ISTA Settlement Includes Divestiture and Debarment

In what has been one of the less prominent drug-settlements in recent times, the federal government recently entered into an agreement with ISTA Pharmaceuticals Inc. to resolve criminal liability and False Claims Act (FCA) allegations. This settlement, while not as widely covered as others, nevertheless has several important considerations that are likely to demonstrate the government's continued focus on finding new ways to punish companies. Specifically, ISTA pled guilty to conspiracy to introduce a misbranded drug into interstate commerce and conspiracy to pay illegal remuneration in violation of the Federal Anti-Kickback Statute. What is unique about this case is that in addition to paying $33.5 million to resolve criminal and civil liability arising from its marketing, distribution and sale of its drug Xibrom, ISTA will face mandatory exclusion from Federal healthcare programs.  Exclusion will mean that on the effective date of the exclusion, any ISTA labeled drugs in ISTA's possession would no longer be reimbursable by Medicare, Medicaid, or other Federal healthcare programs.  In June 2012, Bausch+Lomb (B+L) acquired ISTA.  Simultaneous with the False Claims Act settlement and the entry of the plea, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG), ISTA, and B+L will enter into a Divestiture Agreement under which ISTA agrees to be excluded for 15 years, effective six months after the date of the settlement.  U...
Source: Policy and Medicine - Category: Health Medicine and Bioethics Commentators Authors: Source Type: blogs