GSK SETTLEMENT 1

GlaxoSmithKline Health Care Fraud Settlement with the U.S. Justice Department, 2012

by

Victoria Luu and Murphie Price

Submitted to

Dr. D’Arcy Randall

and

Matthew Chovanec

ChE333T

Fall 2018

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Abstract

This paper evaluates the unethical actions of GSK, a pharmaceutical company headquartered in

London, and the consequences of those actions. The company’s deceitful behavior was exposed by

four former employees who filed suit against it. In its case with the U.S. Justice Department in

2012, it was found that GSK was guilty of falsely branding its drug products and keeping important

health data from the FDA. Consequently, GSK paid $3 billion dollars to the U.S. Department of

Justice and entered in a Corporate Integrity Agreement with the U.S. Government. The paper

begins with an overview of who the whistleblowers are and follows with details regarding the

specific wrongdoings that GSK engaged in, which made the whistleblowers come forward. GSK’s

actions will be evaluated under PhRMA’s Guiding Principles on Direct to Consumer

Advertisements about Prescription Medicines.

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Contents

Introduction 4

GlaxoSmithKline’s Wrongdoings 6

Paxil 6

Wellbutrin 7

Avandia 9

False Promotion 9

The Aftermath of GlaxoSmithKline’s Misbranding of its Drugs 10

The Ethics Behind GlaxoSmithKline’s Actions 11

Conclusion 13

Annotated References 15

List of Tables

Table 1: Largest pharmaceutical-company settlements with the U.S. Government 5

List of Figures

Figure 1: GSK memo claiming efficacy of Paxil 7

Figure 2: U.K ad promoting Wellbutrin 8

Appendix

PhRMA Guiding Principles 18

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GlaxoSmithKline Settlement with the US Justice Department, 2012

Introduction

In 2012, GlaxoSmithKline (GSK), a pharmaceutical company headquartered in London,

became involved in a corporate scandal when four whistleblowers accused the company of

engaging in corrupt schemes of mislabeling their drug products as well as bribery in order to

market the drugs for unapproved uses. The whistleblowers were all former GSK employees:

Thomas Gerahty, Matthew Burke, Greg Thorpe, and Blair Hamrick. Gerahty, GSK’s former senior

marketing development manager, and Burke, GSK’s former regional vice president, were

represented by Phillips & Cohen’s Erika Kelton, an attorney working at one of the top law firms

fighting for whistleblowers (“Glaxo settles record whistleblower case,” 2012). One of the areas that

this law firm specializes in is qui tam lawsuits, cases that have to deal with violating the False

Claims Act, a law that protects the American federal government from fraud. Thorpe, GSK’s

former senior executive sales representative, and Hamrick, GSK’s former sales representative, were

represented by Kenney & McCafferty’s Brian Kenney, one of the founding members of another

notable law firm that also specializes in qui tam lawsuits (“K&M Represents Whistleblowers,”

2012). By stepping forward, these four whistleblowers put into motion the largest healthcare fraud

settlement in U.S. history.

GSK develops and manufactures vaccines, consumer healthcare, and pharmaceuticals. The

company was established in 2000 after a merger between Glaxo Wellcome and SmithKline

Beecham, forming one of the biggest pharmaceutical companies in the world. To this day, GSK

continues to dominate the world drug market.

GSK’s unethical distribution of its drug products and bribery of doctors endangered the

public’s safety by neglecting the patients’ wellbeing, forcing the company to settle with the U.S.

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Department of Justice in 2012. As this company is a pharmaceutical company operating within the

U.S., GSK will be evaluated under PhRMA’s code of ethics. This case is important to study

because it showcases how major corporations have valued profit at the expense of public safety. As

seen in Table 1, GSK is not the only company involved in misconduct; multiple pharmaceutical

companies have had settlements with the U.S. Government due to their corrupt actions.

Table 1: Largest pharmaceutical-company settlements with the U.S. Government (Outterson,

2012).

This case is also important because it examines how GSK prioritized its revenue, and

profitability should not be valued over safety. Patients should not have to worry about the contents

of the medications prescribed to them by their physicians. It is the responsibility of medical

professionals to make the wellbeing of their patients a priority, and even though consumers should

be able to trust their physicians, they still have the right to be informed of the proper effects and

uses of their drugs.

