1. Pink Sheet

Insys ‘Reimbursement Unit’ Fraudulently Boosted Fentanyl Rxs, DOJ Charges

 
• By Brenda Sandburg

Six former Insys executives and managers arrested on changes of misleading insurers and pharmacy benefit managers into authorizing payments for Subsys sublingual fentanyl pain medicine.

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The Department of Justice alleges that former Insys Therapeutics Inc. executives and managers created a reimbursement unit to increase prior authorizations for the company’s fentanyl-based spray Subsys. The government says the individuals then disguised the unit in calls to insurers and pharmacy benefit managers to get them to believe they were getting calls directly from doctors’ offices.

The US Attorney’s Office for the District of Massachusetts announced that six former employees of Insys, including president and CEO Michael Babich, were arrested on Dec. 8 on charges that they led a nationwide conspiracy to bribe medical practitioners to prescribe Subsys and defraud healthcare insurers

More from Legal & IP

More from Pink Sheet

England: HTA Sandbox Helping To Assess ‘Challenging’ Drugs And Indications

 
• By Eliza Slawther

England’s health technology assessment institute explains how its sandbox environment is helping to test new evaluation methods for drugs or indications with which it does not have experience, such as metabolic dysfunction-associated steatohepatitis.

Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 
• By Neena Brizmohun

The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.

Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER

 
• By Sarah Karlin-Smith

Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.