Readers of HealthCareVox are aware that I am posting a three-part series on pharmaceutical marketing in the United States. This series is organized as follows:
-Part I: A brief history of pharmaceutical marketing
-Part II: Pharmaceutical advertising from 1997 to the present day
-Part III: My perspective on pharmaceutical advertising and marketing
Read on for the second article in this series.
To learn about a resource that provides more information on this topic, please click here.
Pharmaceutical Advertising From 1997 – 2006: Nine Years Of Change & Controversy
In 1997 the Food and Drug Administration (FDA) relaxed restrictions on pharmaceutical advertising (see part I for more on this). This action quickly led to intensive direct-to-consumer drug (DTC) advertising by drug companies. During the first six months of 1998, drug makers spent $306 million on television commercials.[1] By the first half of 1999, spending on DTC advertising had increased to $905 million.[2]
The most memorable advertisements aired during the early part of the DTC era were those featuring celebrities like Bob Dole (erectile dysfunction, Viagra), Karl Malone (hair loss, Rogaine) and Joan Lunden (allergies, Claritin).[1]. Other categories of DTC advertisements produced during this period include:
-Educational advertisements: These types of commercials educate consumers on specific diseases like hair loss or erectile dysfunction but do not mention the name of a drug.[2]
-Reminder advertisements: These ads highlight the name of a drug, but do not feature information about its efficacy or safety profile.[2]
Debate Over The Impact Of DTC Advertising
Since 1997, critics and supporters of the pharmaceutical industry have been engaged in a vigorous debate about the impact of DTC advertising on the patient-healthcare provider relationship, prescribing patterns and spending on pharmaceuticals.
Supporters of DTC advertising assert:
-DTC advertisements educate patients: Healthcare consumers benefit from drug advertisements because they transmit important information on various illnesses, encourage them to visit a healthcare professional and reduce the stigma associated with certain conditions like schizophrenia, depression and erectile dysfunction.
-DTC advertisements improve the physician-patient relationship: Advertisements prompt consumers to partner with their physicians. According to pharmaceutical industry trade group, PhRMA: “Studies show DTC advertising brings patients into their doctor's office and starts important doctor-patient conversations about health that might otherwise not have happened.”[3]
Opponents of DTC advertising argue:
-DTC advertising does not educate patients: DTC advertisements often lack critical information about available treatments, prompt consumers to favor prescription medications over lifestyle modifications and do not provide enough information about drug success and failure rates.[2]
-Healthcare consumers do not have the training to understand drug commercials: Few consumers have the training and background to clearly understand a drug’s safety and efficacy.[2]
-DTC advertising increases inappropriate prescribing: DTC advertisements encourage patients to “pressure their physicians” to prescribe brand-name drugs or switch them to newer, more expensive medications.[2]
Concerns About Rising Drug Costs, Prescribing & Safety Prompt Changes In DTC Advertising
Debate about the pros and cons of drug advertising escalated between 1998 and 2003. Three drivers of the controversy included concerns about drug safety, increasing drug costs and the increased prescribing of brand name medications.
Drug Safety Concerns
Between 1997 and 2004, a number of heavily advertised drugs were withdrawn from the market. These medications included Redux (anti-obesity), Lotronex (irritable bowel syndrome [the FDA recently re-approved this drug for limited use]), Baycol (high cholesterol) and Vioxx (arthritis). These withdrawals prompted closer scrutiny of the FDA’s drug approval process and how advertising impacts prescribing patterns.
Drug Costs
From 1990 and 2003, spending on prescription medications increased from $40 billion to $193 billion.[4] Although prescription drug costs account for only 11 percent of the total US healthcare bill, spending on pharmaceuticals significantly increased between 1995 and 2003.[4] In response, public and private payers (insurance companies, government) began to search for ways to decrease the use of brand name medications.
