ISTA Pharmaceuticals to Pay $33.5 Million To Resolve Criminal, Civil Off-Label Cases

As part of a $33.5 million resolution of criminal and civil liability, ISTA Pharmaceuticals Inc. pleaded guilty May 24 to a conspiracy charge stemming from promotion and sale of its anti-inflammatory eye drug Xibrom for unapproved uses (United States v. ISTA Pharmaceuticals).

The company pleaded guilty in the U.S. District Court for the Western District of New York to two conspiracy charges—one for introducing a misbranded drug into interstate commerce, and one for offering payments to doctors to induce them to prescribe ISTA’s drug. ISTA’s plea agreement was part of a larger settlement agreement including two qui tam ...