## Facts

- An FDA-supported clinical study (UGDP) reported that certain oral hypoglycemic drugs for adult-onset diabetes did not improve survival compared to diet alone and might increase cardiovascular mortality.
- After internal review and expert consultation, the FDA proposed and then finalized labeling changes for oral hypoglycemic drugs to warn of a potential increased cardiovascular hazard.
- A group of physicians who treated diabetes, joined by one patient using oral hypoglycemic drugs, petitioned the FDA to rescind or modify the proposed labeling, sought access to UGDP raw data, and requested that labeling present “balanced” opposing views.
- The FDA issued final labeling language and a detailed response addressing scientific criticisms, and it denied requests for a formal evidentiary hearing.
- Plaintiffs sued to enjoin implementation of the labeling changes and to prevent manufacturers from changing labels in response to the FDA’s directives.
- After initial denials, the district court granted a preliminary injunction based largely on new litigation affidavits asserting substantial medical controversy and concluding the labeling likely failed regulatory and statutory “fair balance” requirements; it also treated the FDA’s action as final for APA review.
- The government appealed.

## Issues

1. Whether preliminary injunctive relief was proper when plaintiffs had not adequately exhausted available administrative remedies within the FDA.
2. Whether APA review could be based on litigation-generated expert affidavits rather than the administrative record before the FDA when it acted.
3. Whether, and on what terms, the FDA’s labeling decision was sufficiently final for judicial review, given the technical scientific judgments involved.

## Decision

- The First Circuit vacated the preliminary injunction and remanded.
- The court held the district court acted prematurely because plaintiffs had not sufficiently exhausted administrative remedies.
- The court held the district court improperly relied on litigation affidavits and other extra-record materials instead of reviewing the FDA’s action on the administrative record.
- The court emphasized that evaluation of disputed scientific studies and the content of drug warnings is primarily committed to FDA expertise, subject to limited APA review.

## Legal Principles

- Judicial review under the APA generally must be confined to the administrative record that was before the agency at the time of decision; courts should not conduct de novo technical factfinding through post-hoc expert affidavits.
- Exhaustion of administrative remedies is especially important where the agency must first interpret and apply its own regulations in a scientifically complex setting; premature injunctive relief is disfavored.
- Courts reviewing scientific and medical determinations must apply deferential APA standards (e.g., arbitrary-and-capricious review) rather than reweighing competing expert views.
- Even when agency action is plausibly final for APA purposes, equitable relief should not issue without a proper administrative sequence and record-based evaluation of likely success on the merits.

## Conclusion

The First Circuit set aside a preliminary injunction that blocked FDA-mandated diabetes-drug warning labels, holding that challengers must pursue available agency processes and that any APA review must be anchored in the FDA’s administrative record, with courts refraining from substituting their own evaluation of contested scientific evidence.


Bradley v. Weinberger, 483 F.2d 410 (1st Cir. 1973)