According to Makary, reducing user fees—which make up just under half of the FDA’s budget—could make it easier for smaller companies, individual investors and academics to participate in the process.
FDA Commissioner Marty Makary wants to lower prescription drug user fees for the next iteration of the program, continuing a series of high-level policy proposals for the agency.
Makary made these comments Monday as the FDA kicked off the user fee reauthorization process, according to Regulatory Focus. “I’d like to see lower user fees,” Makary said, noting that the move would make it easier for smaller players—“small companies and individual investors and people in academics”—that are interested in participating in and understanding the process.
Speaking to stakeholders at the kick-off meeting, Makary also emphasized the value of the program for the agency, which derives a large chunk of its budget from user fees. “User fees are critically important,” he said. “We want your input on how to make it better.”
The user fee program enables the FDA to collect certain fees from companies and drug sponsors that want to have their product applications reviewed. Importantly, these payments do not ensure favorable verdicts for the participants but instead allow them to hold the regulator to certain performance standards, such as consistent and reasonable response times, a certain number of meetings and other similar metrics.
For the 2025 fiscal year, sponsors seeking to have a product reviewed must pay more than $4.3 million if the application requires clinical data and almost $2.2 million if the application doesn’t require clinical data. Meanwhile, program fees, which are assessed annually for certain eligible products, cost over $403,000.
All told, these user fees make up just under half of the FDA’s yearly budget and help the agency support its operations, mainly through subsidizing the salaries of its employees.
The user fee program is renewed every five years. The next cycle—the eighth iteration of the program—begins in late 2027, but because negotiations are complex, the reauthorization process is set to start later this year. At the kickoff meeting on Monday, Andrew Kish, director of the FDA’s Office of Strategic Programs and Analysis, explained that a final user fee program package will be submitted to Congress by Jan. 15, 2027, according to Endpoints News. Lawmakers will then need to sign the agreement into law by Sept. 30 that year.
This user fee renewal process comes amid sharp cuts at the FDA, which is losing around 3,500 employees as part of Health Secretary Robert F. Kennedy Jr.’s sweeping reorganization push. The layoffs have sparked concerns about a collapse of the user fee program, which would pose a huge threat to the FDA’s budget—and to its ability to perform its duties. User fee negotiators have since been rehired, though it’s not clear if that team continues to operate at full capacity.
Policy changes and proposals have been coming quickly at the FDA of late. Last month, for instance, the agency unveiled a national priority voucher program that would accelerate drug reviews for products aligned with national interests, cutting the wait from 10-12 months down to 1-2 months. Last week, Makary announced that he is looking to use this priority voucher to incentivize companies that commit to lowering their drug prices.
Meanwhile, in May, Makary and Vinay Prasad, director of the Center for Biologics Evaluation and Research, released a new approval framework for COVID-19 vaccines. The FDA will now adopt a risk-based approach to these applications, focusing on seniors 65 and up and high-risk individuals 6 months through 64 years.
