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SENATE VOTES TO IMPROVE ACCESS TO NEW DRUGS FOR ANIMALS
Source: U.S. Senator Pat Roberts news release

U.S. Senator Pat Roberts said late Tuesday night the Senate approved legislation to speed access to new animal drugs for veterinarians through conditional approval by the Food and Drug Administration (FDA).

Roberts' provision on conditional approval was included in the Animal Drug and Animal Generic Drug User Fee Amendments of 2018 (ADUFA) which reauthorizes the Food and Drug Administration's animal drug and generic animal drug user fee agreements. The House passed identical legislation last month. The bill is headed to the President's desk to be signed into law.

"Given the numerous accelerated pathways on the human drug side of the agency," Roberts said. "It is commonsense to allow additional flexibilities for FDA to review, approve, and provide access to innovative therapies for our animals - both food producing and companion."

At issue are arbitrary limits on the use of animal drugs and therapies with conditional approval. Under the status quo, a drug that is made available by conditional approval can only treat 310,000 cattle and only 70,000 dogs.

"I am pleased we were able to broaden the eligibility for the conditional approval pathway to major species for innovative products and new indications," Roberts said. "We do not change the FDA's gold standard of approval for safety, we simply change the sequencing of the efficacy evaluations."

Senator Roberts is a senior member of the Senate Health, Education, Labor and Pensions Committee which has jurisdiction on FDA. He is also Chairman of the Senate Committee on Agriculture, Nutrition and Forestry. He has been an outspoken advocate in measures to invest in and secure the nation's plant and animal health.


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