JAMA Personal Drug Importation Correction

PSM’s executive director submitted the following correction to the Journal of the American Medical Association (JAMA) in December 2024:

International online pharmacies are illegal, and an unacceptable cost-saving strategy 

Shabbir Safdar

Executive Director, The Partnership for Safe Medicines

JAMA’s October 21, 2024 Special Communication, “Strategies to Help Patients Navigate High Prescription Drug Costs,” by Hussain S. Lalani, MD, MPH, MSc; Catherine S. Hwang, MD, MSPH; Aaron S. Kesselheim, MD, JD, MPH and Benjamin N. Rome, MD, MPH, misrepresents the legality of personal importation, despite citing the U.S. Food and Drug Administration’s page on personal drug importation as a source. It also obscures the risks of foreign online pharmacies in a way that misleads U.S. patients and may lead to medical adverse events.

The article should have all recommendations for U.S. patients to break the law and illegally import non-FDA-approved medicines removed.

The authors assert that the FDA “permits patients to purchase FDA-approved drugs internationally as long as they are for personal use,” but this is a misrepresentation of the author-cited FDA webpage, which says, “In most circumstances, it is illegal [emphasis added] for individuals to import drugs or devices into the U.S. for personal use because these products purchased from other countries often have not been approved by the FDA for use and sale in the U.S.”

There is no such thing as personally imported, FDA-approved medicine. Medicines are not FDA-approved unless they are made within the U.S. track and trace system, which documents the progress of a drug from the factory to the pharmacy shelf. Product tracing allows U.S. regulators to quickly detect and remove harmful drugs from circulation. 

Furthermore, FDA’s policy does not say that the agency will permit imported drugs. Rather, it says that FDA personnel “will use their discretion to decide on a case by case basis whether to detain, refuse, or allow entry of the product.” As recently as 2020 patient treatments have been disrupted because their medicine was seized at the border. Those delays can have a serious impact on patient health. 

Finally, patients should be wary of organizations that independently verify international online pharmacies; owners of “verified” online drug sellers have been criminally prosecuted for selling unsafe or counterfeit medicine across a variety of therapeutic areas. 

For these reasons, clinicians should not recommend international online pharmacies to patients even as a last resort. Suggesting these are legal options is a reckless misreading of FDA policy, and exposes American patients to unacceptable and well-documented health risks.