Internal Documents Show FDA Conflict on OTC Status Rejection of Plan B
FDA scientists "dismissed" the agency's reasoning for its rejection of over-the-counter status for the emergency contraceptive Plan B, according to internal agency documents, the Washington Post reports (Kaufman, Washington Post, 6/18). FDA in May issued a "not approvable" letter to Barr Laboratories -- the manufacturer of Plan B -- citing inadequate data on the use of the pills among girls under age 16. The agency's decision was unusual because it contradicted the recommendations of two FDA advisory panels, which in December 2003 voted 23-4 to recommend that Plan B be sold without a doctor's prescription. In addition, Steven Galson, acting director of FDA's Center for Drug Evaluation and Research, said he made the decision to reject the application on his own and did not follow the recommendations of his staff (California Healthline, 5/13). FDA scientists disagreed particularly with the agency's finding that there was not enough information on how Plan B would affect the sexual behavior of younger women, according to the Post (Washington Post, 6/18).
Dr. John Jenkins, director of FDA's Office of New Drugs, wrote in internal memos that Plan B did not pose any particular risks for younger women and that the agency was subjecting Barr's application to more rigorous examination than applications for other drugs, the Wall Street Journal reports. He added that Barr's application was "fully consistent with the agency's usual standards for meeting the criteria" for OTC status, saying that the key criteria for approving the application should be the evidence that the pills can be used safely and effectively without a doctor's supervision. Jenkins also said that FDA never before had considered young women's use of oral contraceptives to be problematic (Wall Street Journal, 6/18).
Jonca Bull, head of the FDA office that oversees decisions to make drugs available without prescription, wrote in internal memos that the concerns regarding OTC status for Plan B were "speculative and unbalanced." Bull added that because FDA had approved numerous other contraceptive products for OTC status, a precedent existed for Plan B -- which can significantly reduce the risk of pregnancy if taken within 72 hours of sexual intercourse -- to be sold without a doctor's prescription. FDA spokesperson Lawrence Banchorik said that FDA "will not comment on internal deliberative documents that were part of our decision-making process," according to the Post (Washington Post, 6/18).
Rep. Jim Greenwood (R-Pa.), who met with Galson earlier this month, last week said he expected FDA to reverse its decision on Barr's application for Plan B and approve OTC status for the pills for women ages 16 and older (Cusack, The Hill, 6/9). Greenwood, who called FDA's decision a "horrible one," said he was surprised when Galson indicated that he was considering approving OTC status for Plan B within six months. "There was no guarantee from Galson, but he said their only concerns were for girls under 16, and I took that to mean they would approve it OTC for everyone else quite soon," Greenwood said. When asked if he thought FDA's initial rejection of Barr's application was influenced by politics, Greenwood said, "[M]aybe some folks thought it would be more comfortable politically to give an approval after the election," adding that he had no direct information on any political links (Washington Post, 6/18).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.