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89–956 PDF 2004

S. HRG. 107–986

DIRECT TO CONSUMER ADVERTISING (DTC)

HEARING

BEFORE THE

SUBCOMMITTEE ON CONSUMER AFFAIRS, FOREIGN 

COMMERCE AND TOURISM

OF THE

COMMITTEE ON COMMERCE, 

SCIENCE, AND TRANSPORTATION 

UNITED STATES SENATE

ONE HUNDRED SEVENTH CONGRESS

FIRST SESSION

JULY 24, 2001

Printed for the use of the Committee on Commerce, Science, and Transportation

(

(II)

SENATE COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION

ONE HUNDRED SEVENTH CONGRESS

FIRST SESSION

ERNEST F. HOLLINGS, South Carolina, Chairman 

DANIEL K. INOUYE, Hawaii 

JOHN D. ROCKEFELLER IV, West Virginia 

JOHN F. KERRY, Massachusetts 

JOHN B. BREAUX, Louisiana 

BYRON L. DORGAN, North Dakota 

RON WYDEN, Oregon 

MAX CLELAND, Georgia 

BARBARA BOXER, California 

JOHN EDWARDS, North Carolina 

JEAN CARNAHAN, Missouri 

BILL NELSON, Florida 

JOHN MCCAIN, Arizona 

TED STEVENS, Alaska 

CONRAD BURNS, Montana 

TRENT LOTT, Mississippi 

KAY BAILEY HUTCHISON, Texas 

OLYMPIA J. SNOWE, Maine 

SAM BROWNBACK, Kansas 

GORDON SMITH, Oregon 

PETER G. FITZGERALD, Illinois 

JOHN ENSIGN, Nevada 

GEORGE ALLEN, Virginia 

KEVIN D. KAYES, Democratic Staff Director 

MOSES BOYD, Democratic Chief Counsel 

MARK BUSE, Republican Staff Director 

JEANNE BUMPUS, Republican General Counsel 

SUBCOMMITTEE ON CONSUMER AFFAIRS, FOREIGN COMMERCE AND 

TOURISM 

BYRON L. DORGAN, North Dakota, Chairman 

JOHN D. ROCKEFELLER IV, West Virginia 

RON WYDEN, Oregon 

BARBARA BOXER, California 

JOHN EDWARDS, North Carolina 

JEAN CARNAHAN, Missouri 

BILL NELSON, Florida 

PETER G. FITZGERALD, Illinois 

CONRAD BURNS, Montana 

SAM BROWNBACK, Kansas 

GORDON SMITH, Oregon 

JOHN ENSIGN, Nevada 

GEORGE ALLEN, Virginia 

(III)

C O N T E N T S 

Page 

Hearing held on July 24, 2001 ............................................................................... 1

Statement of Senator Dorgan ................................................................................. 1

Statement of Senator Fitzgerald ............................................................................ 48 

Statement of Senator Wyden .................................................................................. 2

WITNESSES

Calfee, John E., Ph.D., Resident Scholar, American Enterprise Institute ......... 20

Prepared statement .......................................................................................... 22

Chockley, Nancy, President, National Institute for Health Care Management 

Foundation ............................................................................................................ 16

Prepared statement .......................................................................................... 18

Cloutier, Mark, Policy Director, RxHealth Value ................................................. 49

Prepared statement .......................................................................................... 51

Dolinar, Richard, M.D., Endocrinologist, Endocrinologist Associates ................. 59

Prepared statement .......................................................................................... 61

Glover, Gregory J., M.D., J.D., on behalf of The Pharmaceutical Research 

and Manufacturers of America ........................................................................... 34

Prepared statement .......................................................................................... 36

Ostrove, Nancy, Ph.D., Deputy Director, Division of Drug Marketing, Advertising, and Communications, Food and Drug Administration .......................... 3

Prepared statement .......................................................................................... 5

Shaw, Michael S., M.D., Executive Director, EthicAd ........................................ 52

Prepared statement .......................................................................................... 54

Wolfe, Sidney M., M.D., Director, Public Citizen’s Health Research Group ....... 29

Prepared statement .......................................................................................... 32

(1)

DIRECT TO CONSUMER ADVERTISING (DTC) 

TUESDAY, JULY 24, 2001

U.S. SENATE, SUBCOMMITTEE ON CONSUMER AFFAIRS, FOREIGN COMMERCE

AND TOURISM, COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION, 

Washington, DC. 

The Subcommittee met, pursuant to notice, at 2:33 p.m. in room 

SR–253, Russell Senate Office Building, Hon. Byron Dorgan, Chairman of the Subcommittee, presiding. 

STATEMENT OF HON. BYRON L. DORGAN,

U.S. SENATOR FROM NORTH DAKOTA 

Senator DORGAN. The hearing will come to order. 

My name is Senator Dorgan. I am Chairman of the Subcommittee, and I will be joined by Senator Fitzgerald and I believe 

Senator Wyden and some others on the Subcommittee. They are 

delayed with other Senate business on the floor and in other committees. So we are going to begin without them and they will join 

us later. 

The hearing today is to discuss the issue of prescription drugs 

advertising directed to consumers, what is it about, what is its purpose, what does it do to the cost of prescription drugs in this country. We want to talk about that from a range of different perspectives. 

It is hard to turn on the television or open a newspaper or a 

magazine these days without seeing an advertisement for a prescription drug. I have a few of them here. You have the opportunity 

with this to vote no on your favorite all-star for the all-star game, 

the 2001 all-star game in Seattle. You get to vote for your favorite 

all-star and also are able to see that you ought to be considering 

taking Claritin. It is an advertisement for Claritin on the all-star 

ballot. 

This is a full-page ad from the Washington Post a month or so 

ago. It says ‘‘What is a better way to lower my blood sugar?’’ Then 

it advertises a medicine to do so, with a free 30-day supply coupon, 

despite the fact that, of course, you must go to a doctor and get a 

prescription. This actually offers a free 30-day supply coupon for 

this medicine. 

This is a Ladies Home Journal, a rather popular magazine. I just 

pulled out a few of the ads in this magazine. It is full of direct advertising to consumers. ‘‘Are you someone who is forgetful? Are you 

repeating questions? Are you having trouble finding words?’’ It 

might apply to all of us, Senator Wyden. If so, here is a prescripVerDate 0ct 09 2002 09:10 Mar 04, 2004 Jkt 089956 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 S:\WPSHR\GPO\DOCS\89956.TXT JACK PsN: JACKF
2

tion medicine you need to have. Go see your doctor, tell him what 

you want prescribed for you. 

What about estrogen loss? Here is what you ought to do, go tell 

your doctor about those symptoms. Rheumatoid arthritis, here is a 

way to solve it: go tell your doctor. 

Dan Reeves, who I saw last night on television in fact, is also 

here in this magazine. Dan Reeves says: ‘‘Lowering my high cholesterol became even more important than football.’’ So this Atlanta 

Falcons coach says to me last night on television, and to you and 

to the world in this ad, that we ought to be considering Zocor and 

we should talk the with our doctor about Zocor. 

Direct-to-consumer advertising for medicines that are prescribed 

by a doctor and available to those the advertising is directed toward only with the prescription of a doctor, what is its purpose, is 

the impact, good, bad? Does it increase the cost of prescription 

drugs? In the last couple of years we have had increases in the cost 

of prescription drugs, both because of utilization and also price inflation, of 18, 19 percent a year. Is some of that caused by directto-consumer advertising? Are there benefits to it? If so, what are 

they? 

We want to talk about all of these issues today, and we have invited a number of witnesses what I think will be able to give us 

some information about it from a number of different perspectives. 

I could go through a whole series of data that talks about increased prices for prescription drugs. I want to just make a point 

about this hearing. I happen to think that there are wonderful, lifesaving, breath-taking new prescription drugs in this country, good 

for those who develop them, good for those who market them. Part 

of it comes from public funding and investment in public-funded research. Part of it comes from privacy research. 

But life-saving drugs only save lives if you can afford them. 

Those who cannot afford a life-saving drug are not going to have 

their lives saved by that particular drug. So we want to talk about 

all of these issues today, focusing especially on the questions that 

have been raised increasingly by people: why am I the target of a 

substantial amount of advertising for prescription drugs that can 

only be achieved by me with a prescription by a doctor. Doctors increasingly tell us that they have patients coming to their office telling them what kind of medicine they want. That is a result of prescription drug direct advertising to consumers. 

This is a rather recent and new approach. Only in recent years 

have we had direct advertising to consumers of prescription drugs. 

So this hearing will explore the impact of that. 

Let me call on my colleague Senator Wyden from Oregon for a 

comment. 

STATEMENT OF HON. RON WYDEN,

U.S. SENATOR FROM OREGON 

Senator WYDEN. Thank you, Mr. Chairman, and thank you particularly for your leadership. You have been extremely involved in 

a whole host of prescription drug issues. You and I have been tackling these issues now for 20 years and it is a pleasure to be able 

to team up with you. This is exactly what the Consumer Affairs 

3

Subcommittee ought to be doing, is tackling these kinds of issues, 

and I commend you for your effort. 

I have been interested in these questions since my days as director of the Oregon Gray Panthers, and I think you are right, Mr. 

Chairman, there is no question that these ads have had an extraordinary impact on the Nation’s senior citizens in particular. I think 

it is important to look now at the ramifications of what these ads 

mean. 

Suffice it to say there are a whole host of issues that have to be 

addressed and a variety of competing interests that need to be balanced. I do not think that the American people want us in the 

United States Senate to be the arbiter of what information they get 

as long as that information is accurate. But at the same time, they 

do think that we ought to look at the health implications, for example, of massive amounts of advertising, as you have touched on. 

That is an area that really has not been examined. 

There are First Amendment rights in this country to communicate and the government’s policy has been that accurate information ought to be made available. But at the same time, one ought 

to take a longer view, a view that gets out beyond just looking at 

an individual prescription and look at the health consequences of 

massive amounts of advertising, and that has not been done. 

The other aspect of all of this is that even without the kind of 

advertising that has gotten most of the attention today in the magazines and television and other sources that have been touched on 

well by you, by the time many older people and consumers come 

to their doctor’s office they come today armed with an enormous 

amount of information from the Internet. So clearly as we look at 

the ways in which consumers get information, we are going to have 

to look at all of the various sources, and the Internet—we saw that 

yesterday in our e-health hearing at one of our other subcommittees—has had revolutionary impact in terms of people’s access to 

information and its consequences, both for their pocketbook and for 

their health. 

So I look forward to working with you and again appreciate your 

leadership. 

Senator DORGAN. Senator Wyden, thank you very much. 

Let me call our first witness. The first witness today will be Dr. 

Nancy Ostrove, Deputy Director of the FDA’s Division of Drug 

Marketing, Advertising, and Communication. If Nancy Ostrove 

would come forward I would appreciate it. We would ask those in 

the audience to please turn off cell phones. 

Dr. Ostrove, thank you very much. You are, I understand, going 

to discuss with us the rationale behind the FDA’s 1997 advertising 

guidelines. We appreciate your being here and hope that you will 

address in your testimony some of the issues that we raised. 

STATEMENT OF NANCY OSTROVE, PH.D., DEPUTY DIRECTOR, 

DIVISION OF DRUG MARKETING, ADVERTISING, AND

COMMUNICATIONS, FOOD AND DRUG ADMINISTRATION 

Dr. OSTROVE. I hope to. Good afternoon. I am Nancy Ostrove, 

Deputy Director of the Division of Drug Marketing, Advertising, 

and Communications at the FDA. We are the group that regulates 

prescription drug promotion. Thank you very much for inviting us 

4

to discuss our oversight of what we call DTC, the promotion of prescription drugs directly to consumers. 

FDA looks at DTC as kind of a double-edged sword. There is real 

potential value in getting patients to recognize the symptoms or 

the non-symptoms of undertreated conditions and getting them 

treated. Ads can help in this respect. There is also the potential for 

increasing the inappropriate use of medications for patients who do 

not need them or should be on other medications. 

The available research in this area is equivocal. You can find 

support for just about any position you want. My written testimony 

touches on some of the research we have conducted or examined. 

What it adds up to is that FDA is not aware of any evidence that 

DTC promotion is increasing inappropriate prescribing. On the 

other hand, there is evidence that DTC promotion may be encouraging patients to obtain additional information about their conditions and products and to talk to their health care providers about 

health issues that they have not raised before. 

There are three important things to understand about our authority. One is that the act and the regulations focus on the content, not the existence, of prescription drug promotion. Two is that 

the law does not make a distinction between targeted audiences. 

The law has never banned prescription drug advertisement to consumers. Up until the early 1980’s it just was not done. Three, the 

act specifically prohibits us from requiring pre-clearance of advertisements except under extraordinary circumstances. 

My written testimony also contains some details of the history of 

DTC promotion, but for today let us start in 1985 with FDA’s announcement that the regulations for overseeing promotion directed 

toward health care professionals also provide sufficient safeguards 

to protect consumers. After we made this announcement, we started seeing more and more print advertisements. 

But the current debate over DTC did not really heat up until we 

issued a draft guidance that specifically addressed broadcast. You 

see, the regulations had always allowed TV and radio ads. Any ad, 

print or broadcast, that makes a claim about a product also has to 

include the product’s most important risk information. Broadcast 

ads also have to do one of two other things. They either have to 

give every single risk from a product’s approved labeling or have 

a mechanism for ensuring that the audience can get the labeling. 

In the late 1980’s product sponsors felt they could not include 

every single risk in a TV ad and get the networks to air the ad—

they still believe that—and FDA was not sure that it was feasible 

to have a mechanism that would ensure that patients could get the 

product information required as an alternative to presenting every 

single risk. 

But by the mid-1990’s many changes had occurred in the marketplace, and in technology, and that included increasing acceptance 

of the Internet, increased availability of print ads, and common use 

of toll-free telephone numbers to get information. Given these 

changes, we came to believe that sponsors could in fact ensure that 

consumers could get the additional product information conveniently. 

So in 1997 we issued a draft that we finalized in 1999 of guidance that gave advice on how sponsors could meet the regulatory 

5

requirement for product information disclosure for broadcast ads by 

giving references to multiple sources of information; not just one 

source but many. At the time we issued the guidance we said that 

we would assess the impact on the public of it and of DTC promotion in general. 

We closely monitor DTC promotion and especially broadcast ads 

to ensure that the information that consumers need to understand 

any claims and the product’s risks is understandably presented. 

Even though the sponsors do not have to submit their promotional 

materials until the time they appear in public, most sponsors voluntarily submit the broadcast ads to us for review and comment. 

Because of this voluntary cooperation, we believe that we review 

most product claim broadcast ads before they appear, although we 

do not know in truth whether we review most reminder and helpseeking ads. 

To sum up, at this time we are not aware of any evidence that 

DTC promotion is harming the public health. However, we continue 

to examine the issue. We intend to continue closely scrutinizing 

DTC promotion, working with industry to ensure that broadcast 

ads comply with regulatory requirements, and taking timely enforcement action when it is appropriate. 

Thank you for your patience. I will be happy to answer any questions. 

[The prepared statement of Dr. Ostrove follows:]

PREPARED STATEMENT OF NANCY M. OSTROVE, PH.D., DEPUTY DIRECTOR, DIVISION

OF DRUG MARKETING, ADVERTISING AND COMMUNICATIONS, FOOD AND DRUG

ADMINISTRATION

Introduction 

Mr. Chairman and Members of the Subcommittee, I am Nancy Ostrove, Deputy 

Director of the Division of Drug Marketing, Advertising, and Communications 

(DDMAC) of the Center for Drug Evaluation and Research (CDER), Food and Drug 

Administration (FDA or the Agency). DDMAC regulates prescription drug promotion 

and helps ensure that FDA-regulated industry complies with the applicable provisions of the Federal Food, Drug, and Cosmetic (FD&C) Act and implementing regulations. 

I am here today to talk about promotion that manufacturers of prescription drugs 

(product sponsors) direct toward consumers and patients. This is referred to as ‘‘direct-to-consumer’’ promotion or DTC. Such promotion uses multiple avenues for 

reaching lay audiences, including, but not limited to: television and radio advertisements, print advertisements, telephone advertisements, direct mail, videotapes and 

brochures. 

It is important to understand the scope of FDA’s authority in this area. It is also 

important to understand the different types of advertisements that are directed toward consumer audiences. 

