONE BY SWAB OR BLOOD DRAW. SO CONCEPTIONALLY WE DO RESTRICT ACCESS TO THE MAJORITY OF OTHER TYPES OF MEDICAL INFORMATION GATHERING PROCESSES. WITHOUT DIRECT ACCESS BY THE CONSUMER. SO WHY ARE WE NOW SAYING THAT WE NEED TO MAKE AN EXCEPTION IN THE OPPOSITE DIRECTION WITH GENETIC INFORMATION AND ALLOW THEM TO HAVE ACCESS TO THAT WHEN IT'S MUCH MORE COMPLEX? THAT'S A CONCEPTUAL QUESTION I WANT TO ADDRESS TO YOU AND MY SECOND ONE IS AGAIN, IN NATURE, I AGREE WITH YOU COMPLETELY THAT WE NEED TO BE COLLECTING DATA. WE NEED TO BE COMPILING A DATABASE OF EXAMPLES OF POTENTIAL ABUSE, TRYING TO FIND HOW THE PUBLIC IS INTERACTING WITH IT. SO I THINK THAT'S VERY IMPORTANT. BUT THERE STILL SEEMS TO BE AN INFERENCE OR AT LEAST AS I AM TAKING YOUR COMMENTS THAT THERE NEEDS TO BE BLOOD ON THE PAVEMENT BEFORE WE HAVE WARRANT TO INTERVENE AND I'M NOT SURE I AGREE WITH THAT. I THINK IF WE CAN SEE THAT HARMS ARE GOING TO BE DONE, AS -- FOR INSTANCE, MR. MURPHY WAS POINTING OUT EARLIER, THAT WE HAVE A SIGNIFICANT AMOUNT OF AMBIGUITY, UNPROVEN UTILITY, EVEN OF THE CYTOCHROME SYSTEMS AND VARIOUS DRUGS WHY DO WE HAVE TO WAIT FOR PEOPLE TO BE HARMED BEFORE WE DO OUR APPROPRIATE JOB OF RECOGNIZING THE POTENTIAL FOR HARM AND INTERVENING TO PREVENT THAT?

LET ME START WITH YOUR SECOND QUESTION. BECAUSE I WANTED TO JUST MAKE SURE THAT I DEPOSIT CREATE A FALSE IMPRESSION. IN TERMS OF -- THE DISTINCTION THAT I'M TRYING TO DRAW IS BETWEEN INFORMATION PROVIDED CONSUMERS AND PRODUCTS OR TESTS, ACTUAL CONCRETE SERVICES. WITH RESPECT TO THE SERVICES, I THINK THAT FORESEEABLE HARM COULD, INDEED BE A BASIS FOR INTERVENING BEFORE THERE IS, AS YOU SAID, YOU KNOW, CONCRETE HARMS. WITH RESPECT TO PROVIDING INFORMATION TO CONSUMERS IN THE COMMERCIAL CONTEXT, THERE ARE LEGAL CONSTRAINTS THAT WILL COME INTO PLAY. AND IN CRAFTING ANY OVERSIGHT SYSTEM THOSE NEED TO BE CONSIDERED. THE SUPREME COURT IN THE PAST SEVERAL YEARS HAS PROVIDED A MUCH HIGHER BURDEN ON THE GOVERNMENT TO SHOW THAT THE INFORMATION ITSELF WILL WILL CAUSE HARM. AND PART OF WHAT THEY HAVE ASKED FOR IS FACTS. FACTS ON THE GROUND. AND THAT IS THE DISTINCTION THAT I'M TRYING TO DRAW. WAS THERE SOMEBODY ELSE WHO WANTED TO RESPOND OR WAS THAT ANOTHER QUESTION? I THOUGHT I SAW A HAND.

WAYNE HAS A QUESTION OR COMMENT.

ACTUALLY, WE DON'T HAVE MUCH TIME TO GO INTO THE PUBLIC HEALTH RESPONSE TO THE MYRIAD OF CAMPAIGNS THIS MORNING. WE MAY HAVE A CHANCE TO DISCUSS IT A BIT LATER. BUT IN YOUR -- WHEN YOU MAKE SOME RECOMMENDATIONS ABOUT THE ROLE OF DIFFERENCE AGENCIES AND YOU PUT DATA COLLECTION AS SORT OF HANGING IN THERE WITH NO JURISDICTION FOR THAT IN ANY LOCALITY, IT ALSO BEGS THE QUESTION OF WHO IS GOING TO DO THIS AND THE MYRIAD CAMPAIGN TAUGHT US A FEW LESSONS. FIRST THING WAS WHEN THE CAMPAIGNS WERE RUNNING IN THE POPULATIONS IN DENVER AND ATLANTA, GEORGIA, THE HEALTH DEPARTMENT WERE BEGINNING TO GET QUESTIONS FROM THE GENERAL PUBLIC, FROM THOSE WHO WERE CONCERNED. AND THAT LED TO THE MOUNTING OF PUBLIC HEALTH ASSESSMENT OF WHAT REALLY HAPPENED. AND I THINK AS THE DIRECT-TO-CONSUMER IN GENETICS OR ANY OTHER THINGS WITHOUT THE GENETIC EXCEPTIONALISM HAS THE POTENTIAL FOR BOTH HURTING AND HELPING PEOPLE, SOMEBODY SOMEWHERE NEEDS TO KEEP THEIR FINGER ON THE PULSE. THAT'S A FUNCTION THAT SHOULD BE WELL-DEFINED AND THIS IS TRULY A PUBLIC HEALTH FUNCTION THAT INVOLVING GOING OUT AND COLLECTING DATA IN THESE COMMUNITIES INVOLVING EPIDEMIOLOGIC TOOLS AND SURVEYS, ET CETERA, AND AS THIS COMMITTEE BEGINS ITS DISCUSSION, I THINK WE NEED TO FIND AND -- FINE TUNE THAT FUNCTION A LITTLE BIT MORE, BECAUSE POLICY DEPENDS ON DATA AND IF WE DON'T HAVE DATA, WHETHER WE WANT MORE REGULATION, OR LESS REGULATION OR MORE OVERSIGHT AND DIFFERENT KINDS OF THINGS. I MEAN, THE DATA COLLECTION IS SO KEY TO PUTTING YOUR FINGER ON THE PULSE SO THAT THE RIGHT POLICY DECISIONS CAN BE MADE. SO DO ME THAT, THAT'S INHERENTLY AND ESSENTIALLY A PUBLIC SERVICE HEALTH SURVEILLANCE FUNCTION.

I THINK THAT WAS MORE OF A COMMENT THAN A QUESTION.

I DIDN'T WANT TO FORGET THE FIRST QUESTION THAT YOU HAD RAISED. MY UNDERSTANDING IN TERMS OF PROVIDING TESTING TO CONSUMERS DIRECTLY IS THAT IT'S A STATE-BY-STATE DECISION ABOUT TO WHOM LABS MAY RECEIVE SAMPLES FROM AND REPORT BACK TO. AND THAT'S A STATE DECISION RATHER THAN A FEDERAL ONE. SO THERE ISN'T NECESSARILY A DISTINCTION BETWEEN GENETIC TESTING IN THAT CONTEXT AND OTHER LABORATORY TESTS.

I WILL LET THE FTC HAVE THE FINAL QUESTION HERE.

WELL, IT'S REALLY JUST A COUPLE OF POINTS TO CLARIFY THE COMMISSION'S LEGAL AUTHORITY. FOR THE GROUP. I THINK ALL ADS WOULD BE SUBJECT TO OUR JURISDICTION. IF THEY'RE ON THE INTERNET, FOR EXAMPLE, THEY ARE CERTAINLY INTERSTATE OR EVEN IF THEY ARE LOCAL IN A LOCAL PAPER, IF THE LAB OBTAINED ANY PART OF THE TEST FROM OUT-OF-STATE, IT'S AFFECTING COMMERCE. SO THAT'S NOT A DIFFICULT ISSUE. I AGREE WITH YOU 100% AT PROVING WHETHER IT'S FALSE OR LACKS SUBSTANTIATION IN THE FORM OF CORRESPOND, RELIABLE SCIENTIFIC EVIDENCE IS ANOTHER ISSUE ALL TOGETHER AND IT MAY BE DIFFICULT IN MANY OF THOSE CASES TO MAKE THAT BURDEN. BUT WE HAVE THE JURISDICTION. THE SECOND POINT IS, THERE'S THE COMMISSION IN TERMS OF DECEPTION ONLY REQUIRES COMMISSION -- THE COMMISSION LAW ONLY REQUIRES THAT AN AD WOULD LIKELY MISLEAD CONSUMERS IN TERMS OF THEIR PURCHASER USE DECISION. WE DON'T HAVE TO SHOW BLOOD ON THE FLOOR F. WE USED OUR OWN FAIRNESS JURISDICTION IT MIGHT BE A DIFFERENT STORY. AND THE THIRD POINT IS THERE'S SIMPLY NO PER SE, FIRST AMENDMENT PERCEPTION FOR COMMERCIAL SPEECH. THAT DOESN'T MEAN WE DON'T HAVE TO USE REASONABLE MEANS TO THE END OF REGULATING IT. BUT THE COMMISSION DOESN'T HAVE THE PROBLEM THE FDA HAS HAD IN A NUMBER OF AREAS BECAUSE IT -- IT LOOKS AT ADS BEFORE THE FACT. SO IT'S A MUCH HIGHER FIRST AMENDMENT BURDEN ON THE FDA, BUT WE DON'T -- TYPICALLY DON'T HAVE THAT PROBLEM IF WE CHOOSE OUR TARGETS WISELY.

ANY COMMENTS?

NO. THANK YOU.

