“Today’s ruling is a victory for government transparency. FDA’s aversion to transparency thwarts government accountability at a time when public confidence in FDA’s decision-making is more important than ever.”
—Cory L. Andrews, WLF General Counsel & Vice President of Litigation

The U.S. District Court for the District of Columbia today rejected the Food and Drug Administration’s claim of privilege when it denied a Freedom of Information Act request from Vanda Pharmaceuticals, Inc. The decision was a victory for Washington Legal Foundation, which filed the sole amicus brief in the case.

The dispute arose from Vanda’s supplemental new drug application for Hetlioz®, a drug that has shown great promise as a jetlag therapy. When FDA did not approve that application, Vanda filed a FOIA request for the scientific reviews informing the agency’s Complete Response Letter. Asserting FOIA’s deliberative-process privilege, FDA denied the request.

Today U.S. 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. FDA routinely discloses medical and statistical reviews when applications are ultimately approved, and the reviews become part of the administrative record when a drug sponsor appeals an application’s denial to federal court.

As WLF’s amicus brief also showed, the deliberative-process privilege is the most widely abused FOIA exemption. The use of this privilege has skyrocketed and has become the go-to exemption of choice for federal agencies. It is so abused that, among government watchdogs, it has been nicknamed the “withhold-it-because-you-want-to” exemption. Today’s ruling arrests that disturbing trend.