Why is Mallinckrodt considered one of the most controversial drug companies?
An FTC monopoly case, a $260 million DOJ fraud settlement, a $1.6 billion opioid liability and two bankruptcies — all centred on a decades-old hormone gel whose price rose from $40 per vial to more than $34,000.
Few companies have been subject to as many different kinds of enforcement. Mallinckrodt (and Questcor, which it bought) paid the FTC $100 million over alleged illegal monopoly maintenance for Acthar Gel; paid the Justice Department about $260 million over Acthar-related Medicaid rebate underpayments and kickbacks; and agreed to a $1.6 billion opioid settlement as the country's largest generic opioid manufacturer, before using a second bankruptcy to cut that obligation.
At the centre is Acthar, a decades-old hormone gel whose price rose from $40 per vial in 2001 to more than $34,000 by 2017, according to the FTC chair at the time. Critics see Mallinckrodt as a case study in extracting value from an old drug with no competition. The company settled each matter and emphasised its restructuring into a stronger business.