## Facts

- CareToLive (an advocacy group) and individual prostate cancer patients sought access to Provenge (sipuleucel‑T), an investigational biologic for advanced prostate cancer.
- A biologics license application for Provenge was submitted to the FDA; an advisory committee voted favorably on safety and evidence of efficacy.
- The FDA declined to approve Provenge at that stage and requested additional clinical data.
- Plaintiffs alleged the FDA’s refusal unlawfully denied terminally ill patients potentially life-extending treatment.
- Plaintiffs sued FDA officials for declaratory and injunctive relief that would effectively require approval or access, asserted Administrative Procedure Act (APA) claims, and raised constitutional claims alleging a right to obtain investigational drugs.
- The FDA moved to dismiss for lack of subject-matter jurisdiction, lack of standing, and failure to state a claim.

## Issues

1. Whether the FDA’s non-approval decision constituted “final agency action” reviewable under the APA.
2. Whether plaintiffs had Article III standing (injury, causation, and redressability) to challenge the FDA’s actions.
3. Whether plaintiffs had a cognizable cause of action, including whether their interests fell within the statutes’ zone of interests and whether any private right existed to compel approval.
4. Whether terminally ill patients have a substantive due process right to access investigational drugs not approved by the FDA.
5. Whether mandamus or injunctive relief could compel the FDA to approve or otherwise make the drug available.

## Decision

- The court granted the FDA’s motion to dismiss.
- The court held plaintiffs could not obtain an order compelling FDA approval or access to the drug through the claims pleaded.
- The court rejected the asserted constitutional right of terminally ill patients to access unapproved drugs.
- The court concluded mandamus and broad injunctive relief were unavailable because approval decisions involve agency discretion.

## Legal Principles

- APA review requires a reviewable, discrete “final agency action”; courts generally will not use the APA to direct the substantive outcome of FDA scientific determinations.
- The APA does not authorize courts to replace FDA’s scientific and regulatory judgment in drug-approval matters; agency action is reviewed under a deferential standard (e.g., arbitrary and capricious).
- The Food, Drug, and Cosmetic Act regulatory scheme does not create a private right for patients to compel FDA approval of a specific drug.
- Substantive due process protects only narrowly defined fundamental rights; there is no fundamental right to obtain unapproved drugs outside the FDA approval process, so rational-basis review applies.
- Mandamus requires a clear, nondiscretionary duty; FDA approval decisions are discretionary and thus not subject to mandamus or injunction compelling approval.

## Conclusion

The court dismissed the action, holding that plaintiffs lacked a judicially enforceable basis to force FDA approval or access to Provenge and that the Constitution does not confer a right for terminally ill patients to obtain investigational drugs not approved by the FDA.


CareToLive v. Von Eschenbach, 525 F. Supp. 2d 938 (S.D. Ohio 2007)