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Health Canada inspection raises concerns about GSK flu vaccine plant

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TORONTO - Health Canada has advised pharmaceutical giant GSK it wants to see an action plan for fixing problems at the country's only flu vaccine production facility.

GSK was given 30 days in which to lay out a proposal and timeline for resolving the problems at the facility, Health Canada said in an emailed response to questions from The Canadian Press.

The deadline was contained in a Health Canada inspection report that GSK — formerly GlaxoSmithKline — received on July 3, the company said via email.

"We have 30 days to review and respond to the findings noted in their report and we are committed to doing so by August 4, 2014," said the email from Michelle Smolenaars Hunter, communications manager for GSK Canada.

Specifics of the problems Health Canada identified at the Ste. Foy, Que., plant were not revealed, though the department said some relate to infractions raised by the U.S. Food and Drug Administration in a warning letter about the plant that it issued last month.

Health Canada said it is currently writing a summary report of its findings and will release it when it is completed.

"We will not hesitate to take firm and immediate action should a serious risk to public health and safety be found," the department stated, though it noted the situation does not pose an immediate threat to the health of Canadians.

Programs to administer vaccine in advance of next winter's flu season won't begin across the country until late October or November.

Health Canada said as the plant's problems don't pose an immediate risk to Canadians, the plant was given a "compliant" rating at the end of the inspection, which concluded June 20.

Smolenaars Hunter said that means that as of the time of the inspection GSK showed the plant's activities were in compliance with the Food and Drugs Act and its regulations. She acknowledged, though, that a compliant rating does not mean corrective actions were not demanded.

"GSK remains fully committed to working with the FDA and Health Canada to ensure we adhere to the requirements of all Good Manufacturing Practices," she said, referring to the accepted standards for quality control that pharmaceutical companies must abide by.

In its letter, the FDA gave GSK 15 working days in which to fix bacterial contamination problems identified during a regularly scheduled inspection of the facility in early April. It linked the problem to the plant's water purification system.

The FDA letter said that since 2011, the company has repeatedly discarded batches of vaccine because of bacterial counts that registered above specified limits. It noted that 21 per cent of the plant's production in 2014 could not be released to the market because of the problem.

The FDA stated if the problems could not be fixed in the specified time frame, the company needed to explain the delay to the U.S. regulatory body and lay out a detailed plan for resolving the ongoing problems. Otherwise, the facility's licence to produce vaccine for the U.S. market could be suspended or revoked without further warning, the agency said.

For the most part the FDA has declined to elaborate on the situation, saying its investigation is ongoing. But recently it acknowledged receiving three written responses from GSK related to the inspection, all dated before the warning letter was issued. "The responses did not provide sufficient detail to fully assess the adequacy of the firm's corrective actions," the agency said via email.

The FDA's 15-day deadline expired at the end of the week. On Wednesday, the agency had little to say about where matters stand regarding its concerns about the plant.

"Because this is an open compliance matter, we cannot discuss information outside of what is already found in the warning letter," spokesperson Tara Goodin said in an email.

"But as a general matter, warning letter recipients who fail to make adequate corrections are subject to enforcement actions such as seizure and injunction."

Smolenaars Hunter said the company has submitted a formal response to the FDA's warning letter.

The Ste. Foy plant is contracted to produce 53 per cent of the seasonal flu vaccine the provincial, territorial and federal governments will offer to Canadians this fall. That is 6.36 million of the roughly 12 million doses the country has ordered for the 2014-15 flu season.

GSK expects to provide between 28 million and 33 million doses of flu vaccine to the U.S. market this fall; about 23 million of that will come from the Quebec plant, Smolenaars Hunter said.

GSK also holds Canada's pandemic flu vaccine contract. It requires the company to make vaccine at the Ste. Foy plant if a pandemic occurred during the life of the 10-year contract, which expires in 2021.

Public Works and Government Services Canada, the federal department that negotiates the combined federal, provincial and territorial flu vaccine purchases, has been consulting with other manufacturers to develop backup plans in case GSK cannot meet its full order.

Three other licenced manufacturers — Sanofi Pasteur, Novartis and Astrazeneca — have contracts to provide Canada with the remaining 47 per cent of its seasonal flu vaccine purchase.

Most of that is provided by Sanofi Pasteur; Novartis and Astrazeneca supply roughly three million and one million doses respectively. Both Novartis and Astrazeneca have indicated they could provide more vaccine this fall if Canada requires it.

Health Canada said GSK has assured it the company's plans for fixing its production problems should not affect its ability to deliver flu vaccine for the Canadian market this fall.

The department's response seemed to suggest, however, that there might be slight delays in the company's delivery schedule, saying GSK's revised plan would "adhere as closely as possible" to the original plan. The company is supposed to ship half of its order by Sept. 15 and the remainder between Sept. 22 and the end of October.

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