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In Defense of Off-Label Drug Use

As anyone who has investigated the subject seriously knows, off-label drug use (physicians' prescribing of a drug for a use other than the one for which the FDA has approved the drug's manufacture) saves thousands of lives. In fact, for many types of cancer, more than 50% of drug use is off-label. Off-label use is perfectly legal, though it infuriates some FDA mavens who regret their loss of control. Now, as the New Jersey Law Journal reports, Schering Plough is moving to dismiss a class-action lawsuit that claims a private right of action for the firm's daring to promote off-label testing. The defense should allow the issue of off-label use, as well as Pharma's free speech rights, to come to the fore.

Some shameless self-promotion: I discuss this issue at length in a law review article: �Loosening the Food and Drug Administration�s Drug Certification Monopoly: Implications for Tort Law and Consumer Welfare�, 4 George Mason Law Review 457 (1996).



Rafael Mangual
Project Manager,
Legal Policy

Manhattan Institute


Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.