Prior to enactment of the AMDUCA, the Federal Food, Drug, and Cosmetic Act had provided that a new animal drug was deemed unsafe unless it was subject to the FDA’s stringent approval process – for exactly what was on the label – specific species, disease indication, dose, duration, frequency, and route of administration. One of the main reasons why fewer drugs exist in veterinary medicine is that FDA’s new drug approval process is very costly and time consuming for pharmaceutical companies, with little return on investment for animal drug products when compared to the return on investment associated with human drug products, creating a relative disincentive for companies to put resources toward creating new veterinary drugs.
Given the relatively few numbers of drugs available to veterinarians, AMDUCA created the professional flexibility that veterinarians need in order to adequately treat animals when their health is threatened. Additionally, many of the minor species have few to no drugs approved for various indications, making it very difficult for a veterinarian to provide the best care for their minor species patient. With ELDU regulation, many of these issues can be resolved and animals may be more readily relieved of suffering.