This report begins by detailing the drugs that GSK misbranded and distributed, the failure

of the company to report safety risk data, and the incentives provided to doctors so they would

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illegally prescribe the drugs. The report then discusses the settlement with the U.S. Department of

Justice, which includes the Corporate Integrity Agreement that was forced upon GSK. Finally, the

ethics behind the case are examined. GSK’s actions will be measured against the PhRMA Guiding

Principles on Direct to Consumer Advertisements About Prescription Medicines as well as Michael

Davis’s code of ethics for engineers.

GlaxoSmithKline’s Wrongdoings

Misbranding and selling of any drug is an illegal practice as it breaks the Federal Food,

Drug, and Cosmetic Act of 1938. Section 301 of the Act illegalizes the distribution of a product

that has been adulterated or misbranded (Armstrong & Staman, 2018). GSK violated this act by

misbranding both Paxil and Wellbutrin. The company also withheld pertinent information

regarding health risks associated with Avandia from the Federal Drug Association (FDA). On top

of these two offenses, GSK bribed physicians in order to help the company sell its misbranded drug

products. The U.S. Department of Justice (DOJ), a federal department of the U.S. government, is

responsible for enforcing laws and administering justice in the U.S. By committing these unethical

acts, GSK put itself in a position to be penalized by the U.S. Department of Justice as the

company’s crimes were under the DOJ’s domain of authority.

Paxil

Paxil was misbranded as an antidepressant for patients under 18 even though the FDA never

approved it for such use. Between 1994 and 2001, three clinical trials were conducted to evaluate

whether Paxil was effective in treating depression in patients under 18, and all three studies failed

to demonstrate the efficacy of the drug (Sifferlin, 2012). Study 329, which was one of the clinical

trials, discovered that teens who took Paxil for depression were more likely to attempt suicide.

Despite the ineffectiveness of Paxil, GSK shared a memo with its sales force and hired a contractor

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to write a favorable article about the drug’s efficacy. A portion of the memo can be seen below in

Figure 1.

Figure 1: GSK memo concluding Paxil as effective and safe (“Drug Maker Withheld,” 2004).

The memo not only falsely declares that the three studies were successful and provided

“evidence of the safety and efficacy of Paxil,” but it also asserts the remarkability of the drug. The

favorable article written claimed Paxil as “generally well tolerated and effective for major

depression in adolescents,” but it failed to include the results of the studies to back up that claim

(Department of Justice, 2012). Rather than recall the drug, GSK kept Paxil on the shelves and

continued to have doctors prescribe it to patients. The company “managed the dissemination of data

in order to minimize any potential negative commercial impact” (“Spitzer sues,” 2004). Also, GSK

ended up making a profit of $55 million just in the year 2002 from its Paxil prescriptions to

children and adolescents (“Spitzer sues,” 2004). The conscious decisions made by GSK to continue

selling Paxil despite its harmful effects on adolescents demonstrate how the company did not

consider the wellbeing of its consumers.

Wellbutrin

Wellbutrin had been approved as an antidepressant by the FDA, but it was falsely branded

for weight loss, ADHD, ADD, addictions, and bipolar disease. Sales representatives for GSK often

referred to the drug as the “happy, horny, skinny pill” (Department of Justice, 2012). This was just

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unbelievable for a major company like this; the fact that GSK tacked on unapproved uses only for

the purpose of increasing sales is alarming. An example of an ad used to promote Wellbutrin can be

seen below in Figure 2.

Figure 2: U.K ad promoting Wellbutrin (Edwards, 2012).

In addition, company employees were rewarded with bonuses if they pitched Wellbutrin for

unapproved uses. Those who did not or had a problem with the kickbacks provided to doctors were

put on leave (Sifferlin, 2012).

The company ended up making a total of $5.9 billion in sales (Thomas & Schmidt, 2012).

For employees who did not support GSK’s actions, their jobs were at risk. Meanwhile, those who

did support GSK’s agenda were rewarded.

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Avandia

Avandia had been approved by the FDA as a safe and effective antidiabetic agent for adults

with type 2 diabetes. Over time, the FDA added two black box warnings to the label, alerting

physicians to the increased risk of heart failure. In an analysis published by Dr. Steven Nissen, a

Cleveland Clinic cardiologist, it was reported that Avandia increased the risk of heart attacks by

more than 40%. GSK also had its own analysis which showed a 29% - 31% increase in heart risks

in patients with type 2 diabetes. These analyses resulted in Avandia being banned in Europe in

2007 because the risks did not outweigh the benefits. (Sifferlin, 2012). Between 2001 and 2007 the

company failed to fully report to the FDA regarding the data detailing these safety risks

(Department of Justice, 2012). Rather than halt the distribution of Avandia, GSK continued to

promote and sell the drug while its sales reps denied any heart risks associated with it (Sifferlin,

2012).

