Karen Owen Gibbs joined McDermott in 2014 after serving as Vice President and Senior Counsel at CVS Health (formerly CVS Caremark), a Fortune 20 integrated pharmacy company. Karen advises a wide variety of health care companies, investors and lenders on operational, regulatory and enforcement issues related to all aspects of the pharmacy distribution chain. Her practice also covers synergistic areas such as substance abuse/behavioral health, physician and veterinarian office dispensing, evolving requirements related to opioid prescribing and dispensing, and a wide variety of prescription reimbursement issues.
Karen has an extensive background in licensing, regulatory, compliance, enforcement and policy issues in the health care and life sciences industries, including pharmacies (specialty, mail, retail, institutional and long-term care), pharmaceutical and biologics manufacturers, pharmacy benefit management (PBM) companies, wholesaler/distributors, behavioral health companies, institutional health care providers, and prescription drug plans. With McDermott’s FDA team, Karen has offered guidance on compounding pharmacy issues, re-packager issues, and compliance with the Drug Quality and Security Act.
In addition to transactional and regulatory work, Karen’s recent representations include internal investigations and enforcement actions related to pharmacy law issues, Drug Enforcement Administration (DEA) and related state issues such as reporting under the Prescription Drug Monitoring Program (PDMP) requirements, and reimbursement issues.