FDA will drop two-study requirement for new drug approvals, aiming to speed access

The Food and Drug Administration (FDA) plans to drop its longtime standard of requiring two rigorous studies to win approval for new drugs, the latest change from Trump administration officials vowing to speed up the availability of certain medical products. Going forward, the FDA's “default position” will be to require one study for new drugs and other novel health products, FDA Commissioner Dr. Marty Makary and a top deputy, Dr. Vinay Prasad, wrote in a piece published in the New England Journal of Medicine. The announcement is the latest example of Makary and his team changing long-standing FDA standards and procedures with the stated goal of slashing bureaucracy and accelerating the availability of new medicines. Since arriving at the agency last April, Makary has launched a series of directives that he says will shorten FDA reviews, including mandating the use of artificial intelligence by staffers and offering one-month drug assessments for new medications that serve “national interests.” It contrasts with the FDA's more restrictive approach to other products, including vaccines. In their piece published in February, Makary and Prasad state that dropping the two-trial requirement reflects modern advances that have made drug research "increasingly precise and scientific." “In this setting, overreliance on two trials no longer makes sense,” they write. “In 2026, there are powerful alternative ways to feel assured that our products help people live longer or better than requiring manufacturers to test them yet again.” The FDA officials predicted the shift would lead to “a surge in drug development.” Dr. Janet Woodcock, the FDA's former drug director, said the change makes sense and reflects the FDA's decades-long move toward relying on one trial, combined with supporting evidence, for various life-threatening diseases, including cancer. "The scientific point is well taken that as we move toward greater understanding of biology and disease, we don't need to do two trials all the time," said Woodcock, who led the FDA's drug center for about 20 years before retiring in 2024. This article was provided by The Associated Press.