Increased Prescribing Of Brand Name Drugs
In 2003, evidence emerged suggesting that DTC advertising was having a significant impact on sales of brand name pharmaceuticals.[5] A study conducted by researchers at Harvard and the Massachusetts Institute of Technology indicates that:
-DTC advertising resulted in an additional $2.6 billion in drug spending in 2000.[5]
-Drug makers’ advertising dollars were well-spent. Every $1 spent on DTC advertising resulted in $4.20 in sales.[5]
-DTC advertising is an important, but not a primary driver of pharmaceutical spending.[5]
The Pharmaceutical Industry Responds To Criticism
Concerns about drug safety, drug costs and increased prescribing fueled criticism of the pharmaceutical industry’s widespread use of DTC advertising. In response, drug makers announced in August 2005 that they had adopted voluntary guidelines governing DTC commercials.[6] Key provisions of the guidelines include:
-Companies will submit all DTC advertising to the FDA prior to release.[6]
-DTC advertisements will feature balanced commentary about the risks and benefits of medications.[6]
-Companies will spend an “appropriate amount of time” educating the public about a medication before engaging in DTC advertising.[6]
-Drug makers will no longer produce reminder advertisements because they do not transmit enough information about drug uses or side effects.[6]
Critics have asserted that the new industry DTC guidelines are inadequate. For example, in April 2006, the Prescription Access Litigation Project (PAL) awarded drug makers a “Bitter Pill” award for “pushing toothless ‘guiding principles’ on drug advertising. PAL asserts that “only a handful of the industry’s principles calls for any significant change in behavior.” In addition, PAL has characterized PhRMA’s principles as “extremely vague” because they “contain no measurable benchmarks to determine” whether an advertisement is in compliance.[7]
In addition, John Mack, author of the Pharma Marketing Blog, has reported that drug companies are still producing reminder ads despite the industry’s voluntary ban on the practice (click here and here for articles).
The Future Of DTC Advertising
Over the past several years the Food and Drug Administration has held a number of public hearings on the issue of DTC advertising. In addition, the FDA recently announced that it is planning to launch a study to determine whether side effect information included in print DTC advertisements is adequate.
In March 2006, the Coalition for Healthcare Communication (CHC) submitted a petition to the FDA about DTC advertising.[8] In the petition CHC requested that the agency:
-Create a standing committee to advise the agency on communications policy.
-Recognize that few consumers fully understand information about the risks and benefits of medications.
-Ask drug advertisers to include the following “core messages” in all DTC advertisements (drug makers would be free to amend the messages):
1. All prescription drugs, including the one being advertised, have potential benefits and potential risks.[8]
2. The advertised drug requires a prescription involving a professional weighing all of the potential benefits, risks and side effects for the individual patient.[8]
3. The patients should fully inform his/her healthcare professional about the patient’s medical history and about other medications the patient is using.[8]
-Request, but not require, advertising to reference a 800 number or Website where consumers can get more information about a drug’s benefits, risks and side effects.
Recent actions by the FDA, CHC, the pharmaceutical industry and others indicate that change is afoot in the DTC advertising arena. However, it is unclear what changes will occur and when they will happen.
If history is any guide, change will occur slowly and will be closely linked to the political and social environment faced by the pharmaceutical industry.
Next Up:My views on pharmaceutical marketing
1. Anonymous, Dr. Celebrity, in Consumer Reports. May 1999. p. 8-9.
2. Wilkes, M.S., R.A. Bell, and R.L. Kravitz, Direct-To-Consumer Prescription Drug Advertising: Trends, Impact, and Implications. Health Affairs, 2000. 19(2): p. 110-128.
3. Anonymous. Direct To Consumer Advertising. 2006 [cited 2006 May 26]; Available from: http://www.phrma.org/direct_to_consumer_advertising/.
4. Anonymous, Prescription Drug Trends. November 2005, Kaiser Family Foundation: Menlo Park, California.
5. Anonymous, Impact Of Direct-to-Consumer Advertising On Prescription Drug Spending. June 2003, Kaiser Family Foundation: Menlo Park, California.
6. Anonymous, PhRMA Guiding Principles: Direct-to-Consumer Advertisements About Prescription Medicines. November 2005, PhRMA: Washington, DC.
7. Anonymous, The Fox Guarding The Henhouse Award: For Pushing Toothless "Guiding Principles" On Drug Advertising. April 26, 2006, Prescription Access Litigation Project: Boston, MA
8. Anonymous. Citizen Petition Requesting Promulgation Of An Amended Regulation For Prescription Drug Advertising. 2006 March 31 [cited 2006 May 26]; Available from: http://www.cohealthcom.org/content/FinalCHCCitizenPetition.pdf.
Understand more by reading about Drug Identification, Prescription Drugs and Ventolin.
-Part I: A brief history of pharmaceutical marketing
-Part II: Pharmaceutical advertising from 1997 to the present day
-Part III: My perspective on pharmaceutical advertising and marketing
Read on for the second article in this series.
