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How Safe and Innovative Are First-in-Class Drugs Approved by Health Canada: A Cohort Study.
Healthc Policy. 2016 11; 12(2):65-75.HP

Abstract

INTRODUCTION

First-in-class drugs use a unique mechanism of action. This study assessed the therapeutic innovativeness and safety of these drugs approved by Health Canada from 1997-2012.

METHODS

A list of new drugs was compiled and a database from the Food and Drug Administration was used to determine first-in-class status. Post-market safety warnings and drugs withdrawn for safety reasons were identified from the MedEffect Canada website. Therapeutic innovation evaluations came from the Patented Medicine Prices Review Board (PMPRB) and Prescrire International. The proportion of first-in-class drugs that were innovative was compared to the proportion of non-first-in-class drugs that were innovative. Kaplan-Meier survival curves assessed safety.

RESULTS

In all, 462 drugs were approved by Health Canada during the period under study. Among these, 345 were evaluated by PMPRB and/or Prescrire, and first-in-class data were available for 292. Ninety-eight of the 292 were first-in-class and 16 were innovative compared to 9 of 194 drugs that were not-first-in-class. There was no difference in safety between the two groups.

DISCUSSION

Overall, the benefit-to-harm ratio of first-in-class drugs, as measured by post-market safety warnings/withdrawals, is better than those that were not-first-in-class.

Authors+Show Affiliations

Professor Emeritus, School of Health Policy and Management, York University, Emergency Physician, University Health Network, Associate Professor, Department of Family and Community Medicine, University of Toronto, Toronto, ON.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

28032825

Citation

Lexchin, Joel. "How Safe and Innovative Are First-in-Class Drugs Approved By Health Canada: a Cohort Study." Healthcare Policy = Politiques De Sante, vol. 12, no. 2, 2016, pp. 65-75.
Lexchin J. How Safe and Innovative Are First-in-Class Drugs Approved by Health Canada: A Cohort Study. Healthc Policy. 2016;12(2):65-75.
Lexchin, J. (2016). How Safe and Innovative Are First-in-Class Drugs Approved by Health Canada: A Cohort Study. Healthcare Policy = Politiques De Sante, 12(2), 65-75.
Lexchin J. How Safe and Innovative Are First-in-Class Drugs Approved By Health Canada: a Cohort Study. Healthc Policy. 2016;12(2):65-75. PubMed PMID: 28032825.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - How Safe and Innovative Are First-in-Class Drugs Approved by Health Canada: A Cohort Study. A1 - Lexchin,Joel, PY - 2016/12/30/entrez PY - 2016/12/30/pubmed PY - 2017/12/13/medline SP - 65 EP - 75 JF - Healthcare policy = Politiques de sante JO - Healthc Policy VL - 12 IS - 2 N2 - INTRODUCTION: First-in-class drugs use a unique mechanism of action. This study assessed the therapeutic innovativeness and safety of these drugs approved by Health Canada from 1997-2012. METHODS: A list of new drugs was compiled and a database from the Food and Drug Administration was used to determine first-in-class status. Post-market safety warnings and drugs withdrawn for safety reasons were identified from the MedEffect Canada website. Therapeutic innovation evaluations came from the Patented Medicine Prices Review Board (PMPRB) and Prescrire International. The proportion of first-in-class drugs that were innovative was compared to the proportion of non-first-in-class drugs that were innovative. Kaplan-Meier survival curves assessed safety. RESULTS: In all, 462 drugs were approved by Health Canada during the period under study. Among these, 345 were evaluated by PMPRB and/or Prescrire, and first-in-class data were available for 292. Ninety-eight of the 292 were first-in-class and 16 were innovative compared to 9 of 194 drugs that were not-first-in-class. There was no difference in safety between the two groups. DISCUSSION: Overall, the benefit-to-harm ratio of first-in-class drugs, as measured by post-market safety warnings/withdrawals, is better than those that were not-first-in-class. SN - 1715-6572 UR - https://www.unboundmedicine.com/medline/citation/28032825/How_Safe_and_Innovative_Are_First_in_Class_Drugs_Approved_by_Health_Canada:_A_Cohort_Study_ L2 - http://www.longwoods.com/content/24851 DB - PRIME DP - Unbound Medicine ER -