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DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE
PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION
ROCKVILLE, MARYLAND 20852

 

October 10, 1980

Dr. Joshua Lederberg
President

The Rockefeller University
1230 York Avenue

New York, NY 10021

Dear Dr. Lederberg:

Thank you for your letter of September 26, 1980 and for sending me a copy
of your American Journal of Medicine editorial on the need to allocate
resources to the study of the predictive value of toxic effects of
chemicals and other environmental hazards.

Your editorial mentioned that much or most of the laboratory information
on toxicity which could be useful in predictive methodology is tucked
away in company files. The FDA is, of course, another repository for
such data and occasionally in a spare moment we talk of the desirability
of compiling the animal findings and attempting to determine which were
predictive for human toxicity and under what circumstances. No one has
the time to do this, however, nor are funds available for this purpose
because of higher priority contracts. Occasionally a drug company will
attempt to show that a metabolite of one of its compounds is responsible
for the toxic effects in an animal model and that this metabolite is not
produced by humans. That is largely the extent of attempts at more
sophisticated evaluation of data.

Perhaps you would agree that the most organized attempts at predicting
toxic effects are those directed to in vitro and short term in vivo
methods for detecting potential mutagenicity and carcinogenicity. I
suspect that it will be a long time, however, before we would be willing
to abandon long term carcinogenicity testing in animals, imperfect as it
is. There is always an uneasy feeling about the exception to the rule.

You asked for some data on elective induction of labor. I have sent your
letter to our Division of Metabolism and Endocrine Drug Products for
reply. The subject was discussed before our Fertility and Maternal
Health Advisory Committee and we can send you a transcript of the
discussion plus any background data available. Much of the data on risk
of nonmedically indicated elective induction is soft. The Committee,
therefore, concluded not that the practice has been shown to be hazardous
but that the benefit/risk ratio of elective induction for nonmedical
indications had not been adequately established; consequently, the
Page 2 - Dr. Joshua Lederberg

labeling for oxytocics with respect to elective induction of labor should
limit the use of the drug to medically indicated situations.

I enjoyed meeting you at the Hoechst Symposium and hearing your
philosophical/technical presentation.

Sincerely yours,

ma af

Marion J. Finkel,
Associate hircctor’

for New Drug Evaluation
Bureau of Drugs