FDA Names Woodcock As Permanent Director Of CDER; Leavitt Releases Documents To Avoid Contempt Charges

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Medical Malpractice / Litigation
Article Date: 12 Mar 2008 - 10:00 PDT

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FDA on Monday named Janet Woodcock, deputy commissioner and chief medical officer at the agency, as director of the Center for Drug Evaluation and Research, which reviews new medications for safety and effectiveness, USA Today reports. Woodcock has served as acting director of CDER since October 2007, according to FDA spokesperson Heidi Rebello (USA Today, 3/11). She will relinquish her current two positions, an FDA spokesperson said.

As director of CDER, Woodcock will oversee the implementation of a 2007 law that requires FDA to hire hundreds of new staffers and develop procedures to implement increased authority over medications after they reach the market. Woodcock previously served as director of CDER from 1994 to 2005.

The appointment of Woodcock as director of CDER "is likely to be generally welcomed by the drug industry," as "she is seen as tough" but has "a seasoned hand," according to the Wall Street Journal. In addition, because Woodcock "is an architect of the FDA's current approach to drug regulation, industry officials don't view her as likely to attempt wholesale reversals," the Journal reports (Wilde Mathews, Wall Street Journal, 3/11).

Leavitt Agrees To Release Documents
HHS Secretary Mike Leavitt has reached an agreement with leaders of the House Energy and Commerce Committee to release documents used to prepare congressional testimony for FDA Commissioner Andrew von Eschenbach about the antibiotic Ketek in an effort to avoid contempt charges, according to a committee aide, CongressDaily reports (CongressDaily, 3/11).

In February, committee leaders said that the Bush administration failed to comply with a subpoena for the documents and that they might hold Leavitt in contempt as a result. During a hearing held by the House Energy and Commerce Oversight and Investigations Subcommittee in March 2007, von Eschenbach testified about issues related to FDA approval of Ketek, which reports have linked with a number of serious side effects (Kaiser Daily Health Policy Report, 3/3).

Last week, committee leaders outlined the conditions for an agreement in a letter to Leavitt. The agreement will allow committee staff to view the briefing book in HHS offices and interview FDA employees (CongressDaily, 3/11).

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