Regulatory decisions and the pharmaceutical industry.
National regulations on medicines are generally accepted as an important mechanism for ensuring that only medicines of adequate quality, safety and efficacy are available in the community. However, there are potential adverse effects of such regulations which should be kept within limits as far as possible. The recent history of non-steroidal anti-inflammatory drugs (NSAIDs) with withdrawal of 9 drugs in 6 years suggests that something is wrong with the current system and that improvements are needed. Attention is drawn to 3 key areas. Firstly, that a number of general conditions are important in the relationship between regulators and pharmaceutical companies. Secondly, the long life cycle of a medicine contains 2 phases for regulatory decisions--pre-marketing and post-marketing--but there is a discrepancy in the data, criteria and standards used in each. A new medicine is licensed on the basis of a large amount of accurate, scientific laboratory and clinical data, but, of necessity, before experience is available from general field use. Hence, research continues after marketing in respect of efficacy and safety in the new situation of ordinary field use. Usually this enables refinements to be made in methods of use and sometimes very useful new formulations or dramatic new uses of the drug are discovered. Testing for efficacy is accurate and becoming further refined by measuring the quality and duration of life provided by medicines. Suspicions of rare serious reactions are easily raised by a few anecdotal reports but are much more difficult to test, as accurate data are not available.(ABSTRACT TRUNCATED AT 250 WORDS)
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects; D004345:Drug Industry; D004739:England; D006801:Humans; D007880:Legislation, Drug; D011358:Product Surveillance, Postmarketing
D000894:Anti-Inflammatory Agents, Non-Steroidal