Ottawa temporarily suspended the license of a Southern Ontario pharmaceutical manufacturer to prevent the injury to its consumers. However, Health Canada did not recall any of the chemotherapy medication manufactured at the facility, causing the company to say that it has been suspended unfairly for minor violations.
On April 11, Biolyse Pharma Corp. from St. Catharines, Ontario was shut down temporarily after an inspection. Injectable paclitaxel used for certain breast and lung cancer treatment and it is the only drug manufactured at that plant. The suspension of Biolyse's establishment license means the company is not allowed to sell paclitaxel from the plant to Canadian consumers until serious industrial concerns are resolved fully and the suspension of its license is lifted.
"In the short term, Health Canada is allowing the Biolyse product currently on the market to continue to be used for treatment," the statement said. "However, 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."
Based on the documents presented by the company, Health Canada provided Biolyse a rating of non-compliance over six observations classified as risks by the drug inspector. However, Biolyse claims that the risk classifications and abrupt suspension are not compliant with Health Canada's own policies. The company stated that many specialists have reviewed the process and agreed that it was reactionary, unfair and irresponsible.
According to the company, it supplies around 80 percent of paclitaxel in the country but after almost a month of suspension, there are still no signs of shortage. Another pharmaceutical company named Hospira noted that it can cover for any shortage. It could also mean that an eventual price hike for paclitaxel can happen, which could be bad news to the consumers given that it is one of the most inexpensive intravenous chemotherapy medication available for breast, gynecological and lung cancer treatments.
MP of St. Catharine Rick Dykstra said he puts Biolyse as a number one priority. Dykstra said his office has been working with Biolyse for hours following the suspension and commented that the latter is doing its part. He adds that the federal Health Ministry is acknowledging the company's efforts to get back to being reinstated and it could cut down the process from months to only a matter of weeks. He also assured that political interference will not be accepted by him or the government.
