The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM), in cooperation with Health Canada’s Veterinary Drugs Directorate (VDD), announced Wednesday the first simultaneous review and approval of a veterinary drug application under a joint initiative to better align the approval process for these products.
Comfortis (spinosad), the product that received the approval, is used to kill fleas and prevent flea infestations in cats. The product is marketed by Elanco. Under an initiative of the Regulatory Cooperation Council (RCC), CVM and VDD worked collaboratively from the same fundamental effectiveness data set to approve Comfortis.
In Wednesday’s FDA Voice, Bernadette Dunham, DVM, PhD, director of FDA-CVM and Murray M. Lumpkin, MD, MSc, FDA Commissioner’s senior advisor and representative for global issues, wrote that 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
What can this mean for food animals?
Though this first approval was for a companion animal drug, this is a great step forward, says Mike Apley, DVM, PhD, Dipl. ACVCP, Kansas State University. “There is an initiative to internationally harmonize areas of drug approval requirements, known as the VICH (Veterinary International Conference on Harmonization),” Apley explains.
“This process has harmonized guidance documents for specific areas (such as good clinical practice guidelines), but to see two agencies actually move forward on an approval together is very encouraging.”
Apley says for food animals, we have additional challenges such as views on what should and shouldn’t be used in food animals, as well as artificial trade barriers, and differing residue limits and testing methods.
“However, maybe we can get these ironed out in the future,” he adds. “With the rising costs of drug approvals in both human and veterinary medicine, these companies can’t afford to run through the approval process multiple times. Some of our potential useful drugs in animal health have some pretty narrow margins, and cooperation such as this might help move some to market that otherwise would not be economically viable.
“I think the harmonization efforts are one of the best things the FDA-CVM is working toward.”