UPDATE: Legislation Promising Quicker FDA Approval of Animal Drugs Signed By President


President Trump recently signed a bill that would give veterinarians more access to FDA-approved drugs.


UPDATE (August 21) — Last week, President Trump signed the Animal Drug and Animal Generic Drug User Fee Amendments of 2018 into law. These amendments will require drug makers to submit applications electronically starting October 1. The legislation charges fees for drug and device applications and then uses that money to speed up their review so the products can head to market faster. The 2 measures are part of the Food, Drug, and Cosmetic Act and are directed at both generic and brand-name drugs.

The bill must be re-authorized every 5 years.

In what is considered a significant victory for the veterinary industry, both the House and Senate have passed a bill that will grant veterinarians more access to FDA-approved drugs. Currently, there are about 25 times more labeled indications approved for human use than for animal use.

“These programs are critically important when it comes to the care of our pets and the farmers that help produce the food that feeds our country,” Rep. Greg Walden, chairman of the Energy and Commerce Committee, and Rep. Michael C. Burgess, MD, chairman of Subcommittee on Health, said in a joint statement. “We applaud the Senate’s swift passage of this important reauthorization and look forward to President Trump soon signing into law.”


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If it is signed into law, the Animal Drug User Fee Amendments (ADUFA) and Animal Generic Drug User Fee Amendments (AGDUFA) of 2018 (H.R. 5554/S.2434) will reauthorize the FDA’s Center for Veterinary Medicine to continue collecting animal drug and animal generic drug user fees from the drugs’ sponsors. These fees support the FDA’s animal drug review procedures and speed up the process of gaining veterinary access to FDA-approved drugs.

The American Veterinary Medical Association (AVMA) has been vocal about its support for the passing of the bill. In March, Michael Topper, DVM, PhD, DACVP, AVMA’s immediate past president, testified before the US House of Representatives in favor of the legislation.

"By providing new animal drugs with a predictable pathway to market, these fees help provide veterinarians with access to new and additional tools that can potentially improve treatment outcomes, provide alternatives to existing therapies, fill unmet medical needs in veterinary medicine, and ultimately improve patient care, which is the center of veterinary practice," Dr. Topper said.

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