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Index:

2 Off-Label Prescription Drug Marketing

Accreditations (Pharmacy): This continuing pharmacy education

activity has been approved by the Ohio State Board of Pharmacy for

Ohio Board-approved jurisprudence and by ACPE for law-related

continuing education for pharmacists and technicians in all states.

Contact Hour(s): 2.0 (or 0.2 C.E.U.’s)

Release Date: August 17, 2011

Expiration Date: June 28, 2013

Fee: $30.00

Pharmacy Jurisprudence, L.L.C.

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Program Title: Off-Label Prescription Drug Marketing

Target Audience: All Pharmacists and Pharmacy Technicians

Expiration Date: June 28, 2013

Ohio State Board of

Pharmacy Program No.: 036-350-11-004-H03

ACPE Program No.: 487-000-11-004-H03-P knowledge-based activity

or 487-000-11-004-H03-T knowledge-based activity

Accreditations: This continuing education activity is approved by the Ohio State

Board of Pharmacy for 2.0 contact hours, or 0.20 C.E.U.’s, of continuing pharmacy

education in Board-approved jurisprudence. This program is also approved by ACPE for

2.0 contact hour, or 0.20 C.E.U.’s, for pharmacists and pharmacy technicians in all 50

states under our trade name Select CE®.

Media: Enduring print material and interactive test-taking at www.selectce.org.

Fee Information: $30.00

Estimated Time to Complete the Activity: 120 minutes

Procedures: To receive a Statement of Credit, read this program, complete the post-test

questions and evaluation on the Answer Sheet, and either:

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A minimum score of 75% is required to earn a Statement of Credit.

Select CE® is accredited by the Accreditation Council for Pharmacy

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Faculty: Patricia A. Nussle, R.Ph., J.D., is the founder of Pharmacy Jurisprudence and

Select CE. She is also a healthcare attorney who has written and published continuing

education programs in pharmacy law and nursing law for over 200,000 healthcare

professionals since 2001.

Disclosure of Commercialism, Unlabeled Uses, Bias, Conflicts of Interest: Prior to

the delivery of the content, we will disclose any commercial support, and we do so here:

No commercial support was requested or accepted for developing or presenting this

program. All development, printing, mailing and ACPE accreditation costs come

solely from your program fees. This program’s topic is unlabeled uses of drugs;

many will be discussed and none are advocated. Our major source of information was

the U.S. Department of Justice which uses brand names almost exclusively, and so brand

names will be used in this program as well; US DOJ and other sources of information

are referenced throughout. Faculty Patricia A. Nussle, Pharmacy Jurisprudence and

Select CE have no real, apparent, or potential conflicts of interest or financial

relationships to disclose, other than that Patricia A. Nussle is the founder of Pharmacy

Jurisprudence and Select CE, and she warrants that she presents this information fairly

and without bias.

Goal Statement: The goal of this activity is for the health care professional to acquire

knowledge of recent prescription drug marketing fraud cases affecting their profession, in

order to promote professional development and enhance the learner’s contribution to

quality health care and the pursuit of professional goals.

Objective: At the conclusion of this program, pharmacists should be able to recognize at

least 5 examples of off-label prescription drug marketing.

Objective: At the conclusion of this program, pharmacy technicians should be able to

recognize at least 5 examples of off-label prescription drug marketing.

Important Note: Colleagues, this is a continuing education program. It is not legal

advice. Do not rely on this CPE program as legal authority. If you do have a legal

problem or question, please consult an attorney experienced in pharmacy law matters to

discuss your specific situation.

Questions: Please call us at (614) 481-8711, or email us at [email protected].

Off-Label Prescription Drug Marketing

mailto:[email protected]


Summary1

Consider this: 9 out of 10 of the largest healthcare fraud settlements in

2010 were paid by pharmaceutical companies. 7 out of 10 involved

allegations of illegal kickbacks to physicians. 6 out of 10 involved off-

label marketing of prescription drugs. The total amount recovered

through the top ten federal False Claims Act healthcare settlements in

2010 was over $4 billion. Below in descending order are the settling

defendants alleged to have committed the biggest federal healthcare

frauds of 2010:

#1

The Company: GlaxoSmithKline. The Settlement: $750

Million ($600M False Claims Act settlement + $150M in

criminal fines and forfeitures). The Allegations: Selling

contaminated drugs to Medicaid and other government

health programs.

#2

The Company: Allergan. The Settlement: $600 Million

($375M False Claims Act settlement + $225M criminal fines).

The Allegations: Illegally marketing Botox for unapproved

uses and paying kickbacks to prescribing physicians.

#3

The Company: AstraZeneca. The Settlement: $520 Million.

The Allegations: Illegally marketing antipsychotic Seroquel

for insomnia and paying kickbacks to prescribing physicians.

#4

The Company: Novartis Pharmaceuticals. The Settlement:

$422.5 Million. The Allegations: Illegally marketing epilepsy

1 Used with permission from http://fraudblawg.com/2011/01/02/top-10-healthcare-fraud-

settlements-of-2010/

http://fraudblawg.com/2011/01/02/top-10-healthcare-fraud-settlements-of-2010/

http://fraudblawg.com/2011/01/02/top-10-healthcare-fraud-settlements-of-2010/


drug Trileptal and other drugs for off-label uses and paying

kickbacks to prescribing physicians.

#5

The Company: Forest Pharmaceuticals. The Settlement: $313+

Million. The Allegations: Illegally marketing anti-

depressants Celexa and Lexapro to children, paying

kickbacks to prescribing physicians, and misbranding

Levothyroid.

#6 (a tie)

The Company: Roxane Laboratories. The Settlement: $280

Million. The Allegations: Fraudulently inflating drug prices,

reporting false pricing, and causing false claims to be

submitted to CMS through Average Wholesale Pricing

(“AWP”) scheme (also known as “Ain’t What’s Paid”). The

alleged purpose of such schemes is to market the spread and

provide a hidden kickback to pharmacies who buy the

defendant’s drugs.

The Company: Dey, Inc. The Settlement: $280 Million. The

Allegations: Near identical AWP false price reporting

scheme.

#7

The Company: Elan Corporation. The Settlement: $214.5

Million ($11M to be paid by Japanese drug maker Eisai, Inc.).

The Allegations: Illegally marketing epilepsy drug Zonegran

for off-label treatment of a variety of illnesses, including

migraines and mood swings.

#8

The Company: Abbott Laboratories, Inc. The Settlement:

$126.5 Million. The Allegations: AWP false price reporting

scheme à la Roxane and Dey.


#9

The Company: The Health Alliance of Greater Cincinnati. The

Settlement: $108 Million. The Allegations: Paying kickbacks

to physicians for referring cardiac patients to hospitals.

