FDA defends five drugs called unsafe by agency staffer
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By Laura Gilcrest, CBS MarketWatch
Last Update: 10:09 AM ET Nov 19, 2004
WASHINGTON (CBS.MW) -- The Food and Drug Administration is defending its approval of five prescription drugs that an agency staffer called unsafe.
David Graham's testimony, delivered Thursday on Capitol Hill, "does not reflect the views" of the FDA, said Steven Galson, acting director of federal agency's Center for Drug Evaluation and Research, in a statement.
"The five specific drugs that Dr. Graham identified in his oral testimony are currently approved as safe and effective for use in the United States," Galson said late Thursday.
Graham serves as associate director for science and medicine in the FDA's Office of Drug Safety. He singled out five drugs in testimony before the Senate Commerce Committee: the cholesterol drug Crestor, the asthma therapy Serevent, the arthritis drug Bextra, the weight-loss drug Meridian, and the acne drug Accutane.
Galson said: "The FDA evaluates the safety and effectiveness of all drugs independently on a case-by-case basis before they are approved to enter the marketplace and also evaluates reported adverse events with all drugs already on the market to assess whether unforeseen safety cancers need to be addressed."
Testifying about the recall of Merck & Co.'s
(MRK) Vioxx, Graham told lawmakers that the agency should take a hard look at the five drugs on the grounds that they have been linked to serious side effects.
AstraZeneca
(AZN) produces Crestor, GlaxoSmithKline (GSK)
makes Serevent, Pfizer (PFE)
markets Bextra, and Abbott Laboratories (ABT)
produces Meridian. Roche's (RHHVF) Accutane, Graham said,
should be under controlled distribution.
Galson also took issue with Graham's allegations to lawmakers that FDA's current structure hinders the agency's ability to protect the public and avert another Vioxx fiasco.
For example, Graham charged that the same division in FDA is responsible for both approved new drugs and for reviewing their safety once they're on the market -- something he called a "conflict of interest."
FDA's Office of Drug Safety, which monitors marketed drugs, "is already an independent office separate from the Office of New Drugs, the office that reviews new drug applications," Galson said.
