Ottawa speeding review of drug applications in light of shortages

Health Canada will be speeding up the review process for drugs to replace medicines that are in short supply because of a production slowdown at Sandoz Canada, federal Health Minister Leona Aglukkaq confirmed Thursday.

TORONTO — Health Canada will be speeding up the review process for drugs to replace medicines that are in short supply because of a production slowdown at Sandoz Canada, 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.

“Under normal circumstances, it would take approximately six months to review any application, and so with the urgency we’re experiencing, 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 plant in Boucherville, Que.

The generic drug maker, which reportedly provides about 90 per cent 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 is 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 approve 23 drugs as substitutes for Sandoz products in short supply, a spokesman said.

The medications are already approved and on the market in Europe and the United States.

As well, Sandoz has put forth separate applications for five pharmaceutical plants it has dealings with to possibly produce some types of medications it is not able to fully supply at this time.

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