WASHINGTON — U.S. health regulators are launching an initiative to expedite the review process for select new medications that align with national health priorities. Announced on Tuesday, the plan aims to reduce review timelines to as short as one to two months for certain drugs. This marks a significant shift from the standard six-month period under the Food and Drug Administration’s accelerated approval program, typically used for treatments targeting life-threatening conditions.
FDA Commissioner Marty Makary emphasized the importance of reevaluating existing frameworks and procedures since taking office in April. In a recent commentary, he proposed the possibility of conducting “rapid or instant reviews,” citing the expedited approach used for COVID-19 vaccine approvals as a model for future practices.
Under this new program, the FDA will issue limited “national priority vouchers” to pharmaceutical companies whose products align with U.S. public health goals. This designation enables these companies to enjoy streamlined communication with the FDA and access to faster internal reviews, as well as the ability to submit critical product information ahead of time.
The initiative to accelerate drug approvals has long been advocated by the pharmaceutical sector, which has effectively lobbied for various pathways to speed up the review process. While some elements of the new plan overlap with existing FDA programs, the broad criteria for eligibility give regulators unprecedented discretion in determining which companies will qualify for expedited reviews. Makary highlighted that the ultimate aim is to increase the availability of effective treatments for the American public.
A spokesperson from the administration reiterated that the initiative will not compromise the FDA’s approval standards. “This common-sense reform maintains rigorous clinical standards while reducing unnecessary bureaucracy,” wrote Kush Desai in an email statement.
Separate from this announcement, Makary has recently indicated a potential shift in the FDA’s scientific standards, particularly for drugs aimed at rare conditions. Discussions are underway about possibly waiving the requirement for large randomized studies, traditionally seen as the benchmark for assessing drug efficacy and safety. The FDA has increasingly accepted smaller studies for rare diseases, although it has faced scrutiny for approving medications based on preliminary findings lacking definitive patient benefits.
The move toward faster drug approvals comes as a contrast to recent policy decisions made by Makary and Health Secretary Robert F. Kennedy Jr. regarding vaccines. Kennedy has advocated for a return to stringent scientific standards, asserting that all new vaccines must undergo trials comparing them to placebos to obtain approval. Furthermore, new protocols for updating COVID-19 vaccines have been established, requiring thorough testing before approvals can be granted for general use among healthy children and adults.
As the FDA pivots to adopt this new approach, the efforts indicate a significant shift in priorities aimed at better addressing public health needs while navigating the complexities of drug approvals.