Historical Background

The beginning of substantial government intervention in the field of medicines paralleled the prolifer-

2 It is obviously impossible to list substances that will be regulated if anybody should choose one day to synthesise them. Therefore regulation is based on the supply of 'medicinal products', i.e. substances are regulated according to their proposed use; and they must be defined in a way that will resist legal challenge (hence the stilted regulatory language). The following terms have gained informal acceptance for 'borderline substances' (which may or may not be regulated): nutriceuticah a food or part of a food that provides medicinal benefits cosmeceutical: a cosmetic that also has medicinal use.

3 However much doctors may mock the bureaucratic 'regulatory mind', regulation provides an important service and it is expedient that doctors should have some insight into its working and some of the very real problems faced by public servants who are trying to do good without risking losing their jobs.

ation of synthetic drugs in the early 20th century when the traditional and familiar pharmacopoeia4 expanded slowly and then, in mid-century, with enormous rapidity.

The first comprehensive regulatory law that required premarketing testing was passed in the USA in 1938, following the death of about 107 people due to the use of diethylene glycol (a constituent of antifreezes) as a solvent for a stable liquid formulation of sulphanilamide for treating common infections5. It was convenient for children to take; the toxicity (CNS, renal, hepatic) of ethylene glycol was already known. The only premarketing 'tests' were for appearance, fragrance and flavour. The procedure was compatible with the then-existing law in the USA. The head of the company said he was sorry for the deaths but he felt no responsibility.

Other countries did not take on board the lesson provided by the USA and it took the thalidomide disaster of 1961 (Chapter 5, Appendix) to make governments all over the world initiate comprehensive control over all aspects of drug introduction, therapeutic claims and supply. Those governments that already had some control system strengthened it.

In the UK two direct consequences were the development of a spontaneous adverse drug reaction reporting scheme (the Yellow Card system) and legislation to provide regulatory control on the safety, quality and efficacy of medicines through the systems of standards, authorisation, pharmcovigilance (see p. 69) and inspection (Medicines Act 1968). A further landmark was the establishment of the Committee on Safety of Medicines in 1971 to advise the Licensing Authority in the UK. Despite these protective systems, other drug disasters occurred. In 1974 the (J-blocking agent practolol was withdrawn because of a rare but severe syndrome affecting the eyes and other mucocutaneous regions in the body (not

4 Pharmacopoeia: a book (often official) listing drugs, their uses, standards of purity, etc.

5 Report of the Secretary of Agriculture submitted in response to resolutions in the House of Representatives and Senate (USA). 1937 Journal of the American Medical Association 111: 583, 919. Recommended reading. A similar episode occurred as recently as 1990-1992: See Hanif M et al 1995 Fatal renal failure caused by diethylene glycol in paracetamol elixir: the Banglandesh epidemic. British Medical Journal 311: 88. Note: diethylene glycol is cheap.

detected by animal tests), and in 1982 benoxaprofen, a nonsteroidal anti-inflammatory drug, was found to cause serious adverse effects including onycholysis and photosensitivity in elderly patients. In 1995, the new European regulatory system was introduced (below).

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