#10

The Company: Kos Pharmaceuticals. The Settlement: $41

Million. The Allegations: Illegally off-label marketing

Advicor and paying kickbacks to prescribing physicians.

When 6 of the 10 largest healthcare fraud settlements are paid by

pharmaceutical companies due to the alleged off-label marketing of

drugs, it raises the questions such as: Why are these companies doing

this? How have I been impacted by such improper marketing? What can

I do to help stop it?

In this continuing education program, our goal is educate you about

recent examples of alleged off-label prescription drug marketing in the

United States. We use the term “alleged”, which means it has not proven

to be true in a trial; in fact, in most of these cases the prescription drug

marketer entered into a voluntary settlement with authorities, which can

be done for very legitimate reasons. And we use the term “marketing

fraud” interchangeably with the term “improper marketing” and “off-

label” marketing, although in the strict legal sense these terms mean

slightly different things.

But first, we need to examine the difference between a “labeled” and

“off-labeled” use of prescription medicines. This distinction is crucial,

because it is proper, and legal, to market drugs only for “labeled” uses,

also known as “approved” uses or “FDA-approved” uses. It is improper

to market a drug for “off-label”, also called unlabeled or unapproved,

uses.


Question 1:

Of the top 10 largest healthcare fraud settlements in 2010:

a. 7 out of 10 involved allegations of illegal kickbacks to

physicians;

b. 6 out of 10 involved allegations of off-label marketing of

prescription drugs;

c. both of the above are true.

Question 2:

Of the top cases involving off-label marketing of prescription

drugs in 2010:

a. settlements ranged from $600 million to $41 million;

b. the pharmaceutical companies were all found guilty by a

judge or jury;


Question 3:

It is proper to market prescription drugs:

a. for any use whatsoever;

b. only for its FDA- labeled use;

c. for either a labeled use or off-label use.


“Labeled Uses” of Drugs2345

The “labeled use” of a drug means its Food and Drug Administration

(FDA)-labeled use, or indication. The way a drug gets an FDA-approved

use is when its manufacturer has submitted information to the FDA to

show that the drug is both safe and effective if it is used in the dose and

other manners indicated on the FDA-approved drug product label.

Background

The fundamental precept of drug regulation in this country is that drug

products must be proven safe and effective before they can be sold.

The Food, Drug, and Cosmetic Act of 1938 requires drug

manufacturers to show that a drug is safe before it can be marketed. Of

course a drug should be safe, you say. Yet it was not until 107 people

died from a poisonous ingredient in Elixir Sulfanilamide, made by the

S.E. Massengill Co. of Bristol, Tenn., that this federal requirement came

about. The Elixir had been sold to reduce fever in children, and the

active ingredient sulfanilamide was able to reduce some fevers. But

sulfanilimide is bitter, and needed to be dissolved in something palatable

to children. The company chemist chose diethylene glycol, in which

sulfanilamide dissolved very well, but which is a chemical relative of

antifreeze now used in automobiles. As the product use and deaths

climbed, and the reason was discovered, in its largest undertaking to date

the FDA confiscated all outstanding bottles of the Elixir, even jailing a

Massgenill salesman until he revealed his client list. It is estimated the

FDA saved more than 4,000 lives through this confiscation. However,

the tragedy continued when the Massengill chemist who developed the

preparation, although unaware of the poisonous nature of the diethylene

glycol at the time he developed the product, reportedly committed

suicide the year after the FDA action.

2 http://www.hhs.gov/asl/testify/t960912a.html

3

http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/romotingSafeand

EffectiveDrugsfor100Years/default.htm 4 Laughing Gas, Viagra and Lipitor – The Human Stories Behind the Drugs We Use by

Jie Jack Li, 2006 Oxford University Press 5 http://www.fda.gov/Drugs/InformationOnDrugs/ucm079846.htm


The Kefauver-Harris Drug Amendments of 1962 to the Federal Food,

Drug and Cosmetic Act require a drug manufacturer, before marketing a

drug, must prove not only safety, but also provide substantial evidence of

effectiveness for the product's intended use. The evidence of

effectiveness, or efficacy, is for a specific use and must consist of

adequate and well-controlled studies.

The 1962 amendments established rules for new drug studies, including a

requirement for the informed consent of study subjects. The amendments

also formalized good manufacturing practices, required that adverse

events be reported, and transferred the regulation of prescription drug

advertising from the Federal Trade Commission to the FDA.

This 1962 “effectiveness standard”, more commonly known as the

"efficacy standard", revolutionized drug development and approval.

Data of lesser quality, anecdotal reports, and poorly controlled

observations would no longer suffice because these data or reports may

be wrong or may not be an adequate basis to reach a sound conclusion.

What does any of this have to do with the labeled use? A drug’s

safety and efficacy are directly tied to its FDA-labeled use, because a

drug is safe and effective only when the drug is used in the dose and

manner indicated on its drug product label. The drug product label is not

the prescription label affixed to an individual patient’s prescription

bottle, but is the label the manufacturer supplies to the FDA. The drug

product label includes not just approved uses, but also:

description of the drug

clinical pharmacology

indications (uses for the

drug)

contraindications (who

should not take the drug)

warnings

precautions

safety information for the

patient

adverse events (side

effect)

drug abuse and

dependence

dosage and

administration

use in pregnancy, use in

nursing mothers

use in children and older

patients

how the drug is supplied


Question 4:

The “labeled use” or “approved use” of a drug means:

a. the directions for use provided by the physician;

b. the directions for use on the patient’s bottle;

c. its FDA-approved use, or indication.

Question 5:

The FDA approves a drug’s use, or indication:

a. if the drug is shown to be safe;

b. if the drug is shown to be effective;

c. only when its manufacturer has submitted information to the

FDA to show that the drug is both safe and effective if it is used

in the dose and other manner indicated on the drug product

label.

Question 6:

The landmark case that led to the drug safety requirement

involved:

a. overdoses due to a highly concentrated drug;

b. misuse of controlled substances;

c. over 100 people, mostly children, who died due to use of an

elixir whose inactive ingredient turned out to be poisonous and

similar to today’s antifreeze.


Question 7:

The Kefauver-Harris Drug Amendments of 1962 to the

Federal Food, Drug and Cosmetic Act require a drug

manufacturer, before marketing a drug, to prove not only

safety, but also provide substantial evidence of:

a. effectiveness for the product's specific, intended use;

b. effectiveness for any use a physician may decide;

c. effectiveness for any use a patient may decide.

