Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today highlighted a legislative proposal contained in the FDA's FY 2027 Congressional Budget Justification.

The proposal would eliminate the simple statutory requirement that the FDA must review a new drug application (NDA) within 180 days of filing.

In plain terms, this change would extend statutory review timelines rather than shorten them. It would replace the 180-day legal requirement with the longer Prescription Drug User Fee Act (PDUFA) and Generic Drug User Fee Amendments (GDUFA) performance goals. Under those goals, the FDA takes up to two months simply to decide whether to "file" the application. Only after that does the official review clock begin, resulting in 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 a weaker, internal streamlined appeal. The FDA has avoided providing the statutorily mandated opportunity for a formal evidentiary hearing on drug non-approvals for over 40 years, until Vanda's successful litigation forced the agency to grant the first such hearing in more than four decades.