Business as usual,
Capitalism is about profits. The problem with off-label marketing is that the
studies done to support such usage is well below the standards of science, they
are then published in select journal, and then such studies are used to market
the drugs to doctors who have become pill pushers. This is the norm for off-label
marketing.
Big Pharma behaving badly: A timeline of
settlements
October 5, 2010 — 8:49am
ET | By Erica
Teichert
http://www.fiercepharma.com/special-reports/big-pharma-behaving-badly-timeline-settlements/big-pharma-behaving-badly-part-2
Sometimes pharma companies bend the rules. And increasingly, they're getting
caught. After Novartis' recent $422.5
million settlement with the U.S. Attorney's
office and reader requests, we looked back at other Department of Justice and
government fines levied against Big Pharma for improper marketing and other
infractions. Those fines range from a relatively light slap on the wrists
to multi-billion dollar charges in addition to criminal
penalties.
Eleven
companies have
paid a total of over $6 billion to the government in 22 months. The biggest
offender? Eli Lilly, with three appearances and over $1.4 billion in fines, all
for Zyprexa. But those three settlements pale in comparison to Pfizer's massive
$2.3 billion charge for mis-marketing a host of drugs, including Bextra,
Geodon, Lyrica and Zyvox.
Novartis
With: U.S. Attorney's office for the Eastern District of Pennsylvania
When: Sept. 30, 2010
Scoop: Novartis agreed to a $422.5
million settlement
with the Eastern District of Pennsylvania for its off-label
promotion of Trileptal and other allegations against Diovan, Exforge, Sandostatin,
Tekturna and Zelnorm.
Forest
Labs
With: Dept. of Justice
When: Sept. 15, 2010
Scoop: After
marketing Levothroid,
an unapproved thyroid drug, Forest Labs received its penalty, to
the tune of $313 million. The settlement also covered Forest's off-label use of
Celexa for children's use.
Allergan
With: Dept. of Justice
When: Sept. 1, 2010
Scoop: Allergan's $600
million DoJ settlement
was broken into two parts: $375 million in
fines and $225 million in civil penalties, all of which stemmed from its
off-label use of Botox for headaches, pain management and cerebral palsy.
Elan
With: U.S. Attorney's Office in Massachusetts
When: July 15, 2010
Scoop: The Irish drugmaker received its $203.5
million fine
for its marketing tactics of Zonegran, an epilepsy drug. Also,
the company's U.S. branch pled guilty to a misdemeanor and the company will
enter into a corporate integrity agreement with the HHS Inspector General.
Johnson
& Johnson
With: Department of Justice
When: April 29, 2010
Scoop: Though J&J's more infamous woes stem from its phantom
recalls, two of the troubled drugmaker's subsidiaries received a $81 million
penalty for off-label
promotions of Topamax,
an epilepsy drug.
AstraZeneca
With: U.S. Attorney's office in Philadelphia
When: April 27, 2010
Scoop: In the same week as the J&J settlement, AstraZeneca
was hit with a $520 million penalty
for its antipsychotic, Seroquel. The company
misled doctors and patients about the drug's safety.
Abbott
With: Twenty-three states
When: Jan. 7, 2010
Scoop: In a case involving 23
different states,
Abbott Laboratories and its partner, Fournier Industrie et
Sante, were ordered to pay $22.5 million for blocking the states from obtaining
a cheaper alternative for its cholesterol drug, TriCor.
Eli
Lilly
With: Connecticut
When: Sept. 29, 2009
Scoop: Thirteen states total had filed suit against Eli Lilly for
Zyprexa marketing issues, but the company was ordered to pay $25
million to Connecticut
in this ruling.
Eli
Lilly
With: West Virginia Attorney General
When: August 21, 2009
Scoop: In another Zyprexa case, West Virginia Attorney General Darrell
McGraw levied
$2 billion in fines against Eli Lilly.
As the motion put it, "At $5,000 per
violation, therefore, the State is attempting to fine Lilly approximately $2
billion for use of a product label that was approved by the FDA." In the
end, the company
agreed to $22.5 million in fines.
Merck
With: 35 states' attorney offices
When: July 15, 2009
Scoop: Merck escaped relatively unscathed from 35
state investigations
against the Enhance study of Vytorin, only paying $5.4 million
without admitting fault in the cases.
Sanofi-aventis
With: Department of Justice
When: May 28, 2009
Scoop: In an agreement with the federal government, Sanofi paid $95.5
million total,
doled out to the feds, state Medicaid agencies and other public
health service agencies, all for its subsidiary Aventis' nasal spray price
inflation between 1995 and 2000.
GlaxoSmithKline
With: U.S. Attorney's office in Colorado
When: Jan. 29, 2009
Scoop: After seven years of off-label promotion on nine of its
best-selling drugs, GSK was ordered
to pay $400 million
to the U.S. Attorney's office in Colorado.
Pfizer
With: Department of Justice
When: Jan. 26, 2009
Scoop: Right after acquiring Wyeth, Pfizer dropped a bombshell in its
fourth quarter earnings report; the
company was charged $2.3 billion,
the largest fine levied on our list, for
off-label promotions of its COX-2 drugs. That settlement lowered the company's
2008 net income by 90 percent.
Eli
Lilly
With: Department of Justice
When: Jan. 15, 2009
Scoop: In the first Zyprexa settlement (and one of three on our list),
the Department of Justice levied $1.4
billion in fines against Eli Lilly.
Also, as part of the settlement, the company
pled guilty to a misdemeanor: violating the Food, Drug and Cosmetic Act.
