Washington– the Food and Drug Administration The company plans to abandon its long-standing standard requiring two rigorous studies to gain approval for new drugs, the latest change from Trump administration officials who have pledged to speed up the availability of some medical products.
From now on, the FDA’s “default position” will be to require a single study for new drugs and other new health products, the FDA commissioner said. Dr. Marty McCary And his senior deputy Dr. Vinay Prasad“, he wrote in the New England Journal of Medicine piece Published Wednesday.
The announcement is the latest example of McCary and his team shaking up the long-standing US Food and Drug Administration (FDA). Standards and procedures With the stated goal of reducing bureaucracy and accelerating the availability of new medicines.
Since arriving at the agency last April, McCurry has released a series of directives that he says will shorten FDA reviews, including mandating the use of artificial intelligence by employees and providing… Drug reviews for one month For new medicines that serve “national interests.”
It contrasts with the FDA’s more restrictive approach to other products, including vaccines.
In their article published on Wednesday, Macari and Prasad said that dropping the two-trial requirement reflects recent developments that have made drug research “increasingly rigorous and scientific.”
“In this context, overreliance on two experiments no longer makes sense,” they wrote. “In 2026, there are powerful alternative ways to feel reassured that our products help people live longer or better than asking manufacturers to test them again.”
FDA officials expected this shift to lead to a “boom in drug development.”
Dr. Janet Woodcock, a former FDA drug director, said the change makes sense and reflects the FDA’s decades-long move toward relying on a single trial, along with supporting evidence, for various life-threatening diseases. Including cancer.
“The scientific point is well-accepted that as we move toward a greater understanding of biology and disease, we don’t need to be doing two trials all the time,” said Woodcock, who led the FDA’s drug center for more than 20 years before retiring in 2024.
The two-drug study standard dates back to the early 1960s, when Congress passed a law requiring the FDA to review data from “adequate and controlled investigations” before approving new drugs. For decades, the agency interpreted this requirement to mean at least two studies, preferably with a large number of patients and a long follow-up time.
The reason for ordering the second study was to ensure that the results of the first experiment were not just a fluke and could be reproduced.
But starting in the 1990s, the US Food and Drug Administration (FDA) increasingly began accepting single studies to approve treatments for rare or fatal diseases that companies often struggled to test in large numbers of patients.
Over the past five years, approximately 60% of first-in-class drugs approved each year have been approved based on a single study. The shift reflects laws passed by Congress that directed regulators to be more flexible when reviewing drugs for serious or difficult-to-treat conditions.
The new policy announced Wednesday will mainly affect drugs for common diseases that previously did not qualify for the reduced testing standards, Woodcock said.
“Cancers and rare diseases are not the ones that will be affected by this,” she noted. “The agency has approved those undergoing one trial already.”
The latest approach by FDA leadership stands in contrast to recent actions by the agency on vaccines, gene therapies and other treatments.
Last week, the FDA’s Vaccine Division, headed by Prasad, Refuse to accept Moderna has requested a new mRNA flu vaccine, saying its clinical trial is inadequate. Then on Wednesday the agency Reverse pathShe said she would review the vaccine after Moderna agreed to conduct an additional study in older people.
Separately, Prasad dismissed a series of experimental gene therapies and biotech drugs, citing the need for additional studies or more definitive evidence. The trend weighed on stocks of several biotechnology companies and ran counter to McCurry’s public statements touting the speed and flexibility of FDA reviews.
The drug industry will have to wait and see if the FDA’s approach to promising experimental treatments changes, Woodcock said.
“Implementation will be everything,” she said. “Since the agency’s approach is unclear, and the industry is already confused, I don’t think this adds any clarity.”
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