New initiative cuts drug review time to as little as 30 days
The U.S. Food and Drug Administration (FDA) announced Tuesday a new fast-track initiative to accelerate the review of medicines deemed critical to American public health. Select drugs could now be approved in just one to two months, a significant reduction from the typical 10-month timeline or even the six months used under the existing accelerated approval program.
FDA Commissioner Marty Makary said the agency would issue a limited number of “national priority vouchers” to companies working on treatments that align with U.S. health priorities, such as public health crises or rare diseases. These vouchers will grant enhanced FDA support, early data submission privileges and streamlined regulatory pathways.
Operation Warp Speed model inspires new approach
The new program draws inspiration from the expedited approval process used for COVID-19 vaccines under Operation Warp Speed. Makary, who joined the agency in April, has advocated for rethinking traditional FDA procedures and reducing red tape without compromising safety.
In a commentary published last week, he argued for “instant reviews” in some cases, particularly where public need is urgent and conventional review cycles may delay access to life-saving drugs.
Criteria broaden, but standards remain
While the initiative provides FDA leadership with broad discretion, White House spokesperson Kush Desai emphasized that the agency’s scientific standards will remain intact. “This is a common-sense reform that maintains rigorous clinical standards while streamlining needless bureaucracy,” he said.
The new program does not replace current FDA pathways but complements them by offering an optional route for products addressing high-priority needs. Areas such as cancer, Alzheimer’s, rare diseases and unmet health conditions may see faster access to potential treatments through this initiative.
Industry welcomes but experts urge caution
Pharmaceutical companies have long pushed for faster drug approvals. However, some medical experts warn that speed should not come at the expense of evidence. The FDA has faced criticism in recent years for approving drugs based on early data that later failed to show patient benefit in larger trials.
Interestingly, this push for accelerated drug reviews contrasts with the FDA’s recently tightened stance on vaccines. Makary and Health Secretary Robert F. Kennedy Jr. have implemented stricter standards, requiring new placebo-controlled trials for vaccine approvals and updated seasonal COVID-19 shots.