Developers: Politics behind slow approval process

Woodcock's defense, though, may seem particularly hard to accept at a slate of big pharma companies which have been able to win European approvals only to run straight into a roadblock at the U.S. agency. Galvus [1], Acomplia [2] and Cervarix [3]have all been OK'd by the European Medicines Agency, but are still languishing at the FDA. And Novartis says it may simply skip the U.S. market for Galvus if the feds raise the bar too high for the diabetes drug. The Wall Street Journal notes that a number of analysts believe the FDA faces a higher degree of public and political pressure during the approval process--precisely the kind of influences that Woodcock rejects as a significant factor.

"The scientists and physicians who are reviewing the products are looking over their shoulder at Capitol Hill," says James Shannon, Novartis' departing head of drug development. "I think it results in them taking decisions which are conservative [4]."

- read the story [5] in the Wall Street Journal

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