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Some might even say they “fly under the radar,” which is an apt description considering that a jet flying low would certainly shake things up on the ground.
The research team at the UMESC led by William Gingerich shook things up enough, in fact, that it got some favorable notice among the country’s top brass in Washington.
Gingerich, chief of the UMESC’s chemistry-physiology branch, recently was given the Food and Drug Administration’s Commissioner’s Special Citation, a prestigious award that recognizes him “for exceptional leadership, outstanding coordination of resources and sustained efforts in the development of data for the approval of new animal drugs for aquaculture.”
The work on aquaculture medicines that earned the award for Gingerich and his team — he emphasizes it was a team effort — 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 emphasized in the early ’90s, Gingerich said, 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.
“They basically were going to try to lower the boom on him,” Gingerich said.
To help remedy the situation, Gingerich led the effort to bring drug manufacturers together with users and coordinated 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 be approved 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 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.
Gingerich’s former project partner, Roz Schnick, now the national coordinator for aquaculture drug development, also received an FDA special citation for the aquaculture drug project.
Randy Erickson is editor at the Onalaska Community Life.
