OPINION AND ORDER 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.
