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Cancer Drug Manufacturer Settles Three-year Court Battle Over Alleged FCA Violations

The Department of Justice announced that the pharmaceutical manufacturer Celgene has agreed to pay $280 million to settle allegations that the company fraudulently promoted two cancer treatment drugs for uses not approved by the FDA. A whistleblower accused Celgene of allegedly violating the False Claims Act (FCA) and the laws of various states by submitting claims that were based on these unapproved uses. Under the agreement, the federal government will receive nearly $260 million dollars, and 28 states will split just over $20 million.

The allegations involved the two cancer medications called Thalomid and Revlimid. The company allegedly promoted uses of these two medications that were unapproved and also allegedly paid kickbacks to physicians to induce them to prescribe the drugs. A sales manager for Celgene brought the case.

In a statement found on the Celgene website, the company denied any wrongdoing in the matter and emphasized that the settlement was meant to avoid further costly litigation. The company also noted that it was not required to enter into a Corporate Integrity Agreement as part of the settlement.

Robert B. Vogel, MD, JD
Retinal Ophthalmologist at Piedmont Eye Center, Lynchburg VA;
Attorney, Overbey Hawkins & Wright, PLLS, Lynchburg, VA;
Adjunct Professor, Humanities and Bioethics, Liberty University School of Medicine, Lynchburg, VA.