OKAY. THANK YOU VERY MUCH. WE APPRECIATE ALL THE COMMENTORS. FOR YOUR INPUT AND I WOULD ALSO REMIND THE COMMITTEE THAT THERE ARE WRITTEN COMMENTS THAT WE RECEIVED THAT ARE IN YOUR TABLE FOLDERS THIS IS A NICE LEAD-IN TO OUR NEXT TOPIC, WHICH IS DIRECT-TO-CONSUMER MARKETING. THIS WAS RANKED AS THE FOURTH ISSUE OF OUR TOP PRIORITY ISSUES REQUIRING IN-DEPTH STUDY AT OUR LAST MEETING. HOWEVER, THE COMMITTEE FELT THAT THE TOPIC WARRANTED AN IMMEDIATE RESPONSE TO ENCOURAGE THE FEDERAL TRADE COMMISSION'S EFFORTS IN THIS AREA. DURING THE NEXT HOUR, WE WILL CONSIDER AND FINALIZE A DRAFT DTC RESOLUTION THAT WAS PREPARED BY THE DTC TASK FORCE. THE RESOLUTION CAN BE FOUND ON TABLE 6 OF YOUR BRIEFING BOOK. I WOULD LIKE TO THANK CHRIS HOOK FOR CHAIRING THIS TASK FORCE, AS WELL AS BRAD VARGUS AGNES MASZNEY, MATT DANER AND TIM FOR YOUR SERVICE ON THE TASK FORCE. BEFORE WE BEGIN DISCUSSION I WOULD LIKE TO REMIND YOU THAT HGRI ORGANIZED A WORKSHOP ON MARCH 23rd TO CONSIDER DTC MARKETING OF GENETIC TECHNOLOGIES AND SERVICES. AND SO AT THIS TIME, I WOULD LIKE TO ASK ALAN GUTMOCKER TO UPDATE THE COMMITTEE ON THE OUTCOME OF YOUR WORKSHOP, ALAN.

SURE I WOULD BE HAPPY TO DO THAT AND I SHOULD NOTE THAT DR. McCABE CORRECTLY IDENTIFIED THIS AS A WORKSHOP TO CONSIDER DTC ADVERTISING THIS. WAS NOT, FOR INSTANCE AN NIH CONSENSUS PANEL TO COME UP WITH SPECIFIC ADVICE OR THAT TYPE OF THING. IT WAS THAT, INCLUDING THE FEELING THAT THERE HAD NOT BEEN ENOUGH TIME, PERHAPS FOR THE FIELD TO REALLY LOOK AT THIS TO BE ABLE TO COME UP WITH THOSE TYPES OF FINAL DETAILED TYPES OF RECOMMENDATIONS; HOWEVER, CLEARLY, WE LIKE THE SACGHS IDENTIFIED THIS AS AN AREA SOME POTENTIAL CONCERN SO WE GATHERED ABOUT 50 PEOPLE TOGETHER AND THEY CAME FROM SEVERAL DIFFERENT KINDS OF BACKGROUNDS. THERE WERE GENETICS AND OTHER HEALTH PROFESSIONALS. THERE WERE INDIVIDUALS THAT REPRESENTED HEALTH CONSUMER ORGANIZATIONS, THERE ARE INDIVIDUALS FROM FEDERAL AGENCIES BOTH REGULATORY AND NON-REGULATORY FEDERAL AGENCIES AND THERE ARE ALSO INDIVIDUALS WHO CAME FROM VARIOUS INDUSTRY ORGANIZATIONS OR ACTUALLY INDUSTRY -- BOTH ORGANIZATIONS AND INDIVIDUAL COMPANIES. THERE WAS BASICALLY -- THE MORNING WAS SPENT IN LOOKING AT THE DATA. WE THOUGHT THAT IT MIGHT MAKE SENSE TO BASE POLICY CONSIDERATIONS ON DATA. SO WE SPENT THE MORNING LOOKING AT THE DATA. WHAT DO WE KNOW CURRENTLY? AND YOU WILL SEE THAT THERE IS A WORKSHOP SUMMARY FOR YOU THAT'S RIGHT AFTER THE DRAFT RESOLUTION BEHIND TAB 6. AND THAT -- YOU CAN SEE IS A NICE SUMMARY OF THE FIRST FOUR AND A HALF PAGES OF THE IS OF THE SUMMARY. I WILL GO OVER THE DATA PRESENTED AND THE REST OF IT DESCRIBES THE AFTERNOON DISCUSSIONS AND YOU WILL SEE THE AFTERNOON IS REALLY INFORMED BY THE MORNING DATA. DISCUSSION OF BOTH THE QUESTION OF ARE THERE -- IS THERE REASON FOR CONCERN HERE? IF SO, WHAT ARE THE REASONS FORE CONCERN? AND THEN ALSO A LOOK AT HOW ONE MIGHT MOVE FORWARD. YOU WILL SEE ON THE LAST FEW PAGES, THAT THERE WAS -- THERE WERE THREE MAJOR AREAS THAT THERE WAS SOME KIND OF GENERAL -- I WON'T TRY TO USE THE TERM "CONSENSUS" BUT GENERAL AGREEMENT PONG THE GROUP. THE FIRST IS THAT IT WOULD MAKE SENSE TO HAVE THE WHITE PAPER OUTLINING BEST PRACTICES FOR DTC ADVERTISING THE GENETIC TESTS AND GENETIC SERVICES AS WELL. THERE WAS SOME DISCUSSION DURING THE DAY ABOUT THE DISTINCTION AS YOU JUST HEARD BETWEEN TESTING AND SERVICES. THE SECOND WAS TO COORDINATE OR FACILITATE TO THE FTC OUTLINING CONCERNS WITH CURRENT DTC ADVERTISING FOR FETIC TESTS AND THE THIRD WAS A RESEARCH INCLUDING SPECIFIC COLLABORATIONS WITH THE PRIVATE SECTOR. AND THE IDEA OF DEVELOPING A RESEARCH AGENDA ABLE TO POLICY DEVELOPMENT. SO I WOULD JUST CALL THE SUMMARY TO YOUR ATTENTION. TAKE A LOOK AT IT AND WE KNOW THAT SOME OF THE PEOPLE INVOLVED IN THE GROUP THAT CAME UP WITH THE DRAFT RESOLUTION WERE INVOLVED IN THIS PETING AND I HOPE SOMEWHAT INFORMED BY. THAT I WOULD BE HAPPY TO ANSWER ANY QUESTIONS.

ANY QUESTIONS FOR ALAN REGARDING THE MEETING? YES? EMILY?

SO NOT SO MUCH REGARDING THE MEETING, BUT JUST WHAT DOES NIH VIEW AS ITS NEXT STEP? ARE YOU GOING TO STOP WITH HAVING CONVENED THIS SORT OF STATE OF THE STATE KIND OF CONFERENCE OR DO YOU HAVE SPECIFIC PLANS TO GO ON AND MAKE SOME CONSENSUS CONFERENCE OR KIND OF RECOMMENDATION?

I THINK AT THIS POINT, WE PROBABLY AR WAITING TO SEE PARTLY WHAT THIS COMMITTEE DOES. AND THEN -- ARE ARE AWAITING TO SEE PARTLY WHAT THIS COMMITTEE DOES. THEN I THINK WE WOULD BE INTERESTED IN DEVELOPING AND ARE PLANNING TO DEVELOP A MORE PRECISE RESEARCH AGENDA IN TERMS OF WHERE THERE ARE RESEARCH QUESTIONS THAT NEED TO BE ANSWERED IN ORDER TO ENABLE GOOD SCIENCE AND POLICY.

YES, HUNT?

ALAN, WERE THERE ANY REPRESENTATIVES THERE FROM INDUSTRY?

YES, THERE WERE. WE INVITED A NUMBER. SOME CHOSE NOT TO ATTEND AND SOME CHOSE TO ATTEND, INCLUDING, YOU WILL SEE THERE WERE PRESENTATIONS FROM MYRIAD.

SO MYRIAD ATTEND FHD.

THEY DID. AND GAVE A PRESENTATION, IN FACT.

YES. KAY?

HI. FOLLOWING UP ON THE EARLIER QUESTION, WERE THERE ANY REPRESENTATIVES FROM THE PROVIDER ORGANIZATIONS, PARTICULARLY NOT NECESSARILY HOSPITALS BUT PHYSICIANS? BECAUSE I WOULD IMAGINE THAT PROVIDER AND CLINICIAN PERSPECTIVES WOULD BE IMPORTANT HERE AS --

THERE WERE.

AND WOULD WERE THEY.

I DON'T REMEMBER THE NAMES. WE CAN GIVE YOU THE LIST OF THE PEOPLE WHO ATTENDED IF YOU LIKE.

THAT WOULD BE VERY HELPFUL.

COME SEE ME AFTERWARDS.

COULD YOU PROVIDE THAT TO THE COMMITTEE AS WELL, PLEASE?

SURE, WE'D BE HAPPY TO. YEAH, I DON'T HAVE TO MAKE -- I DON'T HAVE ANY REASON TO THINK IT'S A -- NOT A PUBLIC DOCUMENT.

THANK YOU.

OTHER COMMENTS OR QUESTIONS? OKAY. IF NOT, LET'S MOVE FORWARD. THANK YOU VERY MUCH, ALAN. I'D LIKE TO CALL YOUR ATTENTION TO THE WRITTEN PUBLIC PUB COMMENTS IN YOUR TABLE FOLDERS IN RESPONSE TO THE RESOLUTION ON DTC AND THAT THE PUBLIC COMMENTS WE HEARD THIS MORNING. I WILL NOW TURN TO CHRIS HOOK, TO LEAD THE DISCUSSION ON THE DTC RESOLUTION. CHRIS?

