OTTAWA—The federal health department is taking far too long to warn Canadians about the significant risks posed by some prescription and over-the-counter drugs, the auditor general said Tuesday.
“It can take up to two years to review the safety issue and to communicate the results to Canadians,” Interim Auditor General John Wiersema told reporters in Ottawa on Tuesday. “We think that is too long.
Canadians spent about $31 billion on pharmaceutical products last year, but an audit of Health Canada tabled to the House of Commons on Tuesday shows the regulatory process meant to keep them safe is often clouded by secrecy and long delays.
The audit revealed that while Health Canada is usually quick to review submissions to approve new brand-name prescription drugs, it routinely does not meet its own standards when it comes to the amount of time it takes to review generic and over-the-counter drugs, and chemical or labelling changes to drugs already on the market.
It can take even longer for drug manufacturers — and the public — to learn of any changes because officials who work in one section of the department are not communicating that information to their colleagues in another.
The report cites the example of Topiramate (brand name Topamax), a drug prescribed for epilepsy, migraine headaches, several psychiatric conditions and to promote weight loss that was found to be associated with birth defects in August 2009.
It took six months after being notified in September 2009 for the brand-name manufacturer to update its label with the birth defects warning, but it took another 10 months for Health Canada officials responsible for generic drugs to find out about the change. As a result, auditors found that only one of a dozen generic Topiramate manufacturers had updated the product monograph by this May.
Wiersema blamed a lack of resources and a mounting workload that he hopes will be offset by new user fees that pharmaceutical companies are being charged to have their products approved by Health Canada.
New Democrat MP and health critic Libby Davies said the findings give Canadians little reason to feel confident the federal government is staying on top of the pharmaceutical industry.
Health Minister Leona Aglukkaq said during question period on Tuesday that Health Canada agreed with all 10 recommendations and has already begun making changes.
The report also criticized Health Canada for not following through on commitments to publish a list of authorized clinical trials.
The report describes how parents discovered advertisements that claimed Health Canada authorized an out-of-country clinical trial their child was taking part in were false only after filing a complaint with the department over safety concerns.
The report also noted that while Health Canada has increased the amount of information it makes public about the drugs it approves, auditors were troubled by the secrecy surrounding the review of new drugs, particularly those fast-tracked to market under a conditional approval.
Auditors also found that Health Canada is still collecting adverse reaction reports — about 30,000 domestically and 330,000 from other countries last year — via fax and courier, which is labour intensive and means officials are not analyzing them for emerging trends as closely as they should.
Russell Williams, president of the pharmaceutical industry association Canada’s Research-Based Pharmaceutical Companies (Rx&D), said manufacturers would be reviewing the recommendations to see how they could “further contribute to a stronger and more effective drug review system”.
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