Question 8:

Evidence of effectiveness, or efficacy:

a. is for a specific use and must consist of adequate and

well-controlled studies;

b. can include anecdotal reports of usefulness, as long as

observed by more than one health care provider;

c. can include observations of usefulness, as long as there

are enough patients to make it statistically significant.

Question 9:

A drug product label contains:

a. approved uses, contraindications, and warnings;

b. side effects, dosage and administration, how the drug is

supplied;



The most common place for health care providers to learn the FDA-

approved uses is the patient package insert (PPI), which is supplied by

the manufacturer with each container of the drug product. Special note

to pharmacy technicians: this is that folded up wad of paper, often taped

to the lid of the stock bottle. You probably rip off at least one and throw

it away every day. Unfold one of these someday and look at it: it

contains very useful drug information. In fact, it is the source of most

other drug information about the product. Another place to access a

FDA-approved drug product label is by an internet search using the

search term “drugs@FDA” (or going directly to

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/).

Once a drug is approved for marketing, a drug manufacturer may

promote, or market, the use of that drug for the approved indication or

indications. This promotion can be to health care practitioners, health

maintenance organizations, health insurance plans, and directly to

consumers. After the initial approval, if a drug manufacturer wants to

change how its drug is manufactured or the indications for which it is

approved, it must submit a NDA (new drug application) supplement.

Supplements for approval of an additional use or indication are called

efficacy supplements or supplemental new drug applications. After

review and approval by FDA, the new indication is added to the

approved labeling and can be promoted by the drug's manufacturer.

Once approved by the FDA for any use, a physician is free to prescribe

the drug product for any use he/she sees fit, based on the individual

physician’s experience and professional judgment. But the drug

Question 10:

The most common place for you to find an FDA-approved use or

indication is:

a. that wadded up piece of paper taped to the lid of a stock bottle;

b. the patient package insert (PPI);


http://www.accessdata.fda.gov/scripts/cder/drugsatfda/


manufacturer can only promote, or advertise, the product for the FDA-

approved use(s).

Why is Off-Label Marketing Wrongful?

Off-label drug marketing is wrongful because it intentionally misleads

people into thinking that a drug is safe and effective to treat their

particular disease or illness, when in reality there is no science to show

that it is:

“Marketing departments of many drug companies don’t respect

any boundaries of professionalism or the law,” says Jerry

Avorn, a professor at Harvard Medical School in Boston and

author of “Powerful Medicines: The Benefits, Risks, and Costs

of Prescription Drugs” (Random House, 2004). “[These recent

cases] involved the illegal promotion of drugs that have been

shown to cause substantial harm and death to patients.”

“It’s an unbearable cost to a system that’s going broke,” says

Avorn, who heads the pharmacology economics unit of

Brigham and Women’s Hospital in Boston. “We can’t even

afford to pay for effective, safe therapies.” 6

And it is the safe, effective therapies that are often by-passed in favor of

an alleged cure-all.

6http://www.bloomberg.com/apps/news?pid=newsarchive&pos=10&sid=a4yV1nYxCGo

A

Question 11:

Once a drug has an FDA-approved use,

a. the drug manufacturer can promote, or market, the drug for

that use only;

b. the drug manufacturer can never gain additional uses, or

indications, for the use of that drug;


http://search.bloomberg.com/search?q=Jerry+Avorn&site=wnews&client=wnews&proxystylesheet=wnews&output=xml_no_dtd&ie=UTF-8&oe=UTF-8&filter=p&getfields=wnnis&sort=date:D:S:d1

http://search.bloomberg.com/search?q=Jerry+Avorn&site=wnews&client=wnews&proxystylesheet=wnews&output=xml_no_dtd&ie=UTF-8&oe=UTF-8&filter=p&getfields=wnnis&sort=date:D:S:d1

http://www.powerfulmedicines.org/pages/1/index.htm

http://www.powerfulmedicines.org/pages/1/index.htm

http://www.harvardscience.harvard.edu/directory/programs/brigham-and-womens-hospital


What Can I Do About Off-Label Drug Promotion?7

As a healthcare professional, you can make clear that the only

information you want to see is in regard to FDA-approved uses. This

applies to drug company representatives, as well as to others that are

being paid to educate you about their products at meetings and symposia.

Also, you can help the FDA by reporting off-label promotion to

[email protected]. You are, after all, the primary target of promotion by

drug companies, and the FDA’s BadAd service wants to hear from you:

The impact of prescription drug promotion on health care

professionals is significant…spending on advertising to health

care professionals outpaces spending on Direct-to-Consumer

advertising by nearly 3 to 1. This form of advertising directly

to health care professionals, commonly called “detailing,”

occurs primarily in places such as medical offices, hospitals,

pharmacies, at medical meetings and symposia, and sometimes

other meeting facilities.

Informative and responsible promotional efforts by

pharmaceutical companies can provide health care

professionals with valuable information about the latest drug

therapies. However, information that may affect prescribing

decisions must be accurate and balanced. I am asking you to

help FDA in our efforts to stop misleading prescription drug

promotion.8

FDA reminds us that prescription drug advertising must:

Be accurate

Balance the risk and benefit information

Be consistent with the prescribing information approved by FDA

Only include information that is supported by strong evidence

from clinical studies

7

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Surve

illance/DrugMarketingAdvertisingandCommunications/UCM211560.pdf 8 Id.

mailto:[email protected]


Off-Label Marketing Case #1 9

The Company: Allergan

The Product: Botox®Therapeutic

The Allegations: Illegally marketing Botox for unapproved uses and

paying kickbacks to prescribing physicians

The Settlement: $600 Million ($375M False Claims Act settlement +

$225M criminal fines).

In October 2010, Allergan Inc. pled guilty to criminal liability arising

from the company’s unlawful promotion of its biological product,

Botox® Therapeutic, for uses not approved as safe and effective by the

Food and Drug Administration (FDA).

Under the Food, Drug and Cosmetic Act (FDCA), a company in its

application to the FDA must specify each intended use of a biological

product. After the FDA approves the product as safe and effective for a

specified use, any promotion by the manufacturer for other uses – known

as “off-label” uses – renders the product misbranded.

Allergan was charged by the U.S. Department of Justice (DOJ) with

promoting Botox® for headache, pain, spasticity and juvenile cerebral

palsy – none of which were approved by the FDA. According to the

U.S. DOJ, Allergan made it a top corporate priority to maximize sales of

Botox® for such off-label uses.

By way of background, in 1989 the FDA approved Botox®, a

prescription biological product containing botulinum toxin type A, a

purified neurotoxin, to treat strabismus (crossed eyes) and

blepharospasm (involuntary eyelid muscle contraction). In 2000 and

2004, approval was given to treat cervical dystonia (involuntary neck

muscle contraction) and primary axillary hyperhidrosis (excessive

underarm sweating), respectively. In 2010, approval was given to treat

adult upper-limb spasticity.

