Vanda Pharmaceuticals has urged the FDA to withdraw a proposal in the FY 2027 Congressional Budget Justification that would eliminate the statutory 180‑day review requirement for new drug applications. The proposal would replace the 180‑day clock with the longer Prescription Drug User Fee Act (PDUFA) and Generic Drug User Fee Amendments (GDUFA) performance goals, effectively extending review timelines to roughly 10‑12 months.
Vanda argues that the FDA’s current practice of exceeding the 180‑day statutory deadline has already been ruled unlawful by federal courts. The company’s litigation led to the first formal evidentiary hearing in more than four decades, underscoring its commitment to procedural transparency. The proposal would also replace the formal evidentiary hearing process with a streamlined internal appeal, a change that Vanda sees as a rollback of due‑process protections.
The company’s concern centers on the potential impact on its pipeline, which includes Fanapt, HETLIOZ, and NEREUS. A longer review cycle could delay the approval of these products, affecting market entry and revenue timing. Vanda’s CEO, Mihael H. Polymeropoulos, M.D., said, “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. Instead of complying with the law as written, this proposal asks Congress to change the law so the slower system becomes legal. This is especially concerning because Commissioner Makary said just days ago that the current two‑month filing review is too long and should take just days—yet this proposal seeks to codify that very delay into law.”
The FDA has not publicly disclosed its rationale for the proposal, and the specific court cases cited by Vanda were not identified in the available sources. The proposal remains part of the FY 2027 Congressional Budget Justification, but no further details have been released about the agency’s justification or the expected implementation timeline.
Vanda’s lobbying effort reflects its interest in maintaining a faster, more predictable approval pathway for its products. The company’s stance highlights the broader debate over the balance between regulatory efficiency and statutory compliance, and it underscores the importance of transparent review timelines for patients and smaller innovators.
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