Thalidomide disaster

As mentioned above, significant changes in dmg regulation in Australia, Cypms and the Netherlands, were made as a result of the thalidomide disaster that occurred in Europe in 1961. This is a classic example of a crisis-led change. The disaster increased public concerns about pharmaceutical safety governments responded by imposing more stringent controls on the pharmaceutical sector, and with less resistance from the industry than would normally have been the case. 

An official product assessment and registration system for pharmaceuticals exists in each of the 10 countries. Their functions are determined by legal provisions. Systems for registration of pharmaceutical products came into operation at quite different times in the 10 countries — as early as 1942 in Tunisia and as late as 1993 in Uganda. Some of the systems have evolved in response to dmg-related crises such as the thalidomide disaster, public pressure to expand the scope of dmg assessment and the pressure from industry and consumers to expedite the registration process. 

The WHO system, created in response to the thalidomide disaster, seeks to capture worldwide adverse events and identifies problems (WHO, 1975 Olsson, 1998). It is proposed that all such gathered reports should first be analyzed for mortality effects and trends (Rose and Elnis, 2000) as such would identify the most critical trends and be easiest to evaluate. 

The thalidomide disaster in 1961 was to blow apart the complacency on regulation of drugs. The confidence in the therapeutic revolution promised by the pharmaceutical industry was... 

Scottish Standing Medical Advisory Committees, set up in the aftermath of the thalidomide disaster, made three main recommendations that ... 

The thalidomide disaster was to provide the impetus to the introduction, for the first time in most non-US countries (including those in Western Europe), of regulatory control of drugs to be marketed for clinical use. In the United Kingdom the result was the Medicines Act 1968 and the establishment of the Licensing Authority. 

This is the way the methods for the scientific study of drugs in humans, the first theme of clinical pharmacology, were developed. The thalidomide disaster of 1961 stimulated the acceptance of the need for scientific evidence of efficacy and safety of drugs before they are marketed and promoted. Requiring this evidence by government agencies before approval for marketing then followed. 

Perhaps the singular event that has had the most profound impact on the drug regulation process to date was the infamous thalidomide disaster in the... 

The second catastrophe that influenced the development of medicines regulation far more than any event in history was the thalidomide disaster. Thalidomide was a sedative and hypnotic that first went on sale in Western Germany in 1956. Between 1958 and 1960 it was introduced in 46 different countries worldwide resulting in an estimated 10,000 babies being born with phocomelia and other... 

Drug adverse events will always remain part of modern medicine and the potential for another thalidomide disaster cannot be totally dismissed. The prevention of a future disaster lies, not in simply increasing the number of regulatory hurdles but in the ability to communicate and control unexpected events and where necessary make rapid withdrawal from the market. 

Formal testing guidelines were established after thalidomide disaster. In 1966 guidelines were established by the FDA Guidelines for Reproduction Studies for Safety Evaluation... 

Before the disaster in Europe and Canada, thalidomide had been submitted to the FDA for approval in the United States. The FDA did not consider the safety tests of Chemie Griinenthal to be adequate and withheld approval of thalidomide. The United States was therefore spared the thalidomide disaster. Withholding approval for thalidomide is considered to be one of the triumphs of the FDA in protecting public safety.1... 

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 aU aspects of drug introduction, therapeutic claims and supply. Those governments that already had some control system strengthened it. 

---