The characteristics and fulfillment of conditional prescription drug approvals in Canada.
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 Approval conditions were fulfilled for 29 approvals (41%), remained outstanding for 34 (49%), had been revoked for 7 (10%).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).


CONCLUSIONS
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.
The Centre for Health Services and Policy Research, School of Population and Public Health, The University of British Columbia, Vancouver, British Columbia, Canada. Electronic address: michael.law@ubc.ca.
Michael R
MR
Law
D000970:Antineoplastic Agents / Q000627:therapeutic use; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000379:methods* / Q000706:statistics & numerical data; D033161:Government Regulation; D006801:Humans; D055553:Prescription Drugs / Q000627:therapeutic use; D018570:Risk Assessment; D013997:Time Factors
D000970:Antineoplastic Agents; D055553:Prescription Drugs
Canada; Conditional approval; Prescription drugs; Regulation