Interpellative sociology of pharmaceuticals: problems and challenges for innovation and regulation in the 21st century

This paper develops a framework with which to interrogate how well pharmaceutical innovation and regulation are performing to produce drugs that improve health. That framework comprises five key dimensions: therapeutic advance of drug product innovations; safety standards in drug testing; use of surrogate measures of clinical benefit; independence of regulatory agencies; and public access to regulatory science. It is concluded that: more demanding regulatory intervention is required in order to increase the proportion of drug innovation that actually offers therapeutic benefits over existing products; drug regulatory agencies need much greater independence from the pharmaceutical industry; the erosion of safety standards since 1990 needs to be reversed; accelerated approvals of drugs based on surrogate, rather than clinical endpoints, require much greater critical attention; and much more extensive public access to regulatory science is required in order for regulatory decision-making to be thoroughly accountable to the public and the wider scientific community.