## Facts

- The FDA issued a final regulation, 21 C.F.R. § 310.515, requiring specified estrogen drug products to include an FDA-authored patient package insert.
- The insert was required to be provided to patients each time the drug was dispensed or administered.
- The mandated insert contained standardized risk-benefit and use information, including warnings about serious risks associated with estrogen therapy.
- A prescription-drug manufacturers trade association and several medical and pharmacy organizations sought declaratory and injunctive relief to bar enforcement of the regulation.
- Plaintiffs argued the FDA lacked statutory authority under the FDCA, the rule improperly intruded into the physician-patient relationship and compelled speech, and the rule was arbitrary and capricious.
- The case was resolved on cross-motions for summary judgment (or equivalent requests for final judgment) addressing the regulation’s validity.

## Issues

1. Whether the FDCA authorized the FDA to require that certain prescription estrogen drugs be dispensed with a patient-directed package insert containing specified information.
2. Whether the regulation unconstitutionally interfered with the physician-patient relationship or violated physicians’ First Amendment rights.
3. Whether the regulation was arbitrary, capricious, or otherwise unlawful under the Administrative Procedure Act in light of the administrative record.

## Decision

- The court upheld 21 C.F.R. § 310.515 and denied relief sought by the challengers.
- The court held the FDCA’s misbranding and labeling provisions authorized the FDA to require patient package inserts for certain prescription drugs.
- The court rejected constitutional objections, concluding the rule required distribution of written drug information and did not control physicians’ medical advice or bar additional physician speech.
- The court found the rule was not arbitrary or capricious because the FDA identified safety concerns and supported the requirement with a reasoned explanation grounded in the record.

## Legal Principles

- The FDCA grants the FDA broad discretion to determine what labeling is necessary to prevent a drug from being misbranded, including requiring patient-directed written materials when needed for safe use.
- FDA-required patient package inserts are treated as part of regulated “labeling” and may be mandated for particular drugs based on demonstrated risk and public-health concerns.
- A requirement that regulated products be accompanied by specified written information generally does not, by itself, constitute unconstitutional interference with physician speech where physicians remain free to counsel patients and supplement or disagree with the written material.
- Under APA review, a labeling rule will be upheld if the agency examined the relevant evidence, responded to material comments, and articulated a rational connection between the record and the regulatory choice.

## Conclusion

The court sustained the FDA’s estrogen patient package insert regulation as a lawful exercise of FDCA labeling authority, rejecting claims that it exceeded statutory power, violated constitutional rights related to physician communication, or lacked a reasoned basis under the APA.


Pharmaceutical Mfrs. Ass’n v. Food & Drug Admin., 484 F. Supp. 1179 (D. Del. 1980)