Once again, Vanda Pharmaceuticals is challenging the FDA in court.
This time, the company says the agency failed to give its application for Hetlioz in jet lag disorder a proper hearing after the FDA issued a complete response letter more than three years ago.
Since 2014, Hetlioz has been approved to treat a circadian rhythm condition called non-24-hour sleep-wake disorder. The company submitted its application for the jet lag disorder indication back in October 2018.
The following year, the FDA handed back a complete response letter, saying it couldn't approve Vanda’s application "in its present form” and directed the company to resubmit its application.
After the company unsuccessfully disputed the finding, Vanda requested a hearing on the application this past July. In August, the agency “privately" delivered a notice of opportunity for hearing, Vanda says.
But there's still a problem, Vanda argues. The notice has not been published in the Federal Register, and without that step, the hearing process can’t begin, according to the company.
Vanda argues that the FDA’s failure to act on the drug’s application within 180 days and on the company’s request for a hearing within 60 days is unlawful. The company notes it's been more than 1,300 days since it submitted the application and 74 days since it requested a hearing.
The non-public notice to Vanda does not count as satisfying the agency’s obligation, the lawsuit alleges, and the agency “must abide” by the mandatory timeframes. The suit asks the court to order the FDA to comply with its obligation to act on the company’s request for a hearing and on the drug’s application.
It's not the first time Vanda has tangled with the regulatory agency. In a prior dispute over a partial clinical hold on a separate medicine, the FDA prevailed.