ISTA Pharmaceuticals Inc. pleaded guilty on Friday in a federal case involving its eye drug Xibrom, admitting it promoted the drug for unapproved uses and agreeing to pay $33.5 million in fines and fees.
ISTA, which was acquired by Rochester-based Bausch & Lomb Inc. last year, also pleaded guilty to violating anti-kickback laws by sponsoring outings intended to persuade doctors to prescribe Xibrom, an anti-inflammatory approved by the Food and Drug Administration to treat pain and inflammation after cataract surgery, the Department of Justice said.
“The fact that ISTA offered doctors illegal inducements — such as a wine tasting, golf outing and payments to attend what were in essence marketing sessions — makes the company’s illegal conduct particularly deserving of the hefty penalty ISTA has agreed to pay,” U.S. Attorney William Hochul said.
The violations took place more than a year before Bausch & Lomb gained control of the Irvine, Calif., company and integrated its products and operations. Bausch & Lomb said it will wind down the ISTA corporate entity by the end of the year.
“Bausch & Lomb is committed to earning trust in everything that we do and is pleased to have resolved this pre-acquisition issue,” the company’s executive vice president of law, policy and communications, Bob Bailey, said in a statement.
Bausch & Lomb did not hire any of ISTA’s senior managers or executives, said Daniel Levinson, inspector general of the U.S. Department of Health and Human Services.
ISTA, in its plea, admitted that some employees promoted Xibrom for unapproved uses including following Lasik and glaucoma surgery and for the treatment and prevention of cystoid macular edema.
Managers instructed employees not to keep written records of telling doctors about the other uses and told them not to leave printed materials in doctors’ offices, prosecutors said.
The company pleaded guilty in U.S. District Court to conspiracy to introduce a misbranded drug into interstate commerce and conspiracy to pay illegal remuneration.