False Promotion

In addition to the misbranding and improper distribution of multiple drug products, GSK

bribed doctors to falsely promote its drugs. The company paid doctors to attend lavish meetings in

Jamaica and Bermuda and to promote and prescribe its drug products for unapproved uses. Doctors

were paid up to $25,000 to be a GSK “advisory board” member (Kenney & McCafferty, 2012).

These lavish meetings were often referred to as “advisory board” or “consulting” meetings, but

little to no actual consulting happened. Instead, doctors were given off-label information so they

could prescribe GSK products for uses not approved by the FDA (Department of Justice, 2012).

GSK also sponsored continuing medical education programs, where off-label information

about the company’s products was spread. Typically, continuing medical education programs run

independently. GSK, however, influenced a lot of the content presented at these programs. The

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company decided on the location, the speakers, how much they were paid, and who was invited

(Department of Justice, 2012).

The Aftermath of GlaxoSmithKline’s Misbranding of its Drugs

Since Gerahty, Burke, Thorpe, and Hamrick were former GSK employees, they were able

to provide the U.S. government with valuable insider information to make a winning case against

GSK. The whistleblowers informed the government of GSK’s wrongful marketing practices which

included bribery of doctors and inaccurate promotion of its drug products (“K&M Represents,”

n.d.). Backed up by detailed allegations and strong evidence to support them, the U.S. Government

was able to commence a large-scale investigation, revealing everything the whistleblowers claimed

was true (“Glaxo settles,” 2012).

In the largest healthcare fraud settlement in U.S. history, the four whistleblowers who filed

suit forced GSK to face the legal consequences of misbranding its drugs. GSK pled guilty and paid

$3 billion to the U.S. Justice Department. Under the terms of the plea bargain, two-thirds of the

payment went toward civil liability for breaking the False Claims Act, and one-third of the payment

went toward the criminal charges of misbranding the drugs. In addition, GSK was forced into a

Corporate Integrity Agreement (CIA) with the U.S. Government for five years to increase its

accountability and transparency. The company was required to change the unethical way that it

conducted its business. Compensation for workers based on sales goals was removed, and if

misconduct was engaged in by executives and/or their subordinates, annual bonuses and incentives

were taken away from them (Department of Justice, 2012). This also applied to past employees; if

they engaged in any misconduct during their time working at GSK, annual bonuses and incentives

that were previously awarded would be revoked. The CIA also required that GSK be more

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transparent in their research and publications, and the company must follow policies based on

contracts it entered with its healthcare providers.

After the company accepted the terms of the settlement, CEO Andrew Witty apologized on

behalf of GSK. In his statement, Witty said that “the company had learned from the mistakes that

were made. We have fundamentally changed our procedures for compliance, marketing, and

selling. We understand how important it is that our medicines are appropriately promoted to

healthcare professionals and that we adhere to the standards rightly expected by the U.S.

Government” (“GlaxoSmithKline concludes,” 2012). Although Witty issued this apology

statement, it is difficult to say whether GSK’s actions changed to be more transparent and in the

best interest of its patients. It is not known how strictly the CIA is enforced to make sure that

compliance is met and real change occurs.

The Ethics Behind GlaxoSmithKline’s Actions

Michael Davis, a philosophy professor specializing in professional ethics at the Illinois

Institute of Technology, discusses why it is important for engineers to follow their profession’s

code of ethics in his book Thinking Like an Engineer. Davis lists four reasons as to why this is

necessary: to protect themselves and those they care about from injuries, to establish a working

environment where engineers are able to resist peer pressure, to avoid feeling immoral about one’s

job, and to fulfill the obligation to pass on these benefits to others (Davis, 1991). Although Davis

focuses on engineers’ ethical guidelines, his ideals can be applied to other professions as well,

particularly to pharmaceutical companies, because having and maintaining a common code of

ethics benefits all professions by establishing a mutual understanding of how to conduct oneself

professionally. However, GSK’s actions did not follow Davis’s ideals. At the expense of public

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safety and its employees’ ethics, GSK earned temporary profit; GSK presented its employees an

ultimatum: either continue supporting the company’s illegal actions or be at risk of losing a job.

