Monday, April 20, 2009

Wall Street Journal on Provenge & the FDA

Editorial in today's Wall Street Journal on the delay in approving prostate-cancer drug Provenge by the FDA -- Prostate Cancer and FDA Politics: Their first priority should be to save patients.  Here's an excerpt:

The larger question is why Provenge wasn't made available sooner to the 30,000 American men who die each year from prostate cancer. The FDA regularly -- and pointlessly -- slow-walks potentially revolutionary therapies, relying on overly simplistic and unscientific statistical models that don't take into account the fact that some drugs may work better in certain subgroups than in others. Its regulatory blockade is especially cruel to terminally ill patients for whom drugs like Provenge may mean extra months or years of life.

Id.  One wonders if rather than an FDA-centric regulatory approach, a flexible negligence standard incorporating evolving industry custom for testing would better serve public policy by expeditiously moving safe and effective drugs to market.


FDA, Pharmaceuticals - Misc., Products Liability | Permalink

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