The Case for Improved Post-Market Surveillance of Pharmaceuticals

Abstract

In Canada, as in other countries, drug approval is predominantly focused on assessing safety and efficacy at market-entry, based on pre-market clinical trials data. In this paper, we discuss how the fixation of the drug approval system on pre-market activities results in a host of serious issues including: 1) a lack of good evidence on drug safety when assessments are based solely on data produced in clinical trials; 2) a lack of comparative evidence on patient benefit between different drugs; 3) problems with lack of data about off-label prescription, which is directly associated with these two above problems; and 4) an inadequate reporting of adverse drug reactions (ADRs). In this memorandum, prepared for a presentation at an expert witness hearing of the Canadian Standing Senate Committee on Social Affairs, Science and Technology for its study of Prescription Pharmaceuticals in Canada, we argue that improving and expanding post-market surveillance is a critical to address these issues. In particular, we highlight that drug regulatory reforms should include a more explicit requirement for both comparative effectiveness studies and for post-market clinical research on the effects of drugs in real-world settings. Further, we advocate for improvements to the current ADR reporting system, as well as for improvements in the systems for collecting, storing and analyzing ADR data. Finally, the memorandum concludes with a brief discussion of Health Canada’s recent reform proposals to adopt a progressive licensing framework, which while offering important reforms such as the ability to compel drug manufacturers to conduct post-market studies, nonetheless fall short in certain respects.