FDA's Crawford Readies Himself For "Intense Week" Of Congressional Hearings
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA Acting Commissioner Lester Crawford will appear in front of four congressional committees this week in what amounts to "the most intense week of congressional hearings that we have had in FDA's history," he said
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FDA Acting Commissioner Lester Crawford will appear in front of four congressional committees this week in what amounts to "the most intense week of congressional hearings that we have had in FDA's history," he said. The lineup includes three hearings on the flu vaccine shortage and one on the withdrawal of Merck's Vioxx . "The other thing about these congressional hearings, although two of them are occurring at the same time, I'm testifying at all four," Crawford said at the Pharmaceutical Leadership Forum in Washington, D.C. Nov. 15. The Senate Finance Committee's Nov. 18 hearing on Vioxx will discuss specific issues related to the safety of the COX-2, but the broader focus "is what FDA does once a drug is approved," he said. The Vioxx withdrawal has prompted calls for an overhaul of FDA's safety oversight. At this hearing, Crawford will discuss the Institute of Medicine study announced Nov. 5 that will examine the possibility of creating a separate entity to handle drug safety issues as part of a comprehensive review of safety regulation (1 (Also see "FDA Drug Safety Review Will Consider Pros And Cons Of Separate Safety Agency" - Pink Sheet, 5 Nov, 2004.)). FDA hopes the study "will be kind of like a turning point and we believe a focus of the hearing on that this week," he said. Crawford noted that "2.7% of the drugs put on the market by FDA have to be recalled from the market. Now this factoid is part of the process, given the current controversy about Vioxx and the SSRIs and some other classes of drugs. We're probably going to be dealing with that." Of the flu vaccine hearings, "two of these will be extremely significant, the other one may be somewhat routine," he said. Crawford will be discussing flu vaccine supply for the 2005-06 season. Currently, only one supplier is interested in providing flu vaccine for next season (see 2 (Also see "FDA's Cure For The Flu: Orphan Drug-Like Incentives, Tissue-Based Production" - Pink Sheet, 15 Nov, 2004.)). Crawford is slated to testify at flu hearings in the House Energy & Commerce Committee Nov. 18, the Senate Special Committee on Aging Nov. 16 and the House Government Reform Committee Nov. 17 (3 (Also see "HHS To Award Vaccine Cell-Culture Contract" - Pink Sheet, 10 Nov, 2004.)). - Andrew Shelton |