FDA Issues Proposed Rule and Draft Guidance on Drug Importation

King & Spaulding

In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two pathways for drug importation. HHS previewed these approaches in its Safe Importation Action Plan last July.

These proposed pathways are broadly, if not necessarily effectively, aimed at reducing U.S. drug prices in two different ways:

1. The Proposed Rule sets out a means by which States and certain other non-federal governmental entities would be permitted to import certain drugs (notably excluding biologics and many specialty pharmaceuticals) from Canada. Manufacturer consent is not required for importation under this “Pathway I,” but many manufacturer obligations and risks flow from it.

2. The Draft Guidance creates a framework under which manufacturers could choose to bring their drugs that are manufactured and intended for sale outside the U.S. into the U.S. market. This “Pathway II” would permit both “domestic” National Drug Codes (NDCs) and “imported” NDCs of the same product to be marketed simultaneously.

Full Article

This post expires and will no longer be available at 7:42 pm on Friday, January 8th, 2021

Tags:
0 Comments

Leave a reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.

National Association of Drug Diversion Investigators Federal Tax ID: 52-1660752 / DUNS Number: 073539913

Copyright © 2020 - NADDI. All Rights Reserved. Privacy Policy / Trademark Policy / Copyright Policy / Refund Policy

Log in with your credentials

or    

Forgot your details?

Create Account