Business as usual,
Capitalism is about profits. The problem with off-label marketing is that the
studies done to support such usage is well below the standards of science, they
are then published in select journal, and then such studies are used to market
the drugs to doctors who have become pill pushers. This is the norm for off-label
marketing.
Big Pharma behaving badly: A timeline of
settlements
October 5, 2010 — 8:49am
ET | By Erica
Teichert
http://www.fiercepharma.com/special-reports/big-pharma-behaving-badly-timeline-settlements/big-pharma-behaving-badly-part-2
Sometimes pharma companies bend the rules. And increasingly, they're getting
caught. After Novartis' recent $422.5
million settlement with the U.S. Attorney's
office and reader requests, we looked back at other Department of Justice and
government fines levied against Big Pharma for improper marketing and other
infractions. Those fines range from a relatively light slap on the wrists
to multi-billion dollar charges in addition to criminal
penalties.
Eleven
companies have
paid a total of over $6 billion to the government in 22 months. The biggest
offender? Eli Lilly, with three appearances and over $1.4 billion in fines, all
for Zyprexa. But those three settlements pale in comparison to Pfizer's massive
$2.3 billion charge for mis-marketing a host of drugs, including Bextra,
Geodon, Lyrica and Zyvox.
Novartis
With: U.S. Attorney's office for the Eastern District of Pennsylvania
When: Sept. 30, 2010
Scoop: Novartis agreed to a $422.5
million settlement
with the Eastern District of Pennsylvania for its off-label
promotion of Trileptal and other allegations against Diovan, Exforge, Sandostatin,
Tekturna and Zelnorm.
Forest
Labs
With: Dept. of Justice
When: Sept. 15, 2010
Scoop: After
marketing Levothroid,
an unapproved thyroid drug, Forest Labs received its penalty, to
the tune of $313 million. The settlement also covered Forest's off-label use of
Celexa for children's use.
Allergan
With: Dept. of Justice
When: Sept. 1, 2010
Scoop: Allergan's $600
million DoJ settlement
was broken into two parts: $375 million in
fines and $225 million in civil penalties, all of which stemmed from its
off-label use of Botox for headaches, pain management and cerebral palsy.
Elan
With: U.S. Attorney's Office in Massachusetts
When: July 15, 2010
Scoop: The Irish drugmaker received its $203.5
million fine
for its marketing tactics of Zonegran, an epilepsy drug. Also,
the company's U.S. branch pled guilty to a misdemeanor and the company will
enter into a corporate integrity agreement with the HHS Inspector General.
Johnson
& Johnson
With: Department of Justice
When: April 29, 2010
Scoop: Though J&J's more infamous woes stem from its phantom
recalls, two of the troubled drugmaker's subsidiaries received a $81 million
penalty for off-label
promotions of Topamax,
an epilepsy drug.
AstraZeneca
With: U.S. Attorney's office in Philadelphia
When: April 27, 2010
Scoop: In the same week as the J&J settlement, AstraZeneca
was hit with a $520 million penalty
for its antipsychotic, Seroquel. The company
misled doctors and patients about the drug's safety.
Abbott
With: Twenty-three states
When: Jan. 7, 2010
Scoop: In a case involving 23
different states,
Abbott Laboratories and its partner, Fournier Industrie et
Sante, were ordered to pay $22.5 million for blocking the states from obtaining
a cheaper alternative for its cholesterol drug, TriCor.
Eli
Lilly
With: Connecticut
When: Sept. 29, 2009
Scoop: Thirteen states total had filed suit against Eli Lilly for
Zyprexa marketing issues, but the company was ordered to pay $25
million to Connecticut
in this ruling.
Eli
Lilly
With: West Virginia Attorney General
When: August 21, 2009
Scoop: In another Zyprexa case, West Virginia Attorney General Darrell
McGraw levied
$2 billion in fines against Eli Lilly.
As the motion put it, "At $5,000 per
violation, therefore, the State is attempting to fine Lilly approximately $2
billion for use of a product label that was approved by the FDA." In the
end, the company
agreed to $22.5 million in fines.
Merck
With: 35 states' attorney offices
When: July 15, 2009
Scoop: Merck escaped relatively unscathed from 35
state investigations
against the Enhance study of Vytorin, only paying $5.4 million
without admitting fault in the cases.
Sanofi-aventis
With: Department of Justice
When: May 28, 2009
Scoop: In an agreement with the federal government, Sanofi paid $95.5
million total,
doled out to the feds, state Medicaid agencies and other public
health service agencies, all for its subsidiary Aventis' nasal spray price
inflation between 1995 and 2000.
GlaxoSmithKline
With: U.S. Attorney's office in Colorado
When: Jan. 29, 2009
Scoop: After seven years of off-label promotion on nine of its
best-selling drugs, GSK was ordered
to pay $400 million
to the U.S. Attorney's office in Colorado.
Pfizer
With: Department of Justice
When: Jan. 26, 2009
Scoop: Right after acquiring Wyeth, Pfizer dropped a bombshell in its
fourth quarter earnings report; the
company was charged $2.3 billion,
the largest fine levied on our list, for
off-label promotions of its COX-2 drugs. That settlement lowered the company's
2008 net income by 90 percent.
Eli
Lilly
With: Department of Justice
When: Jan. 15, 2009
Scoop: In the first Zyprexa settlement (and one of three on our list),
the Department of Justice levied $1.4
billion in fines against Eli Lilly.
Also, as part of the settlement, the company
pled guilty to a misdemeanor: violating the Food, Drug and Cosmetic Act.