Press release
WASHINGTON—The U.S. House of Representatives today passed H.R. 5554, Animal Drug and Animal Generic Drug User Fee Amendments of 2018, sponsored by Congressman Markwayne Mullin (OK-2). H.R. 5554 was passed by voice vote.
First authorized in 2004, Animal Drug User Fee Agreements (ADUFA) and Animal Generic Drug User Fee Agreements (AGDUFA) give the Food and Drug Administration (FDA) authority to collect user fees from sponsors to help speed the approval process for new drugs for pets and animals.
“America’s farmers, ranchers, and veterinarians rely on drug user fee agreements to drive the cost of medications down and keep their animals healthy,” said Mullin. “Similarly, American consumers need ADUFA and AGDUFA, too. Today’s reauthorization of ADUFA and AGDUFA will promote innovation and keep food costs down for millions of Americans. I am proud to sponsor H.R. 5554 in order to maintain these agreements that are vitally important to our country’s food supply.”
The House Energy and Commerce reviewed a discussion draft of the legislation in March 2018. Congressman Mullin formally introduced H.R. 5554 in April 2018 alongside Congressman Kurt Schrader (D-OR).