Answers 03/15/1994
T94-16 Susan M. Cruzan
March 15, l994 301-443-3285
American Cyanamid Pleads Guilty in Poultry Drug Case
We have been receiving inquiries about the American Cyanamid
Co.'s Feb. 28 guilty plea for failure to maintain accurate
records in its effectiveness studies for Cygro in combination
with other animal drugs. These combination drugs are given to
poultry to increase weight gain and feed efficiency. The study
results were submitted to FDA by Cyanamid in the firm's new
animal drug applications.
Charges were also filed, on March 11, against Dr. David L.
Sharkey, the Cyanamid employee who was responsible for
supervising the Cygro studies.
The following may be used to respond to questions.
As part of the plea agreement between Cyanamid and the
United States, the firm agreed to pay a $200,000 fine plus
government investigation costs of $200,000.
According to the Department of Justice's statement of facts,
study records maintained by Cyanamid contained inaccurate data
about the weights and feed consumption of birds in the Cygro
combination studies. The records also contained incorrect drug
assay results, did not indicate that certain animals had been
intentionally exposed to a common disease organism that may have
enhanced the effect of the combination drugs, and did not include
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Page 2, T94-16, Cyanamid
certain adverse reactions observed.
Failure to maintain accurate and complete records of the use
of new animal drugs in field investigations is a violation of the
Food, Drug and Cosmetic Act.
Cygro (maduramicine ammonium) was originally approved in
l989 for prevention of coccidiosis, a serious disease in poultry.
Subsequently, approvals were granted for use of Cygro in
combination with bacitracin MD, in combination with roxarsone and
in combination with chlortetracycline. The combination products
have been withdrawn from the market by the company in response to
FDA's concerns.
The investigation that led to the filing of these charges
is part of a broader effort to ensure the integrity and accuracy
of all scientific data submitted to the FDA in support of
applications to market drugs for animal or human use. As part of
the plea Cyanamid has agreed to cooperate with FDA in this
effort.
Cyanamid is headquartered in Wayne, N. J.
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