Resources for Food and Drug Administration (FDA)

As FDA Focuses on Safety, Fewer New Drugs Are Approved

blogs.wsj.com

Why are new drug approvals tapering off? For one, there’s the industry’s research labs, which have produced a leaky pipeline of promising products lately. Janet Woodcock, head of the FDA’s Center for Drug Evaluation and Research, notes that new drug applications submitted to the FDA by the industry dropped 33% in 2006. “You can’t approve drugs you don’t get applications for,” she told the WSJ in this front-page story about the changing drug-approval climate.

And the drug industry has fanned public mistrust by allegedly manipulating clinical data, concealing dangerous side effects and going gangbusters with marketing, the WSJ notes.

But the FDA’s own mood appears to have shifted, especially since Merck’s late-2004 withdrawal of painkiller Vioxx after it was linked to heart attacks and strokes.

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