It used to take federal officials an average of 2.5 years to review a new drug application. Now, it takes just 10 months. That efficiency may be in jeopardy, however, if the existing user fee model is upended.
User Fees Support Program Costs
Since 1992, the Prescription Drug User Fee Act, often shorted to its acronym PDUFA, has funded timely drug approval processes. User fees paid by manufacturers now support about 75% of the program’s total costs, including staffing the Food and Drug Administration. Congressional appropriations contribute just 25%.
User fee revenue has provided the regulatory agency with increased capacity to review new products, facilitating timely access to new treatments, while ensuring that products are safe and effective.
A Risky Shift Away from Stable Funding
Despite the benefits of the current system, recent statements from the Secretary of the Department of Health and Human Services suggest skepticism about user fees as a way of supporting the nation’s drug safety apparatus.
Other programs, like the Biosimilars User Fee Agreement and Generic Drug User Fee Agreement, also follow PDUFA’s model, so the effects of changing PDUFA could be wide ranging across disease states and treatment areas.
The loss of funding from user fees would likely result in significant staff reductions at the FDA and could further slow drug reviews. Application backlogs are almost certain. Patients may face longer waits for life-changing treatments, which will be limited to only clinical trials for years longer than needed. The FDA’s ability to maintain efficient approvals hangs in the balance.
The Future of User Fees and FDA Efficiency
Grace Graham, a top FDA official, suggested that reexamining the fee structure could build more public trust in FDA decisions. But major changes could ripple across the FDA’s regulatory framework, with wide-reaching consequences for industry, agencies and patients.
Reduced funding or staffing may hinder the FDA’s ability to review drugs efficiently, reversing decades of progress and capacity-building to bring the latest medical innovations to market. In contrast, stable funding increases the likelihood that patients can access innovative treatments sooner.
Two public meetings scheduled for July will allow stakeholders to weigh in before the next reauthorization cycle, which covers fiscal years 2028 to 2032. With the current authority expiring in September 2027, these discussions are vital for the maintenance of the program. Stakeholders would be wise to advocate for a balanced approach during the reauthorization process.
