FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Feds Face Down Mallinckrodt in Acthar Whistleblower Lawsuits 

May 9, 2019

The Department of Justice has entered the legal battle against Mallinckrodt over HP Acthar gel, joining a pair of whistleblower lawsuits that allege a company the drugmaker acquired bribed doctors to push the drug, among other unlawful tactics.

The two suits claim the UK pharma giant’s subsidiary, Questcor, paid doctors to oversell the drug and engaged in other fraudulent schemes to boost the sales of HP Acthar Gel, a drug first approved in the 1950s that currently has 19 indications, including arthritis, infantile spasms and multiple sclerosis.

Mallinckrodt said it “strongly disagrees with the substance of the complaints and the sensational characterization of the allegations” and expressed disappointment in the DOJ’s decision to move forward with the lawsuit.

“Mallinckrodt has cooperated fully with the DOJ in its review of this historical conduct, voluntarily providing documents and information to the government,” the company said, noting that talks of a settlement have been in the works for “the past several months.”

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