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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: Twitter: Dereklowe

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December 11, 2012

Free To Promote Off-Label? Not So Fast. . .

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Posted by Derek

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?

Comments (2) + TrackBacks (0) | Category: Regulatory Affairs


1. Hap on December 11, 2012 12:05 PM writes...

The problem would be with the "truthful, non-misleading" part - if you haven't shown sufficiently (in a large enough set of people such that you can distinguish between effective outcomes caused by a drug and random chance) that a drug works for an indication, then selling it to treat such an indication would seem to be both untruthful and misleading.

Since people have had a difficult time assessing whether the benefits of many drugs are worth their potential problems (and instead simply insist that they be riskless), I don't see how a model where "Buyer beware" becomes the motto for pharma advertising will do the industry any good. Turning pharma into supplementeering might be the ultimate outcome for pharmas interested in profit now, but salting the ground for future pharma development is not a smart move.

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2. NoDrugsNoJobs on December 11, 2012 1:02 PM writes...

I believe the decision was one panel on one circuit and it was a 2:1 split. I would think an en banc (appeal to the whole court) would be the next step and by no means would any drug company take this early decision as a license to do anything.

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