Lawmakers Debate Picks For FDA Chief; Possibilities Include Drug Safety Director Woodcock

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Sexual Health / STDs;  Women's Health / Gynecology
Article Date: 08 Dec 2008 - 0:00 PDT

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Debate over whether any current FDA officials should be named as successor to current FDA Commissioner Andrew von Eschenbach and how quickly the decision should be announced is dividing congressional officials, "reflecting a divergence of views ... on how to fix the FDA's problems," the Wall Street Journal reports. According to Congressional aides, Democratic officials have discussed naming Janet Woodcock, director of FDA's drug safety division, as commissioner, and individuals close to the pharmaceutical industry also have mentioned her as a possible pick after von Eschenbach's predicted departure.

The Journal reports that Woodcock has been "involved in several controversies" during her tenure with FDA, including over FDA's delayed approval of nonprescription sales of the emergency contraceptive Plan B amid political pressure. The agency as a whole has "come under fire from both parties in Congress in recent years for problems related to pharmaceutical safety," in which Woodcock, as drug safety director, has been involved, according to the Journal. Other controversies involving Woodcock include the 2004 withdrawal of the painkiller Vioxx and the recent contamination of the blood thinner heparin from Chinese ingredients.

Rep. Bart Stupak (D-Mich.) in a letter to President-elect Barack Obama on Wednesday called for a "complete change in the FDA's leadership" and "encourage[ed]" him to not appoint any senior FDA employees as commissioner. He said current senior officials are "too close with the industries they regulate, creating a question of who they are working for." The Journal reports that other possible appointees to the position include Joshua Sharfstein, head of the Baltimore Health Department, and Steven Nissen, chief of cardiovascular medicine at the Cleveland Clinic (Mundy, Wall Street Journal, 12/5).

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