NCPA - National Center for Policy Analysis

Controversy over "Off-Label" Prescribing

August 2, 2011

What can you do if you learn you have a life-threatening illness but there is no Food and Drug Administration-approved medicine to treat it?  Sometimes, there is nothing to do but hope.  Very often, though, your doctor will be able to prescribe a drug or medical device that has been approved by the Food and Drug Administration (FDA) for a different condition.  This practice, called "off-label" prescribing, is perfectly legal, commonly practiced within the medical community, viewed as an essential component of good medical care, and offers greater choice in treatment options for millions of American patients.  It is not without controversy, however.  Gregory Conko, a senior fellow at the Competitive Enterprise Institute, examines this practice in a new study.

  • Section I of Conko's paper examines the convention of off-label prescribing, its role in the practice of medicine and its broad support within the medical community. It also sets out some of the pros and cons of the practice.
  • Section II discusses the evolution of the Food, Drug and Cosmetics Act and the FDA's role in the drug and device approval process.
  • Section III turns specifically to the regulation of medical product labeling and advertising, and discusses FDA's regulation of off-label speech. In particular, he examines Congress' and the agency's effort to carve out limited exemptions for certain types of off-label speech, and it introduces a discussion of the treatment by federal courts of off-label speech restrictions.
  • Section IV examines three recent court challenges to the off-label promotion ban, one of which was still on-going at the time of publication.
  • Section V discusses the scope of permissible commercial speech regulation and analyzes the constitutionality of off-label speech restrictions in light of applicable case law. It finds that the FDA's current ban on off-label promotion is unconstitutional, but suggests less burdensome alternative restrictions that likely would pass constitutional muster while still advancing the government's asserted interests.

Source: Gregory Conko, "Hidden Truth: The Perils and Protection of Off-Label Drug and Medical Device Promotion," Competitive Enterprise Institute, August 1, 2011.

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