The DOJ alleged that Allergan exploited its on-label cervical dystonia

(CD) indication to grow off-label pain and headache (HA) sales. In

2003, Allergan developed the “CD/HA Initiative” as a “rescue strategy”

9 http://www.justice.gov/opa/pr/2010/September/10-civ-988.html


in the event of negative results from its clinical trials to ensure continued

expansion into the pain and headache markets. As part of this initiative,

Allergan claimed that cervical dystonia was “underdiagnosed” and that

doctors could diagnose cervical dystonia based on headache and pain

symptoms, even when the doctor “doesn’t see any cervical dystonia.”

Allergan’s off-label marketing tactics also included calling on doctors

who typically treat patients with off-label conditions. In 2003, Allergan

doubled the size of its reimbursement team to assist doctors in obtaining

payment for off-label Botox injections. Allergan held workshops to

teach doctors and their office staffs how to bill for off-label uses,

conducted detailed audits of doctors’ billing records to demonstrate how

they could make money by injecting Botox, and operated the Botox

Reimbursement Hotline, which provided a wide array of free on-demand

services to doctors for off-label uses. Allergan also lobbied government

health care programs to expand coverage for off-label uses, directed

physician workshops and dinners focused on off-label uses, paid doctors

to attend “advisory boards” promoting off-label uses, and created a

purportedly independent online neurotoxin education organization to

stimulate increased use of Botox® for off-label indications.

“The FDA had approved therapeutic uses of Botox for only four rare

conditions, yet Allergan made it a top corporate priority to maximize

sales of far more lucrative off-label uses that were not approved by

FDA,” said Sally Yates, U.S. Attorney for the Northern District of

Georgia. “Allergan further demanded tremendous growth in these off-

label sales year after year, even when there was little clinical evidence

that these uses were effective. The FDA approval process ensures that

pharmaceutical companies market their medications for uses that are

proven to be safe and effective, and this case demonstrates that

companies that fail to comply with these rules face criminal prosecution

and stiff penalties.”

Allergan pled guilty to a criminal misdemeanor for misbranding Botox in

violation of the FDCA. Under the plea agreement, the company will pay

a criminal fine of $375 million, which includes forfeiting assets of $25

million.

“Fraudulent marketing of drugs through off-label promotion or kickbacks

to prescribers undermines the protections afforded by the drug approval


process and medical decision-making. This conduct will not be

tolerated,” said Daniel R. Levinson, Inspector General of the U.S.

Department of Health and Human Services. “As a result of this

settlement, [our office] will oversee a Corporate Integrity Agreement

with Allergan that increases the transparency of Allergan’s interactions

with physicians and helps to ensure the company’s future compliance

and accountability.”

Allergan markets Botox for its approved cosmetic use under the trade

name Botox® Cosmetic. Botox® Cosmetic has its own FDA-approved

label and drug code. This resolution does not address Botox® Cosmetic.

Question 12:

After the FDA approves the product as safe and effective for a

specified use, any promotion by the manufacturer for other uses

– known as “off-label” uses – renders the product:

a) unsafe;

b) misbranded;

c) mistaken.

Question 13:

Allergan was charged by the U.S. Department of Justice (DOJ)

with promoting Botox® for:

a) headache, pain, spasticity and juvenile cerebral palsy – none

of which were approved by the FDA;

b) strabismus and blepharospasm;

c) eliminating wrinkles.


Question 14:

According to the DOJ, Allergan claimed that cervical dystonia

was “underdiagnosed” and that doctors could diagnose cervical

dystonia based on:

a) headache and pain symptoms;

b) even when the doctor “doesn’t see any cervical dystonia”;

c) both of the above are true.

Question 15:

According to the DOJ, Allergan’s off-label marketing tactics

included:

a) calling on doctors who typically treat patients with off-label

conditions;

b) doubling the size of its reimbursement team to assist doctors

in obtaining payment for off-label Botox® injections;


Question 16:

According to the DOJ, Allergan’s off-label marketing tactics

included:

a) holding workshops to teach doctors and their office staffs

how to bill for off-label uses;

b) operating the Botox® Reimbursement Hotline, which

provided a wide array of free on-demand services to doctors

for off-label uses;




11

The Company: AstraZeneca

The Product: Seroquel®

The Allegations: Illegally marketing antipsychotic Seroquel® for

insomnia and paying kickbacks to prescribing physicians.

The Settlement: $520 million

AstraZeneca LP and AstraZeneca Pharmaceuticals LP signed a

settlement agreement with the U.S. Department of Justice (DOJ) and

others to resolve allegations that it marketed Seroquel® (quetiapine) for

unapproved uses, and by doing so the company caused false claims for

payment to be submitted to federal insurance programs including

Medicaid, Medicare and TRICARE programs, and to the Department of

Veterans Affairs, the Federal Employee Health Benefits Program and the

Bureau of Prisons.

The FDA originally approved Seroquel in September 1997 for the

treatment of manifestations of psychotic disorders. In September 2000,

FDA proposed narrowing the approval for Seroquel to the short term

treatment of schizophrenia only. In January 2004, the FDA approved

Seroquel for short term treatment of acute manic episodes associated

with bipolar disorder (bipolar mania). In October 2006, the FDA

approved Seroquel for the treatment of depressive episodes associated

with bipolar disorders.

The United States DOJ claimed that AstraZeneca illegally marketed

Seroquel for uses never approved by the FDA. Specifically, between

January 2001 through December 2006, AstraZeneca promoted Seroquel

to psychiatrists and other physicians for certain uses that were not

approved by the FDA as safe and effective (including sleeplessness,

aggression, Alzheimer’s disease, anger management, anxiety, attention

deficit hyperactivity disorder, bipolar maintenance, dementia, depression,

mood disorder, and post-traumatic stress disorder). These non-FDA

approved uses were not medically accepted indications for which state

Medicaid programs provided coverage for Seroquel.

10

http://www.justice.gov/usao/pae/News/2010/apr/astrazeneca_settlementagreement.pdf 11

http://www.justice.gov/opa/pr/2010/April/10-civ-487.html


According to the settlement agreement, AstraZeneca targeted its illegal

marketing of the anti-psychotic Seroquel towards doctors who do not

typically treat schizophrenia or bipolar disorder, such as physicians who

treat the elderly, primary care physicians, pediatric and adolescent

physicians, and in long-term care facilities and prisons.

