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December 11, 2012
Free To Promote Off-Label? Not So Fast. . .
Steve Usdin at BioCentury has a very interesting article (free access) following up on that surprise decision that the FDA's restrictions on off-label promotion are a violation of the First Amendment:
But companies and individuals who take the decision as a signal that the rules of the road have changed and they are now free to promote off-label indications put themselves in great legal and economic peril, attorneys who helped persuade the court to overturn Caronia's conviction told BioCentury.
At the same time, the decision by one of the country's most influential and respected courts to overturn a criminal conviction on First Amendment grounds is persuasive evidence that, in the long term, FDA will have to change some of the assumptions underpinning its regulation of medical products.
FDA, which now has lost a string of First Amendment cases, cannot forever hold on to the notion that it is empowered to prohibit drug companies and their employees from saying things that anyone else is free to say. Sooner or later, according to legal experts, the agency will have to reconcile itself with the idea that industry has the right to truthful, non-misleading speech.
Some of the people the article quotes are expecting the same thing I am - a further appeal to the Supreme Court - but no matter what, it's going to be quite a while before all the debris stops landing. Any company that tries to be the first to take advantage of what might be a new-found freedom could find itself right back in court, becoming a test case for what this ruling really means. Anyone feel like being a pioneer?
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