Our dysfunctional FDA

You know things are bad with the Food and Drug Administration when even Europe is better at approving new life-saving drugs than the US FDA. In today's Wall Street Journal, former FDA commisioner Scott Gottlieb provides some details:

Europeans are now approving novel drugs an average of three months more rapidly than we do. Of 82 novel drugs that were submitted for approval in both the U.S. and Europe between 2006 to 2009, 11 were approved only in Europe. One is for relapsed ovarian cancer, another for bone cancer.

The FDA Modernization Act of 1997 gave the FDA discretion to speed up the approval process but the FDA rarely uses that authority, as Mr. Gottlieb reports:

Of 76 cancer drugs approved since 2005, the FDA gave only 13 "accelerated approval"—another process created under the Modernization Act to expedite drug development. From 2001 to 2003, 78% of the novel cancer drugs approved were granted accelerated approval. Since then only 32% got the designation.

Whether you regard that information as just statistics or as a tragedy depends on whether you have a loved one currently dying of cancer.

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