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Personalized Medicine Advocates Urge New HHS Secretary to 'Strike the Right Balance' in Regulating Genetic Tests

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More than 100 proponents of personalized medicine have issued a letter to the new Secretary of the Department of Health and Human Services Kathleen Sebelius asking her to "get personalized medicine right" by "creating and implementing a reasonable and responsible regulatory framework" for genetic tests and other advanced medical diagnostics.

Signatories of the letter are asking the HHS Secretary to develop "a new regulatory framework" for oversight of advanced diagnostics, including in vitro diagnostic test kits and lab-developed tests.

The letter emphasizes that oversight of new personalized diagnostics should "strike the right balance between assuring patient safety and embracing policies that encourage the incorporation of rapidly advancing scientific methods and knowledge."

It further recommends that Sebelius embrace policies that "encourage the incorporation of rapidly advancing scientific methods and knowledge" and urges development of guidelines that are "clearly stated and publicly vetted" before they are implemented.

The letter was signed by a diverse coalition of personalized healthcare advocates, including diagnostics firms, genetic testing laboratories, patient advocates, and disease groups. The effort was organized by the Genetics and Public Policy Center at Johns Hopkins University and the Coalition for 21st Century Medicine, two organizations that have been strongly urging the US Food and Drug Administration to take a risk-based approach toward regulation genetic tests.

Currently, the regulatory environment for genetic tests, particularly for laboratory-developed genetic tests, is in flux. The FDA has expressed its intent to regulate a complex subset of LDTs, called in vitro diagnostic multivariate index assays. The agency has held a public hearing on the topic and issued two draft guidances, one in 2006 and another in 2007, on the regulation IVDMIAs, all of which have stirred up controversy and debate within the genetic testing industry [see PGx Reporter 08-01-2007].

As it stands, test developers can take one of two pathways to bring a genetic test to market. Test developers can get certification through the Centers for Medicare & Medicaid under CLIA for laboratory-developed tests or they can get clearance from the FDA to market test kits that are deemed high risk. FDA has traditionally practiced "enforcement discretion" for LDTs, leaving them under the purview of CMS. However, since IVDMIAs fall into the Class II or Class III category for high-risk devices, they must be cleared through the FDA, the agency has said.

The FDA has not yet provided a timeline for when it plans to issue a final IVDMIA guidance, however, and as the regulation of genetic tests continue to evolve, personalized medicine stakeholders are certainly not united in their view how best to move ahead.

On the one hand, laboratory test developers criticize FDA's approach as piecemeal, confusing, and overly burdensome to the point of deterring innovation. On the other hand, pharmaceutical companies and diagnostic test developers that have taken tests through FDA's regulatory process demand a more equitable oversight policy where the agency clears all genetic tests.

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Taking the opposite view of the GPPC and the Coalition for 21st Century Medicine, drug maker Genentech filed a Citizen Petition in December, urging the FDA to regulate all predictive LDTs and take a more consistent approach to regulating in vitro diagnostics [see PGx Reporter 12-17-2008].

Among the more than 100 signatories, no major pharmaceutical companies signed the letter to the HHS Secretary.

The HHS Secretary's Advisory Committee on Genetics, Health, and Society finalized a report last year on the regulation of genetic tests, recommending FDA exercise regulatory oversight over all LDTs. In the report, SACGHS also suggested HHS create a mandatory, web-based registry for all LDTs as one of the main vehicles for improving federal oversight of genetic tests [see PGx Reporter 05-28-2008].

Although GPPC is not a proponent of FDA regulating all LDTs, the letter to the HHS Secretary echoed SACGHS' recommendation to establish 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."

According to the letter, the SACGHS group offered "many thoughtful recommendations," but it 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 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."

CMS 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.

The group also said that Sebelius should move beyond where former HHS Secretary Michael Leavitt had taken personalized medicine policy. "We believe that now is a critical time to move to the next stage to create and implement a reasonable and responsible regulatory framework for advanced diagnostic tests," the letter states.

Leavitt commissioned SACGHS in 2007, which has made recommendations on diagnostics oversight policies and issued a report on advancing personalized medicine research.

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