WASHINGTON, D.C. - Yesterday, U.S. Senator Patty Murray (D-WA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, issued the following statement on the passage of legislation that renewed the Food and Drug Administration’s (FDA) authority to collect user fees from the makers of new animal drugs and generic animal drugs.
“The health of our nation is closely tied to the health of our animals, which is why it’s so important to families across the country that we make sure the drugs that keep our pets, livestock, and other animals healthy, are safe and properly used. This bipartisan legislation takes valuable steps to help the Food and Drug Administration in its critical work to protect public health-including the health of our animal population.
“I’m glad we were able to pass this important bill and that the FDA has responded to concerns about the proper use of conditional approvals by committing to follow congressional intent, issue clear standards, and be vigilant in the oversight of antibiotic usage."
In addition to reauthorizing the user fees, the bill also:
· Requires FDA to issue guidance on the use of various elements of clinical investigations such as real world evidence, biomarkers, and surrogate endpoints in the regulatory review and development of animal drugs.
· Clarifies requirements and considerations for the Secretary in reviewing petitions for food additives intended for use in animal food.
· Requires FDA to report on how the agency will incorporate veterinary oversight of approved medically important antimicrobial drugs administered to animals that are not currently subject to veterinary oversight, including requirements related to labeling of such drugs.
· Expands the conditional approval pathway for minor use or minor species to include new animal drugs that would treat a serious or life-threatening disease or condition, or address an unmet animal or human health need, and that the Secretary determines that a demonstration of effectiveness would require a complex or difficult study or studies.
· Requires a GAO study on the effectiveness and impact of the conditional approval pathway.
