ISTA Pharmaceuticals, Inc. has pled guilty to two felony counts: conspiracy to introduce a misbranded drug into interstate commerce, and conspiracy to pay illegal remuneration in violation of the Federal Anti-Kickback Statute. In a federal court proceeding in the Western District of New York, the drug company admitted that it conspired to misbrand its anti-inflammatory drug Xibrom by promoting it for off-label uses. ITSA also admitted that its employees offered kickbacks in the form of free drugs, golf outings, and honoraria to doctors who prescribed Xibrom.
As a consequence of the plea, ISTA’s parent company has agreed to institute a rigorous new Compliance and Ethics Program. ISTA will also pay a total of $33.5 million to state and federal authorities, $15 million of which will settle a related civil case. Approximately $2.5 million of that amount will be awarded to Keith Schenker, the whistleblower who originally initiated the suit as a qui tam action.
Read the entire press release, “ISTA Pharmaceuticals Inc. Pleads Guilty to Federal Felony Charges; Will Pay $33.5 Million to Resolve Criminal Liability and False Claims Act Allegations”