The United States contends that AstraZeneca promoted the unapproved

uses by improperly and unduly influencing the content of, and speakers,

in company-sponsored continuing medical education programs. The

company also engaged doctors to give promotional speaker programs on

unapproved uses for Seroquel and to conduct studies on unapproved uses

of Seroquel. In addition, the company recruited doctors to serve as

authors of articles that were ghostwritten by medical literature companies

and about studies the doctors in question did not conduct. AstraZeneca

then used those studies and articles as the basis for promotional messages

about unapproved uses of Seroquel.

The United States also contends that AstraZeneca violated the federal

Anti-Kickback Statute by offering and paying illegal remuneration to

doctors it recruited to serve as authors of articles written by AstraZeneca

and its agents about the unapproved uses of Seroquel. AstraZeneca also

offered and paid illegal remuneration to doctors to travel to resort

locations to "advise" AstraZeneca about marketing messages for

unapproved uses of Seroquel, and paid doctors to give promotional

lectures to other health care professionals about unapproved and

unaccepted uses of Seroquel. The United States contends that these

payments were intended to induce the doctors to prescribe Seroquel for

unapproved uses in violation of the federal Anti-Kickback Statute.

AstraZeneca denies that it engaged in any wrongful conduct, and states

that the settlement agreement it ultimately signed, its signature on the

settlement agreement, the performance of any obligation under the

settlement agreement including payment and fact of settlement are not

intended to be and should not be understood as any admission of liability

or wrongdoing, but to avoid the delay, uncertainty, inconvenience and

expense of protracted litigation, AstraZeneca agreed to the settlement.

Under the terms of the settlement, the federal government will receive

$301,907,007 from the civil settlement, and the state Medicaid programs

and the District of Columbia will share up to $218,092,993 of the civil


settlement, depending on the number of states that participate in the

settlement.

In addition to the civil settlement agreement, resolution of the matter

includes a Corporate Integrity Agreement (CIA) between AstraZeneca

and the Office of Inspector General of the Department of Health and

Human Services. The five-year CIA requires, among other things, that a

board of directors committee annually review the company’s compliance

program and certify its effectiveness; that certain managers annually

certify that their departments or functional areas are compliant; that

AstraZeneca send doctors a letter notifying them about the settlement;

and that the company post on its website information about payments to

doctors, such as honoraria, travel or lodging.

Question 17:

Seroquel is a drug FDA-approved today for:

a) the treatment of manifestations of psychotic disorders, short

term treatment of acute manic episodes associated with bipolar

disorder (bipolar mania), and depressive episodes associated with

bipolar disorder;

b) insomnia;

c) bipolar maintenance and mood disorder.

Question 18:

The DOJ claims AstraZeneca promoted Seroquel for:

a) sleeplessness, anger management, anxiety;

b) attention deficit hyperactivity disorder, bipolar maintenance,

dementia, depression, mood disorder, and post-traumatic stress

disorder;



Question 19:

As a result of AstraZeneca marketing Seroquel for non-FDA

approved uses (off-label marketing), the DOJ claims that:

a) some patients died;

b) AstraZeneca caused false claims for payment to be submitted

to federal insurance programs including Medicaid, Medicare and

TRICARE programs, and to the Department of Veterans Affairs,

the Federal Employee Health Benefits Program and the Bureau

of Prisons;


Question 20:

Regarding Seroquel’s off-label marketing, AstraZeneca:

a) denies that it engaged in any wrongful conduct, and states that

the settlement agreement it ultimately signed with the DOJ, its

signature on the settlement agreement, the performance of any

obligation under the settlement agreement including payment and

fact of settlement are not intended to be and should not be

understood as any admission of liability or wrongdoing;

b) claims that to avoid the delay, uncertainty, inconvenience and

expense of protracted litigation, it agreed to the settlement of

$301,907,007 to the federal government and $218,092,993 to

state Medicaid programs and the District of Columbia, depending

on the number of states that participate in the settlement;




13

14

The Company: Novartis Pharmaceuticals

The Product: Trileptal®

The Allegations: Illegally marketing Trileptal® as well as Diovan

®,

Exforge®, Sandostatin

®, Tekturna

® and Zelnorm

® for off-label uses and

paying kickbacks to prescribing physicians

The Settlement: $422.5 million in criminal and civil fines

In 2005, Novartis Pharmaceutical Corporation (Novartis) received a

subpoena from the United States Department of Justice (DOJ), claiming

Novartis had illegally marketed its anti-seizure drug Trileptal for off-

label uses.

The Food and Drug Administration (“FDA”) had approved Trileptal

(generic name “oxcarbazepine”) in 2000 for the treatment of partial

seizures in epilepsy patients. According to the DOJ, Novartis’

management created marketing materials promoting Trileptal for off-

label uses, including neuropathic pain and bipolar disease, which were

not FDA-approved uses. Novartis allegedly targeted psychiatrists and

pain specialists, who were known to use anti-epileptic drugs like

Trileptal off-label. The DOJ charged that Novartis decided to market and

promote Trileptal as a treatment for both of these indications and

directed its sales force to visit doctors who would not normally prescribe

Trileptal due to the nature of their practice. The company also allegedly

funded continuing medical education programs, using other medical

professionals to promote off-label uses of Trileptal. According to the

DOJ, Novartis profited by hundreds of millions of dollars from this

misbranding and off-label promotion of Trileptal.

One example of the illegal marketing of Trileptal can be found in the

Bilpolar Child Newsletter, a newsletter targeted to parents with children

with bipolar children and promoting the use of Trileptal15

12 http://www.novartis.com/newsroom/media-releases/en/2010/1448151.shtml 13 http://www.justice.gov/usao/pae/Pharma-Device/novartis_release.pdf 14

http://www.justice.gov/usao/pae/News/Pr/2010/Sept/novartis_settleagreement.pdf 15

http://www.scribd.com/doc/48475461/Trileptal-Illegal-Marketing-Material


Novartis claims that prior to receiving the DOJ’s subpoena, it had

already taken steps to correct the challenged practices and comply with

new government guidance in regards to Trileptal and five other products.

Novartis also denies the claims made against it by the DOJ, as well as

any liability or wrongdoing, except for its guilty plea that it “promoted

Trilpetal® for bipolar disorder and neuropathic pain. Trileptal® is not

approved by the FDA for treatment of bipolar disorder or neuropathic

pain. [Novartis’] promotion of Trileptal® for these additional intended

uses violated 21 U.S.C. § 352(f)(1), because Trileptal’s labeling did not

bear adequate directions for each of the drug’s intended uses,” and that it

introduced drugs into interstate commerce drugs that were misbranded, a

misdemeanor, in violation of 21 U.S.C. §§ 331(a), 331(a)(1), and

352(f)(1).16

In 2010 and early 2011, Novartis settled its criminal and civil issues with

the DOJ, pleading guilty as described above, paying a fine of $185

million for Trileptal and also paying a fine of $237.5 million in False

Claim Act claims related to all six drugs (Trileptal, as well as Diovan,

Zelnorm, Sandostatin, Exforge and Tekturna.

