Animal Drug User Fee Act

​Formal Title: Docket Number [FDA-2011-N-0656] Animal Drug User Fee Act; Public Meeting; Request for Comments.

Brief Description:

The Food and Drug Administration (FDA) announced a public meeting on the Animal Drug User Fee Act (ADUFA). The FDA invited public comment on the ADUFA program and suggestions regarding the features FDA should propose for the next ADUFA program.

AVMA Response:

The FDA Center for Veterinary Medicine’s (CVM) procurement of drug sponsor “user fees” and how those user fees are utilized, are topics of keen interest to the veterinary profession. The effective utilization of these fees is important to veterinarians who are key purchasers, customers, and end-users of many of the drugs that are ultimately approved by the FDA. The AVMA supports user fees for new animal drug applications only if such fees are directed toward expediting the review and approval process for animal drug products. The AVMA supports means to expedite drug approvals. The greater number of approved animal drugs for use in veterinary medicine helps to ensure that veterinary patients are receiving the best care.

The AVMA understands that FDA CVM has been meeting the goals established by ADUFA; however, the AVMA is concerned about an apparent decrease in approvals, especially of new and novel products.  It would appear that further enhancements to the process are required in order to facilitate an increase in the availability of new products and uses.

Background Documents:

View Federal Register Document (PDF)

Status:

The AVMA provided verbal comments to the FDA on November 7, 2011. (PDF)