Prescription Pharmaceuticals

• Rachel DiDominica

• Thomas Hawing

• Dylan Hull

The Pharmaceutical Industry

 The prescription pharmaceutical industry is primarily engaged in the development of innovative prescription and over-the-counter products that are used to prevent or treat illnesses in humans or animals. Brand-name drugs are products with patent protection. The industry is significantly engaged in the research and development of new drugs.

Industry Competitors

 Pfizer Inc.

 Merck & Co.

 AstraZeneca PLC

 GlaxoSmithKline PLC

 Johnson & Johnson

 Bristol-Myers Squibb

 Eli Lilly & Company

Market Share

Major Players

30,8

7,5

7,5

8,9

13,6

9,4

12,8

9,5

Pfizer

Merck & Co

AsterZeneca PLC

GlaxoSmithKline PLC

Johnson & Johnson

Bristol-Myers Squibb

Eli Lilly & Co

Other

Barriers to Entry = HIGH

 Knowledge:

 Patents

 The Patent Protection and Affordable Care act of 2010

 Companies have a 12-year patent period on their drugs

 Proprietary knowledge is required to compete with other established companies

 Drug Firms keep discovery process very secret

 Production and Development of New Drugs

 As patents expire new drugs need to be made

 Cant have a company with one drug

Research and Development

 Pharmaceutical manufacturers invest a higher percentage of sales in R&D than companies in any other industry

 Drug firms invest around 19-25% of total revenue in research and development

 Those who do not invest in R&D often end up struggling to survive in the face of stiff generic competition once their patent protection has expired

 One in 5,000 new chemicals discovered actually goes to market

 It takes around 10 to 15 years and $1.5 billion to develop a new product and just two out of ten approved products recover the R&D costs necessary to research them

HHI Index

 699.28

 HHI = 10,000 x Σw i

2

 HHI tells us whether an industry is acting in a monopolistic behavior or as if it were in a competitive market

 An HHI of 699.28 indicates that the Prescription

Pharmaceutical industry is acting as if they were in a completive market.

Four-Firm Concentration Ratio

 CR4 =

45.3

 C

4

= w

1

+ w

2

+ w

3

+ w

4

 The CR4 Index measures the market power of the top 4 companies

 This is under 50%

 Shows that the Prescription Pharmaceutical industry is a competitive industry.

Government Regulation = HEAVY

 In 1962 the Kefauver-Harris Amendments shifted all Federal

Food, Drug and Cosmetic regulation and promotion from the

Federal Trade Commision to the FDA.

 Prescription Drug promotional materials cannot be false or misleading, must provide "fair balance" coverage of risks and benefits of using the drug, must provide a "brief summary" of side effects, and effectiveness and must also meet specific guidelines for readability and size of print.

 The FDA interpreted this as everything must be in print form.

 They must disclose where they spend all of their advertising dollars ( Doctor Payments )

A Change in Government Regulation

 In 1997 the FDA eliminated the requirement that ads present the entire "brief summary" taken from the product label.

 The advertisements needed only to include:

 “major statements” of the risks and benefits of the drug

 Directions to information sources in addition to a physician such as a toll-free phone number, a website or a print advertisement

 This removed a major barrier that had made television and radio advertising infeasible and could only be done through print media

Television Ad. Occurrence

Count of Ad

35000

30000

25000

20000

15000

10000

5000

0 Ряд1

Company Background

Pfizer

 Founded in 1849

 Lipitor, Viagra, Caduet, Chantix, Advil, Robitussin

 2011 Revenue = $67.425 billion

 2007 Ad Spending = $1.253 billion

 $456.6 million on TV

 $225.2 million on Magazines

• Heart Medication

• $12.7 billion in sales

• $220 million spent on advertising

Bristol-Myers Squibb

 Founded in 1887

 Abilify, Atripla

 2009 Revenue = $18.8 billion

 2007 Ad Spending = $796.3 million

 $201.4 million on TV

 $158.3 million on Magazines

Antidepressant

AstraZeneca

 Merger between Astra (1913) and British ICI (1993) in 1999

 Seroquel, Arimidex, Crestor

 2011 Revenue = $33.59 billion

 2007 Ad Spending = 697.4 million

 $55.6 million on TV

 $196.9 million on Magazines

Advertising Strategies

Total Market View

Direct-to-Consumer (DTC) Advertising

Direct-to-Consumer (DTC) Advertising

 Targets general public via lay media

 Expenditure has grown from $985 million in 1996 to

$4,237 million in 2005

 Real spending on DTC advertising increased by

330% from 1996 to 2005

(See Table)

