The BIG Pharma Dirty Laundry List


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ALPHABETICAL (by drug name)
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ACTIQ
GABITRIL
PROVIGIL

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$425 MILLION ($425,000,000) – 9/29/2008, MondayCephalon Inc., Biopharmaceutical Company
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Enter Plea to Resolve Allegations of Off-Label Marketing
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Cephalon Inc. will enter criminal plea to resolve claims it marketed 3 drugs for uses not approved by Food and Drug Administration (FDA)
——————————————————————
Lawsuits brought by former employees and filed under qui tam provisions of False Claims Act
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Suits alleged engaged in scheme to market:
1. Actiq
2. Gabitril
3. Provigil
for unapproved uses in violation of Food, Drug and Cosmetic Act
——————————————————————
Suits against company alleged as result of off-label marketing campaign, false claims for payment were submitted to federal insurance programs such as:
1. Federal Employee Health Benefits Program
2. Medicaid
which did not provide coverage for such off-label uses
——————————————————————
Criminal information filed by Justice Department alleges
(1/2001 – 2006)
promoted drugs for uses other than what FDA approved
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Charged with one count of Distribution of Misbranded Drugs:
——————————————————————
Inadequate Directions for Use, misdemeanor offense
——————————————————————
FDA approved Actiq for use only in opioid-tolerant cancer patients
(2001 – 2006)
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Allegedly promoted drug for non-cancer patients to use for such maladies as:
1. migraines
2. sickle-cell pain crises injuries
3. in anticipation of changing wound dressings
or
4. radiation therapy
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Also promoted Actiq for use with patients who were not opioid tolerant
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Gabitril approved by FDA for use as anti-epilepsy drug in treatment of partial seizures
(2001 – 2005)
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Allegedly promoted drug as remedy for anxiety, insomnia and pain
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2005, following reports of seizures in patients taking Gabitril who did not have epilepsy, FDA required Cephalon send warning letter to doctors advising of connection between off-label Gabitril use and seizures
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Company then ceased promotion of drug
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Provigil 1st approved to treat excessive daytime sleepiness associated with narcolepsy, then expanded label to include treatment of excessive sleepiness associated with sleep apnea and shift work sleep disorder
(2001 – 2006)
allegedly promoted Provigil as non-stimulant drug for treatment of:
1. decreased activity
2. lack of energy
3. fatigue
4. sleepiness
5. tiredness
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2002 – FDA sent letter warning company not to continue to promote Provigil off-label
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Cephalon undertook off-label promotional practices via variety of techniques, such as:
1. training sales force to disregard restrictions of FDA-approved label
2. promote drugs for off-label uses
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Actiq label stated drug was for “opioid tolerant cancer patients with breakthrough cancer pain, to be prescribed by oncologist or pain specialists familiar with opioids.”
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Using mantra “pain is pain,” instructed Actiq sales representatives to focus on:
1. physicians other than oncologists
including general practitioners
2. promote drug for many uses other than breakthrough cancer pain
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In case of Gabitril, which had been approved for use for epilepsy, told sales force to visit not just:
1. neurologists
but also
2. psychiatrists
and promote drug for anxiety and other psychiatric indications
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Structured:
1. bonuses
2. sales quota
in such way sales representatives could only reach sales goals if they promoted and sold drugs for off-label uses
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1. Employed sales representatives
2. retained medical professionals
to speak to doctors about off-label uses of the 3 drugs
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Funded continuing medical education programs, through millions of dollars in grants, to promote off-label uses of drugs, in violation of FDA’s requirements
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Separate civil settlement executed contemporaneously with guilty plea agreement, to resolve False Claims Act allegations arising from claims to:
1. Medicaid
2. Medicare
3. other federal programs
including:
a. Bureau of Prisons
b. Defense Logistics Agency
c. Every Employees Occupational Illness Compensation Program
d. Federal Employees Compensation Act Program
e. Federal Employees Health Benefits program
f. Postal Worker’s Compensation Program
g. Public Health Service Entities
h. TRICARE
i. Department of Veterans Affairs
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Civil settlement resolves 4 qui tam (whistleblower) actions
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3 of cases filed by former sales representatives
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As part of resolution of allegations, HHS Inspector General and Cephalon have entered into 5 year Corporate Integrity Agreement, which requires Cephalon to:
1. send doctors letter advising of resolution
2. post payments to doctors on web site
3. board and top management regularly certify company is in compliance with all applicable requirements
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ADVAIR
AVANDIA
FLOVENT
IMITREX
LAMICTAL
LOTRONEX
PAXIL
VALTREX
WELLBUTRIN
ZOFRAN