GlaxoSmithKline will be ethically evaluated by the PhRMA Guiding Principles on Direct to

Consumer Advertisements about Prescription Medicines. PhRMA is a trade group representing

American pharmaceutical companies. This trade group was chosen because GSK is a PhRMA

member and although GSK is a British company, this case only deals with its illegal activities in

the U.S. In addition to not obliging by Davis’s ethical guidelines, almost all of the guiding

principles were broken (see Appendix). To name a few broken guidelines, patients were not

educated of the treatments undergone nor did they receive appropriate care for their conditions;

direct to consumer information was inaccurate, untruthful, and misleading, yet the products were

not discontinued; GSK did not properly educate healthcare professionals before launching its

products; the seriousness of health conditions was disregarded; and drug products were advertised

to audiences of an inappropriate age (PhRMA, 2009). GSK inaccurately marketed its drug products

to both medical professionals and patients when it bribed doctors to prescribe its products and

advertised Wellbutrin for uses aside from an antidepressant. Instead of protecting the public (which

in this case would be the patients that were unaware of the drug contents they were intaking) from

health risks, such as worsening depression, withdrawal symptoms, or heart attacks, GSK protected

its earnings by continuing to sell Paxil and Avandia at the expense of the public’s safety. Paxil

should not have been advertised to adolescents because the drug worsened users’ health conditions,

but the company disregarded this and continued to keep it on the shelves. Similarly, black box

warnings should have been included when marketing Avandia, but GSK omitted them to avoid

lowering sales. Even though GSK as a whole took part in fraud, not all of its employees were okay

with partaking in this action but followed along anyway. Under pressure from GSK’s higher-ups,

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there were employees who disagreed with the company’s wrongdoings but disregarded their own

and PhRMA’s code of ethics due to fear of losing their jobs. With no regard to the health risks that

its actions posed to its consumers, the company prioritized revenues above safety and ethics. If

GSK’s employees had stuck to their code of conduct as Davis suggested, it could have helped them

navigate this difficult ethical terrain.

Conclusion

GSK’s unethical choices affected many lives, and this case highlights the impact that it has

on the pharmaceutical industry. As one of the largest pharmaceutical companies in the world, GSK

takes on the responsibility of setting a standard for others. By not following safety protocol, GSK

allows other companies to believe that they can also take shortcuts to quickly earn profit. This case

demonstrates that engaging in fraudulent behavior will eventually lead to a downfall. GSK’s

corruptive schemes cost the company a lot of money as well as tarnished its reputation. The

pharmaceutical giant should have considered the consequences of its actions and adhered to its

responsibility as a PhRMA member to develop medicines that enable patients to have healthier

lives.

It can be argued that the consequences that GSK faced were not enough. Because it is such

a powerhouse pharmaceutical company, the $3 billion that GSK got charged with is miniscule

compared to the revenue that it makes. The CIA is also meant to curb corruption, but one may ask

whether anything was put in place to ensure that the terms of the agreement were met and thus if

the company could make real change within five years. It appears that the company did not change

since GSK got wrapped up in another scandal involving bribing doctors to promote its products

soon after the settlement. While this paper did not go into detail about that case, the fact that the

company acted unethically again suggests that GSK did not learn from its mistakes, and tougher

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actions need to be taken to better prevent fraud. Monetary charges against large corporations like

GSK are nothing but a small road bump for them. The CIA needs to be better enforced, and a close

eye needs to be kept on companies after the terms of the CIA are over because they may only make

temporary changes and go back to their actions prior to facing legal trouble.

Word count: 2773

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Annotated References

Armstrong, K. B., & Staman, J. A. (2018, February 09). Enforcement of the Food, Drug, and Cosmetic

Act: Select Legal Issues (CRS Report No. R43609). Retrieved from

https://fas.org/sgp/crs/misc/R43609.pdf

This source provides information about the federal act that prohibits the sale of adulterated and misbranded

products.

Davis, M. (1991). Thinking Like an Engineer. Retrieved November 9, 2018, from

http://ethics.iit.edu/publication/md_te.html

This source outlines an ethical standard that engineers should be held to. Although GSK is not an

engineering company, the ethics Davis describes is applicable to the company.

Department of Justice. (2012). GLAXOSMITHKLINE SETTLEMENT FACT SHEET.

This source contains all the specific details, such as the drugs, the CIA, and the fine, regarding the

settlement.

Drug Maker Withheld Paxil Study Data. (2004, December 09). Retrieved from

https://abcnews.go.com/Health/story?id=311956&page=1

This source includes the figure of the memo that claimed how effective and safe Paxil was at treating

depression in adolescents.

