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U.S. Department of Health and Human Services

Animal & Veterinary

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15 Years of Fish Drug Approvals: A Success Story

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 Cover of 15 Years of Fish Drug Approvals

by Melanie McLean, DVM, Center for Veterinary Medicine, FDA

A saying heard in aquaculture circles is, “A cow is a cow and a chicken is a chicken, but a fish is not a fish.” It expresses that, while there are many breeds of domestic cows and chickens, there are only two species of cows and one species of chicken. But, there are over 24,500 species of fish.

Variety is the spice of life in the fish world. This variety also adds complexity to the approval process for fish drugs, posing unique challenges and obstacles. For example, a drug that is safe and effective in one fish species may not be safe and effective in another. Fifteen years ago, the aquaculture industry had few FDA-approved drugs available for fish. But, much has changed since 1995.

The aquaculture industry produces and raises aquatic animals in controlled environments, such as tanks, commercial ponds, and offshore cages. Fish farming involves reproducing, raising, and harvesting fish to be used as food for people, in aquariums, or to boost wild fish populations.

Due to joint efforts by the aquaculture industry, government, academia, and drug companies, the fish drug arsenal grew over the last 15 years. Since 1995, FDA approved seven drugs and 14 different label claims for fish. A session at the 2010 World Aquaculture Society conference, held in San Diego, Calif., earlier this year, highlighted these drug approval successes.

Aquaculture and FDA – A Brief History

Although FDA has been around since 1906, the agency didn’t approve the first drug for fish until January 1972. For many years, only five fish drugs were FDA-approved, and only four of the five were available. In the 1980s, aquaculture was an up-and-coming industry in the United States. The industry grew rapidly in the early 1990s, but there were few fish veterinarians, few approved fish drugs, and little oversight by FDA. The aquaculture industry often relied on unapproved drugs to maintain fish health.

In 1990, FDA began putting pressure both on the aquaculture industry to use approved drugs and on drug companies to get more fish drugs approved. The agency made it clear that fish drugs, like other animal drugs, must comply with the requirements of the Federal Food, Drug, and Cosmetic Act. FDA’s goal was to reduce the use of unapproved drugs by the aquaculture industry. Unapproved drugs may not be safe or effective and may leave harmful residues in fish fillets.

Challenges Faced

One challenge facing FDA in the early 1990s was figuring out which chemicals were fish drugs. The aquaculture industry uses various chemicals. Some chemicals are water treatments, some are pesticides, others are vaccines, and still others are drugs. A certain chemical falls in one of the categories depending on its intended use. The federal agency responsible for regulating the chemical depends on which category the chemical is in. For example, water treatments and pesticides are under the regulatory authority of the Environmental Protection Agency. The U.S. Department of Agriculture (USDA) regulates vaccines for animal diseases, and FDA regulates drugs. The categories often overlap.

In 1990, the Joint Subcommittee on Aquaculture (JSA) was formed, bringing together representatives from all federal agencies with a stake in aquaculture. The JSA worked hard to resolve some of the issues facing U.S. aquaculture in the 1990s, including how to categorize different chemicals. The subcommittee remains active and “continues to work to improve fish health,” noted Gary Jensen, an aquaculture expert at USDA and the current chair of the JSA.

FDA’s lack of fish experts was a second challenge facing the agency in the early 1990s. To address this lack of expertise, Dr. Andy Beaulieu at FDA’s Center for Veterinary Medicine (CVM) created an Aquaculture Staff in CVM’s Division of Therapeutic Drugs for Food Animals. The Aquaculture Staff grew into the Aquaculture Drugs Team in 1999. Also, in 1999, CVM’s Office of Research (OR) created an Aquaculture Research Program and began building a research facility. Today, OR’s state-of-the-art research facility can hold market-size fish, such as tilapia, hybrid striped bass, salmon, and trout. The facility also has an enclosed area to study infectious fish diseases and the ability to use radioactive chemicals to track the amount and location of drugs through a fish’s body.

A third challenge that FDA continues to face is the small size and wide diversity of the U.S. aquaculture industry. Because the drug approval process is expensive and the market for fish drugs is too small to bring in a lot of money, many drug companies do not want to invest the resources it takes to get fish drugs FDA-approved. Richard Endris, from the drug company Intervet/Schering-Plough Animal Health, put a price tag on fish health by explaining a company’s costs to get a fish drug approved. According to Dr. Endris, animal health products represent less than 10 percent of the total sales for a large drug company. Of the total sales of animal health products, fish drugs contribute less than 5 percent.

