## Facts

- Washington Legal Foundation (WLF) challenged federal restrictions affecting how drug manufacturers could distribute information about unapproved (“off-label”) uses of FDA-approved drugs.
- FDA regulation under the FDCA permits inference of a drug’s “intended use” from labeling, advertising, and other written materials, creating enforcement risk when manufacturers share off-label information.
- WLF focused on manufacturers’ dissemination of scientific and educational materials to physicians, including peer-reviewed journal article reprints, excerpts from reference texts, and manufacturer involvement in continuing medical education (CME).
- In a prior decision, the court granted summary judgment to WLF and permanently enjoined FDA guidance documents that conditioned dissemination of off-label information on compliance steps (including pursuit of, or plans to pursue, a supplemental application) and related disclosures and procedures.
- After that injunction, FDAMA and implementing regulations became effective, establishing a statutory scheme that permitted dissemination of certain off-label materials only if specified conditions were met and creating a statutory “safe harbor” for compliant dissemination.
- Defendants moved to amend the earlier injunction to exclude FDAMA and its regulations and to avoid a constitutional ruling against the new statutory scheme.
- The court considered whether FDAMA materially changed the speech restrictions already found unconstitutional or instead continued them in statutory form.

## Issues

1. Whether the permanent injunction should be amended to exclude FDAMA’s provisions and implementing regulations governing dissemination of off-label information.
2. Whether FDAMA and its implementing regulations, as applied to manufacturer dissemination of truthful, non-misleading scientific and educational materials about off-label uses, violate the First Amendment.

## Decision

- The court denied the motion to amend to the extent it sought to remove FDAMA and its implementing regulations from the injunction’s scope.
- The court amended its prior order to declare unconstitutional the relevant FDAMA provisions and implementing regulations restricting dissemination of off-label information.
- The court concluded that FDAMA largely continued the same regulatory approach previously enjoined and therefore remained subject to the court’s earlier First Amendment analysis.
- The amended order maintained a permanent injunction covering the statutory and regulatory restrictions to the extent they burdened dissemination of truthful, non-misleading off-label information.

## Legal Principles

- Truthful, non-misleading commercial speech receives First Amendment protection, and government limits targeting the content of such speech are subject to heightened scrutiny.
- A “safe harbor” scheme that permits speech only if speakers satisfy government-imposed conditions can function as a speech restraint if dissemination outside the scheme remains subject to enforcement and deterrence.
- Conditioning distribution of scientific and educational materials about off-label uses on regulatory prerequisites (including application-related requirements and mandated procedures) can operate as a content- and speaker-based restriction on protected commercial speech.
- Speech restrictions must be no more extensive than necessary to advance asserted governmental interests such as drug safety and efficacy; burdensome conditions that chill truthful dissemination may fail this requirement.

## Conclusion

The district court held that FDAMA’s off-label dissemination framework and implementing regulations continued, in statutory form, the same constitutionally impermissible limits previously imposed through FDA guidance, and it extended the permanent injunction to invalidate those restrictions as undue burdens on truthful, non-misleading commercial speech.


Washington Legal Found. v. Henney, 56 F. Supp. 2d 81 (D.D.C. 1999)