The Canadian Press - ONLINE EDITION
Ottawa promises to speed up reviews to license replacement drugs in short supply
TORONTO - Health Canada is speeding up the review process needed to approve replacement medications in a bid to ease the drug shortage affecting the country, federal Health Minister Leona Aglukkaq confirmed Thursday.
"What I have committed to ... is to initiate the review of any new applications within 24 hours," Aglukkaq said by phone from Ottawa. "Having said that, we will review each application and ensure the product is safe before approving it."
Normally, it takes about six months to complete an assessment and approve a drug for use in Canada, but Aglukkaq said with the urgency of the situation, "we're looking at cutting that down to a month."
Ottawa has called on drug makers to find alternative sources from outside Canada to replace drugs in short supply — including anesthetics, painkillers, cancer drugs and antibiotics — because of production cuts at the Sandoz Canada plant in Boucherville, Que.
The generic drug maker, which provides the majority of injectable medications in Canada, began cutting back production to address concerns by the U.S. Food and Drug Administration about quality standards at the plant. A fire March 4 further curbed production.
Aglukkaq has been saying it would take a few weeks to begin processing applications — a time frame that hadn't been sitting well with provinces and territories, whose hospitals, pharmacies and patients have increasingly been feeling the fallout from the drug shortfalls.
Earlier Thursday, Manitoba Health Minister Theresa Oswald told The Canadian Press she had been in touch with Aglukkaq and had told her that a few weeks was "totally unacceptable in the current climate."
"But over the last 12 hours, we've been able to get the federal government to commit to a 24-hour review period of these licences and that's going to help Manitobans and indeed all Canadians in getting the provinces to procure more drugs from other vendors," Oswald said.
However, that doesn't mean the review will be completed within one day. What it means is that Health Canada officials have been instructed to begin the review process within 24 hours of receiving an application to approve a generic replacement medication.
"We have people on standby 24-7 to do this," said Aglukkaq.
"We're looking at within a month of getting it out to patients," she said of any drug that passes the approval process. "But we will not compromise on the issue. One thing that has to be very clear is we are not going to skip any process in ensuring that the product is safe."
So far, Health Canada has received applications to have 23 drugs made by other manufacturers, primarily companies in Europe and the United States, as substitutes for Sandoz products in short supply, said Dr. Robert Cushman, head of the department's biologic and genetic therapies directorate.
"We know we can expedite the review process, that is to make sure the manufacturing processes are the highest standard to ensure quality and safety," Cushman said from Ottawa.
"They're under review to license them to go and we think we can do that within a month ... But the catch here will be getting the production line going. The real pressure's going to be on the companies to tool up."
As well, Sandoz has identified five pharmaceutical plants outside Canada that could produce some types of medications it is not able to fully supply at this time.
"Given that it's Sandoz, given that it's core medications and given that (the companies have) met ... high international standards, it should be fine," he said. "We still have to do our due diligence, but we can do this quickly."
Cushman said there is a third means of easing the drug shortage — by approving the short-term use of medications through the Special Access Program.
Normally, the program allows doctors to apply for "special access" to certain drugs not licensed in Canada, often for patients with rare or hard-to-treat diseases.
"But clearly this is a different situation we've opened this up for," he said, explaining that the drugs typically come from high-quality plants in Europe and the U.S. and are "legitimate substitutes" for medications approved in Canada.
Cushman said Health Canada has given the green light to five special access drugs, most of them opioid painkillers, allowing them to be provided for up to six weeks at a time.
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(1 of 7 articles for this year)03/31/2015 4:01 PM 0
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