FDA, Bankruptcy, Criminal Prosecution, Forfeitures and GMPs-An Unusual Combination

June 11, 2008

In a case involving a highly unusual set of facts for FDA-regulated companies, Leiner Health Products, Inc. (Leiner) is seeking to have a plea agreement approved by a Bankruptcy court.  The case involves violations of Current Good Manufacturing Practices (cGMPs) for over-the-counter drugs.  What also makes this case unusual is that the violation alleged in the case is not an FDC Act violation for selling adulterated or misbranded drugs.  Instead, the government is apparently seeking a plea from Leiner to violations of the Mail Fraud Act under 18 U.S.C. § 1341.  Also unusual is that under the proposed agreement Leiner would not have to pay any criminal fine.  Instead, it would pay a ten million dollar forfeiture. 

The Motion, proposed Information and Plea Agreement are available here.

Categories: Enforcement