FDA Drafts Guidance for Importation of Medications
On December 17, 2019, The Food and Drug Administration (FDA) proposed guidance for the importation of medications from Canada. The goal of this proposal is to allow patients access to FDA approved medications from abroad at a lower cost. The guidance would allow states, wholesalers, and pharmacies to come up with proposals for safe importation and submit them for federal approval.
In addition, the guidance would allow manufacturers to import from overseas cheaper versions of their medications into the U.S. The manufacturer would have to prove to the FDA the overseas version of its drug is the same as the FDA-approved version, and allow Americans to purchase it for a lower cost. Some experts believe manufacturers may use this to offer a lower cost option that does not offer rebates to Pharmacy Benefit Managers (PBM).