The long-awaited deadline was unveiled in a letter sent by Michael Leavitt, secretary for the Department of Health and Human Services, to high-ranking senators. The news prompted two Democratic senators — Patty Murray of Washington and Hillary Rodham Clinton of New York — to announce Friday that they would allow a vote on the confirmation of Lester Crawford as commissioner of the Food and Drug Administration (search).
The two had placed a hold on the nomination because of the lack of a decision on the pill, which is also called Plan B (search).
"After more than two years of waiting, American consumers and American women will finally get an answer," the two Democrats said.
An FDA advisory committee recommended in December 2003 that Plan B be approved for over-the-counter sales. The vote was 24-3.
Later, however, the FDA overruled that recommendation, citing concern about the pills' use by young teenagers
Maker Barr Laboratories filed a second application to address those concerns; the agency still has not ruled.
Opponents of making the pill more readily available argue that such access could lead some young teens to have sex, leaving them more vulnerable to sexually transmitted diseases (search).
Supporters of making Plan B available over the counter said the drug would help women prevent unintended pregnancies and reduce the need for abortions, but to make a real difference, women need to be able to get it quickly.
A Republican senator, Tom Coburn of Oklahoma, had also withdrawn his hold on the Crawford nomination. Coburn had contested the nomination because the FDA had not implemented a law directing it to develop medically accurate condom labels. The senator received assurances from the administration that his concerns would be addressed, an aide to the senator said.
The two Democratic senators said they continued to have concerns about Crawford, saying that Crawford and the FDA showed a lack of leadership and independence on the issue of Plan B.
"We have been clear all along that our hold on this nomination is about one thing only: the FDA's failure to provide an answer on Plan B," the two senators said.
Leavitt's letter noting the Sept. 1 commitment went to Republican Sen. Mike Enzi of Wyoming, chairman of the Senate Health, Education, Labor and Pensions Committee.
Leavitt said the decision on Plan B must be made according to the scientific evidence, and he is not part of that decision. "However, I have spoken to the FDA, and based on the feedback I have received, the FDA will act on this application by September 1, 2005."
Crawford is a veterinarian who has been acting or deputy FDA commissioner for the past three years.