HHS Drug Import Proposal Is Unlikely To Succeed

Law360 (January 16, 2020, 5:40 PM EST) -- In late December 2019, the U.S. Food and Drug Administration, an agency operating within the U.S. Department of Health and Human Services, issued two documents — a proposed rule and a draft guidance — intended to establish two pathways for drug importation. The U.S. Department of Health and Human Services 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.

The proposed rule sets out a means by which states and certain other nonfederal governmental entities would be permitted to import...

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