Sunday, October 04, 2009

First Amendment challenge to FDA labeling law

I’ve been waiting for this suit for a while: Allergan has filed suit challenging the FDA’s restrictions on off-label marketing on First Amendment grounds. The problem with the challenge is that, if accepted, the entire concept of FDA labeling collapses.

NYT, take it away:

“This is the broadest attack on the constitutionality of F.D.A. restrictions on speech brought by an individual drug company. It’s a precedent-setting case,” said Jeffrey N. Gibbs, a lawyer in Washington who specializes in food and drug law. “They are seeking relief which would invalidate all of the F.D.A. regulations which restrict the promotion of drugs.”

…. “If you could get a drug approved for one narrow use and then market it for everything else, there would be no incentive or motivation for a company to prepare data to ensure that it meets the standard for safety and efficacy,” said Marc J. Scheineson, a lawyer specializing in food and drug regulation at Alston & Bird in Washington.

I for one am very interested to see what happens next.

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