Industry watchers responded mostly positively to the commissioner’s new voucher program, but worries remain over staffing cuts at the agency.
FDA Commissioner Marty Makary has put his money where his mouth is in the form of his new priority review voucher program, which analysts and experts mostly believe will be a positive for biotech.
Jefferies said the new program could even ease investor concerns about the FDA that have been brewing since Makary and the Trump administration took over. While the S&P Biotech index, called the XBI, didn’t move much Tuesday, closing the day down 1.5%, there was cautious optimism across the industry.
“The National Priorities Voucher initiative at FDA goes right to the top of my lists of things that make you go ‘hmmm,’” Steven Grossman, a policy and regulatory consultant, told BioSpace in an email. “I like the boldness in thinking about FDA’s contribution to public health, the clear commitment to quicker decisions by the agency, and the good sense of starting with a pilot program.”
But Grossman is worried that with all the upheaval at the FDA from massive staffing cuts, this new initiative may divert resources to a single focus. “I worry about diluting the focus on unmet medical needs, the subjectivity of who receives the vouchers, and the potential manpower crunch,” he said.
The new vouchers aim to bring together experts across the FDA for a team-based review, shortening the timeframe for regulatory review of drugs selected for the program from 10–12 months down to just one or two. The new vouchers will be offered to companies that are “aligned with U.S. national priorities.” These priorities include addressing a health crisis in the U.S., delivering more innovative cures, addressing an unmet public health need and increasing domestic drug manufacturing as a national security issue.
Mike Exton, CEO of Lexicon Pharmaceuticals, anticipates the new program could benefit several of the genomics drug discovery biotech’s programs. He told BioSpace on the sidelines of the BIO conference in Boston that the new program makes “a lot of sense.”
“This is maybe even the first really concrete evidence that what [Makary] has been saying now for a few months is being translated into action,” Exton said. “So I’m really pleased.”
Jefferies analysts said the criteria for the vouchers are fairly broad but the focus on manufacturing was interesting given the looming threat of tariffs from the president. This new voucher program could represent a “carrot-vs.-stick approach” to incentivize U.S. manufacturing investment, rather than implementing tariffs, Jefferies said. President Donald Trump, however, renewed his tariff threat against the pharma industry on Tuesday while returning from the G7 meeting in Canada.
Overall, the voucher program could be good for rare disease companies, according to Jefferies. Makary and CBER Director Vinay Prasad have both been supportive of accelerating rare disease therapy approvals—as has their boss, HHS Secretary Robert F. Kennedy Jr.
The new voucher program could also provide additional incentives as the existing priority review voucher program for pediatric rare disease sunsets.
