Animal Drug User Fees Reauthorized: Faster Approvals and Antimicrobial Resistance Fight
This law extends user fee programs until 2028, requiring pharmaceutical companies to fund the FDA's review process for new and generic animal drugs. This aims to speed up the availability of safe and effective veterinary medicines, potentially reducing costs for pet owners and livestock producers. Crucially, it introduces new regulations for zootechnical substances in animal feed and strengthens efforts to combat antimicrobial resistance, directly impacting public health and food safety.
Key points
Fee Program Extension: User fees for reviewing new and generic animal drugs are reauthorized through Fiscal Year 2028, ensuring continued funding for faster FDA approvals.
Combating Resistance: The law mandates new reporting on activities supporting antimicrobial stewardship in veterinary settings to protect both animal and human health.
New Feed Regulation: It defines and regulates 'zootechnical animal food substances' (like those affecting digestion or gut health) as food additives, streamlining their path to market instead of classifying them as drugs.
Increased Revenue: Total annual fee revenue targets are set at $33.5 million for new animal drugs and $25 million for generic animal drugs (FY 2024-2028).
Expired
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