Animal industry officials hope the upcoming reauthorization of legislation guiding animal drug reviews will streamline the approval process, preventing the U.S. from falling behind foreign governments.
If passed, the bill would be the fifth installment of the Animal Drug User Fee Authorization (ADUFA) and the fourth of the Animal Generic Drug User Fee Authorization (AGDUFA); both are due to be reauthorized by the end of September. Review times have dropped considerably in the last 20 years, allowing new products to come to the market more quickly. However, groups testified at a recent House subcommittee hearing that the proposed changes could bring needed improvements to increase drug approvals.
Rachel Cumberbatch, the Animal Health Institute's director of international and regulatory affairs, found in examining the 20-year history of the program, it became “apparent that a gap has developed between program capacity and performance.” Over the program's life, she said fees have risen 600% and staff at FDA’s Center for Veterinary Medicine has also increased, yet the workload has declined by 12% and the number of products approved has remained flat.
“Perhaps most concerning,” she added, is products are becoming available in the European Union before they are being approved in the United States. “And that puts the U.S. animal health industry and U.S. pet owners and farmers at a disadvantage.”
Don’t miss a beat! It’s easy to sign up for a FREE month of Agri-Pulse news! For the latest on what’s happening in Washington, D.C. and around the country in agriculture, just click here.
Cumberbatch said the compromise agreement takes some immediate steps to close the gap and proposes further collaboration and data collection that will lead to an improved ADUFA VI.
American Veterinary Medical Association President Lori Teller argued AVMA's belief that U.S. approvals lag behind Europe and Canada by up to a year. “The U.S. is the largest animal drug market in the world. And we should be the leader in bringing innovative products to market.”
AVMA supports CVM adopting processes used by other similar regulatory agencies that could shorten the time needed to approve products for U.S. markets. Teller said generic animal drugs are needed for categories currently lacking competition. What's more, she said multiple generic approvals could provide stability in the market.
For more news, visit www.Agri-Pulse.com.
