Primodos

Department of Health written question – answered on 28th March 2017.

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Photo of Lord Alton of Liverpool Lord Alton of Liverpool Crossbench

To ask Her Majesty’s Government, further to the Written Answers by Earl Howe on 26 October 2010 (HL2589, HL2591, HL2592, and HL2593) concerning the drug Primodos, and to the remarks by the Parliamentary Under Secretary of State for Health on 23 October 2014 (HC Deb 1139) concerning oral hormone pregnancy tests, and in the light of the Sky News documentary Primodos: The Secret Drugs Scandal, what progress has been made on the independent review of the papers and evidence relating to oral hormone pregnancy tests; what assessment that review has made of the decision by the Committee on Safety of Medicines to ask drug companies to stop promoting pregnancy test drugs to doctors in 1969 but not to advise doctors not to use such drugs until 1975; and whether that review will examine the allegations made in the Sky News documentary, in particular (1) that no toxicology or testing was undertaken prior to the drug Primodos being licensed, (2) that Primodos was being used as an abortifacient in some parts of the world whilst being sold in the UK for the purposes of pregnancy testing, and (3) that there may have been collusion between the drug manufacturer and the regulatory bodies.

Photo of Lord O'Shaughnessy Lord O'Shaughnessy The Parliamentary Under-Secretary of State for Health, Lord in Waiting (HM Household) (Whip)

Primodos, a hormonal pregnancy test, first became available in the 1950s. At that time there were no legal requirements on companies to ensure that marketed medicines met appropriate standards of safety, quality and efficacy and a licence to market was not required. Any studies performed on a medicine prior to its use were at the discretion of the company. The Medicines Act came into force in 1971.

The terms of reference of the Expert Working Group on Hormonal Pregnancy Tests, adopted by its members and agreed with by the chair of the main patient association in her role as an ‘observer’ on the Group, 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 (particularly birth defects, miscarriages and stillbirths). The Group’s terms of reference also include what lessons may be learnt for further improving existing regulatory systems to identify, monitor and minimise any adverse effects of medicines in pregnancy.

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