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Copyright (c) 2000 The Food and Drug Law Institute
Food and Drug Law Journal

ARTICLE: Abbott Laboratories Consent Decree and Individual Responsibility Under the Federal Food, Drug, and Cosmetic Act

2000

55 Food Drug L.J. 145

Author

Eric M. Blumberg*

Excerpt

I. INTRODUCTION

This paper will focus on two matters. First, it will describe the background, major provisions, and Food and Drug Administration (FDA) rationale for the recent Consent Decree of Permanent Injunction agreed to by Abbott Laboratories (Abbott). Secondly, it will explain why FDA seeks to identify and hold individual defendants responsible in its enforcement cases, including injunctions.

II. THE ABBOTT CONSENT DECREE

On November 2, 1999, FDA filed a Complaint for Injunction and a Consent Decree of Permanent Injunction in the U.S. District Court for the Northern District of Illinois. 1 The Complaint alleged that:

* An establishment inspection conducted between May and July 1999 disclosed forty-five deviations from the Quality System Regulation at Abbott's K-2 and Abbott Park facilities, which manufacture in vitro diagnostic devices. 2
* Previous FDA inspections, conducted between 1993 and 1998, disclosed deviations similar to those found in 1993. 3
* Abbott and FDA met no fewer than ten times during these years to discuss current good manufacturing practices (cGMPs) and, to avoid taking judicial action, FDA allowed the company to continue to operate under an FDA-monitored compliance plan that began in 1995. 4
* FDA terminated the plan in early 1998 because, in its view, the company was not making sufficient progress. 5

The 1999 inspection and court filings followed.

Three provisions make this consent decree novel and of particular interest: 1) a one-time payment by Abbott to the U.S. Department of Treasury for $ 100 million; 6 2) provisions requiring ...
 
 
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