To learn about a resource that provides more information on this topic, please click here.
Pharmaceutical Advertising From 1997 – 2006: Nine Years Of Change & Controversy
In 1997 the Food and Drug Administration (FDA) relaxed restrictions on pharmaceutical advertising (see part I for more on this). This action quickly led to intensive direct-to-consumer drug (DTC) advertising by drug companies. During the first six months of 1998, drug makers spent $306 million on television commercials.[1] By the first half of 1999, spending on DTC advertising had increased to $905 million.[2]
The most memorable advertisements aired during the early part of the DTC era were those featuring celebrities like Bob Dole (erectile dysfunction, Viagra), Karl Malone (hair loss, Rogaine) and Joan Lunden (allergies, Claritin).[1]. Other categories of DTC advertisements produced during this period include:
-Educational advertisements: These types of commercials educate consumers on specific diseases like hair loss or erectile dysfunction but do not mention the name of a drug.[2]
-Reminder advertisements: These ads highlight the name of a drug, but do not feature information about its efficacy or safety profile.[2]
Debate Over The Impact Of DTC Advertising
Since 1997, critics and supporters of the pharmaceutical industry have been engaged in a vigorous debate about the impact of DTC advertising on the patient-healthcare provider relationship, prescribing patterns and spending on pharmaceuticals.
Supporters of DTC advertising assert:
-DTC advertisements educate patients: Healthcare consumers benefit from drug advertisements because they transmit important information on various illnesses, encourage them to visit a healthcare professional and reduce the stigma associated with certain conditions like schizophrenia, depression and erectile dysfunction.
-DTC advertisements improve the physician-patient relationship: Advertisements prompt consumers to partner with their physicians. According to pharmaceutical industry trade group, PhRMA: “Studies show DTC advertising brings patients into their doctor's office and starts important doctor-patient conversations about health that might otherwise not have happened.”[3]
Opponents of DTC advertising argue:
-DTC advertising does not educate patients: DTC advertisements often lack critical information about available treatments, prompt consumers to favor prescription medications over lifestyle modifications and do not provide enough information about drug success and failure rates.[2]
-Healthcare consumers do not have the training to understand drug commercials: Few consumers have the training and background to clearly understand a drug’s safety and efficacy.[2]
-DTC advertising increases inappropriate prescribing: DTC advertisements encourage patients to “pressure their physicians” to prescribe brand-name drugs or switch them to newer, more expensive medications.[2]
Concerns About Rising Drug Costs, Prescribing & Safety Prompt Changes In DTC Advertising
Debate about the pros and cons of drug advertising escalated between 1998 and 2003. Three drivers of the controversy included concerns about drug safety, increasing drug costs and the increased prescribing of brand name medications.
Drug Safety Concerns
Between 1997 and 2004, a number of heavily advertised drugs were withdrawn from the market. These medications included Redux (anti-obesity), Lotronex (irritable bowel syndrome [the FDA recently re-approved this drug for limited use]), Baycol (high cholesterol) and Vioxx (arthritis). These withdrawals prompted closer scrutiny of the FDA’s drug approval process and how advertising impacts prescribing patterns.
Drug Costs
From 1990 and 2003, spending on prescription medications increased from $40 billion to $193 billion.[4] Although prescription drug costs account for only 11 percent of the total US healthcare bill, spending on pharmaceuticals significantly increased between 1995 and 2003.[4] In response, public and private payers (insurance companies, government) began to search for ways to decrease the use of brand name medications.
