[Congressional Record (Bound Edition), Volume 146 (2000), Part 9]
[Extensions of Remarks]
[Pages 13288-13289]
[From the U.S. Government Publishing Office, www.gpo.gov]



                SEVERE SHORTAGE OF APPROVED ANIMAL DRUGS

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                   HON. CHARLES W. ``CHIP'' PICKERING

                             of mississippi

                    in the house of representatives

                        Wednesday, June 28, 2000

  Mr. PICKERING. Mr. Speaker, I rise today in order to bring attention 
to a problem faced by livestock and food animal producers, animal and 
pet owners, zoo and wildlife biologists, and the animals themselves, 
which unfortunately goes largely unnoticed except by those who are 
directly affected.
  There currently exists a severe shortage of approved animal drugs for 
use in minor animal species. These minor animal species include animals 
other than cattle, horses, chickens, turkeys, dogs, and cats. In 
addition, there also exists a similar shortage of drugs and medicines 
for major animal species for diseases that occur infrequently or which 
occur in limited geographic areas. Due to the lack of availability of 
these minor use drugs, millions of animals go either untreated or 
treatment is delayed. This results not only in unnecessary animal 
physical and human emotional suffering but may threaten human health as 
well.
  Because of limited market opportunity, low profit margins involved, 
and enormous capital investment required, it is generally not 
economically feasible for drug manufacturers to

[[Page 13289]]

pursue research and development and then approval for drugs used in 
treating minor species and infrequent conditions and diseases.
  In addition to the animals themselves, without access to these 
necessary minor use drugs, farmers and ranchers also suffer. An 
unhealthy animal that is left untreated can spread disease throughout 
an entire stock of its fellow specie causing severe economic hardship 
to struggling ranchers and farmers.
  For example, Mr. Speaker, sheep ranchers lost nearly $45 million 
worth of livestock alone in 1999. The sheep industry estimates that if 
it had access to effective and necessary drugs, growers' reproduction 
costs for their animals would be cut by up to 15%. In addition, feedlot 
deaths would be reduced to 1-2% adding approximately $8 million of 
revenue to the industry.
  The catfish industry, a top agriculture industry in my home state of 
Mississippi generating enormous economic opportunity in the State, 
especially in the impoverished Mississippi Delta, estimates its losses 
at $60 million per year attributable to diseases for which drugs are 
not available. The U.S. aquaculture industry overall, including food as 
well as ornamental fish, produces and raises over 800 different 
species. Unfortunately, this industry has only 5 drugs approved for use 
in treating aquaculture diseases resulting in tremendous economic 
hardship and animal suffering.
  Mr. Speaker, joined with my colleagues Mr. Hall of Texas, Mr. Combest 
of Texas, Mr. Stenholm of Texas, and Mr. Pombo of California, I resolve 
to correct this unfortunate situation by introducing the Minor Animal 
Species Health and Welfare Act of 2000. This legislation will allow 
pharmaceutical companies the opportunity to develop and approve minor 
use drugs which are vitally needed by a plethora of animal industries. 
Our legislation incorporates the major proposals of the FDA's Center 
for Veterinary Medicine to increase the availability of drugs for minor 
animal species and rare diseases in all animals. The Animal Drug 
Availability Act of 1996 required the Food and Drug Administration 
(FDA) to provide Congress with a report, describing administrative and 
legislative proposals to improve and enhance the animal drug approval 
process for minor uses and minor species of new animal drugs. This 
report by FDA, delivered to Congress in December 1998, laid out nine 
proposals. Eight of FDA's proposals required statutory changes. The 
bill my colleagues and I introduce today reflects the changes called 
for in FDA's minor species/minor use report. The Act creates incentives 
for animal drug manufacturers to invest in product development and 
obtain FDA marketing approvals. Furthermore, it creates a program very 
similar to the successful Human Orphan Drug Program that has, over the 
past 20 years, dramatically increased the availability of drugs to 
treat rare human diseases. Mr. Speaker, besides providing benefits to 
livestock producers and animal owners, this measure will develop 
incentives and sanctioning programs for the pharmaceutical industry 
while maintaining and ensuring public health.
  The Minor Animal Species Health and Welfare Act is supported by the 
Food and Drug Administration, the American Farm Bureau Federation, the 
Animal Health Institute, the American Veterinary Medical Association, 
and virtually every organization representing all genres of minor 
animal species. Mr. Speaker, this is vital legislation which is needed 
now. This Act will alleviate much animal suffering, it will promote the 
health of minor animal species while protecting and promoting human 
health, it will benefit pets and promote the emotional security of 
their owners, benefit various endangered species of aquatic animals, 
and will reduce economic risks and hardships to farmers and ranchers. 
This is common-sense legislation which will benefit millions of 
Americans from farmers and ranchers to pet owners. I call on all my 
colleagues in this House to support the Minor Animal Species Health and 
Welfare Act of 2000.

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