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AHI Statement on Senate Passage of H.R. 5554

The Animal Health Institute expressed appreciation to the U.S. Senate 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 U.S. Food and Drug Administration (FDA) 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 Senate Health, Education, Labor and Pensions Committee, led by Chairman Alexander and Ranking Member Murray,” said AHI President and CEO Alexander S. Mathews.   “The strong bipartisan leadership on this critical legislation helps ensure that veterinarians, livestock and poultry producers, and pet owners have access to the drugs they need to keep their animals healthy.”

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 allows companies to innovate in areas where veterinarians currently have no approved medicines for treating serious or life-threatening diseases in animals. The innovative research and development encouraged by the expansion of conditional approvals will benefit animals of all species and contribute to a safe and nutritious food supply for American families.