NEWS
11/05/1993

<TITLE>FDA Approves New Animal Drug SOMETRIBOVE</TITLE>
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P93-40                                        Susan M. Cruzan
FOR IMMEDIATE RELEASE                         Office 301-443-3285

     The Food and Drug Administration today announced approval of
the new animal drug sometribove, a recombinant bovine somatotropin
(bST) product for increasing milk production in dairy cows.
     Sometribove increases milk output by supplementing a cow's
natural bST, a hormone produced in the pituitary gland.  Milk from
treated cows has been found to have the same nutritional value and
composition as milk from untreated cows.
     "This has been one of the most extensively studied animal drug
products to be reviewed by the agency," said FDA Commissioner David
A. Kessler, M.D.  "The public can be confident that milk and meat
from bST-treated cows is safe to consume."
     As reported by the General Accounting Office in September
1992, FDA found evidence in the submitted clinical trials that bST-
treated cows have a slightly increased incidence of mastitis, a
common infection of a cow's udder.  In March, an FDA advisory
committee met to discuss concerns raised by GAO that antibiotic
treatments for mastitis could lead to increased antibiotic residues
in milk.
     The committee concluded that adequate safeguards are in place
to prevent unsafe levels of antibiotic residues from entering the
milk supply.  States require milk to be tested for drug residues. 
Milk found to have unsafe levels of residues must be discarded, and
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ATTENTION TV BROADCASTERS:  Please use open caption for the hearing 
impaired.


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producers responsible for violative residues are subject to
regulatory sanctions.
     Nevertheless, additional steps have been taken to ensure that
any unsafe residues in the milk of bST-treated cows are detected
well before the milk or its products reach the grocery shelves.
Monsanto Co. of St. Louis, Mo., the drug's sponsor, has agreed to
conduct a post-approval monitoring program that includes the
following elements:
o    A two-year tracking system of milk production and drug
     residues in 21 top dairy states that will periodically compare
     the amount of milk discarded after bST is marketed to the
     amount discarded prior to approval.
o    A 12-month comparison of the proportion of milk discarded due
     to positive drug tests between bST-treated and untreated
     herds.
o    A reporting system to monitor all bST use and follow up on all
     complaints.
o    The use of sometribove in 24 commercial dairy herds will be
     specifically monitored for mastitis, animal drug use and the
     resulting loss of milk.
     In the Aug. 24, 1990, issue of Science magazine, FDA
scientists summarized more than 120 studies that examined the human
safety of recombinant bST.  The agency's conclusion that bST poses 
no risk to human health has been affirmed by scientific reviews in
the past several years conducted by the National Institutes of 
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                                         Page 3, P93-40, BST
Health, the Congressional Office of Technology Assessment and drug 
regulatory agencies of Canada, the United Kingdom and the European 
Economic community, and by an issues audit by the HHS Office of
Inspector General.
     In May, FDA sponsored a two-day joint advisory committee
meeting on the labeling of food products derived from bST-treated
cows.  Based on the conclusions of the committee members, and on
its review of the facts, FDA has concluded that it lacks a basis
under the statute to require special labeling of these foods.  Food
companies, however, may voluntarily label their products provided
the information is truthful and not misleading.
     "There is virtually no difference in milk from treated and
untreated cows," Kessler said about bST.  "In fact, it's not
possible using current scientific techniques to tell them apart. We
have looked carefully at every single question raised, and we are
confident this product is safe for consumers, for cows and for the
environment." 
     Sometribove is manufactured by Monsanto.  It will be marketed
under the trade name Posilac.
     FDA and NIH are Public Health Service agencies within HHS.
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