§ Mr. AshleyTo ask the Secretary of State for Social Services what action has been taken by the Committee on Safety of Medicines to investigate the activities of pharmaceutical companies prescribing drugs for the National Health Service which have been fined by the United States of America's Food and Drug Administration for convening drug regulations.
§ Mr. Newton[holding answer 16 November 1987]I refer the right hon. Member to my reply to him on 2 November at column561. It is not licensing authority policy to give details of any action it may take in specific cases.
§ Mr. AshleyTo ask the Secretary of State for Social Services what checks are being carried out by the Committee on Safety of Medicines or his Department to ensure that all side effects, including deaths, which are known to a pharmaceutical company are reported to the committee; on how many occasions it has been found that a company has not made a complete report; and what action is taken in such circumstances.
§ Mr. Newton[holding answer 16 November 1987]Power under the Medicines Act 1968 and its subordinate legislation is used to make it a condition of the grant of a product licence that the licence holder must report to the licensing authority, in accordance with standard directions, adverse reactions associated with the medicinal 355W product immediately they come to notice. Licence holders have been reminded of this requirement on a number of occasions in Medicines Act information letters, and given detailed guidance on reporting: the most recent guidance, MAIL 49 issued in March 1987, is in the Library. When the safety of a marketed drug is under particular scrutiny the licence holder may be asked to provide all information known to the company about adverse drug reactions. Information provided in response to such a request is compared with previous reports made by the company, and any discrepancies are investigated. Where the licensing authority is satisfied that the licensing conditions have been breached, the action open to it can include the suspension, revocation, or variation of the licence where safety or other relevant factors apply. The Department is currently conducting two investigations which relate to the possible failure to disclose serious suspected adverse drug reactions. Because information on suspected under-reporting is held on files relating to specific products and giving the full licensing history, a count of earlier possible instances cannot be made without disproportionate cost.
§ Mr. AshleyTo ask the Secretary of State for Social Services (1) whether the Committee on Safety of Medicines carried out any investigation into the circumstances surrounding Eli Lilley's failure to report deaths attributed to Opren to the United States of America's Food and Drug Administration;
(2) whether Eli Lilley gave any indication to the Committee on Safety of Medicines prior to the launch of Opren that the drug would cause particular problems for elderly people taking it; and if he will make a statement.
§ Mr. Newton[holding answer 16 November 1987]I am advised that as both the Committee on Safety of Medicines and the Licensing Authority are involved in current legal actions concerning Opren, related matters are sub-judice.
§ Mr. AshleyTo ask the Secretary of State for Social Services what action he proposes to take in the light of new evidence that pharmaceutical companies providing drugs for the National Health Service have tried to prevent doctors from making critical comments about the company's drugs in court actions; and if he will make a statement.
§ Mr. Newton[holding answer 16 November 1987]If the right hon. Member has any evidence that a criminal offence (such as conspiracy to pervert the course of justice) has been committed, I hope he will bring it to the attention of the police.