The Drug Lag: An Interpretive Review of the Literature

Abstract

This article reviews the literature pertinent to the “drug lag” issue, in order to evaluate the evidence underlying the thesis that the U.S. has suffered from a slowdown in the rate and timing of new drug introductions, to the detriment of patients, because of the stricter requirements since 1962 regarding proof of safety and efficacy for new drugs. Comparing the post-1962 record in the U.S. with (a) the U.S. record before 1962 and (b) the post-1962 record in other, mainly Western European, countries, the weight of evidence and argument falls on the side of those who see a lag existing in the U.S. Other evidence, more subjective, supports the view that this lag imposes net positive costs on U.S. patients. However, it is not clear that the 1962 Drug Act is the sole, or even the main, cause of the lag. Instead, the drug information system and its inefficiencies emerge as the fundamental reason for the existence of a lag; hence, changes in the administration of the law by the Food and Drug Administration and greater efficiency by companies in supporting New Drug Applications can help close the gap, but probably only in minor degree. The solution to the lag problem lies in formulating and implementing a drug information system that quickly and accurately gathers, interprets, and disseminates information on the positive and negative effects of newly introduced drugs; with such a system, protection of drug users from undue risk is compatible with a greater rate and more rapid appearance of new drug discoveries.