## Facts

- Public Citizen Health Research Group submitted a FOIA request to the FDA seeking records about investigational and related drug applications that were discontinued for health or safety reasons.
- The requested records included materials from investigational new drug applications (INDs) and related submissions that contained clinical protocols, safety and efficacy data, and technical information.
- The FDA withheld portions of the requested records, asserting FOIA Exemption 4 for confidential commercial information.
- Schering Corporation, whose IND materials were among the requested records, intervened to support nondisclosure.
- Public Citizen argued that the withheld information was not confidential under Exemption 4 and that 21 U.S.C. § 355(l) required greater disclosure than FOIA.

## Issues

1. Whether the FDA could withhold IND-related records under FOIA Exemption 4 as confidential commercial information.
2. Whether 21 U.S.C. § 355(l) imposes a stricter nondisclosure standard than FOIA Exemption 4, requiring disclosure of information otherwise protected by Exemption 4.
3. Whether FOIA required release of reasonably segregable nonexempt portions of the requested records.

## Decision

- The D.C. Circuit affirmed in part, reversed in part, and remanded.
- The court rejected the district court’s conclusion that 21 U.S.C. § 355(l) creates a “higher” nondisclosure standard that displaces or narrows FOIA Exemption 4.
- The court held that some IND material could properly be withheld under Exemption 4 because disclosure would likely cause substantial competitive harm.
- The court required a more detailed, document-by-document (and portion-by-portion) analysis to determine what was exempt and what was segregable and releasable.

## Legal Principles

- FOIA Exemption 4 protects trade secrets and confidential commercial or financial information obtained from a private party.
- In this circuit’s Exemption 4 framework, commercial information is “confidential” if disclosure would likely impair the government’s ability to obtain necessary information in the future or cause substantial competitive harm to the submitter.
- 21 U.S.C. § 355(l) must be read consistently with FOIA and does not independently override or tighten FOIA’s Exemption 4 protections for confidential commercial information in drug-application records.
- FOIA requires agencies and courts to release any reasonably segregable nonexempt portions of responsive records after redacting exempt material, supported by sufficiently specific justifications.

## Conclusion

The D.C. Circuit held that FOIA Exemption 4 can protect commercially sensitive IND submissions from disclosure, and that 21 U.S.C. § 355(l) does not impose a separate, stricter standard that compels disclosure of Exemption 4 material; the case was remanded for a granular segregability review to determine which portions must be released.


Public Citizen Health Research Grp. v. Food & Drug Admin., 185 F.3d 898 (D.C. Cir. 1999)