Health Canada’s drug safety procedures lacking, says study

Monday 20 April 2009, by Canadian Centre for Policy Alternatives

Health Canada’s drug safety procedures leave a lot to be desired, says a new study released by the Canadian Centre for Policy Alternatives.

Drug Safety and Health Canada: Going, Going… Gone? by Dr. Joel Lexchin says Health Canada’s priorities are skewed in favour of rapid approval of new drugs at the expense of the post-marketing pharmaco-surveillance system.

“In Canada 3-4% of drugs approved will eventually be withdrawn from the market because of safety issues and the number of people exposed to these drugs is increasing because of aggressive marketing tactics by the pharmaceutical industry,” says Dr. Lexchin.

According to the study, there are significant limitations to The Food and Drugs Act.

“Health Canada cannot force a drug company to recall drugs deemed harmful from pharmacy shelves,” says Dr. Lexchin. “Nor can they directly compel a company to revise product labels to reflect new safety information.”

In order to improve drug safety, the study makes several recommendations for Health Canada, including:

· Stop the treatment safety information as confidential and make it public available promptly after approving a new drug;

· Decrease dependence on industry for safety information by using progressive licensing and ensuring post-market studies are undertaken, analyzed, and reported on, independent of industry;

· Reorient priorities so that post-marketing pharmaco-surveillance is on equal footing with the approval of new drugs; and

· Undertake a systematic study to examine whether faster drug approvals lead to more post-marketing safety issues.

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