1. Pink Sheet

Mallinckrodt Settles Portion Of DOJ's Acthar Gel Kickback Claims; Charity Copay Probe Continues

 
• By Brenda Sandburg

$15.4m fine will resolve claims of "wining and dining" doctors to get them to prescribe Acthar. Mallinckrodt dropped NORD and switched to Chronic Disease Fund to administer its copay assistance program, a move that Mallinckrodt’s COO purportedly described as "mom & pop vs. WalMart."

DOJ
Mallinckrodt Kickback Settlement With DOJ Does Not Cover Charity CoPay Arrangements

Mallinckrodt PLC reached a settlement with the US Department of Justice to resolve a portion of the government's claims that it paid kickbacks to boost prescriptions of its H.P. Acthar Gel (repository corticotropin injection). But it is still in litigation over its arrangement with a charitable foundation, which could lead to a much higher payout.

The DOJ announced on 4 September that Mallinckrodt agreed to pay $15.4m to resolve claims that its Questcor Pharmaceuticals Inc. subsidiary paid illegal kickbacks to doctors, in the form of lavish dinners and entertainment, to induce them to prescribe Acthar

More from Compliance

More from Pink Sheet

Inclusive By Design: UK Pilots Diversity Plans For Drug & Device Trials

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

UK’s International Recognition Procedure: EU Dossier Faster Than US Or Canada

 
• By Eliza Slawther

Companies that use the European Medicines Agency as a reference regulator for the UK’s International Recognition Procedure can expect a faster approval than those that use other national regulators, such as those in the US and Canada, an MHRA spokesperson has said.

FDA Use Of Artificial Intelligence Will Help US Retain Biotech Leadership

 
• By Sue Sutter and Derrick Gingery

At a House subcommittee hearing, HHS Secretary Robert F. Kennedy Jr. rebutted lawmaker concerns that NIH cuts will drive research and scientists to other countries and said he does not want to advise parents on vaccinating children for measles, chickenpox or polio.