§ Mr. Ashleyasked the Secretary of State for Social Services, pursuant to his reply of 21st June, if he will give the date when action was taken about advertising and licensing of hormone pregnancy test drugs; what that action was; if he will publish details of the communications with doctors that is referred to in the reply; and if he will publish further details about the three other occasions when similar action has been taken.
§ Mr. Moyle,pursuant to his reply [Official Report, 21st July 1978; Vol. 954, c. 457–8], gave the following information:
In June 1975 licences in respect of four hormone pregnancy test drugs were varied to include contraindications in case of pregnancy. One other product licence was revoked and two products were withdrawn from the market by the company. Leaflet 13 in the adverse reactions series was issued to doctors in June 1975 advising the use of alternative methods of pregnancy testing. This advise was reiterated in leaflet 16 issued in November 1977. My hon. Friend has already received copies of these two leaflets.
The three occasions I refer to in my reply to my hon. Friend on 21st June, when early communication to doctors was made in cases in which action was taken on advertising or licensing were:
- (a) The issue of leaflet 11 in the adverse reactions series on practolol. In October 1975 the product licence was varied to limit the product to specialist use;
- (b) The issue of leaflet 14 on neomycin in May 1977. The licences of all aerosol topical products containing neomycin were varied to remove burns as an indication and
965 to require that a suitably worded warning should appear on the containers of the product; - (c) The issue of leaflet 15 on perhexiline maleate in July 1977. The data sheet was amended to emphasise the need for stringent patient monitoring during treatment. After the issue of the leaflet company representatives ceased to promote the product to general practitioners, and all journal advertising directed at general practitioners was stopped.