Pharma companies "must be held fully accountable for defrauding US government," says Public Citizen

Public Citizen strongly supports a measure proposed by US Senator Bernie Sanders (Independent, Vermont) that would more effectively curb fraudulent activity committed by the pharmaceutical industry against the federal and state governments, stated Sammy Almashat, a researcher at the US consumer advocacy group.

The provision, embodied in an amendment to S3187, the Food and Drug Administration Safety and Innovation Act (FDASIA – the renewal of the Prescription Drug User Fee Act) – would rescind data exclusivity rights of a pharmaceutical product granted under the Food, Drug and Cosmetic Act (FDCA) if the company marketing that product is found, or admits to, engaging in unlawful activity involving the drug. Data exclusivity refers to the exclusive marketing rights granted by the federal government to most brand-name pharmaceuticals for several years following approval.

Such an amendment has never been more necessary, says Dr Almashat, adding that, “over the past two decades, the pharmaceutical industry has emerged as the biggest defrauder of the federal government under the False Claims Act (FCA) and has paid $23 billion in settlements and fines to the federal and state governments for myriad civil and criminal violations of the FCA and other laws.”