Obama reauthorizes ADUFA and AGDUFA programs

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President Obama signed legislation on June 13 renewing the Food and Drug Administration’s authority to collect animal drug user fees from pharmaceutical companies.

Funds collected through the Animal Drug and Animal Generic Drug User Fee programs provide the FDA with the resources to evaluate the effectiveness and safety of proposed new animal drugs and new generic animal drugs.

Both programs were set to expire this September. The Animal Drug and Animal Generic Drug User Fee Reauthorization Act signed by the president extends each user fee program until Oct. 1, 2018.

Tom Harkin of Iowa introduced the reauthorization bill in the Senate, which passed the legislation by unanimous consent May 8. Less than a month later, the House voted in favor of the Senate version 390-12 and sent the bill to the president.

Environment and the Economy Subcommittee Chairman John Shimkus of Illinois along with Cory Gardner of Colorado led the effort in the House to renew ADUFA and AGDUFA. “This law will continue the benefits for both animal health and human health that provide for the review of new animal drugs,” Shimkus said.

“Keeping our animals healthy and our food supply safe is crucial in ensuring our own health,” Gardner added. “This legislation gives producers throughout the country access to safe and effective animal drugs to treat their herds, keeping animals, and our food, healthy.”

The AVMA has been advocating for this legislation because it will help ensure that more FDA-approved animal drugs are sent to the marketplace, giving veterinarians a greater ability to provide the best treatment for their patients.