AHI Statement on House Passage of H.R. 5554

The bill, HR 5554, includes an important improvement in the FDA process by allowing the agency to grant conditional approval to products where additional time is needed to collect efficacy data once the safety of the product has been demonstrated.
The bill, HR 5554, includes an important improvement in the FDA process by allowing the agency to grant conditional approval to products where additional time is needed to collect efficacy data once the safety of the product has been demonstrated.
(Animal Health Institute)

The Animal Health Institute expressed appreciation to the U.S. House of Representatives for passage of the Animal Drug and Generic Animal Drug User Fee Amendments of 2018. The bill benefits pet owners, food producers and consumers and veterinarians by ensuring the Food and Drug Administration has the resources necessary to review and approve animal medications in a timely fashion. These medications are vital to improving the length and quality of life for our companion animals and protecting the food supply by keeping food animals healthy.

“We greatly appreciate the work done by the House Energy and Commerce Committee, led by Chairman Walden and Ranking Member Pallone,” said AHI President and CEO Alexander S. Mathews. “We also appreciate the strong bipartisan leadership on this issue from Representatives Mullin, Hudson, Schrader, Butterfield and Bucshon.

The bill, HR 5554, includes an important improvement in the FDA process by allowing the agency to grant conditional approval to products where additional time is needed to collect efficacy data once the safety of the product has been demonstrated. The provision is intended to allow companies to innovate in areas where veterinarians currently have no approved medicines for treating serious or life-threatening diseases in animals.

“This is a good bill that will provide additional tools to protect animal health and welfare. It has strong bipartisan support and we hope the Senate will move to quickly approve it,” said Mathews.

 

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