## Facts

- After the 1962 amendments to the Federal Food, Drug, and Cosmetic Act (FDCA), FDA used NAS–NRC expert panel evaluations to reassess effectiveness of certain previously approved drugs.
- FDA found a lack of substantial evidence that pentylenetetrazol-containing drugs were effective for their intended uses and announced intent to initiate proceedings to withdraw the relevant new drug applications (NDAs).
- FDA took the position that withdrawing an NDA would affect marketing of “me-too” drugs of similar composition, even if those products were not expressly covered by an effective NDA, and invited submission of adequate and well-controlled studies.
- Only one NDA holder submitted additional data; FDA found it insufficient and withdrew the NDAs. No appeal was taken from the withdrawal orders.
- Bentex and other marketers sold pentylenetetrazol “me-too” products not covered by an effective NDA and sought a declaratory judgment that their products were not “new drugs” because they were generally recognized as safe and effective, or alternatively that they fell within the 1962 grandfather clause.

## Issues

1. Whether FDA has authority and primary responsibility to determine in the first instance, through administrative proceedings, whether a marketed product is a “new drug” under FDCA § 201(p) requiring an NDA.
2. Whether eligibility for the 1962 grandfather clause should likewise be determined initially by FDA rather than decided de novo by a district court.
3. How judicial review applies to FDA determinations of “new drug” status and grandfather eligibility as distinct from NDA withdrawal or denial.

## Decision

- The Supreme Court unanimously reversed the Fourth Circuit.
- The Court held that FDA has primary responsibility to decide whether a drug is a “new drug” within § 201(p) and whether it qualifies under the 1962 grandfather clause.
- The Court approved the District Court’s decision to require these questions to be addressed first in FDA administrative proceedings.
- The Court indicated that FDA determinations on “new drug” status and grandfather eligibility are subject to judicial review under the Administrative Procedure Act (APA), rather than initial fact-finding in court.

## Legal Principles

- Determinations of “general recognition” of safety and effectiveness under FDCA § 201(p) involve technical scientific questions appropriately addressed initially by FDA.
- Under primary-jurisdiction principles, courts should allow an expert agency to make first-instance determinations when issues are bound up with technical factual assessments entrusted to the agency.
- Direct court-of-appeals review under FDCA § 505(h) applies to orders denying or withdrawing NDAs; other FDA administrative determinations (such as “new drug” status as such) are reviewed under the APA in district court.
- Whether a product meets the 1962 grandfather clause criteria (including continuity of composition and labeling) also presents factual and scientific issues for initial FDA determination, subject to APA review.
- Parties affected by FDA’s efficacy and regulatory determinations, including marketers of “me-too” products, may participate in agency processes and later obtain judicial review on the administrative record.

## Conclusion

The Court required that disputes over whether pentylenetetrazol “me-too” products were “new drugs” or qualified for the 1962 grandfather exemption be decided first by FDA, with courts limited to APA review rather than making initial technical determinations through declaratory-judgment litigation.


Weinberger v. Bentex Pharms., Inc., 412 U.S. 645 (1973)