## Facts

- A nonprofit consumer health advocacy group submitted a FOIA request to the FDA seeking clinical-study records about intraocular lenses (IOLs), including information reflecting adverse reactions and complications.
- The requested records were generated in connection with ongoing manufacturer-run clinical studies aimed at obtaining FDA approval to market IOLs.
- Manufacturers provided the clinical data to the FDA pursuant to regulatory requirements and treated significant portions as nonpublic and commercially sensitive.
- The FDA denied disclosure, invoking FOIA Exemptions 3 and 4; HHS reviewed the denial, and IOL manufacturers intervened to oppose disclosure.
- The district court granted summary judgment for the FDA, HHS, and the intervenors, concluding the records were exempt under FOIA Exemptions 3 and 4.
- The requester appealed.

## Issues

1. Whether the FDA could withhold the IOL clinical-study records under FOIA Exemption 3 based on provisions of the Food, Drug, and Cosmetic Act and related statutes allegedly barring disclosure.
2. Whether the records qualified for FOIA Exemption 4 as trade secrets or confidential commercial information obtained from a person.
3. Whether the FDA satisfied FOIA’s duty to disclose reasonably segregable nonexempt portions of the records.

## Decision

- The court held Exemption 3 did not justify withholding because the cited statutes did not specifically exempt the requested materials from disclosure in the manner Exemption 3 requires.
- The court held Exemption 4 applied to substantial portions of the IOL clinical-study submissions because the data constituted commercial information and was confidential.
- The court largely sustained nondisclosure under Exemption 4 but required a more precise, record-specific application of Exemption 4 and segregability principles for any portions potentially releasable without revealing protected commercial information.

## Legal Principles

- FOIA exemptions are construed narrowly, but courts apply their plain terms where the exemption’s requirements are met.
- Exemption 3 applies only when a statute clearly and specifically requires withholding (or sets particular withholding criteria or identifies particular matters to be withheld); general confidentiality provisions do not automatically bar disclosure of an entire category of records.
- Clinical safety and efficacy data submitted to a regulator by manufacturers can constitute “commercial” information under Exemption 4 when tied to product development, approval strategy, and market competition.
- Information is “confidential” under Exemption 4 where disclosure is likely to cause substantial competitive harm or impair the government’s ability to obtain needed information in the future.
- Agencies must release any reasonably segregable nonexempt material, but segregability does not require disclosure of fragments that remain intertwined with protected commercial content.

## Conclusion

The D.C. Circuit rejected the FDA’s reliance on Exemption 3 because the cited statutes did not specifically bar disclosure, but it held that substantial portions of manufacturers’ IOL clinical-study submissions could be withheld under Exemption 4 as confidential commercial information, subject to careful segregability and record-specific review.


Pub. Citizen Health Rsch. Grp. v. Food & Drug Admin., 704 F.2d 1280 (D.C. Cir. 1983)