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Saturday
Jun252011

Has the US Supreme Court opened the door to off label promotion?

In a judgement Thursday [IMS v Sorrell]  the US Supreme Court ruled that information provided by manufacturers about possible off label uses of medicines is subject to First Amendment protections of free speech.  

The implications for what's can be said in direct to physician promotion of drugs and medical devices may well be profound.

This case was actually about a (successful) challenge on a Vermont State law restricting access to drug prescribing information.  However as an aside - the judgement got into issues of free speech.

The relevant passage is on page 22 of the judgement. 

But the “fear that people would make bad decisions if given truthful information”  cannot justify content-based burdens on speech.  Thompson, 535 U. S., at 374; see also Virginia Bd. of Pharmacy v.  Virginia  Citizens Consumer Council,  Inc., 425 U. S. 748, 769–770 (1976).   “The First  Amendment directs us to be especially  skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good.”  44 Liquormart, supra, at 503 (opinion of Stevens, J.); see also Linmark Associates, Inc. v.  Willingboro, 431 U. S. 85, 97 (1977). These precepts apply with  full force when the audience, in this case prescribing physicians, consists of “sophisticated and experienced” consumers.  Edenfield, 507 U. S., at 775.

The very clear reference to the sophisticated audience of physicians will mean there some urgent rethinking to be done as to the restrictions on advertising and promotion in the US of FDA regulated products.