Vanda Pharmaceuticals Urges FDA Review on Generics Approval Decision for Hetlioz®
Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) has formally requested a review from Martin Makary, the Commissioner of the U.S. Food and Drug Administration (FDA), concerning a controversial decision made days before the retirement of Jacqueline Corrigan-Curay, the outgoing Director of the FDA's Center for Drug Evaluation and Research (CDER). This decision upheld the approval of two generic variants of Hetlioz®, the company's flagship medication, none of which Vanda believes met necessary approval criteria.
The controversy began in 2023 when Vanda filed citizen petitions challenging the FDA's endorsement of the generics. Vanda asserted that the approval process was flawed, arguing that significant shortcomings in the studies and data presented were overlooked. Vanda contended that the generic manufacturers relied on limited studies conducted primarily on Indian male subjects to claim bioequivalence for a medication intended for the wider U.S. population.
In July 2025, the outgoing CDER Director issued a resolution that maintained the original FDA decision, supporting the contention that minimal studies involving a narrow demographic were sufficient to establish bioequivalence. Further compounding the issues, Corrigan-Curay reportedly accepted dubious data inconsistencies regarding the levels of the drug in the bloodstream. One of the generic formulations showed levels substantially higher than those recorded for Hetlioz®, with a difference of more than double, a matter she deemed inconsequential due to the supposed varying psychological states of test subjects.
Vanda has expressed that this outcome reflects a troubling culture at the FDA, which they claim is biased towards approving generic drugs irrespective of whether they comply with the necessary legal and evidentiary standards. Katherine Eban's 2019 publication, "Bottle of Lies: The Inside Story of the Generic Drug Boom," raised similar concerns about the FDA's regulatory framework, highlighting an enduring issue.
In response to the recent ruling, Vanda is urging Commissioner Makary to intervene and reassess the legitimacy of the approval process. Reports suggested that FDA bureaucrats indicated the Office of the Commissioner would take approximately two months to determine whether the request for review would be granted. Vanda has underscored the need for a return to adherence to legal standards and Commissioner priorities within the FDA under Dr. Makary's leadership.
Vanda Pharmaceuticals, as a leading international biopharmaceutical company, is dedicated to developing and commercializing innovative therapies that address unmet medical needs, working to enhance patient lives. To learn more about Vanda's initiatives and products, visit their official website or follow them on social media platforms like X (@vandapharma).
For complete U.S. prescribing information concerning HETLIOZ®, including indications and important safety information, visit hetlioz.com.
Various statements contained in this release, including those regarding anticipated timeframes for decisions by the FDA, are considered "forward-looking statements" as per securities laws. These statements are subject to risks and uncertainties that could lead to actual results differing from those predicted. Factors that could influence these results include the decision-making process within the Office of the Commissioner and various market dynamics affecting Vanda's operations. Investors and stakeholders are encouraged to evaluate such statements in light of the complete disclosure provided in Vanda's recent filings with the U.S. Securities and Exchange Commission, accessible at SEC website.
For additional information, you can reach:
Phone: 202-734-3400
News media inquiries may be directed to:
Jim Golden / Jack Kelleher / Dan Moore
Collected Strategies
Email: [email protected]
The controversy began in 2023 when Vanda filed citizen petitions challenging the FDA's endorsement of the generics. Vanda asserted that the approval process was flawed, arguing that significant shortcomings in the studies and data presented were overlooked. Vanda contended that the generic manufacturers relied on limited studies conducted primarily on Indian male subjects to claim bioequivalence for a medication intended for the wider U.S. population.
In July 2025, the outgoing CDER Director issued a resolution that maintained the original FDA decision, supporting the contention that minimal studies involving a narrow demographic were sufficient to establish bioequivalence. Further compounding the issues, Corrigan-Curay reportedly accepted dubious data inconsistencies regarding the levels of the drug in the bloodstream. One of the generic formulations showed levels substantially higher than those recorded for Hetlioz®, with a difference of more than double, a matter she deemed inconsequential due to the supposed varying psychological states of test subjects.
Vanda has expressed that this outcome reflects a troubling culture at the FDA, which they claim is biased towards approving generic drugs irrespective of whether they comply with the necessary legal and evidentiary standards. Katherine Eban's 2019 publication, "Bottle of Lies: The Inside Story of the Generic Drug Boom," raised similar concerns about the FDA's regulatory framework, highlighting an enduring issue.
In response to the recent ruling, Vanda is urging Commissioner Makary to intervene and reassess the legitimacy of the approval process. Reports suggested that FDA bureaucrats indicated the Office of the Commissioner would take approximately two months to determine whether the request for review would be granted. Vanda has underscored the need for a return to adherence to legal standards and Commissioner priorities within the FDA under Dr. Makary's leadership.
Vanda Pharmaceuticals, as a leading international biopharmaceutical company, is dedicated to developing and commercializing innovative therapies that address unmet medical needs, working to enhance patient lives. To learn more about Vanda's initiatives and products, visit their official website or follow them on social media platforms like X (@vandapharma).
About HETLIOZ®
For complete U.S. prescribing information concerning HETLIOZ®, including indications and important safety information, visit hetlioz.com.
Cautionary Note on Forward-Looking Statements
Various statements contained in this release, including those regarding anticipated timeframes for decisions by the FDA, are considered "forward-looking statements" as per securities laws. These statements are subject to risks and uncertainties that could lead to actual results differing from those predicted. Factors that could influence these results include the decision-making process within the Office of the Commissioner and various market dynamics affecting Vanda's operations. Investors and stakeholders are encouraged to evaluate such statements in light of the complete disclosure provided in Vanda's recent filings with the U.S. Securities and Exchange Commission, accessible at SEC website.
For additional information, you can reach:
- - Kevin Moran
Phone: 202-734-3400
News media inquiries may be directed to:
Jim Golden / Jack Kelleher / Dan Moore
Collected Strategies
Email: [email protected]
Topics Health）
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