ISTA Pharmaceuticals, Inc. has pled guilty to felony charges relating to its marketing of Xibrom, an anti-inflammatory drug that was approved by the FDA to treat pain and inflammation following cataract surgery. The criminal charges arise from violations of the Food, Drug and Cosmetic Act (FDCA), which prohibits a drug company from introducing into interstate commerce any drug that the company intends to be used for purposes that have not been approved by the Food and Drug Administration. According to the government’s allegations, ISTA Pharmaceuticals, Inc. employees promoted Xibrom for unapproved new uses, including its use following Lasik and glaucoma surgeries, and for the treatment of cystoid macular edema.
ISTA Pharmaceuticals, Inc. also pled guilty to a conspiracy to offer remuneration to physicians to induce them to prescribe Xibrom, which violates the federal Anti-Kickback Statute. The illegal inducements included providing physicians with free Vitrase (another ISTA Pharmaceuticals product), and sponsoring free golf outings, wine-tasting events, and paid speaking arrangements.
In addition to pleading guilty to criminal charges, ISTA Pharmaceuticals, Inc. also agreed to resolve two federal False Claims Act lawsuits. The whistleblower who initiated these cases will receive $2.5 million as his share of the government’s recovery
For more information on this case, click here: http://www.justice.gov/opa/pr/2013/May/13-civ-606.html