Democrat Lawmakers Probe FDA Voucher Program
U.S. House and Senate health committee leaders are voicing concern about a new FDA review pilot program because it appears designed to enable corruption and reward President Trump’s allies with faster drug approvals. In an 11/20 letter to FDA commissioner Marty Makary, House Energy and Commerce Committee ranking member Frank Pallone, Jr. (D-NJ) and Senate Health, Education, Labor, and Pensions Committee ranking member Bernie Sanders (I-VT) demanded answers on the recently announced Commissioner’s National Priority Voucher (CNPV) pilot program — under which the agency has doled out awards worth millions of dollars to companies without congressional authorization. They said the program risks politicizing drug approvals, undermining public confidence, and compromising patient safety.
The FDA unveiled the pilot program in June, positioning it as a way to speed reviews for companies aligned with national priorities. But lawmakers say the program lacks congressional authorization, established criteria, transparency, and guardrails against political favoritism. As of early November, the agency had awarded 15 vouchers — far more than initially expected.
The lawmakers cited reports that at least four companies awarded vouchers did not apply for them and were “surprised” to receive the designation. Several had already been in conversations with Trump administration officials, raising concerns that voucher awards could be influenced by political connections rather than public health priorities.
Experts have also warned that the dramatically shortened timelines — reportedly as short as one or two months — could force FDA staff to take shortcuts. The letter notes the agency’s reduced workforce, including a net loss of more than 1,000 drug center employees in FY2025, and ongoing delays in standard reviews. Compressing review periods, the lawmakers wrote, risks safety oversight failures and lower-quality evaluations. The letter also raised alarms about statements from commissioner Makary that FDA may approve drugs under the CNPV pathway before clinical trials have been completed — an approach experts warn would make it “impossible” to write adequate drug labeling.
The lawmakers requested extensive documentation, including all communications with voucher recipients, agreements with companies, lists of those approached about applying, and internal processes for selecting review teams. It also presses the agency to detail how it will protect other expedited programs, how much staff time has been diverted to the pilot, and whether user-fee dollars are being used.
Meanwhile, new CDER director Richard Pazdur has privately warned colleagues that several initiatives, including the voucher program, aimed at speeding drug approvals may be unlawful and could jeopardize patient safety, according to people familiar with internal discussions who spoke to the Washington Post. Internally, Pazdur has warned that the program’s framework may conflict with long-standing statutory requirements governing drug approvals. His predecessor, George Tidmarsh — who resigned earlier this month — had similarly warned that the initiative could upend decades of regulatory precedent.
Pazdur has also raised concerns about Makary’s efforts to sharply reduce evidence requirements for certain decisions — including label changes — from multiple studies to a single study. Makary has argued that lowering evidentiary burdens will help the agency act faster when new data emerge. Pazdur has countered that multiple studies are often necessary to ensure robust conclusions and protect public health, according to the Post.
The tensions come at a moment of turbulence for the FDA, which has faced a wave of departures this year, including senior scientific staff. Several industry groups sent letters this week to Trump, Makary, and HHS Secretary Robert F. Kennedy Jr., arguing that the agency’s regulatory decisions have become erratic and less predictable, complicating drug-development planning.
Makary has also pushed rapid changes to policies surrounding antidepressants, puberty blockers, psychedelics, and other politically sensitive areas. According to people familiar with the matter, Pazdur has urged that career scientists be central to these decisions, pushing back against efforts to exclude them from politically high-profile topics.
Despite early friction between the two leaders, Pazdur has told colleagues he intends to remain in his role. In a statement through HHS, he said he is committed to CDER’s mission, according to the Post. Makary, through an HHS spokesman, called Pazdur “a true regulatory innovator,” helping advance the agency’s modernization agenda.