Auchincloss Calls FDA Voucher Program ‘Illegal,’ Warns Of Political Pressure
House lawmaker Rep. Jake Auchincloss (D-MA) is raising legal and oversight concerns about the FDA Commissioner’s National Priority Voucher (CNPV) pilot program, citing multiple whistleblowers at senior levels of the agency who he says have described a “culture of fear” undermining its scientific credibility.
Auchincloss, who is vocal on FDA issues, said despite defenses from FDA of its processes, the review voucher program is being used by the Trump administration to score political wins for the White House. He also argues that the program lacks congressional authorization -- making it unlawful -- and promised an upcoming hearing with FDA Commissioner Marty Makary on the issue that could lead to future oversight action if Democrats retake the House in November. FDA says the program is authorized by its general authority to implement the Food, Drug & Cosmetic Act and to promote the public health.
“The culture at the FDA right now... is one of fear and retaliation,” Auchincloss, a member of the Energy & Commerce health subcommittee, told Inside Health Policy in an exclusive interview amid reports of growing White House discontent with Makary’s leadership. The Washington Post reported Tuesday (May 5) that Makary is “on thin ice” with President Donald Trump after several policy disagreements.
“[Makary] does not take feedback well. He is creating a sense of paranoia, almost. And he is absolutely fixated upon White House approval instead of operating as a gold standard biomedical regulator,” Auchincloss said.
Scrutiny of the priority review voucher program intensified following FDA’s decision last month to issue three national priority vouchers to companies studying psilocybin for depression and methylone for post-traumatic stress disorder, after an executive order signed by President Donald Trump directing the agency to accelerate approval of and patient access to psychedelic drugs, including the plant-derived psychoactive alkaloid ibogaine.
Auchincloss argues the agency’s use of the vouchers in that context reflects what he sees as a broader pattern of political influence over the regulatory process and raises concerns that decisions are being driven by administration priorities rather than scientific review.
“When the president texts Joe Rogan, ‘Sounds great. Let’s do it. Do you want FDA approval?’ and then, within hours, the FDA issues three national priority vouchers -- that undermines the credibility of the FDA,” Auchincloss said. “The use of the commissioner’s national priority voucher to score wins for the White House degrades the agency’s adherence to safety and efficacy, and that has been validated to me by multiple whistleblowers and senior officials at the FDA.”
The Massachusetts Democrat has been pressing FDA on the issue for months, sending a series of letters in September and November 2025 and again in February 2026 questioning the program’s legal basis, transparency and potential politicization. In those letters, Auchincloss argued that, unlike other priority review voucher programs created and governed by statute, the CNPV initiative was established without explicit congressional authorization and raised concerns that the process -- rather than being led by FDA’s specialized review teams -- may be influenced by senior leadership and political appointees who could have conflicts of interest.
He also said there has been little transparency into how voucher decisions are made, warning that giving FDA leadership broad discretion over how vouchers are awarded could open the door to political considerations influencing the process.
“I want to be very clear . . . [the CNPV pilot program] is illegal. There is no congressional authorization for the commissioner’s national priority voucher,” Auchincloss said, adding he expects Makary to testify before lawmakers this summer on the program, including its recent use to support psychedelic drug development.
"I had a full and frank conversation with the commissioner about this... I expect the commissioner is going to be coming to Congress for a hearing this summer, and he's going to have to address this,” Auchincloss said.
A FDA spokesperson told IHP, "The FDA’s ability to prioritize review of certain applications based on public health reasons is well settled and stems from FDA's general authority to implement the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Public Health Service Act (PHS Act) consistent with its mission to promote and protect the public health. All products in the CNPV program are reviewed by relevant career staff under existing law and standards."
The 22nd voucher offered under the program was granted Tuesday for zenocutuzumab-zbco, a treatment for an ultra-rare cancer that forms in the bile ducts.
FDA did not immediately respond to a request for comment on whether Makary plans to testify before Congress this summer or further elaborate on its legal justification for the program.
However, in a March 26 letter to Auchincloss obtained by Inside Health Policy, FDA defended the program as a pilot designed to accelerate review timelines for drugs aligned with national priorities while preserving existing safety and efficacy standards. The agency said the initiative builds on earlier expedited review models, including the Real-Time Oncology Review (RTOR) program, which initially focused on supplemental applications before being expanded to cover original new drug applications and biologics license applications for new molecular entities.
“CNPV is not about cutting corners or bypassing FDA’s standards for review. Rather, it reflects a deliberate effort to apply proven lessons from prior FDA initiatives -- such as RTOR -- to advance critical national and public-health priorities, while maintaining transparency, accountability, and scientific integrity,” the agency said in the letter.
The agency also sought to address concerns about the role of senior leadership, saying applications are first reviewed by multidisciplinary teams of career scientists who conduct the primary analysis of safety and effectiveness. Those findings are then presented to a “CNPV Review Council” -- described as a multidisciplinary group that includes both career staff and political appointees -- which provides a nonbinding recommendation. FDA stressed that the council does not determine outcomes, and that final decisions remain with the director of the Center for Drug and Evaluation and Research per the standard agency process.
“Following the Center Director’s recommendation, the application proceeds through normal administrative procedures (e.g., finalization of reviews, final labeling discussions, action letter preparation),” FDA said. “The decision maker on an approvability decision remains within the relevant centers and follows the usual FDA processes . . . In the event of non-alignment between the Center Director and the primary review team, policies and procedures will respect principles of equal voice.”
FDA further emphasized that the program does not guarantee approval and that applications must still include complete clinical data meeting existing evidentiary standards. The agency said the accelerated timelines are flexible and can be extended if additional time is needed to fully assess safety or efficacy concerns.
“If the primary teams feel they need additional time for a comprehensive review . . . additional time may be granted. A flexible approach is being applied given that this is a new process and to ensure that scientific review quality is retained,” FDA said.
Auchincloss said he remains open to the potential therapeutic benefits of psychedelics if supported by rigorous clinical evidence but drew a sharp distinction between that policy question and what he described as a more pressing concern about the integrity of FDA’s regulatory process. He also pointed to a recent voucher awarded for Eli Lilly’s anti-obesity pill Foundayo (orforglipron) which is available through the “Trump Rx” platform.
“They are being used as a platform for political wins for the White House . . . Lilly was given a priority voucher for its tablet GLP-1 in exchange for doing an MFN deal with the White House -- not how the FDA is supposed to operate,” Auchincloss said. “The FDA is supposed to evaluate drugs based on safety and efficacy, not based on Trump.”
If Democrats regain control of the House, Auchincloss said he would push for investigations into the program and its use, including how vouchers may intersect with the administration’s “most favored nation agenda.”
“You can be assured that I will be pressing for transparency, oversight and investigations into each of these deals signed with Big Pharma and into the interplay of CNPV,” he said.
By: James Jarvis
Source: Inside Health Policy