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$3 BILLION – 2/7/2012, MondayGlaxoSmithKline LLC (GSK) (4/1998 – 2007)
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Plead guilty to 3-count criminal information
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2 counts of introducing misbranded drugs into interstate commerce:
1. Paxil
2. Wellbutrin
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1 count of failing to report safety data about drug to Food and Drug Administration (FDA):
Avandia
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Civil settlement resolves claims relating to:
1. Avandia
2. Paxil
3. Wellbutrin
4. as well as additional drugs
5. resolves pricing fraud allegations
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Paxil:
In criminal information, government alleges
(4/1998 – 8/2003)
unlawfully promoted drug for treating depression in patients under age 18, even though FDA never approved it for pediatric use
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United States alleges participated in:
1. preparing
2. publishing
3. distributing
misleading medical journal article that misreported clinical trial of drug demonstrated efficacy in treatment of depression in patients under age 18, when study failed to demonstrate efficacy
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United States alleges, at same time, didn’t make available data from 2 other studies in which drug also failed to demonstrate efficacy in treating depression in patients under 18
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United States alleges sponsored:
1. lunch programs
2. dinner programs
3. spa programs
4. similar activities
to promote use of drug in:
1. adolescents
2. children
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Paid speaker to talk to audience of doctors (and paid for doctors who attended):
1. meal
or
2. spa treatment
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Since 2004, drug, like other antidepressants, included “black box warning” on label stating antidepressants may increase risk of suicidal thinking and behavior in short-term studies in patients under age 18
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Agreed to plead guilty to misbranding drug in that labeling was false and misleading regarding the use of drug for patients under 18
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Wellbutrin:
United States alleges
(1/1999 – 12/2003)
promoted drug approved at that time only for:
Major Depressive Disorder, for (among other off-label uses):
1. Attention Deficit Hyperactivity Disorder
2. treatment of sexual dysfunction
3. substance addictions
4. weight loss
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United States contends paid millions of dollars to doctors to (sometimes at lavish resorts at which off-label uses of drug were routinely promoted):
1. attend
2. speak at
meetings
and (to promote drug for unapproved uses) used:
1. sales representatives
2. sham advisory boards
3. supposedly independent Continuing Medical Education (CME) programs
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Agreed to plead guilty to misbranding drug in that labeling didn’t bear adequate directions for these off-label uses
For
Paxil
Wellbutrin
misbranding offenses
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Avandia:
United States alleges
(2001 – 2007)
failed to include certain safety data about drug, a diabetes drug, in reports to FDA meant to allow FDA to determine if drug continues to be safe for approved indications and to spot drug safety trends
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Agreed to plead guilty to failing to report data to FDA
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Missing information included data regarding certain post-marketing studies
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Data regarding 2 studies undertaken in response to European regulators’ concerns about cardiovascular safety of drug
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Since 2007 FDA added 2 black box warnings to drug label to alert physicians about potential increased risk of:
(1) congestive heart failure
(2) myocardial infarction (heart attack)
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Civil Settlement Agreement
As part of global resolution, agreed to resolve civil liability claims set forth in complaint filed by United States for following alleged (for unapproved, off-label, non-covered uses) conduct:
(1) promoting drugs
a. Advair
b. Lamictal
c. Paxil
d. Wellbutrin
e. Zofran
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Paying kickbacks to physicians to prescribe those drugs
as well as drugs:
1. Flovent
2. Imitrex
3. Lotronex
4. Valtrex
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(2) making false and misleading statements concerning safety of Avandia
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(3) reporting false best prices and underpaying rebates owed under Medicaid Drug Rebate Program
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Off-Label Promotion and Kickbacks:
Civil settlement resolves claims set forth in complaint filed by United States alleging promoting drugs:
for unapproved, non-covered uses
promoted its asthma drug:
Advair
for 1st-line therapy for mild asthma patients even though it wasn’t approved or medically appropriate under these circumstances
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Promoted Advair for chronic obstructive pulmonary disease with misleading claims as to relevant treatment guidelines
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Civil settlement resolves allegations promoted Lamictal, an anti-epileptic medication, for off-label, non-covered
1. neuropathic pain
2. pain management
3. psychiatric uses
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Resolves allegations promoted certain forms of Zofran, approved only for post-operative nausea, for treatment of:
morning sickness in pregnant women
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Allegations paid kickbacks to health care professionals to induce them to:
1. promote
2. prescribe
drugs as well as drugs:
1. Flovent
2. Imitrex
3. Lotronex
4. Valtrex
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United States alleges conduct caused false claims to be submitted to federal health care programs
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Avandia:
Civil settlement agreement
United States alleges promoted drug to:
1. physicians
2. other health care providers
with:
1. false
2. misleading
representations about drug’s safety profile
causing false claims to be submitted to federal health care programs
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United States alleges stated drug had positive cholesterol profile despite having no well-controlled studies to support that message
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United States alleges sponsored programs suggesting cardiovascular benefits from drug therapy despite warnings on FDA-approved label regarding cardiovascular risks
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Price Reporting:
also resolving allegations
(1994 – 2003)
GSK and corporate predecessors reported false drug prices, which resulted in underpaying rebates owed under Medicaid Drug Rebate Program
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By law, required to report lowest, or “best” price it charged customers and to pay quarterly rebates to states based on reported prices
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When drugs sold to purchasers in contingent arrangements known as “bundles,” discounts offered for bundled drugs must be reallocated across all products in bundle proportionate to dollar value of units sold
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United States alleges bundled sales arrangements included steep discounts known as “nominal” pricing and yet failed to take such contingent arrangements into account when calculating and reporting its best prices to Department of Health and Human Services
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Had it done so, effective prices on certain drugs would have been different, and, in some instances, triggered a new, lower best price than what reported
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As result, United States (who paid inflated prices for drugs at issue) contends:
1. underpaid rebates due to Medicaid 2. overcharged certain Public Health Service entities for its drugs
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Non-monetary Provisions and Corporate Integrity Agreement
executed 5-year Corporate Integrity Agreement (CIA) with Department of Health and Human Services, Office of Inspector General (HHS-OIG)
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Plea agreement and CIA include novel provisions that require implement and/or maintain major changes to way it does business, including changing way its sales force is compensated to remove compensation based on sales goals for territories, one of driving forces behind much of conduct at issue in this matter
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Under CIA, required to change executive compensation program to permit company to recoup:
1. annual bonuses
2. long-term incentives
from:
1. covered executives
2. or their subordinates
if they engage in significant misconduct
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May recoup monies from:
1. executives who are current employees
2. those who have left company
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CIA requires implement and maintain transparency in research practices and publication policies and to follow specified policies in contracts with various health care payors
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Criminal plea agreement includes certain non-monetary compliance commitments and certifications by:
1. GSK’s U.S. president
2. board of directors
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Subject to stringent requirements under corporate integrity agreement with HHS-OIG, designed to increase:
1. accountability
2. transparency
and prevent future:
1. fraud
2. abuse
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ARANESP – 12/19/2012, WednesdayAmgen Inc.
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Under terms of criminal plea agreement
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Amgen Inc. Pleads Guilty to Federal Charge
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Pays to Resolve Criminal Liability and False Claims Act Allegations
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Biotech Giant Pleads Guilty to Illegally Introducing Drug into Market for Uses That the Fda Declined to Approve
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Resolve False Claims Act Suits
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Guilty plea by American biotechnology giant Amgen Inc. (Amgen) for illegally introducing misbranded drug into interstate commerce
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Plea part of global settlement with United States in which Amgen agreed to resolve criminal and civil liability arising from sale and promotion of certain drugs
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Settlement represents single largest criminal and civil False Claims Act settlement involving a biotechnology company in U.S. history
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As part of plea agreement and criminal settlement, Amgen entered guilty plea to criminal information charging company with illegally introducing misbranded drug, Aranesp, into interstate commerce
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Under Food, Drug and Cosmetic Act, illegal for drug companies to introduce into marketplace drugs that company intends will be used “off-label,” i.e., for uses or at doses not approved by FDA
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Aranesp is erythropoiesis-stimulating agent (ESA) approved by FDA at calibrated doses for particular patient populations suffering from anemia
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In order to increase sales of Aranesp and reap resulting profits, Amgen illegally sold drug with intention it be used at off-label doses FDA specifically considered and rejected, and for off-label treatment that FDA never approved
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As part of civil settlement, Amgen agreed to resolve claims it caused false claims to be submitted to:
Medicare
Medicaid
other government insurance programs
——————————————————————
Federal civil settlement agreement encompasses allegations Amgen:
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(1) promoted Aranesp and 2 other drugs it manufactured, Enbrel and Neulasta, for off-label uses and doses:
not approved by FDA
not properly reimbursable by federal insurance programs
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(2) offered illegal kickbacks to wide range of entities in effort to influence health care providers to select its products for use, regardless of whether they were reimbursable by federal health care programs or were medically necessary
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(3) engaged in false price reporting practices involving several of its drugs
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As part of global settlement, Amgen also agreed to enter into Corporate Integrity Agreement (CIA) with HHS-OIG that will govern its conduct, and ensure careful oversight of branding and marketing practices
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Criminal Plea Agreement
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Information alleges following:
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Beginning at launch of Aranespin 2002 and extending until 2007, Amgen illegally introduced Aranesp for uses and dosage levels FDA specifically declined to approve due to insufficient clinical evidence to establish safety and efficacy
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In particular, Amgen illegally introduced Aranesp into oncology and nephrology ESA markets, intending it be used for patients suffering from anemia due to chronic kidney disease or chemotherapy at off-label, unapproved doses that were larger and less frequently administered than those approved by FDA for these patient populations
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Amgen illegally introduced Aranesp into oncology ESA market intending it be used to treat anemia caused by cancer, irrespective of whether patient had been prescribed chemotherapy – a use which FDA had never approved and which FDA subsequently determined caused increased risk of death
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2007 – FDA mandated “black box” label be added to Aranesp’s label, warning Aranesp “increased the risk of death . . . in patients with active malignant disease [cancer] receiving neither chemotherapy nor radiation.”
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At approximately time FDA issued black box warning, Amgen ceased promotion of Aranesp for treatment of anemia caused by cancer rather than the cancer’s treatment
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Amgen’s internal sales and marketing materials made plain that Amgen’s misbranding of Aranesp was company’s core business strategy to gain market share from its only ESA competitor, Procrit, sold by Johnson & Johnson
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At time of Aranesp’s 2002 launch, doctors typically prescribed Procrit to treat anemic patient populations for which Aranesp was approved
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To compete with Procrit, Amgen built Aranesp commercial strategy around unapproved, off-label approach of less frequent dosing schedule, which Amgen sales representatives argued was more convenient for patients and more profitable for doctors
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Amgen implemented illegal commercial effort through promotion of off-label doses from 2 to 4 times larger than those approved by FDA, administered far less frequently than approved by FDA
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When unapproved, off-label dosing effort proved commercially successful, Amgen sales and marketing executives determined capturing population of anemic cancer patients who were not undergoing chemotherapy was
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“the next big thing”
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and would give Amgen “51 percent [ESA] market share.”
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Accordingly, company set about capturing off-label market of patients suffering from anemia caused by cancer itself, rather than anemia caused by chemotherapy, and sales representatives began marketing safety and efficacy of Aranesp in that population
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2007 – FDA determined Aranesp increased risk of death in that very population
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Aware its misbranding of Aranesp was illegal, Amgen instructed sales representatives to promote off-label uses through guise of “reactive marketing.”
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This technique attempted to circumvent law by inducing doctors to ask questions about off-label use, to serve as a smokescreen to hide Amgen’s intentional effort to introduce drug for unapproved, “off-label” uses
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Amgen trained sales representatives to intentionally elicit questions from doctors about off-label uses as legal cover to then provide doctors with studies supporting off-label use, thereby promoting drug for unapproved use
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Studies Amgen provided to doctors to support off-label uses were often very same studies FDA rejected as insufficient to support safety and efficacy of off-label uses, when Amgen had applied to expand Aranesp’s label to encompass them
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Civil Settlement Agreement
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$612 million dollar civil settlement encompasses broader allegations by United States against Amgen than those contained in Information
——————————————————————
Civil settlement agreement resolves claims contained in 10 lawsuits against Amgen brought under qui tam, whistle-blower, provisions of False Claims Act
Like Information, civil settlement contains allegations Amgen improperly marketed Aranesp
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United States contends
(9/2001 – 9/2011)
Amgen knowingly promoted sale and use of Aranesp for dosing regiments and indications which were
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(a) not approved by FDA
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(b) not medically accepted indications
including:
1. anemia caused by cancer
2. anemia caused by chronic disease
3. chronic anemia
4. anemia caused by myelodysplastic syndrome
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United States contends Amgen used journal articles that were insufficient to support safety and efficacy of off-label uses at issue, and improperly obtained listings in medical compendia in effort to establish that off-label uses were medically accepted, and thereby eligible for coverage by federal health care programs
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United States contends Amgen similarly promoted drugs Enbrel and Neulasta for off-label indications that were not eligible for coverage by federal health care programs
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Civil settlement agreement also covers claims Amgen knowingly reported inaccurate pricing information such as:
1. Average Manufacturer Prices
for several drugs
2. Average Sales Prices
3. Best Prices
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In separate civil settlement, International Nephrology Network (INN), renamed Integrated Nephrology Network, subsidiary of AmerisourceBergen Corporation, also agreed to pay $15 million to resolve civil liability arising from role in marketing of Aranesp
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Agreement encompasses claims INN offered illegal kickbacks to influence health care providers’ selection of Aranesp for treatment of kidney disease and in so doing also caused false price reporting for Aranesp
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Agreement resolves single qui tam action
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Corporate Integrity Agreement
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Amgen executed CIA with HHS-OIG
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5-year CIA includes provisions designed to increase accountability of:
1. Board members
2. individuals
to:
1. increase transparency
2. strengthen Amgen’s compliance program
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CIA requires:
1. committee of Amgen’s board of directors annually review effectiveness of company’s compliance program
2. executives in key areas certify to compliance
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Requires Amgen post on website information about payments to doctors
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Under CIA, Amgen must establish and maintain centralized risk assessment and mitigation program and policies relating to research, publications and Amgen’s interactions with federal payors
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Amgen:
1. subject to exclusion from federal health care programs for material breach of CIA
2. subject to monetary penalties for less significant breaches
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AVANDIA (see ADVAIR)
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BRACHYTHERAPY SEEDS, form of radiation therapy, used to treat prostate cancer
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To Resolve False Claims Act Claims
used to treat prostate cancer in violation of False Claims Act
——————————————————————
Government alleged Bard liable under False Claims
——————————————————————
C.R. Bard Inc. agreed to to resolve claims it knowingly caused false claims to be submitted to Medicare program for brachytherapy seeds used to treat prostate cancer in violation of False Claims Act
——————————————————————
Bard develops, manufacturers, and markets medical products used for variety of conditions, including prostate cancer
——————————————————————
Settlement resolves claims relating to sale of brachytherapy seeds, form of radiation therapy, to hospitals
——————————————————————
United States alleged
(1998 – 2006)
provided illegal remuneration to:
1. customers
2. physicians
to induce them to purchase seeds, in violation of Anti-Kickback Statute
——————————————————————
Illegal remuneration allegedly took form of:
1. conference fees
2. certain grants
3. guaranteed minimum rebates
4. marketing assistance
and/or
5. free medical equipment
paid to:
1. customers
and/or
2. physicians
who used seeds to perform treatment for prostate cancer
——————————————————————
Hospitals ultimately submitted bills to Medicare for seeds, which government alleged were rendered false by illegal kickback activity
——————————————————————
Government alleged liable under False Claims Act for causing submission of false claims
——————————————————————
According to non-prosecution agreement with United States, agreed to take numerous remedial steps, many of which company identified and began to implement prior to criminal investigation, to enhance corporate compliance program to prevent similar illegal actions in the future
——————————————————————
Agreed to refine:
1. Code of Conduct
2. other written policies and procedures
that promote commitment to full compliance with all Federal health care program requirements and develop effective program to monitor medical education grants provided by Bard to ensure compliance with requirements
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BEXTRA
GEODON
LYRICA
ZYVOX

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$2.3 BILLION criminal fine – 9/2/2009, WednesdayAmerican pharmaceutical giant
Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc.

