Misplaced trust? Gaping flaws in drug approval and licensing

摘要

When a medical practitioner writes a prescription, he or she takes it on faith that the substance he or she is prescribing is safe (within the bounds of disclosed potential adverse effects) and efficacious by virtue of its having been rigorously tested, approved and registered by a statutory regulatory agency such as the Medicines Control Council (MCC) in South Africa, the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, or the Food and Drug Administration (FDA) in the USA. The FDA mandate as stated on its website echoes that of other regulatory agencies, namely to be responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products ... [and] medical devices'.