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FDA weighs the free-speech case for off-label marketing

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FDA CDER Director Janet Woodcock

FDA officials are having a rethink on free speech--and that could end with an about-face on off-label marketing.

What with key court decisions apparently backing First Amendment protections for drug promotions, the FDA has moved off-label communications to the top of its to-do list, officials said at a recent FDA law conference. And off-label marketing is a hot-button issue, what with the series of multibillion-dollar settlements with the U.S. Justice Department.

"[T]he agency is taking these first amendment concerns very seriously," said Elizabeth Dickinson, the FDA's chief counsel. "We are currently carefully evaluating our policies in light of court decisions on first amendment issues," said Center for Drug Evaluation and Research chief Janet Woodcock.

The upshot? Officials are looking to "realign FDA regulatory posture in this area" and have taken "a number of steps to start down this road," said Leslie Kux, FDA assistant commissioner for policy.

One can see by the vague bureaucratic language that the realignment isn't likely to happen next week. And it's been almost 18 months since the infamous U.S. v. Caronia case yielded a ruling that baldly stated, "The government cannot prosecute pharmaceutical manufacturers ... for speech promoting the lawful, off-label use of an FDA-approved drug."

But the agency's comments on free speech renewed debate around the industry, which is understandably a bit confused by officialdom. The FDA declined to appeal the Caronia ruling to the Supreme Court, so there's been a feeling that the agency might soften its stance. Its request for comment on potential guidelines for handing out off-label info would seem to support that view, too.

Not so at the Department of Justice, which said last year that it intends to go after off-label marketing violations aggressively, despite the Caronia ruling.

To PhRMA, disseminating information about off-label use should be allowed; after all, drugmakers know more about their drugs than anyone else. But off-label uses are off-label for a reason: They might have supporting clinical data, but they haven't been backed by official FDA review of the sort of research FDA requires.

- see the blog post at PharmExec

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