House Lawmaker Raises New Concerns Over FDA’s Ultra‑Fast Drug Review Program

A Democratic congressman has raised serious questions about the Food and Drug Administration’s new ultra‑fast drug review initiative, the Commissioner’s National Priority Voucher program, citing a lack of transparency, unclear legal authority and potential ethical issues in how the agency speeds drug approvals.

By David Thompson – News Reporter

Last Updated: Feb. 2, 2026

What Is the Commissioner’s National Priority Voucher Program?

The Commissioner's National Priority Voucher (CNPV) program aims to shorten the FDA’s review timeline for certain drugs to as little as one to two months — a dramatic acceleration from typical regulatory review periods. The initiative is part of FDA Commissioner Marty Makary’s broader agenda to reduce bureaucratic delays and deliver treatments rapidly for products deemed to support 'national interests.' Under the program, select drugmakers can apply for these accelerated reviews, positioning the policy as a tool to speed innovation and address unmet medical needs. :contentReference[oaicite:1]{index=1}

Lawmaker’s Concerns: Transparency and Ethics

Rep. Jake Auchincloss of Massachusetts has expressed strong concerns about the program’s transparency and governance. In a letter to the FDA, he argued that critical details about the CNPV initiative have been kept hidden from Congress and the public, and that the agency has failed to respond to multiple inquiries about how it functions. Auchincloss also highlighted that key financial disclosure forms for eight senior FDA officials involved in prioritizing voucher recipients have not been made public, raising questions about potential conflicts of interest in a process that fast‑tracks decisions with significant industry implications. :contentReference[oaicite:2]{index=2}

Questions About Legal Authority

Beyond transparency, the lawmaker’s letter also focuses on the legal basis for the ultra‑fast review program. Auchincloss questioned whether the FDA had the statutory authority to establish the CNPV program without explicit approval from Congress — a notable point, since most regulatory priority review pathways are grounded in legislation enacted by lawmakers. His letter indicates that the FDA’s legal office was not consulted before launching the initiative, further complicating the agency’s defense of its authority to operate the program independently. :contentReference[oaicite:3]{index=3}

Internal and External Debate at the FDA

The concerns raised by Auchincloss come amid tensions within the FDA itself. According to reports from agency staffers, an internal town hall was held on the program the same day as Auchincloss’s letter. While FDA leadership emphasized that final approval decisions remain with career staff at relevant product centers, some senior agency scientists have reportedly declined to sign off on approvals routed through the fast‑track program due to legal and procedural concerns. This internal debate reflects broader unease about balancing rapid access to treatments with maintaining confidence in the agency’s scientific rigor. :contentReference[oaicite:4]{index=4}

Wider Political Scrutiny and Congressional Interest

Auchincloss’s letter is part of a growing wave of congressional scrutiny. In previous actions, lawmakers including Sen. Bernie Sanders and Rep. Frank Pallone have sought answers from the FDA about the priority voucher program, requesting detailed information on how it operates and its criteria for selecting candidate drugs. As lawmakers push for more oversight and possible legislative guardrails, the debate over the program’s future and its role in U.S. health policy is likely to continue — especially as the FDA tests new approaches to streamline drug approvals. :contentReference[oaicite:5]{index=5}