A
Anth
Guest
http://www.pharmabiz.com/article/detnews.asp?articleid=21870§ionid=
Pfizer Inc will plead guilty to criminal charges and pay $430 million in
fines to settle charges that a company it bought four years ago illegally
promoted non-approved uses for a drug by flying doctors to lavish resorts
and paying them hefty speakers' fees to tout it.
The settlement with the world's largest pharmaceutical company over the
company it bought, Warner-Lambert, includes a $240 million criminal fine -
the second-largest criminal fine ever imposed in a health care fraud
prosecution, the Justice Department said.
Whistleblower David Franklin, the scientist who reported the marketing
abuses to authorities, will receive $26.6 million as part of the settlement.
"This is a standard industry practice," Franklin told The Associated Press
in an interview. "Hopefully, real change will happen now, and this will be
the start of something and not the end."
Under the agreement announced Thursday by federal prosecutors, the company
acknowledged spending hundreds of thousands of dollars to promote
non-approved uses for the anti-seizure drug Neurontin.
Pfizer will plead guilty to violating the Food, Drug and Cosmetic Act.
Besides the $240 million criminal fine, the company will pay $152 million in
civil fines to be shared among state and federal Medicaid agencies. Another
$38 million would go to state consumer-protection agencies.
The company said the activity occurred years before it bought Warner-Lambert
in 2000.
"Pfizer is committed to compliance with all healthcare laws and FDA
requirements and to high ethical standards in all aspects of its business
practices," the company said in a statement.
The case began in 1996, when Franklin filed a whistleblower lawsuit against
drug maker Parke-Davis and its parent company Warner-Lambert, alleging it
used an illegal marketing plan to drive up Neurontin sales in the 1990s.
The lawsuit alleged that while Neurontin was approved only as an epilepsy
drug, the company promoted it for relieving pain, headaches, bipolar
disorder and other psychiatric illnesses.
While doctors can prescribe drugs for any use, the promotion of drugs for
these so-called "off-label uses" is prohibited by the Food and Drug Cosmetic
Act.
Last May, federal prosecutors in Boston filed a brief in support of
Franklin's lawsuit, and have since been in settlement negotiations with New
York-based Pfizer to recover money the Medicaid program spent on Neurontin.
Franklin's lawsuit alleged that the company's publicity plan included paying
doctors to put their names on ghostwritten articles about Neurontin and to
induce them to prescribe the drug for various uses by giving them tickets to
sporting events, trips to golf resorts and speakers fees. One doctor
received almost $308,000 to speak at conferences about the drug.
Neurontin's sales soared from $97.5 million in 1995 to nearly $2.7 billion
in 2003.
"We believe we have exposed an illegal practice in the pharmaceutical
industry that caused the Medicaid program to pay tens of millions of dollars
for off-label prescriptions that were not eligible for reimbursement under
the Medicaid program," said Franklin's attorney, Thomas Greene.
Franklin, 42, said Warner-Lambert had conducted a clinical trial that showed
Neurontin was less effective than a placebo for treating bipolar disorder,
but it never published those findings and told doctors the drug was highly
effective for treating the psychological condition.
"Patients every day are still taking this drug hoping it's effective, and
there's really no evidence for that," Franklin said.
They'll do anything to make a few bucks...
Anth
Pfizer Inc will plead guilty to criminal charges and pay $430 million in
fines to settle charges that a company it bought four years ago illegally
promoted non-approved uses for a drug by flying doctors to lavish resorts
and paying them hefty speakers' fees to tout it.
The settlement with the world's largest pharmaceutical company over the
company it bought, Warner-Lambert, includes a $240 million criminal fine -
the second-largest criminal fine ever imposed in a health care fraud
prosecution, the Justice Department said.
Whistleblower David Franklin, the scientist who reported the marketing
abuses to authorities, will receive $26.6 million as part of the settlement.
"This is a standard industry practice," Franklin told The Associated Press
in an interview. "Hopefully, real change will happen now, and this will be
the start of something and not the end."
Under the agreement announced Thursday by federal prosecutors, the company
acknowledged spending hundreds of thousands of dollars to promote
non-approved uses for the anti-seizure drug Neurontin.
Pfizer will plead guilty to violating the Food, Drug and Cosmetic Act.
Besides the $240 million criminal fine, the company will pay $152 million in
civil fines to be shared among state and federal Medicaid agencies. Another
$38 million would go to state consumer-protection agencies.
The company said the activity occurred years before it bought Warner-Lambert
in 2000.
"Pfizer is committed to compliance with all healthcare laws and FDA
requirements and to high ethical standards in all aspects of its business
practices," the company said in a statement.
The case began in 1996, when Franklin filed a whistleblower lawsuit against
drug maker Parke-Davis and its parent company Warner-Lambert, alleging it
used an illegal marketing plan to drive up Neurontin sales in the 1990s.
The lawsuit alleged that while Neurontin was approved only as an epilepsy
drug, the company promoted it for relieving pain, headaches, bipolar
disorder and other psychiatric illnesses.
While doctors can prescribe drugs for any use, the promotion of drugs for
these so-called "off-label uses" is prohibited by the Food and Drug Cosmetic
Act.
Last May, federal prosecutors in Boston filed a brief in support of
Franklin's lawsuit, and have since been in settlement negotiations with New
York-based Pfizer to recover money the Medicaid program spent on Neurontin.
Franklin's lawsuit alleged that the company's publicity plan included paying
doctors to put their names on ghostwritten articles about Neurontin and to
induce them to prescribe the drug for various uses by giving them tickets to
sporting events, trips to golf resorts and speakers fees. One doctor
received almost $308,000 to speak at conferences about the drug.
Neurontin's sales soared from $97.5 million in 1995 to nearly $2.7 billion
in 2003.
"We believe we have exposed an illegal practice in the pharmaceutical
industry that caused the Medicaid program to pay tens of millions of dollars
for off-label prescriptions that were not eligible for reimbursement under
the Medicaid program," said Franklin's attorney, Thomas Greene.
Franklin, 42, said Warner-Lambert had conducted a clinical trial that showed
Neurontin was less effective than a placebo for treating bipolar disorder,
but it never published those findings and told doctors the drug was highly
effective for treating the psychological condition.
"Patients every day are still taking this drug hoping it's effective, and
there's really no evidence for that," Franklin said.
They'll do anything to make a few bucks...
Anth
