According to the New York Times (free registration required) George Bush is seeking to block medical legal cases brought against the manufacturers of FDA approved products. This is a dangerous move as scandals such as Opren the anti-inflamatory drug and Thalidomid are extreme examples of ‘the ones that got away’ in a regulatory system that fails quite a lot of the time. Because of the nature of spending on medical treatment this will impact the most on babies, children, women and older people. According to research done by the United States General Audit Office in their report FDA Postapproval Risks 1976 – 1985 51.5 per cent of FDA approved drugs approved during this nine-year period showed serious postapproval risks that meant they had to be relabelled or withdrawn from sale. Serious postapproval risks were defined as adverse reactions that could lead to hospitalization, increases in the length of hospitalization, severe or permanent disability, or death.
This has the potential to impact on the UK and Europe as this US administration has been known to throw its weight around to steamroll through uniform trade orientated legislation to match their own standards.
The second link is a report on electronic patient record privacy in the US that raises some interesting issues including the fact that online records have brought a better definition to privacy, but that has not mean’t existing standards.