[Congressional Record (Bound Edition), Volume 147 (2001), Part 7]
[Extensions of Remarks]
[Pages 9340-9341]
[From the U.S. Government Publishing Office, www.gpo.gov]



                MINOR ANIMAL SPECIES HEALTH ACT OF 2001

                                 ______
                                 

                   HON. CHARLES W. ``CHIP'' PICKERING

                             of mississippi

                    in the house of representatives

                        Wednesday, May 23, 2001

  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 those 
animals other than cattle, horses, chickens, turkeys, dogs, and cats. 
In addition, there exists a similar shortage of pharmaceutical 
medicines for major animal species for diseases that occur infrequently 
or which occur only in limited geographic areas. Due to the lack of 
availability of these minor use drugs, millions of animals go either 
untreated for illnesses or treatment is delayed. This results not only 
in unnecessary animal suffering but may threaten human health as well.
  Because of limited market opportunity, low profit margins, and 
enormous capital investment required, it is generally not economically 
feasible for drug manufacturers to pursue research and development and 
then approval for medicines 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 through an 
entire stock of its fellow species resulting in severe economic losses 
and hardships to agriculture producers.
  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 minor use medicines, grower 
reproduction costs for these animals would be cut by upwards of 15%. In 
addition, feedlot deaths would be reduced 1-2% adding approximately $8 
million of revenue to the industry.
  The catfish industry, a top agriculture sector in my home state of 
Mississippi which generates enormous economic opportunities for our 
people, especially within the Mississippi Delta, estimates its losses 
at $60 million per year attributable to minor diseases for which drugs 
are not available. The U.S. aquaculture

[[Page 9341]]

industry overall, including food as well as ornamental fish, produces 
and raises over 800 different species. Unfortunately, the industry has 
only five drugs approved for use in treating aquaculture diseases. The 
result is tremendous economic hardship and animal suffering within the 
industry.
  Mr. Speaker, joined with my colleagues, Mr. Combest of Texas, Mr. 
Pombo of California, Mr. Otter of Idaho, Mr. Simpson of Idaho, and Ms. 
Thurman of Florida, I resolve to correct this unfortunate situation by 
introducing the Minor Animal Species Health Act of 2001. This 
legislation will allow companies the opportunity to develop and approve 
minor use drugs which are of vital interest to a large number 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 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 of 
1998, laid out nine proposals. Eight of the FDA's proposals required 
statutory changes. The bill I am introducing today reflects the changes 
called for in the Agency'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 twenty 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 Act of 2001 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. This is vital legislation which is desperately needed 
now. The Act will alleviate much animal suffering, it will promote the 
health and well-being of minor animal species while protecting and 
promoting human health, it will benefit pets and improve the emotional 
security of their owners, benefit various endangered species of aquatic 
species, 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 the House to support the Minor Animal Species Health Act 
of 2001.

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