Seife v. Food and Drug Administration

Background

Charles Seife sued the Food and Drug Administration (FDA) and the Department of Health and Human Services under the Freedom of Information Act (FOIA). He sought records about the testing and approval of eteplirsen, sold as Exondys 51, a drug developed by Sarepta Therapeutics, Inc. for Duchenne muscular dystrophy.

Under an agreed production schedule, the FDA released tens of thousands of pages. It withheld or redacted some information under FOIA Exemption 4, which protects trade secrets and confidential commercial or financial information obtained from another person. Sarepta later intervened as a defendant and participated in defending the redactions. Seife challenged redactions involving clinical-study procedures, study results, exploratory endpoints, adverse events, and related charts, tables, descriptions, and document identifiers. He did not challenge the adequacy of the FDA’s search or other redactions.

The parties filed renewed cross-motions for summary judgment. Summary judgment is a decision made without a trial when the undisputed record shows that one side is entitled to judgment under the law.

Confidentiality Under Exemption 4

The court applied the Supreme Court’s standard from Food Marketing Institute v. Argus Leader Media. Under that standard, commercial or financial information is confidential when its owner customarily and actually keeps it private or closely held; the court also noted that the Supreme Court had identified an assurance of privacy as a possible additional requirement.

The court did not decide whether the test has one or two required parts because it found both conditions satisfied. Sarepta’s declarations stated that it kept the information confidential through internal access restrictions, restricted databases, and nondisclosure agreements with outside providers. The declarations also stated that disclosure could allow competitors to copy or modify Sarepta’s study design, use its control data, learn about exploratory endpoints, and benefit from years of research and expense without making the same investment.

Seife argued that Sarepta had made the information public through a European Medicines Agency submission and through collaborations with third parties. The court rejected those arguments because Seife did not show that the publicly released materials contained information identical to the withheld material, and the third-party disclosures were limited and subject to confidentiality agreements. The court also held that the FOIA decision generally must be evaluated based on what was public when the agency made its decision, rather than later disclosures.

Foreseeable Harm

The court explained that a 2016 FOIA amendment requires an agency to withhold information only when disclosure would foreseeably harm an interest protected by an exemption or when disclosure is prohibited by law.

For the clinical-study procedures, the court held that FDA regulations prohibited disclosure of the confidential information at issue. The regulations generally make certain information in a drug application available after approval but protect qualifying trade secrets and confidential commercial information. The court concluded that the FDA lacked discretion to disclose the confidential study procedures under those regulations.

For the non-patient-level study results, endpoints, and adverse events, the court applied the foreseeable-harm requirement. It did not choose between competing approaches to that requirement because the defendants satisfied either approach. Disclosure would destroy the information’s confidential nature, and the declarations showed that disclosure would harm Sarepta’s competitive interests. The court emphasized the competition in developing Duchenne muscular dystrophy treatments and concluded that competitors could use the information to reduce the time and expense of developing competing products.

The court rejected Seife’s public-interest and public-health arguments. It acknowledged the controversy surrounding the FDA’s approval of Exondys 51 but held that FOIA provides no public-policy exception allowing disclosure when Exemption 4 and the foreseeable-harm requirement are satisfied.

Segregability and Disposition

FOIA requires agencies to release reasonably separable nonexempt portions of records. The court declined to conduct an in-camera review, meaning a private judicial inspection of the documents. It relied on the FDA’s Vaughn index and sworn declarations stating that the remaining redacted information was not public and was exempt. The court found that Seife had not shown that the withheld information was identical to publicly available information or otherwise provided a sufficient basis to question the FDA’s updated review.

Judge Furman granted the summary judgment motions of the FDA, HHS, and Sarepta and denied Seife’s cross-motion for summary judgment. The court stated that any remaining issues involving FOIA Exemption 6, which protects personal privacy, were moot because the redactions were proper under Exemption 4. The Clerk was directed to terminate the listed motions and close the case.