Vanda claims that two generics to its sleep disorder drug Hetlioz were approved despite inadequate data and is requesting that FDA Commissioner Marty Makary revisit the decision.
Vanda Pharmaceuticals is taking the fight over contested approvals to the top of the FDA’s chain of command, asking Commissioner Marty Makary himself—not merely his office—to revisit the agency’s decision several years ago to clear two generic version of the company’s sleep disorder drug Hetlioz.
Designed to be taken orally, Hetlioz (tasimelteon) is a melatonin receptor agonist that was first approved in 2014 for sleep-wake disorder. Vanda in late 2018 sought to expand the drug’s label to cover jet lag disorder, but the FDA denied the application in July 2019. Vanda appealed the decision and, in July 2022, asked for a hearing to resolve the matter. The FDA failed to respond to Vanda’s request in a timely manner, pushing the company to sue the agency in September 2022, alleging that it violated its mandate under the Food, Drug, and Cosmetic Act, which requires the regulator to grant a hearing within 60 days of the request.
On Monday, a federal court ruled in Vanda’s favor, finding that the company had “clearly offered meaningful evidence of tasimelteon’s efficacy in improving sleep disturbance.” The court has passed the matter back to the FDA, which Vanda expects will issue an approval for Hetlioz in jet lag disorder or grant it a hearing.
Now, Vanda is looking to score another win over what it calls the “unacceptable culture of bias” toward generics at the agency. In a news release on Thursday, the company claimed that the agency, under outgoing Center for Drug Evaluation and Research director Jacqueline Corrigan-Curay, allowed the approval of two generics to Hetlioz despite “significant flaws in the studies and data presented.”
The FDA has previously granted a handful of approvals for generic drugs containing tasimelteon, the same active ingredient present in Hetlioz. In May 2020 and September 2021, for instance, it signed off on MSN Pharmaceuticals’ and Teva Pharmaceuticals’ copycats, respectively. In both cases, the FDA informed the companies that their products use patent-protected technologies and would therefore have to delay their market entries until such protections have lapsed.
Taking issue with these approvals, Vanda launched a citizen petition in May 2023 asking the FDA to revoke these two decisions. The company pointed to several issues in the generics applications. MSN Pharma, for instance, “only tested its drug in 44 Indian males,” according to the petition, and “did not test the drug in any women nor in a population representative of the racial and ethnic makeup of the United States.” Teva had also failed to satisfy the bioequivalence requirement of generics, Vanda claimed.
The FDA denied the petition in June, standing by its original decision to approve the drugs.
Vanda on Thursday claimed that in maintaining the approval of these generics, Corrigan-Curay seemingly agrees that “generic drug manufacturers need only conduct small studies that include only Indian male subjects to establish bioequivalence for use in the general US population.” Corrigan-Curay’s decision, the company continued, is clear evidence of the agency’s bias toward generics “regardless of whether they meet the requisite legal and evidentiary standards.”
Vanda is asking Makary to revisit this decision in a timely manner. “It is time that the rule of law return to the FDA under Dr. Makary’s leadership. Agency personnel must abide by the law and Commissioner priorities,” the biotech wrote in its news release.
