The Canadian medicine's regulator, Health Canada, are reportedly sitting on information pertaining to a recent FDA inspection of a GlaxoSmithKline plant in Québec, Canada.
In a letter to John Glavas Site Director, Quebec Operations GSK Biologicals, North America, the FDA raised concerns that related to bacterial contamination problems that were ongoing and may date back to 2011. Moreover, the FDA raised concerns about the purified water system at the plant.
The FDA also noted that since 2011 a total of 60 lots of vaccine from the plant have been rejected due to endotoxin levels that are over a pre-specified limit. Endotoxins are created by bacteria.
Glaxo manufactures roughly half of Canada’s seasonal flu vaccine order and has the country’s pandemic flu vaccine contract.
Health Canada carried out its own inspection of the plant but, according to The Toronto Star, are refusing to release its findings,
“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.
Great line, “Health Canada seems to be prioritizing what the companies claim is confidential business information"
So, if there is information that could be potentially damaging Glaxo scream, "Hey that's confidential business information".
Back in April the FDA sent GlaxoSmithKline a warning letter listing a series of violations regarding one of their plants in Ireland. The plant, located at Currabinny, Carrigaline, Cork, Ireland, had been inspected by FDA officials back in October 2013 and it was found that batches of paroxetine [Known by it's brand names of Paxil, Seroxat and Aropax] had become contaminated with material from Glaxo's waste tank, which contained APIs [Active Pharmaceutical Ingredients], intermediates, and solvents.
A month later the Brazilian drug regulatory agency, ANVISA, sent Glaxo a warning letter stating that batches of Paxil may have been manufactured with the use of active ingredient in the presence of residues. As a result, the sale of Paxil was temporarily suspended.
Furthermore, in 2010 Glaxo were fined $750 million for failing to meet government standards for their drugs that were being manufactured at their Cidra plant in Puerto Rico. Violations that included...
- Antidepressants containing different dosage strengths.
- Heart medication containing different strengths.
- A diabetes medication with a defect.
- A children's ointment that was contaminated with a microorganism associated with bacteranemia, urinary tract infections, meningitis, wound infection, and peritonitis.
- And a injectable drug used to treat nausea and vomiting in patients undergoing chemotherapy that was contaminated with micro-organisms.
Maybe they should start by reassuring consumers that there are no contaminated medicines leaving their plants!
Bob Fiddaman.
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