The Generic Animal Drug Advancement Act (GADA Act)
To amend the Federal Food, Drug, and Cosmetic Act to make certain changes with respect to the approval of abbreviated applications for the approval of new animal drugs, and for other purposes.
H.R. 1683, the Generic Animal Drug Advancement Act will update the Federal Food, Drug, and Cosmetic Act to correct current limitations standing in the way of approval of generic animal drug applications. Expanding pathways for generic animal drug approval as combination products, and update labeling requirements to enable generic animal drugs to seek approval for a single species as opposed to all species on the pioneer drug label.
“The Generic Animal Drug Advancement Act will help cut bureaucratic red tape and ensure that safe, effective, and affordable generic animal drugs are readily available. This will help our farmers and ranchers keep their livestock healthy and will allow pet owners the best ability to take care of their pets. I'm so grateful to have such great partners in GADA and its members," said Rep. Mace, upon introduction of the legislation.
Under current regulations, the Food and Drug Administration (FDA) is responsible for the review and approval of all new animal drugs (pioneers) and abbreviated new animal drugs (generics). Generics approved by the FDA must prove bioequivalency or “sameness” to pioneer drugs in all species listed on pioneer drugs’ labels, despite the industry standard for generic drugs to treat one or a subset of species treated by a pioneer drug. Additionally, generics are unable to create combination products like pioneers. As a result, generic animal drug applications are disadvantaged in the new animal drug approval process, damaging the animal drug industry’s ability to innovate and drive down prices.