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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

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US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
• By Sarah Karlin-Smith

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

 
• By Jessica Merrill

At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.

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.

Austria To Fine Companies For Violating New Drug Stockpiling Rule

 
• By Neena Brizmohun

A new ordinance for addressing drug shortages in Austria requires drug companies distributing any of the hundreds of products listed in an accompanying annex to maintain adequate stock in the country to meet patient demand for four months.

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Darzalex Faspro Gains US FDA AdComm Support For Smoldering Myeloma Claim

 
• By Bridget Silverman

The use of J&J’s Darzalex Faspro in high-risk smoldering multiple myeloma could result in overtreatment, but the FDA committee voted in favor of the new claim for delay in development of multiple myeloma.

STARGLO Dulled: Genentech’s Columvi Data Not Generalizable To US Patients, FDA Panel Says

 
• By Sue Sutter

The glofitamab trial results are not generalizable due to the small number of enrolled US lymphoma patients and adverse results across multiple endpoints for patients from non-Asian regions, the Oncologic Drugs Advisory Committee said.

Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy

 
• By Sarah Karlin-Smith

The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.