Seife v. Food & Drug Admin.

• Decision Date: 06 October 2020
• Docket Number: 17-CV-3960 (JMF)
• Parties: Charles SEIFE, Plaintiff, v. FOOD AND DRUG ADMINISTRATION, et al., Defendants.
• Court: U.S. District Court — Southern District of New York

492 F.Supp.3d 269

Charles SEIFE, Plaintiff,

v.FOOD AND DRUG ADMINISTRATION, et al., Defendants.

17-CV-3960 (JMF)

United States District Court, S.D. New York.

Signed October 6, 2020

Cortelyou Churchill Kenney, Mark Howard Jackson, Cornell Law School First Amendment Clinic, Ithaca, NY, Christopher John Morten, New York University School of Law, Jennifer Pinsof, Knight First Amendment Institute at Columbia University, David A. Schulz, Ballard Spahr LLP, New York, NY, Devon Charles Holstad, Novack & MacEy LLP, Chicago, IL, Sarah Catherine Curl Tishler, Williams Simons & Landis PLLC, Austin, TX, Thomas S. Leatherbury, Vinson & Elkins LLP, Dallas, TX, for Plaintiff.

Dominika Natalia Tarczynska, Peter Max Aronoff, United States Attorney's Office, New York, NY, for Defendants.

OPINION AND ORDER

JESSE M. FURMAN, United States District Judge:

Plaintiff Charles Seife, a science writer and journalism professor, sues the Food and Drug Administration ("FDA") and Department of Health and Human Services ("HHS") under the Freedom of Information Act ("FOIA"), 5 U.S.C. § 552, seeking documents and records regarding the testing and approval process for eteplirsen (which is sold under the trade name Exondys 51), a drug created by Sarepta Therapeutics, Inc. ("Sarepta") for the treatment of Duchenne Muscular Dystrophy ("DMD"), a rare neuromuscular disease. See ECF No. 1 ("Compl."). Pursuant to a stipulation between the parties, the FDA produced over 35,000 pages of documents to Seife, some of which were redacted pursuant to FOIA's Exemption 4 ("Exemption 4"), which applies to documents containing "trade secrets and commercial or financial information obtained from a person and privileged or confidential." 5 U.S.C. § 552(b)(4). Now pending are renewed cross-motions for summary judgment regarding the propriety of the FDA's redactions. For the reasons that follow, the Court grants Defendants’ and Sarepta's motions for summary judgment and denies Seife's motion.

BACKGROUND

The relevant facts are drawn from the parties’ affidavits and are undisputed for purposes of this motion. DMD is a progressively debilitating and ultimately fatal neuromuscular disease that affects only about 9,000 to 12,000 young males in the United States. See ECF No. 72 ("Estepan Decl."), ¶¶ 4-5. DMD is caused by genetic mutations that result in a lack of dystrophin, a protein that plays a vital role in the structure of muscle cells and ultimately leads to the progressive loss of muscle tissue and function. Id. ¶ 6. While the mutations causing DMD vary, for more than half of patients DMD is caused by the deletion of one or more exons (a sequence within the gene that will be expressed once transcribed by RNA). Id. ¶ 8. "Exon skipping" is a molecular biological process used to treat genetic diseases such as DMD; in simplest terms, exon skipping instructs the body's cellular machinery to "skip over" a segment of the gene sequence during the RNA translation process. Id. ¶ 9.

Sarepta, a pharmaceutical company, began researching possible treatments for DMD patients in the early 2000s. After several years of research, Sarepta, in collaboration with others, created eteplirsen, a compound designed to cause exon 51 to be skipped during processing in patients with mutations amenable to such skipping. Id. ¶ 12. Approximately thirteen percent of DMD patients have this mutation. Id. ¶ 13. Accordingly, in 2007, Sarepta initiated the pre-drug approval process with the FDA. First, it submitted an Investigational New Drug ("IND") Application to the agency for the use of eteplirsen to treat DMD, which, after approval, allowed Sarepta to conduct clinical trials. Id. ¶ 14. The company conducted the clinical trials with strict confidentiality protocols, including nondisclosure agreements executed with any third-party providers. Id. ¶ 19. After Sarepta achieved preliminary success in proof-of-concept (that is, "Phase 1") clinical studies, it initiated a twenty-eight-week double-blind, placebo-controlled "Phase 2" study in 2011 ("Study 201"). Id. ¶ 15. Twelve patients, each with DMD mutations amenable to exon 51 skipping, participated in the study. Id. ¶ 17. Sarepta transitioned Study 201 into a longer-term "Phase 2b" study in 2012 ("Study 202"). Id. ¶ 16.

