FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Whistleblower: Mallinckrodt Concealed Vital Information to Drive Acthar Sales

April 16, 2018

A whistleblower lawsuit accuses Mallinckrodt of systemically concealing concerns about the composition of its drug Acthar, indicated for treatment of infantile spasms.

Former Mallinckrodt executive Rasvinder Dhaliwal alleged a senior company director told her that Acthar was not highly-purified adrenocorticotropic hormone (ACTH 1-39) and contained other fragments of ACTH, which could jeopardize the company if the FDA knew.

When Mallinckrodt acquired Questcor in 2014, the ingredients/recipe was transferred in a file that was “locked up and can't even be open, due to all of the protections in the file,” the complaint states.

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