Statutory and Regulatory Authority 

The FD&C Act and regulations do not distinguish between professional and consumer audiences. Section 502(n) of the FD&C Act specifies that prescription drug 

advertisements must contain ‘‘a true statement of... information in brief summary relating to side effects, contraindications, and effectiveness’’ of the advertised 

product. The implementing regulations (Title 21, Code of Federal Regulations [CFR] 

Section 202.1), originally issued in the 1960s, specify, among other things, that prescription drug advertisements cannot be false or misleading, cannot omit material 

facts, and must present a fair balance between effectiveness and risk information. 

Further, for print advertisements, the regulations specify that every risk addressed 

in the product’s approved labeling must also be disclosed in the advertisements. 

For broadcast advertisements, however, the regulations require ads to disclose the 

most significant risks that appear in the labeling. The regulations further require 

that the advertisement either contain a summary of ‘‘all necessary information reVerDate 0ct 09 2002 09:10 Mar 04, 2004 Jkt 089956 PO 00000 Frm 00009 Fmt 6633 Sfmt 6621 S:\WPSHR\GPO\DOCS\89956.TXT JACK PsN: JACKF
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lated to side effects and contraindications’’ or provide convenient access to the product’s FDA-approved labeling and the risk information it contains. 

Finally, the FD&C Act specifically prohibits FDA from requiring prior approval 

of prescription drug advertisements, except under extraordinary circumstances. 

Also, the advertising provisions of the FD&C Act do not address the issue of drug 

product cost. 

Types of Advertisements 

There are three different types of ads that product sponsors use to communicate 

with consumers: ‘‘product-claim’’ advertisements, ‘‘help-seeking’’ advertisements, and 

‘‘reminder’’ advertisements. Advertisements that include both a product’s name and 

its use, or that make any claims or representations about a prescription drug, are 

known as ‘‘product-claim’’ advertisements. These ads must include a ‘‘fair balance’’ 

of risks and benefits. In addition, they must provide all risk information included 

in the product’s FDA-approved labeling or, for broadcast advertisements, provide 

convenient access to this information. In our regulations, the phrase ‘‘adequate provision’’ is used to identify the convenient access option. Unlike the ‘‘product claim’’ 

ads, ‘‘help-seeking’’ advertisements and ‘‘reminder’’ ads need not include any risk information. 

A ‘‘help-seeking’’ advertisement discusses a disease or condition and advises the 

audience to ‘‘see your doctor’’ for possible treatments. Because no drug product is 

mentioned or implied, this type of ad is not considered to be a drug ad and FDA 

does not regulate it. 

The second type of advertisement that does not need to include risk information 

is called a ‘‘reminder’’ advertisement. The regulations specifically exempt this type 

of ad from the risk disclosure requirements. Like ‘‘help-seeking’’ ads, the ‘‘reminder’’ 

ad is limited, although in a different way from ‘‘help-seeking’’ ads. ‘‘Reminder’’ ads 

are allowed to disclose the name of the product and certain specific descriptive (e.g., 

dosage form) or cost information, but they are not allowed to give the product’s indication or dosage recommendation, or to make any claims or representations about 

the product. The exemption for ‘‘reminder’’ ads was included in FDA’s regulations 

for promotions directed toward health care professionals, who presumably knew 

both the name of a product and its use. ‘‘Reminder’’ ads serve to remind health care 

professionals of a product’s availability. They specifically are not allowed for products with serious warnings (called ‘‘black box’’ warnings) in their labeling. 

Evolution of DTC Promotion 

Prior to the early 1980’s, prescription products were not promoted directly to consumers and patients. Instead, product sponsors often produced materials that were 

given to health care professionals to pass on to patients if they thought this would 

be appropriate for particular patients. In the early 1980’s, a few companies started 

advertising products directly to patient audiences (specifically, older people concerned about pneumonia and people taking prescription ibuprofen to treat arthritis 

pain). As a result of questions and concerns about promotion directed toward nonhealth care professionals, in 1983 FDA requested that sponsors suspend DTC ads 

to give the Agency time to study the issue. 

The industry complied with this request, and during the ensuing moratorium FDA 

conducted research and sponsored a series of public meetings. In 1984, the University of Illinois and Stanford Research Institute jointly sponsored a symposium to 

discuss consumer-directed prescription drug advertising from a broad research and 

policy perspective. On September 9, 1985, FDA withdrew the moratorium in a Federal Register (FR) Notice (50 FR 36677), which stated that the ‘‘current regulations 

governing prescription drug advertising provide sufficient safeguards to protect consumers.’’ 

During the early 1990’s, product sponsors increasingly used consumer magazines 

to advertise their products. These ads typically included a promotional message together with the ‘‘brief summary’’ of adverse effects, similar to that used in physician 

directed ads. The ‘‘brief summary’’ statement, which frequently appears in small 

print, is not very consumer friendly. In the 1990’s, product sponsors also started 

using television advertisements in a limited fashion. Television advertisements were 

limited because FDA and industry did not believe that it was feasible to disseminate 

the product’s approved labeling in connection with the ad. The extensive disclosure 

needed to fulfill this requirement essentially precluded the airing of such ads. For 

example, one way to satisfy this requirement would be to scroll the ‘‘brief summary,’’ 

which would take a minute or more even at a barely readable scrolling rate. The 

industry, therefore, resorted to television ads that did not require risk disclosure. 

By the mid-1990’s, product sponsors started placing ‘‘reminder’’ ads on television. 

Because these ads only mentioned the name of the drug, however, they were exVerDate 0ct 09 2002 09:10 Mar 04, 2004 Jkt 089956 PO 00000 Frm 00010 Fmt 6633 Sfmt 6621 S:\WPSHR\GPO\DOCS\89956.TXT JACK PsN: JACKF
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tremely confusing to consumers, who, unlike health care professionals, were not 

knowledgeable about the name and the use for these products. 

In response to increasing consumer demand for information, FDA began to consider whether broadcast advertisements could be constructed to ensure access to 

product labeling, the only alternative to including all of an advertised product’s risk 

information. FDA considered suggestions about providing access to multiple sources 

of product labeling as a means of satisfying the requirement that consumers have 

convenient access to FDA-approved labeling when manufacturers broadcast a ‘‘product-claim’’ advertisement. 

In August 1997, FDA issued a draft guidance entitled: ‘‘Guidance for Industry: 

Consumer-Directed Broadcast Advertisements’’ that clarified the Agency’s interpretation of the existing regulations. The Guidance described an approach for ensuring 

that audiences exposed to prescription drug advertisements on television and radio 

have convenient access to the advertised product’s approved labeling. The proposed 

mechanism consisted of reference in the broadcast advertisement to four sources of 

labeling information: a toll-free telephone number, a website address, a concurrently 

running print advertisement, and health care professionals. Following a comment 

period, and detailed review and consideration of the comments, FDA made only 

minor changes to the draft guidance, and issued it in final form in August 1999 (64 

FR 43197, also found at www.fda.gov/cder/guidance/1804fnl.htm). In announcing 

the final guidance, FDA advised that the Agency intended to evaluate the impact 

of the guidance, and of DTC promotion in general, on the public health, within two 

years of finalizing the guidance. 

Stakeholder Perspectives 

A number of stakeholder groups have expressed strong interest in DTC promotion. Those that are positive about DTC promotion assert that this practice will:

• Improve consumers’ knowledge of drugs and drug availability.

• Encourage consumers to talk with their health care providers about their health 

problems.

• Allow consumers and patients to have a greater role in decisions about their 

own health care that they say they desire.

• Improve communication between patients and their physicians.

• Improve appropriate prescribing by allowing physicians to get more information 

about their patients from their patients.

• Lower the cost of prescription drugs.

Not all stakeholders are positive about DTC promotion. Opponents assert that 

DTC advertising will:

• Confuse consumers about drugs.

• Make it appear that prescription drugs are safer than they are.

• Interfere with the patient-physician relationship because patients will insist 

that their physicians prescribe the advertised products.

• Increase inappropriate prescribing.

• Raise the cost of prescription drugs.

Finally, there is a group of stakeholders with a less polarized view of DTC promotion. They believe that such promotion has both benefits and risks, but that it 

should be strictly regulated, and that, preferably, all DTC materials should be ‘‘preapproved’’ by FDA. They often assert that there are potential public health benefits 

associated with patients visiting health care providers about untreated diseases or 

conditions, particularly those that appear to be under treated in the population and 

that are responsible for long-term harm (for example, high cholesterol, high blood 

pressure, diabetes and osteoporosis). 

Current Situation 

FDA recognizes that drug promotion raises certain issues for health care professionals and different issues for consumers, in light of differences in medical and 

pharmaceutical expertise. For this reason, FDA has monitored DTC promotion, and 

especially broadcast promotion, very closely to help ensure that adequate contextual 

and risk information, presented in understandable language, is included to fulfill 

the requirement for fair balance and to help the consumer accurately assess promotional claims and presentations. 

Product sponsors of prescription advertisements are required to submit their promotional materials to FDA around the time these materials are initially put into 

public use. FDA receives approximately 32,000 of these submissions per year, for 

8

all types of promotion, including promotion to health care professionals. Product 

sponsors also can submit draft materials to FDA for review and comment prior to 

using them. DDMAC has made it a high priority to provide comments to product 

sponsors on voluntarily submitted draft broadcast advertisements within a reasonable time. In fact, although it is not required, a majority of product sponsors voluntarily submit their broadcast advertisements to DDMAC for prior review and comment at some point as advertising materials are being produced. Product sponsors 

may ask for review and comment at the very initial stages of production (by supplying the words they intend to use along with rough drawings of their proposed 

graphics), or at the later stages of final videotape production. DDMAC only gives 

final comments on final videotapes because inappropriate presentations can turn an 

otherwise acceptable advertisement into an unacceptable one (for example, by pacing the risk disclosure too rapidly, including multiple distracting visual images during the risk disclosure, or including images that overstate the efficacy of the product 

beyond what is supported by substantial clinical evidence). 

Since January 1997, sponsors of about 65 prescription drugs have aired ‘‘productclaim’’ advertisements on television or radio. A small number of prescription biological products also have been advertised. Nine products fall into the allergy category 

(nasal and ocular anti-histamines, and nasally administered corticosteroids), while 

another eight products treat skin or hair-related problems (acne, cold sores, rosacea, 

baldness, unwanted facial hair, nail fungus). More importantly, ten products are designed to treat diseases that are believed to be under treated, including high cholesterol and heart disease, and mental health problems like depression. Five products 

to treat or prevent osteoporosis or menopausal symptoms have been advertised. 

Other advertised products are approved to treat such conditions or diseases as asthma, Alzheimer’s Disease, arthritis, chronic obstructive pulmonary disease, diabetes, 

insomnia, migraine, obesity, overactive bladder, serious heartburn, smoking cessation, and sexually transmitted diseases. Most of these are serious problems where 

patients are in the best position to recognize symptoms. 

It is important to note that DDMAC does not know how many different advertisements have aired in broadcast media for these 65 drugs. There have been multiple 

campaigns for a number of the products, including the allergy and high cholesterol 

products. In addition, many campaigns include different length ‘‘product-claim’’ commercials, as well as multiple short ‘‘reminder’’ commercials. DDMAC does not track 

the number of different broadcast advertisements that are submitted. Further, because ‘‘help-seeking’’ advertisements, if done properly, are not considered to be drug 

ads, most product sponsors do not send them to DDMAC under the submission requirements for prescription drug promotional materials. Therefore, we have no 

measure of how many of these have been in the public domain. 

Enforcement Related to DTC Promotion 

Since 1997 FDA has issued:

• 30 ‘‘untitled’’ (or ‘‘Notice of Violation’’) letters on ‘‘product-claim’’ broadcast advertisements. Such letters request that the violative promotion be stopped immediately. Product sponsors virtually always comply immediately with this request.

• 3 ‘‘warning letters’’ on broadcast advertisements. This is a higher-level enforcement action, and requests that a remedial campaign be conducted by the company to correct the impressions left by the ad.

• 12 ‘‘untitled’’ letters on purported ‘‘reminder’’ broadcast advertisements.

• 3 ‘‘untitled’’ letters on purported ‘‘help-seeking’’ broadcast advertisements.

Most of the violations cited were because the ad overstated or guaranteed the 

product’s efficacy, expanded the indication or the patient population approved for 

treatment, or minimized the risks of the product, through either inadequate presentation or omission of information. 

Since January 1997, the Agency has issued:

• 44 ‘‘untitled’’ letters that addressed DTC print advertisements or other promotional materials, including purported ‘‘reminder’’ and ‘‘help-seeking’’ materials.

• 1 ‘‘warning letter’’ for a specific DTC print advertisement, and 1 ‘‘warning letter’’ that included a DTC print advertisement as part of an overall misleading 

campaign.

Generally, the violations involving print ads making ‘‘product-claim’’ ads were 

similar to those cited above. Nearly all ‘‘reminder’’ ad violations were the result of 

representations about the product that triggered the need for full disclosure of beneVerDate 0ct 09 2002 09:10 Mar 04, 2004 Jkt 089956 PO 00000 Frm 00012 Fmt 6633 Sfmt 6621 S:\WPSHR\GPO\DOCS\89956.TXT JACK PsN: JACKF
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fits and risks. ‘‘Help-seeking’’ ad violations were due to a particular product being 

implied in the message. As noted above, however, FDA cannot determine how many 

specific advertisements serve as the denominator for assessing how many have resulted in enforcement action compared with those that have not. 

Research on DTC Promotion 

A number of groups have been conducting research on DTC promotion. Much publicly available research consists of surveys utilizing samples of consumers or patients to examine attitudes about DTC promotion and self-reported behaviors related to DTC promotion in the context of patient-physician visits and use of prescription drugs. The groups sponsoring this research include: Prevention magazine, 

TIME Inc., the National Consumers League, and American Association of Retired 

Persons. Partial results of a few surveys of physicians have been made publicly 

available. FDA remains concerned, however, about the representativeness of the 

physician survey sample. 

In 1999, FDA sponsored a telephone survey that focused on a national probability 

sample of patients who had seen a physician for a problem of their own within the 

three months prior to the survey. The results of this patient survey suggested that 

patients are seeking additional information as a result of DTC promotions that they 

have seen. This information was sought primarily from health care professionals, 

and secondarily from reference texts and family. Generally, between 10 and 20 percent of respondents said that they sought additional information from the sources 

referenced in broadcast advertisements—toll-free telephone numbers, websites, and 

print advertisements. A major result, and one that is consistent with results of Prevention’s national surveys, is that a significant minority of respondents said that a 

DTC ad has caused them to ask a doctor about a medical condition or illness they 

had not previously discussed. This could represent a significant and positive public 

health benefit, particularly if these patients are talking about undiagnosed heart 

disease or other serious disorders. 

The survey results also suggest that DTC advertisements are not significantly increasing visits to a physician’s office. For the most part, patients said that they had 

recently visited their doctors for the traditional reasons: because it was time for a 

check-up (53 percent), because they were feeling ill (42 percent), or because they had 

a sudden symptom or illness (41 percent). Only two percent said that they had visited their doctor because of something they had seen or heard. Of those patients 

who had a conversation with their doctor about a prescription drug: 81 percent said 

that their doctor had welcomed the question, 79 percent said that their doctor discussed the drug with them, and 71 percent said that their doctor had reacted as 

though the conversation was an ordinary part of the visit. Only four percent said 

that their doctor seemed upset or angry when the patient asked about a prescription 

drug. According to the patients, therefore, physicians seem to be reacting well to 

questions about prescription drugs. Finally, only 50 percent of these patients said 

that their doctor gave them the medication discussed. Thirty-two percent said that 

the doctor recommended a different drug. Twenty-nine percent of the respondents 

indicated that behavioral or lifestyle changes were suggested by the doctor. It therefore appears, from FDA’s patient survey, that physicians are comfortable denying 

prescriptions when the prescription would not be right for the patient. 

A small number of patients who were denied prescriptions said that their doctors 

told them why. Reasons included: the drug was not right for the patient; the doctor 

wanted the patient to take a different drug; the drug had side effects of which the 

patient was unaware; the patient did not have the condition treated by the drug; 

the patient did not need a prescription drug; the patient could use a non-prescription drug; and there was a less expensive drug available. 

Patients also were asked about their attitudes concerning prescription drug advertisements. Their answers indicated somewhat mixed feelings. Eighty-six percent 

agreed that these ads help make them aware of new drugs, 70 percent agreed that 

the ads give enough information to help the patient decide if they should discuss 

the product with a doctor, and 62 percent agreed that ads help the patients have 

better discussions with their doctors about their health. Only 24 percent agreed that 

DTC ads make it seem like a doctor is not needed to decide whether a drug is right 

for someone. In contrast, 58 percent agreed that DTC ads make drugs seem better 

than they really are, 59 percent agreed that ads do not give enough information 

about the advertised product’s risks and negative effects, and 49 percent agreed that 

these ads do not give enough information about the benefits and positive effects of 

the advertised product. 

