Antibiotics in Feed Animals: Animal Generic Drug User Fees Act (AGDUFA)

Issues

Antibiotics in Feed Animals: Animal Generic Drug User Fees Act (AGDUFA)

The Breakdown

The Animal Generic Drug User Fees Act (AGDUFA) amends the Federal Food, Drug, and Cosmetic Act (FFDCA) by authorizing the first-ever generic animal drug user fee program.

• AGDUFA authorizes the US Food and Drug Administration (FDA) to collect user fees for certain abbreviated applications of generic new animal drugs, generic new animal drug products, investigative submissions for generic new animal drugs, and certain sponsors of new animal drugs through fiscal year 2018.

• The fees collected under AGDUFA aim to enhance the performance of the generic new animal drug review process and enable the FDA to better ensure that new generic animal drug products are safe, effective, and provide consumers with a lower cost alternative to pioneer drugs.

• These drugs help treat victims of some foodborne illnesses. Anytime antibiotics are used, there is the possibility that bacteria will develop a resistance to the once-lifesaving drugs. The higher the dose and the longer they are used, the higher the probability resistance will develop, and the less likely they will work when needed most.

• Following the Animal Drug User Fee Act (ADUFA) model, AGDUFA provides funding for increased review staff, training and development for staff members, refinement of business processes, and development of policies targeted at more efficient drug review.

Our Position

• Stop Foodborne Illness holds the same stance on AGDUFA as it does for the AGDUFA.

• We encourage Congress to ensure that the next reauthorization of AGDUFA includes provisions to help preserve the efficacy of antibiotics vital to protecting public health.

• Specifically, Stop Foodborne Illness urges Congress to enact data collection and reporting requirements for all reviews of animal drugs.

Glossary & Acronyms

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