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Fraudulent Marketing
——————————————————————
Arising from illegal promotion of certain pharmaceutical products
——————————————————————
Agreed to plead guilty to felony violation of Food, Drug and Cosmetic Act for misbranding drug with intent to defraud or mislead
——————————————————————
Bextra, anti-inflammatory drug Pfizer pulled from market 2005
——————————————————————
Promoted sale of drug for several uses and dosages FDA specifically declined to approve due to safety concerns
——————————————————————
To resolve allegations under civil False Claims Act that company illegally promoted 4 drugs –
1. Bextra
2. Geodon, anti-psychotic drug
3. Lyrica, anti-epileptic drug
4. Zyvox, antibiotic
– and caused false claims to be submitted to government health care programs for uses that weren’t medically accepted indications and therefore not covered by those programs
——————————————————————
Civil fraud settlement resolves allegations paid kickbacks to health care providers to induce them to prescribe these, as well as other, drugs
——————————————————————
As part of settlement, agreed to enter into expansive corporate integrity agreement with Office of Inspector General of Department of Health and Human Services
——————————————————————
Agreement provides procedures and reviews to be put in place to avoid and promptly detect conduct similar to that which gave rise to this matter
——————————————————————
Violated the law over an extensive time period
——————————————————————
At very same time negotiating and resolving allegations of criminal conduct by newly acquired subsidiary, Warner-Lambert, was in its other operations violating very same laws
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CLARITIN
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$345 MILLION – 7/30/2004, FridaySchering Sales Corp., sales and marketing subsidiary of drug manufacturer Schering-Plough Corporation
——————————————————————
Global resolution (stemming from fraudulent pricing of Claritin, its blockbuster allergy medication), includes following components:
——————————————————————
(1) Schering Sales Corp. agreed to plead guilty for violating Anti-Kickback Statute in exchange for preferred treatment of drug on its formulary
——————————————————————
(2) Schering Plough Corporation agreed to settle False Claims Act liability as result of failure to report true best price for drug
——————————————————————
(3) Schering Plough Corporation enter into Corporate Integrity Agreement with Department of Health and Human Services to correct government pricing and Medicaid rebate reporting failures
——————————————————————
Criminal Charges
——————————————————————
Information filed charges Schering Sales Corp.:
1. offered
2. paid
health maintenance organization (“HMO”) kickback of $1.8 million to induce HMO to keep drug on formulary
——————————————————————
(list of drugs HMO covers for beneficiaries)
——————————————————————
In late 1990s, drug was Schering Sales’ best-selling drug
——————————————————————
Substantially more expensive, than biggest competitor, Allegra
——————————————————————
When one of Schering Sales’ best customers demanded price reduction in drug– because it cost HMO millions of additional dollars a year to purchase drug instead of Allegra– Schering Sales refused, in part, because it knew that by doing so it would have to lower drug price for Medicaid programs
——————————————————————
Following HMO’s decision to remove drug from its formulary

(in essence, death knell for drug sales to that customer)

Schering Sales offered to make up difference between price of drug and Allegra by offering HMO $10 million package of added value, in lieu of actual price reduction on drug
——————————————————————
As part of “value added” package to induce HMO to keep drug on formulary, Schering Sales offered to pay annual fee of 2% of annual gross sales of Schering drugs to HMO, approximately $2.4 million
——————————————————————
Schering Sales disguised true nature of fee by calling it a “data fee” in order to give appearance fee was fair market value transaction rather than hidden inducement to HMO to keep drug on formulary
——————————————————————
“Schering used terms like:
1. “data fee”
2. “value added”
as camouflage for what was nothing more than an old-fashioned kickback
——————————————————————
Result was programs created to provide healthcare to poorest among were actually paying more for drugs than those who have private health insurance
——————————————————————
As participant in Medicaid Rebate Program, Schering Plough was required to report “best price” for and to pay rebates on drug
——————————————————————
Under provisions of Public Health Service drug pricing program, Schering required to charge PHS entities such as:
1. AIDS drug programs
2. community health centers
discounted price, based in part on Medicaid price
——————————————————————
In late 1990’s, Schering Plough’s powerhouse allergy drug, faced growing competition
——————————————————————
2 of Schering Plough’s largest managed care customers
Cigna Healthcare (Cigna)
Pacificare Health Systems (Pacificare) threatened to remove drug from respective drug formularies in favor of less expensive, Allegra, as way to decrease drug costs
——————————————————————
In order to match Allegra’s price and keep drug on formularies, while simultaneously attempting to avoid additional rebate obligations under Medicaid Drug Rebate Program, Schering Plough funded significant price concessions to:
1. Cigna
2. Pacificare
through assortment of payments and services
——————————————————————
To Cigna
Schering provided data fee subject of criminal charge:
1. $3 million worth of deeply discounted Claritin reditabs
2. health management services at far below fair market value
3. interest free loan in form of prepaid rebates
——————————————————————
To PacifiCare
Schering provided risk share arrangement in which Schering:
1. covered portion of managed care customer’s respiratory drug costs
2. deep discounts on other Schering products
3. payment and services for Internet development
4. interest free loan in form of prepaid rebates
——————————————————————
By failing to account for discounts in reported best price for drug:
1. Medicaid program
2. PHS entities
paid far more for drug
(1998 – 2002)
than 2 managed care customers
——————————————————————
Schering Plough agreed to enter into corporate integrity agreement with Department of Health and Human Services that addresses Schering’s sales, marketing and pricing of drugs to government programs
——————————————————————
Integrity agreement includes 5 years of independent audits to ensure Schering’s compliance with all federally funded health care programs
——————————————————————
As result of criminal plea, Schering Sales Corporation will be excluded from participation in all federal health care programs for at least 5 years
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DEPAKOTE
======================================
$1.5 BILLION – 5/7/2012 – Abbott Laboratories (1/1998 – 12/2006)
——————————————————————
FDA approved only 3 uses:
1. epileptic seizures
2. bipolar mania
3. prevention of migraines
——————————————————————
Unlawful promotion of prescription drug for uses not approved as safe and effective by Food and Drug Administration (FDA)
——————————————————————
Illegal promotion of drug to control in dementia patients:
1. Aggression
2. Agitation
——————————————————————
Continued to promote drug off-label to treat schizophrenia
——————————————————————
In agreed statement of facts admitted:
(2001 – 2006)
misbranded drug by marketing drug to treat schizophrenia
——————————————————————
Pleaded guilty to criminal misdemeanor for misbranding drug in violation of FDCA (neither use FDA approved) by:
1. promoting drug to control behavioral disturbances in dementia patients
2. to treat schizophrenia
——————————————————————
FDA never approved drug as safe and effective for off-label use of controlling behavioral disturbances in dementia patients
——————————————————————
Trained / used sales force to promote drug to:
1. employees of nursing homes
2. health care providers
as advantageous over antipsychotic drugs for controlling behavioral disturbances in dementia patients
——————————————————————
In agreed statement of facts filed in criminal action admits:
(1998 – 2006)
maintained specialized sales force trained to market drug in nursing homes for control (in elderly dementia patients) of:
1. aggression
2. agitation
despite absence of credible scientific evidence drug safe and effective for that use
——————————————————————
Exploiting fact drug wasn’t subject to certain provisions of Omnibus Budget Reconciliation Act of 1987 (OBRA) and implementing regulations designed to prevent use of unnecessary medications in nursing homes, which didn’t yet apply to drug, sales representatives stated by using drug, nursing homes could avoid administrative burdens and costs of complying with OBRA
——————————————————————
Off-label promotion
created:
1. materials
2. programs
to train pharmacy providers’ consultant pharmacists about off-label use of drug to encourage them to recommend drug for unapproved use
——————————————————————
Entered into contracts that provided long-term care pharmacy providers with payments of rebates based on increases in use of drug in nursing homes serviced by providers
——————————————————————
Under contracts, paid millions of dollars in rebates to pharmacy providers
——————————————————————
5 years probation:
As condition of probation
1. will report any probable FDCA violations to probation office
2. CEO will certify compliance with reporting requirement
3. board will report annually on effectiveness of company’s compliance program
——————————————————————
During term of probation:
1. will not compensate sales representatives for off-label sales
2. will ensure continuing medical education grant-making decisions aren’t controlled by sales and marketing
3. will require letters communicating medical information to healthcare providers be
a. accurate
b. unbiased
4. will have policies designed to ensure clinical trials are approved by company’s medical or scientific organizations and published in consistent and transparent manner
——————————————————————
Under civil settlement agreed to resolve claims:
1. unlawful marketing
2. illegal remuneration
3. practices caused false claims to be submitted to government health care programs such as:
a. Medicare
b. Medicaid
c. TRICARE
e. Federal Employees Health Benefit Program
f. Department of Veterans’ Affairs
g. Department of Labor’s Office of Workers’ Compensation Programs
——————————————————————
Civil settlement addresses broader allegations by United States:
(1998 – 2008)
unlawfully promoted drug for unapproved uses, including:
1. alcohol and drug withdrawal
2. anxiety
3. attention deficit disorder
4. autism
5. behavioral disturbances in dementia patients
6. conduct disorders
7. depression
8. obsessive-compulsive disorder
9. post-traumatic stress disorder
10. psychiatric conditions in children and adolescents
11. schizophrenia
——————————————————————
Some unapproved uses weren’t medically accepted indications for which United States and state Medicaid programs provided coverage for drug
——————————————————————
United States contends promotion included, in part, making false and misleading statements about:
1. cost-effectiveness of drug for some unapproved uses
2. dosing
3. efficacy
4. safety
5. claiming use of drug to control behavioral disturbances in dementia patients would help nursing homes avoid administrative burdens and costs of complying with OBRA regulatory restrictions applicable to antipsychotics
——————————————————————
Civil settlement covers allegations:
1. offered
2. paid
illegal remuneration to:
1. health care professionals
2. long term care pharmacy providers
to induce them to:
1. promote
and/or
2. prescribe
drug and:
1. improperly
2. unduly influence
content of company sponsored Continuing Medical Education programs, in violation of Federal Anti-Kickback Statute
——————————————————————
As part of resolution:
Executed Corporate Integrity Agreement (CIA) with Department of Health and Human Services, Office of Inspector General (HHS-OIG)
——————————————————————
5-year CIA requires:
1. board of directors review effectiveness of company’s compliance program
2. high-level executives certify compliance
3. maintain standardized risk assessment and mitigation processes
4. post on website information about payments to doctors
——————————————————————
Subject to exclusion from federal health care programs, including
1. Medicare
2. Medicaid
for material breach of CIA
——————————————————————
Subject to monetary penalties for less significant breaches
——————————————————————
Will be subject to court-supervised probation reporting obligations for:
1. CEO
2. Board of Directors
======================================

