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FDA Looks to Open Up the Medicine Cabinet
The Food and Drug Administration Transparency Task Force held the first of its two public meetings for public recommendations on how to increase transparency in decision making yesterday. At the meeting, Kristi Zonno, Director of Genetics and Health Policy at the advocacy group Genetic Alliance called for FDA to create a public registry of “genetic, genomic, and pharmacogenomics testing available to the U.S. market,” as well as make warning letters to pharmaceutical companies public in real time.
A public registry would give patients, their doctors, and their parents access to information essential to making informed decisions about genetic testing, Zonno said. It should include the name of the laboratory performing tests, the name of the test developer, and facts about the test’s ability to enhance existing care.
Genetic Alliance suggested that the National Center for Biotechnology Information maintain the registry and that the FDA oversee it so information could be combined with other genetic resources. One such resource already available from the NCBI, GeneTests, provides “current, authoritative information on genetic testing and its use in diagnosis, management, and genetic counseling.” A public registry with the characteristics Zonno recommended would be more comprehensive than the current GeneTests system.
When FDA sends warning letters to pharmaceutical companies, only some are made public. After FDA released a group of these letters last year, former CAP senior fellow Rick Weiss wrote that although the “rare bit of transparency” was good news, the delay in disclosure leaves time for patients and physicians to be affected by the companies’ “bold twists of truth.” In a warning letter to Novartis Pharmaceuticals concerning the ADHD drug Focalin XR, FDA warned Novartis to remove the claim that the drug’s benefits are sustained for over six months since the effectiveness of Focalin XR had never been studied beyond seven weeks. Over at TechPresident, Nancy Scola considers a new open document management project, DocumentCloud, that could support this sort of transparency.
The Transparency Task Force, formed in January to address the Obama Administration’s Transparency and Open Government agenda, is led by FDA deputy commissioner Joshua Sharfstein. The task force is considering all views including supporters of strong trade secret protection and a comprehensive report will be submitted to FDA commissioner Margaret A. Hamburg in five months.
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