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FDA Redactions Upheld in FOIA Suit for Drug Approval Documents

Oct. 7, 2020, 12:42 AM

The Food and Drug Administration correctly redacted documents regarding the approval of a drug, based on a Supreme Court ruling on the application of the Freedom of Information Act, a federal judge in New York said Tuesday.

Charles Seife, a science writer and journalism professor sued the agency under FOIA in the U.S. District Court for the Southern District of New York, seeking records related to the accelerated approval of eteplirsen, a drug created by Sarepta Therapeutics Inc. for the treatment of a rare neuromuscular disease.

The decision to grant the drug accelerated approval was controversial, because while the FDA’s advisory committee concluded Sarepta’s studies failed to show substantial evidence that eteplirsen would provide a clinical benefit, the head of the Center for Drug Evaluation and Research intervened and unilaterally granted accelerated approval.

The FDA ultimately produced 45,000 pages, adopting several redactions proposed by Sarepta, based on the company’s assertion that they covered confidential commercial information, and were therefore exempt from disclosure under FOIA.

Seife challenged several of the redactions relating to clinical study procedures and results, exploratory endpoints, and unrelated adverse events. While the parties’ cross-filings for summary judgment were pending, the Supreme Court granted review in Food Marketing Institute v. Argus Leader Media, which also concerned a FOIA exemption for confidential documents.

In Argus Leader, the Supreme Court rejected the test of confidentiality adopted by the D.C. Circuit in Nat’l Parks & Conservation Ass’n v. Morton, which deemed information confidential if its disclosure would either impair the government’s ability to obtain information in the future, or cause substantial harm to the competitive position of the party providing the information.

To qualify as confidential, the documents just had to be customarily kept private, or at least held closely by the person imparting it, the Supreme Court said.

Applying Argus Leader, Judge Jesse M. Furman upheld the redactions, rejecting Seife’s argument that the documents had not been kept confidential because Sarepta had publicized it when submitting an application for market approval of the drug in Europe, and collaborated with third parties.

Seife provided no evidence the published report contained the same information as the requested documents, and limited disclosures not made to the general public don’t preclude exemption, Furman said. Further, Seife failed to undermine the conclusion that Sarepta had consistently maintained the confidentiality of the information.

Additionally, Argus Leader’s second condition could also apply, Furman said, because the information Sarepta provided to the FDA was under an assurance of privacy.

Cornell Law School First Amendment Clinic, New York University School of Law, Knight First Amendment Institute at Columbia University, Novak & MacEy LLP, Williams Simons & Landis PLLC, and Ballard Spahr LLP represent Seife. The U.S. Attorney’s Office represents the FDA. Arnold & Porter Kaye Scholer LLP represents Sarepta.

The case is Seife v. Food & Drug Admin., 2020 BL 385289, S.D.N.Y., No. 17-CV-3960, 10/6/20.

To contact the reporter on this story: Maeve Allsup in San Francisco at

To contact the editors responsible for this story: Rob Tricchinelli at; Meghashyam Mali at