Health Law Daily Wrap Up, PRESCRIPTION DRUGS—D.D.C.: FDA may provide more information on ‘foreseeable harm’ limiting Levaquin FOIA release, (Aug 18, 2026)

By Steven Melendez

A federal judge found the agency conducted an adequate search for requested information and allowed it to provide more information on why it withheld certain records from release.

In a suit brought by Freedom Watch, Inc., under the Freedom of Information Act (FOIA) against the Food and Drug Administration (FDA), a federal court granted summary judgment for the FDA about the adequacy of its search for records. But the court denied the FDA’s motion for summary judgment on the appropriateness of its withholding of certain records, allowing the FDA to provide more information about “foreseeable harm” from releasing the files, as required to withhold information under current law (Freedom Watch, Inc. v. FDA, No. 16-cv-1981 (JMC) (D.D.C. Aug. 13, 2026)).

Background. In June 2016, Freedom Watch sent a FOIA request to the FDA seeking 25 categories of information, mostly related to “correspondence related to the antibiotic drug Levaquin,” including “communications” involving “former FDA Commissioner Dr. Margaret Hamburg,” according to the ruling in the case.

The FDA released more than 1,700 pages of material, withholding some pages in full while redacting portions of others. The withheld information was covered by FOIA exemptions, according to the FDA. Three records were redacted under Exemption 4, which covers confidential commercial information, another was redacted under Exemption 5, which covers “inter-agency or intra-agency memorandums or letters that would not be available by law to a party other than an agency in litigation with the agency,” and several were redacted under Exemption 6, which addresses “personnel and medical files and similar files” whose “disclosure . . . would constitute a clearly unwarranted invasion of personal privacy.”

Freedom Watch sued to challenge the FDA’s response and filed a motion for in camera review, while the FDA moved for summary judgment, arguing it had demonstrated that it conducted an adequate search and properly applied the various FOIA exemptions. Freedom Watch argued summary judgment is premature, since it says the government has not demonstrated the adequacy of its search or reliance on exemptions.

Records search. The government provided two affidavits explaining how it conducted its search. Its main FOIA office identified four FDA offices likely to have relevant records: the Office of the Commissioner, the Office of Legislation, the Office of the Executive Secretariat, and the Center for Drug Evaluation and Research. It ran searches for relevant documents at each, including using a series of “search terms and Boolean connectors” to search the former commissioner’s archived emails, similarly searching for requested communication with certain senators at the Office of Legislation, searching the former commissioner’s “paper files” at the Office of the Executive Secretariat, and searching databases at the Center for Drug Evaluation and Research.

Freedom Watch argued the FDA failed to sufficiently describe the records searched, “who conducted the search,” or what the search process looked like. But, the court found, the FDA did adequately describe the type of records searched, including describing the archived emails, paper files, and databases. And the FDA also provided “lots of detail in the declarations about ‘the search process,’” including identifying employees who conducted targeted searches, the digital search terms and Boolean operators used, and how paper records were searched.

Additionally, the court found, the FDA does not need to identify exactly which individual people conducted the search. Identifying agency components involved in the search and why they were chosen is sufficient, and the FDA has done that here, according to the ruling.

Withheld records. Under the FOIA Improvement Act, enacted by Congress in 2016, an agency can only withhold information under FOIA exemptions if it “reasonably foresees that a disclosure would harm an interested protected by an exemption” or if “disclosure is prohibited by law,” according to the ruling.

The FDA has not yet addressed the foreseeable harm requirement, according to the ruling, which prevents granting summary judgment to the government. But, the court found, the motions were briefed when few courts had yet analyzed this requirement, granting the FDA leave to provide more information and either party the option to address changes in law that have come since the motions were briefed.

The court also declined to order in camera review at this point in the case.

The case is No.16-cv-1981 (JMC).

Judge: Cobb, J.

Attorneys: Jonathon Alden Moseley (Jonathon Moseley, Attorney at Law) for Freedom Watch, Inc. Christina O'Tousa, U.S. Department of Justice, for U.S. Food and Drug Administration.

Companies: Freedom Watch, Inc.

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