§ Mr. Ashleyasked the Secretary of State for Social Services (1) if he will require all pharmaceutical companies which make payments for adverse reactions from drugs supplied by the National Health Service to inform him of the level and total of payments made, so that his advisers can assess the incidence and severity of the various side effects that have occurred;
(2) if he will ensure that the Committee on Safety of Medicines routinely obtain the scientific evidence that is presented in United States courts when there is a compensation claim following adverse reactions to a drug that also has a British product licence and is, or has been, prescribed for British citizens;
555W(3) if he will ensure that the Committee on Safety of Medicines routinely obtains any evidence about a pharmaceutical company's integrity that is presented in United States courts when there is a compensation claim following adverse reactions to a drug that also has a British product licence and is or has been prescribed for British citizens;
(4) if, unless there are exceptional circumstances, he will make it a condition of the purchase by the National Health Service of a pharmaceutical company's products that in the event of a company making payments because of adverse reactions from one of its drugs, the company must inform his Department of the nature, scope and cost of the payment scheme;
(5) if, unless there are exceptional circumstances, he will make it a condition of the purchase by the National Health Service of a pharmaceutical company's products that all known medical data or information relating to the company's integrity regarding research findings or adverse reactions reporting should immediately and routinely be reported to the Committee on Safety of Medicines.
§ Mr. NewtonCompanies are already required to provide the licensing authority with any evidence that is relevant to their application for a product licence at the time it is submitted. Under the terms of their product licence, they must also report adverse drug reactions and any other evidence which might cast doubt on the validity of the data submitted with their application immediately these are known to them. The licensing authority is concerned with the safety, quality and efficacy of medicinal products. Any question of compensation for adverse drug reactions is a matter for the claimant, the company and the courts. I see no reason to change the current arrangements relating to the purchase of medicinal products by the National Health Service.
§ Mr. Ashleyasked the Secretary of State for Social Services if he will request the Committee on Safety of Medicines to require companies when they warn of uncommon side effects to (a) draw attention to particularly vulnerable groups of people, (b) if the side effects are considered transient, to provide a time scale and (c) give specific descriptions of such side effects rather than use general terms.
§ Mr. NewtonThe data sheets which accompany all medicinal products promoted to doctors must be consistent with the relevant prooduct licences, contain an accurate description of known side effects and, where appropriate, provide warnings about use by particular categories of patient. Appropriate warnings must also appear on produce labels or leaflets accompanying licensed medicinal products. For adverse reactions which are considered transient, a time scale is given where appropriate. I refer the right hon. Member to my reply to him on 9 July 1987 at columns261–62.
§ Mr. Ashleyasked the Secretary of State for Social Services if, whenever a drug is withdrawn by the Committee on Safety of Medicines, he will publish the data which led to its withdrawal.
§ Mr. NewtonMedicinal products are withdrawn either as a result of voluntary action by pharmaceutical companies or the revocation of the product licence by the licensing authorities. In either case, action may be preceded or followed by one or more publications by the556W Committee on Safety of Medicines, such as "Dear Doctor" letters or "Current Problems", in which the medical profession is informed of data on adverse reactions to the drug. It is the general policy of the Committee on Safety of Medicines, wherever possible, to provide doctors with reasons when medicinal products are withdrawn from the market or are subject to major limitations in their use, providing that to do so would not breach the commercial confidentiality requirements of section 118 of the Medicines Act 1968.
§ Mr. Ashleyasked the Secretary of State for Social Services if a product licence is requested for a drug primarily intended for long term use by elderly people; and what are the current criteria laid down by the Committee on Safety of Medicines for the drug trials with respect to (a) the length of the trials and (b) the number and proportion of elderly people involved.
§ Mr. NewtonI refer the right hon. Member to my reply to him on 9 July 1987 at column261.
§ Mr. Ashleyasked the Secretary of State for Social Services how often his Department's statisticians check the validity of significance tests made in drug trials.
§ Mr. NewtonAll data provided in support of any product licence application are rigorously assessed by professional DHSS staff and, when appropriate, by the expert members on the Committee on Safety of Medicines or other appropriate expert committee. Careful consideration of statistical techniques is an important part of this assessment.
§ Mr. Ashleyasked the Secretary of State for Social Services (1) what checks are made by the Committee on Safety of Medicines on the data provided by a company applying for a product licence; whether visits are made to the company's premises; whether there is consultation with the United States Food and Drug Administration; and to what extent the reputation of the company is relevant to the acceptance of its data;
(2) if he will appoint Committee on Safety of Medicines investigators with a similar role to the United States Food and Drug investigators to check the validity of pharmaceutical companies research findings and the integrity of their adverse reaction reports;
(3) if he will make it his policy that whenever there is firm evidence that a pharmaceutical company has violated drug regulations either in the United Kingdom or the United States of America, and in particular if it has paid a fine to the United States Food and Drug Administration for doing so, any further applications from such a company will only be accepted after a visit to the research premises and a personal investigation of the relevant records, with the additional cost to be borne by the company.
§ Mr. NewtonIn assessing an application for a product licence, and in monitoring the safety of a medicinal product after marketing, the licensing authority takes into account all relevant factors, including any information provided by other regulatory authorities such as the United States Food and Drug Administration. We have no plans to appoint investigators to check companies' research or their reporting of adverse drug reactions, but if there were any reason to doubt the accuracy of the data supporting a particular licence application, the matter 557W would be rigorously pursued with the company until the issue was resolved to the satisfaction of the licensing authority.