The characteristics and fulfillment of conditional prescription drug approvals in Canada

Health Policy. 2014 Jun;116(2-3):154-61. doi: 10.1016/j.healthpol.2014.03.003. Epub 2014 Mar 15.

Abstract

Background: In order to more quickly approve drugs for rare and serious conditions, many countries have developed approval pathways that require companies to fulfill conditions after marketing. This analysis assessed the use and outcomes of Canada's Notice of Compliance with Conditions (NOC/c) program.

Methods: Two publicly available databases from Health Canada were used to study the characteristics of the drugs approved using a NOC/c. Further, Kaplan-Meier analysis was used to estimate the median time-to-fulfillment for approval conditions.

Results: Seventy NOC/c approvals have been made, most commonly for cancer treatments. The conditions of the approvals were only publicly available for 24 of these approvals (34%). Approval conditions were fulfilled for 29 approvals (41%), remained outstanding for 34 (49%), had been revoked for 7 (10%). The median time to the fulfillment of conditions was about five years (1828 days; 95%CI: 1222-2325).

Discussion: Canadians have limited information on why conditional approvals are granted. As drugs are typically marketed for 5 years before conditions are met, better information should be provided to clinicians and patients so they can better understand treatment options. Further, steps to speed the fulfillment of conditions, such as time-limited approvals and the capability to levy financial penalties, should be added to the NOC/c regime.

Keywords: Canada; Conditional approval; Prescription drugs; Regulation.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antineoplastic Agents / therapeutic use
  • Drug Approval / legislation & jurisprudence
  • Drug Approval / methods*
  • Drug Approval / statistics & numerical data
  • Government Regulation
  • Humans
  • Prescription Drugs / therapeutic use
  • Risk Assessment
  • Time Factors

Substances

  • Antineoplastic Agents
  • Prescription Drugs