ProPublica Sues Food and Drug Administration Over Generic Drug Safety Records It Withheld

ProPublica reports that it has filed a federal lawsuit against the US Food and Drug Administration (FDA), alleging that the agency unlawfully withheld records related to the safety and manufacturing origins of generic drugs in violation of the Freedom of Information Act (FOIA).

ProPublica, Inc. v. U.S. Food and Drug Administration, filed in a New York federal court, challenges the FDA’s refusal to promptly release information that ProPublica contends is critical to public understanding of drug safety, given growing concerns about generics manufactured in overseas facilities with troubled compliance histories.

The FDA has begun releasing some records, but the case remains active.

ProPublica initiated four FOIA requests in 2023 to obtain records that would shed light on the FDA’s oversight of generic drug manufacturing, particularly factories in India.

While inspection reports detailing violations at these plants are public, the FDA typically redacts the specific drugs produced at those sites.

ProPublica argues that this lack of transparency leaves consumers, pharmacists, and policymakers in the dark about whether drugs from noncompliant facilities continue to be sold on the market.

The agency initially denied expedited processing, citing a lack of compelling need.

The lawsuit emphasizes that many generics continued to reach American patients even after manufacturing violations were identified and facilities were banned, due to special exemptions granted by the FDA.

In response to litigation, the Food and Drug Administration has begun disclosing some requested documents but has not fully complied. A similar lawsuit by ProPublica over withheld records related to a Philips Respironics recall ultimately led to the release of documents.

The lawsuit highlights the FDA’s discretionary limits, as of July 2, 2025, and potential litigation exposure when redacting safety-critical information, especially in cases with clear public health implications. Lawyers advising clients in pharmaceutical, regulatory, or transparency litigation might take note of the strategic utility of FOIA in investigative advocacy.