On November 1, 2019, the Office of Management and Budget (OMB) received a proposed rule that would allow the importation of prescription drugs from outside the United States. The full details of the proposal are not yet available, but the U.S. Food and Drug Administration (FDA) released a preliminary plan earlier this year. OMB’s receipt of the proposal indicates that it will be issued publicly in the near future.
Permitting the importation of prescription drugs is an attempt to reduce the costs that Americans pay for their medications, as they are priced higher in the United States. A report issued last year found that many medications covered by Medicare cost, on average, 1.8 times as much as in the United States. According to the FDA’s tentative plan, states would be allowed to apply to conduct demonstration projects to import prescription drugs from Canada. However, importation carries risk because such medications are not subject to the rigorous safety and efficacy standards of the United States and could be contaminated, not handled or stored property, or lack active ingredients.
Stay tuned for additional developments regarding prescription drug importation.