10

Next Steps 

In issuing both the draft and the final broadcast advertisement guidance, FDA 

stated its intent to assess the impact of the guidance, and of DTC promotion in general, on the public health. FDA is also aware that privately funded research is being 

planned to examine the effects of DTC promotion. At present, FDA is not aware of 

any evidence that the risks of DTC promotion outweigh its benefits. FDA intends 

to carefully examine all available data, to determine whether the public health is 

adequately protected. 

This concludes my prepared remarks. I will be glad to answer any questions you 

may have on this topic.

Senator DORGAN. Dr. Ostrove, thank you very much. 

You indicated near the start of your testimony that the FDA is 

not aware of any information that would suggest inappropriate prescribing as a result of direct-to-consumer advertising. The fact that 

you are not aware of information, does that suggest no information 

exists or no studies have been done, or is it just that you are not 

aware of them? 

Dr. OSTROVE. Well, it does not suggest that no information exists. Certainly there might be some. We have tried to make it clear 

to the public and we have asked in many circumstances and in 

many venues for any information that would be useful to our assessment of the impact of DTC promotion. People have come forward. There have been studies that have been done looking at patients. There have been some studies of physicians. The representativeness of the samples is a little questionable. We recently participated in a design conference that HHS sponsored to try to encourage research into this area. 

So it is not that it necessarily is not out there, but it certainly 

has not been brought to our awareness. 

Senator DORGAN. One of the next witnesses, Nancy Chockley, 

President of the National Institute for Health Care Management 

Research and Educational Foundation, says in her testimony: ‘‘In 

an analysis we will be releasing soon, we have found that the 50 

drugs most heavily advertised to consumers in 2000 had aggregate 

sales increases last year of 32 percent compared to 14 percent for 

all other drugs.’’

Can you give me an analysis of that? That follows a comment she 

makes in her testimony: ‘‘Direct-to-consumer advertising appears to 

be inducing significant new demand for prescription drugs and 

thus contributing to the recent sharp rise in pharmaceutical spending.’’ Do you agree or disagree with that conclusion? 

Dr. OSTROVE. I think it is extremely difficult to tease out the impact of direct-to-consumer advertising, given the other factors that 

are involved. In addition to DTC advertising, the manufacturers 

are out there advertising to health care professionals, and in many 

cases when they have a DTC campaign, and if they are smart, the 

first thing that they do is they let the health care professional 

know about that campaign, because they do not want the prescriber to be blind-sided. 

So at the same time you are having a campaign to consumers, 

which by the way is also seen by health care professionals, there 

is also a separate campaign that is going to the health care professionals. In addition to that, of course the manufacturers put their 

money where they think the market is. So they are going to spend 

more where they think that there is a market for something. 

11

So this is one of the issues that was raised in the design conference, how do you tease out the impact of DTC without doing a 

controlled study, which we are not aware that anyone has done and 

would be a fairly significant undertaking. 

The other piece of that is that even if there is an influence of 

DTC on utilization, our concern is, our question is, is that appropriate? Are people going in and appropriately talking to their doctors about conditions that are important for them and that in fact 

they have, and are they getting the appropriate treatment, or is it 

increasing inappropriate treatment? That is what we have no data 

on. I do not think that the data that are going to be a part of this 

report are likely to address that. 

Senator DORGAN. That is an important question, I think, and if 

we have no data on it should we aspire to get data and, if so, how? 

Does the FDA propose that we aspire to get such data? 

Dr. OSTROVE. Well, the FDA has in fact requested a number of 

times to the industry and to other interested stakeholders that research be done to look at this. The agency itself, of course, has—

the agency itself is doing what research it feels it can do. We recently in 1999, we did a survey of patients, people who had seen 

their doctors in the last 3 months, and we are hoping to do another 

one. We are also hoping to do a survey of physicians and looking 

at their experiences with DTC and how it has influenced their 

practices. 

So we are doing what we can in this area, and we have encouraged the private sector to do the same. We have not seen anything 

as yet. We are aware that at least some manufacturers are interested in doing this, but we really do not know where that is. 

Senator DORGAN. But I am wondering whether it should be the 

manufacturers that would do such a study. They obviously have an 

interest in the outcome of the study. Should there not be some 

independent party doing a study? Should the FDA be recommending some mechanism in government to have a study completed? 

Dr. OSTROVE. Well, certainly HHS is interested in this whole 

area, in the cost issues as well as in FDA concerns, which is the 

public health issues and the protection of the public health. It is 

difficult for me to answer whether this should be done. Certainly 

I think on a theoretical basis, yes, it should be done. Then it is a 

matter of who is going to do it, how is it going to get done. 

As I said, one of the reasons for kind of hoping that the manufacturers would do it is the relative—the resources that they have. 

Senator DORGAN. But you would agree that manufacturers have 

a vested interest in the outcome? 

Dr. OSTROVE. Yes. 

Senator DORGAN. It seems to me not logical that you would have 

someone do a study who has an interest in the outcome of the 

study. 

Dr. OSTROVE. It would be best for an uninterested party, a party 

that does not have a vested interest, to do this. 

Senator DORGAN. Senator Wyden. 

Senator WYDEN. Thank you, Mr. Chairman. 

Let me start, if I could, Dr. Ostrove. Chris Castle, who I met 

when I was teaching gerontology in Oregon, recently said—she is 

12

now chairman of geriatrics at Mount Sinai in New York. She said 

recently: ‘‘Direct to consumer advertising has made a huge impact 

on sales of medications which are not always the best medications 

for people to take.’’

Would you by and large agree with that statement of Dr. Castle’s? 

Dr. OSTROVE. That is a very general statement, a huge impact 

on medications that are not always the best. I am not sure exactly 

what data she is basing that statement on, so it would be difficult. 

Senator WYDEN. In your opinion, are there any ramifications for 

the use of generic drugs in this whole focus on direct-to-consumer 

advertising? As we know, in many instances, not always but in 

many instances, the generic drug is cheaper. It sure looks like the 

bulk of the advertising direct-to-consumer is of the more expensive 

brand names. I would be interested in your knowing whether you 

think there are any ramifications in this trend for the use of 

generics? 

Dr. OSTROVE. I think certainly there are potential ramifications 

for the use of generics. The innovator manufacturers clearly have 

greater resources, monetary resources to advertise their products 

than the generic manufacturers do. 

What is kind of interesting is, at least from some of the data that 

we have from our study, is that when patients went in to see a doctor and talked to the doctor about a particular prescription product, 

in only 50 percent of the cases did they actually get the product 

that they had discussed. In a number of cases what ended up happening is that they got another product. 

My suspicion is that—and we do not have the actual details of 

this, but in many of those cases it may have been case where the 

gatekeeper prescriber said: You know, I am glad you came in to 

talk to me about this condition; you do have this condition, but you 

do not need that drug, it is more expensive, or it is not what you 

need; here is one that has been out on the market a long time, it 

has got a better safety profile; why do you not take it. 

So certainly in some cases that is what I believe happened. We 

also know that in that certain percentage of the cases the doctor 

told the patient that what they needed was behavioral and lifestyle 

changes. 

So the gatekeeper—the physician or the prescriber, excuse me, is 

acting as a gatekeeper in these particular situations. So it is hard 

again to kind of tease out how much of that is going to be influencing the use of generics. Hopefully, physicians will be using this, 

prescribers will be using this opportunity as kind of a learning opportunity, a point to communicate with the patient. 

Senator WYDEN. This is an area I am going to follow up with you 

and others in government, because I think Senator Dorgan is absolutely right. What we hear about from our constituents, older people and others, is the affordability question. I am very concerned 

about the ramifications of direct-to-consumer advertising for access 

to generics. If you just look at the ads that Senator Dorgan held 

up, these are blockbuster brand name drugs, they are exciting 

products. You do not seem to see the same kind of focus on marketing this way on generics. I think we need to do follow-up work 

in this area. 

13

Dr. OSTROVE. If I can add one more thing, we have also looked 

at the products that are being advertised most heavily to consumers and in many cases for those products they are breakthroughs and there are no generics. I am not saying that is true 

in all the cases, but in many of the cases there are not generics 

available. 

Senator WYDEN. It is a fair comment, and one of the things I 

think we ought to look at is the evolution of how this drug comes 

into market and what happens when it goes off to a patent. 

Dr. OSTROVE. Absolutely. 

Senator WYDEN. Let me ask you just a couple of other questions. 

I appreciate Senator Dorgan’s indulgence. A number of physician 

groups across the country have been urging resolutions through 

their state societies to in effect block this whole trend. What their 

argument largely appears to be is that they feel the this trend in 

advertising is interfering with the doctor-patient relationship, that 

the pharmaceutical industry in some way is intruding into the doctor-patient relationship. 

Do you think there is any validity to that argument? 

Dr. OSTROVE. We have heard a lot of anecdotal reports from physicians that they feel that DTC advertising is interfering with the 

doctor-patient relationship. We have also heard anecdotal reports 

from other physicians that it is improving the relationship they 

have with their patients, because the patients are coming in, they 

are more informed, they are more willing to take their medication, 

in other words their adherence is better. 

Our data—in our survey we asked patients how their doctor reacted to the discussion of the prescription drug when they had 

these discussions. The majority of them, in the high 70’s, low 80’s, 

said that the doctor was very good about it. Very few of them, only 

4 percent I think of the patients, said that the doctor seemed to be 

disturbed by their interaction. 

So it would appear that the physicians are doing a pretty good 

job on the whole of dealing with patients. The patients do not perceive any problems. But this is an area that we feel needs more research and it is one of the reasons why we would like to do a survey of a representative sample of physicians, to get it from their 

perspective. 

Senator WYDEN. That would be helpful as well. 

The last question I wanted to ask: Do you see any relationship 

between direct-to-consumer advertising and this trend toward coupons and guarantee programs? The concern is I think you all have 

had discussed with you is that they use these coupon programs and 

these discount programs to sort of bring people in, but they bring 

them in on the most expensive drugs again, and that this has been 

tied in some way to the direct-to-consumer advertising trend. 

What, if anything, has the agency picked up on that? 

Dr. OSTROVE. Well, it is a marketing technique. 

Senator WYDEN. Are you troubled by this? Are you concerned 

about what I have described? 

Dr. OSTROVE. We have looked at the whole area and we are troubled by some—more troubled by some things than others. 

Senator WYDEN. Tell me what part of this troubles you, then? 

14

Dr. OSTROVE. Anything that gets into the cost issue, where apparently a product is being touted for its cost benefits as opposed 

to its clinical benefits, is troubling. But in terms of our authority, 

these coupons, these offers, unless they are false or misleading, 

lacking in fair balance in some way, or involving an omission of 

material fact, there is not a good argument for us to object to them 

on the basis of the regulations. 

Senator WYDEN. I understand that. My time is up, but I think 

it goes again to the point that I was making, that if they are accurate so be it, but I am troubled by the fact that you give people, 

you give senior citizens discounts on something, so in effect you get 

them tied, you get them bonded to a certain kind of pharmaceutical 

at a very expensive price. Then the coupon program is over and 

they have developed an affinity for that product and it is sort of 

cemented by direct-to-consumer advertising. 

I just want us to start looking at what is really going on in the 

marketplace, and that is why I think what Senator Dorgan is doing 

is important and I appreciate it. 

Senator DORGAN. Thank you, Senator Wyden. 

Dr. OSTROVE. One other piece with regard to that. I hope I am 

not interrupting. 

Senator DORGAN. That is fine. 

Dr. OSTROVE. But there is a value or at least there appears to 

be some data that indicate that direct-to-consumer advertising actually makes it more likely that people will take their medications, 

will continue on their regimen, will fill their prescriptions. Given 

that noncompliance is such a big problem in taking medications, 

there is that other side of it, that if people in fact do become committed to their medications perhaps they will use them more appropriately and not stop taking them, or at least go to their doctors 

if they do. 

Senator DORGAN. Will you submit that information for the record 

that you just cited? Is there a source for that? 

Dr. OSTROVE. A survey that Prevention magazine has done. I believe that they asked those kinds of questions about compliance in 

their 1998 and 1999 surveys. 

Senator DORGAN. Dr. Ostrove, how large is the Division of Drug 

Marketing, Advertising, and Communication? 

Dr. OSTROVE. We have 32. 

Senator DORGAN. You seem to, based on the questions I have 

asked and Senator Wyden has asked, seem to come down on the 

side of suggesting this is really a good thing. You have used a little 

cautionary language, but by and large as I interpret what you are 

saying, on balance you think direct-to-consumer advertising is 

probably fine, probably helps. Is that a good way to summarize 

what you just told us? 

Dr. OSTROVE. Well, I am not sure—it is the double-edged sword 

metaphor. I guess we believe that there are good aspects to it, but 

we believe that there are potentially not so good aspects to it as 

well. So we are hoping for a balance. 

Senator DORGAN. When I started today I held up this, which is 

a Washington Post full page ad, ‘‘What is the better way to lower 

my blood sugar,’’ and then it provides a medicine, name of a medicine, and a free 30-day supply coupon. If you read this in all the 

15

smaller type, you understand that you have got to get a prescription from a doctor. 

But someone who is not a careful reader would just see, I have 

got a high blood sugar level, I get a free 30-day supply. Is this the 

sort of thing you look at in terms of advertising? You have how 

many people looking at that at your agency? 

Dr. OSTROVE. We have 14 reviewers who do primary reviews and 

one of them is devoted full-time to direct-to-consumer advertising. 

Yes, we look at the overall presentation. 

Senator DORGAN. 14. The consumer advertising has increased 

very substantially, as you know, in recent years, the rampup since 

1997. Have the resources that you employ to respond to these increased at all? 

Dr. OSTROVE. Well, the person who is devoted to direct-to-consumer is a relatively new—yes, we have kind of moved resources 

around. We prioritize our workload as a function of what we think 

is important out in the marketplace, so we respond to changes in 

the marketplace. 

Senator DORGAN. When you said a person, there is more than 

just one person? 

Dr. OSTROVE. Oh, absolutely. All the primary reviewers—the primary reviewers work on different classes of drugs, and depending 

on the class they will work more or less on DTC advertisement. 

Some classes have very little DTC, other classes have a lot. 

Senator DORGAN. My understanding is in 1998 the FDA issued 

158 warnings and untitled letters regarding promotional materials, 

drug promotional materials, both for direct-to-consumer ads and 

detailing. In 1999 it went from 158 down to 107, in 2000 it went 

down to 79. What is this decrease attributed to? Is there less enforcement or is there better compliance? 

Dr. OSTROVE. I think there are probably a lot of factors that go 

into that. We are in the process of looking at how best to structure 

things so that we can use our resources most effectively. I am not 

really sure how to attribute that decrease. We have had some turnover. That may be part of it. We are spending a lot of time on kind 

of advisory activities, and the hope of that is to get the information, 

to get the promotional materials, before they reach the public. So 

again on a voluntary basis, manufacturers can submit their promotional materials and we give advice and comment. 

So some of the change may be due to that. Some of it may be 

due to more people working on educational——

Senator DORGAN. Would you submit for the record an analysis of 

that after you have had a chance to visit with your agency? 

Dr. OSTROVE. Happy to do that. 

Senator DORGAN. Again, one would expect as direct-to-consumer 

advertising dramatically increases, and it really has—I think all of 

us understand that—one would expect FDA warnings not to drop 

by 50 percent, but would expect them to probably keep pace with 

the increase in promotional advertising, because there is a lot of 

money at stake. This is a large industry with a very substantial 

bankroll that is advertising very, very aggressively. 

What I see is a decrease by 50 percent of the warnings and untitled letters that you are sending out. Somehow that seems to sugVerDate 0ct 09 2002 09:10 Mar 04, 2004 Jkt 089956 PO 00000 Frm 00019 Fmt 6633 Sfmt 6601 S:\WPSHR\GPO\DOCS\89956.TXT JACK PsN: JACKF
16

* The information referred to was not available at the time this hearing went to press. 

gest to me a less aggressive enforcement attitude with respect to 

this. 

Dr. OSTROVE. Well, actually let me clarify that, please. You were 

talking about all of the untitled and warning letters, and that deals 

with—actually, most of those are toward professionally directed 

materials. I do not have the numbers with me, but I can get the 

numbers back to you that would demonstrate that in fact our enforcement of direct-to-consumer promotion has not decreased in the 

last 5 years. 

