Protect and expand safe personal drug importation practices permissible under current law
Over the past 25 years, personal prescription drug importation has become a lifeline of affordable medications for Americans. Federal law is far more permissive of this lifesaving channel than is commonly known. Clearly, Americans should be able to import safe prescription drugs if they cannot afford them here. Even when technically illegal, federal law supports their choice to do so through the use of enforcement discretion when the import does not pose an unreasonable risk.
- Stop destroying patients’ prescription drug orders at international mail facilities. The FDA should not destroy international prescription drug orders placed by patients in the U.S. who cannot afford those treatments domestically. Nevertheless, every year, the FDA destroys tens of thousands of prescription drug orders. We have no visibility into whether those patients end up getting sicker, hospitalized, or dying because they do not get their prescribed drugs.
- Make full use of Congress’s declaration that Americans should be permitted to import prescription drugs for personal use. Federal law, 21 U.S.C. § 384(j)(1), favors Americans who choose to import prescription drugs for personal use. It states that the FDA should permit it even when it’s technically unlawful, so long as the importation is not an “unreasonable risk” to the patient.
- Issue waivers expressly permitting personal drug importation. Separately from the use of enforcement discretion under 21 U.S.C. 384(j)(1), the FDA should issue waivers under 21 U.S.C. 384(j)(2) to grant advance and express permission to import prescription drugs for personal use.
- Legal channels for safe personal drug importation exist. The FDA says on its website that “under most circumstances,” it is illegal to import prescription drugs for personal use because, often, drugs outside the U.S. have not been approved by the FDA. “Most” is not all. There are thousands of drugs manufactured outside the U.S. that have been approved by the FDA. Importing those drugs can be legal under certain circumstances.