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Direct to consumer advertising of Prescription drugs-Pharmaceutical industry perspective

Jinender KumarGraduate studentPharmacy administration

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Overview Objective Introduction Pharmaceutical company perspective Phrma and its Mission Guiding Principles Critique of DTC advertising Summary References

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Objective

To provide information about the perspective of Pharmaceutical industry on direct to consumer advertising.

Guiding principle followed by pharmaceutical companies.

Critique of DTC advertising

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Definition

Direct to consumer advertising is promotion of prescription drugs through-

1) Newspaper2) Magazine3) Television4) Internet5) Brochure and Videos

5Julie M.Donahue’ “a decade of direct to consumer advertising of prescription drugs” NEJM Aug 2007 Vol 357:673-681no.7

6Julie M.Donahue’ “a decade of direct to consumer advertising of prescription drugs” NEJM Aug 2007 Vol 357:673-681no.7

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Pharmaceutical company perspective DTC advertising benefit public health by

starting a dialogue between patients and physician, which can lead to education and treatment of patients.

DTC advertising foster competition among products which lead to improved quality and lower prizes.

DTC advertising enhances consumer knowledge by making them aware of new products, help them identifying symptoms and new treatments for previously untreatable disease.

http://www.phrma.org/direct_to_consumer_advertising/

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Pharmaceutical company perspective

DTC advertising encourage consumers having interactive dialogue with their physician about medical condition and illness they may never have discussed before.

Patient compliance could be increased.

http://www.phrma.org/direct_to_consumer_advertising/–phrma-The pharmaceutical and research manufacturers Association

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The Pharmaceutical and research manufacturer of America (Phrma)

Phrma represents United states leading pharmaceutical and biotechnological companies devoted to inventing medicine.

Phrma member companies spends $43 billion in research in 2006 out of $55.2 billion by whole industry.

http://www.phrma.org/about_phrma/

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Phrma mission

To win advocacy for public policy that encourages the discovery of life saving and life enhancing medicines by pharmaceutical/biotechnological research companies.

http://www.phrma.org/about_phrma/mission_statement/

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How Phrma accomplish its mission

Phrma works with government to achieve

1) Broad patient access to safe and effective medicines through a free market, without price controls.

2) Strong intellectual property incentives.

3) Transparent, efficient regulation and a free flow of information to patients.

http://www.phrma.org/about_phrma/mission_statement/mission_statement/

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Guiding principles1) Premised on the recognition DTC advertising 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

http://www.phrma.org/publications/policy_papers/phrma_dtc_guiding_principles/

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Guiding principle2) Pharmaceutical companies should comply

In accordance with FDA regulations which state that all DTC information

To be accurate and not misleading; To make claims only when supported by

substantial evidence; To reflect balance between risks and

benefits; and To be consistent with the FDA-approved

labeling.

http://www.phrma.org/publications/policy_papers/phrma_dtc_guiding_principles/

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Guiding principles3)DTC 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.

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.

http://www.phrma.org/publications/policy_papers/phrma_dtc_guiding_principles/

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Guiding principles5)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 before commencing the first DTC advertising campaign

http://www.phrma.org/publications/policy_papers/phrma_dtc_guiding_principles/

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Guiding principles

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.

http://www.phrma.org/publications/policy_papers/phrma_dtc_guiding_principles/

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Guiding principles

9)DTC television and print advertising should include information about the availability of other options such as diet and lifestyle changes where appropriate for the advertised condition.

10)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.

http://www.phrma.org/publications/policy_papers/phrma_dtc_guiding_principles/

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Guiding principles11)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 in DTC television advertising should be presented in clear, understandable language, without distraction from the content, and in a manner that supports the responsible dialogue between patients and health care professionals.

http://www.phrma.org/publications/policy_papers/phrma_dtc_guiding_principles/

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Guiding principles

12)All DTC advertising should respect the seriousness of the health conditions and the medicine being advertised.

13) 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.

http://www.phrma.org/publications/policy_papers/phrma_dtc_guiding_principles/

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Guiding principles

14)Companies are encouraged to promote health and disease awareness as part of their DTC advertising.

15) Companies are encouraged to include information in all DTC advertising, where feasible, about help for the uninsured and underinsured.

http://www.phrma.org/publications/policy_papers/phrma_dtc_guiding_principles/

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Critique of DTC

Advertising

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More spend on marketing than R&D

DTC Constitute only 10 % of R& D spending in 2006.

DTC constitute about 2.6% of total sales as in 2005.

DTC constitute of 14% of total promotional budget of industry as in 2005.

