Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) called on the FDA to withdraw a legislative proposal that would eliminate the 180-day statutory requirement for reviewing new drug applications, according to a company statement.

The proposal, contained in the FDA's fiscal year 2027 Congressional Budget Justification, would replace the current 180-day legal requirement with longer Prescription Drug User Fee Act and Generic Drug User Fee Amendments performance goals. Under those goals, the FDA takes up to two months to decide whether to file an application, with typical total review times of 10 to 12 months from submission to decision.

The proposal would also replace the formal evidentiary hearing process required by current law with an internal streamlined appeal process. The FDA has not provided the statutorily mandated opportunity for a formal evidentiary hearing on drug non-approvals for over 40 years until Vanda's litigation resulted in the first such hearing in more than four decades.

"The FDA's current practice of exceeding the 180-day statutory timeline by issuing Complete Response Letters and operating under longer PDUFA timelines has already been ruled by federal courts to violate the law," said Mihael H. Polymeropoulos, president, CEO and chairman of Vanda Pharmaceuticals.

The U.S. Court of Appeals for the D.C. Circuit ruled that the FDA unlawfully denied Vanda a proper hearing in the HETLIOZ jet-lag case. The agency was subsequently compelled to grant Vanda the first formal drug approval hearing required by statute but effectively avoided by the FDA for more than 40 years.

Vanda urged FDA Commissioner Dr. Marty Makary to withdraw the provision from the fiscal year 2027 legislative agenda and asked Congress to reject the proposal.