1. Pink Sheet

US Enforcement 2019: Compounding, Opioids Top Priorities But Beware Of REMS Violations, Too

 
• By Sue Sutter

Drug manufacturer reimbursement support services also are garnering a growing amount of enforcement attention, and misleading promotion - whether on- or off-label - remains on the radar of government investigators.

James Burnham, deputy assistant attorney general in the Department of Justice’s Civil Division
Deputy Assistant AG James Burnham discusses DoJ enforcement priorities at FDLI. • Source: Sue Sutter

While compounding and opioids will continue to be high enforcement priorities for the US FDA and Department of Justice (DoJ) in the year ahead, biopharma manufacturers need to keep an eye on additional areas of legal risk, including Risk Evaluation and Mitigation Strategy (REMS) violations, misleading drug promotion, and reimbursement support services.

In speeches and panels at the recent Food and Drug Law Institute (FDLI) Enforcement, Litigation and Compliance Conference, leaders from...

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