After drug rejection, Vanda scores courtroom win over FDA in records case

Vanda Pharmaceuticals has scored a legal win in its long-running dispute with the FDA surrounding the agency's 2018 rejection of Hetlioz in jet lag disorder.

After months of litigation and years of back-and-forth, a court ruled that the FDA must turn over records relating to its denial of the label expansion, Vanda said in a Wednesday release (PDF).

After the drug rejection in 2018, the company disputed the decision and last July requested an FDA hearing. The FDA "privately" agreed to the hearing but never published a notice in the Federal Register, meaning the process couldn't move forward, Vanda said in its September lawsuit.

Aside from its lawsuit, the company has been seeking records through a Freedom of Information Act request.

In the suit, Vanda argued that the agency failed to act on its application and on its hearing request within timelines stipulated by the law. When Vanda filed the lawsuit, it had been more than 1,300 days since it submitted the label expansion application and 74 days since it requested the hearing.

Now, the U.S. District Court for the District of Columbia has sided with the company and ordered the FDA to release the relevant records. Its final judgement rejected the FDA’s argument that it would suffer “foreseeable harm” by disclosing the relevant records, Vanda said in a release.

In a statement, Vanda’s co-founder and CEO Mihael Polymeropoulos, M.D., called the ruling an “important step” in ensuring “appropriate transparency” at the FDA.

Hetlioz won approval in 2014 to treat a circadian rhythm condition called non-24-hour sleep-wake disorder. 

This is the second time Vanda has gone after the agency in court but the first time that it has prevailed. In 2020, the FDA put on a partial hold on two of its studies, a decision Vanda challenged with an unsuccessful lawsuit.