Introduction - Uppsala Monitoring Centre

1981).
Dr Kelsey said at an open public scientific workshop on ‘Thalidomide:
potential benefits and risk’ on September 9th-10th 1997: ‘I joined the
Food and Drug Administration as a medical officer in August of 1960.
I spent the first months going around various areas of the Food and
Drug Administration getting familiar or getting introduced to the type
of work that was done there. On September 1st, I reported to the
Bureau of Medicine as a reviewing medical officer. The thalidomide
application was filed shortly after September the 8th. Although it was
usual to give applications around more or less in rotation, since I was
new, they selected an easy one for me…. Now, I should explain,
however, that the applications really were quite a bit different from
what they are today. A lot of them were for fairly ordinary drugs,
minor molecular modifications of long-used drugs, or a new mixture
of old drugs. It was rare that a really new and exciting drug came in,
and it was in those applications that the best clinical and animal
studies were performed. In general, at the time, drug testing was not
considered a very scholarly pursuit by most people. Many of the
studies in support of new drugs were written really more as
promotions than as scientific studies. The ground rules in those days
were that after an application had been submitted and filed with the
agency, the agency had 60 days in which to decide that the drug was
safe for the proposed use or uses. There was no requirement for
efficacy, and this of course was one reason why the applications
were so much smaller. In fact, the thalidomide application was four
volumes in size, as I recall. That was about standard. I think I
remember one that was 11, and one that was one or perhaps two.
Now, although I guess they’re mostly computerized, it’s a matter of
100 or 200 volumes. The applications were reviewed, as they are
now, by a chemist, and a pharmacologist, and a medical officer. The
chemists were in the same little prefab building that we were in on
the Mall between 7th and Independence, where the Museum of
Science and Industry now is. The pharmacologists were in another
bureau altogether, in the Department of Agriculture. The medical
officer really had the choice. They could do the pharmacology
themselves or they could ask for a consult from the pharmacologist. I
chose the latter course. We had, as I said, 60 days. If we hadn’t
communicated with the company before that, they could have
automatically assumed that it was okay, and marketed it. So very
close tabs was always kept on the date. We did get our letter out on