14% of total promotional expenditures in 2005

Role of DTC Advertising for Top-Selling

Drugs

 Drugs advertised to consumers: new drugs used to treat chronic conditions

 Manufacturers of proton-pump inhibitors, statins, and erythropoietin medications

 Spent 34%, 34%, and 31% of their total marketing budget respectively on DTC advertising in 2005

 Spending for advertising of antidepressant agents, seizuredisorder medications, and

antipsychotic agents was lower

Empirical Findings on DTC Advertising

 Increases traffic to clinics

 May help the sponsoring brand more than the competing brand

 DTC advertising of competing firms could have synergistic effects on consumers

 Demand for prescription drugs is sensitive to price

Television DTC Advertising

 Average American television viewers see as many as 16 hours of prescription drug advertisements per year

 Average ad length: 44.9 seconds

 Time above average

Informative- educates people about health conditions and available treatments

Television DTCA- FDA Regulations

 Product Claim Ads

 Must include name and indication of the drug, major statement of product risks, and must direct consumers to a detailed summary of product risks and benefits

 Reminder Ads

 Shorter

 Can mention product name

 May not discuss indications, efficacy, or dosage recommendations

How Ads Attempt to Appeal to

Viewers

Rational appeals

 Providing information about product use, features, or comparison with similar products

 Positive emotional appeals

 Evoking favorable affect

 Negative emotional appeals

 Evoking negative affect– fear, regret

 Humor appeals

 Using puns, jokes, or satire

 Fantasy appeals

 Depicting unrealistic or surreal scene

 Sex appeals

 Showing characters in an intimate encounter, scantily clad, or using provocative gestures

 Nostalgic appeals

 Using images from an earlier time, or black-and-white or sepia tone visuals

Study on Television DTCA

 Programming Sample: 103 Ads

31 unique product claim ads  focus of study

7 unique reminder ads

 3 story structures:

44.7%: showed characters before and after taking the product

39.5%: showed characters only after taking the product

7.9%: showed characters only before taking the product

Study on Television DTCA

 Appeals

 Product claim ads

100% used rational appeals

95% used positive emotional appeals

68.9% used negative emotional appeals

 Reminder ads

Never use rational appeals

100% used positive emotional appeals

Conclusions of Study

 Most product claim ads made some factual claims about target conditions and the disease mechanisms

 Ambiguous about whether viewers might legitimately need the product

 Offered limited info about risk factors, prevalence of condition, or subpopulations at greatest risk

 Provided info to viewers through rational arguments that detail product use or potential risks and benefits of use

 DTCA focuses on convincing people that they may be at risk for a wide array of health conditions that product might help with

Conclusions of Study

 Themes about role of lifestyle in achieving and maintaining health

One quarter of ads: target condition interferes with healthy or recreational activities

Never described behaviors as a reasonable alternative

More than 56% of the ads showed the product enabling healthy or recreational activities

DTCA: suggests improvement comes from taking the medication alone or in combination with healthy activities

NEVER from behavior modification alone

DTCA Advertising Example

 Abilify Anti Depression 2011 Commercial

 http://www.youtube.com/watch?v=jfPDrNrHAg&feature=related

Issues with DTCA

 Television advertising

 Use of programs like

TiVo

 Commercial skipping

 Companies resort to different strategies

Product Placement

 Inclusion of brand into story line

2004: market for service increased by 30.5% to

$3.46 billion

 Use of Viagra in the film

Love and Other Drugs

 http://www.youtube.co

m/watch?v=RNmi5ZNOt

Ys

Celebrity Spokespeople

 Speak on behalf of particular diseases and mention specific brand treatments during interviews

Peggy Fleming on Good

Morning America for Lipitor

Sampling

Sampling

 Pharmaceutical representatives provide office-based physicians free drug samples

 Accounts for 55% of advertising expenditures

 Totaled $10.5 billion in 2001

Sampling

 Samples also being made available through DTC advertising venues like TV, newspapers, and the

