Does Regulatory Bureaucracy Drive Disparities in Cancer Drug Access Around the World?
Disparities include bureaucratic differences and variation in health care spending.
Patient access to new cancer drugs varies dramatically around the world, recent studies show, prompting some researchers to call for better international collaboration between regulatory bodies.1,2
The U.S. Food and Drug Administration (FDA) approves new cancer drugs for patient use 6 months earlier, on average, than the European Medicines Agency—and 7.6 months earlier than Health Canada regulators.1 The longest such discrepancy in a recent study by Canadian researchers was for azacitidine, which the FDA approved 66 months before Health Canada and 55 months ahead of the European Medicines Agency.1
That might be caused more by bureaucracy than science, some experts suspect. One reason for the difference is likely to be the FDA's accelerated new drug approval process, for example.
“One of the observations in our study is that the FDA actively utilizes accelerated drug approval and priority review mechanisms for some cancer drugs,” Nardin Samuel, a coauthor of the Canadian study, told Cancer Therapy Advisor.
“This has not consistently been the case in Canada, for example, as it has been noted that Health Canada did not frequently utilize its accelerated drug approval process for putative breakthrough drugs, such as the Priority Review process instituted in 1996,” noted Samuel, who is an MD/PhD student at the University of Toronto in Toronto, Ontario, Canada.
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Canada's expedited approval process was “met with scrutiny,” she said, because it was reported to create backlogs for regulatory reviews of other new drug submissions. Also, eligibility criteria is unclear, she added. In general terms, “accelerated approval processes are a suitable mechanism for drugs that demonstrate markedly superior efficacy in clinical trials, without compromising safety,” she explained.
But the reasons for the different approval times between the FDA and other regulatory bodies is probably not due to any one “straightforward ‘cause and consequence'” factor or policy, she was quick to add.
“There are a multitude of factors contributing to these differences, starting at the very basic differences in infrastructure of federal regulatory bodies, down to differences in health care [delivery] models,” Samuel stated. “I think it is also important to understand that drug sponsors, such as pharmaceutical companies, often make initial submissions to the FDA, prior to other agencies.”
Samuel's coauthor Sunil Verma, MD, of the Sunnybrook Odette Cancer Center in Toronto, Ontario, Canada, said there needs to be international discussions between industry, regulators, and clinicians about “how best we can reduce the time to approval while ensuring safety.” He called for “a coordinated international approach to reduce the disparity in time to access new drugs around the world.”
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Disparities in access do not end with drug approvals, however. European researchers report that patients with HER2-positive breast cancer have poor access to trastuzumab in Eastern European nations compared with those living in the United States or Western Europe.2 The authors reported a correlation between national health expenditures and survival times for patients with cancer.
“The more [money] spent, the fewer patients died after a cancer diagnosis,” noted Felipe Ades Moraes, MD, of the Institut Jules Bordet in Brussels, Belgium.
- Samuel N, Verma S. Cross-comparison of cancer drug approvals among international regulatory bodies. In: Proceedings of the ESMO 2014 Congress; September 26-30, 2014; Madrid, Spain. Abstract 1036O.
- Moraes FA, Senterre C, Zardavas D, et al. Are life-saving anticancer drugs reaching all patients? Patterns and discrepancies of trastuzumab use in the European Union and USA. In: Proceedings of the ESMO 2014 Congress; September 26-30, 2014; Madrid, Spain. Abstract 1387PD_PR.