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’s 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!
