To ask the Secretary of State for Social Services if, pursuant to his answer of 27 November, Official Report, column 355, he will give the names of the two drugs for which there has been a possible failure to disclose serious suspected adverse drug reactions; for how long the investigations have been continuing; what form they are taking; and if he will make a statement.
Neither of the investigations has yet reached a conclusion so it would be improper for me to name at this time the drugs concerned. The investigations, which began, respectively, in 1986 and very recently, are being carried out by correspondence and, where necessary, meetings and interviews.
To ask the Secretary of State for Social Services if, pursuant to his answer of 27 November, Official Report, column 355, on past suspected underreporting of adverse reactions, his officials make a note of such cases as they occur in addition to recording the operation in the product file; and how many such files are there.
Any information relevant to the licensing of a particular medicinal product is recorded on a file designated for that product; there are no separate files concerned specifically with the investigation of alleged under-reporting of adverse drug reactions. Licences have been issued for over 50,000 medicinal products, including some 39,000 licences of right issued when licensing began in the United Kingdom in 1971. Separate files, sometimes with many volumes, are held for all product licence and clinical trial applications made since 1971 as well as for many of the product licences of right.