THANK YOU, ED. I WOULD LIKE TO BEGIN MY COMMENTS BY THANKING THE MEMBERS OF THE TASK FORCE, AND AS EMILY HAD ACKNOWLEDGED OUR TREMENDOUS DEBT TO FAYE SHAMASKI AND THE STAFF FOR PUTTING THIS DOCUMENT TOGETHER. ON TOP OF THE SIGNIFICANT AMOUNT OF TIME AND WORK THAT THEY HAD DONE ON THE OTHER DOCUMENTS THAT WE'VE BEEN DISCUSSING AND THANK YOU VERY MUCH FOR THAT. IN FACT, THE PROCESS WAS, QUOTE, RELATIVELY EASY FOR THE TASK FORCE BECAUSE OF THAT. THE FIRST DRAFT HAD BEEN CIRCULATED FOR KMENTD. MOST OF THE CHANGES WERE -- COMMENT. MOST OF THE CHANGES WERE OF A CLARIFYING NATURE. THERE WAS SOME DISCUSSION THAT I SHOULD HIGHLIGHT AGAIN TO MAKE SURE THAT THE CONCERNS WERE ADDRESSED. BRAD HAD RAISED A GOOD POINT AND THAT WAS THAT AS WE BRING THESE CONCERNED FORWARD WITH THE INTENT OF THIS DOCUMENT, REALLY TO ENCOURAGE THE FTC, AND THE FDA AND OTHER AGENCIES TO BEGIN TO PUT THESE ISSUES ON THEIR RADAR SCREEN, WE DID NOT WANT TO COMPLETELY CLOSE THE DOOR ON THE POSSIBILITY THAT THERE MAY COME A TIME IN WHICH SOME OF THE GENETIC TESTING COULD VERY EASILY BE DONE IN A -- A MARKETER OR PROVIDER DIRECT CONSUMER RELATIONSHIP. WE HADN'T ESSENTIALLY ACKNOWLEDGED THAT WE WERE AT THAT STATE BUT WE DIDN'T WANT TO CLOSE THE DOOR THAT THAT MIGHT NOT BE A POSSIBILITY AND AS WE GET TO THAT POINT IN THE DOCUMENT, WE'LL BRING THAT UP AND MAKE SURE THAT OTHERS ARE SATISFIED WITH THE LANGUAGE THAT KEEPS THE DOOR OPEN TO SOME EXTENT IN THAT REGARD. IN TERMS OF REVIEWING THIS DOCUMENT, I WOULD ASK IF THE CHAIR WOULD AGREE, BECAUSE OF ITS BREVITY, THAT WE JUST READ THROUGH IT IN ITS ENTIRETY, SO THAT RATHER THAN START WORDSMITHING PARAGRAPH BY PARAGRAPH, WE ARE ALL AGAIN REMINDED THAT PERHAPS A CONCERN HAD A SOMEONE HAS AT A GIVEN POINT MAY HAVE, INDEED BEEN COVERED LATER ON IN THE DOCUMENT. IS THAT ALL RIGHT, ED.

SURE, CHRIS. YOU MISSED THE DISCUSSION YESTERDAY. THE DOCUMENT MAY SHOW BREVITY. I HOPE OUR DISCUSSION CAN BE INFORMATIVE. BUT AS BRIEF AS WE CAN -- AS WE CAN ACCOMMODATE. THANK YOU.

INDEED. WITH THAT THEN, I WILL JUST QUICKLY RUN THROUGH THE DOCUMENT, AND THEN WE CAN BEGIN THE WORDSMITHING THEREAFTER. "WHEREAS THE SECRETARY'S ADVISORY COMMITTEE ON GENETICS HEALTH AND SOCIETY IS ESTABLISHED TO ADVISE THE SECRETARY OF HEALTH AND HUMAN SERVICES ON THE RANGE OF COMPLEX AND SENSITIVE MEDICAL ETHNIC ETHICAL AND LEGAL ISSUES RAISED BY NEW TECHNOLOGICAL ISSUES BY HUMAN GENETICS AND SCIENTISTS ARE DEVELOPING GENETIC TESTS THAT HELP TO DIAGNOSE AND PREDICT DISEASE AT THE PRESENT TIME, THE MAJORITY OF THE MORE THAN 1,000 GENETIC TESTS AVAILABLE ARE IN DEVELOPMENT FOCUSES ON RARE DISEASES OR SINGLE GENE DISORDERS. FOR MANY HUMAN GENES DEFINITIVE LINKS TO A PARTICULAR DISEASE OR HEALTH OUTCOME HAVE NOT BEEN VALIDATED. WITH ERR OWN BEGINNING TO UNDERSTAND THE BASIS OF THE COMPLEX LINKS BETWEEN GENES, THE ENVIRONMENT AND COMMON DISEASES OR BEHAVIORS AND WHEREAS RECENT MARKETING PRACTICES WHICH CAN BE DIRECTED AT BOTH ADVERTISING AND SELLING, GENETIC TESTS AND SERVICES TO THE GENERAL PUBLIC HAVE INCLUDED PROMOTIONS, IN PRINT MEDIA, TELEVISION AND INCREASINGLY THE INTERNET, WHEREAS THERE MAY BE VALID AND APPROPRIATE GENETIC TESTS DIRECTLY MARKETS TO CONSUMERS WE ARE NONETHELESS GREATLY TROUBLED THAT SOME ENTITIES ARE MISREPRESENTING GENETIC INFORMATION IN ORDER TO RECOMMEND UNSUBSTANTIATED HEALTH AND DIETARY CHANGES TO CONSUMERS WHICH IN SOME INSTANCES MAY DIVERT INDIVIDUALS FROM APPROPRIATE TREATMENT OPTIONS; WHEREAS EXAMPLES OF WEB SITES THAT MARKET QUESTIONABLE GENETIC TESTS INCLUDE THOSE OFFERING GENETIC PROFILING TO ASSESS RISKS FOR DISEASES SUCH AS DIABETES OR HEART DISEASE, GENETIC TESTING TO PREDICT RISK OF BEHAVIOR SUCH AS ADDICTION OR IMPULSIVITY AND NEWT TORONTOCUTICAL. AND MANY CONSUMERS VALUE ACCESS TO INFORMATION ABOUT NEW HEALTHCARE TECHNOLOGIES AND PRODUCTS, MADE POSSIBLE THROUGH DIRECT-TO-CONSUMER ADVERTISEMENTS, WHEREAS THE FOOD AND DRUG ADMINISTRATION IN ITS ROLE IN IMPLEMENTING AND ENFORCING THE FEDERAL, FOOD, DRUG AND COSMETIC ACT OF 1938, REGULATES DEVICES TO ASSURE THAT THEY ARE NOT MISBRANDED, AS A RESULT OF MANUFACTURER ADVERTISEMENTS AND PROMOTIONAL AND WHEREAS THE FDA CURRENTLY DOES NOT REGULATE THE MARKETING OF GENETIC TESTING DEVICES AND THE FEDERAL TRADE COMMISSION ACT GRANDS THE FTC AND PRACTICES OF FALSE ADVERTISEMENT, DRUGS DEVICES AND SERVICES INCLUDING THE GENETIC TESTING SERVICES, AND WHEREAS SACGHS PLANS INSTUDY OF DIRECT-TO-CONSUMER MARKETING IN THE FUTURE THE COMMITTEE WISHES TO EXPRESS CONCERN AT THIS TIME ABOUT MARKETING OF GENETIC TESTS. AS SUCH, AND IN LIGHT OF THE POTENTIAL HEALTH CONSEQUENCES TO INDIVIDUALS, SACGHS BELIEVES THAT THE GENETIC TESTS SHOULD NOT BE SOLD DIRECTLY TO CONSUMERS WITHOUT THE INFORMED GUIDANCE OF AN APPROPRIATELY TRAINED HEALTHCARE PROFESSIONAL, AT LEAST AT THIS TIME. AND THAT IN ORDER TO PROTECT THE PUBLIC INTEREST WE URGE THE SECRETARY OF HEALTH AND HUMAN SERVICES TO THE STEPS TO ENSHURJ THAT THE MARKETING OF FLETIC TESTS IS OVERSEEN. DIRECT THE FDA TO MONITOR THE MARKETING OF GENETIC TESTS UNDER ITS STATUTORY AUTHORITY, AND TO CONTINUE TO EXPLORE WAYS THE FDA CAN ENHANCE THE OVERSIGHT OF GENETIC TESTS OFFERED AS SERVICES, WORK CLOSELY WITH THE FTC TO ACT AGAINST THOSE COMPANIES OR PROVIDERS ENGAGED IN MISLEADING MARKETING OF GENETIC TESTS, ENGAGE OTHER COLLEAGUES OF THE FEDERAL AND STATE LEVELS AND HEALTH PROFESSIONALS AND TEST DEVELOPERS IN THE PRIVATE SECTOR TO PROMOTE THE APPROPRIATE USE OF VALIDATED GENETIC TESTS AND PROTECT THEIR INAPPROPRIATE MARKETING SO THAT THE FULL PROMISE AND BENEFITS OF THESE GENETIC TECHNOLOGIES WILL BE REALIZED FOR THE PUBLIC GOOD AND DISCUSS THE IMPLICATIONS OF A GENETIC TEST WITH A HEALTH PROFESSIONAL BEFORE SEEKING A GENETIC TEST.

OKAY. SO THAT'S A QUICK READ THROUGH. I TAKE IT THAT CHRIS -- SINCE CHRIS WAS NOT INTERRUPTED, IT'S ACCEPTED IN TOTO.

SO MOVED? [ LAUGHTER ]

ACTUALLY DEB WAS QUITE BUSY OVER HERE WITH HER PEN. SO...

