FDA answers Vanda's yearslong call for public hearing on unsuccessful jet lag approval bid

Vanda Pharmaceuticals’ seven-year ambition to score a coveted label expansion for sleep drug Hetlioz has taken an unusual turn, with the FDA acquiescing to a formal hearing on the matter.

The arrangement for an evidentiary public hearing comes after the agency rejected Vanda’s proposed jet lag label expansion for Hetlioz for the second time in January, citing concerns that the company’s clinical trial protocols were not “sufficiently analogous to actual jet travel,” according to Vanda’s description of the rejection.

Vanda disagreed with the assessment and pledged to explore “all appropriate avenues” in pursuit of its long-sought jet lag indication, arguing that the decision didn’t fully reflect the “collaborative spirit” the sides had established in October, when Vanda agreed to hit the brakes on its active litigation against the FDA in exchange for regulatory action. 

The company has been badgering for a hearing since the FDA first turned down its jet lag application in 2019, eventually taking the matter to court in 2022. 

Now, Vanda’s wish for a hearing is being granted, the company said in a March 3 press release.

“We are encouraged by the FDA's decision to grant a formal evidentiary hearing on the proposed refusal of our jet lag application for Hetlioz,” Vanda CEO Mihael H. Polymeropoulos, M.D., said in the release. “This procedural victory reflects Vanda's 7-year persistence in advocating for fairness and the rigorous pursuit of scientific truth on behalf of patients.”

A formal evidentiary public hearing in response to a complete response letter is permitted under the U.S. Code of Federal Regulations but hasn’t occurred in the context of drug regulation for decades, “potentially over 40 years,” Vanda pointed out, citing “publicly available records and historical accounts.”

The door to the hearing was opened last summer, when a federal appeals court sided with Vanda in what the company called a “landmark victory” in its pursuit of transparency behind the FDA rejection. 

The ruling specifically upheld a prior legal victory for Vanda in 2024, when a D.C. court mandated that the FDA must resolve Hetlioz’s pending drug application or hold a hearing, considering that the company’s application had been pending for “almost 2,000 days” at the time, with more than 500 days since the company’s hearing request. 

Instead of granting a hearing at the time, the FDA issued an order refusing to approve the jet lag indication. The 2025 appeals court win vacated the order and tossed the ball back into the FDA’s court, which Vanda expected would result in an approval or a formal hearing. 

During its seven-year squabble with the FDA, the company has not minced words about its qualms surrounding the “serious flaws in FDA regulations governing drug-approval processes,” as it said in 2024. Vanda has also sued the agency for other matters related to Hetlioz. 

Despite the Hetlioz holdup, the company has recently scored a pair of other regulatory wins with approvals for motion sickness drug Nereus and atypical antipsychotic Bysanti. 

Hetlioz, meanwhile, was first approved in 2014 to treat non-24-hour sleep-wake disorder and later in 2020 for Smith-Magenis syndrome.