## Facts

- Advocacy groups representing terminally ill patients challenged federal restrictions preventing the commercial sale of “post–Phase I” investigational drugs not yet approved as safe and effective.
- The suit arose from a terminally ill patient’s inability to obtain an investigational cancer drug outside a clinical trial.
- Plaintiffs alleged that mentally competent, terminally ill adults who had exhausted approved treatments had a substantive due process right to access investigational drugs after Phase I safety testing.
- Defendants were federal officials responsible for administering the federal drug-approval and investigational-drug regulatory system.

## Issues

1. Whether the Fifth Amendment’s Due Process Clause protects a fundamental right of terminally ill, competent adults to purchase post–Phase I investigational drugs not approved as safe and effective.
2. If no fundamental right exists, whether the federal restrictions on access to such drugs satisfy rational basis review.

## Decision

- The en banc court affirmed dismissal of the complaint.
- The court held there is no fundamental due process right for terminally ill patients to access post–Phase I investigational drugs lacking FDA approval for safety and effectiveness.
- Because no fundamental right was recognized, rational basis review applied, and the regulatory scheme was upheld as rationally related to legitimate public-health objectives.
- A prior panel decision recognizing a fundamental right and requiring strict scrutiny was vacated.
- The Supreme Court denied certiorari.

## Legal Principles

- Substantive due process recognition of new fundamental rights requires a carefully described asserted liberty interest and proof that it is deeply rooted in the Nation’s history and tradition and implicit in ordered liberty.
- The asserted interest must be defined narrowly; broad appeals to bodily autonomy do not substitute for a historically grounded, specific right.
- Longstanding governmental regulation restricting distribution of unsafe or unproven drugs weighs against treating access to unapproved drugs as a fundamental right.
- Common-law doctrines of necessity and self-defense typically function as defenses to liability and do not establish affirmative constitutional entitlements to obtain regulated medical products.
- The liberty interest in refusing unwanted medical treatment does not entail a right to demand access to drugs the government bars from commercial distribution pending proof of safety and effectiveness.
- Where no fundamental right exists, FDA restrictions on unapproved drugs are reviewed for rationality and are valid if reasonably related to protecting public health and ensuring drug safety and efficacy.

## Conclusion

The en banc D.C. Circuit refused to constitutionalize access to unapproved post–Phase I investigational drugs, concluding that such access is not a fundamental right under the Fifth Amendment and that the FDA’s limitations are permissible under rational basis review.


Abigail All. for Better Access to Dev. Drugs v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007) (en banc)