I'M SURE THAT PEOPLE WERE JUST BEING POLITE, CHRIS, AND NOW WE WILL BEGIN TO MOVE THROUGH. LET'S TRY AND DO THIS FROM -- FROM -- CAN YOU TURN OFF YOUR THING, PLEASE.

OH.

IF WE CAN TRY AND DO IT FROM TOP TO BOTTOM, IN SOME SORT OF ORGANIZED FASHION. SO IF WE COULD TAKE WHEREAS THE SECRETARY ADVISORY COMMITTEE ON GENETICS HALE AND SOCIETY WAS -- HEALTH AND SOCIETY WAS ESTABLISHED. I THINK THAT'S STRAIGHT OUT OF OUR CHARTER. SO I DON'T THINK THERE SHOULD BE A WHOLE LOT OF DISCUSSION ABOUT THE FIRST WHEREAS.

I HAVE A QUESTION ABOUT THE TITLE. [ LAUGHTER ]

NOT TO CHANGE THE TITLE BUT A QUESTION WE HAVE, I THINK THE COMMITTEE HAS TO CONSIDER ABOUT THE WHOLE RESOLUTION. AND THAT IS, WHAT WE ARE REALLY BOTHERED BY ABOUT MARKETING, IS IT -- BECAUSE MARKETING IS A VERY BROAD TERM, INCLUDING ADVERTISING, AND SELLING OR DELIVERY, AND WHILE THE PARK ETING IS WHAT WE HAVE SEEN SO FAR MOSTLY AND THAT TROUBLES US, YOU KNOW, UNDER DIFFERENT SCENARIOS MAYBE NOT SLEAZY SENSATIONAL WEB SITES BUT IF A MAJOR PHARMACEUTICAL COMPANY TOMORROW HAD AN AD LIKE THE CLAIRTON ADS WHERE THEY HAVE THE FINE PRINT AND THEY SEND YOU TO A FASHION OR A PERSON KNOWS WHAT THEY ARE DOING, WE DON'T SEEM TO HAVE A PROBLEM WITH THAT CONSUMER MARKETING, AS LONG AS IT'S BEING DELIVERED THROUGH THE RIGHT THING. SO IF SOMEONE WERE ADVERTISING A GENETIC TEST IN THE SAME WAY BUT IT WAS DELIVERED WITH COUNSELORS AND EVERYTHING, WOULD WE STILL HAVE TROUBLE WITH IT? ARE WE HAVING A PROBLEM WITH ALL DIRECT MARKETING? OR IS IT PRIMARILY THE CONCEPT OF EVEN -- EVEN SELLING OR DELIVERING THE GENETIC TESTS THAT TROUBLES US? IF THAT'S WHAT IT IS, MAYBE WE SHOULD AB I LITTLE CLEARER AND NOT JUST SAY, YOU KNOW, BROADLY GLOBALLY MARKETING BUT WE SHOULD SAY, IT'S DELIVERING PART. SO.

NOT THE TITLE BUT SOMEWHERE LATER ON, FOR EXAMPLE WHEN WE GET TO WHAT -- AFTER ALL THE WHEREASS THE FIRST THING YOU SAY IS TESTS SHOULD NOT BE SOLD DIRECTLY TO CONSUMERS. SO WHEN WE GET ACTIVE ABOUT IT, WE'RE FOCUSING ON THE DELIVERY, NOT THAT WE MIND THE ADVERTISING SO MUCH. SO THAT WAS KIND OF BECAME LESS CLEAR TO ME AFTER THE TEST TASK FORCE DELIVERED FHIL LET YOU RESPOND CHRIS, BUT I THINK IT'S IMPORTANT TO RECOGNIZE THE POINT THAT GAIL JAVIT MADE IN THE PUBLIC COMMENT SECTION AND THAT IS THAT THERE IS DIRECT-TO-CONSUMER MARKET AND THERE'S DIRECT-TO-CONSUMER ACCESS TO GENETIC TESTS. AND THOSE WE ALWAYS HAVE TO SEPARATE, RECOGNIZING, OF COURSE, THAT THE DIRECT TO CONSUMER ACCESS IS NOT GOING TO BE TER LIBERALY PROFITABLE, UNLESS THERE'S RECOGNITION THAT THIS ACCESS IS -- TERRIBLY PROFITABLE, UNLESS THERE'S RECOGNITION THAT THIS ACCESS IS AVAILABLE. SO YOU CAN HAVE DIRECT-TO-CONSUMER MARKETING WITH OR WITHOUT DIRECT ACCESS. BUT PART OF THE CONCERN, WITH GENETIC TESTING IS THE ACCESS. LOOKING AT THIS, YOU KNOW, I THOUGHT THAT IT WAS PRETTY STRAIGHTFORWARD AND IT DID NOT CONFUSE MARKETING AND ACCESS THE WAY I KNOW SOME OTHER DOCUMENTS HAVE IN THE PAST. BUT I WILL LET YOU -- IT LET YOU RESPOND THEN, CHRIS.

I WOULD JUST ECHO WHAT ED JUST STATED IN THAT I ANY BECAUSE WE DID FOCUS ON THE ACCESS THAT THAT WAS IN OUR SPECIFIC RECOMMENDATIONS, THAT WAS HIGHLIGHTING WHAT WE THOUGHT TO BE THE MOST IMPORTANT POINT OF OUR CONCERNS, OR THE FOCUS OF OUR CONCERNS. YOU KNOW, WE COULD CHANGE MARKETING TO BREAK IT DOWN TO SAY ADVERTISING AND SALES OF GENETIC TESTS TO ACKNOWLEDGE WE RECOGNIZE THE DISTINCTION BETWEEN THE TWO. BUT I THINK AS YOU LOOK AT THE WHOLE DOCUMENT, IT'S THE SALES WHICH COMES THROUGH, AND SO I DON'T KNOW THAT WE NEED TO CHANGE THAT.

I JUST WANT TO EMPHASIZE THAT I BELIEVE THAT A DAY WILL COME, HOPEFULLY SOON WHEN THERE REALLY ARE LEGITIMATE TESTS THAT WE MAY WANT TO COMMUNICATE TO THE PUBLIC ARE NOW AVAILABLE, NOT THAT WE WANT THEM TO BE DELIVERED DIRECTLY, AND WHEN THOSE COMMUNICATIONS BECOME MORE COMMON, I DON'T THINK WE'RE AS MUCH AGAINST THEM AS WE ARE AGAINST DIRECT DELIVERY OR ACCESS.

YES, SO I THINK THAT OTHER THING WE HAVE TO BE VERY CLEAR ABOUT ARE TESTS WITHIN AN ESTABLISHED, LEGITIMATE MEDICAL UTILITY AND CONSEQUENCE. SO, YOU KNOW, EITHER A LIFESTYLE MODIFICATION OR TREATMENT OR SOMETHING THAT YOU DO WITH THAT INFORMATION, VERSUS THE THING THAT YOU BRING UP, I THINK IT'S IN PARAGRAPH FOUR OF THE TASKS THAT ARE BEING PUT OUT THERE WITH UNSUBSTANTIATED CLAIMS OR WITH SPECIFIC RECOMMENDATIONS FOR SAY, NEUTRACAUTICAL INTERVENTION WHICH ARE WELL ESTABLISHED AS MEDICALLY USEFUL AND MIGHT PREVENT SOMEONE FROM SEEKING AN APPROPRIATELY VALIDATED MEDICAL TREATMENT. NOW I THINK THAT, TO ME, IS THE THING THAT CONCERNS ME, AS WELL. IS -- SO I THINK WE'VE GOT SORT OF MULTIPLE SCENARIOS AND I THINK WE ALMOST HAVE TO WORK THROUGH WHAT IS OUR STANCE ON, YOU KNOW, VALIDATED TESTS LIKE THOSE MARKETS TO THE CONSUMER SO WE HAVE A VERY GOOD CASE STUDY WITH MYRIAD AND THAT TEST TO SORT OF DISCUSSION. -- DISCUSS. THEN WE HAVE UNVALIDATED THING, MARKETED TO THE CONSUMER. DO WE EVEN THINK THAT MARKETING MESSAGE SHOULD BE ALLOWED TO GO OUT? AND THEN THE THIRD IS, YOU KNOW, WE RECOMMEND OR NOT RECOMMEND DIRECT ACCESS TO YOUR RESULTS WITHOUT THE INVOLVEMENT OF A HEALTHCARE PROFESSIONAL.

CAN I JUST REPLY TO THAT AND THEN CYNTHIA AND THEN ED. I AGREE THAT ULTIMATELY WE WILL NEED FIRM, CLEAR, DISTINCTION BETWEEN VARIOUS SI FAIRIOS THAT YOU PROPOSE. BUT I THINK WE'RE AHEAD OF WHERE WE ARE TRYING TO BE WITH THIS STATEMENT. IN IN OTHER WORDS, WE'RE TRYING TO BRING THIS TO A LEVEL OF AWARENESS, TO THE LEADERSHIP OF THE TFC AND TO OTHER GOVERNMENT AGENCIES. WE HAVE NOT GONE THROUGH THE FULL PROCESS THAT ULTIMATELY THIS COMMITTEE WILL UNDERGO WHERE WE WILL LOOK AT THOSE VARIOUS SCENARIOS. AND SO I MANY QUESTION TO YOU, EMILY, IS THE LANGUAGE OF THIS PARTICULAR DOCUMENT SUFFICIENTLY OBTUS OR OPAQUE AS TO BE MAKING FIRM STATEMENTS ALREADY THAT THAT WE SHOULDN'T FHB IN OTHER WORDS AT THIS POINT IN THE DISCUSSION, ARE WE OVERSTEPPING WHAT WE SHOULD BE SAYING AT THIS POINT.

