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Seife v. FDA, No. 17-3960, 2020 WL 5913525 (S.D.N.Y. Oct. 6, 2020) (Furman, J.)


Seife v. FDA, No. 17-3960, 2020 WL 5913525 (S.D.N.Y. Oct. 6, 2020) (Furman, J.)

Re:  Request for records concerning "the testing and approval process for eteplirsen (which is sold under the trade name Exondys 51), a drug created . . . for the treatment of Duchenne Muscular Dystrophy ("DMD"), a rare neuromuscular disease"

Disposition:  Granting defendants' and submitter's motions for summary judgment; denying plaintiff's motion for summary judgment

  • Exemption 4:  The court relates that "four categories of redactions . . . are at issue:  (1) clinical study procedures, (2) clinical study results, (3) exploratory endpoints, and (4) unrelated adverse events. There is no dispute that these categories of information are commercial or financial in nature, [and] that they were obtained from a 'person' within the meaning of FOIA . . . ."  "Thus, the principal dispute is whether they qualify as 'confidential' within the meaning of Exemption 4."  "[The] Court [notes that it] need not decide whether the test is one- or two-pronged either because, as with the information at issue in Argus Leader, both conditions are satisfied here."  "[The submitter's] chief of staff and head of corporate affairs . . . attests that the company customarily and actually kept the information at issue confidential at all stages of the clinical study process and thereafter because release would allow its competitors to more easily conduct their own DMD-related studies – by 'copy[ing] [the submitter's] study design, or selectively modify[ing] it,' 'build[ing] the type of control dataset that [the submitter] spent years and millions of dollars producing,” discovering which exploratory endpoints [the submitter] might pursue in the future, and gaining insight into [the submitter's] analysis of which adverse events occurred – all 'without having invested the resources into producing their own study.'"  "And even though [the submitter] has published some information related to [the studies at issue], it has not disclosed specific information regarding the timing of certain tests, the dosing methods used, specific data tables that include statistical analysis of patient-level indicators, certain exploratory endpoints, and details about the adverse events."  "Moreover, as [the submitter's] chief intellectual property counsel . . . avers, such information is subject to strict confidentiality protocols both within and outside of [the submitter]."  The court also finds that "[plaintiff] does not actually dispute that the FDA gave [the submitter] assurances of privacy when the company submitted the information at issue pursuant to the FDA's regulations."
  • Exemption 4, Foreseeable Harm:  The court holds that "[t]his provision does not call for disclosure here."  "First, the Court agrees with Defendants that disclosure of the confidential clinical study procedures 'is prohibited by law.'"  "The Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., authorizes the FDA to promulgate substantive regulations regarding the drug approval process."  "To the extent relevant here, the FDA regulations provide that, '[a]fter FDA sends an approval letter to the applicant' certain information in the NDA is 'immediately available for public disclosure, unless the applicant shows that extraordinary circumstances exist' or an enumerated exception applies."  "The regulations specify that '[a] protocol for a test or study' is subject to disclosure 'unless it is shown to fall within the exemption established for trade secrets and confidential commercial information in [Section] 20.61.'"  "Section 20.61(b) provides, in turn, that '[c]ommercial or financial information that is privileged or confidential means valuable data or information which is used in one's business and is of a type customarily held in strict confidence or regarded as privileged and not disclosed to any member of the public by the person to whom it belongs.'"  "Although the FDA has discretion under Section 20.61(e)(3) to reject a submitter's designations and disclose the information, if the designations are accepted the confidential information is not subject to public disclosure."  "[The submitter] submitted the Studies as part of its NDA on June 26, 2015, and marked its submissions as containing confidential information pursuant to Section 20.61."  "After the FDA approved the application on September 19, 2015, the requested data become subject to Section 314.430(e) of the regulations, and the FDA has not provided any reason to disclose the clinical study procedures that [the submitter] re-identified as confidential in response to this FOIA litigation."  "Thus, under its own regulations, the FDA does not have discretion to disclose [the submitter's] non-public clinical study procedures, and the foreseeable harm standard set forth in Section 552(a)(8)(A)(i)(I) does not apply."

    "The Court, however, will apply the foreseeable harm requirement to the non-patient-level study results, endpoints, and adverse events, as their disclosure is not prohibited by statutory or regulatory law."  "In the four years since the FIA was enacted, few courts have addressed how the foreseeable harm requirement applies to Exemption 4, but nevertheless a split has already developed."  "In American Small Business League, the court rejected an argument, relying on National Parks, that the agency must show that disclosure would cause foreseeable competitive harm to the submitter, calling the argument an attempt to 'circumvent' the Supreme Court's rejection of the discredited opinion's 'reliance on the legislative history in determining the scope of the term "confidential."'"  "The court held, instead, that, under Argus Leader, 'the plain and ordinary meaning of Exemption 4 indicates that the relevant protected interest is that of the information’s confidentiality – that is, its private nature.'"  "By contrast, in Center for Investigative Reporting, the court relied in part on National Parks to conclude that the agency may satisfy the foreseeable harm requirement by showing that disclosure would cause 'genuine harm to [the submitter's] economic or business interests, and thereby dissuad[e] others from submitting similar information to the government.'"  "The Court need not and does not decide which approach is correct because, either way, Defendants and [the submitter] satisfy the foreseeable harm requirement."  "Under the American Small Business League approach, the requirement is satisfied because, by definition, disclosure would destroy the confidential nature of the information at issue."  "And under the Center for Investigative Reporting approach, the requirement is satisfied because Defendants and [the submitter] show through affidavits that [the submitter's] competitive interests would be harmed if the non-public clinical study results, exploratory endpoints, and adverse events were disclosed."  "As an initial matter, it is indisputable that the pharmaceutical industry is highly competitive."
  • Litigation Considerations, "Reasonable Segregable" Requirements:  The court holds that "Defendants' Vaughn index and affidavits are sufficient for the Court to hold that the withheld information is subject to Exemption 4 and barred from disclosure by law."
Court Decision Topic(s)
District Court opinions
Exemption 4
Litigation Considerations, “Reasonably Segregable” Requirements
Updated November 6, 2020