FDAs Approval of AQUAFLOR Marks New Era in Teamwork

The Fish Site
by The Fish Site
15 March 2006, at 12:00am

US - The U.S. Food and Drug Administrations recent approval of AQUAFLOR (florfenicol) Type A Medicated Article for catfish marked a significant milestone in the industrys combined efforts to make more products available for public and commercial aquaculture.

Schering-Plough invested more than five years bringing this product to market, but we couldnt have done it without the teamwork and commitment from our development partners, stresses Richard Endris, Ph.D., research program manager, Schering-Plough Animal Health Corporation, the company that developed AQUAFLOR.

Working toward a common goal

Dr. Patricia Gaunt an associate professor, aquatic animal health at Mississippi State University College of Veterinary Medicine who played a significant role in the development of AQUAFLOR for U.S. channel catfish approached Schering-Plough Animal Health in 1997 about a pilot project using florfenicol in catfish, which was funded and completed the following year.

Shortly thereafter, Rosalie (Roz) Schnick, the National Coordinator for Aquaculture New Animal Drug Applications, proposed gaining approval of AQUAFLOR in a variety of fish species including channel catfish through the Federal-State Aquaculture Drug Approval Partnership Project under the auspices of the International Association of Fish and Wildlife Agencies.

A self-described matchmaker, Schnick, worked with state and federal agencies as well as other organizations to support AQUAFLOR, which last fall became the first in-feed antibiotic licensed for U.S. aquaculture in more than 20 years.

Not only was AQUAFLOR approved in the United States, but it became one of the first drugs to meet new FDA requirements for antimicrobial resistance and microbial food safety, she says.

The result, she adds, is that U.S. catfish industry has a new tool for managing disease one that can be used with a high level of confidence.

MSUs Gaunt helped Schering-Plough Animal Health conduct necessary studies on efficacy, residue depletion and catfish safety. Dr. Craig Tucker, head of the National Warmwater Aquaculture Center in Stoneville, provided information needed to assess the environmental safety of AQUAFLOR in pond systems. Another research group, the Upper Midwest Environmental Sciences Center (UMESC), US Geological Survey, in La Crosse, Wisc., carried out the pivotal target animal safety study as part of the cooperative effort.

Dr. William H. Gingerich of UMESC says his group partnered with Schering-Plough Animal Health and other members of the aquaculture team to develop the safety data for catfish required by FDAs Center for Veterinary Medicine.

The cooperation among all the groups involved was unprecedented, he says. We were extremely pleased to be considered by Schering-Plough Animal Health to be a member of their team.

Gaunt agrees. There was good communication and a strong desire by everyone involved to make more products available for U.S. aquaculture, she says. I think the level of cooperation with AQUAFLOR will serve as a valuable model for other new products and registrations.

The FDAs Center for Veterinary Medicine also loaned its expertise. CVM has provided direct guidance to assure a more efficient approval process for aquaculture drugs, says Schnick. The agency has also helped to educate us on how to meet requirements and really formed a partnership with us through the drug approval process.

Cooperation between this large number of groups is certainly unique, as is the major role played by Schering-Plough and their steadfast efforts and investment to get a new aquaculture drug approved, says Dr. Tom Bell of the U.S. Fish and Wildlife Service and its Aquatic Animal Drug Approval Partnership Program (AADAP).

Cooperation pays off

In the end, however, it was the dedication and commitment of specific individuals who were leading the various teams. For example, MSUs Gaunt credits Endris of Schering-Plough Animal Health with coordinating efforts of all the scientists involved.

He watched over the approval process every step of the way making sure that the necessary studies were completed and reports submitted to the FDA in a timely fashion, she says.

She also credits Dwayne Holifield of Delta Western, a major feed company based in Indianola, Miss., for his role in manufacturing medicated feeds for the clinical studies as well as the analytical studies. There was no method in place for the manufacture of FFC catfish medicated feed when we began. Dwayne literally began from scratch and helped develop a reproducible method for preparation of feed that was accepted by the FDA.

With the approval of AQUAFLOR, aquaculture not only has the first new drug in more than two decades, it has exclusive Veterinary Feed Directive status from the FDA to regulate its use and ensure its long-term effectiveness.

This approval model for new drugs allows for mutually beneficial partnerships to form, stresses Schnick, and that can only benefit aquaculture.

Only the beginning

Mississippi State University and AADAP continue working jointly with Schering-Plough Animal Health to develop studies on Flavobacterium columnare, the second leading cause of catfish disease, which is also an important pathogen of salmonids. UMESC and others are also working on other AQUAFLOR label claims that will help benefit all of US aquaculture.