Throughout its studies, Sarepta followed certain timing and dosing procedures and adopted certain "endpoints" to measure the drugs’ efficacy. Id. ¶ 35. The endpoints consisted of both "clinical" endpoints that considered direct effects on patients and "surrogate" endpoints that used lab measurements to track markers affiliated with a disease. Id. After much research and expense, Sarepta chose an increase in dystrophin (measured via muscle biopsies taken at designated points during the study) as a surrogate endpoint and patients’ ability to complete a six-minute walk test as a clinical endpoint. Id. ¶ 36. The results of Studies 201 and 202 were documented in clinical study reports ("CSRs"), which were submitted to the FDA as part of Sarepta's New Drug Application ("NDA") in June 2015, thus initiating the primary stage of the drug approval process. Each CSR consists of an approximately 100-page narrative document, accompanied by thousands of pages of attachments containing supporting data and background information. Dissemination of CSRs, and study results in general, is carefully controlled, even within Sarepta. Disclosure is limited to certain members of Sarepta's clinical development, regulatory, biostatistics, and data-management functions along with certain members of the executive committee. Id. ¶ 19.

On September 19, 2016, the FDA granted eteplirsen accelerated approval to treat DMD patients. See Compl. ¶ 34. The decision, however, was not without controversy. Although accelerated approval is allowed for drugs that treat a "serious or life-threatening disease[ ]" and provide "meaningful therapeutic benefit to patients over existing treatments," the manufacturer must either directly demonstrate that the drug provides a "clinical benefit" or indirectly do so by using a surrogate endpoint. 21 C.F.R. 314.500 ; see 21 U.S.C. § 356(c)(1)(A). The FDA's advisory committee tasked with ascertaining whether Sarepta's studies showed "substantial evidence" that eteplirsen would provide a clinical benefit ultimately concluded that the studies were deficient. See ECF No. 153-4. Nevertheless, Dr. Janet Woodcock, head of the Center for Drug Evaluation and Research, intervened and unilaterally granted accelerated approval for the drug. See ECF No. 153-5.

On December 5, 2016, Seife submitted a FOIA request to the FDA seeking records related to the accelerated approval of eteplirsen. See Compl. ¶¶ 1-3; see also ECF No. 76 ("Kotler Decl."), ¶¶ 11, 13 & Ex. A. Seife requested, among other things, materials submitted by Sarepta to the FDA to support its approval application, as well as internal Government communications and deliberations regarding the approval. See Kotler Decl. Ex. A. On May 25, 2017, after the FDA denied his appeal for expedited processing, Seife initiated this lawsuit. Just over one month later, Seife filed a motion for partial summary judgment seeking expedited processing. See ECF No. 15. He and the Government then reached agreement on a schedule for the production of documents responsive to the FOIA request (as refined during the course of the parties’ negotiations), which was so ordered by the Court on July 27, 2017. See ECF No. 39. On September 15, 2017, Sarepta moved to intervene as a Defendant. See ECF Nos. 43-44. Sarepta's motion was granted on September 18, 2017. See ECF No. 47.

Pursuant to 21 C.F.R. § 20.61, the FDA consulted with Sarepta regarding the confidentiality of Study 201 and Study 202, which were subject to Seife's FOIA request. See ECF No. 77 ("Sager Decl."), ¶¶ 25-26 & Exs. K-N. Sarepta proposed redactions to the two Studies and provided a draft index to the FDA explaining the bases for the proposed redactions. See id. ¶¶ 28, 31. The FDA removed a few of the redactions, but adopted the rest based on Sarepta's representation that they covered confidential commercial information that would cause competitive harm to Sarepta if disclosed. See id. ¶¶ 29, 32, 37. In accordance with the agreed-upon production schedule, between July 24, 2017, and December 8, 2017, the FDA produced a total of approximately 45,000 pages to Seife. See id. ¶¶ 13, 15-23. In December 2017 and January 2018, in response to specific questions raised about the productions, the FDA reproduced some documents with redactions removed. See id. ¶ 23. On January 8, 2018, Seife provided the FDA and Sarepta with an annotated version of the FDA's Vaughn index identifying a subset of FOIA Exemption 4 redactions from the Studies and their appendices that Seife wished to challenge in this litigation — specifically, redactions of all adverse event reports; descriptions of adverse events; charts, graphs, and tables; descriptions of test results, clinical endpoints; and titles and identifiers of specific documents. See ECF No. 63. Seife does not challenge the adequacy of the Government's search, nor does he challenge any other redactions. See ECF No. 66, at 2.

Thereafter, the parties filed cross-motions for summary judgment, see ECF Nos. 69, 74, 85, and Seife filed a motion to strike a declaration submitted by Sarepta in connection with its motion for summary judgment, ECF No. 93. While these motions were pending, the Supreme Court granted certiorari in Food Marketing Institute v. Argus Leader Media , ––– U.S. ––––, 139 S. Ct. 915, 202 L.Ed.2d 641 (2019), which concerned the FOIA Exemption 4 standard. On March 27, 2019, this Court issued an opinion and order denying Seife's motion to strike and reserving judgment on the cross-motions for summary judgment pending the Supreme Court's decision in Argus Leader . See Seife v. FDA , No. 17-CV-3960 (JMF), 2019 WL 1382724, at *1 (S.D.N.Y. Mar. 27, 2019) (ECF No. 129). At the same time, the Court directed Sarepta to re-review the...