Posted At National Post
BY : Tom Blackwell
Health Canada is looking at the idea of conducting joint reviews of new drugs with the American government, an idea long promoted by the pharmaceutical industry as a way to get their products on the market more quickly.
Officials stressed plans are in the early stages. But hooking up with the U.S. Food and Drug Administration (FDA) could result in new medications reaching the Canadian market an average of almost a year earlier than is the case now.
Manufacturers submit their applications for approval sooner in the much larger U.S. market and the American regulator reviews those requests in about half the time it takes Health Canada.
The first stage could be pilot projects involving "parallel" reviews by the Canadian agency and the FDA, Health Canada officials indicated at a recent meeting with the brand-name drug-industry association.
The goal initially would be just to share information and views, focusing collective brain-power on the process instead of performing the same task completely independently, said Jirina Vlk, a Health Canada spokeswoman.
"Four heads are better than two ... You're exploring the possibility of real-time dialogue with the FDA," she said.
"It is broadening the expertise, the perspective on product reviews," Ms. Vlk said. That proposed parallel process "could ultimately result in joint review," she said.
Joint reviews would involve the two jurisdictions actually dividing up the workload, producing a common factual report, then making their own decisions about approving or rejecting the drug.
One drug-safety watchdog cautioned that Canada could lose some of its regulatory independence with such a move, but pharmaceutical industry representatives were heartened by the prospect of more Canada-U.S. cooperation.
"Unless Health Canada can show that an independent review process is essential to the health and safety of Canadians ... why not piggyback?" asked Jonathan Goodman, a spokesman for Canada's Research-based Pharmaceutical Companies (Rx&D), the brand-name-drug makers' association.
"Why should Canadians have to wait a year longer for the latest breakthrough in the treatment of cancer, or asthma or whatever condition? It's just not right."
A parallel review pilot project is already in the works with Australian drug regulators.
On average, it takes 640 days to approve a new drug in Canada, compared with 350 days in the United States, where the FDA has 10 times the resources, according to Rx&D.
Ms. Vlk suggested that joint reviews would not necessarily speed up the process here, and said Health Canada's main interest is to improve the quality of the process by tapping into foreign expertise.
At a Dec. 12 meeting with Rx&D, department officials raised the possibility of parallel review pilot projects with the FDA, minutes of the session indicate.
Officials said actual joint drug-approval projects would require a commitment from both agencies, evidence of compatibility between their approval systems and support from industry, the minutes reported.
FDA officials were not available to comment yesterday.
The European Union member countries now approve most pharmaceutical products jointly through the European Medicines Agency. Australia and New Zealand are also working on a joint program.
An alliance between Health Canada and the FDA could have some benefit if it brought useful new drugs to the market sooner, said Dr. Joel Lexchin, an emergency physician and associate professor at York University's School of Health Policy and Management.
But he warned of possible pitfalls, including coming under the influence of the kind of politics that seemed to affect the FDA's handling of the morning-after contraceptive pill. While agency scientists recommended the pill be available over the counter, the organization, which is controlled by the Bush administration, ruled women would need a prescription.
The FDA is so much larger that there is also the risk that Health Canada's influence in the process could diminish greatly, Dr. Lexchin said.