To help drug companies overcome the financial roadblocks to getting animal drugs with small markets FDA-approved, in 2004, Congress passed the Minor Use and Minor Species Animal Health Act (the MUMS Act, for short). This law provides financial incentives to drug companies to make more drugs legally available for minor species. Because all fish are minor species, a fish drug can qualify the company for the MUMS Act incentives. The MUMS Act also provides a way for researchers to receive grants to support safety and effectiveness testing of drugs for minor species, including drugs for fish.

Commitments Made

In the mid-1990s, the aquaculture industry, drug companies, and CVM made commitments to advance aquatic animal health. The aquaculture industry committed to using approved drugs and doing drug research. Drug companies committed to getting more fish drugs approved. CVM committed to helping fish drugs get through the approval requirements.

Because research is critical to fish drug approvals, the aquaculture industry, drug companies, and government agencies also committed to partnerships that research and generate data on fish drugs. In 1995, a new position, called the National Coordinator for Aquaculture New Animal Drug Applications, was created to help coordinate research activities and data collection. The National Coordinator acted as a conduit, or liaison, between the aquaculture industry, fish researchers, drug companies, and CVM.

A Fond Farewell

Rosalie Schnick served as National Coordinator from 1995 to her retirement from the position in 2010. Roz, as she is known to friends and colleagues, was integral to the success of the last 15 years of fish drug approvals. Fittingly, she was the moderator for the session at the 2010 World Aquaculture Society conference that celebrated those approvals.

Several people who presented at the conference used their talks as a way to thank Roz for her dedication to the fish world. Based on their interactions with Roz as National Coordinator, veterinarians from CVM described her as the “go-to person for questions about fish drugs,” a “problem solver extraordinaire,” and a “dynamo of dynamos with a ‘can-do’ attitude.” One CVM veterinarian recalled Roz’s “long history of tireless advocacy” for aquaculture.

Although there’s no longer a National Coordinator, Roz left as her legacy a framework for a committed aquaculture community to continue her work.

A Group Perspective

The session moderated by Roz included speakers from all areas of the aquaculture community, including CVM and other federal agencies, both large and small drug companies, and fish researchers. Each speaker presented their own perspective on the success story of fish drug approvals over the last 15 years. Jim Bowker, from the U.S. Fish & Wildlife Service, summed up a common theme of the session in his presentation’s title, “Partnerships are the Key to Aquaculture Drug Approval Successes.” Because of these partnerships, several more fish drugs are getting closer to approval.

The aquaculture industry’s expanding tool box of approved drugs safeguards the health of fish and the public. As Randy McMillan, from the National Aquaculture Association, said in his presentation, “FDA’s animal drug approval process allows the public to trust the safety of fish farmed in the United States for food.”

The Next 15 Years

According to Jennifer Matysczak, fish veterinarian and leader of CVM’s Aquaculture Drugs Team, the future holds “encouraging prospects and engaged drug sponsors with experience. Active research is going on, and [there’s] a commitment from CVM to make more safe and effective fish drugs available.”

The next 15 years builds on the strong foundation of the last 15 years. Three core “C” principles make up this strong foundation: Collaboration + Cooperation + Communication = an Equation for Success!

2010 World Aquaculture Society Conference
Session on “15 Years of Aquaculture Drug Approval Successes”

FDA’s Center for Veterinary Medicine
Charles Gieseker
Joan Gotthardt, DVM
Jennifer Matysczak, VMD
Meg Oeller, DVM
Donald Prater, DVM
Steve Vaughn, DVM

Joint Subcommittee on Aquaculture
Gary Jensen, PhD, chair (USDA)
Kevin Greenlees, PhD, former co-chair (CVM)
Gary Stefan, former co-chair (retired, CVM) 

U.S. Fish and Wildlife Services
Jim Bowker, representing the Aquatic Animal Drug Approval Partnership Program

U.S. Geological Survey, Upper Midwest Environmental Sciences Center
Mark Gaikowski
Bill Gingerich, PhD

Association of Fish & Wildlife Agencies (AFWA)
Steve Sharon, chair of AFWA’s Drug Approval Working Group

National Coordinator for Aquaculture New Animal Drug Applications
Rosalie Schnick

Aquatic Life Sciences, Inc.
Jim Brackett, DVM

AQUI-S New Zealand Ltd
Don Bell, PhD
Jan Holland 

Eka Chemicals Inc.
Dave Lovetro

Intervet/Schering-Plough Animal Health
Richard Endris, PhD

Mississippi State University, College of Veterinary Medicine
Patricia Gaunt, DVM, PhD, DABVT

University of Idaho
Christine Moffitt, PhD
Lubia Cajas Cano

National Aquaculture Association
John (Randy) MacMillan, PhD