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A southern Ontario city is calling on the federal Health Minister to intervene in her department's decision to suspend the licence of one of only two companies in Canada that sells a commonly used chemotherapy drug.
St. Catharines city council passed a motion on Monday night asking Rona Ambrose to ensure the "long-term viability" of Biolyse Pharma Corp., a generic drug maker Ottawa temporarily shut down on April 11, citing concerns about manufacturing, testing and documentation at the company's plant.
The regulatory agency also barred the company from shipping out finished batches of the only drug it produces, an injectable chemotherapy medication called paclitaxel that is used primarily to treat breast, lung and gynecological cancers.
Biolyse, which has threatened legal action against Health Canada, is warning that the suspension could force it to fold, which it says would imperil the supply of paclitaxel in this country.
The United States is experiencing a shortage of paclitaxel, according to the American Society of Health System Pharmacists, which tracks pharmaceutical shortfalls south of the border.
However, Health Canada and provincial cancer agencies contacted by The Globe and Mail say they see no signs of a paclitaxel shortfall here and are not expecting one because the other Canadian supplier, Hospira Healthcare Corp., has promised to fill the gap.
"We've received confirmation from Hospira that they have adequate supply to supply the Canadian market. We at this point have no indication that there is a shortage," said Scott Gavura, director of provincial drug reimubursment at Cancer Care Ontario.
Despite concerns serious enough to halt operations at the plant, Health Canada did not recall any of the paclitaxel already on hospital shelves, which one drug policy expert called puzzling.
"I found that, actually, pretty strange," said Joel Lexchin, a professor in the school of Health Policy and Management at York University and an emergency room doctor at Toronto's University Health Network. "If they think that the plant should no longer be manufacturing it, then I don't know why they wouldn't recall the drugs that the plant had been making."
Health Canada responded that in deciding against a recall it had to weigh the risk of interrupting the supply of a cancer medication that is fairly widely used. For instance, about 1,000 patients per month take the drug in Ontario alone, while 1,918 patients in British Columbia took it in 2013-2014.
"Given the critical role of paclitaxel in cancer therapy, Health Canada had to consider all factors, including the risk to patients of a possible short-term disruption in their treatment with paclitaxel. The department determined that the product already on the market does not pose a significant risk to health and can continue to be used," the regulator said in an e-mailed statement.
Cancer care agencies in two of the largest provinces that use paclitaxel from Biolyse – Ontario and British Columbia – said through spokespeople that they trusted Health Canada's conclusions and had no concerns about treating patients with a drug produced at the St. Catharines factory.
Health Canada said it is working to resolve issues at the plant, but Biolyse president Brigitte Kiecken argued it might already be too late to save her company, which was poised to expand with a loan of up to $2.9-million from Ottawa announced last September.
Ms. Kiecken said that because production has been paused for more than a month, the company is in danger of losing contracts with the group-purchasing organizations that buy chemotherapy drugs for hospitals.
Those buyers will now turn to the competition and force Biolyse to pick up the incremental cost, she predicted.
"If they buy [paclitaxel] from the competition at [a higher price] a vial, we have to pay the difference. We sell it at $50. The company will be bankrupt before you know it," Ms. Kiecken said.
That would force the company to throw 60 people out of work in a city of just over 130,000.
"If your staff are going to force ... a company out of business, we think that deserves the minister's attention," St. Catharines mayor Brian McMullan said, adding he understands the department's need to guard public safety. "We're saying there's got to be another way besides forcing this company out of business, given that they've got a long and proven track record."
Rick Dykstra, the Conservative MP for St. Catharines, said his office has been toiling for weeks to get the plant up and running again and that city council should not expect the minister to intervene in the work of inspectors trying to ensure Biolyse produces a safe drug.
"There's no way the minister is going to supersede the authority of officials who have spent a lifetime in this industry," he said.
It is unclear what will happen to the price provincial governments pay for paclitaxel if Biolyse goes under.
Ms. Keicken said her customers include suppliers of hospitals in Ontario, Quebec, New Brunswick and B.C., which gets its entire supply of paclitaxel from the company.
The group buyers who use Biolyse could go out to tender again. Besides Hospira, two other companies have permission to sell the drug in Canada, but neither does at the moment.
The next move for Biolyse is completing a "media fill," a kind of test run requested by Health Canada's inspectors. Ms. Kiecken said it would take at least three weeks to get the results, a delay she insists Biolyse cannot afford.
"I wish somebody would come and take a second look at this. Who's inspecting the inspectors?" she said. "If you get a bad experience with a policeman, you can go to the police station and complain and they'll have a department for you. In this case, you get mistreated by some inspector and nobody listens."
A spokesman for Ms. Ambrose said late on Tuesday in an e-mail that the minister has asked Health Canada to continue to work with the company and will not get involved.
"We understand Health Canada has inspectors on stand-by ready to go into re-inspect the facility as needed, and will continue to work with the company."
Kelly Grant