Wednesday, May 14, 2014

No shortage over shutdown of drug maker: Health Canada

TORONTO – Health Canada says a recent decision to shut down an Ontario company that manufactured the cancer treatment medication paclitaxel won’t result in any market shortages of the drug.

The agency says it suspended the establishment licence for Biolyse Pharma Corp. after identifying what it described as “significant concerns with the manufacturing process” back in January. It did not offer any details as to the nature of those concerns.

The licence was terminated in early April, and the 60-employee company in St. Catherines, Ont., shuttered operations last week.

Biolyse disputes Health Canada’s findings, saying it adheres to stringent industry safety standards and is the only manufacturer of injectable paclitaxel in the country.

Health Canada, however, says it has identified another supplier for the drug that is commonly used to treat breast, ovarian and lung cancers.

A search of Health Canada’s Drug Product Database indicates four Canadian companies, including Biolyse, that produce injectable paclitaxel containing the same active ingredients and delivering the same dosage.

Biolyse did not respond to a request for an interview, but issued a statement defending their manufacturing practices.

“Biolyse’s manufacturing process is supported by sound scientific evidence which substantiates the safety of the manufacturing method, environmental conditions and testing methods which all reflect the requirements of the Good Manufacturing Guidelines. Supportive data and trend monitoring was available to the inspectors,” the company said.

Health Canada said it decided that Biolyse’s existing paclitaxel products did not need to be recalled, but said it opted to shut down the company out of concern over future supplies.
“The fact that we have been able to identify an alternative source of supply for the drug means that cancer patients will not face a gap in treatment …,” Health Canada said in an email.
Health Canada says it is willing to reinspect the facility as needed.

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