U.S. and Canada Working Together To Provide Access to Needed Veterinary Drugs

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By: Bernadette Dunham, D.V.M, Ph.D. and Murray M. Lumpkin, M.D., M.Sc.

Bernadette Dunham, D.V.M, Ph.D., Director of FDA’s Center for Veterinary Medicine

The first simultaneous review and approval of a veterinary drug by the United States and Canada marks a successful start to a collaboration aimed at providing quicker access to needed veterinary medicines. The collaboration is also intended to remove trade barriers and reduce costs for consumers, regulators and manufacturers.

Here’s the background: Last year, President Obama and Canada’s Prime Minister Stephen Harper announced the creation of the U.S.-Canada Regulatory Cooperation Council (RCC). The council’s goal is to better align several regulatory approaches, to remove duplicative requirements, and to better share regulatory resources.

Eliminating overlapping efforts is expected to result in reduced costs and more timely access to products while encouraging trade and investment.

Murray M. Lumpkin, M.D., M.Sc., FDA Commissioner's Senior Advisor and Representative for Global Issues

 

After the agreement to create the council was signed, one of the first projects was to have drug regulators in both countries simultaneously review the same effectiveness data for approval of Elanco’s new animal drug, Comfortis, used to kill fleas and prevent flea infestation in cats. That effort culminated in this week’s announcement that FDA’s Center for Veterinary Medicine and Health Canada’s Veterinary Drugs Directorate had simultaneously approved the drug.

Regulators in both countries have determined that several other veterinary drugs are also potentially eligible for simultaneous review by both countries under the RCC action plan.

 

Because of this successful initial collaboration, there is much potential opportunity going forward to continue to improve our review efficiency and the use of our review resources to improve access to safe and effective products on both sides of the border.

Bernadette Dunham, D.V.M, Ph.D., is Director of FDA’s Center for Veterinary Medicine.

Murray M. Lumpkin, M.D., M.Sc., is FDA Commissioner’s Senior Advisor and Representative for Global Issues.