I GUESS MY CONCERN IS ARE WE READY TO HAVE A RESOLUTION. BECAUSE A RESOLUTION TO ME IS SORT OF A CALL TO ACTION, THAT YOU HAVE SOMETHING SPECIFIC THAT YOU WOULD LIKE TO MAKE SPECIFIC RECOMMENDATIONS FOR, ACTION BY THE SECRETARY. IF WE'RE JUST INFORMING -- I'M NOT EVEN SURE WE'RE TOTALLY INFORMED AS A COMMITTEE ON SOME OF THESE THINGS AND READY TO MAKE A RESOLUTION. I GUESS THAT'S MY CONCERN HERE. NOT THAT ANYTHING THAT'S IN THIS IS AN INCORRECT STATEMENT, BUT DO WE -- DO WE NEED TO -- INSTEAD OF WORKING ON THIS AS A RESOLUTION, WORK ON IT AS -- WHAT ARE THE SPECIFIC THINGS WE'RE CONCERNED ABOUT? WHERE DO WE NEED TO GET INFORMATION SO WE COULD, YOU KNOW, FOR SCENARIO ONE SAY THIS IS OUR RECOMMENDATION. SCENARIO TWO, THIS IS OUR RECOMMENDATION. AND I JUST DON'T KNOW IF THAT'S A MORE PRODUCTIVE WAY FOR THE COMMITTEE TO OPERATE THAN WORKING THROUGH A RESOLUTION THAT REALLY -- I'M NOT SURE WE HAVE THE INFORMATION AT HAND TO ACTUALLY MAKE SPECIFIC RECOMMENDATIONS TO THE SECRETARY.

CYNTHIA?

WELL, BRETT BROUGHT UP A GOOD POINT WHICH I HADN'T THOUGHT ABOUT UNTIL HE JUST SAID IT. BUT IF DIRECT ACCESS IS WHAT WE ARE CONCERNED ABOUT, THEN IT DOES SEEM TO ME -- EVEN THOUGH I LAUGHED WHEN HE WAS TALKING ABOUT THE TITLE, WE PROBABLY SHOULD CHANGE THE TITLE THEN AND HAVE IT BE DIRECT-TO-CONSUMER ACCESS INSTEAD OF TALKING ABOUT MARKETING. AND WE COULD HAVE IN THE WHEREAS SECTION SORT OF AN ACKNOWLEDGEMENT THAT THE REASON WE RIGHT NOW ARE TAKING THIS STANCE AGAINST DIRECT ACCESS TO THESE TESTS AND SERVICES IS BECAUSE THERE IS MISLEADING MARKETING GOING ON OUT THERE. THERE ARE TESTS THAT JUST SIMPLY REQUIRE INTERPRETATION BY A COMPETENT HEALTHCARE PROVIDER, GENETIC COUNSELOR AND PEOPLE NEED THAT IN ORDER TO REAP THE BENEFIT OF THESE TECHNOLOGIES AND, AND, AND, WE CAN SORT OF GO ON AND LAY IT OUT AND SAY THEREFORE RIGHT NOW, WE THINK THAT THERE SHOULD NOT BE DIRECT ACCESS, AND WE CAN COME UP WITH FUTURE RECOMMENDATIONS. MAYBE THERE ARE GOING TO BE CIRCUMSTANCES WHEN WE GET ADDITIONAL INFORMATION. MAYBE THERE ARE SERVICES OR TESTS WHERE DIRECT ACCESS MIGHT BE OKAY ONCE WE SATISFY OURSELVES THAT IT IS OKAY. AND I AGREE WITH EMILY THAT FOR SOME OF THESE THINGS WE PROBABLY DON'T HAVE ALL OF THE INFORMATION BEFORE US YET BUT WE PROBABLY CAN MAKE AT LEAST AS PRELIMINARY STATEMENT IN THE FORM OF THIS RESOLUTION. CONVERSELY, IF FOLKS FELT THAT HE WITH WANTED TO MAKE A STATEMENT ABOUT MARKETING, BECAUSE THAT IS ONE CONCLUSIONS AT THE END HERET. TALKS ABOUT WORKING WITH FTC TO WORK AGAINST THOSE ENGAGED IN MISLEADING MARKETING. THEN WE COULD CHANGE THE TITLE TO CLAW BOTH, MARKETING AND ACCESS IF WE WANTED TO MAKE THAT CONCLUSION, THAT WE WANT TO TAKE A STANCE AGAINST DIRECT ACCESS BUT IN THE MEANTIME THERE'S THIS CONCERN THAT WE DO HAVE ABOUT MISLEADING MARKETING AND WE WANT TO WORK WITH FTC ON. I HAVE NO PROBLEM WITH THAT EITHER. AND I THINK WE SHOULD CLARIFY AND THEN WITH A VIEW TOWARDS GOING DOWN THE PATH THAT EMILY TALKED ABOUT, COLLECTING ADDITIONAL INFORMATION BECAUSE WE PROBABLY NEED TO MAKE MORE SPECIFIC RECOMMENDATIONS ONCE WE GET THAT INFORMATION.

OKAY. I JUST WANT TO REMIND THE COMMITTEE OF WHY WE UNDERTOOK THE PROCESS OF DRAFTING THIS RESOLUTION. AND THAT WAS BECAUSE OF CONCERNS ABOUT DIRECT-TO-CONSUMER MARKETING. SO ACCESS IS AN ISSUE. I THINK THIS IS REALLY FOCUSED ON THE MARKETING. I THINK THE ONE AREA WHERE IT COULD CONFUSING AND WE MAY WISH TO DELETE IT, SO AS NOT TO OPEN UP OTHER DOORS BUT TO FOCUS IT OJ MARKETING IS UNDER THE BULLET ONE OF THE -- OPEN UP OR DOORS BUT TO FOCUS IT ON MARKETING IS UNDER THE BULLET ONE OF THE RESOLUTION. ENHANCE THE TESTS. REALLY AMONG THE RESOLUTIONS THAT'S THE ONLY ONE DEALING WITH SERVICES. THE REST ARE ALL DEALING WITH MARKETING. AND PART OF THE CONCERN WAS THE INFORMATION WE HAD RECEIVED THAT INDICATED THAT THERE REALLY WAS MISLEADING MARKETING GOING ON, AND OUR, DID OUR INTEREST IN MOVING TOWARDS QUICKLY BEFORE WE DID THE IN-DEPTH STUDY TO GIVE FTC PRIMARILY BUT TO SOME EXTENT THE FDA AS WELL, THE OPPORTUNITY, BASED ON THIS RESOLUTION, TO, WITHIN THEIR AGENCIES LOOK INTO DIRECT-TO-CONSUMER MARKETING AND PARTICULARLY THE MISLEADING MARKETING.

MY QUESTION TO THE COMMITTEE IS DO YOU BELIEVE THAT THE MISLEADING MARKETING MAY FAIL TO TELL THE CONSUMERS THAT THE INTERVENTION OF MEDICAL PROFESSION IS NECESSARY? I MEAN BECAUSE IF THAT'S THE CASE THEN IT MAKES A LITTLE BIT MORE SENSE TO INCLUDE THEM BOTH IN HERE. IF WE HAD A SITUATION -- WE HAD A SITUATION ONCE WHERE THERE WAS A VERY LOW CALORIE DIET BEING OFFERED TO CONSUMERS AND VERY LOW CALORIE DIETS REQUIRE THE INTERVENTION OF A MEDICAL PROFESSIONAL BEIGE IT CAN BE DIFFICULT TO HAVE00 OR 1,000 CALORIE DIET AND IT CAN BE DANGEROUS TO YOUR HEALTH. BUT THE ADVERTISER WAS NOT SAYING THAT. OFFERING THE VERY LOW CALORIE DIET BUT PART OF THE MARKETING PROBLEM WAS THAT IT DIDN'T TELL CONSUMERS YOU BETTER CONSULT A PROFESSIONAL OR YOU COULD BE IN DEEP TROUBLE. AND IF -- SO IF THEY THINK PART OF THE MISLEADING MARKETING IS THAT OMISSION OF MATERIAL OR INFORMATION, THEN MAYBE YOU OUGHT TO SAY SO IN HERE. THE OTHER -- WELL, I GUESS THAT'S ENOUGH.

OKAY.

I WAS JUST GOING TO COMMENT THAT I THINK THAT IS SORT OF IN THERE. UNDER THE FINAL BULLET OF THE RESOLUTION, ENCOURAGE PUBLIC TO KIS US THE IMPLICATIONS OF A GENETIC TEST WITH THE HEALTH PROFESSIONAL BEFORE SEEKING A GENETIC TEST.

THERE REALLY ISN'T A DISTINCTION -- IT IS A DISTINCTION WITHOUT A DIFFERENCE BECAUSE THE ACCESS IS PART OF THE MARKETING ISSUE? AND AS LONG AS THE RESOLUTION FOCUSES ON THE MARKETING THEN I THINK YOU'VE GOT IT RIGHT.

AND THE -- IT DOES TALK ABOUT THAT MARKETING PRACTICES UNDER THE THIRD -- THE THIRD PARAGRAPH, THE THIRD WHEREAS, MARKETING PRACTICES CAN BE DIRECTED AT BOTH ADVERTISING AND SELLING GENETIC TESTS AND SERVICES TO THE PUBLIC. BUT, AGAIN, THAT REVERTS BACK TO THE ISSUE OF MARKETING. IT SAYS HAVE INCLUDED PROMOTIONS IN PRINT MEDIA, TELEVISION AND INCREASINGLY THE INTERNET. SO I THINK THIS IS -- I THINK THAT ACCESS IS AN ISSUE BUT THIS ONE IS FOCUSED THIS IS FOCUSED ON MARKETING WITH THE EXCEPTION OF THAT ONE CLAUSE IN THE FIRST BULLET OF THE RESOLUTION WHICH WE COULD STRIKE. TO KEEP IT VERY FOCUSED.

