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Private aquaculture will also benefit from approval
of the new drug. According to industry figures, uncontrolled diseases
cause around $100 million in losses in the catfish industry alone.
Half of the reported disease cases were attributed to the three
diseases this new drug can treat: bacterial gill disease and external
columnaris disease of fish, and saprolegniasis on fish eggs.
Researchers at the USGS Upper Midwest Environmental
Sciences Center (UMESC) in La Crosse, Wisc., developed the data that
resulted in the approval for the drug, with financial support through
the Federal-State Aquaculture Drug Approval Partnership Project. Dr.
Michael Jawson, UMESC center director, said that this approval is a
critical step forward in helping control diseases in commercially and
publicly raised fishes. He noted that the broad use approval is unique
and significant for U.S. aquaculture in that it covers two fish life
stages – eggs and fish – of a number of cultured freshwater fish
species for three separate diseases. Fish commonly afflicted with
these diseases include trout, salmon, steelhead, channel catfish, and
tilapia.
Rosalie Schnick, National Coordinator for
Aquaculture New Animal Drug Applications, said, “The scientists at the
Upper Midwest Environmental Sciences Center did an excellent job
completing the major data requirements for obtaining this most
significant approval. The 35% PEROX-AID® approval is a tremendous
example of a public research facility cooperating with a private
entity to gain results that will benefit the propagation of finfish
for public good, including fisheries restoration and enhancement.”
USGS scientists completed target animal safety
studies on many freshwater fish species, conducted critical laboratory
and field efficacy studies, and completed a comprehensive
environmental assessment of hydrogen peroxide use in aquaculture. Eka
Chemicals, Inc., completed the requirements for drug manufacturing and
worked with Schnick to complete the requirements for human food safety.
Under the Minor Use Minor Species Animal Health Act as administered by
the FDA, Eka Chemicals, Inc. has an exclusive right for 7 years of
marketing for the approved indications beginning on the date of
approval. This privilege is extended to drug sponsors to encourage the
development of drugs with limited economic potential due to their
restricted market. The drug is expected to be available to commercial
and public aquaculture in late winter or early spring.
USGS began this research in 1994 in response to a
request by the Association of Fish and Wildlife Agencies that state
natural resource agencies needed specific drugs to combat specific
fish diseases. Dr. William Gingerich, the lead researcher on the
project, agrees with Schnick that the approval for this new
aquaculture drug is unique because it is so comprehensive. He credits
the Food and Drug Administration reviewers and policy makers for being
open to the concept of broad drug approvals for aquaculture drugs. Dr.
Gingerich and his team members will be recognized for their
achievements today from Eka Chemicals at a ceremony at the Center. |
