Legislation to speed animal drug review and drive innovation advances

The U.S. House of Representatives Committee on Energy and Commerce has moved to advance the Animal Drug and Animal Generic Drug User Fee Amendments of 2018 (H.R. 5554) and included language that would expand conditional approvals beyond minor uses and minor species.

User fees are vital to increasing pharmaceutical resources available to veterinarians, and this success follows testimony before the committee by AVMA President Dr. Michael Topper in favor of reauthorizing the user fees. The AVMA is grateful to members of Congress, including Reps. Markwayne Mullin (R-Okla.), Kurt Schrader (D-Ore.) and Richard Hudson (R-N.C.), who have championed this legislation and the conditional approval process.

Passage of animal drug user fee amendments would reauthorize the U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine to continue collecting animal drug and animal generic drug user fees from the drugs’ sponsors. These fees help provide FDA with resources to deliver an efficient review process for animal drugs. The AVMA has worked aggressively to secure congressional support for the legislation and the expansion of conditional approvals to be used for major uses and major species to increase veterinary access to FDA-approved animal drugs.

This legislation is necessary because currently there simply aren’t enough FDA-approved drugs for use in animals. In fact, there are 23 times more labeled indications approved for human use than approved for animal use. Animal drug user fees and expanded use of conditional approvals are crucial to speeding up the review process and increasing veterinary access to FDA-approved drugs.

Following the May 9 vote by the House Committee on Energy and Commerce to move forward with the legislation, it now heads to the full House for a vote. The Senate bill, which was marked up out of the Senate Committee on Health, Education, Labor and Pensions earlier this spring, also awaits its next steps.

As lawmakers move forward with drug user fee amendments, the AVMA will continue working closely with both chambers of Congress to facilitate the timely passage of this legislation to meet veterinary needs.