Pharmaceutical "Free Speech" Harms Patient Health

United States v. Caronia may determine the extent to which FDA regulation also affects how drug makers sell their medicines to clients, and whether they are allowed to overstate drugs' benefits. 

What's the Latest Development?

Tempted by the lure of increased sales, drug companies are developing an unfortunate history of paying large legal penalties for overstating the benefits of the medicines they create. Now, a federal appeals court has ruled that off-label drug promotion--the kind that occurs between drug sellers and clients--should be protected as free speech. The case, United States v. Caronia, "relates to the conviction of a pharmaceutical salesman for Orphan Medical, who was recorded telling a potential client that the drug Xyrem could treat a variety of ills, including muscle disorders, chronic pain, Parkinson’s disease and fibromyalgia."

What'st the Big Idea?

Beneath the case's legal arguments is a controversy over the necessity of strict drug regulation. If medicines work as doctors and patients expect, then drug sellers should be allowed to advertise their medicines for use beyond what they have been tested for. "Off-label uses, however, are off-label precisely because the drugs have not been studied well enough to understand their benefits and risks in this context. ... Moreover, prohibitions on off-label promotion encourage good science. ... If the FDA cannot regulate how drugs are marketed, the incentive to conduct [controlled] trials will evaporate."

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