“Today's settlement demonstrates the government's continued scrutiny of

the sales and marketing practices of pharmaceutical companies that put

profits ahead of the public health,” said the FDA in 2010. “We will

continue to seek this kind of criminal resolution and stiff sanctions when

pharmaceutical companies undermine the drug approval process by

promoting drugs for uses not approved by the FDA as safe and

effective.”

Novartis also signed a Corporate Integrity Agreement (CIA) with the

Department of Health and Human Services, Office of Inspector General

(HHS-OIG). The company is subject to exclusion from Federal health

care programs, including Medicare and Medicaid, for a material breach

of this CIA and subject to monetary penalties for less significant

breaches. Among other things, the CIA requires the Board of Directors

(or a committee of the Board) to annually review the company's

compliance program with the help of an outside expert and certify its

effectiveness; that certain senior executives annually certify that their

16

http://www.justice.gov/usao/pae/News/2010/Sept/novartis_entryofplea.pdf


departments or functional areas are compliant; that Novartis send doctors

a letter notifying them about the settlement; and that the company posts

on its website information about payments to doctors, such as honoraria,

travel or lodging. The five-year agreement further requires the

implementation of a compliance program addressing promotional

activities.

Question 21:

Novartis received FDA approval to promote Trilpetal for:

a) partial seizures;

b) neuropathic pain;

c) bipolar disease.

Question 22:

Novartis pled guilty to misbranding Trilpetal, by stating it was

safe and effective for:

a) grand mal seizures;

b) neuropathic pain and bipolar disease;

c) psychotic disorders.

Question 23:

As a result of Novartis’ misbranding actions, it:

a) pled guilty to a misdemeanor crime;

b) paid at least $185 million to the U.S. government;



Question 24:

Novartis denies any wrongdoing, yet the U.S. DOJ charged that its

sales and marketing practices were wrongful when it:

a) paid illegal kickbacks to health care professionals through

mechanisms such as speaker programs, advisory boards,

entertainment, travel and meals to induce them to prescribe

Trileptal, as well as Diovan, Zelnorm, Sandostatin, Exforge and

Tekturna;

b) paid prescribing bonuses to physicians for prescribing Trileptal,

Diovan, Zelnorm, Sandostatin, Exforge and Tekturna;

c) paid dispensing bonuses to pharmacists for switching patients to

generic medications.


Off-Label Marketing Case #41718

The Company: Forest Pharmaceuticals

The Product: Celexa® and Lexapro®

The Allegations: Illegally promoting Celexa® and Lexapro® as safe

and effective in children, and distribution of unapproved Levothroid®

The Settlement: $149 million – Celexa® (citalopram) and Lexapro®

(escitalopram)

$164 million – Levothroid® (levothyroxine sodium)

According to the DOJ, Forest chose to disregard some of its regulatory

obligations in regards to 3 drugs: Celexa, Lexapro, and Levothroid.

Celexa

Regarding Celexa, the DOJ alleged that Forest Pharmaceuticals

promoted the drug for unapproved pediatric use. Despite a limited

approval only for adult depression, Forest Pharmaceuticals promoted

Celexa for use in treating children and adolescents suffering from

depression. The government also claims that Forest Pharmaceuticals

publicized and circulated the positive results of a double-blind, placebo-

controlled Forest study on the use of Celexa in adolescents while, at the

same time, Forest Pharmaceuticals failed to discuss the negative results

of a contemporaneous double-blind, placebo-controlled European study

on the use of Celexa in adolescents.

The government further alleged that Forest Pharmaceuticals’ off-label

promotion consisted of various sales techniques, including directing its

sales representatives to promote pediatric use of Celexa in sales calls to

physicians who treated children and adolescents, and hiring outside

speakers to talk to pediatric specialists about the benefits of prescribing

Celexa to children and teens.

Forest pled guilty to illegal promotion of Celexa for use in treating

children and adolescents suffering from depression.

17

http://www.justice.gov/civil/ocpl/cases/cases/ForestPharm/Forest_DOJ_Press_9-15-

10.pdf 18

http://www.justice.gov/civil/ocpl/cases/cases/ForestPharm/Forest%20settlement%20agr

eement%20--%20signed.pdf


Lexapro

The government claimed that Forest engaged in such marketing practices

in regards to Lexapro, too, which at the time also lacked any approvals

for pediatric use. The government further alleged that Forest used illegal

kickbacks to induce physicians and others to prescribe both Celexa and

Lexapro. Kickbacks allegedly included cash payments disguised as

grants or consulting fees, expensive meals and lavish entertainment. The

civil complaint alleges that as a result of the foregoing conduct, Forest

caused false claims to be submitted to federal health care programs.

Lexapro was eventually approved for use for acute and maintenance

treatment of Major Depressive Disorder in adolescents, 12 - 17 years of

age, on March 19, 2009.

As with most other off-label marketing situations, the DOJ claimed that

because of the company’s conduct in marketing both of these drugs for

off-label use, the drugs were used in situations where they would not

otherwise have been prescribed, and the federal and state governments

were wronged when they paid for patients’ use of these medications in

federal health care programs.

Also as with most other off-label marketing situations, the company

denied any wrongdoing and wishes to make clear that it entered into a

settlement agreement and corporate integrity agreement with the

government and paid fines only to resolve the matter without undue

delay, expense, and uncertainty and inconvenience to the company.

Levothroid

In regards to Levothroid, the underlying issue is a bit different from what

you have seen so far in this program. The government alleges that Forest

Pharmaceuticals began distributing Levothroid in the early 1990s without

first obtaining FDA approval. Orally administered levothyroxine sodium

drugs had been on the market to treat hypothyroidism since the 1950s,

and manufacturers had introduced these drugs into the market without

first obtaining FDA approval. In 1997, however, the FDA announced

that these drugs were “new drugs” under the Food Drug and Cosmetic

Act and needed the agency’s approval. Nonetheless, because the FDA

deemed the drugs to be medically necessary, the manufacturers were


given four years – until Aug. 14, 2001 – in which to conduct the

necessary studies and obtain FDA approval. Later, in order to meet

continuing patient demand, the FDA announced that, as a matter of

enforcement discretion, the agency would permit manufacturers of

unapproved levothyroxine sodium drugs to continue distributing their

unapproved drugs after Aug. 14, 2001, on certain conditions. One of

those conditions was that any manufacturer which had not obtained NDA

approval for its levothyroxine sodium drug product needed to comply

with a two-year, gradual distribution phase-down of its unapproved drug

until it obtained FDA approval to distribute the drug.

