## Facts

- The Food and Drug Administration (FDA) issued guidance documents addressing manufacturer dissemination of information about off-label uses of approved drugs and devices.
- The guidance covered (1) manufacturer distribution of peer-reviewed journal articles and medical textbook reprints (“enduring materials”) and (2) manufacturer involvement in continuing medical education (CME) programs.
- The FDA treated these communications as potentially unlawful “promotion” and set conditions under which such activities could be used as evidence of an intent to promote off-label uses.
- Washington Legal Foundation, representing members including pharmaceutical manufacturers, sought declaratory and injunctive relief barring the FDA and the Department of Health and Human Services from enforcing or giving effect to the guidance.
- The government argued the guidance regulated conduct rather than speech, and that the communications fell outside First Amendment protection given the FDA’s regulatory authority.
- The case was decided on cross-motions for summary judgment with no genuine dispute of material fact.

## Issues

1. Whether the guidance restrictions on dissemination of enduring materials and CME-related communications about off-label uses regulate protected commercial speech or merely unprotected conduct.
2. If the guidance regulates protected commercial speech, whether the restrictions satisfy the Central Hudson test, including whether they directly advance a substantial governmental interest and are no more extensive than necessary.

## Decision

- The court granted summary judgment for Washington Legal Foundation and denied the government’s cross-motion.
- The court held the regulated activity was protected commercial speech, not mere conduct.
- Applying Central Hudson, the court held the guidance restrictions violated the First Amendment because they were more extensive than necessary to serve the government’s interests.
- The court issued declaratory and injunctive relief barring enforcement of the guidance to the extent it restricted truthful, non-misleading manufacturer communications about off-label uses through enduring materials and CME-related activities.

## Legal Principles

- Manufacturer communications conveying truthful, non-misleading information about lawful off-label uses to physicians can constitute protected commercial speech.
- Government limits on commercial speech are evaluated under Central Hudson: (1) the speech must concern lawful activity and not be misleading; (2) the government interest must be substantial; (3) the restriction must directly advance that interest; and (4) the restriction must not be more extensive than necessary.
- A substantial interest in drug safety and the integrity of the approval process does not justify broad suppression of truthful, non-misleading off-label communications when narrower, disclosure-based alternatives (e.g., disclaimers about non-approval) could address the concern.

## Conclusion

The court held that FDA guidance restricting manufacturers’ dissemination of truthful, non-misleading off-label information via scientific reprints and CME involvement regulated protected commercial speech and failed Central Hudson because it burdened more speech than necessary, warranting declaratory and injunctive relief.


Washington Legal Found. v. Friedman, 13 F. Supp. 2d 51 (D.D.C. 1998)