§ Mrs. Sally Oppenheimasked the Secretary of State for Social Services whether he has now received the advice of the Committee on Safety of Drugs about the list of products published by the United States Food and Drug Administration in November, 1970 in respect of which that Administration announced its intention to withdraw approval ; and if he will make a statement.
§ Sir K. JosephYes. The terms of its advice, which I accept, follow. This does not cover the cosmetic and toilet preparations in the list but I am advised that no health hazard could arise from the use of these. No further action by me seems called for.
The Committee on Safety of Drugs has considered the list of 369 drugs notified by the Food and Drug Administration of the United States of America in November, 1970 as being subject to withdrawal on the grounds that they 'lack substantial evidence of effectiveness or that an unfavourable benefit to risk ratio exists'.The Committee noted that the list contains a small number of cosmetic and toilet preparations which do not come within its terms of reference.A large number of the remaining products are not marketed in the United Kingdom. The Committee has, however, been able to identify 90 products which are known to be available here and which are identical with or very similar to products in the F.D.A. list.In many cases, the F.D.A. withdrawal notices were issued because there was not considered to be substantial evidence that the products were effective for the purposes for which they are marketed in the U.S.A. In other cases, certain combinations of drugs were regarded as 'ineffective as fixed combinations', irrespective of the merits of the individual components.The Committee on Safety of Drugs, in accordance with its terms of reference, considers the efficacy of drugs only in relation to their safety and it has considered the F.D.A. list in this light.Very few drugs are entirely without some toxicity, and for this reason the Committee has always stressed the need for doctors to report serious or unforeseen reactions which are suspected to be caused by the use of particular drugs. Since 1964 the Committee has collected and assessed reports of adverse reactions to medicines on the market in the 153W United Kingdom and has received similar information from other drug control authorities.On the evidence available to it about the products which are included in the list and are on sale in this country, the Committee has concluded that those products on sale directly to the public do not present any hazards sufficiently serious to justify their withdrawal from the market, and that those which are available only on prescription present no special hazards not already well documented and known to the medical and pharmaceutical professions.Any product to be brought on to the market in future will of course need clearance by the Committee, on or after the first Appointed Day, to fulfil licensing requirements.