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<p>The terms of reference of the Expert Working Group on Hormonal Pregnancy Tests
are focused on a scientific review of the strength of evidence for a possible association
between exposure in pregnancy to hormonal pregnancy tests and adverse outcomes in
pregnancy. An important part of the Group’s work is to consider what lessons may be
learnt for further improving existing regulatory systems to identify, monitor and
minimise any adverse effects of medicines in pregnancy.</p><p>Records show that the
Committee on Safety of Drugs (subsequently the Committee on Safety of Medicines) carefully
considered the results of the 1967 study and considered the methodology to be flawed.</p><p>In
1969, the Committee on Safety of Drugs requested the manufacturers of hormonal pregnancy
tests to provide all relevant laboratory data and initiated their own long-term study
of maternal drug histories in mothers of children with birth defects. In 1970, the
Standing Committee on the Classification of Proprietary Medicines (the ‘MacGregor
Committee’) asked Schering, the then licence holder, to remove ‘diagnosis of pregnancy’
from the indications for Primodos.</p>
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