NYT: Report Lists Faults of F.D.A. Drug-Safety Process

[DeepModem Mom]

Report Lists Faults of F.D.A. Drug-Safety Process
By GARDINER HARRIS
Published: September 22, 2006

WASHINGTON, Sept. 22 — The nation’s system for approving and monitoring the safety of medicines is inadequate and needs far-reaching reforms, and the Food and Drug Administration is plagued with poor management and persistent internal squabbling, according to a long-anticipated study of the agency.

The report by the Institute of Medicine is likely to intensify a debate about the safety of the nation’s drug supply and the adequacy of the F.D.A.’s oversight. The debate began in earnest in September 2004 when Merck withdrew its popular arthritis drug, Vioxx.

The Institute of Medicine, a nonprofit organization created by Congress to advise the federal government on health issues, conducted the study at the request of the F.D.A....

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Citing the Vioxx withdrawal, which happened when long-term studies revealed risks to patients five years after the drug was approved, several prominent senators have already proposed significant reforms of the F.D.A., some of which the report seems to endorse.

The report’s conclusions are striking and often damning – particularly when discussing the agency’s Center for Drug Evaluation and Research, known as C.D.E.R....

http://www.nytimes.com/2006/09/22/business/22fdacnd.html?hp&ex=1158984000&en=0c27c1350fcf4c8b&ei=5094&partner=homepage