Canadian online pharmacy CanadaDrugs.com suspended from supplying drug wholesalers and pharmacies after Health Canada investigations produced “significant concerns” with their shipping and storage practices. Canada Drugs has previously been identified as the owner of several subsidiary companies in the United States and United Kingdom that have been implicated in the importation of counterfeit versions of cancer drugs, osteoporosis drugs, and injectable wrinkle treatments such as Botox.
On June 9th 2 2014, Health Canada posted a notice suspending the wholesale license of CanadaDrugs.com LP of Winnipeg, Manitoba, owned by Kris Thorkelson. Health Canada suspended CanadaDrugs.com’s business-to-business, license “due to significant concerns with Good Manufacturing Practices (GMP) discovered during an inspection of its drug wholesaling activities.”
While wholesale operations have been completely suspended for Canada Drugs, CBC reports that they are still able to distribute medication through their chain of retail websites, because retail pharmacy is regulated by the provincial and territorial governments. Health Canada has notified the College of Pharmacists of Manitoba, the licensing authority for the company, regarding its inspection findings and subsequent suspension.
CBC reports that CanadaDrugs.com was required by Health Canada to recall two fragile medications due to poor storage and handling this year. Myochrysine, an injectable treatment for rheumatoid arthritis, and Evra, a contraceptive patch for women, were “distributed to a pharmacy located in B.C. Canada and further distributed to end users in the United States,” in March and February, respectively. Both medications may have been exposed to temperatures outside the recommend storage requirements and had efficacy and safety impacted as result.
When counterfeit Avastin was initially reported by the FDA in February 2012, they warned that “19 medical practices in the United States purchased unapproved cancer medicines and, potentially, the counterfeit Avastin, from Quality Specialty Products (QSP), a foreign supplier that may also be known as Montana Health Care Solutions. Volunteer Distribution in Gainesboro, Tennessee is a distributor of QSP’s products. FDA has requested that the medical practices stop using any remaining products from these suppliers. FDA cannot ensure the safety or efficacy of any of these unapproved products.”
In July 2012, the Wall Street Journal cited investigations that uncovered Canada Drugs’ role in the distribution of fake Avastin:
“Corporate documents show Mr. Thorkelson’s Canada Drugs controls the maze of subsidiaries that procured and shipped the counterfeit products, including Montana Healthcare Solutions and a British wholesaler called River East Supplies Ltd.
The records show Mr. Thorkelson’s company also does business as Clinical Care, Quality Specialty Products and Bridgewater Medical, which are other distributors identified by the FDA in the Avastin case.”
While the legal counsel for CanadaDrugs.com told the Wall Street Journal that “CanadaDrugs.com is separate from companies that the FDA said handled the counterfeit Avastin,” the company’s website identifies itself as the same business Canada Drugs with the same founder, Mr. Thorkelson.
Canada Drugs has been mentioned in three separate incidents in the US. In 2012, the FDA sent Canada Drugs a warning letter, telling them to stop selling non-FDA approved medication to U.S. consumers. The FDA cited hundreds of website URLs identified as being online pharmacies owned by Canada Drugs. FDA explained their action, saying:
“FDA is taking this action against your firm because of the inherent risk in buying unapproved and misbranded new drugs. Unapproved new drugs from unregulated sources do not have the same assurance of safety and effectiveness as those drugs subject to FDA oversight, and such drugs have been found to be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.”
In September 2012, the FDA sent warning letters to doctors in 10 states, cautioning them that they may have purchased counterfeit versions of the osteoporosis treatments Prolia and Aclasta from Canada Drugs’ subsidiaries. The FDA noted that the drugs in question were not FDA-approved, and expressed concern that “products distributed by this distributor may cause harm to patients, because they may be unsafe or ineffective.”
And then in December of the same year, the FDA sent warning letters to hundreds of medical practitioners throughout the United States that counterfeit versions of the cosmetic treatment Botox were being sold and identified Canada Drugs as the supplier of the fake treatments:
“To minimize the chance of patients receiving an unapproved, counterfeit, unsafe, or ineffective medication, FDA requests that medical practices stop administering the unapproved versions of Botox and any other products they have received from foreign suppliers owned and operated by Canada Drugs and known under the following names: Quality Specialty Products (QSP), A+ Health Supplies, QP Medical, Bridgewater Medical, or Clinical Care. Many, if not all, of the products sold and distributed by these suppliers have not been approved by FDA. Therefore, FDA cannot confirm that the manufacture and handling of these products follow U.S. regulations or that these medications are safe and effective for their intended uses.”