The US Food and Drug Administration (FDA) has withdrawn 11 prescription drugs from the market since 1997. Serious side effects and patient deaths have forced these withdrawals.
Is the FDA's drug review process breaking down? According to Sidney Wolfe, Director the Health Research Group (part of Ralph Nader's Public Citizen advocacy organisation), "Changes in FDA review and approval policies in the past several years appear to have led to a significant decline in the safety and efficacy standards for new drugs." Under congressional pressure the FDA has accelerated its review process. In 1997, the Congress passed the Food and Drug Administration Modernization Act expanding use of 'fast track' approval mechanisms for drugs to treat life-threatening conditions and allowing use of surrogate endpoints in clinical trials. It also included a number of mechanisms for accelerating FDA review and changed the legal standard for new drug approval to a single clinical trial ...