Senator DORGAN. We will just ask you to submit that for the 

record. 

Dr. OSTROVE. I will definitely do that. * 

Senator DORGAN. Dr. Ostrove, thank you very much for being 

with us. We appreciate your testimony. 

We would like to ask the next panel to come forward: Dr. Stephen Findley, Director of Research and Policy, the National Institute for Health Care Management; Dr. Sidney Wolfe, Director, Public Citizen, Health Research Group; Dr. Gregory Glover, attorneyphysician, representing the Pharmaceutical Research and Manufacturers of America, PhRMA; Dr. John Calfee, a Resident Scholar at 

the American Enterprise Institute. 

We welcome all four of you. We have asked that you submit your 

statements for the record and ask that you summarize your statements in 5 minutes. Let me begin—we have Nancy Chockley here 

in place of Stephen Findley. Let me begin with Ms. Chockley, 

President of the National Institute for Health Care Management. 

Would you proceed. 

STATEMENT OF NANCY CHOCKLEY, PRESIDENT, NATIONAL 

INSTITUTE FOR HEALTH CARE MANAGEMENT FOUNDATION 

Ms. CHOCKLEY. Yes. Good afternoon, Mr. Chairman and Senator. 

Thank you very much for this opportunity to testify. I am Nancy 

Chockley, President of the National Institute for Health Care Management Foundation. We are a research and policy group based 

here in Washington. We get our funding from health plans, from 

the government, and from private foundations. We have been doing 

a lot of work looking at the pharmaceutical industry and what is 

driving expenditure growth. I would like to make just a couple of 

points, four points really, here today on what we have been finding. 

One is that, as you already stated, direct-to-consumer advertising 

appears to be inducing new demand for prescription drugs and 

thus contributing to the recent sharp rise in pharmaceutical spending. Specifically, the data show that the drugs driving the growth 

in utilization and sales are also the drugs that are most heavily advertised. Simply put, we have found what Madison Avenue has 

known all along: advertising works. 

In an analysis, as you mentioned before, that we will be releasing probably in the next month, we found that the 50 drugs most 

heavily advertised to consumers in 2000 had an aggregate sales increase last year of 32 percent compared to about 14 percent for all 

other drugs, which by the way number over 9,800 drugs. So we are 

looking at 50 versus about 9,800 drugs. 

17

A large portion of the increase in sales for the 50 most heavily 

advertised drugs comes from a sharp increase in the number of 

prescriptions filled for them. As the chart over here illustrates, the 

combined number of prescriptions for these 50 drugs was up almost 

25 percent last year. You compare that to the other 9,800 drugs, 

they were up less than 2 percent. So it does appear that it is having an impact. 

I would like to note, though, that these numbers are preliminary 

and we are still working on them. But let me give you a specific 

example with Vioxx. We found that the growth in sales for the new 

arthritis drug Vioxx contributed more than any other single drug 

to the 19 percent increase in retail prescription drug spending in 

2000. Sales of Vioxx shot up from $330 million in 1999 to $1.5 billion. So that is an over a billion dollar increase in sales in just 1 

year. 

Perhaps not surprisingly, Vioxx was the most heavily advertised 

prescription drug in the Nation in 2000. Its maker, Merck, spent 

over $160 million promoting the drug to consumers. 

With the success of direct-to-consumer advertising and the new 

avenues open to reaching the consumers, we would predict that the 

pharmaceutical industry will be spending more to reach out and 

market directly to consumers. This expansion will follow the trend 

that you have alluded to. Over the last 3 years 1998 to 2000, 

spending on direct-to-consumer advertising has almost doubled. 

It is important to note, though, that the $2.5 billion spent on direct-to-consumer advertising really is only a small part of what the 

industry spends in total in promoting their drugs. They spend 

about $15.7 billion in total, $2.5 billion on DTC ads. 

As was referred to earlier by Nancy, we do not know how directto-consumer ads are affecting the physician-patient relationship or 

how they are changing health outcomes for patients. We need more 

studies on this and some of the work they are doing—there was a 

meeting with the Department of Health and Human Services on 

this. But we really need more information. Prevention magazine is 

really kind of out there in front and that is a little scary when you 

are talking about such a big industry. 

But they have found some interesting things, including that 

when a consumer comes in and asks for a specific drug 70 percent 

of the time they walk out with that drug. So it clearly is having 

an impact. 

While some contend that direct-to-consumer ads are a valuable 

source of information for consumers, we must recognize that the information in such ads is not packaged for the benefit of the public’s 

health, it is really meant to sell a specific drug. In this unique consumer market, direct-to-consumer ads prompt consumer behavior 

without providing substantive and complete information about the 

advertised product, treatment alternatives, or the disease. 

In conclusion, I would like to say that for consumers to make 

really informed decisions they need better, more balanced information on prescription drugs and we should facilitate that in two 

ways. One is I think we should raise the standards for direct-toconsumer ads and what is in them. I guess we will be hearing from 

some other groups on that point. 

18

But also, I think that we need to organize the different stakeholders in this industry with government leadership to try to provide an independent source of information. What we are spending 

on prescription drugs is going up, as you said, 19 percent a year. 

You are debating about adding Medicare prescription drug benefit. 

It really behooves us all to come up with an independent source of 

information so we can actually make some good comparisons between treatment options. 

[The prepared statement of Ms. Chockley follows:]

PREPARED STATEMENT OF NANCY CHOCKLEY, PRESIDENT, NATIONAL INSTITUTE FOR

HEALTH CARE MANAGEMENT FOUNDATION

Good afternoon, Mr. Chairman and Members of the Subcommittee. Thank you for 

the opportunity to testify today on this important issue. 

I am Nancy Chockley, president of the National Institute for Health Care Management Foundation. The NIHCM Foundation is a non-partisan, non-profit group. 

We conduct research on health care policy issues and manage health projects with 

funding from health plans, the government and private foundations. One of our research priorities has been and continues to be analysis of the pharmaceutical marketplace. Two of our recent studies are included in the supporting materials, and 

the others are available on our web site. 

I will focus my remarks today on four key points:

1. Direct-to-consumer advertising appears to be inducing significant new demand for prescription drugs, and thus contributing to the recent sharp rise in 

pharmaceutical spending. Specifically, our data show that the drugs driving the 

growth in utilization and sales are also the drugs that are being most heavily 

advertised to the public. Simply put: DTC advertising works.

In an analysis we will be releasing soon, we have found that the 50 drugs most 

heavily advertised to consumers in 2000 had an aggregate sales increase last 

year of 32%, compared to 14% for all other drugs (which number about 9,850).

As the chart behind me illustrates, most of the increase in sales for the 50 most 

heavily advertised drugs came from a sharp increase in the number of prescriptions filled for them. Combined, the number of prescriptions for these 50 drugs 

was up almost 25% from 1999 to 2000. In contrast, the number of prescriptions 

for all other prescription drugs increased less than 2%. I would like to note 

these numbers are preliminary.

To give you an example, we found that growth in the sales of the new arthritis 

drug Vioxx contributed more than any other single drug to the 19% increase 

in retail prescription drug spending in 2000. Sales of Vioxx shot up from $330 

million in 1999 to $1.5 billion in 2000. Perhaps not suprisingly, Vioxx was the 

most heavily advertised prescription drug in the nation in 2000. Its maker, 

Merck, spent $160.8 million promoting the drug to consumers.

2. The success of DTC advertising, combined with computer technology which 

is opening up new ways to reach consumers directly, lead us to predict that 

drug companies will continue to expand their efforts to market their products 

directly to consumers. This expansion will follow the trend seen over the last 

three years: from 1998 to 2000, spending on direct-to-consumer advertising has 

almost doubled. In 2000, the pharmaceutical industry spent $2.5 billion on DTC 

ads. It is important to note this accounts for only a portion of the $15.7 billion 

total expenditure on promotional spending for prescription drugs.

3. We don’t know how DTC ads are affecting the physician-patient relationship 

or how they are changing health outcomes for patients. We need more studies 

to better understand the role marketing is playing. The Department of Health 

and Human Services held an important conference on this issue in May, and 

the FDA is also currently studying this question. We strongly encourage more 

federal funding of research that helps explain the impact of marketing on 

health and health care.

4. While some contend that DTC ads are a valuable source of information for 

consumers, we must recognize that the information in such ads is not packaged 

for the benefit of the public’s health. It is meant to sell prescription drugs. In 

this unique consumer market, DTC ads prompt consumer behavior without proVerDate 0ct 09 2002 09:10 Mar 04, 2004 Jkt 089956 PO 00000 Frm 00022 Fmt 6633 Sfmt 6621 S:\WPSHR\GPO\DOCS\89956.TXT JACK PsN: JACKF
19

viding substantive and complete information about the advertised product, 

treatment alternatives, or the disease.

For consumer decisions to be truly informed, consumers must be provided with 

better, more balanced information on their prescription drugs. We should facilitate 

this by: one, raising the standards for the content of DTC ads; and two, organizing 

collaboration among key stakeholders in the health care industry and the government to develop objective sources of information that compare treatment options. 

Currently, consumers and physicians rely on the pharmaceutical companies as their 

primary source of information on pharmaceutical products. With prescription drug 

expenditures increasing by almost 19% a year and Congress looking at adding a prescription drug benefit for Medicare beneficiaries, the timing is right to address the 

scarcity of unbiased pharmaceutical information that exists. It is essential for physicians and consumers to have access to a source of information which may help them 

to discern and compare the benefits and costs of pharmaceutical products. The government could play a key role in facilitating such a vital information source. 

Elaborating on the preceding points 

In September 2000, we released our first research brief on DTC prescription drug 

ads. In May 2001, we released a study on pharmaceutical spending in the retail 

marketplace in the year 2000. Although we will not be releasing our next study of 

DTC ads until September, we have included in this testimony data on ad spending 

in 2000 which will be published in that study. Pharmaceutical companies spent $2.5 billion on all forms of DTC prescription 

drug ads in 2000; 85% of that total was spent on the 50 most heavily promoted 

drugs. 

Like the Vioxx example given earlier, we found that growth in the sales of the 

heavily-promoted antiulcer drug Prilosec was responsible for a substantial portion 

of the rise in overall pharmaceutical spending in 2000. Retail sales of the drug rose 

from $3.6 billion in 1999 to $4.1 billion in 2000. It’s now the best selling drug in 

the country. Prilosec’s maker, AstraZeneca, spent $107.7 million promoting the drug 

to consumers in 2000. It was the second most heavily promoted drug. 

It is important to note that DTC ads are only one factor among many factors that 

drive the sales growth of a product. While it is feasible that DTC ads are playing 

a comparatively small role relative to these other factors, our data and recent surveys indicate otherwise. 

Recent studies by the FDA and Prevention magazine have found, for example, 

that consumers are quite receptive to the ads. They are not only aware of them; 

they appear to be acting on them. In a recent survey by Prevention magazine, conducted in June 2000, 32% of respondents who had seen or heard a drug ad—and 

90% had—talked to their doctor about an advertised medicine or the disease it targets. Of this group, one in four asked their doctors for a specific medicine they had 

seen advertised. And 70% of those who made such a request walked out of the office 

with a prescription for that specific drug. 

Let me translate those percentages into numbers of people. If 150 million adults 

saw the ads, 48 million will have talked to their doctor as a result, 12 million will 

have asked for a specific drug, and 8.4 million will have gotten it that same day. 

This brings me to another central point I want to make today: we don’t yet know 

whether DTC advertising is, on balance, beneficial or detrimental. 

Are the ads leading to the inappropriate use of some drugs? Are they compromising the safe use of some drugs, leading consumers to believe the drugs are safer 

or more efficacious than they may actually be? Are they inducing demand for drugs 

that would not otherwise be first-line treatments? 

I am sure we will all agree today that we will soon need to know the answers 

to these questions. Opinions about the effects of DTC ads will not suffice in the long 

run. We strongly support research that probes these issues. 

Research is needed to better understand the positive role that DTC ads could be 

playing. If studies find that DTC ads are inducing millions of Americans to go to 

the doctor for needed visits and that they are then getting appropriate care they 

would not otherwise get, then DTC advertising may be a powerful new tool to help 

create a healthier population. If, on the other hand, studies find that prescription 

drug mass media ads are inducing millions of inappropriate prescriptions, then we 

may have to conclude we have a problem. 

Until studies can determine the impact of DTC advertising, we will have to weigh 

carefully what we already know about the benefits against the social and health 

costs of DTC ads. 

Furthermore, we must recognize that DTC drug ads are not primarily designed—

and probably never could be—as public health tools. They are designed to successfully market specific products. Quite simply, consumers need other sources of inforVerDate 0ct 09 2002 09:10 Mar 04, 2004 Jkt 089956 PO 00000 Frm 00023 Fmt 6633 Sfmt 6621 S:\WPSHR\GPO\DOCS\89956.TXT JACK PsN: JACKF
20

mation on prescription drugs to make truly informed choices. We would recommend 

that the Department of Health and Human Services initiate a process to examine 

how that might come about. All health care stakeholders should be involved. 

My final point today is one that often gets overlooked in this debate. Spending 

on DTC ads is growing at a time when pharmaceutical companies appear to be increasingly reliant upon the earnings of their blockbuster drugs. The power of DTC 

ads could be an incentive for drug companies to invest resources in extending the 

exclusivity of their blockbuster drugs, instead of investing in the development of innovative new products. To the extent that DTC ads give companies further inducement to protect their aging blockbusters, DTC ads may ill serve public health. 

The health of the population is best served by an industry that is putting the 

maximum amount of money into developing truly innovative new drugs for the most 

serious life-threatening and debilitating diseases. The public’s health will not be advanced as much if drug companies focus disproportionately on inducing potentially 

inappropriate consumer demand for repackaged or slightly improved drugs to treat 

a range of non-threatening conditions. 

Prescription drugs help millions of Americans live normal, productive lives, yet 

they are unique consumer products. They have the potential for serious harm as 

well as great benefit. They are part of a complex system of medical care that must 

be ruled first and foremost by science and careful human judgement. Congress has 

long recognized the complexity and uniqueness of the pharmaceutical marketplace 

in their regulation of this industry. The growth of DTC advertising poses new questions about how consumers perceive prescription drugs and use them. DTC ads—

just as the products they promote—appear to have the potential for benefit but also 

for harm. 

Thank you.

Senator DORGAN. Ms. Chockley, thank you very much. 

Mr. Calfee, I understand that you are to catch a plane to leave 

the country. 

Mr. CALFEE. That is right. 

Senator DORGAN. So we will call on you so that you can testify 

and leave the country, and I hope it is not a reflection on your testimony here. 

[Laughter.] 

Senator DORGAN. But why do you not, so that we can accommodate your time issue, why do we not let you proceed, Mr. Calfee. 

STATEMENT OF JOHN E. CALFEE, PH.D., RESIDENT SCHOLAR, 

AMERICAN ENTERPRISE INSTITUTE 

Mr. CALFEE. I appreciate it. I want the record to reflect that I 

planned to leave the country, I made plans to leave the country before I made plans to testify. 

I have submitted written testimony and I have some briefer remarks to read into the record right now. Mr. Chairman, I would 

like to thank you for inviting me to testify today on the effects of 

direct-to-consumer advertising of prescription drugs. 

Economic research has shown that advertising makes markets 

work better. For example, advertising increases the incentives for 

manufacturers to create new or improved products. Especially important is the ability of advertising to provide information. Society 

has yet to discover another mechanism that is the equal of advertising in its power to provide crucial information in a concise, usable, and memorable format, and to provide that information to 

those who need it most. 

The question today is whether the prescription drug market provides yet another example of the benefits of advertising or, on the 

contrary, is an exception to the rule. There are good reasons, I believe, to expect direct-to-consumer advertising of prescription drugs 

21

to be a valuable tool for consumers and patients. The medical literature documents that millions of consumers remain undiagnosed 

or untreated for serious medical conditions for which useful drug 

therapies exist. A prime reason appears to be that consumers are 

not aware of therapies that could help them, especially therapies 

that are relatively new or are improvements over older treatments. 

Examples of such undertreated conditions include depression, diabetes, obesity, high blood pressure, and elevated cholesterol. In 

most cases, it is consumers themselves who must take the initiative to see their physician and discuss their symptoms and possible 

treatments. 

A striking example of this situation was provided this past May 

in a Federal report on the treatment of elevated cholesterol. That 

report came from the National Cholesterol Education Program at 

the National Institutes of Health. It said that millions of middle 

aged and elderly people could reduce their risk of a heart attack 

by one-third or more if they begin taking one of the powerful 

statin-class drugs for reducing serum cholesterol. 