According to the criminal charges, Forest Pharmaceuticals made a

deliberate decision to continue distributing its unapproved Levothroid

product in quantities far exceeding the amounts permitted by the FDA’s

distribution phase-down plan. The charges further allege that, on Aug.

7, 2003, the FDA sent a warning letter advising that Forest

Pharmaceuticals was no longer entitled to distribute its unapproved

Levothroid product because the company had made a deliberate decision

not to comply with the FDA’s distribution phase-out plan. After

receiving the warning letter, Forest Pharmaceuticals directed its

employees at its St. Louis distribution center to work overtime until

approximately 1:00 a.m. the following morning and, during that time, to

continue shipping as much of its unapproved Levothroid as possible.

The criminal charges further allege that Forest Pharmaceuticals

submitted inaccurate information to the FDA as part of its NDA

submission for Levothroid and that Forest Pharmaceuticals obstructed an

FDA regulatory inspection concerning the data submitted in the

Levothroid NDA. Specifically, when FDA inspectors saw a portable

humidifier at a 2003 inspection of a manufacturing plant in Cincinnati,

certain company management personnel falsely advised the investigators

that the portable humidifier was being stored in the room and had not

been used for humidity control, when in fact it had been.

Forest Pharmaceuticals halted its commercial distribution of its

unapproved version of Levothroid as of Aug. 9, 2003. Since the fall of

2003, Forest Pharmaceuticals has been commercially distributing a

different orally administered levothyroxine sodium drug, also called

Levothroid, in accordance with a supply agreement with Lloyd

Pharmaceuticals. This resolution does not involve that product.


In regards to Levothroid, Forest pled guilty to one felony count of

obstruction of justice, and one misdemeanor count of distributing an

unapproved drug in interstate commerce.

Question 25:

Celexa and Lexapro are:

a) anti-depressants labeled for use in adult depression;

b) anti-depressants labeled for use in pediatric depression;

c) anti-depressants labeled for use in adults and pediatrics in

whatever doses the prescribing physician thinks appropriate.

Question 26:

The DOJ alleges that Forest Pharmaceuticals:

a) used illegal kickbacks to induce physicians to prescribe Celexa

and Lexapro;

b) caused false claims to be submitted to federal health care

programs for at least one of its drugs;


Question 27:

The DOJ alleges that the kickbacks Forest paid included:

a) cash payments disguised as grants or consulting fees, expensive

meals and lavish entertainment;

b) free samples of Celexa and Lexapro to prescribers;



Off-Label Marketing Case # 5 19

20

The Company: Elan Corporation

The Product: Zonegran

The Allegations: Illegally marketing Zonegran for a variety of illnesses,

including migraines and mood swings

The Settlement: $214 million

Zonegran was approved by the Food and Drug Administration (FDA) as

an anti-epileptic drug, for the treatment of partial epileptic seizures in

adults over the age of 16, and was not approved for any other uses. The

DOJ alleges that Elan (which is an Irish pharmaceutical manufacturer

known as Elan Corporation PLC and its U.S. subsidiary Elan

Pharmaceuticals Inc.) promoted the sale of Zonegran for a wide variety

of improper off-label uses, and its marketing efforts targeted non-

epilepsy prescribers and it paid illegal kickbacks to physicians in an

effort to persuade them to prescribe Zonegran for these off-label uses.

Elan, and the company that bought Zonegran from Elan in 2004, Eisai,

Inc., agreed to a plea agreement with the DOJ to pay a criminal fine of

$97 million and plead to a misdemeanor violation of the Food Drug and

Cosmetic Act. Elan will also forfeit $3.6 million in assets.

In addition, Elan agreed to pay $102.89 million to resolve civil

allegations under the False Claims Act and related state statutes that the

company illegally promoted Zonegran and caused false claims to be

submitted to government health care programs for a variety of uses that

were not medically accepted indications and therefore not covered by

those programs.

Elan and Eisai deny any wrongdoing, and claim that it settled this case in

order to avoid delay, expense and uncertainty of a trial. The U.S.

government says that if the case had gone to trial, this is what the U.S.

government would have proven:

“Had this case gone to trial, the government’s evidence would have

proven that in April 2000, the Food and Drug Administration approved

19

http://www.justice.gov/opa/pr/2010/December/10-civ-1444.html 20

http://www.justice.gov/usao/ma/news/2010/December/2010-6-17---EISAI-

EXECUTED-SETTLEMENT-AGRMNT.PDF


Zonegran only as an adjunctive therapy for the treatment of partial

seizures in epilepsy for adults over the age of 16, and not for any other

uses. From 1999 and continuing at least through the date of launch in

May of 2000, Elan closely examined the potential markets for all

potential uses of anti-epileptic drugs (AEDs) and the actual sales related

to these uses. Elan was aware that over 50% of the AED prescriptions

written were for uses beyond epilepsy. As a result, both prior to and after

launch, Elan employees analyzed the potential for sales for uses of

Zonegran that were beyond the use applied for in the Zonegran New

Drug Application. Promotions for uses unapproved by the FDA are

characterized as "off-label."

Both prior to and after the launch of Zonegran, Elan marketing

employees and data analysts conducted extensive evaluations of the AED

market. The AED market was divided into older and newer AEDs.

Zonegran was included in the newer AED class of drugs. Zonegran was

the last of three new AEDs to be introduced to the market in 2000, and

the last of seven AEDs on the market at that time. The other AEDs had

broader approvals from the FDA than did Zonegran. Zonegran’s

placement as the last AED to enter the market in 2000 immediately and

adversely impacted sales of Zonegran.

In 2000, Elan’s first marketing campaign and sales aid for Zonegran was

called, "A Track Record of Success," and conformed generally to the

approved use of the drug. It focused on the safety and efficacy of the

drug and included fair balance regarding any adverse effects. The "Track

Record of Success" sales aid did not contain any graphic illustration or

diagram highlighting the drug's "mechanism of action," as did

subsequent campaigns. This sales aid was required to be reviewed by the

FDA as part of the approval process prior to the launch of the drug.

When using this sales aid during its first year of sales, Zonegran’s market

share ranged between 0.22% and 1.0%.

In 2002, Elan came under significant financial pressure as a result of,

among other factors, an investigation into its financial practices by the

Securities and Exchange Commission, during which Elan’s stock prices

dropped from a high of $65 per share to $2 per share in six months. As a

result, Elan evaluated various means to raise cash, including which drugs

to divest and which to retain because of potential profit. As part of that

evaluation, Elan conducted market research and decided to retain


Zonegran because of its large potential for growth, particularly in the

area of uses unapproved by the FDA. With these areas of growth in

mind, Elan developed marketing and sales strategies to capture these off-

label markets. In response to its financial difficulties, Elan developed a

series of promotional sales campaigns to obtain additional revenues

through sales of Zonegran for unapproved uses. These sales and

marketing campaigns became increasingly and deftly directed to off-

label uses.

