On Thursday, the public had the first chance to air their grievances about the FDA’s controversial Commissioner’s National Priority Voucher (CNPV) pilot program, the flagship initiative of recently departed agency leader Marty Makary, M.D.
Comments at the June 4 public hearing largely fell along three main fault lines—industry voiced general support for the program; physicians and public health experts expressed concerns; and patient advocates pressed for vouchers to be given to promising treatments for their diseases of interest.
The hearing was moderated by Dayle Cristinzio, the FDA’s director of public engagement, with the most prominent agency attendees including Michael Davis, M.D., Ph.D., the current acting head of the Center for Drug Evaluation and Research (CDER) and Mallika Mundkur, M.D., deputy chief medical officer.
Though the hearing is now over, the public can still comment on the CNPV pilot until midnight on June 29. Public feedback, Mundkur said, will “directly inform how FDA evaluates the program's future.”
Mundkur started the hearing by outlining the CNPV review process, which includes a 60-day pre-submission period followed by a two-to-three-week window in which the sponsor can file for approval and the application is checked for completeness. After that, the goal is to review the application in one or two months.
The biggest industry players represented at the hearing were Johnson & Johnson and Merck & Co., which both expressed support for the program—and have received vouchers through it.
“Our experience reflected a highly collaborative review process with close engagement between FDA and J&J,” Ginny Beakes-Read, J&J’s head of global regulatory policy, said during the hearing.
As the first speaker of the event, Beakes-Read highlighted the voucher awarded to J&J’s multiple myeloma medicine Tecvayli, which was proactively granted by the FDA in December 2025 and not sought after by the Big Pharma. The voucher resulted in a speedy approval for Tecvayli in combination with Darzalex Faspro in March.
While lauding the agency’s close collaboration with J&J during the Tecvayli review, Beakes-Read noted that a more structured review process with clearer expectations around communication would be good for the program moving forward. She also expressed a desire for high-level feedback from the CNPV review council, to “help sponsors understand and address issues identified by the council.”
Merck, too, shared some suggested tweaks to the program, drawing on its own experience of being granted two vouchers. One of these was for its PCSK9 inhibitor enlicitide decanoate and another for the TROP2-targeting antibody-drug conjugate commonly known as sac-TMT.
“In our experience, success in the pilot has come through earlier structured scientific engagement with the review team that aids with early alignment on strategy and data requirements, particularly in CMC, while ensuring regulatory rigor,” Ashley Wivel, M.D., Merck’s vice president of global regulatory affairs, said during the hearing.
Overall, the New Jersey drugmaker is “supportive of the CNPV pilot, and Merck is supportive of FDA’s goal of accelerating access through well-prepared, high-quality submissions,” Wivel said.
Meanwhile, Partner Therapeutics also used the hearing to share its gratitude to the CNPV program, which led to the approval of its cancer medicine Bizengri in cholangiocarcinoma.
“The CNPV program accelerated FDA review time from 10 months to six weeks, streamlining access to this small patient population with significant unmet need,” Partner’s chief technology officer Debasish Roychowdhury, M.D., told the audience.
“Drug development is a complex and difficult endeavor, and when the scientists, physicians and healthcare providers, as well as regulators and sponsors, work together, magic happens,” Roychowdhury said. “In this case, the CNPV was the magic wand.”
The opposition
Not all the speakers at the hearing viewed the CNPV program as a near-mythical tool to hasten drug development. Others took to the lectern to align themselves with past criticisms from lawmakers, medical ethicists and former CDER director Richard Pazdur, M.D.
The harshest words came from Peter Lurie, M.D., the president and executive director of the Center for Science in the Public Interest, who himself spent just under eight years at the FDA.
“We encourage the agency to wind down this pilot,” Lurie said. “Given our concerns about politicization in voucher selection and review, strained agency resources and lack of transparency.”
As examples of politicization, Lurie highlighted the recent granting of vouchers to three psychedelic biotechs on President Trump’s orders, which apparently followed a text exchange between the president and podcaster Joe Rogan.
“There's a taint here of political involvement, and none of them have to do with the safety and effectiveness criteria, which are the actual criteria for drug approval,” Lurie said.
He also pointed to the structure of the CNPV review council, as outlined in a staff manual guide (PDF), which includes the FDA commissioner, agency center directors and other senior leadership.
“Although the guide says that the commissioner will not vote on discussions related to approvability, as the chair of the council, he or she is likely to exert heavy influence over the council's recommendations,” Lurie explained. “Almost everyone else on the council is likely to be a political appointee in marked contrast to FDA historical practices, which went to great lengths to insulate drug review from inappropriate political intervention.”
“We urge the agency to set up career scientists and subject matter experts in the approval process to ensure the drug approvals are guided by science and not by politics,” he added.
Lurie also lambasted the agency’s lack of transparency over why certain companies receive vouchers, noting that some of the national priorities outlined by the program—like drug pricing and domestic manufacturing—fall outside the FDA’s purview.
“Of the 22 drugs so far awarded vouchers through the program, 10 are marketed by companies that have made deals with the White House on drug pricing,” he said.
Janet Krommes, M.D., the head of the FDA task force at Doctors for America, also expressed her organization's “deep concerns” about the CNPV program. Notably, the fact that the CNPV was unveiled through a journal publication and press release rather than through normal administrative procedures or an act of Congress “opens up the entire FDA to questions about whether their process is going to be fair and open.”
“The ambiguity of the criteria in this context and lack of transparency has given life to rumors about political influences determining winners and losers,” Krommes said. “This is extremely corrosive to patient care.”
Scholars agreed that the program as currently constructed could pose a risk to the public’s trust in the FDA and urged it to be formalized through normal procedures.
“I strongly encourage FDA to prioritize the development of notes and comment rules or guidance that would put the program on strong footing and help deliver benefits to American patients,” Lowell Schiller, a nonresident senior scholar at the USC Schaeffer Institute and former FDA official, said during the hearing.
“Although FDA decisions have long been trusted, both in the U.S. and internationally, for their scientific rigor and their independence, the CNPV pilot program has serious flaws that could undermine that trust,” Thomas Hwang, M.D., of Harvard Medical School and Brigham and Women’s Hospital, added.
Public appeals
The third category of comments heard at the hearing came from patient advocates for various diseases, who pressed the FDA to include patient voices in the program and grant vouchers to potential breakthrough medicines.
Kristen Wheeden, president of the United Porphyrias Association, described the “crushing blow” of the FDA’s rejection of Disc Medicine’s drug candidate for the rare disease, which received a CNPV voucher only to later be denied approval.
“I ask today, what needs to change in the Commissioner's National Priority review Voucher process to ensure that it is fair, equitable, transparent and meaningfully informed by the patient voice?” Wheeden said.
Two advocates for Huntington’s disease, which was recently ensnared in controversy due to the FDA’s handling of a gene therapy from uniQure, asked that the agency consider granting vouchers to breakthrough therapies for the devastating progressive condition.
“Life-changing therapies for HD are a strong fit for the Commissioner's National Priority Voucher pilot program,” Huntington’s advocate Christina DeGryse said. “For families like mine, time matters.”