Vanda Pharmaceuticals has called on the FDA to withdraw a legislative proposal included in the agency’s Fiscal Year 2027 Congressional Budget Justification, citing concerns that the measure would significantly extend statutory drug review timelines and weaken procedural protections for sponsors.
According to Vanda, the proposal would eliminate the current statutory requirement that the FDA complete the review of a new drug application (NDA) within 180 days of filing. The change would instead align reviews with longer timelines set by the Prescription Drug User Fee Act (PDUFA) and the Generic Drug User Fee Amendments (GDUFA), which typically result in total review times of 10 to 12 months from submission to decision. The company contends that this would formalize delays rather than improve efficiency.
The proposal also seeks to replace the formal evidentiary hearing process for non-approvals with an internal streamlined appeal. Vanda notes that the FDA has historically avoided offering such hearings, until its recent successful litigation compelled the agency to grant the first formal drug approval hearing in more than four decades.
“Instead of complying with the law as written, this proposal asks Congress to change the law so the slower system becomes legal,” said Mihael H. Polymeropoulos, M.D., President and CEO of Vanda Pharmaceuticals. The company urges FDA Commissioner Dr. Marty Makary and Congress to reject the measure, arguing that it would increase bureaucracy, extend patient wait times, and undermine innovation in drug development.
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