[Congressional Record Volume 149, Number 50 (Thursday, March 27, 2003)]
[Senate]
[Pages S4530-S4531]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. SESSIONS (for himself, Mr. Bingaman, Mr. Gregg, Mr. 
        Miller, Mr. Allard, Mrs. Lincoln, Mr. Ensign, Ms. Collins, Mr. 
        Crapo, Mr. Craig, and Mr. Harkin):
  S. 741. A bill to amend the Federal Food, Drug, and Cosmetic Act with 
regard to new animal drugs, and for other purposes; to the Committee on 
Health, Education, Labor, and Pensions.
  Mr. SESSIONS. Mr. President, I rise today in order to bring attention 
to a problem that unfortunately goes largely unnoticed except by those 
who are directly affected. Livestock and food animal producers, pet 
owners, zoo and wildlife biologists, and animals themselves face a 
severe shortage of approved animal drugs for use in minor species.
  Minor species include thousands of animal species, including all 
fish, most birds, and sheep. By definition, minor species are any 
animals other than the major species--cattle, horses, chickens, 
turkeys, dogs, and cats. A similar shortage of drugs and medicines for 
major animal species exists for diseases that occur infrequently or 
which occur in limited geographic areas. Due to the lack of 
availabiliity for these minor use drugs, millions of animals go 
untreated or treatment is delayed. Unnecessary animal physical and 
human emotional suffering results, and human health may be threatened 
as well.
  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. This 
causes severe economic hardship to struggling ranchers and farmers. For 
example, sheep ranchers lost nearly $42 million worth of livestock 
alone in 2002. The sheep industry estimates that if it had access to 
effective and necessary drugs to treat diseases, growers' reproduction 
costs for their animals would be cut by up to 15 percent. In addition, 
feedlot deaths would be reduced by 1 to 2 percent, adding approximately 
$8 million of revenue to the industry.
  Alabama's catfish industry ranks second in the Nation. Though it is 
not the State's only aquacultural commodity, catfish is by far its 
largest. The catfish industry generates enormous economic opportunity 
in the State, particularly in West Alabama, one of the poorest regions 
in the State.
  The catfish industry estimates its losses at $60 million per year 
attributable to diseases for which drugs are not available. Indeed, it 
is not uncommon for a catfish producer to lose half his stock due to 
disease. The U.S. aquaculture industry overall, including food fish and 
ornamental fish, produces and raises over 800 different species. 
Unfortunately, this industry has only 6 drugs approved and available 
for use in treating aquaculture animal diseases. This results in 
tremendous economic hardship and animal suffering.
  Because of limited market opportunity, low profit margins, and the 
enormous capital investment required, it is seldom economically 
feasible for drug manufacturers to pursue research and development and 
then seek approval for drugs used in treating minor species and for 
infrequent conditions and diseases in all animals.
  I, along with Senator Bingaman, Senator Allard, Senator Collins, 
Senator Crapo, Senator Miller, Senator Craig, Senator Ensign, and 
Senator Lincoln, resolve to improve this situation by introducing the 
Minor Use and Minor Species Animal Health Act of 2003. This legislation 
will allow animal drug manufacturers the opportunity to develop and 
obtain approval for minor use drugs which are vitally needed by a wide 
variety 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 Act creates incentives for animal drug manufacturers to 
invest in product development and obtain FDA marketing approvals.

  This legislation creates a program very similar to the successful 
Human Orphan Drug Program that has dramatically increased the 
availability of drugs to treat rare human diseases over the past 20 
years.
  The bill establishes two new ways to lawfully market new animal 
drugs:
  First, 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 new approval requirements for safety as 
new animal drugs approved under section 512 of the FDC Act. However, 
the effectiveness standard for conditionally approved drugs would 
differ from the effectiveness standard for new drugs approved under 
Section 512 in that a ``reasonable expectation of effectiveness'' 
rather than ``substantial evidence of effectiveness'' would be 
demonstrated. If the FDA approves an application for conditional 
approval, this approval will be in effect for 1 year, renewable for a 
maximum of 4 additional 1 year terms. This conditional approval is 
intended to allow drug sponsors to recoup some development costs 
through marketing the product prior to full, unconditional approval.
  Second, this legislation provides for an index of legally marketed 
unapproved new animal drugs for some non-food minor animal species. The 
index is intended to provide a way to lawfully market those minor 
species drugs for which there is unlikely to be sufficient financial 
incentive to seek a full or conditional approval. If the FDA determines 
that a new animal drug is eligible for listing on the index, the new 
drug will be added to the index if the

[[Page S4531]]

benefits of using the drug outweigh the risks, taking into account the 
harm caused by the absence of an approved or conditionally approved 
drug for the use in question. The addition of a drug to the index will 
be based in large part on a report of an independent expert panel.
  The Minor Use and Minor Species Animal Health Act will not alter FDA 
drug-approval responsibilities that ensure 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. This 
rigorous testing and review process provides consumers with the 
confidence that animal drugs are safe for animals and consumers of 
products derived from treated animals. Current FDA requirements include 
guidelines to prevent harmful residues and evaluations to examine the 
potential for the selection guidelines to prevent harmful residues and 
evaluations to examine the potential for the selection of resistant 
pathogens. Any food animal medicine or drug considered for approval 
under this bill would be subject to these same assessments.
  The Minor Use and Minor Species Animal Health Act is supported by 43 
organizations, including the American Farm Bureau Federation, the 
Animal Health Institute, the American Veterinary Medical Association, 
and the National Aquaculture Association. This is vital legislation.
  This Act will reduce the economic risks and hardships which fall upon 
ranchers and farmers as a result of livestock diseases. It will benefit 
pets and their owners and benefit various endangered species and 
aquatic animals. The Act also will promote the health of all animal 
species while protecting human health and will alleviate unnecessary 
animal suffering. This is common-sense legislation which will benefit 
millions of American pet owners, farmers, and ranchers.
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