The US Department of Justice stated Friday that Bausch & Lomb's ISTA Pharmaceuticals unit agreed to pay $33.5 million to settle criminal and civil allegations arising from its marketing, distribution and sale of the anti-inflammatory drug Xibrom (bromfenac). The company, which was acquired by Bausch & Lomb last year, also pled guilty to conspiracy to introduce a misbranded drug into interstate commerce and to conspiracy to pay illegal remuneration in violation of the Federal Anti-Kickback Statute, the DOJ said.
The DOJ alleged that ISTA promoted Xibrom for unapproved uses, including after Lasik and glaucoma surgeries and to treat cystoid macular oedema. Additionally, company management instructed some employees not to document their interactions with doctors concerning unapproved uses of the drug or to leave printed material regarding these uses in doctors' offices. The company admitted to offering enticements, such as free products, paid consulting work and honoraria to doctors to induce them to prescribe the medicine.
In total, ISTA agreed to pay $18.5 million to resolve criminal charges and $15 million to the federal government and states in a civil settlement related to claims submitted to the federal government for off-label use of Xibrom. ISTA will also be barred from participating in federal healthcare programmes such as Medicare and Medicaid, although Bausch & Lomb noted that several products that it transferred within itself, including the eye treatments Bepreve (bepotastine besilate) and Bromday (bromfenac), will be exempted from the ban. Additionally, Bausch & Lomb agreed to maintain a compliance and ethics programme to ensure compliance with FDA regulations and state and federal laws.
Bausch & Lomb noted that the settlement involves conduct by ISTA that occurred between January 2006 and March 2011, prior to its acquisition of the company. Since then, the company says it has integrated ISTA's portfolio of products and related operations, and will wind down the ISTA corporate entity by the end of the year.
In related news, Valeant Pharmaceuticals reached a definitive agreement to acquire Bausch & Lomb for $8.7 billion.
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