I JUST WANTED TO COMMENT ON THAT THIRD WHEREAS STATEMENT. IN DEFINING MARKETING PRACTICES, WE WERE TRYING TO MAKE IT CLEAR THAT MARKETING PRACTICES INCLUDE ADVERTISING AND SELLING WHICH INCLUDES ACCESS. SO IF IT'S NOT CLEAR THAT THAT ACCESS IS INCLUDED WITHIN MARKETING, WE CAN CLARIFY THAT. BUT I JUST WANTED TO POINT THAT OUT.

MATT RAISING -- I'M SORRY, YOU WERE TUNING IN THERE TO HER REPLY.

BECAUSE THE FTC HAS NO GENERAL DISTINCTION MARKETING AND SELLING. I MEAN IF YOU CAN SELL THE SERVICE WITHOUT ADVERTISING IT, MORE POWER TO YOU. BUT IT'S NOT LIKELY. SO ANYTHING THAT'S SAID -- WE'RE TALKING ABOUT A TEST KIT VERSUS COMING IN FOR A TEST, RIGHT?

NO.

TELL ME WHAT THE DIFFERENCE IS BETWEEN MARKETING AND THE SERVICE.

OKAY. A KIT IS REGULATED BY THE FDA, AND IT HAS VERY SPECIFIC CLAIMS. MOST GENETIC TESTS ARE MARKETED AS SERVICES, WHERE THE LABORATORY DEVELOPS THE REAGENTS THEMSELVES.

RIGHT.

AND THEN THEY CAN MARKET THAT TEST FOR WHATEVER PURPOSE AND I THINK THAT'S THE ISSUE, IS THAT MOST OF THE -- OF THE MARKETING ISSUES ARE NOT AROUND KIT, REAGENTS, PRODUCTS THAT THE FDA HAS REMOVED. THEY ARE AROUND HOME BREWED LAB-DEVELOPED TESTS THAT THE LAB IS, IN SOME WAY TAKING ON A RESPONSIBILITY TO CREATE A CLINICAL UTILITY WHICH MAY OR MAY NOT BE REAL.

OKAY. I JUST WANTED TO OUT AS FAR AS THE FTC IS CONCERNED, IF YOU ADVERTISE A TEST KIT OR A SERVICE, YOU KNOW, IT IS ALL IN THE SAME --

BUT THERE HAS TO BE A DIFFERENCE BETWEEN IF YOU ADVERTISE AND THEN PEOPLE CAN BUY IT DIRECTLY FROM YOU OR IF YOU ADVERTISE AND THEN PEOPLE HAVE TO GO TO A CHANNEL, LIKE A PHYSICIAN TO GET IT OR A GENETIC TESTING CENTER OR SOMETHING WHERE YOU CAN GET COUNSELING. FROM THE ADVERTISING POINT OF VIEW, I KNOW IT DOESN'T MATTER, BUT THE QUESTION WE HAVE IS WHAT ARE WE MOST CONCERNED ABOUT? JUST TO BE CLEAR, IF WE WANT TO COVER IT ALL, THEN I THINK WE SHOULD JUST LEAVE IT AS IT IS AND MAYBE SOME CHANGES ARE A GOOD IDEA BUT IN BUSINESS SCHOOL, MARKETING INCLUDES THE DELIVERY, AND INCLUDES NOT JUST THE PROMOTION AND THE ADVERTISING BUT ALSO THE DELIVERY, THE ACCESS. MY ONLY QUESTION AT THE VERY BEGINNING WAS THAT IF YOU DON'T REALLY HAVE A PROBLEM, IF YOU REALLY THINK ABOUT IT AS OUR BIGGEST PROBLEM, THE ACCESS PART, NOT THE ADVERTISING PART, IN WHICH HE CASE WE SHOULD MAKE IT MORE REAL F. HE WANT TO COVER IT ALL. AND THE BIGGEST POINT THAT CHRIS MADE IS THIS IS JUST A RESOLUTION TO GET IT ON THE RADAR RIGHT AWAY. WE'RE TELLING THEM THAT WE'LL CONTINUE DELIBERATING MUCH MORE. WHY DON'T WE JUST SAY MARKETING AND WE'LL GET BACK ON WHAT PARTS WE REALLY CARE ABOUT LATER.

AND JUST TO REINFORCE BRAD'S COMMENT I THINK THAT THERE ARE ELEMENTS OF DELIVERY. AS WELL AS ADVERTISING THAT CAN BE ISSUES OF CONCERN FOR US. SO THE BROADER LANGUAGE ISN'T NECESSARILY INAPPROPRIATE FOR OUR LARGER SET OF CONCERNS. AGAIN, WE'RE NOT -- I'M HOPING PEOPLE ARE NOT LOOKING AT THIS AS "THE" FINAL STATEMENT OF OUR CONSUTIONS -- CONCLUSIONS ABOUT ALL THE PERMEATIONS. BUT IF WE'RE GOING TO PARTNER WITH THE FTC AND OTHERS THEY NEED TO BE ENCOURAGED TO SPEND THE TIME AND THE LABOR TO GET SOME OF THE DATA WE NEED TO GET THE FINAL RECOMMENDATIONS AND THAT'S WHAT THE PURPOSE OF THIS WAS. DEBRA AND THEN ED.

WELL, GAIL POINTED OUT THAT THERE IS STATE-TO-STATE VARIATION ON WHETHER YOU CAN MARKET MEDICAL SERVICES DIRECTLY TO CONSUMERS. AND SO I THINK THAT HAS TO BE TAKEN INTO ACCOUNT, AS WE DECIDE WHAT BLANKET KIND OF STATEMENTS WE'RE GOING TO MAKE AND MAYBE THE MARKETING OF GENETIC TESTS HAS TO BE CONSIST ENTERWITH STATE REGULATIONS, UNLESS WE WANT TO OVERRIDE THOSE. WHAT? OH, SORRY. I THOUGHT THERE WAS A COMMENT BACK THERE. AND THE OTHER CONCERN THAT I HAVE IS THAT ONCE THE WHEREASS ARE DONE, WE'RE VERY STRONG ABOUT SAYING THAT GENETIC TESTS SHOULD NOT BE SOLD, SOLD AND WE'RE SPECIFYING THE SELLING PART, DIRECTLY TO CONSUMERS BUT I DON'T SEE ANYTHING IN THE BULLETS THAT IS A MECHANISM FOR ACHIEVING THAT. AND SO ESPECIALLY THE LAST BULLET, WHICH IS ENCOURAGE THE PUBLIC TO DISCUSS THE IMPLICATIONS OF A GENETIC TEST WITH A HEALTH PROFESSIONAL AND IT IS NOT CLEAR WHO A HEALTH PROFESSIONAL IS, BECAUSE MANY DOCTORS DON'T KNOW HOW TO INTERPRET GENETIC TEST RESULTS BEFORE SEEKING A FETIC TEST. ENCOURAGING IS DIFFERENT THAN SHOULD NOT -- GENETIC TEST, ENCOURAGING IS DIFFERENT THAN SHOULD NOT BE SOLD DIRECTLY TO CONSUMERS. I THINK WE WIMP OUT IN THE BULLETS BASICALLY AND I DON'T KNOW WHY WE CAN'T JUST MAKE THE STATEMENT THAT IS THE BEGINNING PARAGRAPH IT. IF WE'RE GOING TO DO FURTHER INVESTIGATION, MAYBE FOLLOWING UP ON MUIN'S COMMENT IS ASK THE CDC TO START COLLECTING INFORMATION IN PUBLIC HEALTH INTEREST OF WHAT MARKETING IS GOING OUT TO CONSUMERS AND IF THERE'S HARM, ET CETERA. BUT BASICALLY HAVE TWO BULLETS ONE IS THAT IT SHOULDN'T BE SOLD CORRECTLY TO CONSUMERS AND ASK THE CDC TO COLLECT MORE INFORMATION INFORM OUR FUTURE DISCUSSIONS.

WELL, I WAS GOING TO, I GUESS, WIMP OUT COMPLETELY THEN, SINCE WE HADN'T ADDRESSED THAT IN THE BULLETS AND REMOVE THAT AND TAKE THE FIRST SENTENCE OF THE LEAD-IN PARAGRAPH TO THE RESOLUTION -- RESOLUTIONS AND SAY AS SUCH AND IN LIGHT OF THE POTENTIAL HEALTH CONSEQUENCES TO INDIVIDUALS, AND IN ORDER TO PROTECT PUBLIC INTEREST, WE URGE THE SECOND TEAR... AND TAKE OUT THAT ABOUT -- SECRETARY... AND TAKE OUT THAT ABOUT THE SELLING BECAUSE THAT BRINGS US DIFFERENCES BETWEEN STATE-TO-STATE AND REALLY WHAT WE WERE TRYING TO DO IS GET SOMETHING QUICKLY OUT TO THE SECRETARY TO MAKE SOME RECOMMENDATIONS TO THOSE AGENCIES THAT FALL WITHIN HIS PURVIEW. WHICH HERE WAS DIRECTED AT THE FDA. I THINK IF YOU WANTED TO INCLUDE THE -- SOME SORT OF MONITORING OF DIRECT-TO-CONSUMER MARKETING OF GENETIC TESTS THAT WOULD BE GOOD IN THE BULLET AND THAT COULD BE COVERED HERE, BUT I THINK IT'S IMPORTANT THAT WE KEEP THIS TIGHT AND FOCUSED SO THAT WE CAN GET IT OUT QUICKLY.

