Wednesday, August 31, 2005
Last Friday, the FDA further delayed making a decision about Plan B, the emergency-contraception drug. Currently, seven states allow women access to the drug without a prescription, but approval by the FDA for distribution without a prescription would have national scope.
What is apparently surprising about the further delay is that the recently appointed head of the FDA personally pledged to resolve the status of Plan B by the first of September, and Sens. Patty Murray, D-Wash., and Hillary Rodham Clinton, D-N.Y. had blocked the appointment of the FDA head until Lester Crawford, the now-serving FDA head, made his pledge to Congress. The delay appears to directly violate his pledge.
Secondly, the FDA’s own scientists have recommended that Plan B be approved for non-prescription sales; the FDA appears to be ignoring their advice.
Today, the “highly regarded women�s health chief at the Food and Drug Administration” resigned in protest over the delay. She said:
“There�s fairly widespread concern about FDA�s credibility” among agency veterans as a result, Wood told The Associated Press hours after submitting her resignation Wednesday.
“I have spent the last 15 years working to ensure that science informs good health-policy decisions,” Wood, director of FDA�s Office of Women�s Health, wrote in an e-mail about her departure to agency colleagues. “I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended by the professional staff here, has been overruled.”
“It is time for the FDA to stop playing games with the health and well-being of millions of American women,” said Sens. Patty Murray, D-Wash., and Hillary Rodham Clinton, D-N.Y. “Day by day, the public�s confidence in the FDA�s ability to make decisions based on scientific evidence of safety and efficacy is eroding.”