But again, consumers must take the initiative in order to realize 

these benefits. What is needed is to get essential information about 

cholesterol and heart disease to the consumers who need it. Now 

that the flurry of publicity about the NIH report has passed, it is 

up to advertising to do the real work of alerting consumers. 

I believe it is fair to say that direct-to-consumer advertising is 

likely to provide consumers with essential information about cholesterol and heart disease faster and better than any information 

program mounted by governments, public health organizations, or 

health care providers. 

The proposition that advertising can help consumers in dealing 

with prescription drugs is not merely theoretical. We now have 

ample evidence of the benefits of direct-to-consumer advertising. 

Much of this evidence can be found in the consumer surveys conducted by the Food and Drug Administration, Prevention magazine, and other organizations. These surveys show that consumers 

like DTC advertising and they think it helps them talk to their doctors about medical conditions. DTC advertising inspires consumers 

to learn more about illnesses and drug therapies. It tends to make 

consumers more aware of both the benefits and risks of pharmaceuticals as many consumers read and pay attention to the risk information in advertising. 

Twenty-seven percent of respondents in the FDA survey were 

prompted by ads to talk to their doctors about medical conditions 

they had never previously discussed with their doctors. DTC ads 

also remind patients to refill their prescriptions and to have confidence in the value of continuing their therapies, as was pointed 

out by the FDA spokesman just earlier. 

Fortunately, there is little convincing evidence of adverse effects 

from DTC advertising. Expenditures on DTC ads are only about 2 

percent of total spending on prescription drugs. There is little reason to think that DTC ads raise prices. Average prices in the heavily advertised statin drug market, for example, have been stable for 

the past 6 years despite escalating demand. 

DTC advertising is also unlikely to contribute to overall expenditures on prescription drugs except to the extent that ads encourage 

22

patients to obtain needed therapies that they would otherwise do 

without. There is little, if any, evidence that DTC ads have caused 

systematic inappropriate prescribing. Risk-benefit information in 

ads tends to be reasonably balanced. Indeed, the FDA would hardly 

tolerate anything else. 

Only about 4 percent of respondents to the FDA’s 1999 survey 

on DTC advertising said that they had encountered adverse reactions from their doctors when they talked about advertised drugs. 

In fact, overwhelming proportions of survey respondents in the 

FDA survey reported that when they asked their physicians about 

advertised drugs their questions were met with tolerance and respect and were treated as ordinary parts of physician-patient interactions. 

In conclusion, DTC ads appear to be providing consumers with 

a useful, even essential, tool in today’s rapidly changing health 

care market. 

That concludes my remarks. I would be glad to answer questions. 

[The prepared statement of Mr. Calfee follows:]

PREPARED STATEMENT OF JOHN E. CALFEE, PH.D., RESIDENT SCHOLAR, AMERICAN

ENTERPRISE INSTITUTE

Mr. Chairman, I wish to thank you for inviting me to testify today on the effects 

of direct-to-consumer (DTC) advertising of prescription drugs. I am an economist 

who has devoted considerable attention to advertising, health care markets, and the 

pharmaceutical industry. During 1980–1986, I served in the Bureau of Economics 

at the Federal Trade Commission, where I specialized on consumer protection, including advertising regulation. Some of what I say today is drawn from my recently 

published book, Prices, Markets and the Pharmaceutical Revolution (AEI Press, 

2000). That book is available from the publisher, AEI Press, and is also 

downloadable from the American Enterprise Institute website (www.aei.org). Earlier, I wrote a book on advertising, Fear of Persuasion: A New Perspective on Advertising and Regulation (London: Agora; North American distribution by the American 

Enterprise Institute). I have also written numerous articles and book chapters on 

pharmaceutical advertising and related topics, and recently presented the results of 

a new empirical study of the effects DTC advertising for the statin class of cholesterol-reducing drugs (Calfee, Winston, and Stempski 2001). Much of this testimony 

is based on a recently released paper on what we can learn from consumer surveys 

on DTC advertising (Calfee 2001). 

This statement addresses four topics: (1) the relationship between DTC advertising and prescription drug prices; (2) the relationship between DTC advertising 

and prescription utilization and costs; (3) why DTC advertising is likely to help consumers and patients; and (4) what consumer research can tell us about the impact 

of DTC advertising. 

DTC Advertising and Prescription Drug Prices 

Expenditures for out-patient prescription drugs have been increasing at about 

15% annually (Berndt 2000; NIHCM 2001). Several studies have found that about 

three-fourths of these increases have been caused by expanded usage and switching 

to newer and more effective drugs, while price increases have accounted for only 

about one-fourth (Berndt 2000; Dubois et al. 2000; RxHealth Value 2001). Even this 

modest role for price increases is overstated, because standard measures of pharmaceutical prices fail to take into account improvements in the quality and value of 

new drugs or drugs that have found expanded uses (Triplett 1999). 

These facts suggest that even if DTC advertising increases prices, such an effect 

has been quite limited simply because overall price increases have been small. But 

there is little reason to expect DTC advertising to significantly increase prices at 

all. Research has generally found that advertising tends to reduce prices, rather 

than increase them, primarily because advertising makes markets more competitive 

(Calfee 1997, p. 10–11, and citations therein). 

A current example of the separation between DTC advertising and prescription 

drug prices can be found in the market for the statin class of cholesterol-reducing 

drugs such as Pravachol, Zocor, and Lipitor. Total expenditures for statin drugs 

23

have increased rapidly, making this one of the largest therapeutic categories in 

terms of total sales (NIHCM 2001). Statin drugs have also been among the leaders 

in DTC advertising (NIHCM 2001). Yet average statin drug prices have been stable 

or even slightly declining, according to data from the widely respected market research firm, IMS Health (proprietary data supplied to author, summarized in 

Calfee, Winston, and Stempski 2001). Moreover, the oldest statin drug, Mevacor, is 

about to go off patent. Hence average statin drug prices may substantially decline 

in the future. 

DTC Advertising and Prescription Drug Expenditures and Utilization 

DTC advertising totaled approximately $2.6 billion in 2000 (Adams 2001). This is 

about 2% of total prescription drug expenditures, which were recently estimated at 

$132 billion (NIHCM 2001). Clearly, even the total elimination of DTC advertising 

would have a negligible direct effect on total pharmaceutical costs. 

The real question, however, is whether DTC advertising pushes expenditures upward and if so, whether it increases expenditures inappropriately. There is little evidence that recent increases in drug expenditures have been caused by inappropriate 

prescriptions. For example, a recent unpublished study of the rapidly growing statin 

drug market found no tendency toward less appropriate prescribing in this rapidly 

growing market (Dubois, et al., 2001). On the whole, increases in drug utilization 

seem to be driven primarily by the fact that health care organizations, physicians, 

and patients find many of the newer drugs to be extremely valuable. In fact, there 

is strong evidence that many of the most effective drugs are underused, rather than 

overused (see citations in the next section). Hence public debate has focussed on 

how to pay for more extensive drug therapy, rather than on how to curtail it. 

Whether DTC advertising is actually increasing usage has apparently been the 

subject of very little systematic research. In an attempt to fill this gap, I and two 

co-authors undertook a study of the statin drug market (Calfee, Winston, and 

Stempski 2001). Using proprietary data on DTC advertising, other forms of promotion, statin prescriptions, statin sales, and cholesterol-related office visits, plus 

other data, were found no detectable influence from DTC advertising or other forms 

of promotion on the volume of statin prescriptions, which simply increased steadily 

throughout the study period regardless of large fluctuations in DTC advertising. 

One reason for the apparent lack of a short-term connection between advertising 

and prescriptions is the fact that several steps must take place between the time 

when a consumer reacts to an ad and when that consumer receives a prescription 

(initial physician visit, cholesterol check, advice for life-style changes, etc.)—if a prescription is written at all. 

This is not to say that DTC advertising does not increase sales for advertised 

brands. But the evidence suggests that prescribing decisions are dominated by the 

physician’s advice, which may involve non-drug therapy, a generic prescription, or 

an over-the-counter drug recommendation, as alternatives to prescribing the advertised brand. 

Why DTC Advertising Is Likely to Help Consumers and Patients 

Decades of research have established that advertising makes markets work better 

by providing information and enhancing competition (Calfee 1997). Advertising is 

especially useful for providing consumers with essential information that they would 

otherwise ignore, fail to receive, or receive too late. The Federal Trade Commission, 

which regulates most advertising, has emphasized that advertising plays an essential role in improving consumer information and otherwise improving markets (FTC 

1996). 

There are compelling reasons to expect DTC advertising to improve the prescription drug market. Some of the most important medical information—especially relatively new information—often fails to reach physicians or patients in a timely manner. This situation is reflected in the proliferation of practice guidelines for physicians, and also in published findings that medical practice often falls well short of 

what can be achieved by following even the least controversial aspects of consensus 

guidelines (Calfee 2000, p. 24–26). Consumers and patients, of course, tend to be 

even less well informed than their doctors. 

Many of the most valuable new drugs involve conditions or illnesses that require 

consumers to take the initiative in seeking medical advice for dealing with depression, for example, or to learn whether one is at risk for heart disease and if so, what 

can be done to reduce that risk. A number of studies and consensus statements from 

the medical community have documented the existence of large numbers of underdiagnosed and undertreated consumers who suffer from serious, yet treatable medical conditions such as elevated cholesterol, depression, obesity, diabetes, and hypertension (Calfee 2000, p. 24–26). 

24

A new report from the National Cholesterol Education Program at the National 

Institutes of Health illustrates these trends. That report concluded that elevated 

cholesterol should be treated much more aggressively than in the past, even as earlier studies have found that most persons who should have been treated under the 

previous guidelines were in fact not treated and often, not even identified (NIH 

2001). 

These circumstances dictate that patients and consumers must play an active role 

in their own health care. In particular, consumers need to acquire information about 

medical therapies, talk to their physicians about medical symptoms and conditions, 

and decide with their doctors how to deal with illnesses and conditions. 

Both the FTC (1996) and the FDA have noted the potential value of DTC advertising in addressing these problems. The Food and Drug Administration, in particular, has stated, ‘‘It [DTC advertising] is consistent with the whole trend toward 

consumer empowerment. We believe there is a certain public health benefit associated with letting people know what’s available.’’ (Stolberg 2000). Even the American 

Medical Association, whose constituency has traditionally opposed prescription drug 

advertising to consumers, recently issued a statement that concluded, ‘‘If used appropriately, direct-to-consumer (DTC) advertising has the potential to increase patient awareness about treatment options and enhance patient-physician communication. Advertising directly to the public educates patients, enabling them to better 

understand and participate in medical care.’’ (AMA 2000). In 1998, Lancet, a leading 

British medical journal, ran an editorial arguing that DTC advertising would benefit 

European consumers. 

What Consumer Research Can Tell Us about the Impact of DTC Advertising 

In August 1997, the FDA relaxed its regulatory requirements for DTC advertising 

on broadcast media including television (Calfee 2001, FDA 1997). This decision triggered large increases in the volume of television DTC advertising while also prompting a shift from print to broadcast media. In August 1999, after a two-year review, 

the FDA reaffirmed its new policy, while also announcing its intention to review 

DTC advertising again in 2001 (FDA 1999a). This past March, the FDA announced 

the beginning of its latest review, which will include commissioning surveys of both 

consumers and physicians (FDA 2001). 

In the meantime, several studies have appeared on the impact of DTC advertising. These consist primarily of a number of nationally representative surveys of 

consumers. The most notable examples include a 1999 survey commissioned by the 

FDA itself (FDA 1999b, 1999c), and a series of surveys commissioned by Prevention 

Magazine (1999, 2000). Other more limited, but nonetheless useful research includes 

national consumer surveys by AARP, the National Consumers League, and 

NewsHour with Jim Lehrer (with the Kaiser Family Foundation and the Harvard 

School of Public Health); a survey of California consumers (Bell, et al. 2000), and 

content analyses of individual DTC ads (Wilkes 2000). I focus here on the findings 

from national surveys, especially those by the FDA and Prevention Magazine. 

DTC Advertising and Consumer Information 

The national consumer surveys have provided a number of useful findings on the 

relationship between DTC advertising and consumer knowledge about prescription 

drugs. One finding is that DTC ads provide a reasonable balance of information 

about both benefits and risks. In the FDA survey, for example, there was little difference in the prominence of benefits vs risks or warnings, and 70% disagreed with 

the statement that DTC ads ‘‘make it seem like a doctor is not needed to decide 

whether a drug is right for me.’’ In a response to a 1999 Prevention survey question 

about whether advertising made respondents feel more or less confident about drug 

safety, 70% said ‘‘no difference’’ or ‘‘less confident.’’

The surveys also supply direct and indirect evidence that DTC advertising provides valuable information to consumers. Responses revealed very high levels of 

awareness and attention to DTC ads, as the proportion of respondents recalling 

DTC ads ranged between 72% (FDA survey) and 95% (aided recall in the 1999 Prevention survey). Such high awareness levels strongly suggest that consumers gained 

information about the core topics of DTC ads: details on a variety of medical conditions, potential therapies, alternative dosages, and other important topics, in addition to risk information. The potential value of making so much information available through advertising is clear from the AARP survey results, in which 27% of 

respondents said their doctors seldom or never discussed pharmaceutical risks, and 

another 18% said physicians did so only sometimes, while 27% said their doctors 

rarely or never discussed alternative drug therapies. 

The bulk of respondents (on the order of 80% in the FDA survey) noticed information on benefits, risks, and warnings. Substantial proportions read some or all of 

25

the fine-print risk information in print ads, and readership was much higher for 

those who had a special interest in the advertised drug. In particular, the FDA survey found remarkably high levels of readership of the fine-print risk information in 

print ads: 40% said they read half or more of that information, another 26% said 

they read a little of it, and 85% said they would read all or almost all of the information if they were especially interested in the drug. The Prevention survey obtained roughly similar results, also finding high levels of attention to detailed risk 

information. 

The surveys also suggest that DTC ads motivated consumers to seek additional 

information from numerous sources, including, of course, their own doctors. Of special importance is the finding that DTC ads opened up new topics for consumers 

to investigate. Twenty-seven percent of respondents in the FDA survey were 

prompted by ads to talk to their doctors about medical conditions they had never 

previously discussed. These results are consistent with the fact that many of the 

most heavily advertised drugs treat conditions that are widely believed by the medical community to be undertreated, such as elevated cholesterol, depression, obesity, 

diabetes, and hypertension. 

Of special interest in the FDA survey was the balance of information on risks and 

benefits in DTC ads. A series of detailed questions revealed a remarkably balanced 

assessment. Asked what kinds of information they saw in ads, 87% of respondents 

said, ‘‘the benefits of the drug,’’ while 82% said, ‘‘risks or side effects,’’ and 81%, 

‘‘who should not take the drug.’’ The proportion of respondents who thought ads 

lacked information on benefits (49%) was nearly as large as the proportion who 

though ads lack information on risks (59%). The Prevention surveys provided similar 

results. 

DTC Advertising and Patient-Doctor Relationships 

Both the FDA and Prevention surveys document that large majorities of consumers agree that DTC ads provided sufficient information to prepare to talk to 

their doctors—70% in the FDA survey. But advertising was far from a dominant influence. In the FDA survey, respondents said the main reasons for expecting a new 

prescription were: past prescription history, information from friends or relatives, 

and previous discussions with physicians. 

Large majorities of respondents to the FDA survey reported favorable assessments 

of their talks with their doctors, and encountered no resentment or other unfavorable reaction. This is apparent from the numbers in Table 1. Most respondents said 

their doctor welcomed their questions (81%), reacted as if those questions were an 

ordinary part of a visit (71%), and proceeded to discuss the drugs with the patient 

(79%). Only 4% said their physician ‘‘seemed angry or upset.’’ Equally important, 

of those who had not asked such questions of their physicians, only 3% expected to 

encounter an adverse reaction if they were to ask such a question in the future. 

Eighty-five percent of respondents were satisfied or very satisfied with their discussions with physicians about advertised drugs, with only 7% unsatisfied or very 

unsatisfied. Finally, 62% agreed or strongly agreed that DTC ads helped them have 

better discussions with their physicians.

Table 1. Physician Reactions When Asked About an Advertised Drug 

Question 28: ‘‘Which, if 

any, of these possible

reactions did your doctor 

have when you asked 

about the [advertised] 

drug?’’

Question 33: ‘‘Which, if 

any, of these possible

reactions do you think 

your doctor would have if 

you asked about a

prescription drug you had 

seen advertised?’’ (May say 

‘‘Yes’’ to more than one.) 

