[Oct 12, 2005]
A bipartisan group of 62 U.S. legislators is urging acting FDA Commissioner Andrew von Eschenbach to approve Barr Pharmaceuticals' emergency contraceptive Plan B for nonprescription sales, according to a letter made public on Tuesday, Reuters reports (Reuters, 10/11). 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, 10/7). In a letter dated Oct. 7, the lawmakers wrote, "By further delaying the FDA's decision to expand access to emergency contraception, you are seriously hindering efforts to reduce abortions across the U.S.," calling on von Eschenbach to approve Plan B "without further delay." The group, which includes six Republicans and one Independent, also wrote, "We find it contradictory and disconcerting that the FDA's concerns are a direct result of the agency's own recommendations last May," adding, "We believe this new delay does not truly reflect valid scientific or regulatory concerns" (Reuters, 10/11).
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