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A hallmark of an effective compliance program is the existence of a well-functioning process for the investigation of allegations of misconduct. Is your compliance investigation process well-functioning? The four signs I look for are (1) a comprehensive written protocol; (2) consistency of handling and discipline; (3) after-action learning takes place; and (4) reporters are directly

Lately I’ve been thinking a lot about what it means to have a “culture of compliance.” I know … I sound super fun at dinner parties!

The business often thinks a culture of compliance is when the CEO or another executive tells her team that we take compliance rules seriously. This isn’t enough.

At its

Mallinckrodt will pay $260 million to settle two pending DOJ lawsuits.

The first case claimed that Mallinckrodt underpaid Medicaid rebates for Acthar. The government alleged in the complaint that Mallinckrodt and its predecessor Questcor began paying rebates for Acthar in 2013 as if Acthar was a “new drug” first marketed in 2013, rather than a

  • Former Immunomedic CFO Arrested For Insider Trading

The US Attorney’s Office for the District of New Jersey arrested Usama Malik, the former CFO of Immunomedic and Lauren Wood, the former head of Corporate Communications of Immunomedic, for insider trading. As you may recall, Immunomedic was acquired by Gilead in October 2020 for $21 billion.


In a first of its kind settlement, Kaleo, Inc, a Virginia based pharmaceutical manufacturer that sells three marketed products in the US, agreed to pay $12. 7 million to settle claims that it encouraged its customers to use “preferred” pharmacies that in turn submitted false or misleading prior authorizations for one of Kaleo’s products. This