An aquatic animal drug is approved by the Food and Drug Administration after a sponsor, sometimes in collaboration with Aquatic Animal Drug Approval Partnership and other researchers, demonstrates the effectiveness and safety of the drug. Aquatic animal drug approval is a rigorous and expensive process that is necessary to ensure the effectiveness of the drug and its safety for fish, consumers, and the environment. For aquaculture drugs and their manufacturers, the financial benefits of a new drug approval may not be worth the cost of the approval process. The Aquatic Animal Drug Approval Partnership Program was formed to facilitate the aquatic drug approval process in a way that aims to directly meet the needs of conservation, public hatcheries, and the aquaculture industry.
Challenges of Approvals in Aquaculture
Though aquaculture is a growing industry, it still represents a small portion of U.S. agriculture. Aquaculture is also a diverse industry, encompassing numerous species. Each aquaculture drug must be demonstrated to be safe for each species or group of species and effective for each species/pathogen combination before it can be approved for use on that particular species/pathogen combination. The time and funding needed to get a drug approved is substantial. It could take 10 years or longer and cost $10 to $20 million to gain FDA approval. The high cost of the drug approval process has limited the number of new approvals over the years, especially considering the relatively small market for these drugs. Despite the challenges of aquaculture drug approvals, the regulations provide a framework that ensures that all the drugs used in aquaculture are effective and safe for the fish, consumers, and the environment.
What Agency Approves Aquaculture Treatments?
- Aquaculture drugs are regulated by the FDA Center of Veterinary Medicine. The approval of new drugs is determined by Office of New Animal Drug Evaluation. In an aquaculture setting, the same compound may be used as a drug or disinfectant. If the product is being used to treat live animals, then it is considered a drug in that situation and it must go through the FDA approval process.
- Pesticides are any chemical product used for preventing, destroying, repelling, or mitigating any pest. This includes herbicides (and algaecides) which are designed to control plants and weeds. Although pesticides and herbicides are generally regulated by the Environmental Protection Agency, if a pesticide or herbicide is being used to treat external parasites in aquaculture, they are considered a drug and would need to be approved by the FDA for that use.
- Biologics are products of biologic origin used in the diagnosis, prevention, and treatment of diseases. In aquaculture, the most commonly used biologics are vaccines, which are used to immunize animals and reduce the scope of disease that result from specific pathogens. Biologics are regulated by United States Department of Agriculture Animal and Plant Health Inspection Service.
What are the roles of the FDA, sponsors, researchers, and AADAP?
FDA: The FDA has the regulatory authority to approve new animal drugs and determine whether there is sufficient evidence to satisfy the needs of each technical section for each label claim.
Sponsor: A sponsor is the entity in charge of collecting all the information required for the drug approval process. Every New Animal Drug requires a sponsor to facilitate the Investigational New Animal Drug process. Usually, but not always, the sponsor is the drug’s manufacturing or marketing company and it is ultimately the sponsor’s responsibility to satisfy the requirements of the technical sections. In return, the sponsor may be granted exclusive marketing rights for the drug through Minor Use Minor Species designation.
Researchers: Scientists who conduct pivotal studies to provide the required evidence to satisfy the technical sections.
AADAP: AADAP’s goal is to help guide a drug through the approval process. Depending on the drug, AADAP biologists generally act as either researchers, or as a liaison between sponsors and the FDA. In some cases AADAP has acted as an interim sponsor of drugs in the National INAD Program, in order to keep research progress moving forward and allow for continued use under the INAD.
