FDA Taps Chief
For Drug Center
Amid Scrutiny
By ANNA WILDE MATHEWS
March 11, 2008; Page B10
The Food and Drug Administration said former drug-center head Janet Woodcock will return to that post on a permanent basis.
Dr. Woodcock's second stint in the job, which she has held on an acting basis since September, is likely to be generally welcomed by the drug industry. Though she is seen as tough, she is a seasoned hand, having begun her previous directorship of the FDA's Center for Drug Evaluation and Research in 1994. In 2005, she was appointed a deputy commissioner at the FDA, later adding the title of chief medical officer.
Dr. Woodcock, 59 years old, will relinquish both positions, an FDA spokeswoman said.
Because she is an architect of the FDA's current approach to drug regulation, industry officials don't view her as likely to attempt wholesale reversals.
Still, Dr. Woodcock, an internist and rheumatologist, will take back her former job at a challenging time, overseeing major transitions at the center.
Her first and biggest task will be to implement a major law passed last year that will require the hiring of hundreds of new staffers and the drawing up of procedures to implement new authority over drugs already on the market. Under the new law, the FDA is able to take various actions if it believes a drug carries a potential safety concern, including requiring new studies and limiting distribution.
Dr. Woodcock will also take over as Congress has the FDA under particularly close scrutiny. A number of outside groups have said the agency needs more funding and changes in its culture and approach. Some drug-industry officials have ramped up their public venting of concerns that the FDA has become too risk-averse in its approvals, slowing the arrival of new treatments.
Among the congressional investigations focused on the agency are probes into its handling of the Sanofi-Aventis SA antibiotic Ketek and the safety of heparin, the blood-thinner that has been linked to hundreds of allergic reactions and some deaths.
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