|Dr. William Gingerich, winner of the Food and Drug Administration's Commissioner's Special Citation.|
The work on aquaculture medicines that earned the award for Gingerich and his team began back in 1994. At that time, he said, there were only a few drugs approved by the FDA for aquaculture, and those were only approved for use in raising a few commercial species of fish, including catfish, trout and salmon.
The drugs weren’t approved for other species, whether the fish were being raised for use on the food market, to bolster endangered populations or stock lakes, rivers and streams with game fish.
“They overlooked these others,” said Gingerich, who noted that aquaculture in the United States involves 56 species of fish. “The public sector was basically left out ... yet they still had a limited market with the public sector needing to treat their fish.”
The reason the other species were overlooked, Gingerich explained, is it’s very expensive and time consuming to do the scientific testing to pass FDA standards. “It’s a formidable task,” he said, noting that it generally takes about $10 million and as long as 10 years to gain FDA approval for veterinary medicines. And that’s just for one species.
The need to get something done about aquaculture drugs was really emphasized in the early ’90s, when a fish hatchery manager in a Midwest state was arrested for using drugs to treat fish for which the FDA had not given approval, said Gingerich.
To help remedy the situation, Gingerich led the effort to bring drug producers together with the end users and co-ordinated research to get the most out of the data generated.
Doing that, of course, required some money and Gingerich and his team got 38 states to agree to contribute $20,000 per year for five years to the project.
Earlier this year, the research team at UMESC won FDA approval for the first new waterborne aquaculture drug to in more than 20 years. The drug, Perox-Aid, is a hydrogen peroxide-based solution approved for treatment of bacterial infections, fungal infections and some external parasites in freshwater fish and their eggs.
In all, the UMESC’s work gained FDA approval so far for three aquaculture drugs and eight “label claims,” which expand the allowed uses of a drug.
Gingerich’s work also has been recognized by the International Association of Fish and Wildlife Agencies and two pharmaceutical companies. Gingerich also had previously been given the U.S. Department of the Interior’s Meritorious Service Award.
This most recent recognition, though, is very special to Gingerich. “It’s pretty prestigious because it’s the commissioner of the Food and Drug Administration that’s making the presentation, he said.
Source: Onalaska Life