Seife v. U.S. Food & Drug Admin.
| Decision Date | 05 August 2022 |
| Docket Number | Docket No. 20-4072-cv,August Term 2021 |
| Citation | 43 F.4th 231 |
| Parties | Charles SEIFE, Plaintiff-Appellant, v. UNITED STATES FOOD AND DRUG ADMINISTRATION, United States Department of Health and Human Services, Defendants-Appellees, and Sarepta Therapeutics, Inc., Intervenor-Defendant-Appellee. |
| Court | U.S. Court of Appeals — Second Circuit |
Jared Carter (Cortelyou C. Kenney, Tyler Valeska, on the brief), First Amendment Clinic, Cornell Law School, Ithaca, NY, and Thomas S. Leatherbury, Vinson & Elkins LLP, Dallas, TX, and David A. Schulz, Media Freedom & Information Access Clinic, Yale Law School, New Haven, CT, for Plaintiff-Appellant.
Dominika Tarcynska, Assistant United States Attorney (Benjamin H. Torrance, Assistant United States Attorney, on the brief), for Audrey Strauss, United States Attorney for the Southern District of New York, New York, NY, for Defendants-Appellees.
Kristen E. Ittig (Daniel R. Bernstein, Stuart W. Turner, Amanda J. Sherwood, and Aime Joo, on the brief), Arnold & Porter Kaye Scholer LLP, Washington, DC, and New York, NY, for Intervenor-Defendant-Appellee.
Before: Chin, Lohier, and Robinson, Circuit Judges.
In this case, intervenor-defendant-appellee Sarepta Therapeutics, Inc. ("Sarepta") obtained accelerated approval from defendant-appellee the Food and Drug Administration (the "FDA") for a drug Sarepta created to treat a neuromuscular disease. During the approval process, which spanned some nine years, Sarepta submitted tens of thousands of pages of documents to the FDA, an agency within defendant-appellee Department of Health and Human Services ("HHS," and, together with Sarepta and the FDA, "Defendants").
Plaintiff-appellant Charles Seife, a science writer and journalism professor who has written about FDA practices, made a request to the FDA and HHS under the Freedom of Information Act ("FOIA"), 5 U.S.C. § 552, for documents submitted by Sarepta as part of the approval process. After the FDA constructively denied his request, Seife brought this action below.
During the course of the lawsuit, the FDA produced over 45,000 pages of records but redacted some pages pursuant to Exemption 4 of FOIA, which shields from disclosure "trade secrets and commercial or financial information obtained from a person and privileged or confidential." 5 U.S.C. § 552(b)(4). The district court held that the redactions were proper because the information fell within Exemption 4 and met the additional requirement set by the FOIA Improvement Act of 2016 (the "FIA"). Under the FIA, an agency shall withhold information under FOIA only if "the agency reasonably foresees that disclosure would harm an interest protected by an exemption" or if disclosure is "prohibited by law." 5 U.S.C. § 552(a)(8)(A). The principal issue presented on appeal is whether the district court correctly concluded that Defendants satisfied the foreseeable harm requirement. To answer that question, we must first discern the interests protected by Exemption 4.
We hold that the interests protected by Exemption 4 are the submitter's commercial or financial interests in information that is of a type held in confidence and not disclosed to any member of the public by the person to whom it belongs. Because Defendants have shown as a matter of law that the contested information falls within Exemption 4 and that disclosure would foreseeably harm Sarepta's commercial or financial interests, we AFFIRM the district court's grant of summary judgment for Defendants and denial of summary judgment for Seife.
Since 1967, FOIA has provided the public the right to request access to federal agency records or information. The statute reflects "a general philosophy of full agency disclosure unless information is exempted under clearly delineated statutory language." Dep't of the Air Force v. Rose , 425 U.S. 352, 360-61, 96 S.Ct. 1592, 48 L.Ed.2d 11 (1976). Such statutory exemptions include, inter alia , Exemption 4, which provides that an agency need not disclose "trade secrets and commercial or financial information obtained from a person and privileged or confidential." 5 U.S.C. § 552(b)(4). The agency has the burden of "justify[ing] the withholding of any requested documents." U.S. Dep't of State v. Ray , 502 U.S. 164, 173, 112 S.Ct. 541, 116 L.Ed.2d 526 (1991). "All doubts are resolved in favor of disclosure." Bloomberg, L.P. v. Bd. of Governors of the Fed. Reserve Sys. , 601 F.3d 143, 147 (2d Cir. 2010) (quoting Local 3, Int'l Bd. of Elec. Workers v. Nat'l Labor Rels. Bd. , 845 F.2d 1177, 1180 (2d Cir. 1988) ) (cleaned up).
