By: Tim Alamenciak, The Star
Health Canada is keeping the most recent completed inspection of Canada’s largest flu vaccine supplier secret despite a startling report from the U.S. Food and Drug Administration raising questions about quality control.
The Canadian federal regulator refused to provide a copy of its July 2012 inspection of GlaxoSmithKline’s Quebec plant, where about 5 million doses of flu vaccine were manufactured and supplied to the Canadian public in 2013 alone. The move comes in the wake of a warning letter from the U.S. FDA that documented concerns with the plant’s manufacturing process dating back to 2011.
“Health Canada seems to be prioritizing what the companies claim is confidential business information over patient safety and that really isn’t acceptable,” said Dr. Joel Lexchin, a health policy professor at York University and drug safety expert.
Health Canada refused to release the eight-page report in an emailed response. The agency said the inspection found no “critical risks” and the factory was given a “compliant” rating, but that it documented problems with contamination levels.
“Health Canada inspectors took note of a potential concern regarding endotoxins in the 2012 inspection. At that point in time, it was determined that there was no issue with regards to public health, therefore the firm was in compliance with the required regulations, and was given a compliant rating; the FDA had a similar approach,” wrote spokeswoman Leslie Meerburg in an emailed response. A note was added to follow up in the next inspection, which occurred last week and has not yet been finalized.
No information about Health Canada’s concern was made public at the time.
Meerburg said the reports may eventually be released as part of the Regulatory Transparency and Openness Framework, a project that was launched after a 2013 Star investigation into the widespread off-label use of acne drug Diane-35.
“The release of inspection reports is planned for a future phase of the project, but requires work to properly protect personal and confidential business information, and put the technical observations made by inspectors into context for the general public,” said an emailed response from Health Canada.
“I think that this is largely hiding behind a rationale for not doing much,” said Dr. Lexchin, when asked about Health Canada’s response.
GlaxoSmithKline Inc. is the largest single supplier of flu vaccine for Canadians. It was awarded a $425.9-million contract in 2011 to provide flu vaccine for Canada from its factory in Ste-Foy, Que. The plant also provides millions of doses of vaccine to American customers, allowing the FDA to perform regular inspections.
The FDA last inspected the plant in March and April of this year and released a warning letter that extensively documented its concerns. The warning letter specified that the agency found issues with contamination levels in vaccine batches dating back to 2011.
The FDA does not immediately publish all of its reports, but a spokesperson said they’re typically available through a Freedom of Information Act request that can be submitted online.
Health Canada said the July 2012 report could be requested through the Canadian Access to Information Act, which has a mandated response time of 30 days. The Star has requested inspection reports from both agencies.
The FDA publishes frequently requested reports freely on its website and makes all warning letters public. The agency censors information that it deems is a “trade secret or confidential business information” and any medical information but the substance of the concerns remains visible.
In the warning letter dated June 12, 2014, the FDA documents higher-than-normal levels of contamination in batches of flu vaccine dating back to 2011. It said the plant has an ineffective water purification regime, which led to contaminated water being used to wash equipment and winding up in humidifiers in the plant.
“The deficiencies described (in the inspection and warning) are an indication of your quality control unit not fulfilling its responsibility to assure the identity, strength, quality, and purity of your licensed biological drug product and intermediates,” says the warning letter.
The FDA called on Glaxo to fix the issues in its Quebec plant, but also to look at its whole operation.
“In addition to addressing the deviations specifically listed in the warning letter, the FDA expects ID Biomedical and GlaxoSmithKline to undertake a comprehensive and global assessment of all of its manufacturing operations to ensure that all products conform to the FDA’s requirements,” said a statement from the agency.
The contaminants were found in batches before they left the plant, according to a Glaxo spokesman. The batches were then discarded.
Health Canada described the risk to the public as “low.”
Health Canada is mandated to inspect drug manufacturing plants every two years. It completed its scheduled inspection of the Glaxo plant in Quebec last week but has not finalized its findings.
The company responded to the FDA’s concerns on three separate occasions following the inspection, but the FDA was not satisfied with the response. Glaxo has 15 working days from the issuance of the letter to address the agency’s concerns or the FDA could suspend its American license.
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