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Personalized Med Backers Make Suggestions for New HHS Secretary

NEW YORK (GenomeWeb News) – The new Secretary of the Department of Health and Human Services Kathleen Sebelius was welcomed to Washington, DC, last week with a call from over 100 members of the personalized medicine community to implement policy changes that will advance diagnostic and pharmacogenomic technologies.

In a letter signed by businesses, patient advocacy groups, and researchers, the Genetics and Public Policy Center at Johns Hopkins University and the Coalition for 21st Century Medicine jointly asked the new secretary to develop "a new regulatory framework" and to only put in place oversight policies that are "clearly stated and publicly vetted" beforehand.

In the letter, the GPPC said it is critical that oversight of new personalized diagnostics "strike the right balance between assuring patient safety and embracing policies that encourage the incorporation of rapidly advancing scientific methods and knowledge."

Specifically, GPPC seeks oversight of advanced diagnostics, including in vitro diagnostic test kits and lab-developed tests. The oversight should be risk-based and should be "based on an expanding base of advanced scientific capacities" at HHS agencies and in collaborations with extramural experts. The Food and Drug Administration can only "strike the essential regulatory balance" if it conducts a formal notice and comment rulemaking process.

HHS also should create a mandatory registry that would include the names of labs performing specific tests, the names of the labs or makers that develop tests, and information "to support claims about the analytical validity and clinical validity of that specific test or test method."

The group also called for the strengthening of oversight rules in CLIA clinical lab quality systems to assure that information from advanced diagnostic tests is "accurate, reliable, and timely."

The Centers for Medicare and Medicaid Services and FDA should "avoid unnecessary duplication in oversight and reconcile any conflicts in regulation between the medical device rules and regulations under CLIA," it said.

GPPC also said that Sebelius should move beyond where former HHS Secretary Michael Leavitt had taken personalized medicine policy. Leavitt commissioned the Secretary's Advisory Committee on Genetics, Health, and Society in 2007, which has made recommendations on diagnostics oversight policies.

GPPC, which said the SACGHS group offered "many thoughtful recommendations," also said that any new framework "must put patients first, be grounded in science, appropriately incentivize innovation, and be fully consistent with established statutes."

The range of groups that joined in supporting the letter indicates "a level of consensus" that will help lay the "critical foundation for personalized medicine," GPPC Director Kathy Hudson said in a statement.

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