(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.
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