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# Vanda Blasts FDA Plan to Lengthen Drug Review Times
- URL: https://www.fdaweb.com/vanda-blasts-fda-plan-to-lengthen-drug-review-times/
- Published: 2026-04-09T12:00:00.000Z
- Updated: 2026-09-14T13:37:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160959

Vanda Pharmaceuticals says a proposal in the FDA FY 2027 congressional budget justification would eliminate the statutory requirement that the agency must review an NDA within 180 days of filing. “In plain terms,” a company [statement](ttps://www.prnewswire.com/news-releases/vanda-pharmaceuticals-calls-on-fda-to-withdraw-proposal-from-fy-2027-legislative-agenda-that-would-extend-drug-review-timelines-302738440.html) says, “this change would extend statutory review times rather than shorten them. It would replace the 180-day legal requirement with the longer PDUFA and GDUFA performance goals. Under those goals, FDA takes up to two months simply to decide whether to file an 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 statement says FDA also proposes to replace the formal evidentiary hearing process required by current law with a weaker, internal streamlined appeal. It points out that FDA did not hold a mandated opportunity for a formal evidentiary hearing for over 40 years until a successful Vanda lawsuit forced it to grant a hearing.

“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 Vanda CEO **Mihael Polymeropoulos**. “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 **\[Marty\] 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. At the same time, FDA seeks to replace the formal hearing process with a streamlined internal appeal, despite the U.S. Court of Appeals for the D.C. Circuit having ruled only months ago that FDA unlawfully denied Vanda a proper hearing in the Hetlioz jet‑lag case, and after the agency was compelled to grant Vanda the first formal drug approval hearing statutorily required but effectively avoided by the FDA for more than 40 years.”

Vanda says that while it supports genuine efforts to cut red tape and improve efficiency, the proposal does the opposite. It calls on Makary to withdraw the provision from the FY 2027 legislative agenda and urges Congress to reject the proposal.