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Lawmakers Target FDA, Merck In Vioxx Probe

Nov 24, 2004 | Star Ledger Congressional pressure on drug makers and regulators mounted yesterday as the House Energy and Commerce Committee began investigating the approval and recall of Vioxx.

The committee sent letters to Lester Crawford, the acting Food and Drug Administration commissioner, and Ray Gilmartin, Merck's chief executive, seeking documents about Vioxx. Merck, based in Whitehouse Station, withdrew the painkiller on Sept. 30, citing links between Vioxx and heart attacks.

The committee also asked the FDA to provide internal agency memos about the cardiovascular safety of Celebrex and Bextra, two painkillers made by Pfizer. A congressional source familiar with the investigation said Pfizer may also be asked to submit documents.

The move comes less than a week after the Senate Finance Committee held hearings on Vioxx and FDA oversight, which included testimony from an FDA scientist who charged that the agency is incapable of protecting Americans from unsafe medicines.

The comments made by David Graham, who charged his FDA supervisors tried to prevent him from publishing findings that Vioxx caused heart attacks and strokes, capped a year in which drug safety has become increasingly controversial.

The agency was widely criticized this year for not doing enough to warn parents antidepressants could cause suicidal thoughts among teenagers, especially after it became known some drug makers never disclosed data showing safety risks.

The house committee, which two months ago held hearings on antidepressant safety, requested a wide variety of material from the FDA, including Vioxx reviews; internal memos; correspondence between the agency and Merck; and all records of several high-ranking FDA officials who were involved in overseeing Vioxx.

Similarly, Merck was asked to provide numerous documents concerning Vioxx, including all records of current and former employees who might know about Vioxx side effects and all information regarding Vioxx clinical studies.

Merck's Gilmartin has maintained the drug maker only became aware of a definitive link between Vioxx and heart problems a few days before the Sept. 30 withdrawal. For its part, the FDA has maintained it took the appropriate steps to review Vioxx.

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