International – Two New FDA, HHS Plans to Allow Drug Importation From Canada, Overseas

As part of plans to lower the cost of prescription drugs, the US Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) on Wednesday released preliminary plans to create two new pathways to import pharmaceuticals.

The first pathway will allow states, wholesalers or pharmacists to submit plans for demonstration projects to import medicines from Canada under a Notice of Proposed Rulemaking (NPRM) from HHS that has yet to be released. And the NPRM is expected to propose several limitations (i.e. only facilities that also manufacture API for the FDA-approved version would be allowed) and exclusions (no costly biologics, drugs with a REMS or infused or injected drugs) that may raise further questions about what drugs would actually be imported and how much could be saved.

Pharmacists in Canada and others within Health Canada have expressed concerns in recent weeks that allowing such imports could create shortages or raise costs for Canadians.

The second pathway, meanwhile, would mandate new guidance from FDA that allows manufacturers to voluntarily import US versions of drugs sold in foreign countries, potentially at a lower price…