Healthy Skepticism Library item: 10309

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Publication type: news

Perrone M.
FDA Head Defends Working With Companies
Associated Press 2007 May 30
http://biz.yahoo.com/ap/070530/fda_avantia.html?.v=2

Full text:

FDA Chief Says Collaboration With Drug Makers Is Important to Developing Safer Medicine

WASHINGTON (AP) — The head of the Food and Drug Administration on Wednesday deflected criticism of his agency’s coziness with industry and defended a recent decision not to require new warning labels on a GlaxoSmithKline diabetes drug that may substantially raise the risk of heart attack.

FDA Commissioner Andrew Von Eschenbach said close cooperation between government scientists and drug developers is important, and that it will eventually produce safer medicines for consumers.

Von Eschenbach made his remarks to reporters during a press conference aimed at explaining the agency’s ongoing efforts to make drug development faster and more predictable. He said the agency is collaborating with private companies and academics to improve on the current drug research process, in which roughly 9 out of every 10 prospective drugs fail to make it to market.

“We want drug companies to get it right from the very beginning,” Von Eschenbach said.

Last week the FDA was criticized by several lawmakers after it stopped short of requiring new warning labels on GlaxoSmithKline’s diabetes drug Avandia. An analysis published in the New England Journal of Medicine found that diabetics taking Avandia are 43 percent more likely to have a heart attack than those taking a placebo.

Last week House lawmakers said they planned to investigate why FDA did not notify doctors and patients sooner about the risks, pointing out that GlaxoSmithKline gave FDA data on the drug’s safety last August. Sen. Charles Grassley, R-Iowa, also criticized FDA’s plans to wait for the completion of a study due out in 2009 before taking any regulatory action on the drug.

GlaxoSmithKline has maintained that the drug is safe and disputes the analysis that first raised safety concerns.

Part of the agency’s effort to streamline the drug development process involves identifying biological responses in patients that indicate whether they are responding to a drug. Von Eschenbach stressed that these “biomarkers” can also be used to spot negative reactions to drugs in the early testing stages of development.

“This is a collaboration, but it’s not just a collaboration with drug companies, it’s a collaboration with academia and with other agencies,” Von Eschenbach said. “Everyone is an important stake holder and that’s the point: we need to not be exclusive of any one of the important parts of the collaborative effort.”