President Bush signed legislation that provides user fees to the Food and Drug Administration (FDA) for its animal drug review work on November 18. Known as the Animal Drug User Fee Act (ADUFA), this law establishes a funding system for the new animal drug review process that is similar to that established for the human drug review process over a decade ago.
"We expect that the new resources that ADUFA provides will greatly strengthen FDA's animal drug review capabilities, in much the same way that user fees improved our ability to more quickly and efficiently review human drugs," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "Thanks to the hard effort of the Administration and Congress, as well as HHS Secretary Tommy Thompson's strong support, we have a funding system that assures that FDA's Center for Veterinary Medicine can meet the challenges of the 21st Century." "The passage of ADUFA marks the beginning of a new era in CVM history just as the Prescription Drug User Fee Act beneficially altered the review of human drugs," said Stephen Sundlof, D.V.M., Ph.D., Director of FDA's Center for Veterinary Medicine (CVM). "The resources provided by this law will help CVM scientists keep pace with the rapid advances in science and medicine that drive the quality of health care for our animals. We view this legislation as a vital component in our commitment to promote and protect public and animal health."
ADUFA establishes four fees: 1) a sponsor fee, 2) an establishment fee, 3) a product fee and 4) an application fee. About 25% of the total amount to be collected will be received through each fee type. So, in the first fiscal year, FDA expects to receive $1,250,000 from sponsor fees and the same amount from establishment fees, product fees and application fees.
The fees collected for these services will be directed toward the FDA Center for Veterinary Medicine (CVM) and will be used to provide additional resources for its animal drug review program. The goal is to achieve shorter, more predictable review times by increasing the review staff at CVM and building better management systems. As a result, FDA anticipates substantial savings to the industry in regulatory review and developmental expenses – without compromising FDA's high standards for safe and effective products.
FDA is authorized to collect $5 million in fiscal year 2004, which began October 1, 2003, $8 million in fiscal year 2005, and $10 million in each fiscal year 2006 through 2008.
The law provides for specific waivers or reductions of fees, including for small businesses and where the fees would present a significant barrier to innovation. FDA is working to prepare guidance and information for the industry regarding the fees, billings and submission of fees, as well as waivers and reduction of fees.