Speaking at BIO2025, Makary bemoaned what he called “unnecessary steps” and “avoidable delays” in the U.S. regulatory landscape.
Under his tenure as FDA Commissioner, Marty Makary said that he aims to optimize the agency’s drug review process, iron out inefficiencies and ultimately accelerate the time it takes for new drugs to reach the market.
“We need to keep innovating and we cannot be satisfied,” Makary said Tuesday at the BIO International Convention, in a fireside chat with CEO John Crowley. “We have got to modernize the agency.” Changes in this direction, he continued, will help ensure that the U.S. retains its biotech leadership status worldwide.
“We are seeing an increasingly competitive landscape internationally,” Makary said, noting that the U.S. has meanwhile been bogged down by an inefficient regulatory landscape marked by “unnecessary steps” and “avoidable delays.”
“Why does it take over 10 years for a new drug to come to market?” he asked.
The FDA in recent weeks has taken steps to make the drug development process more efficient, Makary said. He pointed to the new Commissioner’s National Priority Voucher (CNPV), also launched on Tuesday, describing it as “essentially a decoupling of the application.” The vouchers aim to speed up approval processes in a few ways: employing team-based, one-day reviews instead of sending out review packages to multiple FDA offices, as well as allowing companies that hold vouchers to submit the chemistry, manufacturing, and controls (CMC) portion of their applications before all clinical data is ready.
“We will start the review process and that way once the final clinical trial results come in, they could be submitted essentially as an addendum or part two of the application,” Makary explained. All told, the FDA hopes the CNPV will cut its review time from the standard 10–12 months down to 1–2 months after the final data submission.
At the same time, the FDA is also turning to artificial intelligence to aid its processes. Last month, the FDA announced that it would adopt a generative AI assistant to help its reviewers, a move that the regulator at the time said could help prevent delays in its work. Observers at the time also hoped that the move could potentially help avoid the missed deadlines that have plagued the agency in recent months. Back in April, the regulator also unveiled plans to phase out animal testing and replace it with “AI-based computational models” that could provide reliable information regarding the efficacy and side effects of a drug candidate.
Despite these changes, Makary insisted that the FDA is “not cutting corners on scientific rigor.”
At BIO, Makary also addressed the recent steep cuts at the FDA, defending the moves as necessary to eliminate what he called the “fiefdom culture” at the agency. Before these cuts, he claimed, each center “had their own lawyers and communication staff and legislation affairs people. They had 12 travel offices. They had I.T. departments that built their own giant clunky reporting systems.”
In response to a question about vaccines, Makary responded: “Vaccines save lives,” telling Crowley, “We want to continue to encourage innovation in the vaccine space.”
Still, he stood by the government’s recent actions of slimming down immunization guidelines for healthy children. “We still have this approach of, based on a theory that every 12-year-old healthy child in America needs another 60 doses for the rest of their life, one every year,” he said, arguing that such an approach is “not supported with good clinical data.”
The HHS last month removed the CDC’s recommendation for a routine COVID-19 shot for healthy children and healthy pregnant women.
