Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has asked Martin Makary, the Commissioner of the U.S. Food and Drug Administration (FDA) to review the decision made by Jacqueline Corrigan-Curay, the departing director of the FDA’s Center for Drug Evaluation and Research (CDER), days before her retirement that upholds an Office of Generic Drugs decision to approve two generic versions of Hetlioz®.
In 2023, Vanda filed citizen petitions challenging the FDA’s approval of two generic versions of Vanda’s drug Hetlioz®. Vanda argued that each was improperly approved in light of significant flaws in the studies and data presented.
In July 2025, outgoing CDER director Corrigan-Curay issued a decision siding with the prior FDA decision to approve these generic versions, seemingly agreeing 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. Further, in the case of one generic version, Corrigan-Curay accepted that significant inexplicable data inconsistencies measuring a drug’s exposure levels in the blood could be justified by the supposedly different “psychological state” of participants at different times and that it was of no concern that one of the generic versions showed exposure levels more than double those Vanda has obtained for Hetlioz®.
This decision reflects the FDA’s unacceptable culture of bias toward approving generic drugs regardless of whether they meet the requisite legal and evidentiary standards, endangering the well-being of American citizens. Katherine Eban extensively exposed this serious flaw in her 2019 book Bottle of Lies: The Inside Story of the Generic Drug Boom, but it appears to remain entrenched at the FDA.
Vanda is now asking Commissioner Makary to review this decision. Unfortunately, FDA bureaucrats have suggested that the Office of the Commissioner (not the Commissioner) will take two months to decide whether the Office of the Commissioner will review the merits of this decision. 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.
