FDA Bureaucrats Unlawfully Delay Hearing on Vanda Drug and Falsely Blame Commissioner Makary and the reductions in force at FDA
Rhea-AI Summary
Vanda Pharmaceuticals (Nasdaq: VNDA) has announced that FDA bureaucrats are delaying a hearing request for tradipitant, a drug intended to treat gastroparesis. The FDA is attributing the minimum 6-month delay to recent staff reductions and newly appointed Commissioner Dr. Martin Makary.
Vanda disputes these claims, noting that Commissioner Makary confirmed the cuts did not affect scientists or reviewers. The company points out similar delays in previous cases, including six-month periods for Hetlioz hearing requests for both jet lag and insomnia applications.
The company highlights that FDA has denied every hearing request on new drug approvability for at least the past decade. Vanda's CEO, Dr. Mihael Polymeropoulos, calls for increased transparency and rational decision-making in the FDA approval process.
Positive
- None.
Negative
- FDA delays hearing request for tradipitant approval by at least 6 months
- Regulatory hurdles and bureaucratic resistance potentially affecting drug approval timeline
- Historical pattern of FDA denying all new drug approvability hearing requests for the past decade
Insights
FDA's 6-month hearing delay for Vanda's gastroparesis drug reveals systemic regulatory obstacles and increases uncertainty for the company's product pipeline.
The very public dispute between Vanda Pharmaceuticals and the FDA represents a significant regulatory setback for the company's gastroparesis candidate tradipitant. The FDA has committed to at least a 6-month delay in providing its recommendation on whether a hearing should be granted - a critical step in the drug's approval pathway.
What's particularly notable is Vanda's claim that FDA has systematically avoided scrutiny by denying every hearing request on new drug approvability for at least a decade. This raises serious questions about the transparency of the agency's decision-making process. The company's reference to similar delays with their Hetlioz applications suggests a concerning pattern affecting multiple assets in their portfolio.
The escalation to federal court involvement is extraordinary, with Vanda citing an instance where a DOJ lawyer explicitly admitted to a judge that the Secretary was "not complying with the statute." This level of regulatory dysfunction creates unpredictable timelines for drug developers.
For a company with Vanda's market cap (
Vanda appears to be strategically appealing to the new FDA leadership under Commissioner Makary, hoping his stated commitment to "radical transparency and common sense" might break the regulatory logjam they've encountered. However, resolution remains highly uncertain, creating significant risks for Vanda's development timeline.
Vanda's public FDA dispute over tradipitant reveals significant regulatory hurdles, extended timelines, and increased uncertainty for pipeline advancement.
This regulatory standoff between Vanda and the FDA represents a material setback for the company's development program. The additional six-month delay in just getting a recommendation on whether to hold a hearing pushes back tradipitant's potential commercialization timeline considerably, affecting a key asset in Vanda's portfolio.
The dispute has reached an unusual level of public confrontation, with Vanda directly accusing FDA bureaucrats of unlawful delays and attempting to falsely shift blame to the new commissioner and recent staff reductions. This aggressive stance, while potentially reflecting legitimate frustration, introduces additional relationship risk with a regulatory body whose decisions are crucial to Vanda's success.
What's particularly concerning is the pattern Vanda identifies - noting similar six-month delays for their Hetlioz applications for jet lag and insomnia. This suggests systemic challenges affecting multiple products in their pipeline, not just an isolated issue with tradipitant.
The escalation to federal court proceedings adds another layer of complexity and uncertainty. Litigation pathways in pharmaceutical regulation can be lengthy and unpredictable, potentially extending the timeline further and draining resources.
For a company with Vanda's market capitalization (
While Vanda is attempting to leverage the new FDA leadership's stated commitment to transparency, the outcome remains highly uncertain, creating significant risk around the company's development timeline and future revenue generation potential.
FDA last night represented to a federal court that the April 1 reduction in force is partially to blame for the Center for Drug and Evaluation and Research's delay of at least 6 more months to provide its recommendation on whether the Commissioner should hold a hearing. But this cannot be true. Commissioner Makary said that any cuts were not to scientists or reviewers, the very individuals who supposedly need more time. This excuse is also suspect because CDER, in prior matters, has requested the same or longer delay to provide hearing recommendations: CDER took six months to submit a proposed order on the Hetlioz jet lag hearing request and likewise requested six months for the Hetlioz insomnia application.
It is unfair for CDER and its lawyers to blame the recent reductions in force for their habitual institutional delays on hearing requests. These statements also conceal the extraordinary fact that FDA has denied every hearing request on new drug approvability for at least the past decade.
FDA bureaucrats have created policies to avoid scrutiny of their decision-making by habitually denying hearings. FDA's office of chief counsel and DOJ have repeatedly defended FDA's right to act unlawfully when confronted by federal judges. When considering FDA's delay in resolving Vanda's hearing request in a prior instance, a federal judge pointedly asked FDA whether it was "conceding that the [HHS] Secretary is presently not complying with the statute," and a DOJ lawyer replied, "Yes, your Honor".
We urge Commissioner Makary to step in and restore adherence to the law at FDA; targeted RIFs are not to blame for FDA's culture of delay and closemindedness. Commissioner Makary and Secretary Kennedy have been clear that "radical transparency and common sense" should be the operating culture of the Agency. We also urge Attorney General Bondi to stop DOJ lawyers from defending unlawful Agency actions.
"Vanda has fought for 'transparency and common sense' for years because rational innovation can only thrive in a democracy and not in a bureaucracy. It is time for FDA and DOJ to stop fighting innovators like Vanda, focus on what is broken and listen to ideas of how it can be fixed, and usher in a new era of rational and transparent decision making," said Dr. Mihael Polymeropoulos, Vanda's President, CEO and Chairman of the Board.
About Vanda Pharmaceuticals Inc.
Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on X @vandapharma.
Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com
Jim Golden/Jack Keleher/Dan Moore
Collected Strategies
VANDA-CS@collectedstrategies.com
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SOURCE Vanda Pharmaceuticals Inc.
FAQ
What is causing the delay in Vanda Pharmaceuticals' (VNDA) tradipitant hearing request?
How long has the FDA been denying new drug approvability hearing requests?
What is Vanda Pharmaceuticals (VNDA) seeking FDA approval for?
How does this delay compare to Vanda's previous FDA hearing requests?