Edwards, J. (2012, July 03). 14 Documents From GlaxoSmithKline's $3 Billion Drug Marketing Scandal

That Will Disgust You. Retrieved from https://www.businessinsider.com/14-documents-from-

glaxosmithklines-3-billion-drug-marketing-scandal-that-will-disgust-you-2012-7#to-promote-paxil-

gsk-wined-and-dined-doctors-in-hawaii-and-puerto-rico-treating-them-to-golf-deep-sea-fishing-

rafting-and-balloon-rides-the-doj-alleges-5

This source provides the Wellbutrin U.K. ad used to promote and sell the drug.

GlaxoSmithKline concludes previously announced agreement in principle to resolve multiple

investigations with US Government and numerous states. (2012, July 02). Retrieved from

https://us.gsk.com/en-us/media/press-releases/2012/glaxosmithkline-concludes-previously-

announced-agreement-in-principle-to-resolve-multiple-investigations-with-us-government-and-

numerous-states/#

This source is the press release from GSK that provides a biased view of the events that transpired as a

result of the company’s crimes. It includes the CEO’s perspective and apology, which gives it a

slight personal touch.

Glaxo settles record whistleblower case for $3 billion – Medicare fraud alleged. (2012, July 2). Retrieved

November 10, 2018, from Phillips & Cohen website:

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https://www.phillipsandcohen.com/whistleblowers-played-major-role-in-glaxo-case-leading-to-

glaxo-s-record-settlement/

This source provides supporting details about two of the whistleblowers and the information they had

about GSK’s wrongdoings.

Kenney & McCafferty. (2012, July 02). GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement

Has Paid for One Of America's Most Expensive Failed Corporate Internal Investigations, Qui Tam

Whistleblowers' Attorneys Say. Retrieved from https://www.prnewswire.com/news-

releases/glaxosmithklines-gsk-3-billion-whistleblower-settlement-has-paid-for-one-of-americas-

most-expensive-failed-corporate-internal-investigations-qui-tam-whistleblowers-attorneys-say-

161083505.html

This source provides details on the false promotion of GSK’s products as well as the specifics regarding

the bribing of doctors.

K&M Represents Whistleblowers in $3 Billion Settlement with GlaxoSmithKline. (n.d.). Retrieved

November 10, 2018, from Kenney & McCafferty website:

https://www.kenneymccafferty.com/notable-cases/glaxosmithkline/

This source provides details about the other two whistleblowers and their exposure of GSK’s defrauding of

government programs.

Outterson, K. (2012, September 12). Punishing Health Care Fraud — Is the GSK Settlement Sufficient?

Retrieved from https://www.nejm.org/doi/full/10.1056/NEJMp1209249

This source contains the table regarding all the pharmaceutical-company settlements with the U.S.

Government.

PhRMA. (2009, March 2). PhRMA Guiding Principles on Direct to Consumer Advertisements About

Prescription Medicines.

This source contains the guidelines and principles that GSK’s actions were evaluated against. They provide

a baseline and highlight the multitude of violations made by the company.

Sifferlin, A. (2012, July 05). Breaking Down GlaxoSmithKline's Billion-Dollar Wrongdoing. Retrieved

from http://healthland.time.com/2012/07/05/breaking-down-glaxosmithklines-billion-dollar-

wrongdoing/

This source provides details about Paxil, Wellbutrin, and Avandia. It includes specifics about the studies

on Paxil and the increased heart risks associated with Avandia.

Spitzer sues GlaxoSmithKline over Paxil. (2004, June 02). Retrieved from

http://www.nbcnews.com/id/5120989/ns/business-us_business/t/spitzer-sues-glaxosmithkline-over-

paxil/#.W-XdkxNKjGI

This source contains all the information specific to Paxil such as the lawsuit filed on the drug.

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Thomas, K., & Schmidt, M. S. (2012, July 02). Glaxo Agrees to Pay $3 Billion in Fraud Settlement.

Retrieved from https://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-

billion-in-fraud-settlement.html

This source provides specific details about the money involved in the settlement as well as the revenue

GSK made.

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Appendix

PhRMA GUIDING PRINCIPLES

1. These Principles are premised on the recognition that DTC advertising of prescription medicines

can benefit the public health by increasing awareness about diseases, educating patients about

treatment options, motivating patients to contact their physicians and engage in a dialogue about

health concerns, increasing the likelihood that patients will receive appropriate care for conditions

that are frequently under-diagnosed and under-treated, and encouraging compliance with

prescription drug treatment regimens.

