Seife v. FDA, No. 20-4072, 2022 WL 3130147 (2d Cir. Aug. 5, 2022) (Chin, J.)

Seife v. FDA, No. 20-4072, 2022 WL 3130147 (2d Cir. Aug. 5, 2022) (Chin, J.)

Re:  Request for documents submitted by drug manufacturer as part of approval process for drug created to treat fatal neuromuscular disease

Disposition:  Affirming district court’s grant of government’s motion for summary judgment

• Exemption 4 & Litigation Considerations, Foreseeable Harm Showing:  First, the Court of Appeals for the District of Columbia Circuit holds that “[a]s a threshold matter, [the requester] does not dispute on appeal that the redacted information falls within Exemption 4.”  “The parties disagree, however, as to whether the information meets the additional burden imposed by the [FOIA Improvement Act].”  Therefore, “[the court] begin[s] with the foreseeable harm requirement.”  “Two questions are presented:  first, what are the interests protected by Exemption 4; and, second, did the district court err in granting summary judgment on the basis that disclosure would result in foreseeable harm to such an interest?”
  
  “[T]he court hold[s] 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.”  “An agency in a FOIA case can therefore meet the foreseeable harm requirement of the [FOIA Improvement Act] by showing foreseeable commercial or financial harm to the submitter upon release of the contested information.”  “Although this is a matter of first impression for the appellate courts, there are two primary competing district court interpretations of the interests protected by Exemption 4.”  “First, the district court for the District of Columbia has held that the interests protected by Exemption 4 are ‘the submitter’s economic or business interests.’”  “Th[at] court . . . held that for an agency to show foreseeable harm to the submitter’s economic or business interests, it has to demonstrate 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.’”  “Second, the district court for the Northern District of California has taken a broader approach, holding that the interest protected by Exemption 4 is ‘the information’s confidentiality – that is, its private nature.’”  “In doing so, the court limited its analysis to the word ‘confidential,’ concluding that ‘under [Argus Leader], the plain and ordinary meaning of Exemption 4 indicates that’ confidentiality is the protected interest.”  “[The court] hold[s] that the interests protected by Exemption 4 of FOIA are the commercial or financial interests of the submitter 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.”  “The plain text of Exemption 4 indisputably protects confidential information.”  “But it protects only certain confidential information, namely, confidential information that is commercial or financial in nature.”  “The statute therefore contemplates harm specifically to commercial or financial interests.”  “Furthermore, the confidential commercial or financial information must be obtained from a person.”  “That requirement indicates the contemplated harm is to the person from whom the agency receives the confidential information – that is, the submitter.”  “Thus, the protected interests are the submitter’s commercial or financial interests, and the [FOIA Improvement Act’s] foreseeable harm requirement refers to harm to the submitter's commercial or financial interests.”
  
  “[The court] conclude[s] that Defendants have made the requisite showing for summary judgment on the foreseeable harm prong of the [FOIA Improvement Act] and affirm[s] the district court’s judgment on that ground.”  “[The court] first conclude[s] that Defendants presented sufficient evidence, in reasonably specific detail, to establish foreseeable harm to [the submitter’s] commercial or financial interests.”  “[The submitter’s] declarations describe how the information could be used to develop studies for other exon-skipping drugs, used in competitors’ head-to-head trials, or be informative as to [the submitter’s] future clinical endpoint research.”  “Even [the requester’s] evidence acknowledges that the information [the requester] seeks would foreseeably cause harm to [the submitter].”  “Furthermore, [the court] do[es] not conduct our analysis in a vacuum.”  “The pharmaceutical industry is, of course, highly competitive.”  “Development of new pharmaceutical drugs is a long and arduous process . . . .”  “The big picture thus further supports Defendants’ contentions that [the submitter’s] commercial or financial interests would be foreseeably harmed by disclosure of information it developed and gathered, [the submitter’s] competitors would benefit from disclosure, and a benefit to competitors would necessarily be a detriment causing harm to [the submitter].”  The court finds that “[the requester] failed to present any evidence that meaningfully controverts Defendants’ showing of foreseeable harm.”  “[The requester’s] evidence[, submissions by the President of the Center for Science in the Public Interest and former Associate Commissioner for Public Health Strategy and Analysis at the FDA,] at most challenges the degree of commercial or financial harm to [the submitter], rather than that such harm would result.”  “In addition, much of [the requester’s] evidence consists of broad, hedging statements.”  “While [the requester] makes numerous policy arguments favoring disclosure, FOIA does not have an exception for cases where public health may be served by disclosure.”