## Facts

- Hoffmann-LaRoche, Inc., a pharmaceutical manufacturer, held approved New Drug Applications (NDAs) for chlordiazepoxide products marketed as Librium and had historically waited for FDA approval before marketing.
- The FDA followed an internal approach for “me-too” drugs—products chemically equivalent to already-approved pioneer drugs—under which some me-too manufacturers could sell while relying on abbreviated submissions or while full NDA review was pending.
- The FDA justified this approach largely on limited compliance resources and the view that copies of approved drugs posed less need for intensive policing.
- During patent litigation involving chlordiazepoxide, Hoffmann-LaRoche learned that Zenith Laboratories, Inc. had shipped its chlordiazepoxide capsules in interstate commerce before obtaining FDA approval of an NDA for that product.
- Hoffmann-LaRoche filed suit in the U.S. District Court for the District of Columbia against the Secretary of Health, Education and Welfare and FDA officials, seeking declaratory and injunctive relief to stop the FDA from permitting marketing of me-too drugs without prior NDA approval.
- Hoffmann-LaRoche contended that the practice conflicted with the Food, Drug, and Cosmetic Act’s (FDCA) “new drug” provisions (including 21 U.S.C. §§ 331, 355) and that the FDA had effectively adopted a generally applicable rule without notice-and-comment procedures required by the Administrative Procedure Act (APA).
- Zenith intervened in the action. The parties filed cross-motions for summary judgment (with the government also seeking dismissal in the alternative).
- While the case was pending, the FDA approved Zenith’s NDA, but Hoffmann-LaRoche continued to press the broader challenge to the FDA’s general me-too policy.

## Issues

1. Whether the FDCA permits the FDA to allow a “me-too” (copy) new drug to be introduced into interstate commerce before the FDA has affirmatively approved an effective NDA under 21 U.S.C. § 355.
2. Whether the FDA’s general me-too policy amounted to a substantive rule that could not take effect without APA notice-and-comment procedures.

## Decision

- The court ruled for Hoffmann-LaRoche on the central statutory question and rejected the FDA’s position that it could tolerate pre-approval marketing of me-too drugs.
- The court held that the FDCA’s premarket approval scheme requires affirmative FDA approval of an NDA before a “new drug” may be introduced or delivered for introduction into interstate commerce.
- The court concluded that me-too drugs are not exempt from § 355 simply because they are chemically equivalent to previously approved products.
- The court determined that the FDA could not defend a broad, generally applied nonenforcement approach that functioned as an exception to Congress’s preclearance requirement.
- The court granted appropriate declaratory relief invalidating the FDA policy to the extent it permitted marketing of new drugs without prior NDA approval, and denied the government’s contrary request for summary judgment (or dismissal) insofar as it sought to sustain that policy.

## Legal Principles

- The FDCA bars interstate marketing of any “new drug” unless an effective NDA is in place; the statute demands approval first, not review after marketing begins.
- A copy or chemically equivalent product may still be a “new drug” subject to § 355; similarity to an approved pioneer drug does not create a statutory carveout.
- Limited agency resources and enforcement priorities do not authorize an agency to permit conduct that the statute forbids, especially where the statutory scheme is a premarket gatekeeping regime.
- An agency may exercise case-by-case enforcement discretion, but it may not implement a generally applicable policy that operates like a standing exception to a statutory approval requirement.
- Where an agency policy operates with binding effect on regulated parties’ ability to market products, it raises serious APA concerns if adopted without notice and opportunity for public comment.

## Conclusion

Hoffmann-LaRoche, Inc. v. Weinberger held that the FDA’s me-too drug approach was unlawful to the extent it allowed copy drugs to enter interstate commerce before FDA approval of an effective NDA, because the FDCA imposes a mandatory premarket approval requirement that the agency could not set aside through a broad compliance policy.


Hoffmann-LaRoche, Inc. v. Weinberger, 425 F. Supp. 890 (1975)