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The Murky Regulatory Arena of Genetic Testing

The FDA has undertaken several measures to make the regulatory process less burdensome for diagnostics companies, but these may not be enough to incentivize companies to take their new genetic tests through the approval process. At the same time, confusion reigns: a special HHS advisory committee on genetic testing has been disbanded, and the FDA is reviewing its jurisdiction to regulate home brews, which are the dominant route to commercialization for genetic tests. Some critics worry that these developments may stifle innovation and companies are waiting for clarity.

It's been a big quarter for organizational changes at the US Food and Drug Administration: a new candidate for Commissioner, the consolidation of some CBER functions into CDER (see "A New Commissioner and Revamped Review Process for the FDA," in this issue Also see "An FDA Nominee, Biologics Reviews Move to CDER" - In Vivo, 1 October, 2002.), and now a new office to handle approval and monitoring of in vitro diagnostic devices.

The new diagnostics group will consolidate all IVD-related functions, including premarket, compliance, and postmarket review activities—an effort intended to bring...

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