Vanda Pharmaceuticals, Inc. v. FDA, No. 22-938, 2023 WL 2645714 (D.D.C. Mar. 27, 2023) (Cooper, J.)

Vanda Pharmaceuticals, Inc. v. FDA, No. 22-938, 2023 WL 2645714 (D.D.C. Mar. 27, 2023) (Cooper, J.)

Re:  Request for records created by FDA during its review of plaintiff’s application to add new approved use for its sleep-disorder drug

Disposition:  Granting plaintiff’s motion for summary judgment; denying defendant’s motion for summary judgment

• Exemption 5, Foreseeable Harm and Other Considerations:  The court holds that “the FDA has failed to show any foreseeable harm that would arise if the requested reviews were released.”  The court relates that “[t]he FDA asserts that the [withheld] clinical and statistical reviews at issue are both predecisional and deliberative, and therefore are protected by the deliberative process privilege in the first instance, and that their release would cause foreseeable harm by (1) chilling agency discourse regarding drug applications and (2) harming public health by causing consumer confusion or contributing to false advertising.”  “The Court is not convinced that disclosure of reviews related to pending [supplemental New Drug Applications (“sNDA”)] would lead to the chilling effect the agency fears.”  “As [plaintiff] points out, the FDA currently discloses clinical and scientific reviews to the public in a variety of circumstances.”  “For starters, the agency is required by statute to publish underlying reviews whenever an [New Drug Application (“NDA”)] is approved.”  “Although the record does not contain definitive statistics on the approval rate of NDAs, at least one study cited by [plaintiff] puts it at over 90%.”  “And in at least one instance, the agency has also disclosed clinical reviews to defend its decision not to grant an evidentiary hearing for an NDA it declined to approve.”  “The FDA may be correct that it does not have a practice of releasing statistical and clinical reviews underlying pending sNDAs like [plaintiff’s].”  “As explained above, however, a pending sNDA may become an approved sNDA should the sponsor choose to adopt the recommendations offered by the review team in the CRL explaining the basis for the conditional denial of the application.”  “As a result, reviews associated with pending sNDAs would be subject to release at least under the circumstances noted above, should the application ultimately be approved.”  “As the FDA acknowledges, the clinical reviewers do not know whether or not an application will be approved when the reviews are compiled.”  “They are, therefore, unaware during the review process whether their work will be made public under any of the circumstances described above.”  “Given that uncertain[t]y, the agency has not established that reviewers currently expect written descriptions of their views and deliberations to be shielded from public view.”  “To be clear, the Court does not hold that the FDA somehow waived its ability to invoke Exemption 5 by voluntarily releasing isolated NDA and sNDA reviews to the public.”  “It finds, rather, that the agency has not established that the reviewers presently expect their deliberations to be kept private given the meaningful potential for release of both types of reviews.”  “And if the reviewers don't expect confidentiality now, this ruling should not affect the tenor of their deliberations in the future.”  “The FDA also asserts that ‘disclosure of clinical and statistical reviews in the context of an unapproved sNDA raises public health and safety concerns.’”  “In particular, the FDA expresses concern that drug sponsors may misrepresent the opinions expressed in the reviews to mislead consumers and medical practitioners about the efficacy and safety of the drug under review.”  “But this concern is insufficient to justify withholding the reviews.”  “To start, the FDA speculates about harm that ‘could’ happen if the reviews were released but has not ‘concretely explain[ed]’ what harm ‘would’ occur.”  “Such conjecture does not satisfy the agency’s foreseeability requirement.”