FDA’s Woodcock to Head Drug Center Permanently

-Wall Street Journal

03/10/2008 - The FDA is going to put acting drug-center head Janet Woodcock in the post permanently, people with knowledge of the matter told the WSJ.

Woodcock’s return to the job, which she’s held in an acting capacity since September, is likely to be generally welcomed by the drug industry. Though she’s seen as tough, she’s also a seasoned hand, having begun her previous stint as director of the FDA’s Center for Drug Evaluation and Research in 1994.

Three years ago, she was formally appointed a deputy commissioner. Because she’s an architect of the FDA’s current approach to drug regulation, industry officials don’t view her as likely to attempt wholesale reversals of agency policy.

Still, Woodcock, an internist and rheumatologist, will take back her former job at a challenging time, overseeing major transitions in the center. Her first and biggest task will be to implement a major law passed last year by Congress, which will require the agency to hire hundreds of new staffers and figure out how to implement a raft of new powers.

The agency is also in the hot spotlight of Congress. Among the open congressional investigations focused on the agency currently are probes into its handling of the Sanofi-Aventis antibiotic Ketek and the safety of heparin, the blood thinner that’s been linked to hundreds of allergic reactions and some deaths. The House Energy and Commerce Committee is particularly focused on how the FDA failed to initially inspect a Chinese facility that was making active ingredient for some heparin that has now been recalled.

In an early signal of Woodcock’s likely middle-of-the-road approach to implementing the new law, the FDA has already unveiled new plans called “Safety First” and “Safe Use” that are intended to bolster the drug center’s focus on the safety of drugs after they are on the market.

Why Should FDA Regulate Drugs? Janet Woodcock explains the rationale in this interview with FDA Consumer magazine.

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