ROCHESTER, N.Y., May 24, 2013 /PRNewswire/ -- Bausch + Lomb, the global eye health company, announced today its subsidiary, ISTA Pharmaceuticals, Inc., a corporation that it acquired in June 2012, has reached agreement with the U.S. government to resolve and conclude civil and criminal allegations against ISTA. The settlement involves conduct by ISTA that occurred between January 2006 and March 2011, well before Bausch + Lomb's acquisition. Bausch + Lomb was aware of the government investigation prior to its acquisition, and has fully cooperated with the government to resolve this matter. The government has acknowledged that it has no knowledge that Bausch + Lomb, any current director or officer of Bausch + Lomb, or any current director or officer of ISTA was party to any conduct related to this case.
In connection with the settlement, ISTA has pled guilty to charges of Conspiracy to Introduce a Misbranded Drug in Interstate Commerce with Intent to Defraud and Mislead and Conspiracy to Violate the Anti-Kickback Statute. As part of the settlement, ISTA has agreed to pay approximately $34M in civil and criminal fines including interest and attorney's fees, and will be prohibited from participating in federal healthcare programs such as Medicare and Medicaid. However, Bepreve ®, Bromday ®, Istalol ®, Prolensa ® and Vitrase ® have been transferred to Bausch & Lomb Incorporated, and therefore are not subject to any exclusion resulting from this settlement and continue to be eligible for reimbursement under those programs.
"Bausch + Lomb is committed to earning trust in everything that we do and is pleased to have resolved this pre-acquisition issue in cooperation with the U.S. Attorney's Office for the Western District of New York, the U.S. Department of Justice and the Office of the Inspector General of the U.S. Department of Health and Human Services," said Bob Bailey, executive vice president, Law, Policy and Communications, Bausch + Lomb.
Since acquiring ISTA Pharmaceuticals in 2012, Bausch + Lomb has integrated ISTA's portfolio of products and related operations, and will wind down the ISTA Pharmaceuticals, Inc. corporate entity by the end of the year.