Animal Drug and Animal Generic Drug User Fee Amendments of 2018

Floor Speech

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Mr. SCHRADER. Mr. Speaker, H.R. 5554 is a bipartisan bill to reauthorize the animal drug and animal generic drug user fee programs, and I am proud to lead it with my colleague, Mr. Mullin.

ADUFA and AGDUFA are crucial to FDA's work to review and approve applications for animal drugs. Over the past several years, animal drug user fee programs have streamlined the approval process for pharmaceuticals and eliminated the FDA's application backlog, reduced review times, and created a more predictable process.

As a veterinarian from Oregon, I am particularly grateful to see this bill come to the floor. I am acutely aware of the great innovations that are occurring in the human health sphere, and I want to ensure our four-footed friends also have access to the latest and greatest medical innovations. That is why I am particularly pleased with this bill and its language to expand conditional approval for animal drugs with major uses in major species.

Conditional approval is a careful, deliberative process based on similar pathways for drugs for minor uses and minor species that was already established in 2004.

Conditional approval is critical for veterinary medicine since it is not cost-effective for drug companies to pursue large, complete clinical trials, given the small population of intended beneficiaries, without some initial interest and success under the conditional approval program.

Before being conditionally approved, drugs must demonstrate a reasonable expectation of effectiveness and meet every other FDA standard for approval, including safety. They still need to get complete FDA approval within 5 years and must apply for annual renewal.

I thank Chairman Walden; Ranking Member Pallone; Mr. Green; my colleague from North Carolina (Mr. Hudson), who worked very hard on the bill; and certainly Mr. Mullin for his partnership in leading this way.

Mr. Speaker, I urge my colleagues to support this important bill.

Mr. GENE GREEN of Texas. Mr. Speaker, I have no further speakers, and I yield back the balance of my time.

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