USA – FDA warns pharmacy benefit company for distributing unapproved foreign drugs

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.”…