By Craig Springer, Guest Author
The Aquatic Animal Drug Approval Partnership (AADAP) moves medicine from the theoretical to the practical
The parallel is too curious to be overlooked. James Henshall, M.D., had his home just a short walk from his work in a Victorian two-story that still stands. There on the grounds at a national fish hatchery in Bozeman, Montana, Dr. Henshall hit his stride in the late 1800s – not practicing medicine – but directing fish culture operations as the superintendent of a fledgling federal hatchery. Henshall, best known for his classic Book of the Black Bass, gave up a medical career for distinguished work in fisheries conservation.
Today, modern fish culture and medicine again merge in Bozeman, at the U.S. Fish and Wildlife Service’s Aquatic Animal Drug Approval Partnership (AADAP) Program. This national program is designed to generate, compile, and manage much of the complex information needed by the U.S. Food and Drug Administration (FDA), for one purpose – to get new aquatic animal drugs on the market and in use. No matter if the drug is to be used for treating parasitic infection in largemouth bass, gill disease in walleye, or bacterial infections in endangered species – or fish you might find on the end of your line or under plastic at the grocery – AADAP plays a major role in generating and channeling that information to the FDA.
It’s an arduous process to get a new aquatic animal drug approved, and it can take years of research and millions of dollars. In some respects, getting new drugs approved for fish and other aquatic animals is more difficult than it is for people. Reason being, people eat fish and shellfish, not people. New drugs must effectively target specific diseases and disease-causing pathogens. They must also be manufactured at the highest quality, and be safe for the target species, the environment, and for people – and all such claims must be supported by solid scientific data.
“With any new animal drug that’s been approved by the FDA, you know it’s met the gold standard,” said Dr. Dave Erdahl, AADAP’s director. “Getting safe and useful drugs approved and into the hands of fishery managers and fish culturists results in healthy fish and a healthy environment.”
Examples of new drug approvals that AADAP has helped to obtain are worthy of note: The FDA approved formalin for controlling external parasites in all species of fish. The new animal drug Chorulon® enhances fish propagation; it induces spawning, and plays an important role in endangered species conservation. A number of new skeletal marking products are now available. With these products fishery biologists can quickly, safely, and with low cost, mark fish en masse so that they can more effectively assess fish populations in the wild. In 2005, the FDA approved Aquaflor® for catfish – the first new oral antibacterial drug approved in over 20 years. More recently, the FDA approved Aquaflor® for use in all freshwater-reared salmonid species. In 2007 PEROX-AID® was approved to treat freshwater finfish and their eggs. In 2008, Terramycin® 200 was approved to control bacterial coldwater disease and columnaris, often-fatal bacterial infections in freshwater-reared trout and salmon.
Progress continues. In 2014, not only is another new, expanded approval of Aquaflor® anticipated, but so is the first-ever FDA approval for the use of Halamid® Aqua (chloramine-T) to control mortality caused by external bacterial infections in freshwater-reared fish.
Inherent in its name, AADAP is a partnership, and works closely with the Association of Fish and Wildlife Agencies’ Drug Approval Working Group to prioritize work and meet the needs of fishery managers across the country. AADAP employs scientists with expertise in physiology, ecology, chemistry, fish biology, study design and statistical analysis. AADAP’s scientists conduct real-life field investigations and consolidate data generated from over 130 entities comprised of state and federal agencies, Native American tribes, and private companies – all set on seeing new aquatic animal drugs approved.
The parallel continues. Henshall made a mark in fisheries conservation. AADAP’s work resounds in fisheries managed for public good or private gain. The science is manifest in staving off extinctions, on anglers’ stringers, and even on your dinner plate.