Red Tape Alert: New FDA Rule Puts Allergan In A Double Bind

I was reading my daily MedPage Today news, when I came across this amusing example of regulatory unintended consequences. As we all know, pharmaceutical companies are not allowed to promote off-label uses of their medications – doing so is punishable with billions of dollars in fines (just ask Pfizer). But a new set of rules created by the FDA’sĀ Risk Evaluation and Mitigation Strategies (REMS) program essentially requires Allergan to provide safety information about off-label uses of the drug — uses that are illegal for them to discuss.

So Allergan has to file a law suit to resolve the issue of being required (by the government) to do something the government considers criminal.

And the winner is?

Lawyers!


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