Julie M.Donahue’ “a decade of direct to consumer advertising of prescription drugs” NEJM Aug 2007 Vol 357:673-681no.7

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DTC increase the price of advertised drug

DTC advertising accounts for less than 2 percent of the total U.S. spending for prescription medicines

M. B. Rosenthal et al., Demand Effects of Recent Changes in Prescription Drug Promotion(Washington, DC: Kaiser Family Foundation, June 2003).

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Overuse of prescription drugs

There is underused of prescription drugs in 7 out of 9 condition for which prescription drugs are recommended, out of 7 conditions for which underuse of prescription medication, 5 are DTC advertised.

One-quarter of adult patients who visited their physician after seeing a DTC ad received a new diagnosis of a condition.

E. A. McGlynn et al., “The Quality of Health Care Delivered to Adults in the UnitedStates,” The New England Journal of Medicine 348, no. 26 (26 June 2003): 2635–2645J. S. Weissman et al., “Consumers’ Reports on the Health Effects of Direct-to-Consumer Drug Advertising,” Health Affairs Web Exclusive, 26 February 2003, http://www.healthaffairs.org (accessed 27February 2003).

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Do patients benefit from pharmaceutical advertising?”

The telephone survey of 943 people who had been to the doctor within the past three months revealed that DTC advertising empowers patients to become more active in their own health care.

Nearly one in five patients reported speaking to a physician about a condition for the first time because of a DTC ad.

Thirty-two percent of patients reported that DTC ads helped them have better discussions about their health with their doctor

K. Aikin, Direct-to-Consumer Advertising of Prescription Drugs: Patient Survey Results, 19 September 2002, http://www.fda.gov/cder/ddmac/Presentations/kithmcc2002out/ sld001.htm (accessed 6 August 2004).

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Pharmaceutical marketing adversely affect patient behavior.

DTC advertising can increase compliance with pharmaceutical usage regimes and can assist in educating patients and health professionals about the risks, diagnosis, and treatment of a particular medical condition.

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DTC advertising interfere with thephysician/patient relationship

93 %of patients who asked about a drug reported that their physician “welcomed the question.

Source: K. Aikin, Direct-to-Consumer Advertising of Prescription Drugs: Physician Survey Preliminary Results, 13January 2003, http://www.fda.gov/cder/ddmac/globalsummit2003/index.htm (accessed 13 January 2003).

30Source: K. Aikin, Direct-to-Consumer Advertising of Prescription Drugs: Physician Survey Preliminary Results, 13January 2003, http://www.fda.gov/cder/ddmac/globalsummit2003/index.htm (accessed 13 January 2003).

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advertising pressure physicians toprescribe advertised medicines

The vast majority of physicians (91 percent) said the patient did not try to influence the course of treatment in a way that would have been harmful.

Of the 86% of physicians that reported that their patient asked about a specific brand name drug, 88 percent reported that the patient did indeed have the condition the drug treats.

Source: K. Aikin, Direct-to-Consumer Advertising of Prescription Drugs: Physician Survey Preliminary Results, 13January 2003, http://www.fda.gov/cder/ddmac/globalsummit2003/index.htm (accessed 13 January 2003).

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pharmaceutical companies have free reign over their marketing activities

FDA divison of drug marketing and communication is responsible for drug advertisement oversight and issue warning letters for violation of FDA rules and regulations.

33Julie M.Donahue’ “a decade of direct to consumer advertising of prescription drugs” NEJM Aug 2007 Vol 357:673-681no.7

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Summary DTC help public health by making

consumer more aware of disease, its treatment option, encouraging him to start a dialogue with Physician, starting early treatment.

DTC increase prescription drug cost by increasing its usage but help saving overall cost due to reduced need of acute care and hospitalization.

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References1) http://www.phrma.org/about_phrma/2) http://www.phrma.org/publications/policy_papers/phrma_dtc_guiding_principles/3) http://www.phrma.org/4) Julie M.Donahue’ “a decade of direct to consumer advertising of prescription drugs”

NEJM Aug 2007 Vol 357:673-681no.75) K. Aikin, Direct-to-Consumer Advertising of Prescription Drugs: Physician Survey

Preliminary Results, 13 January 2003,http://www.fda.gov/cder/ddmac/globalsummit2003/index.htm (accessed 13 January 2003).

6) E. A. McGlynn et al., “The Quality of Health Care Delivered to Adults in the United States,” The New England Journal of Medicine 348, no. 26 (26 June 2003): 2635–

2645J. S. 7) Weismann et al., “Consumers’ Reports on the Health Effects of Direct-to-Consumer

Drug Advertising,” Health Affairs Web Exclusive, 26 February 2003, http://www.healthaffairs.org (accessed 27February 2003).

8) M. B. Rosenthal et al., Demand Effects of Recent Changes in Prescription Drug Promotion (Washington, DC: Kaiser Family Foundation, June 2003).

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Questions?