Patently Innovative

3

Empirical analysis of drug approval*

Abstract:

Canada’s proposed new drug regime, termed the ‘Progressive Licensing Framework’ (PLF), has received considerable attention over the last number of years. PFL is an example of ‘real-world’ or ‘lifecycle’-based models of drug development. On the one hand, its critics claim that ‘flexible departure,’ or expedited approval prior to completion of traditional Phase 3 clinical trials, may lead to a lower standard for drug approval and an increase in unsafe products on the market. Supporters, on the other hand, claim that more emphasis on post-market safety will effectively recalibrate the risks, benefits, and uncertainties of therapeutic product development. Here we develop a novel empirical method ...