EMILY, THEN HUNT, AND THEN I'M GOING TO SUGGEST A PROCEDURAL APPROACH THEREAFTER. GO AHEAD.

JUST LISTENING TO THE DISCUSSION IT SOUNDS LIKE WHAT WE ARE REALLY RECOMMENDING IS NOT THAT WE DIRECT FDA TO MONITOR IT, BUT THAT WE BASICALLY DECLARE MORATORIUM ON DIRECT MARKETING AND ACCESS TO GENETIC TESTS UNTIL SUCH TIME AS WE CAN COME UP WITH SOME VERY SPECIFIC RECOMMENDATIONS FOR THE APPROPRIATE LEVEL OF, I WILL CALL IT OVERSIGHT BUT I DON'T WANT TO CONFUSE THAT WITH THE, YOU KNOW, STANDARD LAB PRACTICE, OVERSIGHT BUT WE NEED TO HAVE SOME VERY CONCRETE RECOMMENDATIONS FOR THE DIFFERENT SCENARIOS. SO FOR THE SCENARIO OF AN ESTABLISHED MEDICAL UTILITY WITH A REPUTABLE PROVIDER, YOU KNOW, HOW DO YOU KNOW WHEN A TEST SHOULD BE ALLOWED TO GO DIRECTLY TO A CONSUMER OR WHEN IT NEEDS TO INVOLVE A HEALTH PROFESSIONAL? WE NEED TO DISCUSS THAT IN-DEPTH AND COME UP WITH A RECOMMENDATION. ARE THERE ANY A NAIRIOS WITH A CONSUMER SHOULD BE ABLE TO GET DIRECT ACCESS? AND WHAT ARE THOSE? THEN THE NEXT LEVEL, WHICH IS, TO ME, THE MOST CONCERNING, ARE THE TESTS WHICH ARE BEING, I WILL CALL IT FALSELY ADVERTISED SO THEY ARE MAKING CLAIMS, AND/OR RECOMMENDATIONS WHICH ARE NOT SUBSTANTIATED. WE NEED TO HAVE A MECHANISM FOR POLICING THOSE THINGS WHAT IS THE RIGHT MECHANISM? IS THAT AN FTC. DO WE JUST SEND ALL THAT STUFF OVER TO MATT AND HOPE THAT HE HAS SOME TIME TO DEAL WITH IT? OR, YOU KNOW, HOW DO WE GET TO THOSE THINGS? AND I'VE SEEN SOME OF THEM THAT I PERSONALLY FIND EXTREMELY CONCERNING, PRIMARILY BECAUSE THEY ARE RECOMMENDING ALTERNATIVE THERAPYS WHEN THERE ARE GOOD ESTABLISHED FDA APPROVED THERAPYS AVAILABLE, WHICH ARE NOT MENTIONED. SO I THINK I'M A LITTLE CONCERNED ABOUT DIRECTING THE FDA TO MONITOR THE MARKETING OF GENETIC TESTS, AS OUR FIRST, YOU KNOW -- IT SOUNDS FIRST OF ALL, VERY DIRECTIVE, AND OVER AN AGENCY, WHICH HAS WAFFLED ON WHETHER IT EVEN FEELS IT HAS THE AUTHORITY TO REGULATE THE DELIVERY OF INFORMATION FROM CLINICAL LABORATORIES. SO I'M NOT SURE THIS IS THE RIGHT TIME TO TRY TO TELL IT THAT IT MUST TAKE THAT AUTHORITY IN HAND. BUT WE NEED TO HAVE SOME CLEAR STATEMENT HERE ABOUT, YOU KNOW, FOR THE TIME BEING THIS SHOULD NOT BE DONE. PERIOD. AND WHAT ARE THE CIRCUMSTANCES UNDER WHICH WE WOULD SORT OF RECOMMEND MOVING AWAY FROM THIS, THIS SHOULD NOT BE DONE, PERIOD TO WHERE IS IT APPROPRIATE?

I GUESS I'M COMING DOWN ON A SIMILAR SIDE. IF I WAS THE SECRETARY I WOULD LOOK AT THESE FOUR BULLETS AND IT'S NOT AT ALL CLEAR WHAT I'M SUPPOSED TO DO AND NONE OF THEM HAS ANY TEETH. SO IT DOES COME OFF AS A VERY WIMPY SORT OF APPROACH THE CLOSEST ONE TO AN -- A TRUE ACTION ITEM OTHER THAN HOPEFULLY GIVE MATT A BIGGER BUDGET BECAUSE WE HEARD AT THE VERY FIRST MEETING THAT HE POSSIBLY CAN'T DO ALL OF THIS STUFF. SO FOR THE SECRETARY TO TELL MATT TO DO ALL OF THIS STUFF IS NOT GOING TO BE VERY EFFECTIVE. THE CLOSEST ONE IS THE LAST BULLET, ALTHOUGH IT'S NOT VERY MEANINGFUL. ARE WE ASKING FOR AN ADVISORY BULLETIN, AND IF WE'RE NOT READY TO SAY WHAT WE WANT BECAUSE AFTER ALL WE NEED TO STUDY THIS AND WE WANT TO STUDY IT IN DEPTH, THEN PERHAPS WE'RE AT THE POINT THAT EMILY MADE TEN MINUTES AGO WHICH IS WE DON'T REALLY NEED A RESOLUTION BECAUSE WE'RE NOT RESOLVING ANYTHING AT THIS POINT. WE'RE NOT RESOLUTE IN ANYTHING UNTIL WE HAVE DONE THE IN-DEPTH STUDY.

AT THIS POINT, I SEE US POTENTIALLY GOING THROUGH A COUPLE OF APPROACHES. I THINK THAT ONE, I WOULD LIKE TO CLARIFY, BECAUSE THERE'S A WHOLE VARIETY OF PROPOSALS ABOUT WHAT THE STATEMENT IS SUPPOSED TO BE ACCOMPLISHING, STILL CIRCULATING AMONG DISCUSSION. AND I THINK WE HAVE TO COME TO CLOSURE ON WHAT IT IS THAT WE'RE GOING TO AKEF TODAY. AND WHAT IT IS WE'RE DEFERRING TO A LARGER AMOUNT OF EFFORT AND INTERVENTION IN THE FUTURE. I WOULD SUBMIT THAT WE ARE, AGAIN, ATTEMPTING TO ASSIST MATT AND HIS COLLEAGUES AND OTHERS AND GETTING THIS TO BE AN ISSUE OF CONSIDERATION. BY THE GOVERNMENT. I THINK IS AN OPPORTUNITY TO ASK OUR COLLEAGUES IN PUBLIC HEALTH TO BEGIN COLLECTING THE DATA AS WAS PREVIOUSLY MENTIONED. AND I THINK THAT WE ARE SUGGESTING THAT AT THE PRESENT STATE-OF-THE-ART AND PRACTICE, WE CAN CHANGE THE LANGUAGE TO BE MORE FIRM, BUT THAT GENETIC TESTING SHOULD BE DONE IN THE CONTEXT OF A RELATIONSHIP WITH APPROPRIATELY TRAINED HEALTHCARE PROVIDER WHO CAN HELP TO KNOW WHETHER IT'S WORTH DOING THE TESTING OR WHETHER -- HOW TO INTERPRET THE RESULTS OF THAT TESTING. IN TERMS OF GOING DOWN THE ROAD OF TAKING EACH POSSIBLE PERMEATION, OBVIOUSLY WE'RE NOT THERE YET. BUT I DON'T BELIEVE THAT WE HAVE TO HAVE THAT INFORMATION IN ORDER TO GO FORWARD WITH THIS DISCUSSION. AND SO I WOULD PROPOSE WITH THE CHAIR'S COMMENT, THAT WE ADD LEAST QUICKLY REVIEW THE PARAGRAPHS OF THE WHEREASESS, THE BACKGROUND INFORMATION, THE FACT SET THAT'S BRINGING FORWARD THIS QUESTION. ARE THERE ANY MODIFICATIONS WE NEED TO MAKE TO THOSE STATEMENTS AND HOPEFULLY WE CAN DO THAT BRIEFLY AND THEN SPEND THE REMAINDER OF OUR TIME WORDSMITHING THE BULLET POINTS AT THIS TIME AS TO WHAT WE THINK IS APPROPRIATE. YES?

MAY I BORROW THIS?

I WOULD LIKE TO MAKE THE COMMENT THAT I THINK FDA HAS PROBABLY VERY LIMITED JURISDICTION, IF ANY, TO MONITOR THE MARKETING OF GENETIC TESTS OVER WHICH THEY HAVE NO OVERSIGHT. I DON'T BELIEVE THAT WE CAN DO THAT, UNLESS SOMEBODY DECIDES THAT WE WILL HAVE OVERSIGHT OVER THESE TESTS.

FORGIVE MY IGNORANCE, BUT DON'T YOU HAVE OVERSIGHT AND MONITORING OVER PREGNANCY TESTS AND THINGS OF THAT NATURE ARE DIRECTLY MARKETED IN.

WE HAVE OVERSIGHT OVER TEST KITS, BUT NOT OVER LABORATORY-DEVELOPED GENETIC TESTS WHICH IS THE MAJORITY OF GENETIC TESTS.

BUT IT SAYS UNDER ITS STATUTORY AUTHORITY WHICH WOULD MEAN AT THIS TIME KITS.

IS --

YES, WE DO MONDAY IT MONITORING THE MARKETING OF KITS AND SO FAR THAT HAS NOT BEEN A SERIOUS ISSUE.

