Risky Acne Drug Diane-35 Underscores Health Canada’s Limitations

The agency has no power to recall bad drugs if the manufacturer won’t; Diane-35, yanked for a time in France, is still being prescribed here.

Health Canada has approved more than 10,000 prescription drugs for use across the country, but the federal health department does not have the power to recall a single one if it is found to be unsafe.

That little-known but long-standing regulatory flaw — first raised after the thalidomide tragedy of the 1960s, when more than 100 Canadian babies were born with malformed limbs — was recently highlighted again in a government-commissioned report on faulty birth control pills.

Canadian laws empower regulators to recall bad toys, tools, cleaning supplies, clothing and food, but not bad drugs. That job is left almost entirely up to manufacturers and distributors.

“People overestimate what the drug regulatory agency is doing,” said Trudo Lemmens, Chair in Health Law and Policy at the University of Toronto.

Health Canada cannot order but only “negotiate” with manufacturers for a drug recall — a process that can last months or years.

– Read the entire article at The Toronto Star.