The Conflict Between the FDA’s Pre-Launch Activities Importation Request Program and the Hatch-Waxman Act

by Alex Cheng and Matthew Avery   –  

In 2008, the Food and Drug Administration (FDA) implemented the Pre-Launch Activities Importation Request (PLAIR) program.  The FDA exercises its enforcement discretion under the guise of the PLAIR program to permit drug manufacturers to import unapproved drugs into the United States so the manufacturers can expedite their commercial launches when they finally receive official FDA approval.  But the ability to import unapproved finished drug products into the United States ahead of anticipated FDA approval conflicts with certain provisions of the Hatch-Waxman Act that permit brand-name companies to use permanent injunctions to prevent the importation of generic equivalents of their drugs before patent expiration.  This article analyzes the conflict between the PLAIR program and the Hatch-Waxman Act and discusses solutions to the conflict.

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