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Tuesday, April 30, 2019
“From $40 a vial in 2000 to nearly $39,000 today”
(CNN)Two whistleblowers at a pharmaceutical company responsible for one of the largest drug price increases in US history said the company bribed doctors and their staffs to increase sales, according to newly unsealed documents in federal court.
The effort, the whistleblowers said in a lawsuit against the company, was part of an intentional "multi-tiered strategy" by Questcor Pharmaceuticals, now Mallinckrodt, to boost sales of H.P. Acthar Gel, cheating the government out of millions of dollars.
The price of the drug, best known for treating a rare infant seizure disorder, has increased almost 97,000%, from $40 a vial in 2000 to nearly $39,000 today.
The Justice Department has now intervened in the case after conducting its own extensive investigation -- a sign that the government believes the allegations levied by the whistleblowers are credible. In a statement to CNN, Mallinckrodt did not deny the accusations but said the fault lies primarily with Questcor.
The bombshell allegations lay bare what the whistleblowers say was a culture designed to sell the drug at all costs, from lying to the Food and Drug Administration to offering bribes to doctors.
The price increase, combined with an aggressive sales push in rheumatoid arthritis, multiple sclerosis and other areas, has pushed the drug's annual sales over $1 billion.
Many of those sales are driven by Medicare reimbursements. A CNN investigation last year found that Medicare spending on Acthar had risen dramatically -- more than tenfold over six years -- to some $2 billion.
In their lawsuit, the whistleblowers said the drugmaker's conduct "has cheated the federal government out of millions of dollars that should not have been paid, thereby enriching [the company] and subjecting patients to unapproved, unsafe and potentially ineffective uses of H.P. Acthar Gel."
"Questcor has attempted to conceal and cover-up its payment of kickbacks and its illegal promotion of H.P. Acthar Gel by making false statements to the FDA and directing employees to conceal evidence by failing to disclose ... the full nature and extent of its advertising, promotional and marketing materials and plan."
Mallinckrodt purchased Questcor in 2014 as part of a $5.6 billion deal. "The illegal practices that Questcor had been engaging in since 2007," the suit said, "have knowingly been continued since the merger and acquisition of Questcor by Mallinckrodt."
The whistleblowers' allegations were unsealed after the Justice Department filed notice on March 6 to intervene in the lawsuit. The Justice Department has 90 days to file its own complaint, according to the March filing.
If found liable, Mallinckrodt could be required to pay up to three times any amount the government is found to have been defrauded, as well as penalties ranging from $5,500 to $11,000 for each false claim, according to the whistleblower statute.
The Justice Department declined comment for this story…
For the complete story, “Whistleblowers: Company at heart of 97,000% drug price hike bribed doctors to boost sales,” click here.