Report questions FDA's safety procedures

Wha? Wha? What???...

great quote at the bottom of the article...trying for a sound bite, I guess...

The Food and Drug Administration "lacks a clear and effective process" for managing postmarket drug safety issues, says a Government Accountability Office report out Monday. The report was requested in late 2004 by Sen. Charles Grassley, R-Iowa, chair of the Senate Finance Committee, and Rep. Joe Barton, R-Texas, chair of the House Energy and Commerce Committee.

Concerns about how the FDA handled high-profile drug safety cases — two were Vioxx, the painkiller linked to heart attacks and strokes, and antidepressants, linked to suicidal behavior in children — spurred the request.

"GAO observed that there is a lack of criteria for determining what safety actions to take and when to take them," the report states, noting that FDA officials, given a chance to review a draft, called its conclusions "reasonable" but did not comment on its recommendations.

In an interview Friday, Grassley said the report backs up "what everybody seems to know, that the FDA needs reform, that things that go on in the FDA don't really protect the consumer. The FDA is kind of a Good Housekeeping seal of approval on drugs, and really, it's questionable (whether) they should have that honor."

In a statement, Barton said the GAO "shows that the drug-safety system is not in crisis, but the FDA's process may need some fine-tuning. Prescription drugs approved by the FDA should keep you out of the hospital, not send you to one."


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