Ascendia Pharmaceutical Solutions Supports Prescription Drug User Fee Act (PDUFA) Renewal

Ascendia Pharmaceutical Solutions supports the Prescription Drug User Fee Act (PDUFA) and urges all members of the biopharmaceutical industry to voice the importance of PDUFA as the act comes up for renewal in September. As a CDMO committed to bringing drugs to market efficiently for the betterment of society, Ascendia Pharmaceutical Solutions recognizes PDUFA helps make that goal achievable.

"Bringing drugs to market has many challenges, including financial roadblocks. PDUFA creates an economic pathway that helps the Food and Drug Administration (FDA) review submissions efficiently so drugs can be brought to market faster and helps control costs," said Jingjun "Jim" Huang, Ph.D., founder and CEO of Ascendia Pharmaceutical Solutions. "If PDUFA is not renewed, it will certainly impact drugs being introduced into the market."

What is the PDUFA?

PDUFA plays a vital role in drug development because it is a cornerstone of the U.S. regulatory framework. The FDA, through PDUFA, collects user fees from biopharmaceutical companies to support the review of new therapies.

Funding provided through PDUFA ensures the FDA has the expertise, experience, and infrastructure to use advanced regulatory science when making decisions. Money is used to employ scientific staff, modernize review systems, and strengthen drug safety monitoring. Through these efforts, FDA standards for drug safety and effectiveness are maintained.

PDUFA was written and approved to address the significant delays in drug review, forcing patients to wait - in some cases years - for new treatments. Since being enacted by Congress in 1992, PDUFA has helped make the drug review process more predictable, efficient, and globally competitive, all while maintaining rigorous scientific evaluation.

Why is PDUFA Important?

PDUFA directly affects how quickly and efficiently the FDA can review new therapies, resulting in patients having more timely access to treatments. It does this by supporting:

• New medicine reviews are done in a timely and predictable manner
• Scientific and regulatory capacity through the entire drug lifecycle is improved
• Patient engagement and communication is more frequent
• U.S. remains a leader innovating and advancing the biomedical field

In the 34 years since PDUFA was enacted, the average new drug review time has decreased from 29+ months to less than 12 months. PDUFA also funds programs that improve patient engagement, benefit-risk assessment, and communication.

When is PDUFA Scheduled for Renewal?

PDUFA operates on a five-year cycle and must be reauthorized by Congress to continue. The current authorization, PDUFA VII, expires on September 30, 2027. If PDUFA is not reauthorized on time, FDA would lose a significant source of funding for its drug review program. The result could be hiring freezes, staff reductions, and delays in new product reviews. That can trickle down to the general public, as it may slow patient access to innovative therapies and disrupt the drug development pipeline.

When is the PDUFA Public Hearing?

The FDA has announced plans to hold its PDUFA VIII public meeting on September 16 at 9:00 a.m. to discuss the proposed enhancements for the reauthorization of PDUFA for 2028 through 2033. People are encouraged to attend and voice their support for PDUFA renewal.

An Eventbrite page has been created by the FDA to registering to attend the meeting. Registration, however, is not required. Additionally, people can make a statement during the public comment session of the meeting. To be considered, interested parties must submit a request to the FDA.