======================================
EVISTA
======================================
$36 MILLION
——————————————————————
Eli Lilly and Company, Indianapolis, Indiana-based company
12/21/2005, Wednesday
——————————————————————
In connection with illegal promotion of pharmaceutical drug
——————————————————————
Pleading guilty to criminal count of violating Food, Drug, and Cosmetic Act by misbranding drug
——————————————————————
In addition to criminal plea
agreed to settle civil Food, Drug, and Cosmetic Act liabilities by entering into consent decree of permanent injunction
——————————————————————
Charged in criminal information filed with violation of Food, Drug, and Cosmetic Act, following investigation by Food and Drug Administration’s (FDA) Office of Criminal Investigations
——————————————————————
Plea agreement signed by Lilly and United States

complaint for permanent injunction

consent decree of permanent injunction signed by company and United States
——————————————————————
Drug approved by FDA for prevention and treatment of osteoporosis in post-menopausal women
——————————————————————
information alleges 1st year’s sales of drug in U.S. were disappointing compared to original forecast
——————————————————————
According to information
10/1998 – company reduced forecast of drug’s 1st year’s sales in U.S. from $401 million to $120 million
——————————————————————
internal business plan noted:

“Disappointing year versus original forecast.”
——————————————————————
Information alleges in order to expand sales of drug, Lilly sought to broaden market for drug by promoting it for unapproved uses
——————————————————————
Information alleges strategic marketing plans and promotion touted drug as effective in preventing and reducing risk of diseases for which drug’s labeling lacked adequate directions for use
——————————————————————
According to information, Evista
1. brand team
2. sales representatives
promoted drug for:
1. prevention in risk of breast cancer
2. reduction in risk of breast cancer

3. reduction in risk of cardiovascular disease
——————————————————————
Under provisions of Food, Drug, and Cosmetic Act, drug misbranded when labeling didn’t bear adequate directions for each of intended uses
——————————————————————
Alleged in information, promoted drug as effective for reducing risk of breast cancer even after proposed labeling for this use specifically rejected by FDA
——————————————————————
Information alleges executed illegal conduct using number of tactics, including:
1. One-on-one sales pitches by sales representatives promoting drug to physicians about off-label uses of drug
2. Sales representatives trained to prompt or bait questions by doctors in order to promote drug for unapproved uses
3. Encouraging sales representatives promoting drug to send unsolicited medical letters to promote drug for unapproved use to doctors on their sales routes
4. Organizing “market research summit’ during which drug was discussed with physicians for unapproved uses, including reducing risk of breast cancer
5.
a. Creating
b. distributing
to sales representatives “Evista Best Practices” videotape, in which sales representative states “Evista truly is the best drug for the prevention of all these diseases” referring to:
1). osteoporosis
2). breast cancer
3). cardiovascular disease
——————————————————————
Complaint for permanent injunction alleges executed illegal conduct using number of tactics, including:
1. Training sales representatives to promote drug for prevention and reduction in risk of breast cancer by use of medical reprint in way that highlighted key results of drug and thereby promoted drug to doctors for unapproved use
2. Some sales representatives were instructed to hide disclosure page of reprint which noted:
a. “All of the authors were either employees or paid consultants of Eli Lilly at the time this article was written,”
b. “The prescribing information provides that “The effectiveness of [Evista] in reducing the risk of breast cancer has not yet been established.”
3. Organizing “consultant meetings” for physicians who prescribed drug during which unapproved uses of drug discussed
4. Calculating incremental new prescriptions for doctors who attended Evista advisory board meetings in 1998
5. advisory board meetings included discussion of unapproved uses for drug
6. By measuring and analyzing incremental new prescriptions for doctors who attended advisory board meetings, Lilly was using this intervention as tool to promote and sell drug
——————————————————————
In addition to agreeing to plead guilty to criminal information and plea agreement signed by Lilly, settlement with United States includes following components:
(a) agreed to settle civil Food, Drug, and Cosmetic Act liabilities by entering into consent decree of permanent injunction
(1). As part of consent decree, agreed to comply with terms of permanent injunction, which will require company to implement effective training and supervision of marketing and sales staff for drug, and ensure any future off-label marketing conduct is detected and corrected
(2). agreed to be permanently enjoined from directly or indirectly promoting drug for use in:
a. preventing or reducing risk of breast cancer
b. reducing risk of cardiovascular disease
c. or for any other unapproved use in manner that violates Food, Drug, and Cosmetic Act unless and until FDA approves drug for additional use or uses
——————————————————————
(b) as part of consent decree, agreed to hire and utilize independent organization to conduct reviews to assist Lilly in assessing and evaluating Lilly’s
1. systems
2. processes
3. policies
4. procedures
relating to promotion of drug and company’s compliance with consent decree
——————————————————————
FDA made following announcement to postmenopausal women who have taken drug for prevention or treatment of osteoporosis:
——————————————————————
“No postmenopausal woman who has taken Evista for the prevention or treatment of osteoporosis is affected by this action, as this matter today relates only to unapproved uses of Evista.”
——————————————————————
Defendant agreed to plead guilty to charge in information
——————————————————————
Defendant agreed to resolve complaint for permanent injunction by agreeing to consent decree of permanent injunction
======================================

======================================
FLOVENT (see ADVAIR)
======================================

======================================
GABITRIL (see ACTIQ)
======================================

======================================
GEODON (see BEXTRA)
======================================

