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Health Canada Blocks Stop-Smoking Ad for Natural Lozenge

Phase 2

According to The Globe and Mail, a Canadian news outlet, Health Canada set out to drive a Canadian-made stop-smoking aid from the market after a complaint from Pfizer Canada Inc., a pharmaceutical company that makes competing products, a judge found.

In its first few months on the market, a lozenge called Resolve, billed as a natural way to stop or reduce smoking, sold more than 250,000 cartons across Canada, according to its manufacturer, The Winning Combination Inc. (TWC) of Winnipeg. Then Pfizer wrote Health Canada a letter saying the product posed health risks. (That same year, 2007, Pfizer sought and obtained Health Canada approval for a quit-smoking prescription medication, Champix, The Globe and Mail said.)

According to a ruling from Federal Court Justice James Russell, Robin Marles, director of Health Canada’s clinical trials bureau, set up roadblocks to Resolve while other Health Canada officials either supported his efforts or stood by. As the makers of Resolve tried to make its case for a license to sell Resolve, Marles denied it any fairness, said Russell.

According to The Globe and Mail, under Health Canada rules at the time, a company could sell a natural health product while its application for a license was under consideration.

Checks and balances “were abandoned and those with the authority and responsibility to make the decision simply followed Marles’ directions, whose directing mind appears to have lost all sense of objectivity and procedural fairness as he attempted to shore up his own misperceived conclusions,” Russell wrote in his 68-page ruling.

The final ruling was that Resolve was wrongly banned from the market for a total of eight years. Rather than send the matter back to Health Canada to rethink whether Resolve meets its standards,  the normal course for this situation, Russell ordered Health Canada to approve a natural-health-product license within 30 days, The Globe and Mail said.

Shazad Bukhari, chief executive officer of The Winning Combination, said the company did not receive fair treatment from Health Canada. “The sense of fair play you would expect and you hope the government would provide isn’t always the case,” he said.

A spokeswoman for Health Canada said the department is appealing the court’s decision. “The department remains committed to a fair and impartial review of all health product license applications,” she said.

Health Canada was ordered to pay The Winning Combination’s legal costs, which was estimated at $1 million. The company laid off 15 employees, at a time when it had just 35, and its suppliers laid off more. The company now has 100 employees, and plans to launch Resolve in Europe, Australia, South Africa and elsewhere, acceding to Bukhari.

For more information, visit www.theglobeandmail.com.

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