Should merck provide testimony on the adequacy of the fda

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Reference no: EM131497767

Question: Congressional Hearings The Senate Finance Committee held hearings in November on whether the FDA was doing enough to ensure post-approval safety of drugs. The FDA's Dr. David Graham stated, "I would argue that the FDA as currently configured is incapable of protecting America against another Vioxx." He testified that five drugs-Accutane, Meridia, Crestor, Bextra, and Serevent- should be reexamined to determine if they should be withdrawn. Earlier in the year Graham had examined the health records of 1.4 million Kaiser Permanente patients, including 40,405 who took Celebrex and 26,748 who took Vioxx. He found that the risk of heart attacks and sudden cardiac death was three times higher in patients that took high doses of Vioxx. He estimated that Vioxx was responsible for an additional 27,785 deaths from 1999 through 2003. His analysis was posted on the FDA Web site. Another FDA official, Dr. Sandra Kweder, head of the Office of New Drugs, disagreed with Graham. Dr. Steven Galson, the FDA's director of drug evaluation and research, later said that Graham's numbers "constitute junk science" and were "irresponsible."

1. Should Merck provide testimony on the adequacy of the FDA's post-approval safety monitoring? How should it respond to Dr. Graham's study?

Reference no: EM131497767

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