:TORONTO — Health Canada’s approach to drug regulation puts too much emphasis on speeding up drug approvals and too little on following the safety profile of drugs once they hit the market, according to a new report that criticizes drug regulation in Canada. Published by the Canadian Centre for Policy Alternatives, the report also suggests the law governing drug licensing offers too few tools to the regulatory agency. As a result, it said, Health Canada cannot compel a manufacturer to undertake additional safety studies after a drug has been approved or demand that it alter safety labels on a product. “I think that there are a lot of well-meaning people within Health Canada who are trying to do a good job. But I think that at the political level, there is not the will to directly confront the drug companies by making changes that would really make a difference,” Dr. Joel Lexchin, author of the report and a long-time critic of the pharmaceutical industry, said in an interview. The report — entitled “Drug Safety and Health Canada: Going, Going … Gone?” — suggests the public’s health may be put at risk by a policy aimed at speeding up drug approvals. It also said Health Canada has no way of gauging whether safety concerns it raises — through so-called “Dear Doctor” letters or in statements to the public — have the desired effect. Lexchin, who has long advocated for more openness in the sphere of drug regulation, criticized the department for treating too much of the data submitted by drug companies as proprietary information. “Within the Canadian drug regulatory system, democratic values such as openness, safety and objective information have been ignored as Health Canada consciously opts instead for a drug regulatory system that reflects the interests of private industry,” wrote Lexchin, who teaches in the school of health policy and management at York University in Toronto. Senior Health Canada officials acknowledged some of the shortcomings Lexchin highlighted in his piece, but strongly rebutted a number of others. Dr. Supriya Sharma, director general of the therapeutic products directorate, said she took offence to the implication in Lexchin’s article that “for whatever reason we would lower standards in favour of a drug company.” “Really from the Health Canada perspective, with the companies we have a regulator-regulatee relationship,” she said from Ottawa. “Our role is health protection first and foremost. And what we’re doing is to make sure that we do the reviews of the products to the best of our abilities for safety and efficacy and quality to make sure that when we’re looking at both the risks and the benefits of the products, that the benefits are outweighing the risks.” Sharma also refuted a suggestion in the report that her division’s funding levels are affected if drug applications aren’t processed within an established timeframe. There are performance targets for how quickly drug companies should receive decisions on drug applications, but the division’s budget is not reduced if they are not met, Sharma said. Nor does the fact that there are targets mean that a new drug is more likely to be approved, she insisted. “I think the implication seems to be that we’re rushing to a positive decision because we need to make a decision.” Dr. Marc Berthiaume, director of the marketed pharmaceutical and medical devices bureau, said Lexchin’s figures are out of date when he suggested resources devoted to drug approvals vastly outweigh those directed towards monitoring the safety of drugs once they hit the market. Staffing levels and resources devoted to post-approval safety monitoring have been tripled over the past couple of years, Berthiaume said. Sharma, Berthiaume and David Lee, director of the office of legislative and regulatory modernization, did agree that the 50-year-old Food and Drug Act doesn’t currently offer enough options when safety concerns arise. The act was to have been updated but the legislation, Bill C51, did not make it through Parliament before last fall’s election was called. The Health Canada officials acknowledged it would be useful to have the authority to compel a drug’s maker to change safety labelling. If a manufacturer resists making requested changes, the option is to cancel the drug’s marketing approval. That’s too blunt a tool for most scenarios, Berthiaume suggested. “It’s a big hammer,” said Berthiaume. “And from just a health perspective, it’s not a tool that has only good sides.” Lee’s group has been studying what regulators elsewhere are doing on these issues in the hopes of finding interim steps worth adopting. “We’ve been looking at the old 50-year-old rules and trying to bring the new thinking up to what we practise right now but don’t have the legal weight (to enforce),” he said. “I think we agree that they’re limited,” Sharma said of the existing tools, “and we would like to modernize that.”
