Federal agency reaches settlement with AbbVie in fraud case.
The Department of Insurance has reached a $24 million settlement with pharmaceutical giant AbbVie requiring it to alter marketing practices for Humira. After the immunology drug, used to treat Crohn’s, arthritis, and colitis, among other ailments, faced off against the competition in the international market, foreign sales dropped by 20 percent. The agreement ends an Alameda Superior Court lawsuit brought by the state of California alleging AbbVie violated the Insurance Frauds Prevention Act.
“AbbVie’s prior practices in marketing Humira egregiously put profits ahead of transparency in patient care and violated California law,” California Insurance Commissioner Ricardo Lara said. “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.”
The issue at the center of the suit was the company’s nurse ambassador program, which the company defended as encouraging engagement with patients at the same time it denied any wrongdoing. The ambassadors hired to speak with clients about Humira did not disclose they were AbbVie employees and, the lawsuit alleged, while “the company also unlawfully provided valuable professional goods and services to doctors at no cost to induce them to prescribe Humira.”
“Patient support programs, such as AbbVie’s Humira Complete Nurse Ambassador program, are important for helping patients to access and adhere to the life-changing treatments their doctors have prescribed,” a company statement said. “Although federal courts have considered the issues raised in this proceeding and have dismissed parallel cases, this resolution allows us to proceed with our important programs and focus our efforts on enhancing the lives of the patients we serve.”
As part of the settlement, AbbVie agreed to a monetary payment under which the state of California will receive $15 million and a former AbbVie nurse who reported the practices will get the remaining $9 million. It must also abide by certain terms and conditions in carrying out its program. In California, nurse ambassadors must now disclose they work for AbbVie and cannot to have patient-specific conversations with providers, particularly regarding patient discussion with their insurers. Prescribing providers will no longer be invited to offsite business meals, and patients must be given copies of the Food and Drug Administration (FDA)-approved Humira medication guide.
In early June, Judge Manish Shah of the United States District Court for the Northern District of Illinois granted AbbVie’s motion to dismiss plaintiff’s Sherman Act claims concerning Humira because the allegations fell “short of alleging the kind of competitive harm remedied by antitrust law.” Plaintiffs were two sets of indirect purchasers in a consolidated class action alleging the drug manufacturer, alongside competing biosimilar manufacturers, “exercised monopoly power over the market for the drug Adalimumab.” The court held, however, “that plaintiffs had failed to show that competitors could have entered the market and lowered Adalimumab drug prices for consumers any sooner than the dates set in the settlement agreements and therefore the antitrust injury in this case was too speculative.” Therefore, “AbbVie’s conduct caused no antitrust injury to consumers.”