HHS Pulls the Plug on Genetics Advisory Committee
The clock has run out the Secretary’s Advisory Committee on Genetics, Health, & Society (SACGHS). As reported by Turna Ray of Pharmacogenomics Reporter, the committee, which reports to Health and Human Services (HHS) Secretary Kathleen Sebelius, will have its charter extended only long enough to conduct one final meeting next month.
According to Ray, SACGHS members were notified this week that Secretary Sebelius and NIH Director Francis Collins had determined that “the major topics related to genetic and genomic technologies had been successfully addressed by the committee through its comprehensive reports and recommendations over the years” and, for that reason, the decision was made “to sunset the committee’s charter.”
A Decade of Discussion. The SACGHS was first established by HHS eight years ago (pdf) to “provide a forum for expert discussion and deliberation…on the range of complex and sensitive medical, ethical, legal and social issues raised by new technological developments in human genetics” and assist policymakers at HHS and other federal agencies in addressing those issues. The committee’s charter, which was last renewed in 2008 (pdf), includes “assessing how genetic technologies are being integrated into health care,” “examining current patent policy and licensing practices” and “analyzing uses of genetic information in education, employment, insurance…and law.”
Over the past eight years, as the range of genetic technologies and information has expanded dramatically, SACGHS has tackled all of these issues, along with many others. Some of the committee’s most significant undertakings included (1) repeated efforts to encourage the passage of the Genetic Information Nondiscrimination Act (GINA) (see here, here and here), (2) a 2008 report on the U.S. System of Oversight of Genetic Testing (pdf), (3) a 2010 report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests (pdf) and (4) a 2010 report on Direct-to-Consumer Genetic Testing (pdf).
Although advisory in nature, the committee’s activities have had a noticeable impact on genetic law and policy in recent years. While far from GINA’s only advocate, SACGHS’s continued support helped to ensure the law’s ultimate passage in 2008. The committee’s 2008 report on the regulation of genetic testing has been widely cited by lawmakers and policymakers, particularly those seeking to reform or extend the current system of oversight. Its 2010 gene patenting and licensing recommendations, along with coverage of the ongoing Myriad gene patent litigation, continues to spur public and private debate about whether and how to redesign the biotechnology patent regime. And its most recent report, on direct-to-consumer (DTC) genetic testing, while largely obscured by other contemporaneous developments within the DTC industry, may well serve as a roadmap for future industry oversight by the Food and Drug Administraton (FDA), Federal Trade Commission (FTC) and other regulatory bodies.
A Challenge for the Next Decade. The central role that SACGHS has played in analyzing the ever-expanding range of ethical, legal and social issues presented by genetic and genomic technologies, and in formulating policy suggestions to address those issues, makes the decision by Sebelius and Collins to disband SACGHS curious, to say the least. According to Ray, Collins was scheduled to provide a more complete explanation to the committee of “why he and [Secretary Sebelius] believe that the committee has accomplished its mission…” We hope that either Collins or Sebelius will choose to share their thinking more broadly.
No matter the rationale, it is clear that even those issues SACGHS investigated in detail have not been resolved with any meaningful degree of finality. GINA, while finally law, is still being implemented by regulatory agencies, and significant enforcement has yet to occur. Regulatory agencies have only recently begun to implement new policies (e.g., the NIH’s announcement that it is developing a voluntary Genetic Testing Registry and the FDA’s proposal to commence risk-based regulation of all laboratory-developed tests (LDTs)) designed to close the gaps in genetic testing oversight identified by SACGHS more than two years ago. The issues identified in the committee’s two most recent reports – on gene patents and DTC genetic testing – have yet to be meaningfully addressed by federal agencies, and represent some of the most contentious issues in genetics law and policy today.
What’s more, the pace of technological development is not slowing and it is difficult to see how anyone could suggest that SACGHS has sufficiently investigated all or even a majority of the important issues attendant to genetic technologies. Coming advances in genomic sequencing promise to make genetic data increasingly inexpensive and available, bringing to the fore new questions about genomic privacy, reproductive genetic technologies and access and affordability, along with many others, including crucial issues we cannot predict today. Indeed, SACGHS recently formed a task force to study the implications of whole-genome sequencing, although it is unclear whether the committee will have the opportunity to pursue that investigation to its conclusion.
In the eight years since SACGHS’s inception, we have seen significant scientific advances, and these have in turn produced an impressive range of associated ethical, legal and social issues. As we head into a second decade of increasingly personal genomic science and services, there is every reason to expect that as our technological capabilities expand, so too will the number and complexity of issues we are forced to address. Our challenge is to continue to develop legal and policy strategies that are reflective and not reactionary – strategies that ensure the safety of individuals while encouraging the innovation necessary to realize the promise of personalized medicine. We hope that the announced disbanding of this experienced and distinguished committee does not signal a declining commitment on the part of Secretary Sebelius or Director Collins to this challenge.
Mission accomplished? I’ve heard that before.
Am I the only one disturbed by the insinuation that the challenges the SACGHS was charged with addressing have been resolved? According to the preface of SACGHS’s latest report, here are the main functions the committee was to serve:
• Assessing how genetic and genomic technologies are being integrated into health care and public health;
• Studying the clinical, public health, ethical, economic, legal, and societal implications of genetic and genomic technologies and applications;
• Identifying opportunities and gaps in research and in data collection and analysis efforts;
• Examining the impact of current patent policy and licensing practices on access to genetic and genomic technologies;
• Analyzing uses of genetic information in education, employment, insurance, and law; and
• Serving as a public forum for discussion of issues raised by genetic and genomic technologies.
Perhaps (I hope) there are other plans in the works that have not yet been announced, so that appropriate resources are set aside and scholars with multidisciplinary expertise are able to address these challenges adequately. While focusing efforts on GWAS and sequencing research may be fruitful in cultivating personalized medicine, the “other” matters (ethical, legal, social, economic, and political implications) will only compound when left unattended.
Dan – Could not agree more…very strange decision! There must be another way they plan to approach these issues structurally…as the challenges have only increased since SACGHS was formed…
This decision is not surprising.
FDA is making a big power grab and wants to assert total authority over LDTs and EHRs. SACGHS is a wild card and could have made off message statements, so they must be silenced. Collins already got a horsehead in his bed and was forced to knuckle under by co-signing the recent NEJM article with Hamburg.
Margaret Hamburg and Jeffrey Shuren have been doing all kinds of political maneuvering to make this happen. Somehow FDA is posting massive budget increases while every state government feels the hurt.
Taking over LDTs and EHRs is a big win for Shuren. CDRH has long been thought of as the kid brother of CDER and CBER because it is younger and because PMAs cost “only” $150 million while NDAs/BLAs cost drug & biologics companies $800 million+.
But if Shuren can successfully take control of all laboratory developed tests and electronic medical records, suddenly CDRH vaults past even CDER in economic impact. And Hamburg can justify yet more budget increases.
In all this there is little or no concern about the consumer. It is just about raw power, what public choice economists call entrepreneurial bureaucratic activity. Hamburg and Shuren’s overweening political ambitions will have devastating consequences for American health care.
For those that are interested, the email announcing the final SACGHS meeting is available here. According to the email, SACGHS has “addressed all the major topics delineated in its charter” and “fufilled its mandate.”