Animal Health Institute Statement on Energy and Commerce Health Subcommittee Action on ADUFA

The Animal Health Institute appreciates the work of Chairman Burgess, ranking member Green and the Energy and Commerce Health Subcommittee in moving the Animal Drug and Generic Animal Drug User Fee Amendments of 2018 toward Congressional approval.   We also thank Representative Mullin and Representative Schrader for sponsoring this important legislation.

The animal drug user fee program ensures an efficient animal drug approval process at the U.S. Food and Drug Administration (FDA) that ensures safe, effective and affordable animal medicines.  These medicines are needed to ensure the health and welfare of the nation’s 393 million companion animals and over 9 billion food animals.  The ability to treat diseases and conditions enables our pets to live longer and healthier lives, and the ability to protect the health of food animals promotes the safety of our food supply.

There are still too many animal diseases and conditions for which there are no treatment options.  One way to address this need is by expanding the current FDA authority on conditional approval for certain qualifying products.  We appreciate the work done by Representatives Hudson, Schrader, Butterfield, Mullin and Bucshon to introduce legislation to enact this important change and look forward to working with the Committee to see this important enhancement to the user fee legislation.