At the December 7, 2022, Food and Drug Administration (FDA) public meeting on the Animal Drug User Fee Act (ADUFA), AHI President and CEO Alex Mathews urged Congress to quickly enact ADUFA V, stating that the new agreement between industry and the FDA provides opportunities for improvements to the twenty year old program. ADUFA must be reauthorized by Congress before the current agreement expires on September 30, 2023.
“The fundamental purpose of ADUFA is to expedite the review process to enable new and innovative products to market to address the many unmet medical needs of farm and companion animals,” Mathews said. “However, publicly available data regarding program performance demonstrates it is lagging in key indicators.”
Though revenue to the program has increased, the number of new drug approvals has remained flat. Additionally, approval time for U.S. drugs now takes up to two years longer than drug approval in Europe. And expanded fees have enabled CVM staffing increases, but the CVM workload has decreased.
“A gap has developed between program capacity and performance. The animal health industry believes the ADUFA program will be successful only if this gap is narrowed,” Mathews continued.
Mathews advocated for the current proposed ADUFA V agreement, citing the following key considerations:
- Metrics should measure progress, not activity. Measuring total time in agency and in industry will facilitate a movement to greater efficiency and help demonstrate to Congress that we’re expediting the review process.
- Face-to-face interaction between sponsors and agency personnel is critical for facilitating communication, which helps eliminate endless rounds of emails and submissions that contribute to activity but not to progress.
- The third-party assessment of financials will help the CVM and industry discover inefficiencies and provide suggestions for enhancements to improve performance. A third-party assessment program has been successful in the human user fee program.
“We believe this agreement begins to close the gap by flattening the cost curve and introducing program changes that should lead to increased performance,” Mathews said. “A successful ADUFA program benefits pet owners, food producers, and veterinarians by providing an expanded toolbox of therapies to protect the health and welfare of their animals. AHI supports this agreement and will urge Congress to act swiftly to enact it into law.”