More Troubles for FDA

The second half of 2012 has not been kind to FDA. Last month, Secretary Hamburg was grilled by the House of Representatives for failing to follow-up on warning letters to the New England Compounding Center (NECC), now comes word that a U.S. District Court has ruled that a sales representative’s off-label promotion of a drug was protected speech. The Food, Drug and Cosmetic Act (FDCA) appears to be coming apart at the seams.

In US v. Caronia, the Court ruled that Alfred Caronia, a sales rep promoting Xyrem for Orphan Medical (now Jazz Pharmaceuticals), could make statements about off-label uses of the drug, even though FDCA specifically prohibits “introducing a misbranded drug into interstate commerce.” The Court did not consider whether the statements were true.

Given the Supreme Court’s general affection for sales rep’s free speech rights, it is not out of the question to presume a difficult fight ahead for FDA. While it is too early to suggest that a wholesale rewrite of the FDCA is in order, clearly some significant revisions are in order.

“FDA and industry will need to come to an understanding on what exactly is needed to substantiate a product claim,” notes Pharm Exec Senior Editor Ben Comer.

It’s not just about free speech and drug marketing, though. With more than five hundred patients stricken and 36 deaths from tainted compounded steroid injections, there is an obvious need to clarify FDA authority over compounding pharmacies as well. Given the range of issues surrounding FDA authority a rethinking of the FDCA might just be in order.