Welcomed question 81% 69%

Discussed drug 79% 82%

Reacted as if the question were ordinary 

part of visit 71% 56%

26

Table 1. Physician Reactions When Asked About an Advertised Drug—Continued

Question 28: ‘‘Which, if 

any, of these possible

reactions did your doctor 

have when you asked 

about the [advertised] 

drug?’’

Question 33: ‘‘Which, if 

any, of these possible

reactions do you think 

your doctor would have if 

you asked about a

prescription drug you had 

seen advertised?’’ (May say 

‘‘Yes’’ to more than one.) 

Got angry or upset 4% 3%

None of the above 2% 1%

Don’t know/refused 1% 2%

Sample size 220 607

Adapted from: Food and Drug Administration, Center for Drug Evaluation and Research, Division of Drug 

Marketing, Advertising, and Communications. Attitudes and behaviors associated with direct-to-consumer 

(DTC) promotion of prescription drugs: main survey results. Available at: http://www.fda.gov/cder/ddmac/

dtcindex.htm. Accessed May 1, 2001. 

In 26% of the discussions motivated by advertising, according to the Prevention

survey, patients said they requested prescriptions for specific brands, and they usually got one. We do not know, however, the extent to which these requests arose 

from discussions in which physicians had already made clear that the decision was 

up to the patient, perhaps because the choice was obvious or because any of several 

alternatives was acceptable. In the FDA survey only about half of physicians wrote 

a prescription when asked about a specific drug. These surveys provide no reason 

to suggest that these requests and questions about specific advertised drugs tended 

to yield inappropriate prescriptions. 

Overall Consumer Attitudes Toward DTC Advertising 

Consumers generally like DTC ads and find them useful. In the FDA survey, 

those who liked DTC ads outnumbered those who did not by nearly two to one. 

Eighty-six percent said the ads ‘‘help make me aware of new drugs,’’ and 62% said 

DTC ads help them have better discussions with their physician about their health. 

In the 1999 Prevention survey, 76% thought that ads ‘‘allow people to be more involved with their health care,’’ 72% said that DTC ads ‘‘educate people about the 

risks and benefits of prescription medicines,’’ and 63% said that DTC ads ‘‘help people make their own decisions about prescription medicines.’’ Finally, 76% of respondents to the National Consumers League survey agreed that prescription drug ads 

‘‘increase consumer knowledge about medicines,’’ and 78% agreed that prescription 

drug ads ‘‘increase consumer knowledge about disease.’’

Positive Spillovers from DTC advertising 

Survey research also provides something that may be surprising to most observers: evidence that DTC advertising provides spillover benefits to consumers, beyond 

any gains realized by the manufacturers who pay for the ads. One spillover benefit, 

for example, is increased consumer awareness of the simple fact that virtually all 

prescription drugs are risky and have side effects. This must be clear to anyone who 

has perused a few of the ‘‘brief summaries’’ in print ads or noticed the staccato list 

of warnings in TV ad voice-overs. In addition, the 1999 Prevention survey found that 

physicians tend to provide more risk information to those patients who ask about 

advertised drugs. 

A second category of spillover benefits is the dissemination of information about 

new, previously undiscussed conditions. Advertising about elevated cholesterol, obesity treatments, and the like do not invariably lead to prescriptions for the advertised drugs. On the contrary, when ads induce patients to talk to their doctor, most 

patients do not actually ask for or about the brand whose advertising sparked the 

discussion, and when they do, the result is a mixture of prescriptions for the advertised drug, prescriptions for a competing drug, recommendations for OTC drugs, and 

advice to change life-styles or behavior. Ads can raise awareness of the need for a 

particular type of drug to treat a particular condition, but the benefits of that consciousness-raising may go to the patient and to competitors rather than to the advertiser. 

27

A third spillover benefit is to call consumers’ attention to nondrug approaches to 

improved health. Many ads start out by mentioning the value of dietary changes 

and exercise. When DTC ads succeed in getting consumers to talk to their doctors 

about obesity, diabetes, depression, and cholesterol levels, those consumers probably 

learn that behavioral and life-style changes are the first line of treatment. In response to a 2000 Prevention survey question asked of respondents who said that ads 

had caused them to talk to their physician, 53% said their doctor had mentioned 

a nondrug therapy for their condition. The proportions were much higher for certain 

conditions: diabetes (77%), high cholesterol (92%), and obesity (84%). 

Finally, a fourth example of spillover benefits is inducing compliance with drug 

therapies. Research has shown that inadequate compliance with physician instructions when taking prescription drugs is an extremely common and dangerous problem (Calfee 2000, p. 19). Advertising is an excellent vehicle for inducing better compliance because consumers tend to pay attention to advertising for brands they use. 

It is no surprise, therefore, that the FDA survey found that consumers pay special 

attention to ads for drugs they are taking or in which they have a special interest. 

In 2000 Prevention survey, about half of those respondents taking a prescription 

drug recalled seeing an ad for a drug they were using. Thirty-six percent said the 

ads made them feel better about the safety of their prescriptions, while only 3% said 

the ads made them feel worse. In response to a crucial question—‘‘Do ads make you 

more or less likely to take your medicine regularly?’’—‘‘more likely’’ outscored ‘‘less 

likely’’ by 22% to 3%. In addition, 33% in the 1999 survey said that prescription 

drug ads reminded them to have their prescriptions refilled. 

There is no reason to expect the reminder powers of DTC advertising to be restricted to the advertised brand. Although no research appears to have been done 

on the topic, these survey results strongly suggest that by reminding patients to 

take their medicine and refill their prescriptions, DTC ads tend to encourage patients to persist in their drug therapy. 

Conclusions 

There are good reasons to expect DTC advertising to provide valuable information 

to consumers and otherwise improve the health care market. The emerging evidence 

on DTC advertising effects, particularly the results of consumer surveys by the 

FDA, Prevention Magazine, and others, indicates that DTC ads are in fact providing 

substantial benefits while avoiding most or all of the problems that some analysts 

have suggested DTC ads could bring. 

This evidence goes far toward explaining why the FDA reaffirmed its policy of 

permitting DTC advertising in August 1999. Indeed, the agency noted at the time 

that ‘‘FDA is unaware of any data supporting the assertion that the public health 

or animal health is being harmed, or is likely to be harmed, by the Agency’s actions 

in facilitating consumer-directed broadcast advertising’’ (FDA 1999b). The FDA is to 

be congratulated for persisting in its policy toward DTC advertising in the face of 

criticism and opposition from diverse segments of the health care community. 

Equally worthy of praise is the fact that the FDA commissioned a well-designed consumer survey that could easily have uncovered severe problems with its new policy, 

rather than providing support for the policy (which it did, of course). 

We have learned at least six things from the leading consumer surveys and other 

evidence on DTC advertising. First, we can largely rule out the possibility that DTC 

advertising is causing systematic consumer deception, including the inappropriate 

downplaying of risks and side effects. The FDA and Prevention surveys, in particular, addressed this topic in so many ways that it is very unlikely that widespread consumer deception has escaped detection by the FDA regulators. 

Second, DTC advertising provides valuable information, and not just on obvious 

topics such as potential treatments and dosages, but also on risks and side effects. 

On the whole, DTC advertising appears to increase the salience of both risks and 

benefits from drug therapy. Third, the information in DTC advertising motivates 

consumers to seek additional information from many sources, but especially from 

physicians and pharmacists. Many of these consumers ask about conditions they 

had not previously discussed with their doctors. 

A fourth finding is that from the patient’s perspective at least, DTC advertising 

is causing almost no tension in the doctor’s office. Very few respondents—usually 

well under 5%—encountered resentment or resistance when they brought up what 

they had seen in advertising, or asked about specific drugs. Fifth, consumers like 

DTC advertising. They think it helps them in making decisions and in talking to 

their doctors. 

Sixth, DTC advertising yields significant spillover benefits that go to consumers 

rather than to advertisers. Such benefits range from heightened awareness of the 

inherently risky nature of prescription drugs to better compliance with drug theraVerDate 0ct 09 2002 09:10 Mar 04, 2004 Jkt 089956 PO 00000 Frm 00031 Fmt 6633 Sfmt 6621 S:\WPSHR\GPO\DOCS\89956.TXT JACK PsN: JACKF
28

pies and even motivation to pursue life-style and behavioral changes that may obviate the need to use pharmaceuticals. In particular, ads reminded consumers to take 

their medications and to refill their prescriptions. Overall, DTC ads appear to make 

patients more comfortable with the risks and benefits of the medicines they take. 

Overall, these survey results are strongly supportive of a situation in which consumers are motivated by advertising first to seek additional information—specially 

from physicians, and particularly for previously untreated or inadequately treated 

conditions—and then to work with their doctor to reach a decision about what if any 

prescription drug to use. 

References 

Adams, C. (2001) ‘‘FDA plans to review policy allowing direct-to-consumer drug 

ads for TV,’’ Wall Street Journal. March 28, 2001, p. B1. 

American Medical Association (2000) Council on Ethical and Judicial Affairs of 

the American Medical Association, ‘‘Direct-to-Consumer Advertisements of Prescription Drugs,’’ 55/1 Food and Drug Law Journal 119–124. 

Bell, Robert A., Michael S. Wilkes, and Richard Kravitz (2000) ‘‘The Educational 

Value of Consumer-targeted Prescription Drug Print Advertising,’’ 49/12 Journal of 

Family Practice (December). 

Calfee, John E. (1997) Fear of Persuasion: A New Perspective on Advertising and 

Regulation, London: Agora; North American distribution by the American Enterprise Institute. 

Calfee, John E. (2000) Prices, Markets, and the Pharmaceutical Revolution. American Enterprise Institute, Washington, D.C. 

Calfee, John E. (2001) ‘‘What Consumer Surveys Show About Direct-to-Consumer 

Advertising of Prescription Drugs,’’ available from author and from the Coalition 

for Health Care Communication (www.cohealthcom.org). 

Calfee, John E., Clifford Winston, and Randolph Stempski (2001) ‘‘The Effects of 

Direct-to-Consumer Advertising for Cholesterol-reducing Drugs,’’ presented at the 

University of Chicago Conference on The Regulation of Medical Innovation and 

Pharmaceutical Markets, April 20–21, 2001. 

Dubois, Robert W., Charles M. Alexander, Sally Wade, Andrew Mosso, Leona 

Markson, J.D. Lu, Soma Nag, and Marc L. Berger (2001) ‘‘Growth in Use of Lipid 

Lowering Therapies: Bad News? Good News? Or the Wrong Question?’’ Draft available from Robert W. Dubois, Protocare Sciences, Inc., 2400 Broadway, Suite 100, 

Santa Monica, CA 90404. 

Federal Trade Commission, Bureau of Consumer Protection and Bureau of Economics (1996), ‘‘Comments to the Food and Drug Administration on Direct-to-Consumer Promotion of Prescription Drugs,’’ January 11, 1996. 

Food and Drug Administration, Center for Drug Evaluation and Research (1997) 

‘‘Draft Guidance for Industry on Consumer-Directed Broadcast Advertisements,’’ 

July 1997; announced in Federal Register, v. 62, n. 155, p. 43171–43173 (Aug. 12, 

1997, Docket 97D–0302). 

Food and Drug Administration, Center for Drug Evaluation and Research (1999a) 

‘‘Guidance for Industry: Consumer-directed Broadcast Advertisements,’’ August 

1999; announced in Federal Register, v. 64, n. 152, p. 43197–43198 (Aug. 9, 1999, 

Docket 97D–0302). 

Food and Drug Administration, Center for Drug Evaluation and Research (1999b) 

‘‘Questions and Answers on Guidance for Industry: Consumer-Directed Broadcast 

Advertisements,’’ August 1999; announced in Federal Register, v. 64, n. 152, p. 

43197–43198 (Aug. 9, 1999, Docket 97D–0302). 

Food and Drug Administration, Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications (1999c) ‘‘Attitudes and 

Behaviors Associated with Direct-to-Consumer (DTC) Promotion of Prescription 

Drugs: Main Survey Results,’’ available at www.fda.gov/cder/ddmac/dtcindex.htm. 

Food and Drug Administration (2001) ‘‘Agency Information Collection Activities; 

Proposed Collections; Comment Request; Assessment of Physician and Patient Attitudes Toward Direct-to-Consumer Promotion of Prescription Drugs,’’ Docket No. 

01N–0078, Federal Register: March 19, 2001 (Volume 66, Number 53). 

Lancet (1998) Editorial, ‘‘Pushing Ethical Pharmaceuticals Direct to the Public,’’ 

v. 351, March 28. 

National Consumers League (1998) ‘‘Health Care Information and the Consumer: 

A Public Opinion Survey.’’ Washington, D.C.: National Consumers League (1701 K 

Street, NW, Suite 1200, Washington, DC 20006). 

National Institute for Health Care Management (NIHCM) (2001) ‘‘Prescription 

Drug Expenditures in 2000: the Upward Trend Continues.’’ Washington, D.C.: 

NIHCM Foundation. 

29

NewsHour with Jim Lehrer, Kaiser Family Foundation, Harvard School of Public 

Health (2000a) ‘‘National Survey on Prescription Drugs: Toplines.’’ Available at 

www.kff.org. 

NewsHour with Jim Lehrer, Kaiser Family Foundation, Harvard School of Public 

Health (2000b) ‘‘National Survey on Prescription Drugs: Highlights and Chartpack.’’ 

Available at www.kff.org. 

National Institutes of Health, National Cholesterol Education Program (2001) 

‘‘Recommendations on Lipoprotein Measurement,’’ from the Working Group on 

Lipoprotein Measurement. 

Prevention Magazine (1999) ‘‘A National Survey of Consumer Reactions to Directto-Consumer Advertising.’’

Prevention Magazine (2000) ‘‘International Survey on Wellness and Consumer Reactions to DTC Advertising of Rx Drugs.’’

RxHealth Value, ‘‘Prescription Drug Expenditures Increase More Than 24%,’’ 

downloaded May 17, 2001 from www.rxhealthvalue.com, summarizing a May 2001 

report from the Schneider Institute for Health Policy at Brandeis University. 

Stolberg, Sheryl Gay (2000) ‘‘Ads that Circumvent Doctors: Want a New Drug? 

Plenty to Choose From on TV,’’ New York Times, January 23, 2000. 

Wilkes, Michael S., Robert A. Bell, and Richard L. Kravitz (2000) ‘‘Direct-To-Consumer Prescription Drug Advertising; Trends, Impact, And Implications,’’ Health Affairs, March/April.

Senator DORGAN. Mr. Calfee, thank you very much. 

You must leave soon, is that correct? 

Mr. CALFEE. That is correct. 

Senator DORGAN. Senator Wyden. 

Mr. CALFEE. But not immediately, please. 

Senator DORGAN. Let me do this, if you do not mind, with your 

permission. Let me hear from Dr. Wolfe and Dr. Glover. It will 

take about 10 minutes, then we will have some questions. We will 

ask the questions of you first so that you may leave. 

STATEMENT OF SIDNEY M. WOLFE, M.D., DIRECTOR, PUBLIC 

CITIZEN’S HEALTH RESEARCH GROUP 

Dr. WOLFE. Thank you. 

There is little doubt that false and misleading advertising to patients and physicians can result in prescriptions being written for 

drugs that are more dangerous and/or less effective than perceived 

by either the doctor or the patient. It is counterintuitive not to believe that misleading advertising, of which there is quite a bit, and 

I will go through some of the numbers, does not convince people as 

much or more than non-misleading advertising, and therefore Dr. 

David Kessler’s statement, which I agreed with when he made it, 

that advertising can cause death and injury if it results in inappropriate prescribing, has got to be true. 

The fact that there are not any studies of it, your point Mr. 

Chairman, it is not that there are careful studies which have 

shown no evidence of inappropriate prescribing. There are not any 

good studies that have been done. As I said, the evidence that the 

industry has is that when they do direct-to-consumer advertising, 

as pointed out, in conjunction with prescription advertising to doctors, the prescribing goes way up. It is a combination of the both. 

An often misled prescriber and a misled patient can combine to get 

a prescription written that might otherwise not have been written. 

This can then lead to a subsequent toll of deaths and injuries 

that would not have occurred had safer, more effective drugs been 

prescribed. Senator Wyden’s question is also very legitimate in the 

sense that inappropriate prescribing may be prescribing a more exVerDate 0ct 09 2002 09:10 Mar 04, 2004 Jkt 089956 PO 00000 Frm 00033 Fmt 6633 Sfmt 6601 S:\WPSHR\GPO\DOCS\89956.TXT JACK PsN: JACKF
30

pensive drug instead of a less expensive drug, ultimately leading 

the patient not to have enough money to take care of themselves. 

