• On Wednesday, the FDA’s Office of Criminal Investigations, as co-lead on an investigation with the Department of Health and Human Services Office of Inspector General, was involved in an indictment in the District of Puerto Rico charging 27 individuals with conspiracy to introduce misbranded drugs and to defraud the United States, as well as unlicensed wholesale distribution and various violations of the Drug Supply Chain Security Act (DSCSA). The defendants included unlicensed wholesale distributors and pharmacy owners and employees who, in violation of the Federal Food, Drug, and Cosmetic Act (FDCA) and the DSCSA, conspired to sell  misbranded and diverted prescription drugs from unauthorized trading partners to pharmacy customers, without the customers’ knowledge that the products were misbranded and diverted. The scheme was identified, investigated and dismantled through the efforts of FDA-OCI, HHS OIG and the U.S. Attorney’s Office, District of Puerto Rico. The co-conspirators and others engaged in this scheme unlawfully generated revenue in an amount exceeding $13,000,000 by selling and distributing misbranded and diverted prescription drugs and billing insurance, costing Medicare and Medicaid over $7.6 million.