## Facts

- In September 2000, the FDA approved mifepristone (RU-486) for medical abortion in the first 49 days of pregnancy.
- Judicial Watch submitted a FOIA request seeking all documents related to the FDA’s approval of mifepristone.
- After Judicial Watch did not receive records, it sued in the U.S. District Court for the District of Columbia to compel production; the court ordered the FDA to produce responsive documents by October 15, 2001.
- The FDA searched roughly 250,000 pages, released over 9,000 pages, withheld more than 4,000 documents in full, and partially withheld nearly 2,000 additional documents.
- The FDA produced an approximately 1,500-page Vaughn index and submitted a declaration from the official overseeing the search and review process.
- Judicial Watch challenged the adequacy of the Vaughn index and the FDA’s reliance on FOIA Exemptions 4, 5 (including deliberative process), and 6.

## Issues

1. Whether the FDA’s Vaughn index and supporting declaration were sufficiently specific to permit judicial evaluation of the asserted FOIA exemptions.
2. Whether the FDA properly withheld records under FOIA Exemption 5’s deliberative-process privilege.
3. Whether the FDA properly withheld confidential commercial information under FOIA Exemption 4.
4. Whether the FDA properly redacted identifying information under FOIA Exemption 6.

## Decision

- The D.C. Circuit affirmed the district court’s summary judgment for the FDA in significant part.
- The court held that portions of the Vaughn index were inadequately detailed to permit meaningful review.
- The court remanded for the FDA to provide additional explanation and clarification for certain Vaughn index entries and related exemption claims.
- The court did not require blanket in camera review, favoring targeted supplementation where the index was deficient.

## Legal Principles

- A Vaughn index must describe each withheld document (or redaction), identify the claimed exemption, and explain why the exemption applies with enough specificity to allow adversarial testing and judicial review; boilerplate or conclusory descriptions are inadequate.
- Under FOIA Exemption 5, the deliberative-process privilege protects materials that are both predecisional (created before the relevant agency decision) and deliberative (reflecting consultative give-and-take); agencies must connect the record to the decisionmaking process with sufficient clarity.
- Under FOIA Exemption 4, commercial or financial information obtained from a private entity may be withheld when disclosure would likely impair the government’s ability to obtain similar information in the future or cause substantial competitive harm; the agency must provide document-specific justification that the material is confidential commercial information.
- Under FOIA Exemption 6, identifying details may be withheld when disclosure would constitute a clearly unwarranted invasion of personal privacy, based on balancing privacy interests against FOIA’s public interest in revealing the agency’s performance of its statutory duties.
- In FOIA summary judgment, courts may rely on reasonably detailed, nonconclusory affidavits and Vaughn submissions; in camera inspection is discretionary and generally unnecessary where the agency’s explanations permit review.

## Conclusion

The D.C. Circuit upheld many FDA FOIA withholdings concerning mifepristone but required remand where the agency’s Vaughn index failed to provide enough document-specific detail to evaluate claimed exemptions, reaffirming that voluminous indexing cannot substitute for meaningful explanatory content.


Judicial Watch, Inc. v. Food & Drug Admin., 449 F.3d 141 (D.C. Cir. 2006)