Personalized Medicine Direct to Consumer Marketing And FDA

1. Personalized MedicineDirect to Consumer MarketingAnd FDA Margaret Foster Riley, JD University of Virginia School of Law May 30, 2008

2. Personalized MedicineHope or Hype? • As we have discussed over the last two days, personalized medicine offers great potential—but it’s far from fully realized • Even pharmocogenic success stories are “limited.” • Her2/neu testing • CYP450 testing • NEJM April 2009

3. Personalized MedicineHope or Hype? • NEJM April 2009 • Great majority of newly identified risk-marker alleles confer very small relative risks • Those relative risks are not stable estimates due to the likelihood of identification of new risk loci • But the potential for preventive therapies, geared to the right population, is beguiling • Some risk loci may already be more stable • Type 1 diabetes and HLA loci?

4. Personalized MedicineHope or Hype? • Once risk estimates are more stable, the usefulness of genetic screening will need to be considered for each disease, and recommendations about potential interventions for people whose predicted risk exceeds a specified threshold (Source: Kraft et al. NEJM April 2009) • Who will decide and how will that be decided?

5. Personalized Medicine • HHS and its subsidiary agencies, FDA, CMS etc., have long been aware of the critical questions that personalized medicine brings to the regulation of medical care and products—but little has actually been done • FDA’s “Critical Path Initiative” and NCTR’s Strategic Plan (March 2009) both focus on personalized medicine initiatives

6. FDA and Personalized MedicineThe Big Picture • Since 1962 FDA has regulated drugs—and since 1976—devices—requiring a showing of safety and efficacy • The question in some instances will become “safe and effective” for whom?

7. Personalized Medicine • Groups promoting personalized medicine have lobbied House Democrats hard regarding the Comparative Effectiveness Research Act of 2009 • Research would study how treatments affect people based on gender, race, age and medical conditions • Some argue that every clinical trial comparing clinical treatments should include DNA sequencing of every volunteer

8. Regulation of Genetic Testing • One of the great challenges of personalized medicine will be the development of “valid” testing—both for • Practitioners • And Consumers • Secretary’s Advisory Committee on Genetic Testing and GAO have recommended better regulation of genetic testing

9. Regulation of Genetic Testing • Many tests are already being commercially offered—not just to practitioners but also to consumers… • Is the horse already out of the barn?

10. Personalized Medicine • Those advocating inclusion of personalized medicine in health reform packages argue that it will allow targeted treatments, avoid unnecessary adverse events, and save money by treating only those who will benefit… • But can it possibly achieve those goals? • Does personalized medicine save money?

11. Regulators • CDC—to the extent involves public health • EGAPP • CMS—CLIA—with exceptions • FDA—to the extent fit within device regulation • FTC—advertising (although FDA plays a role) • NIH, HRSA and AHRQ support research and therefore regulate supported research

12. FDA regulation • Law as Architecture • FDA regulates products not practice • FDA has never defined “genetic test.” • FDA regulates genetic tests as devices—but not all genetic testing is subject to the device regulatory rubric • Devices are subject to different levels of control • 510K vs. PMA • Class 1-general controls • Class II • Class III

13. FDA Regulation • Some argue that genetic tests are no different from other laboratory tests and should be regulated like other laboratory tests • Others argue that genetic tests, although having great potential benefit, have potential to cause great harm without adequate assurance of safety and effectiveness. In some instances, these tests may be the sole basis for making a clinical decision with significant consequences • The majority of genetic testing is subject to no oversight to ensure that they are safe and effective

14. FDA Regulation • Genetic tests fit within the definition of in vitro diagnostics • General-purpose reagents • Analyte specific reagents (ASRs) • Test systems or test kits • ASRs are regulated as restricted devices • But regulatory compliance is poor • IVD test systems or test kits are manufactured for a specific laboratory test • have specific intended use

15. FDA Regulation • Laboratory Developed Tests • Based on an in-house protocol and assembled by the laboratory for its own use • While specific reagents may be directly regulated, FDA has not directly regulated LDTs • CLIA rules do not evaluate the safety and effectiveness of the individual tests performed

16. FDA Regulation • Tension in FDA regulation (or lack of) of LDTs: • Recognition that there is unpredictable quality and there may be a risk to public health • Mechanism for bringing novel, highly specialized tests, for relatively rare diseases • 2006 draft guidance attempted to regulate IVDMIAs • Characterized by proprietary algorithms that generate patient specific results based on multiple pieces of data

