PRESIDENT SIGNS ANIMAL DRUG AVAILABILITY ACT

The Animal Drug Availability Act (H.R. 2508), signed by the President on Oct. 9, l996, 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 new legislation reflects the spirit of the White House program to reinvent the government (REGO) by reducing regulatory burdens on the animal health industry without undermining the safety of animal drug products. 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 veterinarian¹s 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.

The law also directs FDA to issue the following implementing regulations:

• Within six months of enactment, FDA must propose regulations that define the meaning of "adequate and well controlled" field investigations under the actual conditions of the study. These regulations must be finalized within 18 months.
  
• Within 12 months of enactment, FDA is required to propose regulations to define "substantial evidence" necessary to encourage submission of new animal drug applications and supplemental applications, and to address the use of dose range labeling. These final regulations are to be issued within 24 months after the date of enactment.

The passage of ADAA represents the culmination of two years of intense partnering efforts by CVM and its stakeholders to address the need for increased animal drug availability. The success of this initiative displays how regulatory agencies can engage in civil discourse with the regulated industries to reach mutually beneficial agreements. During the process, a greater sense of mutual trust and respect developed and a less adversarial relationship between CVM and the regulated industries emerged.