Currently, CVM is considering whether to retain a regulatory framework in which a generic animal drug can differ in certain ways from the pioneer reference product. GADA supports retaining a framework that allows certain innovations for generic animal drugs. For example, generic animal drug sponsors must be able to add new strengths, dosage forms, routes of administration, and indications to their approved generic products. In addition, CVM should retain the option for application sponsors to pursue "hybrid" applications for new generic drugs that contain certain modifications to existing pioneer drugs. In these cases, CVM and the sponsor can determine the scientific evidence needed to support the differences from the pioneer drug.
Without such a framework, a generic animal drug that differs from the pioneer product may be forced to pursue a New Animal Drug Application (NADA) and conduct all required safety and clinical effectiveness studies. GADA believes requiring sponsors to repeat all the safety and effectiveness studies that were already conducted for the pioneer product without considering the particular change being made, has no scientific basis and is in conflict with spirit of the Generic Animal Drug and Patent Term Restoration Act (GADPTRA). This could add years to the timeframe before new innovations could reach veterinarians and animal owners who benefit from them. Under such a restrictive framework, it is doubtful that any sponsors will have the incentive to pursue such product improvements.
Therefore, it is important for CVM to maintain a regulatory framework that allows the opportunity for innovation to generic drugs. The requirements for these “hybrid” generic drugs should be based on sound science and an appropriate regulatory pathway.