[Congressional Record Volume 141, Number 163 (Friday, October 20, 1995)]
[Extensions of Remarks]
[Page E1993]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




              SUPPORT FOR THE ANIMAL DRUG AVAILABILITY ACT

                                 ______


                           HON. WAYNE ALLARD

                              of colorado

                    in the house of representatives

                       Thursday, October 19, 1995

  Mr. ALLARD. Mr. Speaker, as a veterinarian, I am well aware of the 
importance of animal health products for maintaining the health and 
well-being of companion animals and food-producing animals. 
Unfortunately, during the past two decades, the drug-approval process 
at the Food and Drug Administration's Center for Veterinary Medicine 
has become increasingly prolonged and complicated. In fact, the FDA has 
approved only eight new drugs for food producing animals over the past 
5 years.
  The drug approval process needs to be streamlined so that useful 
health products are made readily available on the market while 
essential safety standards are preserved. Animal drug regulations exist 
to ensure that our family pets are safe and the integrity of our food 
supply is maintained. Any part of the regulatory process which does not 
promote these ends, but merely serves as a needless hurdle that delays 
the approval of beneficial drugs should be reformed. That is exactly 
what we aim to do with the Allard-Klug-Stenholm-Ganske Animal Drug 
Availability Act of 1995. This measure would maintain what is right 
about the current system while it would modify those portions that 
serve to lengthen the approval process while providing negligible 
offsetting benefits for safety.
  The Animal Drug Availability Act would expedite the animal drug 
approval process by expanding the list of studies that FDA can use to 
prove a new drug's effectiveness and by allowing FDA more flexibility 
in determining whether a field investigation is necessary to prove 
drug's efficacy. In addition, the act would provide flexible 
effectiveness requirements for previously approved animal drugs for use 
in minor species and for minor uses. In order to ensure more 
predictability in the approval process for drug applicants, FDA 
officials would be required to convene a presubmission conference with 
an applicant for the purpose of outlining what types of studies will be 
necessary in order to achieve final approval. This agreement would be 
binding upon both parties unless a subsequent scientific development 
conclusively demonstrates that an additional study is essential to 
proving the safety and effectiveness of the drug.
  I am pleased that this bill is a bipartisan approach which enjoys the 
support of over seventy other members of the House. In addition, it has 
the broad support of producer groups and feed groups and is endorsed by 
the Animal Health Institute and the American Veterinary Medical 
Association. I urge my colleagues to join us in improving the health of 
family pets and food-producing animals by supporting this commonsense 
reform to the animal drug approval process.

                          ____________________