On March 27, 2023, a D.C. federal district court rejected the FDA’s claim of privilege when it denied a FOIA request from Vanda Pharmaceuticals. The decision was a victory for Washington Legal Foundation, which filed the sole amicus brief in the case. The case arose from Vanda Pharmaceuticals’ supplemental new drug application for Hetlioz®, a drug that has been shown as effective for treating jetlag. When FDA did not approve that application, Vanda sought, under FOIA, the scientific reviews underlying the agency’s Complete Response Letter. Asserting the deliberative-process privilege, FDA denied the FOIA request. But District Judge Christopher Cooper roundly rejected FDA’s privilege claim, concluding that disclosing the reviews for Hetlioz® will not chill frank discussion at FDA. As WLF showed in its amicus brief, agency staff have no reason to expect these documents to be withheld in the first place.


District Court order

WLF amicus brief