In 2016, Congress enacted the FIA out of concern that "some agencies [were] overusing FOIA exemptions." S. Rep. No. 114-4 (2015), as reprinted in 2016 U.S.C.C.A.N. 321, 322. The FIA thus further limited agency withholding of requested documents. This reform codified executive branch policies adopting "a presumption in favor of disclosure [under FOIA]." Memorandum on the Freedom of Information Act, 74 Fed. Reg. 4683, 4683 (Jan. 21, 2009).1
In relevant part, the FIA amended FOIA to provide that, for FOIA requests submitted after June 30, 2016, an agency could withhold information only if it showed that the information both fell within an exemption of FOIA and at least one of two additional requirements was met. The requirements are that:
5 U.S.C. § 552(a)(8)(A)(i)(I)-(II). Hence, the agency must show that disclosure of the requested information would foreseeably harm a protected interest or that disclosure is prohibited by law; otherwise, it must disclose the information, even if the information falls within one of the FOIA exemptions. Applicability of a FOIA exemption is still necessary -- but no longer sufficient -- for an agency to withhold the requested information. In essence, the FIA imposes an additional, independent burden on the agency.
Neither the Supreme Court nor this Court nor any of our sister circuits has had occasion to consider the burden imposed by the FIA in an Exemption 4 case.2
The relevant facts are drawn from the parties’ affidavits and are undisputed.
On September 19, 2016, the FDA granted accelerated approval to Exondys 51, a drug developed by Sarepta to treat Duchenne muscular dystrophy
("DMD"). DMD is a fatal neuromuscular disease that affects young and adolescent males. In the United States, there are approximately 9,000 to 12,000 DMD patients.
Dystrophin is a protein, encoded by the dystrophin gene, that strengthens muscle fibers. DMD is caused by mutations in the dystrophin gene; the mutations result in a lack of dystrophin, which in turn results in loss of muscle tissue and function. Genes are composed of sequences known as exons. The most common type of DMD mutation deletes exons of the dystrophin gene -- that is, parts of the dystrophin gene -- thus misaligning the remaining parts of the gene and causing reduced dystrophin production.3
Exondys 51 was developed to target the dystrophin gene through a mechanism known as "exon-skipping." "Exon-skipping" causes the cellular machinery to skip the mutated part or parts of the dystrophin gene. With the mutated parts skipped, the remaining exons in the gene are read in the correct alignment, resulting in a shorter but functional form of the dystrophin gene. Sarepta began researching possible treatments for DMD beginning in the early 2000s and, after years of research, designed Exondys 51 -- also known as eteplirsen -- to skip exon 51 of the dystrophin gene. Around 13% of DMD mutations are amenable to exon 51 skipping, and an exon 51 mutation is the most common type of mutation amongst DMD patients.
In 2007, Sarepta submitted the Exondys 51 Investigational New Drug application to the FDA. Sarepta then conducted Phase 1 proof-of-concept studies on the drug. As early as 2011, Sarepta moved to Phase 2 and conducted two Phase 2 studies, Study 201 and Study 202. Sarepta spent over three years developing the clinical study procedure for the studies, in part because of experimentation on dosing approaches and quantifying dystrophin. Both studies involved the same twelve DMD patients with mutations amenable to exon 51 skipping. Study 201 was placebo-controlled, double-blinded,4 and conducted over twenty-eight weeks. Study 202, a long-term Phase 2b study, followed approximately six months after Study 201. In Study 202, all patients received Exondys 51.
The results of both studies were documented in clinical study reports. Each clinical study report was approximately 100 pages long and accompanied by thousands of pages of attachments with supporting data and background information. These clinical study reports and the study results were disseminated to only certain individuals within Sarepta; furthermore, Sarepta's agreements with the clinical trial site included terms of confidentiality. In June 2015, Sarepta submitted the clinical study reports to the FDA as part of Sarepta's New Drug Application. The FDA received thousands of emails and calls from the public urging approval of Exondys 51.
On September 19, 2016, the FDA granted Exondys 51 accelerated approval, a special pathway for drugs treating serious conditions and providing a meaningful advantage over existing therapy. There was, however, intense internal conflict within the FDA over the approval of Exondys 51. Reviewers in the Division of Neurology Products, the Office of Biometrics, the Office of Clinical Pharmacology, the Office of Drug Evaluation-I, and the Office of New Drugs all assessed the documents Sarepta submitted in its application. These reviewers unanimously recommended that Exondys 51 not be approved due to deficiencies in Sarepta's clinical studies. The head of the Center for Drug Evaluation and Research, Dr. Janet Woodcock, nevertheless overrode the...
To continue reading
Request your trial