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Humira Settlement Results in $25M Payment by AbbVie Over Kickbacks, Lack of Proper Side Effects Warnings

California officials indicate AbbVie agreed to pay $24 million to resolve claims the company committed fraud by not fully reporting the side effects of Humira while marketing of the blockbuster immunosuppressant drug.

The California Department of Insurance Fraud issued a press release on August 6, announcing the Humira settlement agreement (PDF) with AbbVie, Inc.

According to state officials, AbbVie’s marketing tactics resulted in more than $1 billion in improper Humira prescription claims. The fraud charges were the result of a whistleblower lawsuit filed in 2018 by a registered nurse, who indicated that she and other so called “Nurse Ambassadors” interacted with patients without telling them they were being paid by Humira, and indicated AbbVie’s sales reps provided valuable goods and services to doctors in order to get them to prescribe Humira.

State investigators found the Nurse Ambassadors interfered with doctor-patient communications and say they failed to provide patients with a full accounting of the drug’s potential side effects and drawbacks.

Humira (adalimumab) is a tumor necrosis factor blocker, also known as TNF blocker, which was approved by the FDA in 2003 for treatment of rheumatoid arthritis. It later gained approval for treatment of psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, moderate to severe chronic psoriasis and juvenile idiopathic arthritis, which was previously called juvenile rheumatoid arthritis. The drug pulled in sales of $6.5 billion in 2010.

“AbbVie’s prior practices in marketing HUMIRA egregiously put profits ahead of transparency in patient care and violated California law,” California Department of Insurance Commissioner Ricardo Lara said in the press release. “This settlement delivers important reforms to AbbVie’s business practices and a substantial monetary recovery that will be used to continue to combat insurance fraud.”

While AbbVie has refused to admit guilt, the company agreed to pay $24 million to resolve the claims and will require nurse ambassadors to disclose they work for the drug maker. AbbVie will also prohibit Humira sales representatives from providing offsite business meals and other gifts; will provide patients with the FDA-approved Humira prescription and medication guides; and will bar nurse ambassadors from having patient-specific discussions with health care providers.

In addition, the company will prohibit its employees from describing nurse ambassadors as extensions of AbbVie officers and will not participate in conversations between patients and insurance companies.

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