- Ravi Gupta, assistant professor of medicine1 2,
- Reshma Ramachandran, assistant professor of medicine3 4,
- Joseph S Ross, professor of medicine and health policy3 4 5 6
- 1Divison of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA
- 2Department of Health Policy and Management, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA
- 3Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT), Yale School of Medicine, New Haven, CT, USA
- 4Section of General Internal Medicine and National Clinician Scholars Program, Yale School of Medicine, New Haven, CT, USA
- 5Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA
- 6Department of Health Policy and Management, Yale University School of Public Health, New Haven, CT, USA
- Correspondence to: R Gupta raviguptaatjhmi.edu
In 2022, the pharmaceutical manufacturer Biogen paid $900m to settle a US suit brought by a former employee alleging that the company paid kickbacks to persuade doctors to prescribe its drugs for multiple sclerosis.12 Biogen admitted no wrongdoing in making the payment, but the whistleblower suit asserted that the company used consulting fees and honorariums for serving on speaker programmes and advisory boards to induce doctors to prescribe Avonex (interferon β-1a), Tysabri (natalizumab), and Tecfidera (dimethyl fumarate), in violation of the Anti-Kickback Statute. The statute prohibits payments to induce the provision of services paid for by federal programmes, including Medicare and Medicaid, which cover healthcare costs for older adults and low income individuals in the US, respectively. The litigation was filed under the US False Claims Act, a federal law that prohibits falsely billing the government.
The $900m settlement in the Biogen suit was among the largest ever and unique in many respects, but it was the latest in a recent string of US suits concerning drug company marketing. These include numerous opioid settlements totalling more than $50bn, a $3bn settlement with GlaxoSmithKline in 2012 for unlawful promotion of several drugs,3 and a $624m settlement with Novartis in 2020 for using speaker and consulting programmes to promote Afinitor (everolimus) and Gilenya (fingolimod).4 None of the companies admitted wrongdoing.
The actions that formed the subject of these lawsuits raise a fundamental question for regulators in the US and around the world about the appropriateness of excess targeted promotion of drugs and medical devices to doctors. The suits also highlight the need for reforming potentially valuable but easily manipulatable interactions between pharmaceutical …
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