Increased Prescribing Of Brand Name Drugs
In 2003, evidence emerged suggesting that DTC advertising was having a significant impact on sales of brand name pharmaceuticals.[5] A study conducted by researchers at Harvard and the Massachusetts Institute of Technology indicates that:
-DTC advertising resulted in an additional $2.6 billion in drug spending in 2000.[5]
-Drug makers’ advertising dollars were well-spent. Every $1 spent on DTC advertising resulted in $4.20 in sales.[5]
-DTC advertising is an important, but not a primary driver of pharmaceutical spending.[5]
The Pharmaceutical Industry Responds To Criticism
Concerns about drug safety, drug costs and increased prescribing fueled criticism of the pharmaceutical industry’s widespread use of DTC advertising. In response, drug makers announced in August 2005 that they had adopted voluntary guidelines governing DTC commercials.[6] Key provisions of the guidelines include:
-Companies will submit all DTC advertising to the FDA prior to release.[6]
-DTC advertisements will feature balanced commentary about the risks and benefits of medications.[6]
-Companies will spend an “appropriate amount of time” educating the public about a medication before engaging in DTC advertising.[6]
-Drug makers will no longer produce reminder advertisements because they do not transmit enough information about drug uses or side effects.[6]
Critics have asserted that the new industry DTC guidelines are inadequate. For example, in April 2006, the Prescription Access Litigation Project (PAL) awarded drug makers a “Bitter Pill” award for “pushing toothless ‘guiding principles’ on drug advertising. PAL asserts that “only a handful of the industry’s principles calls for any significant change in behavior.” In addition, PAL has characterized PhRMA’s principles as “extremely vague” because they “contain no measurable benchmarks to determine” whether an advertisement is in compliance.[7]
In addition, John Mack, author of the Pharma Marketing Blog, has reported that drug companies are still producing reminder ads despite the industry’s voluntary ban on the practice (click here and here for articles).
The Future Of DTC Advertising
Over the past several years the Food and Drug Administration has held a number of public hearings on the issue of DTC advertising. In addition, the FDA recently announced that it is planning to launch a study to determine whether side effect information included in print DTC advertisements is adequate.
In March 2006, the Coalition for Healthcare Communication (CHC) submitted a petition to the FDA about DTC advertising.[8] In the petition CHC requested that the agency:
-Create a standing committee to advise the agency on communications policy.
-Recognize that few consumers fully understand information about the risks and benefits of medications.
-Ask drug advertisers to include the following “core messages” in all DTC advertisements (drug makers would be free to amend the messages):
1. All prescription drugs, including the one being advertised, have potential benefits and potential risks.[8]
2. The advertised drug requires a prescription involving a professional weighing all of the potential benefits, risks and side effects for the individual patient.[8]
3. The patients should fully inform his/her healthcare professional about the patient’s medical history and about other medications the patient is using.[8]
-Request, but not require, advertising to reference a 800 number or Website where consumers can get more information about a drug’s benefits, risks and side effects.
Recent actions by the FDA, CHC, the pharmaceutical industry and others indicate that change is afoot in the DTC advertising arena. However, it is unclear what changes will occur and when they will happen.
If history is any guide, change will occur slowly and will be closely linked to the political and social environment faced by the pharmaceutical industry.
Next Up:My views on pharmaceutical marketing
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References:1. Anonymous, Dr. Celebrity, in Consumer Reports. May 1999. p. 8-9.
2. Wilkes, M.S., R.A. Bell, and R.L. Kravitz, Direct-To-Consumer Prescription Drug Advertising: Trends, Impact, and Implications. Health Affairs, 2000. 19(2): p. 110-128.
3. Anonymous. Direct To Consumer Advertising. 2006 [cited 2006 May 26]; Available from: http://www.phrma.org/direct_to_consumer_advertising/.
4. Anonymous, Prescription Drug Trends. November 2005, Kaiser Family Foundation: Menlo Park, California.
5. Anonymous, Impact Of Direct-to-Consumer Advertising On Prescription Drug Spending. June 2003, Kaiser Family Foundation: Menlo Park, California.
6. Anonymous, PhRMA Guiding Principles: Direct-to-Consumer Advertisements About Prescription Medicines. November 2005, PhRMA: Washington, DC.
7. Anonymous, The Fox Guarding The Henhouse Award: For Pushing Toothless "Guiding Principles" On Drug Advertising. April 26, 2006, Prescription Access Litigation Project: Boston, MA
8. Anonymous. Citizen Petition Requesting Promulgation Of An Amended Regulation For Prescription Drug Advertising. 2006 March 31 [cited 2006 May 26]; Available from: http://www.cohealthcom.org/content/FinalCHCCitizenPetition.pdf.
Understand more by reading about Drug Identification, Prescription Drugs and Ventolin.
I applaud your blog,i took zyprexa which was ineffective for my condition and gave me diabetes.
{Only 9 percent of adult Americans think the pharmaceutical industry can be trusted right around the same rating as big tobacco}
I have a victims support page against Eli Lilly for it's defective Zyprexa product causing my diabetes.--Daniel Haszard
Posted by: Daniel Haszard | May 29, 2006 10:50 AM | Permalink to Comment