BEFORE THE HEALTH SUBCOMMITTEE OF THE SENATE LABOR AND PUBLIC WELFARE COMMITTEE STATEMENT ON BEHALF OF VINELAND LABORATORIES, INC. This statement is submitted in behalf of Vineland Laboratories, Inc. for inclusion in the record of the Subcommittee's hearing held July 20, 1972 to consider actions now pending with regard to the withdrawal of approval of new animal drug applications for diethylstilbestrol (DES), and to consider S. 2818 which would ban DES from use in animal feed. Vineland Laboratories, Inc. holds a new animal drug application for the use of DES in implants. Its current authorization is NADA No. 10964. The rigid safety standard imposed by the applicable law and regulations, i.e., that no detectable residue of DES may exist in edible portions of animal carcasses, is met fully when DES is administered by the use of implants in accordance with approved conditions specified in the applicable label instructions. testing and the use of the new chemical method of assay there has been no instance of detectable residues of DES from implanted animals. This was confirmed by Commissioner Edwards' statement before the Subcommittee Even with the recently increased - 2 on July 20, 1972, which explained that the new controls over the use of DES in animal feed were instituted because of reports of misuse of DES resulting in illegal residues, but which emphatically distinguished the facts with respect to implants, saying: "No new restrictions were instituted for DES administered by This assurance with respect to the safety of implants was reaffirmed specifically by FDA witnesses, and by an industry witness, before the FDA National Advisory Drug Committee in a public hearing at FDA on July 25, 1972. The FDA's own investigations thus prove that the factual basis stated by Commissioner Edwards for the withdrawal of approval of applications relating to DES (37 F.R. 12251, 12252) does not apply to implants. As the proven safety record of the implant method of administering DES shows, it inherently provides a positive and specific means of control. The conditions for the administration of implants specified in the label instructions for implants marketed by Vineland, for example, are simple and easy to follow. Clearly, there is no factual or legal basis for the withdrawal of approval of new animal drug applications which provide for the use of DES in implants. Moreover, the alleged increase in the number of DES violations reported by the Department of Agriculture is based upon questionable data developed by the Department of Agriculture's use of a new chemical assay method to report purported detections of DES residues substantially below 2 parts per billion (ppb). According to the testimony to this Subcommittee - 3 on July 20, this new assay method has not been officially published by the Food and Drug Administration because it has not yet been validated as a reliable means for detecting residues below 2 ppb. Whether the new method is more sensitive than the officially prescribed method, therefore, is seriously in question and the alleged increase in the number of violations reported may in fact be so-called "false positives" resulting from the new method. Such questionable data cannot validly support the total withdrawal of DES from use. Even if it may have some genuine value as an alert to re-examine and improve control procedures and techniques for administration of DES, such efforts should be directed specifically to uses which have developed violations, not towards the use of DES in implants. Specifically, neither new legislation nor new regulatory actions with regard to DES should be permitted to involve or jeopardize in any way the administration of DES by the proven and safe implant method. Respectfully submitted, James L Kaler James L. Kaler 710 Ring Building Counsel for Vineland Laboratories, Inc. July 27, 1972 84-843 O-72-6 |
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