Pallone Opening Remarks at Health Subcommittee Hearing on Animal Drug User Fee Reauthorization

Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ) delivered the following opening remarks at a Health Subcommittee hearing titled, " Reauthorization of the Animal Drug User Fee Programs:"

The two animal drug user fee programs we are reviewing today support the timely review of both pioneer and generic drugs at the Food and Drug Administration (FDA) while supporting the agency's public health mission and gold standard for safety and efficacy.

Today's hearing and these user fees highlight of course the importance of medicine for our four-legged friends at home. At the same time, we have to stress that animal drugs also support a healthy agriculture economy and protect the nation's food supply.

We must also remain vigilant in supporting animal health due to its known impact on human health. As we have repeatedly seen through outbreaks like Ebola, Zika, coronavirus, and avian influenza or "bird flu", infectious diseases can be transmitted between species. Scientists have also drawn a direct connection between our changing environment and the heightened risk of interspecies transmission of disease. Similarly, the careful and responsible management of antimicrobial use in animals is of critical importance in our fight against antimicrobial-resistant pathogens that could infect humans.

Animal drug user fees provide critical supplemental funding for the FDA and have helped ensure faster, more predictable review timelines for new drugs and generic competition.

I want to highlight that user fees are intended to be supplemental to FDA's appropriated budget allocation. Our reauthorization of user fees should not be seen by the Majority as a justification to cut FDA's budget in the Republican quest to dramatically slash funding across the government.

I am committed to seeing these programs reauthorized on time—well ahead of the September deadline—to support the FDA's mission. After successfully reauthorizing human drug user fee programs and enacting the Food and Drug Omnibus Reform Act in a bipartisan way last year, I am confident we can come together again. I look forward to learning more today about the new user fee agreements, as well as additional policy proposals that can improve animal health.

I would like to welcome to our witnesses, and I yield back.

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