Court Sides with Clinics on Freedom of Information Act Exemptions


In a precedent-setting case, a court agreed with three First Amendment clinics that a Freedom of Information Act (FOIA) exemption for confidential commercial information is not meant to protect confidentiality for the sake of confidentiality.

The Media Freedom and Information Access Clinic (MFIA) at Yale Law School, working with clinics at Cornell Law School and the SMU Dedman School of Law, brought the case.

Seife v. FDA concerns a journalist who requested clinical trial data from the Food and Drug Administration related to its approval of a drug. The FDA held that it could withhold the documents, which the drug maker deemed confidential, under an exemption for privileged business information. Now, an appeals court — the first to consider a standard imposed in 2016 — has ruled that agencies cannot withhold such information under this exemption simply because the information is confidential.  

“In recent years, agencies have rampantly overused exemptions to FOIA in ways that limit public oversight produce a less informed electorate,” said MFIA director David Schulz ’78. “By ensuring that exemptions are applied only for their intended purpose, this ruling represents a significant win for transparency and accountability.”  

The plaintiff is Charles Seife, an award-winning science reporter and journalism professor at New York University. Seife was seeking documents from the FDA related to its approval of Exondys 51, a drug created by pharmaceutical company Sarepta for the treatment of a form of muscular dystrophy. The drug’s approval was controversial, in part because some of the FDA’s own experts recommended against its approval and the agency itself acknowledged that the drug’s clinical trials were flawed.

The FDA largely rejected Seife’s request for information because Sarepta considered the documents confidential. According to the agency, clinical trial data and other information Seife sought were covered under exemption 4, which permits an agency to withhold all third-party commercial or financial information if the party considers the information confidential.

The clinics’ case against the FDA centered around a 2016 amendment to exemption 4 that sought to limit agencies’ overuse of FOIA exemptions. According to the amendment’s “foreseeable harm” standard, an agency must disclose even exempt information unless it can show that disclosure would foreseeably harm the third party’s business interests.

For several decades, courts construed exemption 4 narrowly, allowing confidential information to be withheld only if its disclosure would cause competitive harm. But this practice was upended by Food Marketing Institute v. Argus Leader, a 2019 Supreme Court decision holding that all confidential commercial and financial falls under exemption 4 and can be withheld whether or not its release would cause harm.

On Aug. 5, 2022, a ruling of first impression by the United States Court of Appeals for the Second Circuit held that the exemption intends to avoid commercial harm from the disclosure of certain confidential business information. Under the 2016 FOIA amendments, the court ruled, the FDA was required to demonstrate both that the withheld information is confidential and that its disclosure would harm the commercial interests of Sarepta. 

Under the Second Circuit’s ruling, federal agencies are now required to disclose confidential commercial and financial information from third parties unless the agencies can show that disclosing this material will foreseeably harm the commercial interests of the entity that provided the information.

The decision ultimately affirms the FDA’s decision to withhold much of the information Seife sought from the agency. However, the court rejected the FDA’s contention that information can be withheld under exemption 4 simply by virtue of its being confidential.

Seife is satisfied with the outcome. 

“The decision circumscribes exemption 4 in a really important way,” Seife said. “In my future FOIA requests, I will be able to quote this every time and make sure FOIA officers understand that they must be able to show a foreseeable harm from disclosure in order to withhold confidential commercial information.”

The Seife case originated in 2016 when Cortelyou C. Kenney, then a staff attorney at Yale’s Collaboration for Research Integrity and Transparency (CRIT), contacted MFIA. There had been recent scandals involving drugs that turned out to be less safe and effective than pharmaceutical companies’ analysis of trial data suggested. Kenney asked whether a lawsuit might promote transparency for clinical trial data. Working with Kenney, MFIA initiated the case in tandem with a team of pro bono lawyers at Vinson and Elkins headed by Thomas Leatherbury ‘79.  

When Kenney moved to Cornell Law School to become Associate Director of its First Amendment Clinic, a Cornell team joined the ongoing effort. The case went through three rounds of summary judgment briefing in the district court before finally landing in the Second Circuit Court of Appeals last year. 

Kenney believes the years of effort were worthwhile. 

“This case sets a vital precedent,” Kenney said. “The Second Circuit is the first Court of Appeals in the nation to take up the question of the meaning of the foreseeable harm standard under the 2016 amendments, and this ruling will have an important spillover effect as other circuits address the issue.”

Many Yale Law School students contributed to this case over the past five years, including Sam Aber ’22, Mark Dore ’18, James Fitch ’21, Erik Frederickson ’22, Anna Kaul ’21, Aislin Klos ’18, Catherine Martinez ’19, Abby McCourt ’19, Katie Ning ’22, Adam Pan ’18, Shannon Price ’18, Stephanie Rice ’23, Emily Shire ’20, Kelsey Stimson ’20, Katherine Summa ’21, and Anna Windemuth ’18. The students were supervised by MFIA Director David Schulz ’78, MFIA Fellows John Langford ’14 and Jennifer Pinsoff, CRIT Directors Amy Kapczynski ’03 and Margaret McCarthy, and CRIT Fellows Jeanie Kim and Christopher Morten. 

The Media Freedom and Information Access Clinic (MFIA) is a law student clinic dedicated to increasing government transparency, defending the essential work of news gatherers, and protecting freedom of expression by providing pro bono legal services, pursuing impact litigation and developing policy initiatives.