PDUFA 101: A Closer Look at a Policy that Protects Patients and Cures
PDUFA 101: A Closer Look at a Policy that Protects Patients and Cures
Earlier this week, We Work For Health hosted a briefing to help our partners understand the Prescription Drug User Fee Act (PDUFA). This often-overlooked policy is one of the most important contributors to America’s success as the world’s biopharma leader. For more than 30 years, it has ensured timely access to safe and effective medicines for patients throughout the country.
Before PDUFA was enacted in 1992, the U.S. lagged behind other countries when it came to timely access. As recently as the 1980s, more than 70% of new medicines were first approved outside of the U.S. It often took the FDA more than two years to review a new medicine. Today, a majority of new medicines are now approved in the U.S. before other global markets and it now only takes the FDA an average of 10 months to approve a standard application. That efficiency translates directly into faster access to therapies that improve and save lives.
How PDUFA Works
PDUFA supports the FDA through two types of user fees: the application fee, which contributes 20% of total prescription drug user fee revenue, and the program fee, which covers the other 80%. A sponsor is charged an application fee when submitting a New Drug Application (NDA) or Biologics License Application (BLA). The program fee is due annually for most approved prescription drug products that don’t have an approved generic. The combined revenue for these fees provides consistent funding for FDA activities and staffing.
The fee system is mutually beneficial for the industry, as it is tied to a commitment from the FDA to meet certain performance goals.
The PDUFA Reauthorization Cycle
Every five years, Congress must reauthorize PDUFA. This serves as an opportunity for the biopharmaceutical industry and the FDA to make changes or add new provisions that strengthen the program. The program has been reauthorized six times on a bipartisan basis, with each round modernizing FDA's capabilities. The current round of reauthorization — known as PDUFA VII — is focused on modernizing the U.S. regulatory and drug development system to address the latest advances in digital health technologies, cell and gene therapies, and manufacturing.
During the reauthorization process, the biopharmaceutical industry and FDA jointly negotiate performance goals for the agency, which are then finalized in a lengthy written agreement. It is then sent to Congress for approval.
The current PDUFA legislation expires on Sept. 30, 2027. If the program is not reauthorized by July 2027, the FDA will initiate staffing cuts that will drastically hinder timely reviews for new medications. The FDA has released a proposed commitment letter and is holding meetings to discuss the PDUFA VIII agreement.
As the industry and the FDA continue to work on a PDUFA VIII agreement, it is important for advocates and stakeholders to voice their priorities and the importance of timely drug reviews.
Watch the full webinar here:
To learn more about the PDUFA reauthorization process, check out