Forsham v. Harris
Headline: Court limits FOIA access to privately held research data, ruling federally funded researchers’ raw study records need not be disclosed unless a federal agency actually obtained them, affecting medical reviewers and regulators.
Holding:
- Makes it harder for independent reviewers to get raw federally funded research data kept by private grantees.
- Allows federal agencies to avoid FOIA disclosure unless they acquire or possess grantees’ records.
- Affects medical regulators, drug labeling reviews, and public access to clinical-study evidence.
Summary
Background
A private group of physicians and scientists ran a long-term diabetes study (the UGDP) that produced over 55 million patient records. The Committee on the Care of the Diabetic asked for the UGDP’s raw data. The UGDP was funded by federal grants of about $15 million from a federal health institute (NIAMDD), and federal agencies such as HEW and the FDA relied on or reviewed parts of the study in regulatory actions. The UGDP kept the records and the granting agency never obtained permanent custody of the raw data.
Reasoning
The Court addressed whether those privately held, federally funded study records were “agency records” under the Freedom of Information Act (FOIA). It held they are not unless a federal agency actually created or obtained the records. The opinion explains that Congress excluded ordinary grantees from the statutory definition of “agency,” accepted that grants preserve grantee autonomy, and emphasized that FOIA applies to records an agency has made or received, not to documents the agency merely could access or relied upon.
Real world impact
The ruling means outside reviewers cannot force federal agencies to produce privately held research data under FOIA unless the agency has the records in its possession. That outcome affects medical researchers, regulators, and members of the public who seek raw data supporting agency decisions. The decision affirms lower courts’ judgments denying FOIA relief in this case.
Dissents or concurrances
A dissent argued for a broader test: where the government funded, supervised, relied on, and had access to data, those records should count as agency records to protect public oversight and democratic accountability.
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