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ISTA Pharmaceuticals Pleads Guilty to Criminal Charges Involving Xibrom

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According to the Department of Justice, another large pharmaceutical company has recently pled guilty to criminal charges and will pay a $33.5 fine for illegally marketing a prescription medication—this time, a cataract drug called "Xibrom."

A subsidiary of Bausch & Lomb, ISTA Pharmaceuticals agreed to pay the fine to settle criminal and civil liability, and will be barred from participating in Medicare and Medicaid. The case was heard before U.S. District Judge Richard Arcara in the Western District of New York, Buffalo.

Xibrom Approved to Treat Postoperative Pain and Inflammation

Xibrom was originally marketed by Senju Pharmaceuticals Co. Ltd in Japan. Ista acquired U.S. marketing rights in May 2002. They studied the product in over 500 patients, and found that those who used the drops after cataract surgery were more likely to experience an absence of inflammation after the surgery than those who received a placebo. In addition, 75 percent of those experiencing pain after surgery were pain-free within two days of being treated with Xibrom twice daily.

A topical, twice-daily, non-steroidal anti-inflammatory eye drop solution, Xibrom was quickly accepted by ophthalmologists in the U.S. Cleared by the FDA in March 2005, Xibrom (bromfenac) is approved to treat postoperative ocular inflammation in patients who have undergone cataract surgery—and in January 2006 to soothe pain after surgery as well.

ISTA was acquired by Bausch & Lomb in 2012.

ISTA Pleads Guilty

According to court documents, from 2005 to 2010, some ISTA employees allegedly promoted Xibrom for off-label, unapproved uses, such as to treat inflammation after other types of eye surgeries, including Lasik and glaucoma operations. The drug was also promoted to treat cystoid macular edema.

The U.S. Department of Justice stated that under the Food, Drug, and Cosmetic Act (FDCA), "it is illegal for a drug company to introduce into interstate commerce any drug that the company intends will be used for uses not approved by the Food and Drug Administration (FDA)."

Evidence showed that ISTA employees supported continuing medical education programs to promote Xibrom for off-label uses, and that company management told employees not to memorialize in writing certain interactions with physicians regarding unapproved new uses, and not to leave behind any printed materials that mentioned these uses.

The company also pled guilty to paying kickbacks to physicians who prescribed Xibrom, in violation of the federal Anti-Kickback Statue. Evidence showed that ISTA compensated physicians for prescribing Xibrom with free products, monetary payments, golf outings, wine tastings, and paid consulting or speaker arrangements.

"The fact that ISTA offered doctors illegal inducements—such as wine tasting, golf outings, 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," said U.S. attorney William J. Hochul, Jr.

ISTA will pay $16,125,000 for the conspiracy to introduce misbranded Xibrom into interstate commerce, $500,000 for violating the Anti-Kickback Statute, and $1,850,000 in asset forfeiture associated with the misbranding charge. It also agreed to pay $15 million to the federal government and states to resolve claims arising from its marketing of Xibrom.

"It is especially concerning when companies actively take steps to conceal improper conduct which may jeopardize public health," said Antoinette V. Henry, Special Agent in Charge, Metro-Washington Field Office, FDA Office of Criminal Investigations.

Bausch & Lomb said it was pleased to settle the case, and plans to wind down the ISTA corporate entity by the end of 2013.