FDA’s New Fast Drug Review Plan Comes With Trade-Offs for Pharma

The FDA’s effort to expedite reviews for drugs in line with the Trump administration’s priorities was greeted warmly by a pharmaceutical industry interested in moving approvals more quickly, but raised concerns about the scope of the plan in light of recent cuts at the agency.

The Food and Drug Administration’s new Commissioner’s National Priority Review Voucher aims to reduce drug application review times from as long as 12 months to as quickly as one month. The FDA this month granted the first nine vouchers to companies that are aligned with what the agency views as a critical national health priority under President Donald Trump’s agenda.

The plan is both a win and a loss for the pharmaceutical industry, life science experts say, as it pressures the FDA to prioritize which medicines to review. But while priority reviews aren’t new to the FDA, the evaluations will now be made by offices hit hard by recent workforce reductions that could affect decisions for drugs even beyond those included in the program.

“There are going to be winners, and there are going to be losers,” Elizabeth Jungman, a partner at Hogan Lovells US LLP, said in an interview. “Some sponsors are going to leapfrog their competitors and some are going to be left behind.”

“The voucher program didn’t come with additional staff or resources, so there are going to be trade-offs,” said Jungman, who served as the chief of staff to former FDA Commissioner Robert Califf.

Commissioner Marty Makary, in a video posted on social media, shared details on which drugs were split up among the FDA’s centers to review, but said the agency could spend longer on a decision to ensure safety.

“It’s the same people, same decisions,” Makary said. “We reserve the right to take more time if we believe it needs more time.”

Wins, Losses

The pharmaceutical industry benefits from the decreased review time for drugs and biologics. The strenuous process involves the FDA analyzing thousands of pages of an application while being in constant communication with sponsors to ensure a drug is safe and effective along with the facilities where it’s manufactured.

The national priority voucher provides recipients with an expedited review, enhanced communications with the FDA, multidisciplinary team-based evaluation, and accelerated approval if applicable requirements are met.

“This program, if successful, can inform the next generation of product development priorities,” said Julie Tibbets, chair of Goodwin Procter LLP’s life science regulatory and compliance practice. “If the commissioner can create speed to market for the initial programs as a test case, that has the potential to lift industry as a whole.”

The program is also “one solution for FDA to deal with some of the challenges that ultra rare disease therapies have,” said Rachel Turow, head of the FDA regulatory practice at Skadden Arps Slate Meagher & Flom LLP.

Often, therapies for rare diseases are more challenging to approve due to high costs for development and limited clinical trial designs.

But the voucher could also introduce some hurdles for both the drug industry and agency, others say.

The US Department of Health and Human Services’ reduction-in-force carried out this year targeted hundreds of staff that helped reviewers oversee and organize product applications.

While Makary has claimed that no scientific reviewers were fired, many employees in critical drug review centers have left the agency this year, according to a recent headcount report from the FDA.

During the 2025 fiscal year, the Center for Drug Evaluation and Research, which reviews most medicines, experienced a loss of 1,093 employees. The Center for Biologics Evaluation and Research, which oversees vaccines and gene therapies, lost 224 employees by the end of the fiscal year.

“What stakeholders are wondering is whether they have the resources,” said Michael Werner, co-lead of Holland & Knight’s health-care and life sciences team. “Programs for expedited review are really resource intensive—it’s a time crunch.”

Despite the concerns, the agency’s decision-making under this program remains to be seen, others say.

“They have the authority to review a drug in whatever time period they would like,” Turow said. “I think what they cannot do in one to two months is write the kind of documents that we are used to seeing coming out of the agency—the thoroughness of the substance of the review documents.”

More Changes

Additional challenges could also arise from the program as the agency is expected to select another round of medicines for fast review in the coming weeks.

The FDA accepted four additional drugs for the first round on top of the five applications it initially said it would choose.

“If they can expand this program to make manufacturing reviews quicker for existing products, that’s a good thing, assuming it’s done properly,” said Ryan Conrad, a visiting fellow in the Center on Health Policy at the Brookings Institution.

“The bigger issue would be if they expand it to a catch-all,” Conrad, a former senior economist at CDER, said in an interview.

The agency has issued other review vouchers before such as for neglected tropical diseases, rare pediatric diseases, and medical countermeasures to chemical, biological, radiological, or nuclear attacks. Congress permanently authorized the neglected tropical disease voucher program; it hasn’t for the other two programs.

The program would also work in addition to other FDA approaches to make drugs available as rapidly as possible. This includes the accelerated approval, breakthrough therapy designation, and fast track designation pathways.

“Always the concern about a voucher program is that prioritizing something means deprioritizing something else,” Jungman said. “The bigger the program gets, the bigger those trade-offs are going to have to be.”