• J Lexchin.
• Int J Health Serv. 1994 Jan 1;24(2):253-64.

AbstractOver the past decade the Canadian drug approval system has come under intensive scrutiny, with the greatest amount of attention being given to the length of time required to approve new drugs. This issue has obviously also been of considerable interest to the pharmaceutical industry, and the question arises as to whether or not the concerns of the industry may be driving the proposed reforms to speed up the approval process. Both industry and government maintain that quicker approval of new drugs will ensure that Canadians have more rapid access to new medications without sacrificing safety. There are problems with these claims. The number of therapeutically important new drugs introduced annually is less than five and these are already "fast tracked," so the need to speed up approval for all products is dubious. There is also evidence that safety may be compromised with faster approvals. Industry does not need quicker approval times for its financial viability, but getting new, more expensive drugs onto the market more rapidly will increase sales and profit levels. Alternative approaches to dealing with problems such as drug approval times will only be possible when the policy-making process becomes more transparent and open.

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