Testing times: The regulatory environment

The single dramatic episode that led to the now familiar body of legislation regulating the manufacture and supply of medicines in the United Kingdom was the thalidomide tragedy that played out in the early 1960s. The limb deformities in children born to mothers who had taken thalidomide as a treatment to prevent morning sickness early in their pregnancy were readily reproducible in tests in rabbits. But tests in appropriate species had reportedly not been carried out before thalidomide was marketed worldwide. There were proportionately fewer cases of thalidomide-induced deformities in the USA because the drug had not been marketed there, although it had been used by women in clinical trials. The federal Food and Drug Administration (FDA) had taken a more cautious approach requiring additional evidence of safety in pregnant women.