FDA Will Help States Apply to Import Cheaper Drugs From Canada

  • May 22, 2025

    The FDA will facilitate development of drug importation applications by individual states and Indian tribes in an effort to revive the largely dormant program, reversing years of resistance to the idea at the agency.

    The program does not change the existing rules governing state efforts to import cheaper prescription drugs from Canada, which set a high bar for states and tribes interested in submitting importation program proposals to FDA for review and authorization.

    The FDA program allowing drug importation from other countries was enacted in 2000 and updated in 2003. The agency established a regulatory framework for importing cheaper drugs in September 2020.

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  • Cathy Kelly

    Cathy is a senior writer with Pink Sheet and has covered U.S. regulation and reimbursement policy for the biopharma industry since 2004, starting with the establishment of the Medicare Part D program. Since then, she has written extensively about developments in all major sectors of the U.S. insurance market (Medicare, Medicaid and commercial plans). She has covered key legislation affecting biopharma, including the Medicare Prescription Drug, Improvement, and Modernization Act which created Part D, health care reform under President Obama, and the Inflation Reduction Act. She has closely followed the increasing influence of pharmacy benefit managers and their use of formulary negotiations and rebates to control pricing. Cathy also has covered developments in health technology assessments and has monitored industry progress on novel drug contracting that reflects value-based pricing.

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