Rep. Auchincloss Criticizes Commissioner’s Priority Voucher Program
Rep. Jake Auchincloss (D-MA) is escalating his criticism of FDA’s new voucher program that offers select drugmakers sharply shortened review timelines, arguing the program undermines scientific standards and the agency’s credibility. In an interview with U.S. News & World Report, Auchincloss, a member of the House health subcommittee, described FDA’s Commissioner’s National Priority Voucher program as a “short-circuiting” of the traditional drug review process and called on FDA commissioner Marty Makary to step down.
The program, launched last year, promises expedited reviews — by as much as one to two months — for new medicines deemed to support “national interests.” But Auchincloss contends the initiative lacks statutory authority and shifts power away from career scientists toward political appointees.
“It’s actually very hazy what exactly ‘accelerated’ means,” Auchincloss said, noting that meetings with FDA staff have not clarified how much time is being removed from the standard review process. He suggested that the practical effect may be less about speed and more about increasing the likelihood of approval.
Auchincloss argued that the program enables the commissioner to grant favored companies a higher probability of receiving approval, a move he claims is intertwined with drug pricing negotiations and White House priorities.
“The FDA has to evaluate drugs based on safety and efficacy — not on any consideration of price,” he said, asserting that tying regulatory decisions to pricing discussions would be illegal.
He has sent three letters to Makary outlining his concerns, citing whistleblower accounts, industry feedback and public reporting as reinforcing his view that the program constitutes “a political end run around career scientists.”
According to Auchincloss, the review board associated with the voucher program is composed of political officials who report to the commissioner, rather than long-serving scientific staff. That structure, he said, erodes confidence in decisions that have historically been grounded in toxicology data, human safety studies and randomized controlled trials.
The Massachusetts lawmaker warned that patients and physicians rely on the FDA’s reputation as the global “gold standard” regulator. Introducing political considerations into the review process, he said, risks weakening that trust. “When it’s political appointees, then patients have less confidence,” Auchincloss said. “The White House is looking for a short-term win rather than long-term safety and efficacy.”
He suggested that drugs approved under the program could face heightened scrutiny from hospitals and formulary committees, and said the industry itself should not have confidence in the program. “I think it’s a poisoned chalice,” he said.
Auchincloss emphasized that he supports pro-innovation policies, particularly in his home state, where biotechnology is a major economic driver. He argued that meaningful reform would focus on clearer regulatory guidance, faster entry into early-stage trials and streamlined patient enrollment for late-stage studies — changes he said could be achieved on a bipartisan basis. “The wrong way to do it is to basically short-circuit and lower standards,” he said. “What that ends up becoming is a tax on innovators and a premium for snake oil salesmen.”
Auchincloss also criticized House Republicans for not holding oversight hearings on the voucher program. He said the top priority should be compelling Makary to testify before the health subcommittee. “Makary needs to sit in front of the House health subcommittee and answer for his terrible stewardship,” Auchincloss said, adding that if Democrats regain control of the chamber, oversight would intensify.