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

WASHINGTON, April 23, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. ("Vanda") (Nasdaq: VNDA) today announced that FDA bureaucrats have committed to delay Vanda's request for a hearing on the approvability of tradipitant for gastroparesis. Rather than take accountability, FDA bureaucrats identify a new scapegoat: newly appointed Commissioner, Dr. Martin Makary, and reductions in force.

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?

FDA bureaucrats are delaying the hearing request by at least 6 months, citing recent staff reductions and Commissioner Makary's appointment as reasons, though Vanda disputes these claims.

How long has the FDA been denying new drug approvability hearing requests?

According to Vanda, the FDA has denied every hearing request on new drug approvability for at least the past decade.

What is Vanda Pharmaceuticals (VNDA) seeking FDA approval for?

Vanda is seeking FDA approval for tradipitant, a drug developed for treating gastroparesis.

How does this delay compare to Vanda's previous FDA hearing requests?

The delay is consistent with previous cases, as CDER took six months for both Hetlioz jet lag and insomnia application hearing requests.