Biolyse Pharma Voices Concerns About Temporary Cessation Of Paclitaxel Productionq
Biolyse Pharma, a Canadian drug manufacturer, has stated that it is working with safety regulator Health Canada to reopen its manufacturing plant following a temporary shutdown. However, the company is also expressing concerns about the effect the closure has had on the production of Biolyse’s important cancer drug paclitaxel. An article from the Financial Post says that the company is even considering taking legal action against Health Canada after its manufacturing plant was shut down because the company believes the inspection process was inconsistent. The company is responsible for producing nearly 80 percent of Canada’s paclitaxel supply. Paclitaxel is an injectable drug to treat some versions of lung and breast cancer. The company stated that any prolonged stoppage of their paclitaxel production will have an adverse effect on cancer patients in Canada.
According to Health Canada, the country’s medical regulator, it shut down the St. Catherines, Ontario facility because of “significant concerns with the manufacturing process discovered during a recent inspection.” The company’s establishment license was suspended last week. Brigette Kiecken, Biolyse Pharma’s president, said earlier this week that the issues that had caused the shutdown have been resolved and that the company is now working with Health Canada to get its license reinstated.
Because the reinstatement process could take as long as 7 weeks, Biolyse could potentially lose its contracts with buying groups that supply hospitals. Kiecken commented on the situation.. “The hospitals are running out of product and they’re looking for other suppliers. From one inspection to the other, there’s no consistency, and the comments are ambiguous. It’s not clear… For all the observations we got, nothing was critical there.”
Health Canada also released a statement regarding the event, stating, “Health Canada cannot be assured that future supplies of paclitaxel from Biolyse would be safe and effective for use by patients until the serious manufacturing violations are resolved,” said the regulator in an official release.
Health Canada said that it would not recall paclitaxel currently in the market. “The Department determined that the product already on the market does not pose a significant risk to health and can continue to be used,” said Health Canada. The regulator also considered the critical role paclitaxel plays in cancer treatments and the risk taking it out of the market would have on patients.