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Genetic Alliance Asks FDA for Public Genetic Test Registry

NEW YORK (GenomeWeb News) – At a public meeting held by the US Food and Drug Administration in Washington, DC, today focused on ways to create more transparency in agency affairs, the advocacy group Genetic Alliance advised the FDA to host a registry for genetic tests and lab tests, and that it share all of its warning letters with the public.

FDA held the meeting to listen to recommendations from the public about how to make information about its activities more useful, understandable, and accessible.

In prepared statements, Genetic Alliance's Director of Genetics and Health Policy, Kristi Zonno, told the FDA group that integrating personalized, gene-based medical tools into medical practice "requires proactive and informed decision making … and access to reliable information is instrumental to this process."

Zonno said FDA should create a public registry for genetic tests to "enable transparency and promote informed decision making for consumers and providers." She said that registry "could and should include the myriad of genetic, genomic, and pharmacogenomic testing available to the US market."

Open to the public, the registry should at the very least include the name of the lab performing a test, the name of the test developer, and information to support the test's usefulness in obtaining results and improving clinical care, Zonno added.

The registry would have involvement and utility in oversight, quality, and education, and it would be a "gateway to information services," she continued.

Genetic Alliance believes that the registry should be overseen by FDA and be housed at the National Center for Biotechnology Information so that it could be integrated with other genetic resources.

Such a registry at NCBI and handled by FDA would provide answers to questions for patients, doctors, and others about a diagnosis or prognosis, the risk of developing a condition or of having a child with a specific condition, the optimal treatment, or the predicted benefit.

Zonno also called on FDA to institute a policy of immediately releasing all of its warning letters, including those issued to industry but which are not always made available to the public. "Patients and physicians should know who is getting letters from the FDA and why, and this information should be available in real time," Zonno advised.

All public meetings and information from them should be archived and maintained for easy access by the public, she proposed.

Zonno also recommended that when citizen's petitions are filed they should be made public and posted on the agency's website in an "easily accessible" manner, and any responses to them or actions taken should be made public.

The public meeting was held by FDA's Transparency Task Force, which began forming in January in response to the Obama Administration's Transparency and Open Government agenda.

The task force will develop recommendations about transparency and public accessibility and will use public input to develop those recommendations.

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