[Congressional Record Volume 140, Number 143 (Wednesday, October 5, 1994)]
[Senate]
[Page S]
From the Congressional Record Online through the Government Printing Office [www.gpo.gov]


[Congressional Record: October 5, 1994]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]

 
      S. 340--ANIMAL MEDICINAL DRUG USE CLARIFICATION ACT OF 1994

 Mr. COATS. Mr. President, last evening, the Senate-passed 
legislation that codifies the practices allowed under the current 
compliance policy guidelines regarding the extra-level use of 
veterinary pharmaceutical products. I supported this legislation as a 
cosponsor and am pleased at its passage. By passing this legislation, 
we have reaffirmed our trust in veterinarians to use their professional 
judgement in treating animals--both livestock and pets. This 
legislation allows veterinarians to fulfill there professional 
responsibility of animal care in the context of a veterinarian-client-
patient relationship.
  Extra-label drug use is the use of a federally approved product in 
ways not specified on the products labeling. Extra-label drug use in no 
way increases the risk to humans or animals by allowing unsafe or 
unapproved drugs to be used in the treatment of livestock and pets. 
Because there are too few approved animal health products to treat all 
animal illnesses, in order to treat animals adequately and to alleviate 
animal suffering, veterinarians must use some products in an extra-
label fashion. This legislation allows veterinarians to use products in 
an extra-label manner as deemed appropriate by the Food and Drug 
Administration's [FDA] Center for Veterinary Medicine [CVM].
  Although I am quite pleased at the passage of this legislation, it is 
at best a short-term solution to a long-term and larger problem--the 
lack of drugs available to treat animals. The legislation, as it 
passed, will not address this problem.
  The animal health industry spends $400 million each year on research 
to bring new products to the market. The investment is tremendous as 
one takes a product from discovery to the market. Yet, 87 percent of 
all pharmaceuticals, vaccines, and feed additives used in animal health 
generate annual revenues of less than $1 million each. A new animal 
drug application review process mandated by law to take 6 months now 
averages 4 years. S. 340 does nothing to expedite the review process of 
the FDA and CVM. We must now work with the manufacturers of animal 
health products, veterinarians, livestock producers, FDA, and CVM to 
address this larger problem of animal drug review and approval policies 
and procedures.
  The FDA/CVM regulatory process was established to ensure that 
products marketed have met the key criteria of safety, quality, and 
efficacy. As we celebrate the passage of S. 340, we should understand 
that our goal is to have more approved products available to meet the 
needs of animal care. The extra-label use allowed in this legislation 
should be interpreted such that we maintain the incentive to bring 
products through the regulatory process.
  Livestock producers and the animal health industry joined with 
veterinarians in support of this measure to address their valid issues. 
Through future legislative initiatives, we now need to address animal 
drug availability deficiencies. Congress can address these deficiencies 
by improving the animal drug approval process. Improving the process 
will help turn extra-label uses into labeled claims, which ultimately 
serves the animal and pet industry as a whole.
  Again, Mr. President, I am extremely pleased at the passage of this 
legislation, but caution that we must address the larger and 
increasingly urgent problem of animal drug availability.

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