Drug approval times

CMAJ 2000;162(13):1803-4

Canada takes the same amount of time to approve new drugs as Australia, a country with roughly the same level of resources in terms of population size and level of development. It is true that Sweden, a country with roughly 25% of Canada's population, approves new drugs more rapidly, but some of the drugs on the Swedish market have been approved through the centralized European procedure, which could have skewed the figures.

There are 2 additional questions that Rawson did not consider: Is safety compromised by quicker approvals? How important are new drugs to the health of Canadians?

A study of postapproval risks for drugs approved by the FDA between 1976 and 1985 found that 102 of the 198 drugs for which data were available had serious postapproval risks that could lead to hospitalization, increases in the length of hospitalization, severe or permanent disability, or death. Among drugs approved in fewer than 4 years, those that had serious postapproval risks had generally been approved in a shorter time than those without such risks.² In a 1998 survey, 12 FDA reviewers identified 25 new drugs in the previous 3 years that they felt had been approved too quickly.³

The Patented Medicine Prices Review Board categorizes new drugs according to their expected therapeutic benefit. Between 1994 and 1998, 408 patented medicines were introduced into Canada. Discounting the 171 that were not new chemical entities, only 24 of 237 or just over 10% were classified as "breakthrough" drugs or major therapeutic advances.⁴ Between April 1996 and 1998, the British Columbia Therapeutics Initiative assessed 60 new drugs for the BC Ministry of Health. For 46 of the drugs (77%), it found no evidence of a therapeutic advantage over existing therapies.^5,6

Rawson states, "Physicians want to be able to prescribe the most effective drugs for their patients, and patients want access to these drugs to get well quickly."¹ The implication is that more rapid drug approvals will lead to better health. New drugs do not need to show any advantage over existing therapies to be approved; they merely have to be better than placebo. Until the new drugs that the industry produces represent better value and until we are sure that approving new drugs more rapidly does not compromise safety, we are better off putting our limited resources into other areas such as improving Canada's woefully inadequate postmarketing evaluation system.

Joel Lexchin
Emergency physician
University Health Network
Toronto, Ont.
Barbara Mintzes
Department of Health Care & Epidemiology
University of British Columbia
Vancouver, BC

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1. Rawson NSB. Time required for approval of new drugs in Canada, Australia, Sweden, the United Kingdom and the United States in 1996–1998. CMAJ 2000;162(4):501-4.
2. United States General Accounting Office. FDA drug review: post-approval risks 1976–85 (GAO/PEMD-90-15). Washington: GAO; 1990.
3. Lurie P, Wolfe SM. FDA medical officers report lower standards permit dangerous drug approvals. Washington (DC): Public Citizen's Health Research Group; 1998 Dec 2. Report no.: 1466. Available: www.citizen.org/hrg/publications/fdasurvey/fdasurvey.htm (accessed 2000 Apr 14).
4. Patented Medicine Prices Review Board. Eleventh annual report: year ending December 31, 1998. Ottawa: The Board; 1999.
5. Therapeutics Initiative. Annual report 1996/1997. Vancouver: University of British Columbia; 1998.
6. Therapeutics Initiative. Annual report 1997/1998. Vancouver: University of British Columbia; 1999.

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