On May 8, the U.S. Food and Drug Administration (FDA) took steps to begin the process for reauthorizing the Prescription Drug User Fee Amendments (PDUFA) by announcing a public meeting to be held on July 14, 2025. The agency invited public stakeholders, including patient and consumer advocate groups, health care professionals, and scientific and academic experts to participate in the meeting and subsequent public meetings to consult on the PDUFA reauthorization.
First enacted in 1992 and reauthorized by Congress every five years since then, PDUFA authorizes FDA to collect user fees from prescription drug and biologic companies to supplement appropriated funds and help the agency review applications, inspect facilities, and carry out other activities necessary to expedite the drug review and approval process. The most recent PDUFA reauthorization (PDUFA VII) was enacted in 2022 and expires on September 30, 2027.
As part of the reauthorization process, FDA meets with representatives from industry to negotiate proposed fees and performance goals which will correspond to those fees, including commitments from the agency for review timelines and agency staffing levels. In addition, FDA is required to meet with and accept comment from a range of public stakeholders in developing recommendations related to the reauthorization and the agency's performance goals. These goals are compiled in a "commitment letter," which may also include agency objectives to provide additional guidance, to initiate new programs, and to modify meeting practices. The proposed user fees and commitment letter are submitted to Congress as recommendations, which Congress nearly always adopts, often alongside other legislative proposals to reform FDA.
The initiation of the reauthorization process is a significant development, as new Health and Human Services Secretary Robert F. Kennedy, Jr. has repeatedly stated his opposition to the collection of user fees to fund FDA, arguing that they allow for regulatory capture by industry while compromising the agency's focus on public health. Questions have also been raised about whether FDA would meet its staffing requirements under the existing PDUFA VII commitment letter given the announced restructuring and reductions in force at the agency. Although questions about staffing remain, this announcement suggests that FDA may be willing to agree to future staffing commitments as part of a future PDUFA VIII negotiation.
PDUFA public engagement meetings and comment periods provide an important opportunity for health care stakeholders to ensure they have a voice in the user fee reauthorization process, which will likely guide FDA's prescription drug review and development programs for years to come. The Medical Device User Fee Amendments (MDUFA), Generic Drug User Fee Amendments (GDUFA) and Biosimilar User Fee Amendments (BsUFA) similarly require FDA to consult with the public in advance of those programs' reauthorizations, which typically occur alongside PDUFA reauthorization. Stakeholders should expect that opportunities to comment on those user fee programs will be announced in the coming months.
Crowell attorneys have been directly involved in several FDA user fee reauthorizations and are available to provide regulatory and policy counseling and government affairs representation to those wishing to engage with FDA and Congress.
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