Animal drugs and public health

The Animal Drug User Fee Act (ADUFA) of 2003 was renewed and amended in 2008 (ADUFA II). FDA has authority for this act, although it will sunset in 2013 if not reauthorized by Congress. ADUFA allows FDA to collect fees from drug manufacturers to expedite the process of animal drug reviews and to ensure that new animal drug products are safe and effective for animals as well as for the public with respect to animals intended for consumption. FDA is required to compile and release sales data on antibiotics used in food animals, which has profound public health consequences. All uses of antibiotics can select for drug resistance and the scientific consensus is clear that overuse of antibiotics in food animals contributes to antibiotic resistant infections in humans. Non-therapeutic uses of these drugs in food animals creates a large reservoir for the emergence of bacterial resistance to antibiotics. Currently AMDUCA does not collect information in a way that would allow analysis of the amount of antibiotics sold for non-therapeutic purposes, though route of administration data suggests that it is considerable. A roundtable discussion will feature the history and future of AMDUCA from the viewpoint of FDA as regulators, public health law interests, the pharmaceutical industry, and advocacy groups. Likely legislative actions, including potential amendments or revisions to the Act, likelihood of passage, and public health implications will be evaluated.