FDA Urged to Reconsider Enforcement Discretion for Personal Drug Importation
The U.S. Food and Drug Administration (FDA) is being urged to re-evaluate its enforcement discretion regarding the personal importation of lower-cost prescription drugs. Section 804(j)(1) of the Federal Food, Drug, and Cosmetic Act (FDCA), added by Congress in 2003, declares that the Secretary of Health and Human Services should permit otherwise non-compliant drug importation if it is 'clearly for personal use' and 'does not appear to present an unreasonable risk to the individual.' Despite this congressional directive, the FDA's current Personal Importation Policy (PIP) primarily focuses on 'unapproved' drugs rather than lower-cost versions of medications available in the U.S. This has led to the destruction of a significant number of personally imported medications, even those for chronic diseases, without a clear assessment of 'unreasonable risk.' In 2022, out of nearly 53,000 imported drug shipments examined, only 33 contained opioids, and none contained fentanyl, yet most were destroyed. 
