New Jersey-based pharma manufacturer Celgene has agreed to pay $280 million to settle fraud allegations connected to two cancer drugs that were allegedly promoted for uses not approved by the FDA, the Department of Justice announced.
The agreement specifies that Celgene pays $259.3 million to the United States and $20.7 million to 28 states and the District of Columbia. California will receive $4.7 million, the largest sum being paid to any of the states.
The settlement resolves allegations brought in a "whistleblower" lawsuit that Celgene promoted cancer drugs Thalomid and Revlimid for uses that were not approved by the FDA and not covered by federal healthcare programs. That meant that claims submitted for those drugs were fraudulent and violated the False Claims Act. Included in the allegations were that "false and misleading statements" were used to promote the drugs, and kickbacks were paid to physicians to compel them to prescribe the drugs. The lawsuit also claimed Celgene violated the laws of 28 states and the District of Columbia by submitting fraudulent claims to state healthcare programs, including California's Medi-Cal program.
"Patients deserve to know their doctors are prescribing drugs that are likely to provide effective treatment, rather than drugs marketed aggressively by pharmaceutical companies," said Acting United States Attorney Sandra R. Brown.
The whistleblower lawsuit was filed by Beverly Brown, a sales manager with Celgene. The DOJ did not specify any amount Brown might receive for her part in the suit as allowed by the whistleblower, or qui tam, provisions of the False Claims Act.