ISTA Pharmaceuticals Inc., Felony Charges, New York 2023

Grimy Times has obtained information that ISTA Pharmaceuticals Inc., a pharmaceutical company based in California, has pleaded guilty to felony charges in the Western District of New York. The company will pay a total of $33.5 million to resolve criminal and civil liability arising from its marketing, distribution, and sale of its drug Xibrom.

ISTA Pharmaceuticals pleaded 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. U.S. District Court Judge Richard J. Arcara accepted ISTA’s guilty pleas on [Date].

The guilty pleas are part of a global settlement with the United States. ISTA Pharmaceuticals agreed to pay $33.5 million to resolve criminal and civil liability arising from its marketing, distribution, and sale of its drug Xibrom. The company will pay $18.5 million under the terms of the plea agreement, including a criminal fine of $16,125,000 for the conspiracy to introduce misbranded Xibrom into interstate commerce, $500,000 for the conspiracy to violate the Anti-Kickback Statute, and $1,850,000 in asset forfeiture.

ISTA Pharmaceuticals conspired to introduce misbranded Xibrom into interstate commerce. The company conspired to illegally introduce a misbranded drug, Xibrom, into interstate commerce. Under the Food, Drug and Cosmetic Act, 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.

Between 2005 and 2010, some ISTA Pharmaceuticals employees promoted Xibrom for unapproved new uses, including the use of Xibrom following Lasik and glaucoma surgeries, and for the treatment and prevention of cystoid macular edema. The evidence showed that continuing medical education programs were used to promote Xibrom for uses that were not approved by the FDA as safe and effective, and that post-operative instruction sheets for unapproved uses were paid for by some company employees and provided to physicians.

ISTA Pharmaceuticals agreed that this conduct represented an intent to defraud under the law. In addition, ISTA Pharmaceuticals pled guilty to a conspiracy to knowingly and willfully offering or paying remuneration to physicians in order to induce those physicians to prescribe Xibrom, in violation of the federal Anti-Kickback Statute. Under the law, it is illegal to offer or pay remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to physicians to induce them to refer individuals to pharmacies for the dispensing of drugs, for which payments are made in whole or in part under a Federal health care program.

Under the terms of the plea agreement, ISTA Pharmaceuticals will pay a total of $18.5 million, including a criminal fine of $16,125,000 for the conspiracy to introduce misbranded Xibrom into interstate commerce, $500,000 for the conspiracy to violate the Anti-Kickback Statute, and $1,850,000 in asset forfeiture. ISTA Pharmaceuticals agreed to pay $33.5 million to resolve criminal and civil liability arising from its marketing, distribution, and sale of its drug Xibrom.

ISTA Pharmaceuticals is a pharmaceutical company based in California. The company’s guilty plea and $33.5 million settlement are a significant blow to the company’s reputation and finances. ISTA Pharmaceuticals must now face the consequences of its actions and work to regain the trust of its customers and partners.

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