Canadian drug distributor rebuts FDA criticism

Pharmaceutical distributor CanaRx Services has hit back at criticism from the US Food and Drug Administration over the Canadian company’s alleged supply of unapproved and misbranded drugs.

According to its website, CanaRx contracts licensed doctors and pharmacies in Canada, the UK, and Australia to supply brand name medication to the US market. The company was singled out for criticism by the FDA last month, which accused it of causing a public health risk.

CanaRX CEO Gregory Howard earlier this month issued a response to a warning letter sent by the FDA on February 26, in which he said his company’s patient safety record was “second-to-none and a matter of public record”.

The FDA’s letter accused CanaRx of designing its business “to operate in a manner that substitutes the FDA-approved drugs prescribed by the US healthcare provider with unapproved drugs”.

According to the letter, CanaRx is also importing drugs which do not bear “adequate directions for its intended use”.

“The drugs obtained through CanaRx are intended to treat conditions that are not amenable to self-diagnosis and treatment by persons who are not medical practitioners”, the FDA said.

These drugs require exceptions to the misbranding rule which those imported by CanaRx cannot meet because they are not imported by the FDA.

The warning letter urged CanaRx to “promptly cease causing the distribution of unapproved new drugs and misbranded drugs to U.S. consumers and correct all other violations”. Failure to do, it said, may result in further regulatory action.

Howard, in his response, said that CanaRx was not an “internet pharmacy”, but rather assists patients in “obtaining safe affordable medications from duly licensed and regulated brick-and-mortar pharmacies”.

The company’s legal team is formulating a formal response to the FDA, the statement said.

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