Trump’s Importation Program | FTI Consulting

Trump’s Importation Program May Have Small Reach for Now

Healthcare & Life Sciences | (Reprint)

September 17, 2019

Amid an ongoing outcry against rising drug costs, the Trump administration introduced two importation pathways to reduce what U.S. residents pay for drugs. Although industry insiders tell AIS Health the pathways likely will have no effect on drug costs over the next few years, they suggest partnering with states already working on reimportation schemes to build experience with such programs.

Republished with the permission of © Copyright 2019. The views expressed herein are those of the author and do not necessarily represent the views of FTI Consulting, Inc. or its other professionals.

HHS Secretary Alex Azar on July 31 announced two pathways to help U.S. residents pay less for pharmaceuticals. Under the Safe Importation Action Plan, the first pathway would allow states, wholesalers and pharmacists to propose to HHS demonstration projects for importing certain drugs from Canada. Proposals would have to ensure no additional risk to health and safety and must result in “significant cost savings.” However, this pathway would exclude biologics such as insulin, infused drugs and injectables, among other categories.

Under the second pathway, drug manufacturers could import non‐U.S. countries’ versions of their drugs into the United States; manufacturers would need to validate that the drug manufactured outside the United States is the same as the FDA‐approved version and that the drug would be sold under a new National Drug Code, potentially making it less costly to U.S. residents.

Importation Is a Long Way Off

The Trump administration has been working to reduce drug prices at a time when the cost of insulin has nearly tripled between 2002 and 2013 and CAR T‐cell treatments such as Novartis’ Kymriah (tisagenlecleucel) cost $475,000 for a single use.

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