Therapeutic implications of the drug lag

The American lag with respect to Britain in the introduction of new therapeutic drugs over the past decade was analyzed to determine whether, in therapeutic terms, Britain has gained or lost from adopting the more permissive policy. The therapeutic impact of a new drug on the whole community is difficult to assess, mainly because there are few methods or data available for measuring benefit. On the evidence currently available, Britain probably did not lose appreciably from the introduction of ineffective drugs, nor from the fact that a greater number of new drugs were made available. The main deleterious effect was that Britain suffered more tOXicity due to new drugs than did the United States, as could have been anticipated from the fact that mare new drugs were marketed there. However, considering the size of the total burden of drug tOXicity, the portion due to new drugs was extremely small, and would in any case be at least partially offset by the adverse effects of older alternative drugs had the latter been used instead. Conversely, Britain experienced clearly discernible gains by introducing useful new drugs, either sooner than the United States or exclusively. On balance, Britain appears to have gained in comparison from its more permissive policy toward the marketing of new drugs coupled with a more rigorous program of postmarketing surveillance. Wider issues raised by this study include the desirability of further intensifying postmarketing surveillance, particularly in the case of new drugs; the conflict between the presently conceived public health role of a regulatory agency and the desire of a physician to choose optimal therapy for particular patients; the therapeutic and social implications of the control of drug utilization as distinct from marketing; and the significance of the latter controls for the future of medicine.