Antibiotics in Feed Animals: Animal Drug User Fees Act (ADUFA)
• The Animal Drug User Fees Act (ADUFA) amends the Federal Food, Drug and Cosmetic Act (FFDCA) and authorizes the US Food and Drug Administration (FDA) to collect fees from drug manufacturers in order to supplement appropriations for the review of animal pioneer drugs.
• ADUFA authorizes the FDA to collect fees for certain animal drug applications and for establishments, products, and sponsors associated with these and previously-approved animal drug applications.
• The fees collected under ADUFA help to ensure that pioneer drug products are safe and effective for animals as well as for the public with respect to animals intended for food consumption.
• 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.
• ADUFA was originally enacted in September 2003 and was set to expire on September 30, 2008. Each ADUFA authorization lasts for five years and then must be reauthorized.
• In August 2008 President Bush signed the Animal Drug User Fee Amendments of 2008. This extended ADUFA until 2013, when the ADUFA was again reauthorized and extended through fiscal year 2018.
• Stop Foodborne Illness urges Congress to ensure that the next reauthorization of ADUFA includes provisions to help preserve the efficacy of antibiotics vital to protecting public health.
• Specifically, Congress is urged to enact data collection and reporting requirements for all reviews of animal drugs.