TORONTO, Aug. 14, 2013 /CNW/ - Faster drug approvals are not linked to increases in the number of serious drug safety warnings issued by regulators, nor to actual evidence of health risks according to new research published in Canadian Health Policy, the online journal of the Canadian Health Policy Institute.
Dr. Nigel Rawson (Ph.D.) compared data about the number of drug safety warnings issued by regulators in Canada and the United States to the number of actual discontinuations of new drugs due to safety concerns. In total, the analysis included 454 new therapeutic drugs approved in both Canada and the United States over a 20-year period (1992 to 2011).
Rawson found that between 1992 and 2011, new drug approval times in Canada and the USA were becoming more similar overall, but Canadian regulators took longer to approve new cancer drugs compared to American regulators.
Despite finding that new drug approval times in Canada were similar to or longer than in the United States, Rawson also found that the probability of a new drug acquiring a serious safety warning from regulators or being discontinued for a safety reason in the 10 years after approval was higher in Canada (41.6%) than in the United States (30.7%).
The data indicate that relative to Canada, faster approval times in the USA were not linked to an increase in the issuance of regulatory safety warnings.
Rawson also looked at new drug discontinuations separately and found that, despite the increased issuance of safety warnings by regulators in both countries over the period from 2002 to 2011, the rate of discontinuation of new drugs from the market was somewhat smaller than in the period from 1992 to 2001. Further, while Canada had only half the number of priority status (i.e. expedited approvals) drugs as the United States, the rates of discontinuation were the same in each country. In addition, rates of discontinuation were lower within both countries for priority drugs than for standard products - the opposite of what would be expected if faster approvals led to more dangerous drugs being approved.
Rawson's research strongly suggests that changes in the regulatory behaviour of drug approval agencies offers a better explanation for the increased issuance of serious warnings than does an alleged increase in the approval of more dangerous drugs. According to Rawson, "only an assessment of actual health outcomes experience will allow us to judge whether Health Canada's apparent higher rate, relative to the FDA, of issuing serious drug safety warnings is appropriate or indicative of a higher sensitivity threshold for regulatory caution."
The article, Does the increase in safety warnings from regulators actually mean that more dangerous drugs are being approved?, is available for free download from Canadian Health Policy, the online journal of the Canadian Health Policy Institute (CHPI) and can be accessed at the following web link: www.canadianhealthpolicy.com.
About CHPI
Canadian Health Policy Institute (CHPI) is a non-profit think-tank funded by independent research grants and unrestricted operating grants from public sector, private sector and non-profit sector sources. CHPI is dedicated to conducting, publishing and communicating evidence-based socio-economic research on health system performance and health policy issues that are important to Canadians.
Image with caption: "No link between faster drug approvals, regulatory safety warnings and drug withdrawals in Canada and the USA. (CNW Group/Canadian Health Policy Institute)". Image available at: http://photos.newswire.ca/images/download/20130814_C5608_PHOTO_EN_29801.jpg
SOURCE: Canadian Health Policy Institute
Share this article