FDA warns pharmacy benefit company for distributing unapproved foreign drugs
The company, which contracts with public and private employers in the US, states on its invoices that recipients “may have noticed that the medication which has been shipped to you is different in name or presentation to that which you may have received in the past. IF YOU HAVE ORDERED A BRANDED DRUG the name may appear different to the one you are used to. The reason for this is that you have been supplied internationally branded product and for various reasons drug companies market their products under different names and packaging in different countries.”
FDA said that this practice violates the Federal Food, Drug, and Cosmetic Act, and is “particularly concerning, 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 substitution of FDA-approved prescription drugs with unapproved drugs poses significant health risks to U.S. consumers,” FDA added. “Substituting an unapproved drug for the FDA-approved drug prescribed by a patient’s healthcare practitioner can negatively affect patient outcomes because the healthcare practitioner may unknowingly make subsequent treatment decisions based on the patient’s response to the unapproved drug.”
The warning letter goes on to cite other dangers to patients, including drug interactions with other medications, and the presence of drugs with a narrow therapeutic index (NTI), products subject to a risk evaluation and mitigation strategy (REMS), controlled substances and drugs to treat serious conditions.
FDA explains that ElectRx acts as a broker between foreign pharmacies and employee-sponsored health insurance plans to supply patients with medications.
While ElectRx notifies the patient that the drug they have received may have a different name than what is in the prescription, they fail to tell them that the drug isn’t FDA-approved.
FDA notes that drugs approved by the agency have a level of assurance that they have been reviewed by its staff for safety, effectiveness and quality. The manufacturers of those drugs must follow certain manufacturing controls and their facilities are inspected by the regulatory agency.
“Unapproved foreign drugs circumvent these safeguards, which are designed to protect patients,” FDA warned. “Unapproved drugs do not have the same assurance of safety and efficacy as drugs subject to FDA oversight and may be subpotent, superpotent, or adulterated with unknown active ingredients.”
“Treatment with drugs that may be subpotent, superpotent, or adulterated can lead to drug resistance and/or therapeutic failures, and jeopardize the effectiveness of alternative drug therapies on patient outcomes,” the agency added.
FDA has asked ElectRx to respond to its warning letter within 15 working days with details on what steps it has taken or plans to take to address the regulatory violations raised by the agency and what it plans to do to prevent such violations in the future. If the company does not respond within that time frame, FDA warns that it may have to take legal actions such as a seizure, injunction or temporary restraining order.
FDA Response
Dear Valued Clients and Participants:
ElectRx and Health Solutions LLC (“ElectRx”) recently received a letter from the United States Food and Drug Administration (“FDA”) regarding the importation of medication to the United States. 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.
In addition to complying with the exemptions surrounding personal importation, ElectRx goes even further to ensure compliance with international standards for prescriptions obtained by you from Canadian based pharmacies. As you may know, the former Commissioner of the FDA (Dr. Scott Gottlieb) said “Canadians have safe drugs” and “if you are going into a brick-and-mortar pharmacy you are getting a safe and effective drug.” Each prescription filled as part of your plan is done by a Canadian “brick-and-mortar” pharmacy. Dr. Gottlieb’s statement came long after the FDA was required to create regulations to fully allow personal importation of Canadian filled prescriptions under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“Medicare Modernization Act”). The FDA’s failure to put in place the procedures under the Medicare Modernization Act and those required by both former President Trump’s 2019 and President Biden’s 2021 executive orders further establishing Canadian drug importation programs, has resulted in a lawsuit by the State of Florida against the FDA.
Your personal importation of medications directly from a Canadian pharmacy 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. You are receiving, as Dr. Gottlieb professed, safe and effective drugs from Canadian pharmacies. We will continue to work with the FDA on this matter and, as always, please feel free to contact us if you have any further questions or concerns.
Thank you for your continued belief in the benefits of personal importation, and its effectiveness.
Sincerely,
Your Friends at ElectRx and Health Solutions LLC
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“back in the day “… as I remember some 30+ yrs ago. There was some Canadian Pharmacies that contracted with individuals in the USA – NOT PHARMACISTS – to set up “store front Canadian Pharmacies”. That was nothing more than a store which would fax a pt’s Rxs to a Canadian Pharmacy, which would fill those prescriptions and mail them directly back to the pt in the USA.
Canada – using their national healthcare system – purchases Rx meds via a bidding process and because they don’t have a lot of middlemen in their healthcare system – like the USA does – were able to get most meds at a much lower price.
Apparently, when the major pharmas realized that they were shipping a lot more Rx med volumes to Canada, where Canadian pharmacies were shipping them back to USA citizens. Some how, the pharmas put caps or limits on quantities that Canadian pharmacies and/or wholesalers could purchase during some fixed time frame.
“rumor on the street” back then, was that either there was a “loophole” in Canadian pharmacy law and/or pharmacy law was changed that permitted Canadian pharmacies and/or wholesalers to import meds from anywhere in the world, BUT… they could not use these meds to fill Rxs for pts picking up their Rxs at a brick and mortar pharmacy, BUT… they were allowed to ship these Rxs to anywhere outside of Canada… So… all this Rx business that these Canadian mail order pharmacies had built up, those pts started getting Rxs filled with meds from unknown pharma sources.
The USA Canadian “store front pharmacies” have seem to have disappeared… at least I have not seen any nor heard of any. Doing a quick web search, there are a number of Canadian mail order pharmacies still actively advertising on line. If what I heard previously – about Canadian pharmacies — that it is legal for them to import pharma meds from anywhere in the world as long as they don’t use these medications when dispensing to Canadian citizens is true. Then these politicians and bureaucrats that have given exemption to the personal importation of Rx meds from other countries, did not understand the potential of pts getting unapproved FDA medications.
I have also read, that because the wholesale distribution system outside of the USA is so different from ours, that like in Europe, a pharma shipment may change hands a untold number of times moving from country to country thru customs going thru each country. I have seen claims that upwards of 10% of the pharma medication in circulation could be counterfeit and the higher the price of the medication, the more likely it could have been swapped out for a counterfeit at some point as the shipment goes from country to country.
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