Today, the U.S. Food and Drug Administration posted a warning letter to CanaRx for facilitating the distribution of unapproved new drugs and misbranded drugs to U.S. consumers. These drugs are potentially dangerous to U.S. consumers.
“The FDA’s regulation and oversight of the drug approval process and distribution protects consumers by requiring rigorous scientific standards, labeling review for accuracy and completeness, and helping to ensure that counterfeit and unsafe drugs do not penetrate the U.S. drug supply, among other things. When companies sidestep important drug safety measures and put patient health at risk by providing unapproved drugs that have been substituted for FDA-approved prescription drugs, it’s the agency’s responsibility to step in to protect the patients,” said FDA Commissioner Scott Gottlieb, M.D. “If an American consumer goes to Canada and walks into a brick-and-mortar Canadian pharmacy and buys a medicine, they’re getting a high-quality drug because of Canada’s first-class drug regulatory process. When a consumer goes online to buy medicines purportedly from Canada, they may get a medicine sourced from elsewhere that could be counterfeit, expired or misbranded. While operations or illegal online pharmacies may state on their websites that its medicines are coming from Canada, the United Kingdom, Australia, etc., this is not necessarily always the case. Such operations and illegal online pharmacies take advantage of unsuspecting Americans by purporting to distribute safe and effective imported drugs, at least some of which are instead expired, mislabeled, subject to recalls or potentially counterfeit and that are provided outside of the closed American distribution system meant to protect patient safety. Such schemes are particularly egregious, as they deceive patients and their employers who provide prescription drug coverage. Operations like CanaRx use their names to imply that patients are receiving medicines approved in Canada, when it’s likely that patients are receiving medicines from other countries, and which may be sub-potent, super-potent or counterfeit. Importantly, they’re also distributing drugs for which the FDA-approved versions are subject to additional safety requirements, such as special handling or specific safety requirements that apply when drugs are administered to patients (called REMS programs) because the risks associated with the medicines are serious and need to be carefully managed in order to protect patients. These risk mitigation programs are a legal requirement and are in place for important safety reasons. Sidestepping them is unacceptable and puts the safety of patients in great jeopardy. We’re also troubled by robust marketing tactics, like those of CanaRx, which are used to give false credence to their operation. To protect patients from these unapproved drugs, we urge employers and any enrolled employees not to use any medicines from CanaRx. The FDA will pursue additional enforcement actions as needed.”
The warning letter is the result of a lengthy review of the company’s violative practices. The letter expresses the FDA’s concerns with the scheme CanaRx uses to contract with public and private entities to provide prescription drug coverage to their employees. In the scheme, CanaRx facilitates foreign physicians rewriting the employee’s U.S. prescription, and then supplies the employee with unapproved versions of FDA-approved drugs purportedly sourced from Canada, the United Kingdom or Australia that are represented to have undergone review from those countries’ drug regulatory systems. This is particularly troublesome, as employees are likely inclined to trust that they will receive safe and effective drugs through their employer’s “insurance” plan and may not question their legitimacy.
The drugs distributed by CanaRx may have different dosage strengths or be manufactured by companies different than the FDA-approved drug. They may be from different regions and they may be counterfeit. The substitution of FDA-approved prescription drugs with unapproved versions that may have substantially different risk profiles can pose serious health risks to consumers, especially in vulnerable patient populations that suffer from serious conditions such as HIV, cancer or hepatitis.
The closed drug distribution system in the U.S. provides critical assurances to patients. Congress has taken steps in recent years to give the FDA additional authorities to ensure the integrity of the U.S. drug distribution system under the Drug Supply Chain Security Act. Unapproved, imported drugs do not have the same assurance of safety, efficacy and quality as drugs subject to FDA oversight and may be sub-potent, super-potent or counterfeit. CanaRx’s substitution for prescribed FDA-approved drugs can have safety consequences for patients because, for example, their condition may not improve and the patient’s health care provider may not know that this may be attributed to an unapproved drug. This can also cause potentially dangerous drug interactions with the patient’s other medications. In addition, sourcing drugs from uninspected, unregulated or unknown supply chains can result in serious health consequences, especially in vulnerable patient populations, who may receive drugs that are adulterated, or are not shipped or stored properly.
CanaRx also offers certain drugs on its medication lists for which the FDA-approved version is subject to a REMS program and is indicated to treat serious conditions such as HIV, cancer or hepatitis. For example, the REMS for Tracleer, a medicine used to treat certain types of pulmonary arterial hypertension, which is high blood pressure in the vessels of the lungs, restricts distribution of the drug to only health care providers who comply with the requirements of the REMS, in order to minimize the risk of fetal exposure and serious birth defects in female patients taking Tracleer and the risk of liver damage in patients. No such safe-guards are in place for the “Tracleer” distributed by CanaRxv.
In some instances, the FDA-approved versions of several drugs listed on CanaRx’s medication lists have been subject to one or more recalls in the U.S. The FDA has established processes to ensure the recall of unsafe, substandard and poor-quality drugs within the legitimate U.S. drug supply chain, but no such official safeguards exist for unapproved drugs illegally distributed in the U.S. from foreign sources. Many of the foreign versions of FDA-approved drugs substituted by CanaRx are likely to have been subject to foreign recalls not adequately carried out in the U.S., presenting unacceptable risks of harm to U.S. consumers.
The warning letter also lists more than 150 websites affiliated with CanaRx, which is not intended to be an all-inclusive list. The warning letter requests that CanaRx respond within 10 working days, with details of how the violations noted in the warning letter will be corrected. Any violations not corrected in the warning letter could lead to enforcement action.
The FDA is committed to taking steps to promote product competition and the availability of safe and effective generic alternatives to branded medicines as part of a comprehensive effort to improve access to prescription drugs and help lower costs. Many patients have a difficult time affording the medicines that they need to improve or maintain their health. In recent years, the agency has advanced many new policies that have expanded competition and access. The agency remains committed to taking additional steps this year to help consumers get access to the safe and effective, affordable medications that they need.
Consumers who have concerns about any medicine they are taking supplied through CanaRx should talk with their health care provider before stopping or making other changes in their treatment. Health care providers and consumers should report any adverse events related to drugs provided by CanaRx to the FDA’s MedWatchAdverse Event Reporting program.