Vanda Pharmaceuticals' management has not been shy about taking on the FDA. I wonder who their law firm is? If you research their history, they have been fighting the FDA back for years. They have only won recently (on a FOIA). The FDA appears to have been, blatantly, working against them. It will be interesting to see the outcome, and to find out who represents them.

On March 27, 2023 a federal court granted final judgment in favor of Vanda in its Freedom of Information Act ("FOIA" case requesting records created by the Food and Drug Administration ("FDA" during its review of Vanda's application seeking approval of a new use for its drug, Hetlioz® (tasimelteon). Vanda filed the lawsuit, Vanda Pharmaceuticals, Inc., v. Food and Drug Administration, case no. 1:22-cv-00938, in the United States District Court for the District of Columbia in April 2022 to compel the FDA to produce, as required by FOIA, certain records relating to its denial of Vanda's supplemental New Drug Application ("sNDA" for HETLIOZ® in the treatment of jet lag disorder.

Vanda had repeatedly attempted to obtain these records from the FDA pursuant to a FOIA request it submitted in December 2019, but the FDA had refused to disclose those records, invoking the deliberative process exemption under FOIA.


https://www.prnewswire.com/news-releases/vand...83748.html