Ciba Corp. v. Weinberger

Background

A drugmaker that made Ritonic Capsules had an older FDA approval that became effective in 1959 after showing the drug was safe. Congress in 1962 changed the law to require that older approvals also show substantial evidence of effectiveness. An expert panel reviewed Ritonic’s claims and found the drug ineffective. The FDA said the company had not provided adequate evidence of efficacy, notified the company that it planned to withdraw the approval (which would make future sales unlawful), and offered a hearing. The company submitted data but the agency found it insufficient, withdrew the approval, and the Second Circuit upheld that withdrawal. Separately, the company sued in a New Jersey district court for a declaratory judgment and injunction, but that court dismissed for lack of jurisdiction and the Third Circuit affirmed.

Reasoning

The core question was whether the FDA itself may decide in its administrative process whether a product qualifies as a "new drug" under the revised law and thus whether approval can be withdrawn. The Court said yes. It explained that deciding whether a drug meets the statutory definition involves technical, scientific questions for experts, so the agency is the proper forum to make the threshold determination. The Court emphasized that the agency’s decision is subject to judicial review on appeal, and that allowing the company to relitigate the same coverage question in a separate district suit would undermine the agency’s ability to carry out its duties.

Real world impact

The ruling means drug companies with older approvals must raise efficacy and coverage questions before the FDA and may not pursue parallel district-court suits to avoid agency review. If the FDA withdraws approval, sales can become unlawful until approval is restored. The decision preserves administrative review as the main path, with judicial review available only through the review process described in the Act.