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Rep. Schrader’s Bill to Reauthorize Animal Drug User Fee Act Passes the House

Congressman Kurt Schrader’s (OR-05) bipartisan bill (H.R. 5554) to reauthorize the Food and Drug Administration’s (FDA) Animal Drug User Fee Act (ADUFA) and Animal Generic Drug User Fee Act (AGDUFA) passed unanimously in the House today. ADUFA and AGDUFA continues agreements between the FDA and the animal drug industry to pay user fees that help speed the approval of new drugs for farmers, ranchers, families, and veterinarians so they can keep their animals and pets safe and healthy.

“As a veterinarian I am particularly grateful to see this bill pass the House,” said Rep. Schrader. “I am acutely aware of all the great innovations that are occurring in the human health sphere and I want to ensure that our four-footed friends also have access to the latest and greatest medical innovations. Conditional approval is a way to get these important medications to our veterinary patients in a timely manner.”

WATCH: Congressman Schrader Speaks on the House Floor on ADUFA

Rep. Schrader introduced the legislation in April with Congressman Markwayne Mullin (R-OK-02) and the legislation passed unanimously out his Energy and Commerce Committee in May. ADUFA and AGDUFA give the FDA authority to collect user fees from sponsors for the review of animal drug applications. ADUFA was first authorized in 2003, giving the FDA authority for the first time to collect user fees for the review of animal drugs similar to fee programs for human drugs and medical devices. AGDUFA, authorized in 2008, gave the FDA the same authority but for generic drug applications. The current reauthorization of both ADUFA and AGDUFA expires on September 30, 2018.

During markup of the bill, Rep. Schrader introduced an amendment to expand conditional approval to animal drugs for major uses and major species that meet an unmet medical need, have a particularly difficult study design, and are not antimicrobials. Conditionally approved drugs must demonstrate a reasonable expectation of effectiveness and meet all other FDA approval standards, including safety. These drugs can be on the market on a conditional, year-by-year basis for up to five years while the drug sponsor continues trials to prove a full standard of effectiveness.