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Animal Drug Availability Act of 1996
The Animal Drug Availability Act (H.R. 2508), signed by the President on Oct. 9, 1996, introduces several amendments to the Federal Food, Drug, and Cosmetic Act that lend new flexibility to the way FDA regulates animal drugs and medicated feeds.
The law, which is designed to increase the number of animal drugs on the market, was supported by FDA's Center for Veterinary Medicine and a coalition of animal industry groups which included manufacturers of animal health products, veterinarians, and livestock producers. The Animal Drug Availability Act (ADAA) reflects legislative changes that will benefit the animal health industry and the nation's animals without compromising FDA's mission to protect the public health. The ADAA
- injects flexibility into the process FDA uses to evaluate and approve new animal drugs by amending the current definition of substantial evidence of effectiveness. This change will permit flexibility in studies required to demonstrate a new animal drug's effectiveness, and eliminate the requirement for field studies.
- provides for greater direct interaction between animal drug sponsors and the FDA during the drug development process. The law requires a presubmission conference, held at the sponsor's discretion, to discuss the drug development at its earliest stages. The goal is for the FDA and the manufacturers to reach a common understanding regarding what data will be needed to establish safety and effectiveness, and what types of studies can be conducted to generate such data.
- creates a new category of drugs -- "Veterinary Feed Directive Drugs" that allows the approval and use of sophisticated new animal drugs in animal feed, on a veterinarian's order, while incorporating safeguards to ensure the safe use of such drugs.
- supports "flexible labeling" that permits a range of acceptable/recommended doses to appear on animal drug product labeling, rather than one optimum dose. In addition, the law directs FDA to broaden the approval process to make available more animal drugs to treat minor species. The Act requires FDA to propose the necessary changes within 18 months.