Drug Salesmen’s Practice of Medicine Protected by Free Speech

Medicare Set-Aside Blog on December 6, 2012
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In an interesting decision by the 2nd Circuit Court of Appeals on Monday, a pharmaceutical salesman’s statements about a drug’s off-label usages was determined to be nothing more than his first amendment right to speak freely about the drug, despite not being a physician with an actual opinion that might matter. As a matter of law, pharmaceutical companies are not permitted to market drugs for anything beyond the FDA tested and approved indication. Apparently that prohibition does not extend to their sales reps. Now mind you, the drug in question was Xyrem which is approved only for narcolepsy, yet said salesman recommended the drug for insomnia, fibromyalgia and other conditions. Guess if it helps when you can’t stay awake, why not take it when you can’t sleep too?

The insurance industry has enough trouble controlling medical costs and rulings such as this certainly don’t help. While physicians are permitted to prescribe off-label, being fed false information upon which those decisions are made should certainly carry some accountability. Of course I have to wonder about the physician that buys into the notion that the same drug can correct both insomnia and narcolepsy.

To read more, the opinion is attached.
US v. Caronia
Docket No. 09-5006-cr
Decided December 3, 2012