Letter to the FDA Calling for Investigation Into an Apparent Illegal Clinical Trial That Tested Unapproved Naltrexone Implants in Prison Inmates
Public Citizen and 31 doctors, bioethicists, prisoner advocates, and academics called on the Food and Drug Administration (FDA) to immediately investigate California-based BioCorRx, Inc. and the Louisiana Department of Public Safety and Corrections’ testing of an unapproved sustained-release naltrexone implant on prison inmates to determine its effectiveness in managing addiction disorders. Although the FDA has approved naltrexone in oral tablet and injectable forms to treat alcohol and opioid dependence, the agency has never approved any surgically implanted form of the drug.
November 27, 2019, FDA acknowledgment letter.
See Public Citizen’s other work on ethics and clinical trials.