2. In accordance with FDA regulations, all DTC information should be accurate, truthful and not

misleading, should make claims only when supported by appropriate evidence, should reflect

balance between risks and benefits, and should be consistent with FDA approved labeling.

Accordingly, companies should continue to base promotional claims on FDA approved labeling

and not promote medicines for off-label uses, including in DTC advertisements.

3. DTC television and print advertising which is designed to market a prescription drug should also

be designed to responsibly educate the consumer about that medicine and, where appropriate, the

condition for which it may be prescribed. During the development of new DTC television

advertising campaigns, companies should seek and consider feedback from appropriate audiences,

such as health care professionals and patients, to gauge the educational impact for patients and

consumers.

4. DTC television and print advertising of prescription drugs should clearly indicate that the

medicine is a prescription drug to distinguish such advertising from other advertising for non-

prescription products.

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5. DTC television and print advertising should foster responsible communications between patients

and health care professionals to help patients achieve better health and a more complete

appreciation of both the health benefits and the known risks associated with the medicine being

advertised.

6. In order to foster responsible communication between patients and health care professionals,

companies should spend an appropriate amount of time to educate health professionals about a new

medicine or a new therapeutic indication and to alert them to the upcoming advertising campaign

before commencing the first DTC advertising campaign. In determining what constitutes an

appropriate time, companies should take into account the relative importance of informing patients

of the availability of a new medicine, the complexity of the risk-benefit profile of that new

medicine and health care professionals’ knowledge of the condition being treated. Companies are

encouraged to consider individually setting 5 specific periods of time, with or without exceptions,

to educate health care professionals before launching a branded DTC television or print advertising

campaign. Companies should continue to educate health care professionals as additional valid

information about a new medicine is obtained from all reliable sources.

7. Working with the FDA, companies should continue to responsibly alter or discontinue a DTC

advertising campaign should new and reliable information indicate a serious previously unknown

safety risk.

8. Companies should submit all new DTC television advertisements to the FDA before releasing

these advertisements for broadcast.

9. DTC print advertisements for prescription medicines should include FDA’s toll-free MedWatch

telephone number and website for reporting potential adverse events. DTC television

advertisements for prescription medicines should direct patients to a print advertisement containing

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FDA’s toll-free MedWatch telephone number and website, and/or should provide the company’s

toll-free telephone number.

10. Companies that choose to feature actors in the roles of health care professionals in a DTC

television or print advertisement that identifies a particular product should acknowledge in the

advertisement that actors are being used. Likewise, if actual health care professionals appear in

such advertisements, the advertisement should include an acknowledgment if the health care

professional is compensated for the appearance.

11. Where a DTC television or print advertisement features a celebrity endorser, the endorsements

should accurately reflect the opinions, findings, beliefs or experience of the endorser. Companies

should maintain verification of the basis of any actual or implied endorsements made by the

celebrity endorser in the DTC advertisement, including whether the endorser is or has been a user

of the product if applicable.

12. DTC television and print advertising should include information about the availability of other

options such as diet and lifestyle changes where appropriate for advertised condition.

13. DTC television advertising that identifies a product by name should clearly state the health

conditions for which the medicine is approved and the major risks associated with the medicine

being advertised.

14. DTC television and print advertising should be designed to achieve a balanced presentation of

both the benefits and the risks associated with the advertised prescription medicine. Specifically,

risks and safety information, including the substance of relevant boxed warnings, should be

presented with reasonably comparable prominence to the benefit information, in a clear,

conspicuous and neutral manner, and without distraction from the content. In addition, DTC

television advertisements should support responsible patient education by directing patients to

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health care professionals as well as to print advertisements and/or websites where additional benefit

and risk information is available.

15. All DTC advertising should respect the seriousness of the health conditions and the medicine

being advertised.

16. In terms of content and placement, DTC television and print advertisements should be targeted

to avoid audiences that are not age appropriate for the messages involved. In particular, DTC

television and print advertisements containing content that may be inappropriate for children should

be placed in programs or publications that are reasonably expected to draw an audience of

approximately 90 percent adults (18 years or older).

17. Companies are encouraged to promote health and disease awareness as part of their DTC

advertising.

18. Companies should include information in all DTC advertising, where practical and appropriate,

directing patients to company resources that may help them with the cost of their medicine.

19. All DTC television advertising that identifies a prescription medicine by name should include

direction as to where patients can find information about the cost of the medicine, such as a

company-developed website, including the list price and average, estimated or typical patient out-

of-pocket costs, or other context about the potential cost of the medicine.