======================================
IMITREX (see ADVAIR)
======================================

======================================
INVEGA
NATRECOR
RISPERDAL

======================================
$2.2 BILLION + 11/4/2013, Monday Global health care giant Johnson & Johnson (J&J) and its subsidiaries, Janssen Pharmaceuticals Inc. and Scios Inc. (1998 – 2009)
——————————————————————
Allegations Include Off-label Marketing and Kickbacks to Doctors and Pharmacists
——————————————————————
Allegations relating to prescription drugs:
1. Invega
2. Natrecor
3. Risperdal
including promotion for uses not approved as safe and effective by Food and Drug Administration (FDA)
——————————————————————
Payment of kickbacks to:
1. physicians
2. nation’s largest long-term care pharmacy provider
——————————————————————
Global resolution
one of largest health care fraud settlements in U.S. history
——————————————————————
Resolution will subject J&J to stringent requirements under Corporate Integrity Agreement (CIA) with Department of Health and Human Services Office of Inspector General (HHS-OIG)
——————————————————————
Agreement designed to increase:
1. accountability
2. transparency
and prevent future:
1. fraud
2. abuse
——————————————————————
J&J Subsidiary Janssen Pleads Guilty to Misbranding Antipsychotic Drug
——————————————————————
Introduced antipsychotic drug Risperdal into interstate commerce for unapproved use, rendering product misbranded
——————————————————————
For most of time period, drug approved only to treat schizophrenia
——————————————————————
Information alleges Janssen’s sales representatives promoted Risperdal to:
1. physicians
2. other prescribers
who treated elderly dementia patients
by urging prescribers to use drug to treat symptoms such as:
1. agitation
2. anxiety
3. confusion
4. depression
5. hostility
——————————————————————
Information alleges created written sales aids for use by Janssen’s ElderCare sales force that emphasized symptoms and minimized any mention of FDA-approved use:
treatment of schizophrenia
——————————————————————
Provided incentives for off-label promotion and intended use by basing sales representatives’ bonuses on total sales of drug in their sales areas, not just sales for FDA-approved uses
——————————————————————
In plea agreement resolving charges, Janssen admitted promoted drug to health care providers for treatment of psychotic symptoms and associated behavioral disturbances exhibited by elderly, non-schizophrenic dementia patients
——————————————————————
J&J and Janssen Settle Civil Allegations of Targeting Vulnerable Patients with the Drugs Risperdal and Invega for Off-Label Uses
——————————————————————
In related civil complaint, United States alleges Janssen marketed drug to control behaviors and conduct of nation’s most vulnerable patients:
1. children with mental disabilities
2. individuals with mental disabilities
3. elderly nursing home residents
——————————————————————
Government alleges J&J and Janssen caused false claims to be submitted to federal health care programs by promoting drug for off-label uses federal health care programs didn’t cover
making:
1. false
2. misleading
statements about:
1. safety
2. efficacy
of drug
paying kickbacks to physicians to prescribe drug
——————————————————————
In complaint, government alleges FDA repeatedly advised Janssen that marketing drug as safe and effective for elderly would be “misleading.”
——————————————————————
FDA cautioned Janssen that behavioral disturbances in elderly dementia patients weren’t necessarily manifestations of psychotic disorders and might even be “appropriate responses to the deplorable conditions under which some demented patients are housed, thus raising ethical question regarding use of antipsychotic medication for inappropriate behavioral control.”
——————————————————————
Complaint alleges despite FDA warnings and increased health risks
(1999 – 2005)
Janssen aggressively marketed drug to control behavioral disturbances in dementia patients through “ElderCare sales force” designed to target:
1. doctors who treated elderly
2. nursing homes
——————————————————————
In business plans, Janssen’s goal was to:
“[m]aximize and grow RISPERDAL’s market leadership in geriatrics and long term care.”
——————————————————————
Company touted drug as having (in geriatric patients):
1. “proven efficacy”
2. “an excellent safety and tolerability profile”
——————————————————————
In addition to promoting Risperdal for elderly dementia patients
(1999 – 2005)
Janssen allegedly promoted antipsychotic drug for use in:
1. children
2. individuals with mental disabilities
——————————————————————
Complaint alleges J&J and Janssen knew drug posed certain health risks to children, including risk of elevated levels of prolactin, hormone that can stimulate breast development and milk production
——————————————————————
Nonetheless, one of Janssen’s Key Base Business Goals was to grow and protect drug’s market share with child/adolescent patients
——————————————————————
Janssen instructed sales representatives to call on:
1. child psychiatrists
2. mental health facilities that primarily treated children
and market drug as safe and effective for symptoms of various childhood disorders, such as:
1. autism
2. attention deficit hyperactivity disorder
3. obsessive-compulsive disorder
4. oppositional defiant disorder
——————————————————————
Until late 2006, drug wasn’t approved for use in children for any purpose, FDA repeatedly warned company against promoting it for use in children
——————————————————————
Government’s complaint contains allegations Janssen paid speaker fees to doctors to influence them to write prescriptions for drug
——————————————————————
Sales representatives allegedly told doctors if they wanted to receive payments for speaking, they needed to increase drug prescriptions
——————————————————————
In addition to allegations relating to Risperdal
settlement resolves allegations relating to Invega, newer antipsychotic drug also sold by Janssen
——————————————————————
Invega was approved only for treatment of:
1. schizophrenia
2. schizoaffective disorder
——————————————————————
Government alleges
(2006 – 2009)
J&J and Janssen marketed drug for off-label indications and made:
1. false
2. misleading
statements about:
1. safety
2. efficacy
——————————————————————
Kickbacks to Nursing Home Pharmacies
——————————————————————
Civil settlement resolves allegations, in furtherance of efforts to target elderly dementia patients in nursing homes, J&J and Janssen paid kickbacks to Omnicare Inc., nation’s largest pharmacy specializing in dispensing drugs to nursing home patients
——————————————————————
1/2010 – United States alleged J&J paid millions of dollars in kickbacks to Omnicare under guise of:
1. data-purchase agreements
2. “educational funding”
3. “grants”
4. market share rebate payments
——————————————————————
Kickbacks were intended to induce Omnicare and its hundreds of consultant pharmacists to engage in “active intervention programs” to promote use of Risperdal and other J&J drugs in nursing homes
——————————————————————
Omnicare’s consultant pharmacists regularly reviewed nursing home patients’ medical charts and made recommendations to physicians on what drugs should be prescribed for those patients
——————————————————————
Although consultant pharmacists purported to provide
“independent” recommendations based on clinical judgment, J&J viewed pharmacists as “extension of [J&J’s] sales force.”
——————————————————————
To resolve government’s contention kickbacks caused Omnicare to submit false claims to federal health care programs
for claims it accepted kickbacks from J&J and Janssen, along with certain other conduct
——————————————————————
Off-Label Promotion of the Heart Failure Drug Natrecor
——————————————————————
Civil settlement resolves allegations
caused:
1. false
2. fraudulent
claims to be submitted to federal health care programs for heart failure drug Natrecor
——————————————————————
2009 – civil complaint, government alleged shortly after Natrecor approved, Scios launched aggressive campaign to market drug for scheduled, serial outpatient infusions for patients with less severe heart failure – a use not included in FDA-approved label and not covered by federal health care programs
——————————————————————
Infusions generally involved visits to:
1. outpatient clinic
2. doctor’s office
for 4- to 6-hour infusions one or two times per week for several weeks or months
——————————————————————
Scios sponsored extensive speaker program through which doctors were paid to tout purported benefits of serial outpatient use of Natrecor
——————————————————————
Scios urged:
1. doctors
2. hospitals
to set up outpatient clinics specifically to administer serial outpatient infusions, in some cases:
1. providing funds to defray costs of setting up clinics
2. supplied providers with extensive resources and support for billing Medicare for outpatient infusions
——————————————————————
Because Medicaid is joint federal-state program, J&J’s conduct caused losses to both federal and state governments
——————————————————————
To resolve alleged false claims to federal health care programs resulting from off-label marketing of Natrecor
Scios pleaded guilty to misdemeanor FDCA violation
for introducing Natrecor into interstate commerce for off-label use
——————————————————————
Non-Monetary Provisions of the Global Resolution and Corporate Integrity Agreement
——————————————————————
J&J executed 5-year Corporate Integrity Agreement (CIA) with Department of Health and Human Services Office of Inspector General (HHS-OIG)
——————————————————————
CIA includes provisions requiring J&J implement major changes to way pharmaceutical affiliates do business
——————————————————————
CIA requires J&J change executive compensation program to permit company to recoup:
1. annual bonuses
2. other long-term incentives
from:
covered executives if they, or their subordinates, engage in significant misconduct
——————————————————————
J&J may recoup monies from executives who are:
1. current employees
2. those who’ve left company
——————————————————————
CIA requires J&J’s pharmaceutical businesses to implement and maintain transparency regarding:
1. research practices
2. publication policies
3. payments to physicians
——————————————————————
On annual basis, management employees (must certify compliance with provisions of CIA), including:
1. senior executives
2. certain members of J&J’s independent board of directors
——————————————————————
J&J must submit detailed annual reports to HHS-OIG about compliance program and business operations
======================================

======================================
LAMICTAL (see ADVAIR)
======================================

======================================
LOTRONEX (see ADVAIR)
======================================

======================================
LUPRON
======================================
$875,000,000 MILLION – 10/3/2001, WednesdayTAP Pharmaceutical Products Inc. (TAP)
——————————————————————
(1) TAP Pharmaceutical Products Inc. (“TAP”), major American pharmaceutical manufacturer, agreed to resolve criminal charges and civil liabilities in connection with fraudulent drug pricing and marketing conduct with regard to Lupron, a drug sold by TAP primarily for treatment of advanced prostate cancer in men
——————————————————————
Global agreement includes:
——————————————————————
(a) agreed to plead guilty to conspiracy to violate PrescriptionDrug Marketing Act
——————————————————————
Plea agreement between United States and TAP specifically states TAP’s criminal conduct caused losses of $145,000,000
——————————————————————
(b) Agreed to settle federal civil False Claims Act liabilities and filing false and fraudulent claims with:
1. Medicaid
2. Medicare
programs as result of fraudulent drug pricing schemes and sales and marketing misconduct
——————————————————————
(c) Agreed to settle civil liabilities to 50 states and District of Columbia for filing false and fraudulent claims with states, as result of drug pricing and marketing misconduct, and from failure to provide state Medicaid programs best price for those drugs as required by law
——————————————————————
(d) Agreed to comply with terms of sweeping corporate integrity agreement which, significantly changes manner in which TAP supervises marketing and sales staff, and ensures TAP will report to:
1. Medicaid program
2. Medicare program
true average sale price for drugs reimbursed by those programs
——————————————————————
(2) federal grand jury returned indictment, charging one physician and 6 TAP managers with:
a. conspiracy to pay kickbacks to:
1. doctors
2. other customers
b. conspiracy to defraud state Medicaid programs on TAP’s obligation to sell products to those programs at best price
c. conspiracy to violate Prescription Drug Marketing Act by causing free samples to be illegally billed to Medicare program
——————————————————————
Indictment charges defendants offered to give things of value, including:
1. free consulting services
2. free drugs
3. so-called educational grants
4. forgiveness of debt
5. medical equipment
6. trips to resorts
to
1. physicians
and
2. other customers
to obtain their referrals of prescriptions for drug to Medicare program beneficiaries, in violation of anti-kickback statute
——————————————————————
Indictment charges defendants
1. aided
2. abetted
3. caused billings to hundreds of elderly Medicare program beneficiaries and to Medicare program directly, for thousands of free samples of drug, used in treatment of prostate cancer, in violation of Prescription Drug Marketing Act
——————————————————————
7 individuals charged in indictment are:

(1) ALAN MACKENZIE, age 49, of 27068 Wellington Court, Barrington, Illinois, formerly Vice President of Sales for TAP

(2) JANICE SWIRSKI, age 40, of 6 Bellingham Drive, Chestnut Hill, Massachusetts, formerly National Account Manager with TAP

(3) HENRY VAN MOURICK, age 43, of 23 Golfwood Court, Roseville, California, currently District Manager employed by TAP.
(4) DONNA TOM, age 37, of 141 East 56th Street, New York, New York, formerly District Manager employed by TAP

(5) KIMBERLEE CHASE, age 35, of 108 Dedham Street, Dover, Massachusetts, formerly District Manager employed by TAP

(6) DAVID GUIDO, age 30, of 131 New London Road, Colchester, Connecticut, currently Hospital Account Executive employed by TAP

