FDA Defends Its Handling of Vioxx Issues

[Judi Lynn]

Posted on Thu, Nov. 18, 2004

FDA Defends Its Handling of Vioxx Issues

DIEDTRA HENDERSON
Associated Press

WASHINGTON - Congress is looking into whether the Food and Drug Administration shirked its duty by ignoring safety concerns about Vioxx raised by its own reviewers and outside scientists.Hours before a Thursday hearing, the FDA defended its oversight and attempted to paint the reviewer, who will be called to testify, as a maverick who did not follow agency protocol.

In many respects, the FDA finds itself, again, explaining its actions before congressional critics, much like it did when antidepressant safety concerns were raised.This time, however, the agency's acting commissioner more aggressively attempted to set the agenda, citing the FDA's "well-documented and long-standing commitment to openness and transparency in its review of marketed drugs."

Lester Crawford's statement, sent by e-mail to reporters about 16 hours before the Senate Finance Committee's scheduled hearing on Vioxx, also said the FDA initiated and paid for reviews of Vioxx and antidepressants after those drugs had hit the market. "That is evidence the system is working," Crawford said.

Critics contend the agency ignored risks in both instances, then intimidated its own reviewers when they pointed to safety concerns.
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