FDA Delays and Legal Battles: Vanda Pharmaceuticals' Ongoing Struggle

Vanda Pharmaceuticals has once again found itself at odds with the U.S. Food and Drug Administration (FDA), this time over the agency's delay in scheduling a hearing to discuss the rejection of the company's stomach disorder drug, tradipitant. The biotech firm has filed a lawsuit against the FDA, alleging unlawful delay in the hearing process, adding to a growing list of legal disputes between the two entities.

Tradipitant Rejection and Hearing Delay

In September 2024, the FDA issued a complete response letter (CRL) rejecting Vanda's application for tradipitant, an investigational NK-1R antagonist intended to treat gastroparesis. Vanda CEO Mihael Polymeropoulos, M.D., argued that the CRL disregarded evidence provided by the company to support the application.

Following the rejection, the FDA offered Vanda an opportunity for a hearing on January 7, 2025, which the company accepted on January 27. Vanda contends that based on FDA procedures, the hearing should be scheduled within 120 days of the notice, setting a deadline of May 7, 2025. However, the FDA has requested a delay until mid-September 2025, citing multiple reasons for the extended timeline.

FDA Cites Multiple Factors for Delay

The FDA's Office of Scientific Integrity, led by Director G. Matthew Warren, outlined several factors contributing to the proposed September deadline:

1. Vanda's hearing request includes over 15,000 pages of documentation, some of which are new materials not included in the original new drug application (NDA).

2. The same FDA staff reviewing the hearing request are also working on Vanda's pending NDA for tradipitant in a new indication for motion sickness-induced vomiting.

3. Multiple ongoing lawsuits filed by Vanda against the FDA require attention from the agency's staff.

4. The FDA is managing an ongoing tradipitant expanded access trial for gastroparesis.

5. Recent mass layoffs at the FDA, which cut 3,500 workers on April 1, 2025, have impacted the agency's resources and operations.

Broader Implications for the Pharmaceutical Industry

The dispute between Vanda and the FDA highlights broader issues facing the pharmaceutical industry. The recent FDA workforce reduction, which the Department of Health and Human Services initially claimed would not impact drug reviewers, has already affected some companies. Hundreds of biotech leaders have signed a letter expressing concern over the FDA changes and their potential impact on the industry.

These developments raise questions about the FDA's ability to maintain timely reviews and communications with pharmaceutical companies, potentially affecting drug development timelines and regulatory processes across the industry. As companies like Vanda continue to challenge FDA decisions and procedures, the relationship between the regulator and the industry it oversees may face increasing strain.