The Food and Drug Administration (FDA) has announced a new initiative to expedite the review process for medications that align with the health priorities set by the Trump administration. This move aims to enhance the health interests of Americans.
In a statement released Tuesday, FDA Commissioner Marty Makary highlighted that the agency will target a review timeframe of one to two months for selected drugs. In contrast, the FDA’s existing accelerated approval system typically takes around six months for drugs treating life-threatening conditions, while standard reviews average ten months.
Since his appointment in April, Makary has urged FDA staff to rethink traditional procedures. He proposed the idea of “rapid or instant reviews” in a recent commentary in a medical journal, referencing the streamlined process that facilitated the initial COVID-19 vaccine approvals under Operation Warp Speed.
As part of this initiative, the FDA will distribute a limited number of “national priority vouchers” to companies that are in line with U.S. health objectives. This special designation will afford these companies enhanced access to FDA communications, expedited staff reviews, and the opportunity to submit substantial portions of their product information ahead of time.
Accelerated drug approvals have long been a goal of the pharmaceutical industry, which has successfully advocated for various special programs and quick review pathways.
While many elements of this newly announced plan overlap with previous programs, its broad criteria for voucher eligibility provide FDA officials with significant discretion in determining which companies will benefit from the expedited reviews.
“The ultimate goal is to bring more cures and meaningful treatments to the American public,” Makary stated.
Additionally, Makary has indicated that the FDA may relax its scientific standards for certain medications, suggesting that randomized trials—which are generally considered the benchmark for medical research—might not always be necessary. This approach has already been evident in the FDA’s growing willingness to accept smaller, less conclusive studies for rare or critical illnesses.
Recently, the FDA has come under scrutiny for approving drugs based on preliminary data that failed to demonstrate patient benefits. This rapid approval push stands in stark contrast to the policies Makary and Health Secretary Robert F. Kennedy Jr. have implemented regarding vaccines. Kennedy has previously committed to a “return to gold-standard science,” ensuring that all new vaccines must undergo comparative testing against a placebo to gain approval. Furthermore, he and Makary have enforced stricter guidelines for seasonal updates to COVID-19 vaccines, requiring additional testing prior to authorization for use in healthy children and most adults.