The FDA’s regulation of off-label uses for drugs has been a hotly contested issue. While the FDA seeks to ensure compliance with the regulatory process, drug manufacturers argue that off-label prescribing is a well-regarded practice by physicians and that the regulations and the regulations are impermissible under the First Amendment. Recent cases court cases have ended without a clear resolution as to the First Amendment implications, but message from the FDA remains clear—any kind of advertising of an off-label use may be prosecuted.

This paper proposes a compromise between the two extreme positions. Allowable speech and conduct related to off-label prescribing would depend on a number of factors, but the safety of the American public in the face of two distinct dangers would be key amongst these factors. By regulating only advertising which is likely to mislead the public, the regulations can achieve the FDA’s goals and meet the requirements of the First Amendment.

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