§ Dr. John A. Cunninghamasked the Secretary of State for Social Services (1) how many references have been made by his Department to the Committee on the Safety of Medicines or the Dunlop Committee in the last five years; and what are the annual figures for 1968, 1969, 1970, 1971 and 1972;
(2) if he will list in the Official Report the names of the substances re- 180W ferred to the Committee on the Safety of Medicines or the Dunlop Committee since 1968.
§ Sir K. JosephSince 1968 special references have been made to the Committee of Safety of Drugs and its statutory successor, the Committee on Safety of Medicines, on the following subjects:
- Clioquinol.
- Cyclamates.
- Hexachlorophane.
- Imipramine.
- L-dopa.
- Oral Contraceptives.
Oral hypoglycaemic agents (tolbutamide and phenformin).
Streptomycin and aminoglycosidic antibiotics.
A list of 369 drugs considered by the United States Food and Drug Administration to be "dangerous and ineffective".
The following table sets out the annual numbers of new submissions received by the committees in their regular consideration of applications for clinical trial and marketing of medicinal products.
Committee on Safety of Drugs:
Total 1968 791 1969 848 1970 714 1971 (to 31st August, 1971) 554 Committee on Safety of Medicines: 1971 (from 1st September, 1971) 147 1972 (to 13th March, 1972) 86 In addition the committees have regularly reviewed other medicinal products as part of their responsibility for considering suspected adverse reactions, arising from their use through the reporting system which operates in the United Kingdom, and have taken account of reports received from abroad. The annual reports of the Committee on Safety of Drugs outline these activities.
It was not customary, under the voluntary system for the Committee on Safety of Drugs to give the names of substances submitted. As I informed the hon. Member for Willesden, West (Mr. Pavitt) on 19th October, 1971, I have under consideration the question of what information should be published relating to the grant of licences under the Medicines Act, 1968.—[Vol. 823, c. 93.]
§ Dr. John A. Cunninghamasked the Secretary of State for Social Services how many references to the Committee on the 181W Safety of Medicines or the Dunlop Committee have resulted in reports recommending the withdrawal of the substances involved in the last five years.
§ Sir K. JosephDuring the last five years neither the Committee on Safety of Drugs nor its successor the Committee on Safety of Medicines has had occasion to recommend the complete withdrawal from the market of any of the products referred to them. They have, however, recommended that restrictions be made on the sale of certain products, that in some cases warnings should be added to the labels on or enclosures in containers about their effects or possible effects of the products and, in other instances, that the clinical indications for their use should be amended. In every instance the recommendations were accepted and put into effect by the pharmaceutical companies concerned. The committees have also informed doctors and dentists about the possible association of adverse effects with certain products. Furthermore, in a number of instances—for which there are no precise figures—products were withdrawn from the market voluntarily by companies after informal discussions with the committee's secretariat.