SO WHEN A DIRECT-TO-CONSUMER MARKETER OF GENETIC TESTS SENS A PACKET OUT TO -- SENDS A PACKET OUT TO COLLECT A SWAB AND RETURN THAT INFORMATION ARE YOU MONITORING THOSE AND GIVING THEM APPROVAL TO DO THAT?

NOT UNLESS THE KIT HAS BEEN CLEARED OR APPROVED BY THE FDA. MIDDLE EAST OF THOSE DIRECT-TO-CONSUMER ARE LAB-DEVELOPED TESTS -- MOST OF THOSE DIRECT-TO-CONSUMER TESTS ARE LAB-DEVELOPED TESTS AND OUTSIDE OF OUR REGULATORY AUTHORITY.

SO YOU WOULD HAVE THE POWER TO STEP IN TO ENSURE THAT THE INFORMATION IS CORRECT, CORRECT.

NO. NOT THAT I'M AWARE OF.

IT IS A MARKETED KIT FOR THE COLLECTION OF --.

RIGHT BUT WE DON'T REGULATE THE LABORATORY-DEVELOPED TESTS SO WE DON'T HAVE ANY JURISDICTION OVER HOW THEY ARE MARKETED.

JUST A POINT OF CLARIFICATION, WOULD IT BE ABOUT THE COLLECTION ITSELF WAS MONITORED BUT NOT THE TEST THAT'S DONE ON IT? IS THAT THE -- COLLECTION DEVICES ARE REGULATED AS COLLECTION DEVICES. HOW THEY PERFORM, FOR EXAMPLE, BLOOD TUBES AND SO ON, BUT THE ACTUAL COLLECTION OF THE SAMPLE BY WHOEVER IS NOT.

I GUESS BEFORE GETTING INTO THE DETAILS ON THIS, AND SPENDING A BIT OF TIME ON IT, I WOULD JUST ASK OUR EX OFFICIOS WHETHER THEY -- THE PURPOSE OF THIS WAS TO ASSIST THE EX OFFICIOS IN THE INTERIM WHILE WE DEVELOPED A MORE COMPLETE REPORT. SO I WOULD ASK THE EX OFFICIOS WHETHER THEY SEE ANY VALUE IN DEVELOPING THIS RESOLUTION IF IT IS NOT GOING TO BE OF ANY VALUE, I THINK WE NEED TO THEN CONSIDER NEXT STEPS. IS THAT OKAY, CHRIS?

MATT?

WELL, FIRST, I -- I CAN'T SPEAK FOR THE FDA, OF COURSE, BUT I DO DEAL WITH THEM EVERY DAY, AND AS YOU KNOW, VERY WELL, THEIR CHARGES PROTECT THE PUBLIC HEALTH AND SAFETY. AND IF THE COMMITTEE'S CONCERN IS THE PUBLIC HEALTH AND SAFETY IN THE DIRECT-TO-CONSUMER MARKETING OR DELIVERY OF THESE TESTIFYS I MIGHT SUGGEST YOU WANT TO MAKE A STRONGER RECOMMENDATION NOW OR LATER TO THE SECRETARY TO TRY AND GET IMPLEMENTED A CHANGE TO THE FDA AND CACT. I MEAN IF YOU DON'T HAVE AUTHORITY OVER THESE THINGS, IT'S GOING TO BE VERY DIFFICULT FOR THE FTC, UNDER ANY CIRCUMSTANCES TO DO THE KIND OF JOB YOU WANT TO GET DONE WITHOUT THE HELP OF THE FDA. BECAUSE, YOU KNOW, WE CAN'T DO OUR JOB ANYWAY WITHOUT THE HELP OF THE FDA AND MANY OTHER AREAS. SO THAT'S IMPORTANT. AND, YOU KNOW, I JUST -- ALL THROUGHOUT THIS I'VE BEEN WONDERING AND FOLKS AT THE FTC HAVE BEEN SAYING THIS IS REALLY FDA, WE'RE TALKING PUBLIC HEALTH AND SAFETY HERE, AREN'T WE? WHY SHOULD WE BE CONCERNED ABOUT MARKETING. I HAVE A DECENT RESPONSE FOR THEM, BUT IT'S NOT A COMPLETE RESPONSE, BECAUSE THEY'RE LIKELY TO FEEL JUST THAT WAY, THAT IF THE COMMITTEE'S CONCERN IS PUBLIC HEALTH AND SAFETY, THEN DARN IT, THE ACT SHOULD COVER THEM. BUT, YES, I DO FEEL THAT A RESOLUTION IS IMPORTANT BECAUSE THE FTC AT SOME POINT SHOULD BE INVOLVED AND MAYBE IN THE NEAR FUTURE AND THIS RESOLUTION WILL HELP GET IT ON THE FTC'S RADAR SCREEN AND SO I'M IN FAVOR OF IT.

TAKING MATT'S COMMENT, WOULD IT BE APPROPRIATE IF WE DECIDE TO MOVE FORWARD WITH THIS, WITH JUST KEEPING TRACK OF THESE THINGS AS THEY COME UP TO CHANGE THE FIRST BULLET UNDER THE RESOLUTION, DIRECT THE FDA TO MONITOR THE PUBLIC HEALTH AND SAFETY IMPACT OF THE MARKETING OF GENETIC TESTS UNDER ITS STATUTORY AUTHORITY? IS THAT SOMETHING THAT WOULD MORE ACCEPTABLE, ELIZABETH?

I DON'T KNOW THAT WE HAVE ANY STATUTORY AUTHORITY RIGHT NOW. BUT IF YOUR INTENT IS TO CHANGE THE ACT, THEN POSSIBLY, YES.

WELL, OUR CONCERN IS FOR THE -- THE PUBLIC HEALTH AND SAFETY. THAT'S WHY WE DECIDED TO MOVE FORWARD WITH THIS RESOLUTION AND WE FELT THAT IT COULD NOT WAIT FOR THE IN-DEPTH STUDY.

YEAH, I -- I UNDERSTAND THAT. HOWEVER, AT THE MOMENT, LAB-DEVELOPED GENETIC TESTS ARE CONSIDERED TO BE PRACTICE OF MEDICINE, OR A SERVICE AND WE DON'T REGULATE THE PRACTICE OF MEDICINE OR SERVICES. AND SO THE ACT EITHER WOULD HAVE TO BE CHANGED OR SOMEONE ELSE -- SOMEONE'S MIND WITHIN THE FDA WOULD HAVE TO BE CHANGED IN ORDER TO MIKE -- GIVE US OVERSIGHT.

IS A BETTER WAY TO GO THEN TO SAY DIRECT THE CDC TO MONITOR THE PUBLIC HEALTH AND SAFETY IMPACT OF MARKETING OF GENETIC TESTS? I MEAN THAT'S FDA IF THIS ISN'T GOING TO BE HELPFUL TO FDA AND IF WE'RE CONCERNED ABOUT THE PUBLIC'S HEALTH, THEN, PERHAPS, WE MOVE IT TO LOOK AT ANOTHER AGENCY.

PLEASE, PAUL.

WELL -- GO AHEAD, PAUL AND THEN WE'LL GO DOWN THE LIST HERE.

I MEAN, THIS IS NOT PARTICULARLY MY AREA, BUT IN LISTENING TO THE CONVERSATION, TWO THINGS SORT OF STRIKE ME, ONE, IS THAT IF THERE IS -- THAT, ONE, WHAT YOU MIGHT THINK ABOUT DOING IS IF THE FDA IS AN HHS AGENCY, IS THERE A WAY TO -- AND THE FDA IS NOT SORT OF EMBRACING REGULATORY -- YOU KNOW, SORT OF REGULATORY AUTHORITY IN THIS AREA, IS THAT WITHIN THE SECRETARY'S PURVIEW TO DIRECT -- TO INTERPRET THE STATUTE IN SUCH A WAY THAT THE FDA DOES HAVE REGULATORY AUTHORITY? IS THERE ENOUGH LEEWAY WITHIN THE STATUTE AND, IN FACT, THAT WOULD BE AN ACTION RIGHT RESOLUTION TO SAY THAT WE RECOMMEND TO THE SECRETARY THAT THE FDA BE USED IN THIS WAY, BECAUSE THERE IS A HEALTH AND SAFETY ISSUE, THERE'S A GAP AND WE THINK THAT THE SECRETARY SHOULD INTERPRET THE FDA -- THE STATUTE -- THE ENABLING STATUTE IN THAT WAY. I'M NOT SURE SORT OF THE AUTHORITY OF THAT. THAT MAY BE ONE PATH TO GO DOWN OR ONE ROAD MAP TO GO DOWN, SO TO SPEAK. THE SECOND THING IS IF, IN FACT THERE IS NO LEEWAY AND THE FDA IS ENABLING STATUTE, THEN WOULD STRIKE ME THAT THAT IS SORT OF THE PROBLEM, THEN THAT WOULD, IN A SENSE BE A RECOMMENDATION FOR THE SECRETARY TO SORT OF ENGAGE IN A LEGISLATIVE AGENDA TO CHANGE THE STATUTORY AUTHORITY OF THE FDA TO GET THEM ENGAGED IN THAT, SUCH THAT THE FDA IS CLEARLY -- SO THAT THE FDA WOULD CLEARLY HAVE JURISDICTION OVER THESE ISSUES WHICH I THINK IS THE SENSE OF THIS COMMITTEE, AND WOULD ENABLE FTC AND FDA TO WORK -- YOU KNOW, TO WORK IN -- AND SO THAT THE ISSUE DOESN'T FALL THROUGH THE CRACKS.

AND AN IMMEDIATE REPLY TO THAT, I THINK THAT A WAY TO COMMUNICATE THAT IS IN THE SECOND PORTION OF THE FIRST BULLET, TO EXPLORE THE POTENTIAL NEED AND WAY