Informed Consent Action Network v. FDA, No. 20-689, 2022 WL 902083 (S.D.N.Y. Mar. 28, 2022) (Nathan, J.)

Informed Consent Action Network v. FDA, No. 20-689, 2022 WL 902083 (S.D.N.Y. Mar. 28, 2022) (Nathan, J.)

Re:  Request for records concerning particular vaccine trials

Disposition:  Granting defendant's motion for summary judgment; denying plaintiff's cross-motion for summary judgment

• Procedural Requirements, Proper FOIA Requests:  "The FDA argues that summary judgment is justified because [plaintiff's] request—namely, for only those trials 'that had a safety review period longer than seven days following administration of this vaccine'—did not 'reasonably describe' the records sought."  " Notably, the FDA has identified the full universe of potentially responsive records—approximately 3,000 pages of clinical trial reports."  "But [plaintiff's] request contains latent ambiguities that prevent an FDA employee, even one 'familiar with the subject matter,' from determining which of the 3,000 identified pages [plaintiff] would consider responsive and which not."  "To start, [one vaccine] is delivered not as one shot but rather as several doses spread out over months."  "'[A] reviewer would need to determine if the seven-day period should be viewed to begin with the first administration of the vaccine, the final administration of the vaccine, or some other option.'"  "And because 'safety review period' is not a term of art with an authoritative definition to which FDA employees or the Court can refer, the ambiguity remains." 
  
  "In sum, the Court concludes that [plaintiff's] request did not reasonably describe the records sought in such a way that an FDA employee could determine which trials were responsive to [plaintiff's] request and which were not."  "That conclusion is further supported by the Court's finding that the sworn declarations submitted by the FDA, which explain its process and these issues in detail, are properly 'accorded a presumption of good faith.'"  "Moreover, to the extent it is even possible based on the language of [plaintiff's] request, the 'sort of sifting and analysis' required to identify trials responsive to [Plaintiff's] request 'is not a burden that the FOIA imposes on federal agencies.'"  "The purpose of FOIA is for the agency to produce documents, not to develop new opinions or 'answer questions disguised as a FOIA request.'  "In other words, FOIA was 'not intended to permit the public to commandeer agency employees as research assistants.'" 
  
  "Nevertheless, even if the FDA receives an ambiguous FOIA request, it has an obligation to notify the requester of the ambiguity and then to make '[e]very reasonable effort . . . to assist' the requester in identifying the records sought. 21 C.F.R. § 20.40(b)."  "The Court concludes that the FDA did just that."  "First, the FDA informed [plaintiff] that its request did not reasonably describe the records, quoting the particular phrase at issue."  "Second, the FDA offered to ensure that [plaintiff] received all trials that it might consider responsive by producing the full 3,000 pages of clinical trial reports."  "That way, the FDA explains, [plaintiff] 'would then have been free to sort and analyze the responsive records as it saw fit, including to make its own assessment regarding which 'clinical trial reports' had a 'safety review period longer than seven days.'" "[Plaintiff] refused that broader production."  "Additionally, while agencies should generally respond only to the request as worded, an agency may in select circumstances satisfy its FOIA obligations by responding to an overly 'specific' request by conducting 'a broader search' and production of documents."  "The Court finds that this is one such circumstance."  "And while this may have resulted in [plaintiff] receiving a larger volume of documents than it would prefer, the Court does not find that the maximum possible production of approximately 3,000 pages is likely to overwhelm [plaintiff's] ability to review them."