§ Mr. Ashleyasked the Secretary of State for Social Services to what extent there is a liaison between the Committee on Safety of Medicines and the United States Food and Drug Administration; and whether the Food and Drug Administration automatically informs the Committee on Safety of Medicines when a drug available 330W in the United Kingdom is reformulated or withdrawn from the United States market whether it be on the initiative of the Food and Drug Administration or the manufacturing company.
§ Mr. Geoffrey FinsbergThere is regular contact between officials of the United Kingdom licensing authority and the Food and Drug Administration (FDA). Information about variations to and revocations of drug licences in the USA is contained in the FDA's publications, which are sent routinely to the licensing authority, and is also received from the World Health Organisation.
§ Mr. Ashleyasked the Secretary of State for Social Services if he will seek powers to reject applications for product licences for drugs, or to withdraw those already given, if there is evidence that the drug is not efficacious.
§ Mr. Geoffrey FinsbergNo. The licensing authority already has powers to reject an application for a product licence or revoke such a licence on grounds of lack of efficacy of the product.
§ Mr. Ashleyasked the Secretary of State for Social Services if he will list current and past research in the United Kingdom into the extent of pharmaceutical drug-taking by pregnant women; if he will summarise the conclusions; and if he will request the Committee on the Safety of Medicines to consider whether further research is required.
§ Mr. Geoffrey FinsbergNumerous studies have been conducted in this country on drugs used in pregnancy and many have commented on the extent of that use. It would not be practicable to list all these studies or to summarise this information.
Considerable research is currently being conducted into the likely effects of individual drugs on the foetus, including an ongoing survey requested by the Committee on Safety of Medicines (CSM). It is therefore unnecessary for the CSM to consider the need for further research.