On July 31, 2019, the Trump Administration issued a press release that outlined a forthcoming regulatory pathway that would enable the importation of prescription drugs. This announcement follows the Administration’s recent efforts to reduce the costs of prescription drugs, which have been unsuccessful, including the Administration’s proposed changes to the six protected classes, reforms to rebates in the pharmaceutical supply chain, and the requirement for pharmaceutical manufacturers to disclose their list prices in direct-to-consumer advertisements. The Administration’s other proposal, the international pricing index, is still forthcoming.
The Administration’s announcement outlined two pathways for drug importation. The first pathway will use Sec. 804 of the Food, Drug & Cosmetic Act (FDCA) to allow states, wholesalers, and pharmacists to submit plans for drug importation demonstration projects, provided that they are compliant with the FDCA. Additional requirements for these demonstration projects will be detailed in a future notice of proposed rulemaking. The second pathway will allow manufacturers to import versions of FDA-approved products that they sell in other countries. This could allow manufacturers to offer lower prices on these products.
Interested in learning more? Health Affairs has published a full analysis of this proposal, which you can read here.