On November 4, 2022, WLF asked a federal trial court to reject FDA’s claim of privilege in denying a FOIA request. The case arises 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. In an amicus brief urging the court to grant summary judgment on Vanda’s FOIA request, WLF argued that disclosing the reviews will not chill frank discussion within FDA because agency staff have no reason to expect that these documents will be withheld in the first place. WLF’s brief also explained why the deliberative-process privilege is the most widely abused FOIA exemption among government agencies.


WLF amicus brief