Ottawa has temporarily shut down a Southern Ontario pharmaceutical maker to “prevent injury to the health of consumers,” but the federal drug regulator has not recalled any of the inexpensive chemotherapy drug produced at the plant, leading the company to claim it has been unfairly shuttered for minor infractions.
Health Canada suspended the licence of Biolyse Pharma Corp. on April 11, saying in a letter to the St. Catharines-based generic drug maker that an inspection beginning in January “raised significant concerns relating to aseptic manufacturing, chemical testing, microbiological testing controls and documentation.”
Biolyse is vigorously fighting Health Canada’s decision, including promising legal action.
But with the plant now closed for nearly a month, the company is poised to lose its contracts with the group-buyers that supply anti-cancer drugs to Canadian hospitals, something Brigitte Kiecken, Biolyse’s president, said would force her company to fold and throw 60 people permanently out of work.
If that happens, it could mean an eventual hike in the price of paclitaxel, currently one of the most affordable intravenous chemotherapy drugs available to treat primarily breast, lung and gynecological cancers.
Biolyse said it supplies about 80 per cent of the country’s paclitaxel, but so far there are no signs of a shortage, according to Cancer Care Ontario. Another company, Hospira, has promised in writing that it can cover any shortfall, the cancer agency said.
In an e-mailed statement, Health Canada defended its decision not to recall any of the paclitaxel made at Biolyse’s facility.
“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.”