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FACT PROVIDES FDA WITH LIST OF DRUGS REPORTEDLY MISUSED IN FOOD ANIMALS

FACT PROVIDES FDA WITH LIST OF DRUGS REPORTEDLY MISUSED IN FOOD ANIMALS
 /ADVANCE/ BETHESDA, Md. /PRNewswire/ -- In testimony before the Food and Drug Administration (FDA) today (Wednesday, April 29), Food Animal Concerns Trust (FACT) President Robert A. Brown named nine drugs believed to have multimillion-dollar sales for unapproved uses in food-producing animals.
 "While these drugs are approved for some animal species, FACT understands they are widely used in others," said Brown. "This so-called 'extra-label' drug use is hazardous to human health because drug residues may result in meat, milk, and eggs."
 In addition to naming the drugs, Brown presented estimated dollar sales volume and discussed profit margins. "The main point," said Brown, "is that profits from extra-label use are more than sufficient to pay for the studies needed for approvals, yet the drug companies do not obtain them."
 Misuse of veterinary drugs has been a topic of concern for some time, but previously had not been examined in the context of the economics of extra-label usage. FACT is now suggesting to FDA which drugs, reportedly subject to high volume extra-label use in animals in the human food chain, should receive priority attention. "FACT has attempted to initiate the process of resolving this problem by using the services of a consultant to the animal health industry with experience and credentials such that we are confident in the data supplied," Brown said.
 Brown cited the example of Ivomec, a drug used to rid animals of worms and other parasites. "Ivomec is believed to be the most commonly used worming medicine for dairy cows," said Brown, "but this use is extra-label. Even though domestic sales of this drug are estimated to exceed $200 million, Merck, the manufacturer, has not obtained FDA approval for lactating cows. It is the approval process that would determine if Ivomec can be used without producing residues in the milk our children drink."
 It was Brown's recommendation that FDA require manufacturers to do safety studies and apply for approvals whenever drugs are administered to animals in the human food chain. "The problem," said Brown, "is that the drug companies have no financial incentive to do the studies and gain approvals. Not only do they have the sales already, they may also realize that the studies might show that the drug cannot be used safely in the extra-label species. This would happen if effective dosage rates produced unacceptable residues," Brown said.
 Brown pointed out that when approvals are obtained for different species, the criteria for safe use are not the same. In Ivomec, for instance, the withdrawal time, which is the number of days before slaughter that the drug should not be used, is 18 days for swine and 35 days for beef cattle.
 In addition to Ivomec, Brown cited reported extra-label use of such drugs as Spectam (Sanofi), Neomix (Upjohn), and LS-50 (Upjohn), which are cleared for poultry but which FACT understands are used in cattle as well. He also cited Naxcel (Upjohn) and Liquamycin LA-200 (Pfizer), which are the reverse -- approved for cattle but also reportedly used in poultry. Another example given was Baytril (Bayer), cleared for dogs and cats, but which FACT believes is also used in cattle, swine, and poultry.
 The American Veterinary Medical Association is currently campaigning to make extra-label drug use legal for veterinarians. "This," said Brown, "would make a mockery of an approval process designed to protect the public." FACT's extra-label drug list may be obtained from the organization's Chicago headquarters.
 -0- 4/29/92
 /CONTACT: Kevin Morrissey of FACT, 312-525-4952/ CO: Food Animal Concerns Trust ST: Illinois IN: SU:


GK -- NY097 -- 3869 04/28/92 13:45 EDT
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Date:Apr 28, 1992
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