''Feeble’ Health Canada can't block dodgy drug imports
Ottawa admits it failed to prevent drug giant Apotex from importing potentially unsafe ingredients from manufacturer in India — products that were banned in the U.S.
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Canadian drug regulator Health Canada failed to stop pharmaceutical giant Apotex from importing suspect drug ingredients from one of its troubled manufacturing plants in India.
Instead, the potentially unsafe products were allowed into the country to be used in the making of generic blood pressure medications, antihistamines and other drugs for Canadian consumption.
It’s the latest example in an ongoing Star investigation that has found Health Canada so lax that it has allowed drugs and pharmaceutical ingredients into the country that are banned from the United States because the adulterated medications are potentially unsafe.
The drug ingredients in question in this most recent case came from an Apotex facility in Bangalore, India. In April, the U.S. drug regulator barred the importation of all but one product from the plant after its inspectors found Apotex staff had manipulated data, retested samples until they got favourable results and destroyed records. Apotex is a Canadian company headquartered in Toronto.
Health Canada, which mainly relies on other regulators to physically inspect foreign drug manufacturing facilities, was seriously concerned by the U.S. inspectors’ findings. Canadian Health Minister Rona Ambrose said her staff tried to take action.
“Whenever there is a dangerous product identified, Health Canada inspectors act immediately. In the case of a drug produced by Apotex, Health Canada inspectors asked the company to remove it from the shelf and it refused,” Ambrose said in question period this week in response to questions spurred by a recent Star investigation.
In fact, the Canadian government, unable to force the company to recall the drug, twice asked Apotex to “stop sale and cease imports” from the Bangalore facility, Health Canada spokesman Gary Holub said in response to further questions from the Star.
But the government quickly softened its stance. Apotex agreed to do additional quality testing on products from the Bangalore facility, and has given the regulator updates of its efforts to fix problems at the beleaguered plant.
“Although Apotex refused Health Canada’s initial request, it was determined that a more productive course would be to work with the company to quickly determine steps to ensure the safety of its products, over engaging in lengthy court proceedings with no immediate mitigation measures,” Holub said in an email.
Amir Attaran, a University of Ottawa law professor who researches drug policy, called Health Canada’s response “feeble, inadequate and incompetent.”
Around the same time that Apotex rebuffed the regulator’s requests, Health Canada publicly said the products could be imported to Canada because of their “medically necessary nature.”
For two months, Health Canada would not say what drugs available in Canada are made using the questionable chemical ingredients from India that are the subject of this story.
On Thursday, the regulator revealed information about the drugs, saying that Apotex has done additional safety tests on seven of its products: 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.
According to law professor Attaran, Health Canada has said there are “drugs on the market that they want removed and the company refused, and Health Canada is doing nothing about it.” He questioned why the federal agency did not disclose the names of the drugs “when they were in our pharmacies and hospitals, so we could avoid them.
“This proves Health Canada is on the side of drug companies and not Canadians,” Attaran said.
Apotex spokesman Elie Betito said the company has “updated compliance policies and procedures already in place to ensure all of our products remain safe, effective and of the highest quality.”
In August, Health Canada inspectors visited the company’s active ingredient facility in Bangalore. The regulator said the report is still being finalized, adding it has no evidence that “final drug products had been compromised.”
On Wednesday, just days after the Star revealed Canada was allowing in drug products that the U.S. found unfit for its citizens, Health Canada asked another India-based drug manufacturer, Ipca Laboratories, to voluntarily stop shipping about 21 of its pharmaceutical ingredients to Canada. A recent U.S. inspection found the company falsified and manipulated data. The company had already stopped shipping certain products to the U.S.
Health Canada also asked Canadian companies importing the ingredients to temporarily quarantine the products.
A recent Star investigation revealed widespread problems in this country’s drug manufacturing facilities, including Canadian pharmaceutical companies selling drugs with knowledge that their products were defective.
Ambrose said these problems will end if the government’s proposed new drug safety legislation, Vanessa’s Law, passes.
“It will require tough new fines for companies that are putting Canadians at risk. Most importantly, it will give me the authority to recall unsafe drugs when I need to,” Ambrose told the House of Commons on Tuesday.
But Ambrose does not have to wait for the new law to act on Apotex, Attaran said. The current regulations allow the health minister to immediately suspend a drug company’s licence “if it is necessary to do so to prevent injury to the health of the consumer.”
“She can shut down entire facilities belonging to Apotex where it endangers public safety,” said Attaran. “It’s a very big stick the minister has, and clearly she’s not using it.”
Health Canada’s Holub said the regulator considered “all factors” and said, “had there been immediate concern of harm to Canadians,” the government would have considered suspending the firm’s licence.
A Star investigation published last week found egregious conditions at Canadian drug plants — including ones owned by Apotex — using inspection records provided not by Health Canada but by the U.S. Food and Drug Administration (FDA), which also inspects Canadian facilities and drug trials.
Health Canada, which conducts similar inspections, leaves Canadians in the dark by keeping secret the details of problems its inspectors find. The lack of transparency drew condemnation from both the political and medical communities.
New Democrat health critic Libby Davies criticized Health Canada for having a “culture of secrecy.”
Sen. Art Eggleton, who was deputy chair of a Senate committee that recently looked into Canada’s drug regulation, said “you learn from the FDA more than you do from (Health Canada). This is not acceptable.”
Since 2008, the FDA has conducted at least 110 inspections of Canadian facilities or foreign factories owned by Canadian firms that have resulted in objectionable findings.
The Star found details of the inspections because the FDA makes inspection dates and results available to the public on its website. The U.S. regulator has posted online dozens of warning letters to Canadian companies, many of which detail egregious conditions in drug manufacturing facilities.
Meanwhile, Health Canada does not tell the public the number of times it has inspected a facility. It has posted its inspection findings of just one Canadian manufacturer, and that came only after a Star article exposed that Health Canada was keeping the records secret despite a public FDA warning letter detailing problems at the same facility.
Ambrose said the government will post more of its inspection findings online “so they are made public and available.” Health Canada did not provide a timeline for when this will happen.
Dr. Joel Lexchin, a drug safety expert at York University, said the regulator is notoriously slow in posting important safety information it promises to make accessible. With respect to the drug facility inspection reports, the records should already be available for Canadian consumers, he said.
“The expectation is that it should be made available and the fact it’s not speaks to an ongoing attitude about the relationship between Health Canada, the pharmaceutical industry and the public,” Lexchin said.