Bausch + Lomb to Pay $34 Million to Settle Misbranding Allegations

Bausch + Lomb, a global eye health company announced that its subsidiary ISTA Pharmaceuticals reached an agreement with the Department of Justice to resolve civil and criminal allegations involving misbranded drugs. Bausch + Lomb acquired ISTA in 2012 and the controversial conduct occurred between January 2006 and March 2011. ISTA will pay approximately $34 million in fines which includes interest and attorney’s fees and will be prohibited from participating in federal health care programs including Medicare or Medicaid.

Certain drugs previously held by ISTA have been transferred to Bausch + Lomb and are not subject to exclusion or reimbursement. Those drugs include Bepreve®, Bromday®, Istalol®, Prolensa® and Vitrase®. ISTA Pharmaceuticals Inc. will be wound down by the end of 2013.

Although Bausch + Lomb did not discuss the specific allegations, other news sources report that ISTA Pharmaceuticals marketed drugs for unapproved use and tried to incentivize the drugs with golf outings and wine tastings for prescribing physicians. The misbranded drug was approved to treat pain and inflammation following cataract surgery. ISTA employees gave physicians information sheets on unapproved uses for the drug.