17. FDA struggles with the appropriate level of regulation • “FDA considered designating as Class III devices those ASR's that would be marketed independently for use in tests intended for use in overtly healthy people to identify a genetic predisposition to a dementing disease, or to fatal or potentially fatal medical disorders (e.g., cancers or Alzheimer's disease), in situations where penatrance is poorly defined or variable and latency is five years or longer. However, after reviewing the comments and currently available information, FDA has not yet identified criteria that would logically distinguish among genetic tests in order to determine which have the requisite impact to trigger more stringent controls.” • Source 62 Fed. Reg. 62,245-46

18. State Regulation • New York as a model • pre-market review process for genetic tests • Some better than none

19. Direct to Consumer Marketing • In 2002 Myriad Genetics launched the first major direct to consumer genetic testing campaign for BRACanalysis • Since then there has been explosion of sorts—in both print, television and especially, internet advertising

20. Some of the leading companies • 23andME • Navigenics • deCode Genetics • DNA Direct

21. Direct to Consumer Marketing • Some companies market clinically available tests for disorders such as hemochromatosis and cystic fibrosis • Some websites offer genetic tests for nutrition, behavior and aging. A consumer may be offered cosmetics or nutraceuticals based on her “genetic make up”

22. Direct to Consumer Marketing • Genetic tests are marketed not only for health risk information but for genealogy, studying ancestry and as tools for social networking

23. Sponsored Links • Personalized Medicine • www.ageofpersonalizedmedicine.org Learn about a new era of healthcare and improving patient health • Genetic Tests • www.DNAtesting.com/Genetic_Tests Purchase Genetic Tests Now available at a store near you! • Genetic Testing on Kids • www.ResponsibilityProject.com Do You Think It Is Responsible To Use Genetic Testing on Kids?

24. Matrix Genomics' founding mission is to empower you to enhance your life and life expectancy. Are you predisposed for developing breast cancer? Do you have an inherited risk for heart attack or Alzheimer's disease? A DNA home testing kit from Matrix Genomics—a personal genomics company—can identify your propensity for developing common hereditary health conditions, enabling you and your doctor to develop a personalized medicine plan for preventative care that's tailored to your DNA profile. By arming you with powerful knowledge about your genetic risk factors, Matrix Genomics brings the science of genetics from the lab to real life. Current Genetic Risk Assessment Tests Alzheimer's Disease» Breast Cancer» Heart Attack»

26. From 23andme Our customers are saying... "I thought how fascinating if I could know more about my future. I should know. I should be aware for myself. For my children. If there's something that I could prevent for the future, or live my life in a different way, why not learn? Why not help myself? And be knowledgeable in that information for my health and well-being." ~ Susan M.

27. Direct to Consumer Marketing • Advertisers vary as to whether they require a consumer to involve health care professionals or not • Even those that do, do not require expertise in genetic counselling

28. Arguments Posed Supporting DTC Genetic Testing • Genetic information is a “fundamental part of you” and people have a right to it • “It doesn’t say you have a disease…It says you carry a genetic predisposition for the disease and should talk with a health care professional” • Patients deserve direct access to their health information without a physician intermediary • Source: Magnus et al. Genome Medicine 2009

29. Consumer-Directed GenomicsOne View • An extra medical surveillance practice that has some preventive value and is complementary to traditional forms of health surveillance and patient care. • By engaging and educating people in their health care, they will be better served • The problem is not consumer-directed genomics itself, but establishing appropriate standards and practices for commercial providers

30. Consumer-Directed Genomicsand Another • Our ability to read the genome is well ahead of our ability to know whether medical intervention based on such a reading does more good than harm. • We can be sure that haphazard genetic testing will needlessly make well people worry about becoming sick. • We need more research, not pricey genomic scans.

31. FTC 2006 Consumer Notice • Warns against increased (especially internet) sales • But who reads it? • Should the FTC do more?

32. State Law Regulation • As of 2008, 25 state and the District of Columbia permit DTC laboratory testing without restriction; 13 states categorically prohibit it, 12 states (including New York and California) permit some testing—these likely do not include genetic testing—without medical supervision • California and New York have begun sending “cease and desist” orders to genetic testing companies

33. Free Speech Considerations • Regulations affecting commercial speech do not violate the First Amendment if:1. The regulated speech concerns an illegal activity, 2. The speech is misleading, or3. The government's interest in restricting the speech is substantial, the regulation in question directly advances the government's interest, and the regulation is narrowly tailored* to serve the government's interest. *The original Central Hudson test required that the government prove the regulation was no more restrictive of speech than necessary to serve its interest.

34. Questions of Liability • Learned Intermediary Doctrine