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 FDA and DoJ, along with industry attorneys, highlighted key drug

More from Compliance

More from Pink Sheet

Mayne’s Nextstellis Promo Wrong To Suggest Better Safety Than Other Contraceptives, FDA Says

 
• By Sue Sutter

A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.

US HHS Deputy Nominee Talks AI, Not FDA, In Confirmation Hearing

 
• By Ramsey Baghdadi

Silicon Valley investor Jim O’Neill’s Senate confirmation hearings showcased the unique background of someone with government and tech experience and avoided discussions of his past statements about lowering the bar for regulatory approval.

US FDA Waiting On Guidance Agenda Future As HHS Seeks Regulation Cuts

 
• By Derrick Gingery

The FDA continues to wait for a decision on whether its priority guidances will be published as HHS asks the public for potential regulation cuts to fulfill President Trump’s executive order.