asked the Secretary of State for Social Services if it is usual practice for the Committee on Safety of Medicines to issue a licence for the use of a drug solely on the clinical data provided by the manufacturer.
The Committee on Safety of Medicines advises the licensing authority on applications for product licences for medicinal products. In accordance with section 18 of the Medicines Act 1968, the data a company is required to provide with its application are prescribed by the licensing authority. The committee bases its assessment primarily on these data, which in the case of product licence applications are normally supported by clinical trials undertaken at the request of the company by clinicians working in the field. It is, however, open to the committee to seek further evidence or opinions and members do, of course, draw on their own expert knowledge.