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Bipartisan Schrader Bill to Reauthorize Animal Drug User Fees Signed Into Law

Congressman Kurt Schrader’s (OR-05) bipartisan legislation to reauthorize the Food and Drug Administration’s (FDA) Animal Drug User Fee Act (ADUFA) and Animal Generic Drug User Fee Act (AGDUFA) was signed into law today. ADUFA and AGDUFA continue agreements between the Food and Drug Administration (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. Rep. Schrader introduced the legislation in April with Congressman Markwayne Mullin (R-OK-02) and the legislation passed unanimously through the House in July and through the Senate in August.

“I am excited to see my bipartisan legislation to reauthorize animal drug user fees signed into law this month after swift but thorough consideration through both the House and Senate. As a legislator I am very attuned to all the innovations that are occurring in the human health sphere, and as a veterinarian I want to ensure that our four-footed friends also have access to the latest and greatest medical innovations. We worked hard to expand conditional approval in this legislation to animal drugs for major uses and major species, an expansion which is so vital to the veterinary profession. Conditional approval is not a free ride for companies, but rather allows us to do the best for our pets and livestock. This law will continue to allow and encourage innovation across the industry, benefiting owners, veterinarians, and, of course, the animals themselves.”

WATCH: Congressman Schrader Speaks on the Importance of ADUFA from the House Floor

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. Had Rep. Schrader’s bill not passed, ADUFA and AGDUFA would have expired on September 30, 2018.

During markup of the bill in the House Energy and Commerce Committee in May, 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.