The Promise and Peril of Adapting the Regulatory System to the Pharmacogenomic Context

Abstract

Pharmacogenomics – the study of the influence that genetic factors have on drug response – presents significant regulatory challenges. Pharmacogenomics products require the approval of both a pharmaceutical drug and a companion diagnostic, a situation which is further complicated by the fact that authority to regulate these two different types of products is fragmented between different levels of government, different provinces, and even different agencies within the same level of government. Although Health Canada reports that they are ramping up efforts to determine the most appropriate means of incorporating pharmacogenomics information into drug evaluation and regulatory decision-making throughout the stages of drug development, Canada continues to lag behind other jurisdictions in adopting substantial reforms. This is in marked contrast to the significant efforts made by the Food and Drug Administration in the US, which has taken a leadership role in proposing new draft guidance on reforms to improve the evaluation and regulation of pharmacogenomic products – documents that provide useful insight into how Canada may more effectively adapt existing regulatory practices to the pharmacogenomic context. Informed both by the literature and by interviews with key Canadian stakeholders, we explore how pharmacogenomic drugs and tests are evaluated and approved within the current Canadian regulatory system and what reforms may be necessary to more effectively evaluate and regulate these emerging health technologies. We begin by looking at, first, the split regulation of companion diagnostics by federal and provincial authorities and, second, how pharmacogenomic products are currently integrated into the drug regulatory system at the federal level. Subsequently, we consider possible reform efforts to better coordinate the review of drug and test components, to offer more flexible approaches to market authorization and to expand regulatory oversight during the post market phase. Our discussion focuses on the Canadian regulatory system, but our recommendation and discussion are also relevant for other jurisdictions in which pharmacogenomic products are being evaluated.