Regulating the drugs industry transparently

Over the past 10-15 years, drug regulatory authorities in the United Kingdom and elsewhere have streamlined and accelerated the review of new drugs in response to claims by the pharmaceutical industry that over-regulation was stifling innovation.1 2 Despite these policies, the number of new molecular entities—a standard measure of innovation in the industry—submitted to regulatory authorities in the European Union or United States or launched on the world market has fallen overall during the past decade.3^–5

Between 1993 and 2004, almost double the number of drugs were withdrawn from the market in the United Kingdom each year due to lack of safety than in the previous two decades.6 The withdrawal of rofecoxib in 2004, affecting millions of patients, remains an enormous public health issue, as do public concerns about the safety of the widely prescribed selective serotonin reuptake inhibitors.7 8

In this context the House of Commons Health Select Committee began its wide ranging inquiry into the influence of …