FDA issues warning to ElectRx over unapproved drugs

ElectRx has been issued a warning from the FDA after the agency found it in violation of distributing unauthorized, misbranded drugs. 

"Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients or contain different ingredients altogether," the FDA wrote in its warning letter. "Accordingly, FDA requests that ElectRx cease causing the introduction of unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from potential harm."

ElectRx coordinates the dispensing of the prescription drugs by foreign pharmacies to enrollees of certain employee-sponsored health insurance plans. The company issued a statement ensuring customers it is working with the FDA, but maintains that the safety of the drugs is not an issue.

"It is apparent by the content of this form letter that the FDA is unaware of the type of personal importation programs supported by ElectRx and the extensive care, custody, and control procedures that exist for you and your plan sponsors," ElectRx's statement reads.

The statement goes on to explain that the foreign, imported medications are all from Canadian brick-and-mortar pharmacies and "are within the permissive acts established under the proposed regulations and the intent of the numerous executive orders, postal regulations, and language of the Medicare Modernization Act." The company also cited a previous statement from former FDA Commissioner Scott Gottlieb, MD, who has publicly cited the safety of Canadian prescription drugs before the U.S. Congress. 

"You are receiving, as Dr. Gottlieb professed, safe and effective drugs from Canadian pharmacies," the statement reads.

The FDA's warning letter directs ElectRx to "promptly cease causing the distribution of unapproved new drugs and misbranded drugs to U.S. consumers and correct any other violations of the FD&C Act" and detail the steps it is taking to do so in response.

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