To: FDADockets@OHRM-MAIL@FDAOC From: Certify: N Subject: Comments for 98N-339V_WC52 Date: Thursday, September 10, 1998 at 9:56:45 pm EDT Attached: None Comments: My name is James Barton. I am the 1998-99 president of the Association of Veterinarians in Turkey Production (AVTP). The AVTP is a group of 34 veterinarians with extensive experience working for turkey meat producing and turkey breeding companies. The fact that over three-quarters of us are diplomates in the American College of Poultry Veterinarians illustrates the level of technical expertise represented by our membership. I believe the CVM can speed up the review of submissions and more effectively utilize personnel, while protecting the public health and giving the end-users of CVM-reviewed products the service they require by significantly reducing the rigor of efficacy testing required for pharmaceuticals for the poultry industry. It is certain that the burden of efficacy testing causes sponsors to abandon approval of new drugs, not to mention the increased cost that must be passed on to the end-user. I support the use of presubmission conferences, and suggest that they be required for all submissions involving poultry pharmaceuticals. An active, end-user representative, chosen from the Association of Veterinarians in Broiler Production or The Association of Veterinarians in Turkey Production should participate in the conferences. (These volunteers would commit to sign an agreement of confidentiality.) This system would provide guidance on the degree of protection from non-efficacious products that the end-users desire. Since we are bound by the economic requirements of our employers to use only efficacious, cost-effective products, there is certainly no danger of the modern commercial poultry industry being duped into buying "snake oil." Requiring binding presubmission conferences will free up time and money for sponsors and the CVM to pursue critical needs for pharmaceuticals that relieve the pain and suffering related to diseases such as PEMS, histomoniasis, coccidiosis, broodiness, bordetellosis, ORT, and cellulitis. I do not advocate relaxation of efforts to protect human health and the environment. However, CVM's paternalistic view of efficacy is at odds with the reality of modern poultry production. The efficacy of products can be much more effectively evaluated by poultry company veterinarians than sponsors or the FDA reviewers. My comments are submitted in support and to inform the CMV of the nature and needs of commercial poultry production. Signature: Dr. James Barton Submitter: Assoc. of Vets. in Turkey Production E-Mail: jtbcboater@aol.com Keywords: I_ProdApplRev,Q_ClarRevProc,Q_ElimRevBack