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Second FDA Official Resigned Over Plan B Delays

A second official at the Food and Drug Administration has announced that he resigned in September, due to delays in approving the emergency contraceptive Plan B for over-the-counter status. Dr. Frank Davidoff, internal medicine specialist and editor emeritus of Annals of Internal Medicine, served a four-year term on the Nonprescription Drugs Advisory Committee and was part of the panel’s initial vote to approve Plan B for over-the-counter status. Since his term ended earlier this year, he has been consulting for the Committee.

He first considered resigning in May 2004, when the FDA declined Plan B’s application, reports the Hartford Courant, but told the Associated Press that the most recent delay, on August 26, “crossed a line for me.” In his letter of resignation, Reuters reports that Davidoff wrote, “I can no longer associate myself with an organization that is capable of making such an important decision so flagrantly on the basis of political influence, rather than the scientific and clinical evidence.”

Dr. Susan Wood, Director of the FDA Office on Women’s Health, resigned for similar reasons in August. Wood told the Hartford Courant that the circumstances around Plan B demonstrate “the dangers of politicizing the drug-approval process,” and Davidoff said that the FDA staff is “demoralized and depressed,” and that the Plan B delays risk the future credibility of the FDA.

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Sources:

Associated Press 10/6/05; Hartford Courant 10/2/05; Kaiser 10/7/05; Physicians for Human Rights; Reuters 10/7/05