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Rep. Schrader’s Bill to Reauthorize Animal Drug User Fee Act Passes Out of Committee

Congressman Kurt Schrader’s (OR-05) bipartisan bill (H.R. 5554) to reauthorize the Food and Drug Administration’s (FDA) Animal Drug User Fee Act (ADUFA) and Animal Generic Drug User Fee Act (AGDUFA) passed out of his Energy and Commerce Committee unanimously. ADUFA and AGDUFA would continue agreements between the FDA and the animal drug industry to pay user fees that help speed the approval of new drugs for farmers, ranchers, families, and veterinarians so they can keep their animals and pets safe and healthy.

The committee also unanimously adopted Rep. Schrader’s bipartisan amendment to expand conditional approval of animal drugs. This would expand opportunities for drugs that meet specific requirements to reach the market and fill unmet animal medical needs.

“As a veterinarian, I'm acutely aware that a lot of the great innovations that occur in the human pharmaceutical world are unavailable for long periods of time to veterinarians and animals,” said Rep. Schrader. “There isn’t a robust bandwidth to engage the pharmaceutical industry to develop these drugs. So the conditional approval process is critical to gain access to these drugs under a very specific criteria to make sure our four footed friends have some of the greatest and latest innovations that our human folks do. I’m pleased that our bipartisan, broadly supported amendment and bill were unanimously supported by my colleagues on the committee and I look forward to bringing it to the Floor soon.”

WATCH: Video of Congressman Schrader’s remakes on ADUFA during the markup.

Rep. Schrader introduced the legislation last month with Congressman Markwayne Mullin (R-OK-02). ADUFA and AGDUFA give the FDA authority to collect user fees from sponsors for the review of animal drug applications. ADUFA was first authorized in 2003, giving the FDA authority for the first time to collect user fees for the review of animal drugs similar to fee programs for human drugs and medical devices. AGDUFA, authorized in 2008, gave the FDA the same authority but for generic drug applications. The current reauthorization of both ADUFA and AGDUFA expires on September 30, 2018.

Rep. Schrader introduced his amendment this morning with Congressman Richard Hudson (R-NC-08). The amendment expands conditional approval to animal drugs for major uses and major species that meet an unmet medical need, have a particularly difficult study design, and are not antimicrobials. Conditionally approved drugs must demonstrate a reasonable expectation of effectiveness and meet all other FDA approval standards, including safety. These drugs can be on the market on a conditional, year-by-year basis for up to five years while the drug sponsor continues trials to prove a full standard of effectiveness.