(7) DR. JOHN ROMANO, age 48, of 110 Long Pond Road, Plymouth, Massachusetts, urologist with practice in Plymouth, Massachusetts
——————————————————————
Prior to indictment, 4 other physicians charged and pleaded guilty in investigation:

1. Dr. Rodney Mannion, urologist practicing in LaPorte and Michigan City, Indiana, charged 2/28/2000 with healthcare fraud
Dr. Mannion pleaded guilty to charge 4/25/2000

2. Dr. Jacob Zamstein, urologist practicing in Bloomfield, Connecticut, was charged 11/3/2000 with healthcare fraud and pleaded guilty 11/27/2000

3. Dr. Joseph Spinella, urologist practicing in Bristol, Connecticut, was charged 12/8/2000 with healthcare fraud and pleaded guilty 3/29/2001

4. Dr. Joel Olstein, urologist practicing in Lewiston, Maine, charged 4/11/2001 with healthcare fraud and pleaded guilty 7/18/2001
——————————————————————
Drug is marketed primarily for treatment of prostate cancer
——————————————————————
Drug identical in effectiveness to drug Zolodex, produced by competitor, which was also available for prescription in 1990s
——————————————————————
While Medicare does not pay for most drugs needed by Medicare beneficiaries, Medicare does cover drugs, such as Lupron, that must be injected under supervision of physician
——————————————————————
Medicare paid 80% of either urologist’s charge for drug or average wholesale price reported by TAP, whichever was lower, and patient was responsible for remaining 20% as copayment
——————————————————————
As part of civil allegations, Government alleged throughout 1990s, TAP set and controlled price at which Medicare program reimbursed physicians for prescription of drug by reporting average wholesale price (“AWP”)
AWP reported by TAP was significantly higher than average sales price TAP offered physicians and other customers for drug
——————————————————————
Government alleged TAP marketed spread between discounted prices paid by physicians and significantly higher Medicare reimbursement based on AWP as inducement to physicians to obtain their Lupron business
——————————————————————
Government alleged TAP concealed true discounted prices paid by physicians from Medicare, and falsely advised physicians to report higher AWP rather than real discounted price for drug
——————————————————————
Government alleged TAP set AWPs of drug at levels far higher than price for which wholesalers or distributors actually sold drug, resulting in falsely inflated prices that were neither physician’s actual cost nor true wholesaler’s average price
——————————————————————
Indictment against 7 individuals alleges inducements to physicians included:
1. free consulting services
2. free products
3. trips to expensive golf and ski resorts
4. money disguised as “educational grants,” but in fact was used and intended to be used for many purposes, including:
a. office Christmas parties
b. cocktail party bar tabs
d. medical equipment
e. travel expenses for urologists and their staff to attend conferences
f. discounts on drug sold to treat endometriosis in women to effect a lower price on drug used in treatment of men with prostate cancer
——————————————————————
Investigation commenced in 1997 after urologist employed by Tufts Associated Health Maintenance Organization (“Tufts HMO”) in Waltham, Dr. Joseph Gerstein, reported to law enforcement authorities he had been offered educational grant if he would reverse decision he had made on behalf of Tufts that it would only cover less expensive drug Zoladex
——————————————————————
As charged in indictment, SWIRSKI and CHASE met with Dr. Gerstein after he began working with the FBI and Office of Inspector General, and during those meetings, offered him $65,000 in educational grants that he could use for any purpose “whatever,” together with discounts on other products, if he would reverse Tufts’ decision not to include Lupron on its formulary for treating patients it insured who were suffering from prostate cancer
——————————————————————
Investigation also triggered by civil False Claims Act suit filed in 1996 by Douglas Durand, after he quit employment at TAP as Vice President of Sales, after just one year because of concerns about illegal marketing conduct of some of employees
——————————————————————
As part of condition for doing business in future with providers who are members of:
1. Medicaid program
2. Medicare program
TAP agreed to enter into extensive Corporate Integrity Agreement
——————————————————————
Agreement provides for significant training of sales and marketing employees and changes in supervision and controls
——————————————————————
Requires TAP to report to:
1. Medicaid
2. Medicare
programs accurate pricing information showing true average sales price
======================================

======================================
LYRICA (see BEXTRA)
======================================

======================================
NATRECOR
======================================
$85 MILLION criminal fine – 10/5/2011, WednesdayScios Inc., Fremont, California-Based Company, a subsidiary of pharmaceutical giant Johnson & Johnson
——————————————————————
Pleads Guilty to Misbranding Heart Failure Drug Natrecor
——————————————————————
Pleaded guilty to misdemeanor violation of Food, Drug and Cosmetic Act (FDCA) for introducing into interstate commerce heart failure drug, for use that was not approved by Food and Drug Administration (FDA)
——————————————————————
2001 – FDA approved drug for:
——————————————————————
“the intravenous treatment of patients with acutely decompensated congestive heart failure [CHF] who have dyspnea [shortness of breath] at rest or with minimal activity.”
——————————————————————
Approved labeling for drug did not list any other use, and drug was not approved by FDA for any other use
——————————————————————
Drug must be administered intravenously to patients
——————————————————————
It’s vasodilator and opens up blood vessels, which reduces heart’s workload and may help to improve acutely decompensated patient’s shortness of breath
——————————————————————
As part of plea, admitted intended drug be used off-label for infusing chronic (non-acute) CHF patients on scheduled, serial basis and understood this wasn’t approved use of drug
——————————————————————
Admitted FDA-approved labeling for drug did not contain any directions for this scheduled, serial use to treat chronic (non-acute) patients
——————————————————————
United States alleges promotion of scheduled, serial use of drug to treat non-acute heart failure patients caused false claims to be submitted to:
1. Medicare
2. other federal healthcare programs
for unapproved use of drug because it wasn’t medically accepted and effective use of drug
======================================

======================================
NATRECOR (see INVEGA)
======================================

======================================
PAXIL (see ADVAIR)
======================================

======================================
PROTONIX
======================================
$55 MILLION plus interest – 12/12/2012, WednesdayPfizer / Wyeth LLC
——————————————————————
Allegations Wyeth LLC Illegally Promoting Protonix for Off-Label Use
——————————————————————
Wyeth manufactured and promoted Protonix tablets
——————————————————————
Protonix is proton pump inhibitor (PPI) used by physicians to treat various forms of gastro-esophageal reflux disease (GERD)
——————————————————————
Wyeth sought and obtained approval from Food and Drug Administration (FDA) to promote Protonix for short-term treatment of erosive esophagitis–a condition associated with GERD that can only be diagnosed with invasive endoscopy
——————————————————————
Government alleges Wyeth fully intended to, and did, promote Protonix for all forms of GERD, including symptomatic GERD, which was far more common and could be diagnosed without endoscopy
——————————————————————
Alleged in government’s complaint, Wyeth’s illegal promotional campaign for Protonix was multi-faceted
——————————————————————
Before Wyeth even began promoting Protonix, FDA warned Wyeth that proposed promotional materials were misleading because Wyeth had “overstated” “erosive esophagitis indication” by “suggesting that Protonix is safe and effective in the treatment of patients with . . . GERD
Protonix is not indicated for treatment of GERD symptoms that occur in the absence of esophageal erosions.”

——————————————————————
Despite FDA’s admonishment, government alleges Wyeth trained sales force to promote Protonix for all forms of GERD, beyond limited erosive esophagitis indication, and Wyeth sales representatives frequently promoted Protonix to physicians for unapproved uses, such as symptomatic GERD
——————————————————————
Wyeth allegedly promoted Protonix as the “best PPI for nighttime heartburn.” though there was never any clinical evidence Protonix was more effective than any other PPI for nighttime heartburn
——————————————————————
Allegations in complaint are that superiority slogan was formulated at highest levels of the company
——————————————————————
Wyeth retained outside market research firm, at cost of tens of thousands of dollars, to ensure sales representatives delivered misleading superiority message
——————————————————————
Government alleges Wyeth used continuing medical education (CME) programs to promote Protonix for unapproved uses
——————————————————————
CME programs are sponsored by accredited independent providers, such as:
1. nonprofit organizations
2. specialty societies
3. universities
——————————————————————
Pharmaceutical companies are permitted to provide financial support for CME programs, but are not permitted to use CME programs as promotional vehicles for off-label indications
——————————————————————
According to complaint, Wyeth spent millions of dollars providing “unrestricted educational grants” to CME providers, and grants invariably included promises Wyeth would not attempt to influence content of program in any way
——————————————————————
Government alleges one of Wyeth’s core marketing tactics for Protonix was to use CME programs to drive off-label use of drug
——————————————————————
According to complaint, Protonix “brand team” influenced virtually every aspect of CME programs:
1. content
2. organization
3. speaker selection
4. program topics
——————————————————————
Government alleges Wyeth even insisted CME program materials use same color and appearance as Protonix promotional materials–a tactic Wyeth and vendor called “branducation.”
——————————————————————
10/2009Pfizer acquired Wyeth
——————————————————————
Since 8/2009, Pfizer has been under Corporate Integrity Agreement with Department of Health and Human Services, which agreement remains in effect
======================================

