Vanda Pharmaceuticals Inc. (VNDA) has called on the U.S. FDA to withdraw a legislative proposal included in the agency's FY 2027 Congressional Budget Justification.
Proposal Details
The FDA's proposal seeks to eliminate the current legal requirement that new drug applications (NDAs) be reviewed within 180 days of filing. Instead, reviews would follow the longer timelines under the Prescription Drug User Fee Act (PDUFA) and Generic Drug User Fee Amendments (GDUFA), which typically result in 10-12 months from submission to decision. The proposal also aims to replace the formal evidentiary hearing process with a streamlined internal appeal.
Vanda's Position
Vanda argues that the change would entrench delays, reduce transparency, and increase risks for small innovators. The company noted that federal courts have already ruled the FDA's practice of exceeding the 180-day statutory timeline unlawful. Mihael H. Polymeropoulos, M.D., President, CEO and Chairman of the Board emphasized that instead of complying with the law, the FDA is asking Congress to change it, effectively codifying slower review processes.
The FDA currently takes up to two months simply to decide whether to "file" the application, which Vanda highlighted as a key concern.
Broader Implications
According to Vanda, the proposal would mean longer waits for patients to access new medicines and greater uncertainty for biotech innovators. The company urged FDA Commissioner Dr. Marty Makary to withdraw the provision and called on Congress to reject it.
Vanda also noted that the FDA seeks to replace the formal evidentiary hearing process with a weaker, internal appeal, despite a recent U.S. Court of Appeals ruling that the agency unlawfully denied Vanda a proper hearing in the HETLIOZ jet-lag case.
VNDA has traded between $3.81 and $9.94 over the past year. The stock is currently trading at $7.22, down 1.03%.
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