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HHS Will Not Renew SACGHS Charter, Ending Committee's Decade-Long Tenure in October

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Originally published Sept. 23.

By Turna Ray

After a final meeting in October, the HHS Secretary's Advisory Committee on Genetics, Health, & Society will be no more.

According to a notice from SACGHS this week, the committee's charter, slated to expire Sept. 23, will not be renewed by HHS Secretary Kathleen Sebelius.

"In reviewing the SACGHS charter and body of work, the NIH Director [Francis Collins] and Secretary [Sebelius] recognized and appreciated that the major topics related to genetic and genomic technologies had been successfully addressed by the committee through its comprehensive reports and recommendations issued over the years," wrote Sarah Carr, SACGHS executive secretary, in an e-mail to committee members yesterday. "Thus, they have decided to sunset the committee’s charter."

In ending SACGHS' tenure, which started in 2002 as the HHS Secretary's Advisory Committee on Genetic Testing, Sebelius and Collins decided to extend the committee's charter for six months in order to hold a final meeting slated for October and to wrap up its administrative and record-keeping duties.

For the meeting scheduled October 5-6 in Washington, DC — during which Collins is expected to make an appearance — the committee plans to put to bed a report on genetics education and training, as well as have a last round of presentations and discussions on topics for which it had planned to issue recommendations: clinical utility and comparative effectiveness research; implications of affordable whole-genome sequencing; and genomic data sharing. It is currently unclear where the separate SACGHS task forces stand in terms of drawing up recommendations for these issues. But committee members have been discussing and working on these topics for the larger part of this year.

In the decade of its operation, SACGHS addressed topics critical to the advancement and adoption of genetic technologies and information, and is known for issuing long and dense reports on the issues that it takes up, such as pharmacogenomics research, coverage and reimbursement of genetic technologies, and oversight of genetic technologies.

Many of the committee's proposals have effected changes in the way the safety and efficacy of genomic technologies are assessed and tracked by the government. For example, in a 276-page report on the federal oversight of genetic tests, SACGHS was the first to suggest HHS develop a genetic testing registry as a way to keep a publicly available log of the slew of new tests coming to market (PGx Reporter 05/28/08). In March, NIH said it would launch a voluntary genetic test registry by 2011 (PGx Reporter 03/24/10).

Additionally, SACGHS told FDA in 2008 that it should extend its oversight over all genetic tests. This year, the FDA said it is ending its longstanding practice of "enforcement discretion" over LDTs (PGx Reporter 06/16/10).

During its tenure, the committee has also managed to spark controversy by taking unpopular positions on topics of broad public significance in the genomics field.

For example, in March, a federal district court invalidated several gene-association patents held by Myriad Genetics, which, if held up in higher courts, could end the longstanding practice of patenting genes US. Several months before that landmark court decision came out, SACGHS sent a highly controversial report to Sebelius, recommending the HHS Secretary support and work with the Secretary of Commerce to promote statutory changes that would exempt from infringement liability anyone developing or selling a test based on patent claims on genes.

There were several dissenting opinions within SACGHS' membership to this recommendation, and groups like the Biotechnology Industry Organization condemned the report publicly as being anti-innovation. Recognizing that there may be significant opposition to carrying out its recommendation, the committee also proposed intermediary measures, such as urging academia and industry to practice ethical licensing practices, and clarifying whether the Bayh-Dole Act gives agencies the power to influence how patent holders license their inventions (PGx Reporter 10/14/09).

In her letter, Carr recognized SACGHS' accomplishments, saying: "You have addressed all the major areas outlined in your charter and provided advice on a range of complex issues raised by new technological developments in human genetics, advice that is now coming to fruition through increased interagency collaboration and implementation of several SACGHS recommendations. Moreover, you produced a body of work that will provide a lasting framework for addressing new developments in the ongoing integration of genetics into clinical practice and public health."

Collins plans to hold a call with committee members today to "explain why he and the Secretary believe that the committee has accomplished its mission and to discuss the decision to let the charter sunset."

In response to the news that the committee's charter will expire in six months, Sheila Walcoff, a SACGHS member and a partner at the law firm McDermott, Will & Emery, said she was honored to have served on the panel.

"I believe it has advanced the debate on key issues related to genomics and personalized medicine that will influence the development of the future of health care and research in a meaningful way," Walcoff said.

The Personalized Medicine Coalition, which over the years has worked with SACGHS on a number of key issues, also commended the work of the committee.

"SACGHS did a lot of good work and released a number of good recommendations," said Amy Miller, public policy director of the PMC. "We should look back and implement recommendations that will move personalized medicine forward."

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