Internet

 From 1996 to 2005 spending on DTCA and free samples has risen as a share of total promotion

Sampling: Psychological Effects

 Belief and attitudinal confidence are found to be higher for physicians and patients exposed to product sampling alone than for those exposed only to product advertising

 Consumers automatically have a greater affinity to something they have experienced as opposed to something that they haven’t

 Have been shown to directly affect physician prescribing behavior

 More likely to prescribe brand name medications that they have free samples of

 Provides immediate access to the medication and allows patients to find out which brand and dosage amount works best for them

Advertisements in Medical Journals

Advertisements in Medical Journals

 Value of professional journal advertisements

2% of spending

 Specific ads targeting medical profession= cheaper and just as effective

 Six of the top 10 drugs advertised through DTC were also among the top 10 drugs promoted to physicians through detailing and medical journals

Advertisements in Medical Journals

 Companies are now paying journals to publish articles with content about their promoted drugs and to suppress unfavorable study results that would negatively impact their brand image

 1989 study by the Association of Independent Medical

Publications

 Journal advertising with effective sales theme increases a product’s market share of new prescriptions in a predictable way

 Concluded that doctors in study relied on promotional information rather than scientific material in forming opinions

Method Currently Under Scrutiny

 Ability to impact a physician’s prescribing behavior for the wrong reasons

 Major deficiencies in advertisements

Study: Office of the Inspector Study:

Study: General in the Department of

Health and Human Services

 Lacked necessary references and information on efficiency, appropriate populations, safety, and potential side effects

 Reviewers rated 60% of the advertisements poor or unacceptable in terms of scientific references

17%: rejected for publication

24%: required major revisions

50%: little or no educational value

59%: would not lead to proper prescribing if the physician had no other information

FDA: Regulatory Response

 Issue notice of violation and warning letters and requesting that manufacturers publish corrective advertisements or send letters to pharmacists and physicians correcting advertisements

 Many medical journals do not review the content of the advertisements they publish

Detailing

Detailing

 Sales activities of drug representatives directed toward physicians

 $4.8 billion: officebased physicians

 $700 million: hospital based physicians

 $5.5 Billion spent in 2001

Detailing

81,000 pharmaceutical representatives in US

 Relationship selling techniques

 Medical science and product knowledge

 Marketers identify group of physicians most likely to prescribe particular drug

 Detailing is more effective in determining brand share

Detailing

 Combined with other advertising methods

 May provide clinical information paired with the presentation of approved journal articles and free drug samples

Interview with Susan DiDominica

 Current pharmaceutical sales representative

 “Human informative advertisement”

 Sell yourself and the drug

Works Cited

 http://oig.hhs.gov/oei/reports/oei-01-90-00482.pdf

 http://www.nejm.org/doi/full/10.1056/NEJMsa070502#t=a rticleMethods

 http://www.kff.org/rxdrugs/upload/Impact-of-Direct-to-

Consumer-Advertising-on-Prescription-Drug-Spending-

Summary-of-Findings.pdf

Analysis and Recommendations

Industry Outlook

 Revenue continues decline through 2013

 Slow growth after 2014

 Increase in sales, decrease in profit

161 000,00

160 000,00

159 000,00

158 000,00

157 000,00

156 000,00

155 000,00

154 000,00

153 000,00

152 000,00

2012

Industry Revenue Growth ($millions)

2013 2014 2015 2016 2017 2018

Patient Protection and Affordable

Care Act

 Extends health insurance to 32 million more Americans

 2014: more Americans aged 26 to 64 will become covered by the act

 PhRMA deal

 Establishes approval pathway for generic biologic drugs

Biologic Drugs

 Focus on investing in generic biologics production

 Large brand-name companies gain a competitive advantage

 Diversifies and mitigates risk

DTC Advertising

 Rapid pace of growth in developing and launching second and third generation products

 Focus on promoting the product

 Increases in DTC advertising have contributed to overall increases in spending on the advertised drug

DTC Spending

DTC Spending

Social Media Advertising

 More consumers willing to use social media to seek medical information

 FDA Regulations pending

Pharma Ad Spending

Recommendations

 Revenue is relatively steady.

 Revenue is expected to drop in the next few years

 Future of the industry is unclear

Questions?