A newly unsealed whistleblower lawsuit accuses Novartis and Genentech of being at the center of a decades-long kickback scheme to promote their immunology med Xolair across dozens of states.<\/p>\n
Whistleblowers represented by Pharma Integrity\u00a0LLC filed<\/a> the suit against a handful of named pharma companies, including Novartis, Genentech, Sanofi, Regeneron, AstraZeneca, Amgen and GSK in January on behalf of 30 states and Washington, D.C. The lawsuit was unsealed earlier this month by U.S. District Court Judge Michelle Williams, as two states (Maryland and Florida) have now declined to intervene in the case, meaning that the seal on the filing can lift and be served to the pharma companies involved by July 20. The remaining state governments are \u201cnot intervening at this time,\u201d according to the update.\u00a0<\/p>\n According to the 143-page suit, Novartis and Genentech illegally boosted prescriptions of Xolair and later helped its \u201csuccessor biologics\u201d including Sanofi and Regeneron\u2019s Dupixent, AZ\u2019s Fasenra, Amgen and AZ\u2019s Tezspire and Genentech\u2019s Raptiva and Pulmozyme starting in 2003 through illegal kickbacks, off-label promotional messaging, false Medicare coverage instructions and other actions using several specialty pharmacies across the U.S. such as Walgreens, Express Scripts, CVS and others.\u00a0<\/p>\n In exchange for the specialty pharmacies’ overriding codes, falsifying documentation, and using other illegal routes to accelerate Xolair claims, the pharmacies allegedly received office equipment and computers, \u201clavish dinners,\u201d sports events and more incentives. Genentech and Novartis also allegedly used disease-specific co-pay charities as \u201ckickback pass-throughs\u201d to broaden market share, the lawsuit claims, facilitating thousands of false claims to Medicare and state Medicaid programs.\u00a0<\/p>\n The fraudulent scheme speaks to \u201cdeliberate, systemic violations of the Anti-Kickback Act and reckless disregard for Medicare and Medicaid rules,\u201d the lawsuit says. The whistleblower plaintiff group is made up of five former employees with direct knowledge of the companies’ alleged activities across more than 20 states. In their suit, the unnamed whistleblowers testify to their specific experience overseeing Xolair sales and the \u201cpervasive misconduct\u201d involved.<\/p>\n \u201cThe above-described practices by Defendants have caused the submission of hundreds of millions, if not billions, of dollars\u2019 worth of false and fraudulent claims to Government Health Care Programs for reimbursement,\u201d Pharma Integrity explains. \u00a0<\/p>\n Novartis and Genentech did not immediately respond to Fierce Pharma\u2019s request for comment.\u00a0<\/p>\n Novartis and Genentech\u2019s Xolair playbook was allegedly adopted by Sanofi, Regeneron and the others for their own drugs, in some cases using the same speaker networks, sales-force guidance and incentive structures to boost their biologics. These promotions cause \u201cexponentially greater damages than traditional drug fraud\u201d due to the nature of the chronic disease drugs, meant for long-term or lifetime use, the lawsuit explains.\u00a0<\/p>\n For its purported violations under the False Claims Act, the suit seeks trebled (tripled) damages for each state, plus civil penalties for each false claim.\u00a0<\/p>\n Xolair was first approved as an asthma treatment in 2003 and has since stacked on a collection of other indications that cover nasal polyps, allergic asthma, chronic idiopathic urticaria and, most recently, food allergies<\/a>. Last year, Novartis reported<\/a> $1.7 billion in sales of the drug, up 5% from 2024. Genentech\u2019s parent company, Roche, which markets the drug in the U.S., logged $3.7 billion (3.08 billion Swiss francs) in U.S.-specific sales<\/a> (PDF). The company still counts Xolair as one of its five highest growth drivers<\/a>, with steadily increasing sales despite its lengthy tenure on the market.\u00a0<\/p>\n