## Facts

- The Food and Drug Administration (FDA) barred the importation and interstate distribution of Laetrile (amygdalin), treating it as a “new drug” subject to the Federal Food, Drug, and Cosmetic Act (FDCA) and therefore unlawful to distribute without an approved New Drug Application (NDA).
- Glen L. Rutherford, individually and on behalf of a class of terminally ill cancer patients, sued federal officials in the Western District of Oklahoma seeking to prevent enforcement actions that kept Laetrile out of interstate commerce.
- Plaintiffs alleged that many terminally ill patients believed Laetrile could help them and that the federal ban forced patients to change physicians and travel outside the United States to obtain it.
- Earlier proceedings required the FDA to develop an administrative record and make an agency determination on whether Laetrile qualified as a “new drug” and whether any FDCA grandfather exemption applied.
- On July 29, 1977, after administrative proceedings, the FDA Commissioner concluded that Laetrile was not generally recognized by qualified experts as safe and effective for cancer, that it was a “new drug” under the FDCA, and that it did not fall within any statutory grandfather exemption.
- Plaintiffs sought review under the Administrative Procedure Act (APA), arguing the Commissioner’s determination was unlawful and also contending that terminally ill patients have a constitutional right of personal privacy to decide how to handle their own medical care, including use of Laetrile.

## Issues

1. Whether the FDA Commissioner’s decision classifying Laetrile as a “new drug” and denying any grandfather exemption should be set aside under the APA as arbitrary, capricious, or otherwise not in accordance with law.
2. Whether Laetrile qualified for a statutory exemption from the FDCA’s premarket approval requirements under the 1962 grandfather clause.
3. Whether enforcing the FDCA to bar terminally ill cancer patients from obtaining Laetrile infringed a constitutionally protected privacy or liberty interest in personal medical decision-making.

## Decision

- The court set aside the FDA Commissioner’s July 29, 1977 determination as challenged in this action.
- The court held that Laetrile qualified for an exemption from premarket approval under the FDCA’s 1962 grandfather clause and therefore could not be treated, for these purposes, as requiring an approved NDA before distribution.
- In the alternative, the court concluded that denying terminally ill cancer patients access to Laetrile impermissibly interfered with constitutionally protected privacy interests in deciding how to address a terminal illness.
- The ruling granted relief to the plaintiff class and restricted federal enforcement that would block access to Laetrile through interstate channels on the ground that it lacked FDA approval.

## Legal Principles

- Under the APA, a court reviewing final agency action assesses whether the action was arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law, based on the administrative record.
- The FDCA’s “new drug” framework ties lawful interstate distribution to premarket approval unless a product is generally recognized by qualified experts as safe and effective for its labeled uses or falls within a statutory exemption.
- The FDCA’s grandfather provisions, including the 1962 grandfather clause, can exempt certain previously marketed drugs from the post-1962 effectiveness-based approval regime if the statutory conditions are met.
- Constitutional doctrines protecting personal privacy and bodily autonomy may limit government interference with certain medical decisions; the court treated end-of-life treatment choice as within that protected sphere, at least as applied to this class of terminally ill patients.

## Conclusion

In Rutherford v. United States, the district court reviewed the FDA Commissioner’s post-hearing decision that Laetrile was an unapproved “new drug” and held that the agency could not bar its distribution to terminally ill cancer patients because Laetrile qualified for the FDCA’s 1962 grandfather exemption; alternatively, the court found that denying access impermissibly intruded on constitutionally protected privacy in personal medical decision-making.


Rutherford v. United States, 438 F. Supp. 1287 (1977)