§ Mr. Simon HughesTo ask the Secretary of State for Health what measures the Committee on Safety of Medicines took at its meeting on 13 October 1995 to ensure that the apparent association between third generation oral contraceptives and venous thromboembolism was not due to chance, confounding or bias. [20932]
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§ Mr. MaloneThe committee took particular care to examine these issues on the basis of all the evidence available and concluded that the association could not be fully explained by chance, bias or confounding.
§ Mr. HughesTo ask the Secretary of State for Health for what reason the intention of the chief executive of the Medicines Control Agency, as expressed in writing on 18 October 1995, to take regulatory action on third generation oral contraceptives was halted; on whose authority this decision was made; and what was the effect of this decision on the ability of the Licensing Authority to fulfil its statutory duties. [209291]
§ Mr. MaloneRegulatory action is initiated by the Licensing Authority. I refer the hon. Member to the reply I gave the hon. Member for Gordon (Mr. Bruce) on 19 December 1995,Official Report, column 1149, in which I made it clear that such matters are confidential until regulatory action has been completed.
§ Mr. HughesTo ask the Secretary of State for Health who drafted and on what date the "Dear Doctor" letter of 18 October 1995; and if it was agreed by the Committee on Safety of Medicines at its meeting on 13 October 1995. [20935]
§ Mr. MaloneThe chairman of the Committee on Safety of Medicines drafted the letter following the meeting of the Committee on Safety of Medicines on 13 October 1995, on the basis of the recommendations made by the committee.
§ Mr. HughesTo ask the Secretary of State for Health what representations in respect of the Licensing Authority's view of the potential safety concern regarding third generation oral contraceptives the chairman made at the special meeting of the Committee on Safety of Medicines on 13 October 1995. [20936]
§ Mr. MaloneNone.