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Scandals rock FDA

November 2004

FDA whistle-blower David J. Graham, M.D., testified before Congress that Vioxx and other approved drugs are not safe. In the fall of 2004, there has been a storm of reactions by interested parties.

Sen Charles E. Grassley (R-Iowa) warned the agency not to retaliate against Graham.
Sen. Bingaman (D-N.M.) says the FDA is not paying attention to its mission and suffers a "culture of collusion" with the drug industry.
A spokesperson for PhRMA, Pharmaceutical Research and Manufacturers of America, says FDA practices are the "right way to approach safety issues".
The American Medical Assocation, AMA, in an editorial in their journal (JAMA 1Dec2004) says that the FDA's current postmarketing surveillance system of drugs has a "lack of vigilance, lack of trust".
The Union of Concerned Scientists is publicizing a 2002 survey by the HHS Office of the Inspector General in which FDA scientists lacked confidence in their own agency's ability to monitor drug safety.