§ Mr. Ashleyasked the Secretary of State for Social Services (1) how many times the Committee on Safety of Medicines has asked a company to change the nature of the promotion or advertising of its product; and if he will give the reasons for the request in each case;
(2) how often the Committee on Safety of Medicines has issued a warning to doctors when it has asked a company to 229W change its promotion or advertising; and whether it did so when it asked the manufacturers of hormone pregnancy test drugs to change theirs.
§ Mr. MoyleQuestions of changes in advertising are generally dealt with by my Department as part of the functions of the licensing authority, taking into account the advice received from the Committee on Safety of Medicines. Such matters may arise in a variety of ways. In some cases a company may be asked to modify advertising to comply with the terms of the licences or with statutory provisions; in others licences may be formally varied as to the permitted indications and in such case the licence holder has to modify his promotional material and data sheet to conform. No comprehensive data about the numbers involved is available.
In cases where changes in advertising affect safety, the question of communicating the matter to doctors in considered. In some cases the licence holder makes satisfactory arrangements for this to be done. Where on grounds of serious hazard an early communication to doctors is considered necessary, such communication will normally be made at about the same time as any action about advertising or licensing; this was the case with hormone pregnancy tests and there have been three other occasions where this has occurred since 1971.
§ Mr. Ashleyasked the Secretary of State for Social Services (1) what evidence he has of doctors prescribing drugs after a yellow warning notice has been issued, the prescription being for the purpose about which the warning notice was given;
(2) if he will consult the British Medical Association, the Pharmaceutical Society and the community health councils on new methods for ensuring that yellow warning notices are not ignored by doctors;
(3) if he will consider a sample check of all prescriptions of drugs for which yellow warning notices have been given; and if he will seek to penalise doctors if they have been found to be prescribing them for conditions about which the warning notices were issued.
§ Mr. MoyleThe issue of an adverse reactions warning leaflet does not neces-230W sarily imply that it may not be appropriate in some circumstances for doctors to continue to prescribe the drug concerned for their patients. There have been reports that doctors continued to prescribe hormonal pregnancy tests after the Committee on Safety of Medicines had advised that hormonal products should not be used for this purpose. Whether or not to prescribe a product for a particular purpose is a matter for the professional judgment of the doctor treating the patient. I would not wish to interfere with this long-held principle, which was reaffirmed in the joint statement by the Health Departments and the BMA in April, except to ensure that with the aid of the Committee on Safety of Medicines doctors are in possession of full information about the safety and efficacy of the product. In these circumstances, to make a sample check of all prescriptions of drugs for which yellow warnings have been given would serve no useful purpose, nor would the expense be justified. It is proposed to seek the advice of the relevant professional bodies about new measures to ensure that adverse reactions warning leaflets receive doctors' full attention.