======================================
PROVIGIL (see
ACTIQ
)
======================================

======================================
RAPAMUNE
======================================
$490.9 MILLION – 7/30/2013, TuesdayWyeth Pharmaceuticals Inc., a pharmaceutical company acquired by Pfizer, Inc. in 2009
——————————————————————
(1998 – 2009)
——————————————————————
Marketing the Prescription Drug Rapamune for Unapproved Uses
——————————————————————
To resolve criminal and civil liability arising from unlawful marketing of prescription drug for uses not approved as safe and effective by U.S. Food and Drug Administration (FDA)
——————————————————————
Rapamune is “immunosuppressive” drug that prevents body’s immune system from rejecting transplanted organ
——————————————————————
1999, Wyeth received approval from FDA for Rapamune use in renal (kidney) transplant patients
——————————————————————
Information alleges, Wyeth trained national Rapamune sales force to promote use of drug in non-renal transplant patients
——————————————————————
Wyeth provided sales force with training materials regarding non-renal transplant use and trained them on how to use materials in presentations to transplant physicians
——————————————————————
Wyeth encouraged sales force members, through financial incentives, to target all transplant patient populations to increase Rapamune sales
——————————————————————
Wyeth pleaded guilty to criminal information charging it with misbranding violation under FDCA
——————————————————————
Wyeth agreed to settle potential civil liability in connection with off-label marketing of Rapamune
——————————————————————
Government alleged Wyeth violated False Claims Act by promoting Rapamune for unapproved uses, some of which weren’t medically accepted indications and, therefore, weren’t covered by:
1. Medicaid
2. Medicare
3. other federal health care programs
——————————————————————
Unapproved uses included:
1. conversion use (switching patient from another immunosuppressant to Rapamune)
2. non-renal transplants
3. using Rapamune in combination with other immunosuppressive agents not listed on label
——————————————————————
Government alleged conduct resulted in submission of false claims to government health care programs
——————————————————————
Subject to Corporate Integrity Agreement (CIA) with Department of Health and Human Services’ Office of Inspector General entered in connection with another matter in 2009, shortly before acquiring Wyeth
——————————————————————
CIA covers former Wyeth employees who now perform sales and marketing functions at Pfizer
——————————————————————
Under CIA, Pfizer subject to exclusion from federal health care programs, including:
1. Medicaid
2. Medicare
for material breach of CIA, and subject to monetary penalties for less significant breaches
======================================

======================================
RISPERDAL (see INVEGA)
======================================

======================================
SEROQUEL
======================================
$520 MILLION – 4/27/2010, TuesdayAstraZeneca LP / AstraZeneca Pharmaceuticals LP, Wilmington, Delaware-based company (1/2001 – 12/2006)
——————————————————————
Off-label Drug Marketing
allegations illegally marketed anti-psychotic drug for uses not approved as safe and effective by Food and Drug Administration (FDA)
——————————————————————
Signed civil settlement to resolve allegations that by marketing drug for unapproved uses, caused false claims for payment to be submitted to federal insurance programs including:
1. Medicaid program
2. Medicare program
3. TRICARE program
4. Department of Veterans Affairs
5. Federal Employee Health Benefits Program
6. Bureau of Prisons
——————————————————————
9/1997 – FDA approved drug for treatment of manifestations of psychotic disorders
9/2000 – FDA proposed narrowing approval for drug to short term treatment of schizophrenia only
1/2004 – FDA approved drug for short term treatment of acute manic episodes associated with bipolar disorder (bipolar mania)
10/2006 – FDA approved drug for bipolar depression
——————————————————————
United States alleges illegally marketed drug for uses never approved by FDA
(1/2001 – 12/2006)
promoted drug to:
1. psychiatrists
2. other physicians
for certain uses not approved by FDA as safe and effective including:
1. aggression
2. Alzheimer’s disease
3. anger management
4. anxiety
5. attention deficit hyperactivity disorder
6. bipolar maintenance
7. dementia
8. depression
9. mood disorder
10. post-traumatic stress disorder
11. sleeplessness
——————————————————————
Unapproved uses weren’t medically accepted indications for which United States and state Medicaid programs provided coverage for drug
——————————————————————
According to settlement agreement, targeted illegal marketing of anti-psychotic drug towards doctors who don’t typically treat schizophrenia or bipolar disorder, such as:
1. adolescent physicians
2. pediatric physicians
3. physicians who treat the elderly
4. primary care physicians
5. in long-term care facilities
6. prisons
——————————————————————
United States contends promoted unapproved uses by:
1. improperly
2. unduly
influencing content of speakers in company-sponsored continuing medical education programs
——————————————————————
United States contends violated federal Anti-Kickback Statute by:
1. offering
2. paying
illegal remuneration to doctors it recruited to serve as authors of articles written by AstraZeneca and its agents about unapproved uses of drug
——————————————————————
1. offered
2. paid
illegal remuneration to:
1. doctors to travel to resort locations to “advise” AstraZeneca about marketing messages for unapproved uses of drug
2. doctors to give promotional lectures to other health care professionals about unapproved and unaccepted uses of drug
——————————————————————
United States contends payments intended to induce doctors to prescribe drug for unapproved uses in violation of federal Anti-Kickback Statute
——————————————————————
Resolution of matter includes Corporate Integrity Agreement (CIA) between AstraZeneca and Office of Inspector General of Department of Health and Human Services
——————————————————————
5-year CIA requires:
1. board of directors committee annually review company’s compliance program
2. certify its effectiveness
3. certain managers annually certify their departments or functional areas are compliant
4. AstraZeneca send doctors letter notifying them about settlement
5. company post on website information about payments to doctors, such as:
a. honoraria
b. travel
c. lodging
——————————————————————
Subject to exclusion from Federal health care programs, including:
1. Medicare
2. Medicaid
for material breach of CIA
——————————————————————
Subject to monetary penalties for less significant breaches
======================================

======================================
VALTREX (see ADVAIR)
======================================

======================================
VIOXX
======================================
$950 MILLION – 11/22/2011, TuesdayAmerican pharmaceutical company, Merck Sharp & Dohme
——————————————————————
Illegal Marketing
related to promotion and marketing of painkiller Vioxx® (rofecoxib)
——————————————————————
Under terms of resolution, will plead guilty to one-count information charging a single violation of Food Drug and Cosmetic Act (FDCA) for introducing misbranded drug, into interstate commerce
——————————————————————
Under terms of plea agreement with United States, will plead guilty to misdemeanor for illegal promotional activity
——————————————————————
Civil settlement agreement
to resolve additional allegations regarding off-label marketing of drug and false statements about drug’s cardiovascular safety

Settlement and plea conclude long-running investigation of promotion of drug, withdrawn from marketplace 9/2004
——————————————————————
Criminal plea relates to misbranding drug by promoting for treating rheumatoid arthritis, before that use approved by Food and Drug Administration (FDA)
——————————————————————
5/1999 – FDA approved drug for 3 indications, but did not approve use against rheumatoid arthritis until 4/2002
——————————————————————
In interim, for nearly 3 years, promoted drug for rheumatoid arthritis, conduct for which it was admonished in FDA warning letter issued 9/2001
——————————————————————
Parallel civil settlement covers broader range of allegedly illegal conduct
——————————————————————
Settlement resolves allegations representatives made:
1. inaccurate
2. unsupported
or
3. misleading statements
about drug’s cardiovascular safety in order to increase sales of drug, resulting in payments by federal government
——————————————————————
Resolves allegations made false statements to state Medicaid agencies about cardiovascular safety of drug, and agencies relied on false claims in making payment decisions about drug
——————————————————————
Civil settlement recovers damages for allegedly false claims caused by unlawful promotion of drug for rheumatoid arthritis
——————————————————————
As part of settlement, agreed to enter into expansive corporate
integrity agreement with Office of Inspector General of Department of Health and Human Services (HHS-OIG), which will strengthen system of reviews and oversight procedures imposed on company
——————————————————————
Although drug no longer on market, ongoing monitoring of conduct is aimed to deter and detect similar conduct in the future
======================================

======================================
VIOXX
ZOCOR

======================================
$650 MILLION + – 2/7/2008, Thursday – Merck & Company
——————————————————————
Claims of Fraudulent Price Reporting and Kickbacks
——————————————————————
Allegations pharmaceutical manufacturer failed to pay proper rebates to:
1. Medicaid
2. other government health care programs
——————————————————————
Paid illegal remuneration to health care providers to induce them to prescribe company’s products
——————————————————————
Allegations brought in 2 separate lawsuits filed by whistleblowers under qui tam, whistleblower, provisions of False Claims Act
——————————————————————
H. Dean Steinke, former Merck employee, alleged in suit filed, violated Medicaid Rebate Statute in connection with marketing of drugs Zocor and Vioxx
——————————————————————
(Zocor is cholesterol lowering drug
Vioxx, pulled from market by Merck 9/2004, was used for treatment of acute pain and treatment of arthritis)
——————————————————————
Allegedly offered deep discounts for 2 drugs if hospitals used large quantities of drugs in place of competitors’ brands
——————————————————————
Medicaid Rebate Statute requires drug manufacturers report
“best prices”
other cost information
to government in order to ensure Medicaid obtains benefit of same discounts and price concessions other purchasers enjoy
exception to rule allows manufacturers to exclude from prices they report any discounted prices that are “nominal” in amount
——————————————————————
Improperly termed as “nominal” prices it offered to hospitals to boost their sales and excluded discounts from prices it reported to government
——————————————————————
Steinke’s suit alleged
(1997 – 2001)
had approximately 15 different programs used by sales representatives to induce physicians to use its many products
——————————————————————
Programs primarily consisted of excess payments to physicians that were disguised as fees paid to them for:
1. “consultation”
2. “market research”
or
3. “training”

Government alleged fees were illegal kickbacks intended to induce purchase of Merck products
——————————————————————
Agreed to settle Medicaid Rebate as well as kickback allegations
——————————————————————
Suit filed by physician William St. John LaCorte in New Orleans, alleged had established marketing scheme in which it provided substantially reduced prices for Pepcid products once hospitals agreed to primarily use drug instead of competitor’s
——————————————————————
(Pepcid used to reduce stomach acid and treat heartburn and acid reflux)
——————————————————————
Allegedly offered incentives to hospitals in order to obtain benefit of spillover business when patients would continue to purchase drug once discharged
——————————————————————
Improperly termed as “nominal” prices it offered to hospitals to boost sales of drug, excluded discounts from prices it reported to government, and effectively denied government benefit of lower prices
——————————————————————
Agreed to settle allegations
under 2 settlement agreements
——————————————————————
As part of resolution of 2 cases
Department of Health and Human Services Office of Inspector General (HHS-OIG), entered 5-year Corporate Integrity Agreement to ensure improper conduct doesn’t occur in future
======================================

