Quick Facts
FONT-SIZE Plus   Neg
Share SHARE
mail  E-MAIL

ISTA To Pay $34 Mln To Resolve Charges Against Misbranding Xibrom

5/25/2013 3:27 AM ET

Global eye health company, Bausch & Lomb Friday said that its subsidiary ISTA Pharmaceuticals, Inc.,(ISTA: Quote) has agreed to pay about $34 million to resolve charges against it for introducing its anti-inflammatory Xibrom for unauthorized uses in an aim to expand sales. Bausch & Lomb which was aware of the federal issues against ISTA, acquired the latter during June last year.

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, the eye care company said in a statement. Carrying charges of illegally introducing a misbranded drug, Xibrom, into interstate commerce, ISTA also pled guilty in the Western District of New York to have willingly paid remuneration to the physicians in an attemept to make them prescribe Xibrom, in violation of the federal Anti-Kickback Statute.

Between 2005 and 2010, some ISTA employees promoted Xibrom for unapproved new uses, including the use of Xibrom after Lasik and glaucoma surgeries, and for the treatment and prevention of cystoid macular edema. The drug was approved by the FDA to treatr pain and inflammation following cataract surgery. ISTA also pled guilty to offering free products, a golf outing, a wine-tasting event, paid consulting gigs and honoraria to doctors, in an effort to induce them to prescribe Xibrom.

Pursuant to the plea agreement, ISTA will pay a total of $18.5 million, including a criminal fine of $16.1 million for the conspiracy to introduce misbranded Xibrom into interstate commerce, $500,000 for the conspiracy to violate the Anti-Kickback Statute, and $1.85 million in asset forfeiture associated with the misbranding charge. ISTA through a civil settlement agreement agreed to pay $15 million to the federal government and states to resolve claims arising from its marketing of Xibrom, which caused false claims to be submitted to government health care programs. ISTA will further be prohibited from participating in federal healthcare programs such as Medicare and Medicaid.

Register
To receive FREE breaking news email alerts for Ista Pharmaceuticals Inc and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Starbucks Corp. said Thursday after the markets closed that its second quarter profit rose 9.4% from last year, helped by higher revenue. The company's quarterly earnings per share came in line with analysts' expectations, but its quarterly revenue fell short of analysts' forecast. The world's largest specialty coffee retailer also raised its full year earnings outlook. Software giant Microsoft Corp. said Thursday after the markets closed that its third quarter profit fell 6.6% from last year, when results were boosted by special upgrade offer revenues. However, the company's quarterly earnings per share came in above analysts' expectations as did its quarterly revenue. Apple Inc. said Wednesday after the markets closed that its second quarter profit rose 7% from last year, as sales surged and margins improved amid strong sales of its iPhones. The company's quarterly earnings per share also came in above analysts' expectations as did its quarterly revenue. At the same time, the company gave a slightly downbeat revenue forecast for the current quarter.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.