FDA Staff Accounts Conflict On Plan B Decision Timeline, GAO Report Finds
This article was originally published in The Pink Sheet Daily
Executive Summary
Office of New Drugs officials contend they were told the over-the-counter switch application for Barr's emergency contraceptive would be denied following a positive advisory committee review, but Center for Drug Evaluation & Research officials deny the decision was made before the letter was sent.
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Reports from FDA officials vary as to the timing of the decision not to approve Barr's emergency contraceptive Plan B for over-the-counter sale, the Government Accountability Office investigation into the application process reveals. Office of New Drugs Director John Jenkins and Deputy Director Sandra Kweder reported that they were told by high-level management that the drug would be found "not approvable" months before the review period's completion, according to the report released Nov. 14 (1 (Also see "GAO’s Plan B Report Expected In November" - Pink Sheet, 27 Oct, 2005.)). The OND heads said FDA Acting Deputy Commissioner for Operations Janet Woodcock and Acting Director of the Center for Drug Evaluation & Research Steven Galson told them that the Plan B switch would be denied following the December 2003 advisory committee meeting, GAO says. However, Galson and Woodcock "denied that they had said that the application would not be approved," the report states. FDA issued a not approvable letter for the Plan B application May 6, 2004. The decision has drawn heavy political criticism (2 (Also see "Clinton Urges Plan B Decision, Says FDA Changed Standards “Midstream”" - Pink Sheet, 12 Oct, 2005.)). Galson told GAO that he decided to deny the application for the OTC sale of Plan B "shortly before signing the action letter," GAO says. Minutes from a Jan. 15, 2004 staff meeting indicate that Galson told staff a not approvable letter was "recommended" due to concerns about adolescent use, according to GAO. The conflicting reports on when the Plan B decision was made was one of the points GAO finds "unusual" in FDA's decision-making process leading up to the denial of the initial Plan B switch application. GAO also cites the greater involvement of high-level FDA management in the Plan B decision as another "unusual" characteristic in the review process for the emergency contraceptive. Senate Democrats Patty Murray (D-Wash.) and Hillary Clinton (D-N.Y.), who requested the GAO investigation on June 15, 2004, cite the report as confirmation that FDA's denial of the Plan B switch was "politically motivated" in a same-day release. - Jessica Lake |