The Baltimore Sun on Thursday examined advocacy groups' lobbying efforts to influence... FDA's decision on Barr Laboratories' application for nonprescription sales of its emergency contraceptive Plan B, which can prevent pregnancy if taken within 72 hours of sexual intercourse (Rockoff, Baltimore Sun, 8/25). 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 to women ages 17 and older only. HHS Secretary Mike Leavitt in July in a letter to Sen. Mike Enzi (R-Wyo.), who chairs the Senate Committee on Health, Education, Labor and Pensions, said FDA will make a decision on Barr's application by Sept. 1 (Kaiser Daily Reproductive Health Report, 7/19). Supporters and Opponents of the application recently have "stepped up" their efforts to influence the decision, including urging supporters to contact the White House and FDA Commissioner Lester Crawford, the Sun reports. Both sides use science to support their position -- supporters say the drug has been proven safe and effective, while opponents say studies have not looked at the drug's long-term effects or impact on teen girls -- but also "emphasiz[e] positions with crossover appeal," according to the Sun. Supporters say approval of Plan B would reduce the number of abortions and opponents say it would increase the spread of sexually transmitted diseases. FDA spokesperson Suzanne Trevino said, "We value public input, but we make our decision based on science" (Baltimore Sun, 8/25).

Baltimore Sun

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