Cross-comparison of cancer drug approvals at three international regulatory agencies.

N Samuel,S Verma

doi:10.3747/co.23.2803

Abstract

The primary objective of the present study was to examine the drug approval process and the time to approval (tta) for cancer drugs by 3 major international regulatory bodies-Health Canada, the U.S. Food and Drug Administration (fda), and the European Medicines Agency (ema)-and to explore differences in the drug approval processes that might contribute to any disparities. The publicly available Health Canada Drug Product Database was surveyed for all marketed antineoplastic agents approved between 1 January 2005 and 1 June 2013. For the resulting set of cancer drugs, public records of sponsor submission and approval dates by Health Canada, the fda, and the ema were obtained. Overall, the tta for the 37 antineoplastic agents that met the study criteria was significantly less for the fda than for the ema (X̄ = 6.7 months, p < 0.001) or for Health Canada (X̄ = 6.4 months, p < 0.001). The tta was not significantly different for Health Canada and the ema (X̄ = 0.65 months, p = 0.89). An analysis of the review processes demonstrated that the primary reason for the identified discrepancies in tta was the disparate use of accelerated approval mechanisms. In the present study, we systematically compared cancer drug approvals at 3 international regulatory bodies. The differences in tta reflect several important considerations in the regulatory framework of cancer drug approvals. Those findings warrant an enhanced dialogue between clinicians and government agencies to understand opportunities and challenges in the current approval processes and to work toward balancing drug safety with timely access.

Highlights

With the recent evolution of cancer therapy paradigms from pan-cytotoxic therapies toward targeted agents, treatment outcomes for cancer patients have been expected to improve
Overall, the tta for the 37 antineoplastic agents that met the study criteria was significantly less for the fda than for the ema (X = 6.7 months, p < 0.001) or for Health Canada (X = 6.4 months, p < 0.001)
In the present study, we performed the first drug-by-drug analysis of cancer drug approvals by those regulatory bodies, and we dissect the major factors contributing to international disparities in drug approval times

Summary

Introduction

With the recent evolution of cancer therapy paradigms from pan-cytotoxic therapies toward targeted agents, treatment outcomes for cancer patients have been expected to improve. Previous studies have demonstrated that differences in outcomes of approval processes by regulatory bodies result in clinically relevant disparities in drug access on an international scale[2]. The relative pace of drug approvals across the 3 main regulatory bodies—Health Canada, the U.S Food and Drug Administration (fda), and the European Medicines Agency (ema)—can be attributed to a multitude of factors, including specific priorities of the agencies and complexities in regional legislation and processes, among other considerations. The primary objective of the present study was to examine the drug approval process and the time to approval (tta) for cancer drugs by 3 major international regulatory bodies—Health Canada, the U.S Food and Drug Administration (fda), and the European Medicines Agency (ema)—and to explore differences in the drug approval processes that might contribute to any disparities

Objectives

Methods

Results

Discussion

Conclusion