Saturday, February 09, 2008

New drug rules pose grave risks: critics

From the Globe and Mail:
The federal government is about to overhaul the way drugs are regulated in Canada to give consumers faster access to breakthrough treatments, but some medical experts and political critics are worried the changes will turn Canadians into guinea pigs for new drugs that haven't been adequately tested.

A new regulatory system, outlined in a broad package of changes to consumer product and food regulations announced last December, would allow certain drugs to be quickly approved for sale without the safety evidence that is normally required.

The changes are designed to update Canada's aging drug regulation system to allow faster access to new blockbuster pharmaceuticals and let health officials evaluate potential risks throughout a drug's lifespan, instead of focusing on safety mainly before they're approved.

But without massive changes in the way health officials monitor drugs once they hit the market, the new system could pose serious risks to consumers, said David Juurlink, clinical pharmacologist and drug safety researcher at Toronto's Sunnybrook Health Sciences Centre. ...more

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