So from the standpoint of cost, inappropriate prescribing can also 

be dangerous. 

The more than 500 prescription drug advertisements that have 

been found by the FDA to violate Federal laws and regulations 

from 1997 to the present include approximately 90 direct-to-consumer ads. These numbers would be significantly larger if FDA’s 

Division of Drug Marketing, Advertising, and Communication had 

more staff to investigate the rapidly expanding area of DTC drug 

promotion. 

As seen in the table included in my testimony—these are taken 

from FDA’s own data—there has been a sharp and steady decrease 

during the last 3 years in the number of FDA warning letters and 

notices of violation of FDA laws and regulations to drug companies 

concerning prescription drug advertising. For the last full year, 

mid-2000 through mid-2001, the total number of advertising enforcement actions, 74, was less than one-half, 47 percent, of the 158 

enforcement actions taken 3 years ago, mid-1997 through mid1998. 

There is no evidence of an advertising/pharmaceutical industry 

epiphany resulting in fewer illegal advertisements for prescription 

drugs. Therefore the only plausible explanation for this dangerous 

decrease is that the police force, DDMAC, has not been strong 

enough in numbers of investigators, along with the lack of adequate pro-enforcement leadership, meaning from the Commissioner 

and the head of the drugs division, from the top officials. 

That this latter explanation, inadequate enforcement, is correct 

will be seen—and my optimism comes out here—when the FDA, 

with the urging and support of your committee and the Appropriations Committee, begins to increase the number of actions taken 

against these violative acts. Until then, Americans, both physicians 

and patients, will be harmed by prescribing decisions about which 

drugs to use based on all too frequently false and misleading information from advertisements which are much less likely now to be 

stopped because of poor enforcement. 

In addition to more staff, there is a dire need for direct-to-consumer specific regulation since, other than the late 1990’s guidance 

concerning TV advertising which Dr. Ostrove spoke of, which is a 

guidance, not a regulation, there are no regulations specifically 

written for direct-to-consumer advertising. The FDA has been 

using regulations promulgated after the 1962 Kefauver–Harris 

amendments that were clearly intended for prescription drug advertising directed to health professionals, such as doctors and pharmacists. 

We have been urging the agency since the mid-1980’s to propose 

and finalize such consumer-specific DTC regulations that would 

make it easier to evaluate the ads in the context of patient, not 

health professional, comprehension. 

Beyond more staff and direct-to-consumer specific regulations, 

there is a need for much more enforcement power. At present the 

FDA is limited to a notice of violation or warning letter to companies found to violate the law or regulations. Theoretically, in the 

face of multiple warnings to the same company, criminal prosecuVerDate 0ct 09 2002 09:10 Mar 04, 2004 Jkt 089956 PO 00000 Frm 00034 Fmt 6633 Sfmt 6601 S:\WPSHR\GPO\DOCS\89956.TXT JACK PsN: JACKF
31

tion is a possible tool. This latter power has only been used a handful of times in the past 30 years. To our knowledge, never has it 

been used for direct-to-consumer advertising. 

Despite a series of 11 illegal ads for Claritin, 8 of which were direct-to-consumer, 14 illegal ads for Flonase and Flovent, two drugs, 

one used for nasal problems and the other for pulmonary problems—8 of these 14 illegal ads are DTC—and 5 illegal ads for 

Celebrex, one DTC, no criminal prosecution of these companies. 

What is more, the ability to assess drug companies large civil monetary penalties for advertising violations could serve as a deterrent, 

but the FDA has no authority at all to impose civil monetary penalties on any drug company for anything, whether it is advertising 

violations or anything else. 

Senator Kennedy attempted to get such authority included in the 

1997 Food and Drug Modernization Act. It was fought hard and 

successfully by the industry. If the FDA does not have the ability 

to impose massive fines, if not criminally prosecute these companies, the companies will just laugh and continue violating the law 

with another violative ad. 

Just briefly, a few articles that certainly do raise some serious 

questions about some of the optimistic things that Dr. Ostrove 

talked about and that Mr. Calfee talked about. In one study researchers found that consumers rated the safety and appeal of 

drugs described with an incomplete risk statement more positively 

than those drugs for which risks were described more completely. 

It has obvious implications since many direct-to-consumer ads understate the safety of drugs. 

Another study found that consumer beliefs that there was prior 

scrutiny of ads, DTC ads, by the FDA and that they were held to 

higher standards than other ads were generally wrong. Another 

study on the educational content—we hear from the industry these 

are for education; they are really not to sell drugs; we just want 

to educate the public—found that, while may ads provided information about the name and symptoms of the disease for which the 

drug was being promoted, few educated the patients about the success rate of the drug, how long you had to use the drug, alternative 

treatments, including behavioral change, which could improve their 

health, or misconceptions about the disease. The authors concluded 

the ads provide only a minimum amount of educational information. 

Finally, one study asked patients what they would do if a doctor 

refused to prescribe a drug that the patient wanted as a result of 

a DTC ad. One-fourth of the patients said they would seek a prescription elsewhere and 15 percent said they would consider terminating the relationship with the physician. To the extent that this 

obviously impairs the doctor-patient relationship, this goes counter 

to what was said before. 

Patients with these attitudes were ones who had a more favorable evaluation of DTC advertising and who possessed more faith 

in the current government regulation of DTC ads. 

In closing, FDA resources and specific regulatory authority to 

monitor the accuracy of drug safety and effectiveness portrayed in 

DTC ads are dangerously inadequate and many patients’ perceptions of these ads and their subsequent response to the ‘‘informaVerDate 0ct 09 2002 09:10 Mar 04, 2004 Jkt 089956 PO 00000 Frm 00035 Fmt 6633 Sfmt 6601 S:\WPSHR\GPO\DOCS\89956.TXT JACK PsN: JACKF
32

* The information referred to has been retained in Committee files. 

tion’’ therein is similarly dangerous. The present situation concerning DTC advertising is unacceptable and it is our hope that 

your committee will participate in initiating actions to remedy 

these serious problems. 

I would also request that a study put out by another part of our 

organization, Public Citizen Congress Watch, related very much to 

the issues that Senator Wyden raised about drug costs and that 

you raise, be put in the record. It is called ‘‘Prescription Research 

and Development Myths: The Case Against the Drug Industry’s R 

and D Scare Card.’’

Senator DORGAN. Without objection, it will be put in the record. * 

Dr. WOLFE. Thank you. 

[The prepared statement of Dr. Wolfe follows:]

PREPARED STATEMENT OF SIDNEY M. WOLFE, M.D., DIRECTOR, PUBLIC CITIZEN’S

HEALTH RESEARCH GROUP

Because of the strong First Amendment in the U.S constitution, there is no way 

that DTC prescription drug advertising could ever be banned in this country. Having said that, however, there is an urgent need for more fine-tuned, better-staffed 

and much tougher government regulation of its content. There is little doubt that 

false and misleading advertising to patients and physicians can result in prescriptions being written for drugs that are more dangerous and/or less effective than perceived by either the doctor or the patient. This can then lead to a subsequent toll 

of deaths and injuries that would not have occurred had safer, more effective drugs 

been prescribed. 

The more than 500 prescription drug advertisements that have been found by the 

FDA to violate federal laws and regulations from 1997 through the present include 

approximately 90 DTC ads. These numbers would be significantly larger if FDA’s 

DDMAC (Division of Drug Marketing Advertising and Communication) had more 

staff to investigate the rapidly expanding area of DTC drug promotion. Such advertising has more than tripled in dollar volume from $791 million in 1996 to $2.5 billion in 2000. But the number of FDA staff assigned to reviewing and investigating 

all of prescription drug advertising, during the same interval, has only increased 

from 11 in 1996 to 14 at present. I have been informed that there is, or will shortly 

be, an increase in DDMAC staff to monitor such advertising and it comes none too 

soon. Even this may well not be adequate. 

As seen in the table on the next page, there has been a sharp and steady decrease 

during the last three years in the number of FDA warning letters and notices of 

violation of FDA laws and regulations to drug companies concerning prescription 

drug advertising. From a peak of 84 such enforcement actions during the first six 

months of 1998, the number has fallen steadily to 36 FDA actions during the last 

six months of 2000 and an estimated 38 actions during the first six months of 2001. 

For the last year (mid-2000 through mid-2001) the total number of DDMAC advertising enforcement actions—74—was less than one-half (47%) of the 158 enforcement actions taken three years ago (mid-1997 through mid-1998). There is no evidence of an advertising/pharmaceutical industry epiphany, resulting in fewer illegal 

advertisements for prescription drugs. Therefore, the only plausible explanation for 

this dangerous decrease is that the police force—DDMAC—has not been strong 

enough in numbers of investigators along with a lack of adequate pro-enforcement 

leadership from the top officials in FDA. That this latter explanation, inadequate 

enforcement, is correct will be seen when the FDA, with the urging and support of 

your committee, begins to increase the number of actions taken against these violative ads. Until then, Americans—both physicians and patients—will be harmed by 

prescribing decisions about which drugs to use based on all-too-frequently false and 

misleading information from advertisements which are much less likely to be 

stopped because of poorer enforcement by the FDA.

33

In addition to more staff, there is a dire need for DTC-specific regulations since, 

other than the late 1990’s guidance concerning TV advertising—which is a guidance 

not a regulation—there are no regulations specifically written for DTC advertising. 

The FDA has been using the regulations promulgated after the 1962 Kefauver-Harris Amendments to the Food, Drug and Cosmetic Act that were clearly intended for 

prescription drug advertising directed at health professionals such as doctors and 

pharmacists. We have been urging the agency since the mid-1980’s to propose and 

finalize such consumer specific DTC regulations that would make it easier to evaluate the ads in the context of patient, not health professional, comprehension. Beyond 

more staff and DTC-specific regulations there is a need for much more enforcement 

power. At present, the FDA is limited to a Notice of Violation or Warning Letter 

to companies found to violate the law or regulations. Theoretically, in the face of 

multiple warnings to the same company, criminal prosecution is a possible tool. This 

latter power has only been used a handful of times in the past 35 years. To our 

knowledge, criminal prosecution has never been used in the context of DTC advertising, despite, for example, a series of 11 illegal ads for Claritin (8 DTC), 14 illegal 

ads for Flonase/Flovent (8 DTC). (Flonase and Flovent are the same drug in two 

versions, one used for allergy, the other for asthma). There have also been five illegal ads for Celebrex (1 DTC). 

The ability to assess drug companies large civil monetary penalties for advertising 

violations might actually serve as a deterrent for companies who now just stop the 

violative ad, when requested by the FDA, then create and massively disseminate a 

new one shortly thereafter. The FDA currently lacks the authority to impose any 

civil penalties for drug advertising or, in fact, for any other illegal drug industry 

activity concerning prescription drugs. It is long overdue that the Congress give the 

FDA this authority. 


724wol.eps
34

1 J Health Communic 2000 Oct-Dec;5:349–69.

2 J Gen Int Med 1999;14:651–7.

3 J Fam Pract 2000;49:1092–8.

4 J Fam Pract 1999;48:446–52.

A search of the peer-reviewed, published medical studies concerning DTC advertising yields findings that, for the most part, are also quite worrisome:

• In one study, researchers found that consumers rated the safety and appeal of 

drugs described with an incomplete risk statement significantly more positively 

than those whose risks were described more completely. 1 (This has significant 

implications since so many DTC ads understate the safety of drugs.) 

• Another study found that consumer beliefs that there was prior scrutiny of DTC 

ads by the FDA and that they were held to higher standards than other ads 

were generally wrong. A substantial proportion believed that only the safest and 

most effective drugs could be advertised DTC and that the FDA required prior 

review of ads. DTC ads led one-fifth of people to request a prescription. 2

• A study on the educational content of DTC ads found that while many ads provided information about the name and symptoms of the disease for which the 

drug was being promoted, few educated the patients about the success rate of 

the drug, how long you had to use the drug, alternative treatments including 

behavioral changes which could improve their health, or misconceptions about 

the disease. The authors concluded that the ads provided only a minimal 

amount of educational information. 3

• One study asked patients what they would do if a doctor refused to prescribe 

a drug that the patient wanted as a result of a DTC ad. One-fourth of patients 

said they would seek a prescription elsewhere and 15% said they would consider 

terminating their relationship with their physician. The patients with these attitudes were ones who had a more favorable evaluation of DTC advertising and 

who possessed more faith in the current government regulation of DTC drug 

ads. 4

In summary, FDA resources and specific regulatory authority to monitor the accuracy of drug safety and effectiveness portrayed in DTC ads are dangerously inadequate and many patients’ perceptions of the ads and their subsequent response to 

the ‘‘information’’ therein is similarly dangerous. The present situation concerning 

DTC advertising is unacceptable and it is our hope that your committee will initiate 

actions to remedy these serious problems.

Senator DORGAN. Dr. Wolfe, thank you. 

Next on this panel we will hear from Dr. Glover. Dr. Glover, and 

you are an attorney-physician representing PhRMA, is that correct? 

Mr. GLOVER. That is correct. 

Senator DORGAN. Thank you. Welcome. 

STATEMENT OF GREGORY J. GLOVER, M.D., J.D.,

ON BEHALF OF THE PHARMACEUTICAL RESEARCH

AND MANUFACTURERS OF AMERICA 

Mr. GLOVER. Mr. Chairman and Members of the Subcommittee: 

On behalf of the Pharmaceutical Research and Manufacturers of 

America, I thank you for inviting me today to testify on direct-toconsumer advertising of prescription drugs. I am a licensed physician and a practicing attorney with the law firm of Ropes and Gray 

and I specialize in FDA regulatory issues and intellectual property 

law. 

PhRMA represents the country’s major research-based pharmaceutical and biotechnology companies, which are the source of virtually all new drugs in the United States. PhRMA strongly supports direct-to-consumer advertising of prescription medicines as 

currently regulated by FDA and opposes any further restrictions on 

this pro-patient, pro-health activity. 

35

Under current practices, patients are now more actively involved 

in their own health care than ever before. Rather than remaining 

uninformed and relying entirely on an increasingly complex health 

care system, patients are asking questions, evaluating information, 

and making choices. Direct-to-consumer advertising provides a valuable resource for patients to obtain information about specific diseases, conditions, and treatments. 

Patients suffering from chronic conditions may be dissatisfied 

with current treatment, but may be unaware that different options 

are available with fewer side effects and easier dosing regimens. 

Similarly, pharmaceutical advertisements improve the public 

health by raising awareness of conditions and diseases that often 

go undiagnosed and untreated. 

There are encouraging signs that direct-to-consumer advertising 

is helping to address these issues. A survey by Prevention magazine found that, as a result of direct-to-consumer advertising, an 

estimated 24.7 million Americans talked to their physicians about 

a medical condition they had never previously discussed with a doctor. In other words, millions of people who had suffered in silence 

were encouraged to seek help. 

A 1999 survey by Prevention magazine found that 27 percent of 

respondents asked their physicians about conditions they had not 

discussed before. These conditions ranged from arthritis and heart 

disease to depression. In the 2 years that ads for a medicine for 

erectile dysfunction have appeared, millions of men have visited 

their doctors to request a prescription for the drug. For every million men who asked for the medicine, it was discovered that an estimated 30,000 had untreated diabetes, 140,000 had untreated high 

blood pressure, and 50,000 had untreated heart disease. These 

numbers are striking and they are just for one drug. 

A growing body of evidence suggests that consumers like directto-consumer advertising. A 1999 survey by FDA found that those 

who liked these ads outnumbered those who did not by nearly two 

to one. 86 percent said, the ads helped make me aware of new 

drugs and 62 percent said the ads helped them have better discussions with their physicians about their health. 

A survey by Prevention magazine found that 76 percent of respondents thought ads help people be more involved in their health 

care and 72 percent felt the ads educate people about the risks and 

benefits of prescription medicines. 

There is also growing acceptance of this type of advertising by 

doctors. A survey last year found the 64 percent of doctors believe 

that such advertisements had helped educate and inform their patients and 40 percent of the doctors surveyed believed that ads 

have increased patient compliance. 

Critics contend that direct-to-consumer advertising drives up the 

price of drugs. In fact, while total pharmaceutical expenditures are 

rising, price increases have been in line with inflation. Most of the 

increase in drug expenditures has come from the increased use of 

prescription medicines, including the use of newer, more effective 

therapies. 

