[Congressional Record (Bound Edition), Volume 149 (2003), Part 8]
[Extensions of Remarks]
[Page 11354]
[From the U.S. Government Publishing Office, www.gpo.gov]




      MINOR USE AND MINOR SPECIES ANIMAL HEALTH ACT OF 2003 (MUMS)

                                 ______
                                 

                   HON. CHARLES W. ``CHIP'' PICKERING

                             of mississippi

                    in the house of representatives

                         Tuesday, May 13, 2003

  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.
  Without access to these necessary pharmaceutical tools, farmers and 
ranchers also suffer. A diseased animal left untreated can quickly 
spread disease throughout an entire herd of its fellow species. The 
result is economic hardship to farmers and ranchers who are already 
struggling to make their operations' cash flow. For example, the sheep 
industry lost nearly $42 million worth of livestock alone in 2002. The 
industry estimates that if it had access to effective drugs to treat 
disease, production costs for their animals would be cut by 15 percent. 
In addition, feedlot deaths would be cut by up to 2 percent. Perhaps 
that seems like an insignificant loss, but it translates into $8 
million in revenue to the industry.
  The catfish industry is by far the largest livestock industry in my 
home state of Mississippi. It provides jobs for tens of thousands of 
Mississippians and is a key component of my state's economy. The 
industry attributes $60 million per year in losses to diseases for 
which drugs are not available. Of the entire food and ornamental fish 
industry, only 6 drugs are approved and available for treating the 
hundreds of aquaculture diseases which affect it. The losses associated 
with the lack of necessary pharmaceutical tools can be crippling to 
anyone involved in the industry.
  Because of limited market opportunities, low returns, and enormous 
capital investment required, it is generally not economically feasible 
for drug manufacturers to pursue research and development, and then 
approval, for drugs used in treating minor species and infrequent 
conditions and diseases. Mr. Speaker, with a number of our colleagues 
from both sides of the aisle who recognize the urgency of this matter, 
Mr. John and I are today introducing legislation to help mitigate the 
shortage of minor species drugs. The Minor Use and Minor Species Animal 
Health Act of 2003 will provide manufacturers 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 Food and Drug 
Administration's (FDA) 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 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 are introducing today reflects the changes 
called for in FDA's minor species/minor use report while maintaining 
and ensuring public health.
  The MUMS legislation outlines two new ways to lawfully market new 
animal drugs:
  (1) It establishes a conditional approval mechanism for new animal 
drugs for minor uses and minor species. Conditionally approved new 
animal drugs must meet the same safety requirements as new animal drugs 
approved under Section 512 in that a `reasonable expectation of 
effectiveness' as opposed to `substantial evidence of effectiveness' 
must be demonstrated. If conditional approval is granted by the Food 
and Drug Administration, the approval will be effective for one year 
and renewable for a maximum of four additional years. This process will 
allow drug sponsors to recapture some development costs through 
marketing the product prior to full, unconditional approval.
  (2) MUMS establishes an index of legally marketed unapproved new 
animal drugs for non-food minor species. The index will provide a 
mechanism to lawfully market minor species drugs for which there is 
unlikely to be sufficient financial incentives to seek full or 
conditional approvals. If the FDA determines that a new drug is 
eligible for an index listing, it will be included in the index if 
benefits outweigh perceived risks. Additionally, the harm caused by the 
absence of an approved or conditionally approved drug will be taken 
into account when making this determination. An independent expert 
panel will be largely responsible for determining whether or not the 
drug may be allowed to be included in the index.
  None of the provisions outlined in the Minor Use and Minor Species 
Animal Health Act will weaken the FDA's responsibilities of ensuring 
the safety of animal drugs to the public. The FDA Center for Veterinary 
Medicine currently evaluates new animal drug products prior to approval 
and use. The rigorous review and testing process provides consumers 
with the confidence that animal drugs are safe for animals and 
consumers of products derived from those animals. Currently, FDA 
guidelines include requirements to prevent harmful residues and 
evaluations to examine the potential for the selection of resistant 
pathogens. Any animal drug considered for approval under this 
legislation will be subject to the same requirements.
  The Minor Use and Minor Species Animal Health 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 and wildlife 
biologists, in addition to the animals themselves. I call on all my 
colleagues in the House to support the Minor Use and Minor Species 
Animal Health Act of 2003.

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