Pharmaceutical giant Novo Nordisk Inc. has agreed to a significant settlement of $58.65 million, resolving allegations of non-compliance with the Food and Drug Administration (FDA)-mandated Risk Evaluation and Mitigation Strategy (REMS) for its Type II diabetes medication, Victoza. Announced by the Department of Justice, the resolution includes a $12.15 million disgorgement for alleged violations of the Federal Food, Drug, and Cosmetic Act (FDCA) spanning from 2010 to 2012, alongside a $46.5 million payment for alleged False Claims Act (FCA) violations between 2010 and 2014. This case underscores the critical importance of pharmaceutical companies adhering to patient care programs and ensuring transparent communication about medication risks.
Novo Nordisk, a subsidiary of Novo Nordisk U.S. Holdings Inc., itself a subsidiary of Denmark-based Novo Nordisk A/S, faced scrutiny over its Victoza marketing and communication strategies. The U.S. headquarters of Novo Nordisk is located in Plainsboro, New Jersey.
“This resolution today reaffirms the Department of Justice’s unwavering commitment to enforcing legal compliance among drug manufacturers,” stated Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division. “When pharmaceutical companies fail to provide doctors and patients with accurate risk information, they undermine the very foundation of informed medical decision-making.” This failure directly impacts the effectiveness of patient care programs that rely on accurate and timely information.
The crux of the case, detailed in a civil complaint filed in the U.S. District Court for the District of Columbia, revolves around Victoza’s FDA approval in 2010. A key condition of this approval was the implementation of a REMS program. This program was specifically designed to mitigate the potential risk of Medullary Thyroid Carcinoma (MTC), a rare form of cancer, associated with Victoza. The REMS mandated that Novo Nordisk must actively inform physicians about this potential MTC risk. Failure to comply with REMS requirements, particularly concerning accurate risk communication, legally misbrands the drug. This highlights how crucial REMS are as part of a comprehensive patient care program.
According to the complaint, Novo Nordisk sales representatives allegedly disseminated information to physicians that downplayed or misrepresented the REMS-mandated warnings. This created a false and misleading impression that the MTC risk was insignificant or not relevant. The government argued that this misinformation campaign constituted a failure to comply with the REMS, violating the FDCA and potentially leaving physicians unaware of crucial risks when prescribing Victoza. Such actions directly contradict the principles of robust patient care programs, which prioritize patient safety and informed consent.
Further allegations in the government’s complaint revealed that a 2011 survey indicated that half of primary care physicians were not aware of the MTC risk associated with Victoza. In response, the FDA mandated a modification to the REMS to enhance risk awareness. However, instead of fully implementing these modifications, Novo Nordisk allegedly instructed its sales force to continue using statements that obscured the risk information, further failing to comply with the revised REMS. This alleged behavior underscores a serious lapse in Novo Nordisk’s adherence to patient care program standards and regulatory requirements. As a consequence of these FDCA violations, Novo Nordisk has agreed to disgorge $12.15 million in profits.
U.S. Attorney Channing D. Phillips for the District of Columbia emphasized the severity of these actions, stating, “Novo Nordisk’s actions needlessly endangered vulnerable patients. We are dedicated to holding companies accountable for undermining the FDA’s vital role in ensuring doctors and patients have the accurate information necessary for informed healthcare decisions. Working with the FDA and our law enforcement partners, we are sending a clear message to the pharmaceutical industry today.” This sentiment resonates with the core values of patient care programs and the need for pharmaceutical accountability.
Assistant Director in Charge Andrew W. Vale of the FBI’s Washington Field Office added, “Novo Nordisk Inc. sales representatives misled physicians by obscuring a potentially life-threatening side effect of Victoza, thereby increasing risks for patients. The FBI is committed to ensuring honest and accurate risk information from the private sector to the public and will continue to collaborate with law enforcement partners to investigate companies that disregard FDA-mandated policies.” This highlights the FBI’s role in upholding patient safety and ensuring the integrity of patient care programs.
Special Agent in Charge Nick DiGiulio of the U.S. Department of Health and Human Services Office of the Inspector General (HHS-OIG) reinforced this point, stating, “We must have confidence that pharmaceutical companies truthfully represent the potential risks of their products. We will continue to work with our partners to ensure federal healthcare funds are used only for drugs marketed with integrity.” This underscores the financial implications and ethical responsibilities associated with patient care programs and pharmaceutical marketing.
In addition to the disgorgement, Novo Nordisk will pay $46.5 million to the federal government and states to resolve claims under the FCA and state false claims acts. This portion of the settlement addresses allegations that Novo Nordisk’s misleading sales messages, downplaying the Victoza REMS and MTC risk, led to the submission of false claims to federal healthcare programs for Victoza between 2010 and 2014. Furthermore, the settlement addresses allegations that Novo Nordisk encouraged the use of Victoza in adult patients without Type II diabetes, for whom the FDA has not approved the drug. This unauthorized promotion further deviates from responsible patient care program practices.
The FCA settlement will allocate $43,129,026 to the federal government and $3,320,963 to state Medicaid programs, which are jointly funded by federal and state governments.
This settlement resolves seven whistleblower lawsuits filed under the federal FCA, allowing private parties to sue on behalf of the U.S. government for false claims and share in the recovery. The lawsuits are listed in the original article for reference.
The settlements are a result of collaborative efforts between the U.S. Attorney’s Office for the District of Columbia, the Civil Division’s Consumer Protection Branch, and the Commercial Litigation Branch, with support from the FDA’s Office of Chief Counsel. The investigation involved multiple agencies, including the FDA’s Office of Criminal Investigations, the FBI, HHS-OIG, the Defense Criminal Investigative Service, and the Office of Personnel Management, Office of the Inspector General.
This case serves as a stark reminder of the critical role of accurate risk communication and robust patient care programs in the pharmaceutical industry. Novo Nordisk’s settlement underscores the potential consequences of failing to prioritize patient safety and transparent information sharing, even within established care program frameworks like REMS. For more information on related topics, please refer to the websites of the Consumer Protection Branch, the Commercial Litigation Branch’s Fraud Section, and the U.S. Attorney’s Office for the District of Columbia, as provided in the original source.
