Consultant, Former Member of FDA Advisory Panel Resigns Over Handling of Plan B Application

A consultant and former member of FDA's Nonprescription Drug Advisory Committee, Frank Davidoff, has resigned in protest of the agency's action to indefinitely postpone a decision on Barr Laboratories' application for nonprescription sales of its emergency contraceptive Plan B to women ages 17 and older, the AP/San Jose Mercury News reports. Davidoff, editor emeritus of the Annals of Internal Medicine, was a member of the advisory panel when it voted to recommend approval of Plan B for nonprescription sales in 2003 (AP/San Jose Mercury News, 10/6). FDA in May 2004 issued a "not approvable" letter in response to Barr's original application to allow Plan B to be sold without a doctor's prescription and in January delayed a ruling on Barr's revised application, which would allow EC to be sold without a doctor's prescription only to women ages 17 and older. Former FDA Commissioner Lester Crawford at a press conference in August opened a 60-day public comment period on Barr's application and said that science supports giving nonprescription access to Plan B to women ages 17 and older but added that the application presented FDA "with many difficult and novel policy and regulatory issues," including how to keep girls age 16 and younger from obtaining the drug (Kaiser Daily Women's Health Policy Report, 9/26). Davidoff said that FDA is favoring politics over science in delaying approval of the drug for nonprescription sales, adding, "There wasn't any observable scientific or procedural reason for them to first decline and then further delay the decision. ... [I]t seemed to me that [this] was unacceptable." Davidoff, who resigned in September, had served as a consultant to the committee since his term ended earlier this year. He is the second person to publicly leave FDA over the Plan B decision (AP/San Jose Mercury News, 10/6). Former FDA Assistant Commissioner for Women's Health Susan Wood in late August resigned her position (Kaiser Daily Women's Health Policy Report, 9/1).


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