Court Orders Release of FDA Vanda Info

The DC federal court has granted final judgment to Vanda Pharmaceuticals in its Freedom of Information Act (FOIA) fight with FDA to obtain agency records created during the review of Vanda’s sNDA for Hetlioz (tasimelteon) to treat jet lag disorder. In the suit, Vanda complained that FDA had denied its FOIA request and subsequent appeals seeking the review documents. “Not only does Vanda have a legal right to receive copies of the reviews under FOIA’s clear mandate, but providing drug sponsors this information is essential to further scientific inquiry,” the company said.

In a statement, Vanda said the court rejected FDA’s claim that it would suffer “foreseeable harm” if it disclosed to the company the reviews relating to the sNDA. In particular, Vanda says, the court held that in the context of this case, contrary to the agency’s assertion, “disclosure cannot chill [the] deliberations” of FDA staff.