FDA warns pharmacy benefit company for distributing unapproved foreign drugs

Regulatory NewsRegulatory News | 14 March 2023 |  By 

The US Food and Drug Administration (FDA) recently warned pharmacy benefit firm ElectRx for substituting prescription drugs ordered by its customers with drugs sourced from foreign pharmacies that have not been approved by the agency.
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.


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