HHS Importation Efforts Move Ahead, but Questions Remain

Late last month, the Trump administration moved ahead with a proposed rule and draft guidance that could open the door to drug importation. The moves, it contended, would lower U.S. prescription drug prices. But skepticism exists as to whether the policies will ever be implemented, as well as if all involved entities would even participate in the efforts.

An HHS notice of proposed rulemaking (84 Fed. Reg. 70796, Dec. 23, 2019) would allow states and certain nonfederal government entities to submit for review to HHS proposals for programs to import drugs from Canada that have been approved by Health Canada’s Health Products and Food Branch. Those programs also may have co-sponsors, which could be a pharmacist, a wholesaler, another state or another nongovernment entity. Drugs not eligible for importation include controlled substances, biologics, infusibles, intravenous injectables, drugs inhaled during surgery, certain parenteral drugs and drugs with Risk Evaluation and Mitigation Strategies (REMS).

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