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Chafing-up under the charges of the controversial frost-hung federal bag-de-sac H.P. Acthar, Mallinckrodt seemed to be out of the wood with a settlement in the works. It turns out that it was out of the pan and in the fire.
The Justice Ministry issued new charges on Wednesday against Mallinckrodt, who bought the maker of Acthar Questcor Pharma in 2014, accusing the company of channeling money through seed money to illegally subsidize Medicare copays and increase the catalog price of the drug to 85,000%. New charges in Pittsburgh federal court arrive the same day as drug manufacturer and federal government agrees in principle to $ 15.4 million settlement on two charges related to two lawsuits the DOJ adhered to at the beginning of May.
Mallinckrodt called the settlement "fair and reasonable" in a statement and pledged to fight the new federal charges.
"As we have said many times, we will do it when we can solve the inherited legal problems in a reasonable and manageable way,"
In their lawsuit, federal prosecutors accused Mallinckrodt, through Questcor, of using three funds to illegally subsidize Medicare patients' copays for Acthar, while raising the price of the drug from $ 50,000 to $ 32,000. per bottle. In doing so, the Department of Justice alleged that the company had defrauded the federal government for millions of dollars by misrepresenting to Medicare and inciting doctors to increase the number of prescriptions for the drug.
"The funding provided by these funds prompted Acthar to prescribe medication, which was a proven method that refuted concerns about the cost of the drug, allowing Mallinckrodt to continually increase its price. ", said the prosecutors.
RELATED: No More Problems for Mallinckrodt: DOJ Mixes with Fray in Acthar Denunciation Combinations
The most recent charges are only the latest shots at the act in Mallinckrodt's troubled history with Acthar, who appeared to have reached its peak when the DOJ joined two lawsuits against whistleblowing against the company. may.
Prosecutors said Questcor had put in place a "high-level strategy" to pay doctors to reinforce scripts for Acthar, while using "misguided data" to mislead payers about safety and usefulness. of the drug. According to whistleblowers, the company intimidated and fired employees who questioned its marketing strategy, using fake internal investigations to conceal illegal activities.
In its proposed settlement with the federal government, Mallinckrodt admitted no wrongdoing in the scheme, which would have occurred prior to the acquisition of Questcor. Mallinckrodt argued that Acthar's astronomical price hikes had taken place prior to the Questcor takeover, although the company has been implementing regular price increases since the acquisition of the drug.
RELATED: Mallinckrodt's Acthar drama continues with $ 100 million FTC settlement
These price increases were the subject of a separate federal investigation that Mallinckrodt had settled for $ 100 million in 2017, alleging that Questcor had purchased and set aside a competitor from Acthar in order to eliminate the catalog price of the drug. The Federal Trade Commission's investigation focused on the acquisition in 2013 of Synacthen Depot by Questcor, a competing drug that, according to regulators, has been ruled out in favor of development that does not compete with Acthar.
Editor's Note: A previous version of this story has been updated to correct an error.
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