Regulatory Tightness

All countries have organisations to vet the introduction of new drugs. These vary in size from ‘full blown’ departments of state employing many hundreds of people, to ad hoc committees of experts who meet occasionally, as and when there are decisions to be made. The function of such organisations is a mixture of protection and encouragement. The protective role centres around the avoidance of bad drugs. The vetting process is perceived as a screen to filter out Pharmaceuticals that will be harmful to the public. The encouragement role is concerned with the generation of knowledge and the diffusion process. Thus a regulatory agency will be anxious to stimulate the search for new therapies, to improve testing procedures, and to ensure via a scanning of treatments available worldwide, that their own nation’s spectrum of medicines will be as comprehensive as possible. In recent years the protective role has tended to become paramount. A number of catastrophies have occurred; thalidamyde being perhaps the most well known. These have led to an acceptance by regulatory authorities that their major purpose is protective. The sharing in the innovation process implied by the encouragement role has been pressured into the background. This is unfortunate because where a defensive attitude predominates, applicant companies and regulatory authorities assume an adversary stance. The product is almost inevitably a greater degree of formality in procedures, mistrust and longer delays in appraising drugs. The most dramatic example of such a change is perhaps to be observed in the American Food & Drug Administration (FDA) post 1962. Following the Kefauver-Harris Amendments to the Food Drug & Cosmetic Act, a much more cautious attitude resulted. Increased bureaucracy, more onerous testing procedures and a lengthening time to achieve registration were the most obvious outcomes. So marked was the change that the term ‘drug lag’ has been coined to describe the effects.1