§ Mr. BlunkettTo ask the Secretary of State for Health what assessment her Department has made of the drug Mifepristone/RU486; what guidance she has issued on its use; and what plans she has to review its usage.
§ Mr. SackvilleMifegyne (mifepristone; RU486) was granted a licence in accordance with the Medicines Act 1968 on advice from the Committee on Safety of Medicines (CSM), an independent drug safety committee established under the Act. Following a thorough evaluation of the available data from pre-clinical studies, clinical trials and usage in other countries, both the CSM and the licensing authority were satisfied as to the safety, quality and efficacy of the drug.
The use of Mifegyne for the termination of pregnancy is subject to the Abortion Act 1967 (as amended). Guidance to doctors on its usage is contained in the data sheet and information for patients is given in the patient information Leaflet. These documents were approved by both the CSM and the licensing authority.
As with all marketed drugs, information on the safety of RU486 is collected and investigated by the CSM. The safety, quality and efficacy of RU486 are taken into consideration during reviews of its usage.