[Jun 13, 2006]
FDA in a letter dated June 9 denied a petition from more than 60 family planning and health groups that requested Barr Laboratories' emergency contraceptive Plan B -- which can prevent pregnancy if taken up to 72 hours after sexual intercourse -- be sold without a prescription, Bloomberg/CongressDaily reports (Bloomberg/CongressDaily, 6/13). FDA denied the citizen petition, which was dated Feb. 14, 2001, because the groups do not have the standing to make the request and because the petition does not provide "sufficient data to satisfy the statutory requirements" needed to approve Plan B for nonprescription sales, according to the June 9 letter. Randall Lutter, FDA associate commissioner for policy and planning, in the letter wrote that in responding to the petition the agency did not follow its "normal practice" of waiting for a decision on Barr's pending application to allow Plan B for nonprescription sales because of the "significant public interest in the issues raised by [the] petition" and because the groups asked FDA for a prompt decision (FDA letter, 6/9). FDA's decision does not affect Barr's application, according to the letter. "[A]s we've previously committed, the decision to approve [Plan B for nonprescription sales] has and continues to benefit from a process of rigorous review, discussion, even debate of science, medical facts and public health policy," an FDA spokesperson said (Bloomberg/CongressDaily, 6/13). "FDA, in the thrall of the Bush administration's anti-science agenda, has put aside its mission to promote public health in favor of depriving women of easier access to this important drug," Simon Heller -- attorney for the Center for Reproductive Rights, one of the groups involved with the petition -- said (CRR release, 6/12).
For current women's health policy news, visit the National Partnership for Women & Families' website.