White House Reviewing Importation Notice, Framework Forthcoming

Libby Baney and Matthew Rubin examined an October 7, 2019, draft guidance from the U.S. Department of Health and Human Services (HHS). The draft guidance is likely connected to Pathway 2 of HHS' Safe Importation Action Plan, which intends to "provide domestic pharmaceutical manufacturers the ability to re-import FDA-approved prescription drugs sold in other countries through the creation of a new national drug code (NDC), labeling, and identification in compliance with the Federal Food, Drug and Cosmetics Act."