Introduction - Uppsala Monitoring Centre

2. ‘We were forced to work against deadlines of 60 and 180 days
to prevent the automatic approval of the new drug.’ (In 1940
there was only one medical officer working on new drugs
which increased to two in 1950) (Larrick, 1965).
3. ‘There was no provision requiring regular record keeping and
reporting of clinical and other experiences with new drugs.’
4. ‘We could not remove a new drug from the market unless we
could prove that it was unsafe; it was not enough to show that
new developments had drawn the question of its safety sharply
into issue.’
5. ‘There were inadequate controls over the distribution and use
of investigational drugs, as the thalidomide episode showed.’
[Richardson-Merrell distributed 2,528,412 thalidomide tablets
to 1,267 physicians for some 20, 000 patients in the USA
(Sjöstrom & Nilsson, 1972). Over 2,151 patients were given
them in clinical trials. There were at least 7 cases of
phocomelia (Mellin & Katzenstein, 1962)].
6. ‘Prescription drug advertising, at an estimated expenditure of a
quarter-of a- billion dollars per year - $1,000 for each physician
in the United States–was virtually unregulated.’
7. ‘Trade names were being used without proper relationship to
generic names, with resulting confusion to the profession.’
8. ‘The quality of “old drugs” was not assured, as it was with the
“new drugs.” Only five of the classes of antibiotic drugs used to
treat life-threatening infections were subject to routine batch
testing and certification by our laboratories.’
9. ‘And factory inspection authority was so limited as to seriously
handicap our operations.’ (Larrick, 1965).
Geiling and Cannon proposed that the necessary information for
drugs to be supplied by pharmaceutical companies in their New Drug
Applications (NDA):
Chemical composition
Acute toxicity studies in two species
Chronic toxicity studies with different doses in different species
Observation of the animals
Pathologic examination of animals
Studies in animals with experimental lesions
Studies on the absorption and elimination of the chemical
Study of interactions
Knowledge of idiosyncrasies and untoward reactions (Geiling
& Cannon, 1938).