A distinct component of the healthcare industry includes companies that manufacture, distribute or dispense prescription medicines (hereinafter, pharmaceutical company or companies). In general, these companies are regulated by the Food and Drug Administration, which is an agency of the US Department of Health and Human Services (HHS). Pharmaceutical companies that produce, distribute or dispense controlled substance prescription medicines are also regulated by the Drug Enforcement Administration (DEA), an agency of the US Department of Justice (US DOJ). As The Healthcare Industry chapter describes in depth, civil or criminal settlement agreements for violations of law often result in the appointment of a monitor or an independent review organisation (IRO).
For the most part, pharmaceutical company settlements resulting in a monitorship or IRO have involved violations of a broad array of healthcare laws, including fraudulent claims, kickbacks to prescribers, payments of inappropriate speaker fees, misbranding violations and foreign bribery. What has been less common are settlements stemming primarily from violations of the Controlled Substances Act (CSA). The CSA authorises the DEA to regulate licensed pharmaceutical companies that handle controlled substance prescription drugs, including opioids. As the United States continues to battle with opioid addiction (which has been exacerbated by the global pandemic), settlements of CSA-related allegations have...
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