Off-Label Promotion and Free Speech in Medicine

Regulatory Transparency Project Teleforum

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Federal regulation strictly limits how pharmaceutical companies share information about the legal use of their products. Companies that promote or advertise the use of medicines or medical devices in ways that the Food and Drug Administration (FDA) has not approved—so-called “off-label use”—are subject to prosecution for the crime of “misbranding.” In other words, it is legal—and very common—for a physician to prescribe a medicine or to use a device for an off-label purpose but, it is illegal for a company to talk about it. This regulatory framework has been defended, in part, as necessary to prevent companies from misleading the public about drug risks and effectiveness.  Others argue that this limitation amounts to impermissible speech regulation upon those with the most knowledge about drugs and their possible uses and side effects.

This teleforum will cover the First Amendment implications of the FDA's regulation, legal history and major court decisions and settlements, and how state governments are handling the issue.


  • Christina Sandefur, Executive Vice President, Goldwater Institute

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