Kerry McCarthy (Bristol East, Labour)
To ask the Secretary of State for Health whether his Department has made any comparative assessment of the safety assessments made by the (a) US and (b) EU authorities in respect of the drug Roaccutane; and what representations he has received on its availability for prescription in the UK.
Norman Lamb (North Norfolk, Liberal Democrat)
As for all medicines on the United Kingdom market, the Medicines and Healthcare products Regulatory Agency (MHRA) keeps the safety of Roaccutane and all medicines containing isotretinoin under continuous review. As the reference member state for Roaccutane, the MHRA leads the European safety assessment, in which the views of EU authorities are included.
Although no direct comparison with US safety assessments of Roaccutane has been undertaken, the marketing authorisation holders for isotretinoin-containing medicines are required to submit all worldwide safety data including adverse reactions suspected to be associated with isotretinoin, published literature and studies, and to keep MHRA informed of any safety decisions made in other countries.
In the UK, Roaccutane and other isotretinoin-containing medicines are only available on prescription from a doctor and the licensing terms mean that isotretinoin can only be prescribed by or under the supervision of a consultant dermatologist. This information has been communicated to healthcare professionals by the MHRA and is reflected in the clinical guidelines issued by the British Association of Dermatologists.
A search of the Department's ministerial correspondence database has not identified any correspondence or parliamentary questions received since