In April 2002, Elan launched a promotional campaign for Zonegran

entitled, "Expect More, Expect Zonegran," which included direction to

the sales force to sell "mechanisms of action" that would "allow

physician to think beyond just partial seizures" and would "[o]pen doors

for psychiatry, pain, headache, etc." The sales aid for the campaign

included a diagram that highlighted Zonegran’s "Multiple Mechanisms

of Action" which related primarily to unapproved uses for Zonegran in

psychiatric disorders, movement disorders, obesity or weight loss, pain

management and headaches. The sales force was trained to use these

sales aids in a manner that would generate off-label sales of Zonegran.

In December 2002, Elan introduced the "Demand More" promotional

campaign which included a sales aid that highlighted Zonegran’s

"multiple and complementary mechanisms of action." This sales aid

included, among other claims, misleading information such as (1) a

comparison chart of the potential mechanisms of action of Zonegran with

that of its competitor drugs, noting that only Zonegran covered each of

the highlighted characteristics, a chart which was not based upon any

head-to-head clinical trials; and (2) the misleading claim that "Zonegran

has the longest half-life of the newer AEDs," a claim not based on any

head-to-head clinical trials, and which was true only when Zonegran was

used alone, or as monotherapy, an unapproved use.

In early 2003, Elan created a "Zonegran-Drug T Comparison Flashcard"

to go "head-to-head" with another AED, Drug T, that had a broader

indication and was well-known to be used for chronic and migraine

headaches for which Drug T eventually received approval through a

supplemental NDA (sNDA). The training guide for the sales force

explained that: "[t]his hard hitting tool is going to help you take share

from Drug T and this primer is going to show you how!" The flashcard

contained misleading information regarding the number of patients who


had been treated by each drug; misleading claims relating to the

similarity in efficacy of the drugs, unsupported claims regarding

Zonegran's multiple mechanisms of action, improper claims of

differentiation between the drugs and unsupported claims of the

superiority of Zonegran. The sales force was told by Elan "never" to

leave the flashcard behind, and to "use it until they [the FDA] pull it."

Finally, in early 2003, Elan targeted Drug T as Zonegran's number one

competitor and used a double entendre to get the implied message of

superiority across to the physicians. The sales aid contained an even

more detailed graphic diagram that emphasized the "Multiple

Mechanisms of Action" and highlighted qualities of Zonegran that were

unrelated for use in treating epilepsy. The training materials for the sales

force made representations that sent a clear message and were important

to physicians who use AEDs for other purposes beyond epilepsy.

Elan promoted the sale of Zonegran for a wide variety of improper off-

label uses including psychiatric disorders; mood stabilization for mania

and bipolar disorder; migraine headaches; chronic daily headaches;

eating disorders; obesity/weight loss; movement disorders (i.e.

Parkinson's Disease); monotherapy (not using it in combination therapy

but alone); and for a variety of seizures in children under the age of 16.

Elan's off-label marketing efforts targeted non-epilepsy prescribers and

the company paid illegal kickbacks to physicians in an effort to persuade

them to prescribe Zonegran for these off-label uses.”21

###

In summary, remember why such off-label marketing is harmful. The

reason it is harmful is best put forth by the DOJ: "Off-label promotion

of pharmaceutical products undermines the FDA's important role in

protecting the American public by determining whether a drug is safe

and effective for a particular use before it is marketed," said Tony West,

Assistant Attorney General of the Civil Division of the Department of

Justice. "Conduct like that in which Elan engaged here also costs the

government billions of dollars, and the Court’s strong sentence

demonstrates that such conduct will not be tolerated."22

21 http://www.fda.gov/ICECI/CriminalInvestigations/ucm245523.htm 22

http://www.fda.gov/ICECI/CriminalInvestigations/ucm245523.htm


Question 28:

Zonegran was approved by the FDA in 2000:

a) for treatment of headaches;

b) only as an adjunctive therapy for the treatment of partial

seizures in epilepsy for adults over the age of 16, and not for any

other uses;

c) for treatment in Parkinson’s disease.

Question 29:

According to the DOJ, Elan was aware that:

a) over 50% of the anti-epileptic drug prescriptions written were

for uses beyond epilepsy;

b) its claim that "Zonegran has the longest half-life of the newer

AEDs," was not based on any head-to-head clinical trials, and

was true only when Zonegran was used alone, or as

monotherapy, an unapproved use;


Question 30:

The reason off-label promotion is harmful is it:

a) undermines the FDA's important role in protecting the

American public by determining whether a drug is safe and

effective for a particular use before it is marketed;

b) costs the government billions of dollars;

c) both of the above are true, according to the DOJ.


Return this ANSWER SHEET with the $30.00 Program Fee payable to:

Pharmacy Jurisprudence, LLC

P.O. Box 21186

Columbus, Ohio 43221-0186

NAME:

ADDRESS:

CITY, STATE and ZIP:

EMAIL:

NABP e-Profile ID: Month and Day of Birth:

ANSWER SHEET: Off-Label Prescription Drug Marketing Expiration Date: June 28, 2013

Circle the answer for each question (questions are imbedded in the program).

1. a b c 16. a b c

2. a b c 17. a b c

3. a b c 18. a b c

4. a b c 19. a b c

5. a b c 20. a b c

6. a b c 21. a b c

7. a b c 22. a b c

8. a b c 23. a b c

9. a b c 24. a b c

10. a b c 25. a b c

11. a b c 26. a b c

12. a b c 27. a b c

13. a b c 28. a b c

14. a b c 29. a b c

15. a b c 30. a b c

________________________________________________________________


31. For Pharmacists: After completing this program, I am able to recognize at

least 5 examples of off-label prescription drug marketing.

Yes No

31. For Pharmacy Technicians: After completing this program, I am able to

recognize at least 5 examples of off-label prescription drug marketing.

Yes No

32. This program was an effective way for me to learn: Yes No

33. I liked the program’s format: Yes No

34. This program fostered my mental participation: Yes No

35. This was a “user-friendly” way for me to learn: Yes No

36. I could sense some commercialism in this program: Yes No

If yes, please describe:______________________________________________

37. The faculty quality was: Great OK Needs to Improve

38. The learning material quality was: Great OK Needs to Improve

39. How long did it take to complete this program?_______________________

40. What other topics would you like to see?____________________________

41. Comments welcome:____________________________________________

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