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Seife v. FDA

Cornell’s First Amendment Clinic, as co-counsel with Yale Law School’s Media Freedom and Information Access Clinic and Vinson & Elkins LLP, represents plaintiff and veteran investigative journalist Charles Seife in a case before Judge Jesse Furman in the Southern District of New York. The case involves the Freedom of Information Act (FOIA) Exemption 4, and the impact of the Supreme Court’s 2019 decision in Food Marketing Institute v. Argus Leader (FMI). Seife is seeking access to clinical trial data used by the Food and Drug Administration (FDA) in the controversial approval of Exondys 51, a drug to treat Duchenne Muscular Dystrophy. In summary judgment papers filed in 2019, we argued that the 2016 FOIA amendments limit the scope of the FMI decision, and that even under the Supreme Court’s new test, Seife should prevail in his efforts to obtain critical information related to the efficacy of an important FDA-approved drug. We also argued that the textualist approach employed by the Court in FMI applies equally to a new standard, enacted by Congress in 2016, known as the “foreseeable harm” requirement.  This standard requires agencies to reasonably foresee a harm from disclosure of the sought-after information before blocking its release. We further argued that the 2016 amendments incorporated into FOIA a public interest in “knowing what the government is up to,” as well as a rigorous standard for the new FMI test that does not simply allow the government to state that information is “confidential” to render it so. The case is now fully submitted and we are awaiting a decision. The case will provide significant insight as to how lower courts will apply FMI.


According to Seife: “Journalists, especially freelancers, often don’t have the resources to fight in court for information withheld by the government. In this case, however, [the team has] made it possible to push for documents that are important for the public to understand not just what the government is doing behind the scenes when it approves drugs, but also crucial to understanding the safety and effectiveness of new medications.”


Related Documents:

Seife Combined Cross Motion in Opposition to the Defendants’ Motions for Summary Judgment and Cross Motion for Summary Judgment (PDF)

Seife Reply Brief In Further Support of (1) Seife’s Motion for Summary Judgment and (2) Seife’s Motion to Strike (PDF)

Declaration of Charles Seife (PDF)

Reply Declaration of Charles Seife (PDF)

Declaration of Dr. Peter Lurie (PDF)

Reply Declaration of Dr. Peter Lurie (PDF)

Declaration of Dr. Diana Zuckerman (PDF)

Declaration of Cortelyou C. Kenney (PDF)


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