“Health Canada’s secrecy must stop. Health Canada has yet to let Canadians know which drugs it quarantined, so why is the minister so opposed to increasing transparency?” Libby Davies New Democrat MP

Health Canada, criticized recently as a “feeble” watchdog, has convinced a giant Toronto-based company to quarantine suspect drug products from India.

The federal regulator has announced that Canadian generic drug maker Apotex will stop distribution to Canadian retailers of what Health Minister Rona Ambrose described as “all products” manufactured at one of Apotex’s factories in Bangalore, India.

“The quarantine will allow the department time to verify that products from this facility meet Canadian safety and quality requirements,” Health Canada said in a short release.

Health Canada has not told the public what drugs are affected by this quarantine.

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Recent stories by the Star have revealed that Health Canada had so little sway over drug companies that a previous request by the regulator to ban imports from a neighbouring Apotex facility was ignored by the company. Health Minister Ambrose recently had to explain this to Parliament, while critics lambasted her department as “feeble, inadequate and incompetent.”

The Star investigation has shown that the U.S. regulator, the Food and Drug Administration, has a stricter enforcement regime. When the FDA probed issues at another Apotex facility in Bangalore, it successfully banned import of drug products to the United States after finding that Apotex staff had manipulated data, retested samples until they got favourable results, and destroyed records.

Ambrose’s department recently said that though Apotex would not obey its request to stop sale and cease imports of drug products, the company had volunteered to retest products to make sure they were safe.

At the time, Health Canada said the products subject to retesting were: high blood pressure treatments candesartan and enalapril; the immunosuppressant mycophenolate mofetil; the antihistamine olopatadine; lansoprazole, used to treat gastroesophageal reflux disease; entecavir, an antiviral; and linezolid, an antibiotic.

It is not clear if these drugs are among those that are now quarantined. Apotex has so far not provided a list of affected products.

During question period on Thursday, New Democrat MP Libby Davies said, “Health Canada’s secrecy must stop. Health Canada has yet to let Canadians know which drugs it quarantined, so why is the minister so opposed to increasing transparency? Will she publicly disclose details to Canadians about which drugs have been quarantined and why?”

Ambrose said in response that the quarantined drugs will be barred from sale, but she did not provide a list of those drugs. “I expect that Health Canada will take any further action necessary and work with provinces and territories on any distribution of drug issues,” she said.

On Thursday evening, Health Canada told the Star it is “still assessing the information from Apotex regarding finished dose products that may be impacted.” The regulator said it will make the list of products public once it has finished its review.

This new move by Health Canada is an indication that Canada’s regulator is paying attention to results of FDA probes.

“I will not tolerate any drug safety risks for Canadians,” Ambrose said in the House of Commons on Thursday. “I asked Health Canada to act, and it did,”

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Davies, in an interview with the Star, said the regulator did not act fast enough.

“It is very disturbing about how long this had to take, and that it comes after public pressure from the Star and in question period,” she said. “The system is broken. Health Canada is not on top of drug safety.”

A Health Canada spokesperson said the regulator “immediately acted” upon learning the FDA, on Monday, barred imports from the Apotex facility in Bangalore that makes finished drug products.

A June inspection by the FDA uncovered blatant and repeat problems at the plant, including staff manipulating drug test data.

Based on the FDA’s import ban, Health Canada said it took action and will now investigate to see whether “products from this facility meet Canadian safety and quality requirements.”

Health Canada had inspected the facility in February and deemed it was in compliance.

The Health Canada release notes that drug production is a global business and it is not unusual for regulators to work in partnership, relying on each other’s inspections.

“The request to hold shipment of certain products is not a revocation of (our Good Manufacturing Practices) certification, but rather a precautionary request made as a result of the action taken by the FDA,” said an Apotex spokesperson.

“Apotex ... tests every lot of finished product supplied to the domestic market that comes from our Bangalore facility ... Apotex is absolutely confident in the safety and quality of all of our products.

“We understand the different responsibilities of each regulatory agency and we respect their precaution,” the spokesperson added. “We are committed to working with them to provide every assurance necessary to resume shipment of these products and maintain a steady supply of quality products to our customers in both markets.”

Neither the FDA nor Health Canada has issued a recall for products from the Bangalore facility that are already on store shelves in North America.

The Star’s investigation has also targeted the extreme secrecy at Health Canada. Unlike the FDA, which routinely makes its findings public online, Health Canada’s findings are largely shielded from those who use, prescribe and dispense drugs. The majority of the information the Star has obtained on Canadian pharmaceutical companies has come from FDA reports filed after the U.S. agency has performed an inspection.

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