## Facts

- A public-interest organization sued federal health officials, alleging that the Food and Drug Administration (FDA) effectively restricted drug and device manufacturers from distributing information about unapproved (“off-label”) uses of approved products.
- The FDA regulates drug and certain device labeling and requires approval for intended uses reflected in labeling, while physicians may lawfully prescribe approved products for off-label uses.
- The complaint alleged a de facto FDA policy treating manufacturer-supported dissemination of off-label information—such as journal reprints, textbook excerpts, and materials tied to continuing medical education (CME)—as unlawful “labeling” or “promotion,” except in limited situations.
- The alleged policy was conveyed through warning or regulatory letters, informal advice to industry, and public statements, which purportedly caused manufacturers to refrain from distributing off-label information.
- The organization asserted the First Amendment interests of its physician members in receiving truthful, non-misleading information about medical treatments.
- After an administrative petition challenging FDA restrictions was not granted, the organization filed suit seeking declaratory and injunctive relief.
- Defendants moved to dismiss for lack of subject-matter jurisdiction and failure to state a claim, arguing there was no final agency action and the dispute was unripe because the FDA had not adopted a final policy.

## Issues

1. Whether the organization had associational standing to assert its physician members’ First Amendment right to receive information allegedly restricted by the FDA’s enforcement posture.
2. Whether the challenge was ripe and supported by “final agency action” (or its functional equivalent) when the alleged restrictions were communicated through informal guidance and enforcement letters rather than a formally promulgated rule.
3. Whether the FDA’s challenged conduct was sufficiently concrete and binding to be judicially reviewable at the pleading stage.

## Decision

- The court denied the motion to dismiss under Rules 12(b)(1) and 12(b)(6).
- The court held the organization plausibly alleged associational standing based on member physicians’ concrete informational injury and the suitability of declaratory and injunctive relief without individualized participation.
- The court held the case was ripe and reviewable because the FDA’s consistent enforcement signals and communications had direct and immediate practical effects, despite the absence of a formally adopted final rule.
- The court did not decide the ultimate constitutionality of the FDA’s approach; it allowed the case to proceed to merits litigation.

## Legal Principles

- An association may sue on behalf of its members when (1) members would have standing individually, (2) the interests asserted are germane to the organization’s purpose, and (3) the claim and requested relief do not require individual member participation.
- The First Amendment protects not only speakers but also listeners; physicians may assert a cognizable interest in receiving truthful, non-misleading information relevant to lawful medical practice.
- “Final agency action” for reviewability may be satisfied by a settled, de facto policy that guides enforcement and produces concrete, present effects, even if not adopted through formal rulemaking.
- Ripeness turns on the fitness of the issues for judicial resolution and the hardship of withholding review; a credible chilling effect from an agency’s enforcement posture can support immediate review.

## Conclusion

The court held that the plaintiff organization had associational standing and that the challenge to the FDA’s alleged de facto restrictions on manufacturer distribution of off-label information was ripe and judicially reviewable, denying the defendants’ motion to dismiss and permitting the case to proceed to the merits.


Washington Legal Found. v. Kessler, 880 F. Supp. 26 (D.D.C. 1995)