Vanda Pharmaceuticals warns that an FDA FY 2027 budget proposal could eliminate the 180-day NDA review requirement, potentially extending drug review timelines and replacing formal evidentiary hearings with streamlined internal appeals.
Written By: Nikita Jha, BPharm
Reviewed By: Pharmacally Editorial Team
Vanda Pharmaceuticals has raised concerns over a legislative proposal included in the U.S. Food and Drug Administration’s FY 2027 Congressional Budget Justification, warning that the measure could lengthen statutory drug review timelines and weaken formal appeal rights for sponsors.
According to Vanda, the proposal would remove the statutory requirement that the FDA review a New Drug Application (NDA) within 180 days of filing. The company stated that the change would instead rely on performance goals under the Prescription Drug User Fee Act (PDUFA) and Generic Drug User Fee Amendments (GDUFA), which typically result in longer timelines.
Under the current user fee framework, the FDA may take up to two months to determine whether an application is accepted for filing. The official review clock begins only after that step, leading to typical total review times of approximately 10 to 12 months from submission to decision, according to the company.
Vanda also highlighted that the proposal would replace the formal evidentiary hearing process required by statute with an internal streamlined appeal mechanism. The company noted that formal evidentiary hearings for drug non-approvals have rarely been granted, and that recent litigation involving Vanda led to the first such hearing in more than four decades.
Mihael H. Polymeropoulos, M.D., President, CEO and Chairman of Vanda Pharmaceuticals, stated that federal courts have previously ruled that exceeding the 180-day statutory timeline violates existing law. He said the proposal would effectively change the law to align with current longer review practices.
He also pointed to recent remarks suggesting that filing reviews could be shortened, while the proposal would formalize the existing two-month filing period. In addition, he noted that courts recently ruled the FDA improperly denied Vanda a formal hearing related to the HETLIOZ jet-lag application, which ultimately led to the agency granting a formal approval hearing.
Vanda stated that while it supports efforts to improve regulatory efficiency, the company believes the proposal could extend review timelines, reduce transparency, and increase uncertainty for smaller innovators. The company added that longer timelines could delay patient access to new therapies.
Vanda called on FDA Commissioner Dr. Marty Makary to withdraw the provision from the FY 2027 legislative agenda and urged Congress to reject the proposal.
This is not the first time Vanda has publicly opposed FDA policy direction. The company’s comments also follow earlier positions in which it challenged aspects of FDA policy, including a prior call for stronger agency action to accelerate the transition from animal testing toward human-relevant methods. Along with Vanda’s recent regulatory dispute involving the HETLIOZ application and formal evidentiary hearing process, these developments provide context for the company’s continued focus on review timelines, procedural transparency, and evidentiary standards.
Reference
Vanda Pharmaceuticals Calls on FDA to Withdraw Proposal from FY 2027 Legislative Agenda That Would Extend Drug Review Timelines, 09 April 2026, Vanda Pharmaceuticals Calls on FDA to Withdraw Proposal from FY 2027 Legislative Agenda That Would Extend Drug Review Timelines
About the Writer
Nikita Jha BPharm is a pharmacy graduate with expertise in clinical research, pharmacovigilance, and medical writing. In her words, she is passionate about translating complex scientific data into clear, accurate healthcare communications that advance drug safety and patient care.