The FDA and biopharmaceutical industry have reached an important agreement on the next iteration of the Prescription Drug User Fee Act (PDUFA), setting the stage for congressional reauthorization of a program that has been central to the FDA’s drug review process for more than three decades.
The FDA recently released its proposed PDUFA VIII commitment letter, outlining the performance goals and commitments that would govern the program beginning in fiscal year 2028. The agreement is the product of negotiations between the FDA and industry, along with input from patients and other stakeholders.
The key takeaway for the life sciences industry is positive: industry supports the agreement and believes it will strengthen the FDA’s ability to efficiently and predictably review new medicines while supporting continued innovation in the United States.
Why PDUFA Matters
Congress first established PDUFA in 1992, allowing the FDA to collect user fees from pharmaceutical and biotechnology companies to support the review of new drug and biologic applications. The program is reauthorized by Congress every five years and has become an important source of resources for the FDA’s drug review activities.
For innovative life science companies, a well-functioning FDA review process is critical. Developing a new medicine can take years and require significant investment, making predictability, transparency and timely communication with regulators especially important.
Among other provisions, the agreement includes commitments related to:
- More effective communication and transparency between the FDA and drug developers
- Greater accountability and predictability in regulatory review
- Continued advancement of regulatory science and tools that can help expedite drug development
- Improvements to the development and review of next-generation cell and gene therapies
- Greater financial transparency and long-term sustainability of the user fee program
- Improvements to FDA performance management, technology and review operations
Industry Supports the Agreement
The Biotechnology Innovation Organization (BIO), which participated directly in negotiations with the FDA, has endorsed the proposed agreement and is urging timely congressional reauthorization.
For Washington’s life sciences sector, a strong and predictable FDA review system is particularly important. Companies across our state are developing innovative medicines, biologics, cell and gene therapies, and other technologies that depend on an effective regulatory pathway to move discoveries from the laboratory to patients.
Regulatory predictability also supports the broader environment for life science investment and helps ensure the United States remains a global leader in biomedical innovation.
What Comes Next
The FDA will hold a public meeting on September 16 to receive feedback on the proposed PDUFA VIII commitments before final recommendations are sent to Congress.
Congress must ultimately pass legislation reauthorizing the program before the current PDUFA VII authorization expires on September 30, 2027.
Life Science Washington supports the agreement reached between FDA and industry and looks forward to working with BIO and our federal partners to support a timely, bipartisan reauthorization of PDUFA.
Learn more: Review the FDA’s PDUFA VIII commitment letter and BIO’s statement supporting the agreement.