======================================
WELLBUTRIN (see ADVAIR)
======================================

======================================
ZOCOR (see VIOXX)
======================================

======================================
ZOFRAN (see ADVAIR)
======================================

======================================
ZOLADEX (prostate cancer)
======================================
$355 MILLION ($355,000,000) – 6/20/2003, Friday – AstraZeneca Pharmaceuticals LP, headquartered in Wilmington, Delaware – (1/1991 – 12/31/2002)
——————————————————————
drug pricing
marketing practices
——————————————————————
Pleaded guilty to conspiring to violate Prescription Drug Marketing Act (PDMA) by causing to be submitted claims for payment for prescription of drug which had been provided as free samples to urologists
——————————————————————
Criminal conduct caused losses of $39,920,098 to:
1. Medicare
2. Medicaid
3. other federally funded insurance programs
——————————————————————
Allegations company caused false and fraudulent claims to be filed with:
1. Medicare
2. TriCare
3. Department of Defense
4. Railroad Retirement Board Medicare programs
as result of fraudulent drug pricing schemes and sales and marketing misconduct
——————————————————————
Allegations it caused false and fraudulent claims to be filed with states as result of drug pricing and marketing misconduct and failed to provide state Medicaid programs best price for those drugs as required by law
——————————————————————
Agreed to comply with terms of corporate integrity agreement which ensures, AstraZeneca will report to:
1. Medicare program
2. Medicaid program
average sale price for drugs reimbursed by those programs and will promote, through:
1. internal training
2. other programs and policies, marketing
sales practices
in full compliance with the law
——————————————————————
Drug marketed primarily for treatment of prostate cancer,
as is drug Lupron produced by TAP Pharmaceuticals, Inc. (TAP)
——————————————————————
10/2001 – TAP resolved civil pricing and marketing of Lupron
——————————————————————
Medicare doesn’t pay for most drugs needed by Medicare beneficiaries
——————————————————————
Medicare covers some drugs, such as Zoladex, that must be injected under supervision of physician
——————————————————————
United States alleged
(1/1991 – 12/31/2002)
Astra Zeneca engaged in following conduct involving marketing, sale and pricing of drug for treatment of prostate cancer:
——————————————————————
(i) Employees provided thousands of free samples of drug to physicians knowing and expecting certain physicians would prescribe and administer free drug samples to patients and bill those free samples to:
1. patients
2. Medicare
3. Medicaid
4. other federally funded insurance programs
——————————————————————
(ii) In order to induce certain:
1. physicians
2. physicians’ practices
3. others
to purchase drug, AstraZeneca:
1. offered
2. paid
illegal remuneration in various forms including:
1. free Zoladex
2. unrestricted educational grants
3. business assistance grants
4. services
5. travel
6. entertainment
7. consulting services
8. honoraria
——————————————————————
(iii) in order to induce physicians to purchase drug, AstraZeneca marketed
“Return-to-Practice”
program to physicians
——————————————————————
“Return-to-Practice” program consisted of inflating Average Wholesale Price (“AWP”) used by:
1. Medicare
2. others
for reimbursement of drug , deeply discounting price paid by physicians to AstraZeneca for drug (“the discounted price”), and marketing spread between AWP and discounted price to physicians as additional profit to be returned to physician’s practice from Medicare reimbursements for drug
——————————————————————
(iv) AstraZeneca set AWP for drug at levels far higher than majority of physician customers actually paid for drug
——————————————————————
As a result, customers received reimbursement from:
1. Medicare
2. state Medicaid programs
3. others
at levels significantly higher than:
1. physicians’ actual costs
or
2. wholesalers’ average price
——————————————————————
(v) AstraZeneca misreported and underpaid Medicaid rebates for drug used for treatment of prostate cancer, i.e., amounts it owed to states under federal Medicaid Rebate Program
——————————————————————
Generally required on quarterly basis to rebate to each state Medicaid program difference between Average Manufacturer Price (“AMP”) and “Best Price”
——————————————————————
Falsely reported Best Price for drug used for treatment of prostate cancer because AstraZeneca calculated Best Prices for drug without accounting for off-invoice price concessions provided in various forms including:
1. cash discounts in form of grants
2. services
3. free goods
contingent on any purchase requirement
——————————————————————
Prior to guilty plea, 3 physicians charged, and 2 pleaded guilty, for role in conspiring to bill for drug samples
——————————————————————
Dr. Saad Antoun, urologist practicing in Holmdel, New Jersey, charged 1/15/2002, pleaded guilty to conspiracy 9/18/2002
——————————————————————
Dr. Stanley Hopkins, urologist practicing in Boca Raton, Florida, charged 9/30/2002, pleaded guilty to conspiracy 12/17/2002
——————————————————————
Dr. Robert Berkman, urologist practicing in Columbus, Ohio, charged 5/19/2003
======================================

======================================
ZYPREXA
======================================
$1.415 BILLION – 1/15/2009, Thursday – Eli Lilly and Company, headquartered in Indianapolis, Indiana (9/1999 – end 2005)
——————————————————————
Allegations of Off-label Promotion
——————————————————————
Promoting drug for uses not approved by Food and Drug Administration (FDA)
——————————————————————
Agreed to enter global resolution with United States to resolve criminal and civil allegations it promoted drug for uses not approved by FDA
——————————————————————
Charged in information with promoting drug for off-label or unapproved uses as treatment for
dementia
including Alzheimer’s dementia
in elderly people
——————————————————————
Signed plea agreement admitting guilt to misdemeanor criminal charge
——————————————————————
Signed civil settlement to resolve civil claims that by marketing drug for unapproved uses, it caused false claims for payment to be submitted to federal insurance programs such as:
1. Medicaid
2. TRICARE
3. Federal Employee Health Benefits Program
none which provided coverage for such off-label uses
——————————————————————
9/1996 – FDA originally approved drug, also known by chemical name olanzapine for treatment of manifestations of psychotic disorders
3/2000 – FDA approved drug for short-term treatment of acute manic episodes associated with Bipolar I Disorder
11/2000 – FDA approved drug for short term treatment of schizophrenia in place of management of manifestations of psychotic disorders
11/2000 – FDA approved drug for maintaining treatment response in schizophrenic patients who had been stable for approximately 8 weeks and were then followed for period of up to 8 months
——————————————————————
Drug never approved for treatment of:
1. dementia
2. Alzheimer’s dementia
——————————————————————
Criminal information, alleges
(9/1999 – at least 11/2003)
promoted drug for treatment of:
1. aggression
2. agitation
3. Alzheimer’s dementia
4. dementia
5. depression
6. generalized sleep disorder
7. hostility
——————————————————————
Information alleges management created marketing materials promoting drug for off-label uses
——————————————————————
Trained sales force to disregard law and directed sales personnel to promote drug for off-label uses
——————————————————————
Information alleges beginning 1999 expended significant resources to promote drug in:
1. assisted-living facilities
2. nursing homes
primarily through long-term care sales force
——————————————————————
Sought to convince doctors to prescribe drug to treat patients with disorders such as:
1. aggression
2. agitation
3. anxiety
4. Alzheimer’s dementia
5. dementia
6. depression
7. behavioral symptoms such as hostility
8. sleep problems
——————————————————————
Information alleges FDA never approved drug for treatment of:
1. psychosis associated with Alzheimer’s disease
2. Alzheimer’s dementia
3. dementia
4. cognitive deficits associated with dementia
——————————————————————
Information alleges that building on unlawful promotion and success in long-term care market, executives decided to market drug to primary-care physicians
——————————————————————
10/2000 – began off-label marketing campaign targeting primary care physicians, even though company knew there was virtually no approved use for drug in primary-care market
——————————————————————
Trained primary-care physician sales representatives to promote drug by focusing on symptoms, rather than drug’s FDA approved indications
——————————————————————
Qui tam lawsuits alleged
(9/1999 – end of 2005)
promoted drug for use in patients of all ages for treatment of:
1. Alzheimer’s
2. anxiety
3. depression
4. irritability
5. other mood disorders
6. nausea
——————————————————————
Qui tam lawsuits alleged funded continuing medical education programs through millions of dollars in grants, to promote off-label uses of drugs, in violation of FDA’s requirements
——————————————————————
Plea agreement signed admitting guilt to criminal charge of misbranding
——————————————————————
Admits
(9/1999 and 3/31/2001)
promoted drug in elderly populations as treatment for:
dementia
including Alzheimer’s dementia
——————————————————————
Civil settlement to resolve False Claims Act claims and related state claims by:
1. Medicaid
2. other federal programs and agencies, including:
a. TRICARE
b. Federal Employees Health Benefits Program
c. Department of Veterans Affairs
d. Bureau of Prisons
e. Public Health Service Entities
——————————————————————
Corporate Integrity Agreement (CIA) between Eli Lilly and Office of Inspector General of Department of Health and Human Services
——————————————————————
5-year CIA requires:
1. Board of Directors committee annually review company’s compliance program and certify effectiveness
2. certain managers annually certify their departments or functional areas are compliant
3. send doctors letter notifying them about global settlement
4. post on website information about payments to doctors, such as:
a. honoraria
b. travel
c. lodging
——————————————————————
Subject to exclusion from
Federal health care programs
including:
1. Medicare
2. Medicaid
for material breach of CIA
——————————————————————
Subject to monetary penalties for less significant breaches
======================================

======================================
ZYVOX (see BEXTRA)
======================================

======================================
REFERENCE:
======================================
United States Department of Justice (DOJ) versus BIG Pharma: BIG Pharma fought the law, and the law won ?:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/11/26/united-states-department-of-justice-versus-big-pharma-big-pharma-fought-the-law-and-the-law-won/
======================================

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One thought on “The BIG Pharma Dirty Laundry List

  1. an industry was created based upon the needs of children, and i have little friends cursed by it, given mind altering drugs when in their early teens, all because they could not cope too well without a father figure, it’s a global disgrace, and mindless thinking, sadly too many doctors are paid off, and we treasure children?

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