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A federal judge in DC has reminded us that the government does not operate in secret, at least not always and usually not completely in connection with prescription drug approval.  The case is Vanda Pharmaceuticals, Inc. v. FDA, No. 22-cv-938, 2023 U.S. Dist. LEXIS 51853 (D.D.C. Mar. 27, 2023), and the plaintiff was a pharmaceutical company that wanted to know what the FDA really thought of its drug.  The company lodged a request under the Freedom of Information Act (“FOIA”), which the FDA refused.  So the company sued, and the district judge ruled that the FDA had no valid basis to withhold the requested information. 

Here is what happened.  The plaintiff pharma company marketed a drug for sleep disorders and wanted to add a new approved use—treatment for jet lag.  The company therefore submitted a supplemental New Drug Application, or sNDA, seeking approval for that use.  When the FDA receives an sNDA (or an NDA), it assembles an interdisciplinary team of experts to review the submission and compile opinions and recommendations.  After consulting the reviews, the FDA either approves the proposed use or sends the applicant a Complete Response Letter, or CRL, detailing the application’s deficiencies.  An applicant who receives a CRL then has several options.  It can withdraw the application; it can submit additional information to address the deficiencies; or it can appeal.  See Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668, 1683 (U.S. 2019) (discussing CRLs).

The plaintiff company in Vanda went in a different direction.  After receiving a CRL for its jet lag application, the company wanted to see the analysis behind the FDA’s reasoning.  We suspect that the CRL itself provided some explanation, or maybe it did not.  The order does not say.  Either way, the company wanted a more complete peek behind the curtain, and it submitted a FOIA request seeking the reviews generated during the FDA’s multi-disciplinary assessment. 

The FDA refused and invoked FOIA’s “Exemption 5,” which protects “inter-agency or intra-agency memorandums or letters that would not be available by law to a party other than an agency in litigation with the agency.”  2023 U.S. Dist. LEXIS 51853, at *5.  This less-than-clear exemption basically allows government agencies to take advantage of protections and privileges available in civil litigation, including attorney-client privilege, work product protection, and the deliberative process privilege.  Id. 

The litigation that followed focused on the deliberative process privilege.  The deliberative process privilege exists to protect agencies from operating “in a fishbowl,” and it “shields from disclosure documents reflecting advisory opinions, recommendations and deliberations comprising part of a process by which governmental decision and policies are formulated.”  Id.  An agency may invoke the deliberative process privilege only for documents “that are both precedential and deliberative,” i.e., documents generated before the agency’s final decision on the matter, and that were prepared to help the agency formulate its position.  Id. 

In addition—and importantly for this case and this privilege going forward—the government must also demonstrate that it “reasonably foresees that disclosure would harm an interest protected by [a FOIA] exemption” or that “disclosure is prohibited by law.”  Id. at *6 (citing 5 U.S.C. § 552(a)(8)(A)(i)).  In Vanda, the FDA asserted that disclosure 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.  Id. at 86-*7. 

The district court rejected both arguments.  On the chilling point, the FDA already discloses clinical and scientific reviews to the public under a variety of circumstances, including whenever it approves an NDA.  It also releases reviews associated with approved sNDAs upon request.  True, the FDA does not routinely release reviews in connection with pending or rejected applications, but clinical reviewers do not know during the review process whether applications will be approved.  Because it is always possible that the reviews will become public, releasing the requested documents would introduce no additional chilling effect.  Or, as the district court put it,

Absent any current expectation of confidentiality, in the context of NDAs and sNDAs alike, the Court struggles to see how requiring FOIA disclosure of statistical and clinical reviews associated with pending sNDAs would in any way chill the reviewers’ frank and honest deliberations.  Disclosure cannot chill deliberations if those deliberating do not reasonably expect their deliberations to remain private.

Id. at *10-*11.  The district court was quick to emphasize that it was not holding that the FDA had waived Exemption 5.  The agency merely had not established that the exemption applied under these circumstances, where the reviewers had no reasonable expectation that their deliberations would be kept private.

The district court similarly rejected the FDA’s reservations on public health, which were couched as a “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.”  Id. at *12.  We understand that the FDA regulates information on the efficacy and safety of drugs, but we frankly do not see how this relates to the plaintiff’s FOIA request. 

Neither did the district court:  “[T]he 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.”  Id. at *12.  The law already addresses the FDA’s concerns in a number of ways, including by regulating off-label promotion, by making prescription drugs available only through learned intermediaries, and by requiring approval of drugs as safe and effective before they are marketed.  Id. *12-*13. 

The FDA cannot be happy about this.  The agency bears the burden of responding to FOIA requests, and the district court’s order can only add to that burden, not diminish it.  That being said, we do not want to overstate the order’s potential impact.  Exemption 5 still exists, and we can envision circumstances under which agencies could justifiably withhold information as privileged or otherwise protected by law—for example, if a third party requests documents contain proprietary commercial information or sensitive clinical data.  Overall though, the order is a win for government transparency, even if a measured one.