The increased use of prescription drugs is a healthy trend. Drugs 

not only save lives, they save by reducing the need for alternative, 

more expensive care. Still, only 8.2 percent of every health care dolVerDate 0ct 09 2002 09:10 Mar 04, 2004 Jkt 089956 PO 00000 Frm 00039 Fmt 6633 Sfmt 6601 S:\WPSHR\GPO\DOCS\89956.TXT JACK PsN: JACKF
36

lar is spent on prescription medicine, compared to 32 percent on 

hospital care and 22 percent on physician and clinical services. 

In summary, direct-to-consumer advertising helps address consumers’ need for information about diseases and treatments. More 

important, direct-to-consumer advertising can improve public 

health by starting a dialogue between patients and doctors that 

may lead to a better understanding and treatment of a patient’s 

condition. 

I hope you will support patients and oppose those advocating 

adoption of a do not tell, do not ask policy, do not tell people about 

new medicines and hope they will not ask. That policy would be 

bad for the public health. 

I will be pleased to answer any questions you may have. Thank 

you very much. 

[The prepared statement of Dr. Glover follows:]

PREPARED STATEMENT OF GREGORY J. GLOVER , M.D., J.D., ON BEHALF OF THE

PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA

Mr. Chairman and Members of the Subcommittee: 

On behalf of the Pharmaceutical Research and Manufacturers of America, I am 

pleased to appear at this hearing this afternoon on direct-to-consumer (DTC) advertising of prescription medicines. I am a licensed physician and a practicing attorney 

with the law firm of Ropes & Gray, specializing in FDA regulatory issues and intellectual-property law. PhRMA represents the nation’s leading researchbased pharmaceutical and biotechnology companies, which are leading the way in the search for 

new cures and treatments that will enable patients to live longer, healthier, and 

more productive lives. 

This year, PhRMA member companies will invest more than $30 billion to discover and develop new medicines. The mapping of the human genome has opened 

new frontiers, new paths to better health, pointing the way to treatments never 

dreamed possible. The industry is most encouraged about the prospects for exponentially better treatments—and, possibly, cures—for Alzheimer’s, AIDS, arthritis, cancer, diabetes, heart disease, stroke, and many other diseases. 

Just a few weeks ago, for example, a breakthrough drug for leukemia was approved. This medicine, which blocks the biochemical switch that causes normal cells 

to turn cancerous, heralds a whole new era of very promising cancer research. The 

FDA is reviewing an application for a new, life-saving drug that reduced the risk 

of death from sepsis by a dramatic 20 percent in a study published in The New England Journal of Medicine. Sepsis kills more than 1,400 people every day and is the 

leading cause of death in non-coronary intensive-care units with an estimated treatment cost of $17 billion annually in the United States. 

Left sitting on the pharmacy shelf, medicines don’t do anyone any good. Unless 

they are prescribed for patients, medicines cannot prolong life, ease pain, reduce disability, or make life better. And unless medicines are prescribed and used, they will 

not generate the funds needed for private industry to continue to research and develop future cures and treatments. 

That is why PhRMA enthusiastically supports DTC advertising of prescription 

medicines, which is regulated by the FDA, and opposes any further restrictions on 

this pro-patient, pro-health activity. 

Patients are seeking more information as they navigate the increasingly complex 

maze that is our health-care system. We believe more information is good. Medicines have been proven to be the most cost-effective form of health care and can 

often keep patients out of hospitals and nursing homes and help them avoid surgery 

and other, more expensive forms of care. For example, a 1998 study sponsored by 

the National Institutes of Health (NIH) found that treating stroke patients promptly 

with a clot-busting drug nets an average savings of $4,400 a year per patient by 

reducing the need for hospitalization, rehabilitation, and nursing-home care. According to NIH, use of this medicine could save the health-care system more than $100 

million a year. 

Background 

Over the course of history, the medical community has resisted DTC advertising 

of prescription medicines. Physicians wanted tight control over what information 

37

was conveyed to patients. In 1555, for example, the Royal College of Physicians in 

London decreed that ‘‘no physician teach people about medicines or even tell them 

the names of medicines.’’ The fear was that people would use medicines improperly 

and be harmed. 

That attitude persisted for more than 400 years. As recently as the mid-1980’s, 

the FDA imposed a voluntary moratorium on DTC ads. After the moratorium was 

discontinued, many pharmaceutical companies began advertising their medicines directly to consumers, following FDA rules. 

In 1997, the FDA issued guidelines that clarified the agency’s broadcast advertising requirements. No longer would the FDA require ads to contain voluminous 

and often confusing information about a drug’s side effects in radio and television 

ads. Under the FDA’s draft guidance, ads must list major health risks as well as 

side effects, and must set forth four ways for consumers to receive additional information: through an 800 number, an Internet site, reference to a print ad in a major 

national publication, and through their physician or pharmacist. 

The FDA’s 1997 decision stemmed from a policy that had led to ineffective and 

confusing advertisements. Prior to the 1997 guidance, the FDA required that a brief 

summary of the prescribing information for a drug had to be included in all advertisements that both name a prescription drug and state its purpose, including 

broadcast ads. The brief summary is an FDA-approved document that advises physicians, in very technical language, how to properly use a drug. Because of technical, 

scientific wording in the brief summary, it is very difficult for patients and consumers without a medical background to understand. 

Prior to the 1997 guidance, pharmaceutical companies that wanted to include 

both the name of a drug and the condition it was intended to treat were forced to 

include the small print that constituted this complicated prescribing information. 

While feasible in newspapers and magazines, such ads were not possible for radio 

and television. This prompted companies to advertise on television in more oblique 

ways that, while meeting legal requirements, may not have been very helpful to patients. In such ads, either the name of a medicine or the name of the illness could 

be mentioned—but not both. Consumers were often left to guess what disease a 

medicine was intended to treat. 

This system was clearly unsatisfactory. As Dr. William Jacott, a trustee of the 

American Medical Association (AMA), said at the time: ‘‘The problem with the way 

the FDA currently regulates ads is that they discourage companies from providing 

information that may educate the consumer. The merest mention of symptoms and 

a drug requires that a company also include reams of information that most people 

won’t read and many wouldn’t understand anyway.’’

In announcing the clarifying guidance in August 1997, Michael Friedman, M.D., 

then FDA Lead Deputy Commissioner, said: ‘‘Today’s action can help promote greater consumer awareness of prescription drugs.’’ And Robert Temple M.D., Associate 

Director for Medical Policy at the FDA’s Drug Division, said that, under the new 

guidance, ads could inform consumers about new products about which they might 

not otherwise learn. As an example, he cited a new generation of antihistamines 

that don’t cause drowsiness. ‘‘You need to be told by someone that those products 

are out there or you’ll never know,’’ he said. 

The Information Revolution in Health Care 

Under current practices, patients now are more actively involved in their own 

health destinies than ever before. The consumer movement and the information explosion have empowered patients to participate in decisions concerning their health 

care. Armed with information, patients have become active partners with healthcare professionals in managing their own health care. And they are savvy consumers. 

Rather than remaining uninformed and relying entirely on an increasingly complex health-care system, patients are asking questions, evaluating information, and 

making choices. Direct-to-consumer advertising provides a valuable resource for patients to obtain information about specific diseases, conditions, and treatments, particularly in rural areas of the country where access to providers and health-care information may be difficult. 

Too often, many common yet serious conditions go untreated even though effective 

treatments are available. Affected individuals may not realize that they need treatment. Others who are aware of their symptoms may not know that treatment is 

available. Patients suffering from chronic conditions may be dissatisfied with their 

current treatment, but may be unaware that different options are available with 

fewer side effects or an easier dosing regimen. 

Advertising, however, is only one source of user-friendly information that consumers have at their disposal. Some 50 consumer magazines focusing on health care 

38

reach the news stands every month. Just about every television station in the country has an on-screen physician. 

The Physician’s Desk Reference, or PDR, once confined to doctors’ offices, is now 

available in a consumer edition at pharmacy counters. Internet users can surf tens 

of thousands of sites dedicated to health-care topics. In fact, according to health-care 

consultant Lyn Siegel, about 25 percent of online information is related to health 

care and more than half of the adults who go on the web use it for health information. So, while DTC advertising is an important source of information for consumers, 

it is clearly not their only source. But DTC advertising is the most accurate because 

it is regulated by the FDA. 

DTC advertising helps to meet the increased demands of consumers for information about diseases and treatments. Most important, DTC advertising can improve 

public health. It is intended to start a dialogue between patients and doctors. Often, 

this dialogue will not result in a doctor prescribing the drug mentioned by a patient. 

But it will prompt a discussion that may lead to better understanding and treatment of a patient’s condition. It should be emphasized, however, that physicians ultimately decide whether therapy is needed, and, if so, which therapy is most appropriate for a particular patient. 

Underdiagnosis and Undertreatment 

Pharmaceutical advertisements raise awareness of conditions and diseases that 

often go undiagnosed and untreated. For example, the American Diabetes Association estimates that six million Americans have diabetes but don’t know it. One third 

of the people with major depression seek no treatment and millions of Americans 

are unaware that they have high blood pressure. By informing people about the 

symptoms of such diseases and the availability of effective, noninvasive treatments, 

DTC advertising can improve public health. 

There are encouraging signs that this is happening. Following are just a few examples:

• A survey by Prevention Magazine found that, as a result of DTC advertising, 

an estimated 24.7 million Americans talked to their doctors about a medical 

condition they had never discussed with a physician before. In other words, millions of people who had previously suffered in silence were encouraged to seek 

help.

• A 1999 survey by the FDA found that 27 percent of respondents asked their 

doctors about a condition they had not discussed before. Conditions ranged from 

diabetes and heart disease to arthritis, depression, and other undertreated conditions.

• In the two years that ads for a medicine for erectile dysfunction have appeared, 

millions of men have visited their doctors to request a prescription for the drug. 

For every million men who asked for the medicine, it was discovered that an 

estimated 30,000 had untreated diabetes; 140,000 had untreated high blood 

pressure, and 50,000 had untreated heart disease. These numbers are striking—and they’re just for one drug.

• A study by IMS Health, a health-care information company, found that, in the 

one year after an advertising campaign for an osteoporosis drug began, physician visits by women concerned about this disease doubled.

• According to a survey by Scott-Levin, a consulting firm, the number of patients 

visiting their physicians for treatment of depression has increased from about 

17 million in 1996, before treatments for depression were widely advertised to 

consumers, to more than 20 million last year.

• Some 19 million Americans have moderate to severe disability from migraines, 

and 11 million of them are untreated or are treated sub-optimally. Migraine sufferers miss more than 157 million workdays a year and cost U.S. employers as 

much as $17 billion annually in decreased productivity. The good news is that, 

since migraine medicines began to be advertised to consumers, the number of 

people who visited their physicians for treatment rose from about 6,200,000 in 

1996 to about 7,100,000 last year, according to a study by Scott-Levin.

• Many health-care organizations reported an increase in requests for information 

since DTC advertising restrictions were eased in 1997. For example, the American Foundation for Urological Disease experienced a 30–40 percent increase in 

requests for information.

Spillover Benefits 

According to a recent analysis of consumer surveys by John E. Calfee, Ph.D., of 

the American Enterprise Institute, DTC advertising also provides important ‘‘spillVerDate 0ct 09 2002 09:10 Mar 04, 2004 Jkt 089956 PO 00000 Frm 00042 Fmt 6633 Sfmt 6621 S:\WPSHR\GPO\DOCS\89956.TXT JACK PsN: JACKF
39

over’’ benefits to patients, which have nothing to do with the specific products advertised. 

One such benefit is an increased awareness that virtually all prescription medicines have risks and side effects. In addition, physicians, when discussing conditions 

highlighted in advertising such as obesity and high cholesterol, are able to suggest 

lifestyle changes to their patients. And DTC advertising also improves compliance—

it prompts patients actually to take their prescribed medicines. In response to a Prevention survey question, 31 percent of the respondents said that ads made them 

‘‘more likely’’ to take their medicines regularly, compared to only 2 percent who said 

they were ‘‘less likely’’ to do so. 

According to Express Scripts Senior Director of Outcomes Research, Brenda 

Motheral, Ph.D., who was quoted in the Pink Sheet on March 5, 2001: ‘‘People are 

sticking with their chronic medications in higher proportions than what we’ve seen 

in the past... Probably a big driver of that, based on some work that our group 

has done, is direct-to-consumer advertising.’’

The Views of Consumers, Physicians, and Regulators 

A growing body of evidence suggests that consumers like DTC advertising. A 1999 

survey by the FDA found that those who liked these ads outnumbered those who 

did not by nearly 2 to 1. Eighty-six percent said the ads ‘‘help make me aware of 

new drugs,’’ and 62 percent said the ads helped them have better discussions with 

their physician about their health. A survey by Prevention Magazine found that 76 

percent of respondents thought the ads ‘‘help people be more involved in their 

health care’’ and 72 percent felt the ads ‘‘educate people about the risks and benefits 

of prescription medicines.’’

The best way to understand how patients feel about DTC advertising is simply 

to listen to them. Following are comments from patients written to PhRMA companies: 

A patient with herpes wrote: ‘‘For many years people have suffered in silence and 

shame. Making it known that this product is available helps those in need. Putting 

advertisements in magazines and television was a wonderful idea.’’

A patient with chronic obstructive pulmonary disease (COPD) stated: ‘‘You have 

a commercial on TV that mentions COPD and educates the public—in about 30 seconds—as to the prevalence of the disease. I firmly believe more public education is 

not just useful but necessary as the number of people with COPD increases. So I 

want to thank you for raising public awareness of this dreadful disease, and also 

I want to say thanks for helping to keep me alive these past ten wonderful years.’’

Finally, a patient with asthma wrote: ‘‘My concern is the fact that this product 

is not being advertised enough. I have cut back my asthma episodes by 80–90 percent. I have had asthma since I was 3 years old and am now 51. Please get the 

word out about how well this product works.’’

There also is growing acceptance of DTC advertising by doctors. Historically, physician organizations, as well as individual physicians, have expressed concerns 

about DTC advertising. However, a 2000 survey by Louis Harris Interactives and 

the Harvard University School of Public Health found that 64 percent of doctors believe that DTC advertising of prescription drugs helped ‘‘educate and inform’’ their 

patients, and 40 percent of the doctors surveyed believe the ads increased patient 

compliance. 

A 1999 survey by the FDA showed that, when patients asked physicians about 

an advertised medicine, 81 percent of patients said the doctor welcomed the question. Only 4 percent said their physicians appeared angry or upset when asked 

about a medicine. According to Prevention, only 26 percent of patients who talked 

to their physicians about an advertised medicine actually asked for a prescription, 

while 72 percent asked for more information. 

The AMA continues its support of accurate pharmaceutical advertising as ‘‘appropriate and legal,’’ according to a letter by Dr. Richard Johnson in the July 6 issue 

of the Bergen Record. Writing to clarify recent reports about AMA’s policy on DTC 

advertising, Dr. Johnson, who heads the Association’s relevant Reference Committee, stated that the Committee provided language to the AMA House of Delegates ‘‘from numerous physicians who testified that DTC ads are valuable because 

they sometimes educate consumers about health conditions and possible treatments 

that inform consumers better. Testimony also indicated that drug ads may encourage some patients to seek out their physicians and have more knowledgeable discussions about their health conditions and, if applicable, treatment options.’’

The FDA, reaffirming in August 1999 its policy of permitting DTC advertising, 

stated: ‘‘FDA is unaware of any data supporting the assertion that the public health 

or animal health is being harmed, or is likely to be harmed, by the Agency’s actions 

in facilitating consumer-directed broadcast advertising.’’

40

Increased Drug Utilization: a Positive Development 

Critics of DTC advertising claim that it drives up pharmaceutical expenditures. 

While total pharmaceutical expenditures are rising because there is a growing realization of the value of prescription medicines, drug expenditures still make up less 

than 10 cents of every health-care dollar. 

The fact that more patients are getting more and better medicines is good news—

for patients, for the health-care system, and for society. Just a few weeks ago, the 

federal government published new cholesterol standards in an urgent attempt to encourage people to reduce their risk of heart attacks. The National Institutes of 

Health recommended that millions more Americans should take cholesterol-lowering 

drugs, which would nearly triple the number of adults using these drugs. Dr. 

Claude Lenfant, director of the Heart Institute, said that adherence to these guidelines could mean that heart disease would no longer be the top killer of Americans. 

Following are a few more examples of the cost-effectiveness of medicines, using 

drugs that have been the subject of DTC advertising:

• A cholesterol-lowering drug was found to reduce hospital admissions by a third 

during five years of treatment, according to a study by University of Pennsylvania researchers. In addition, patients who were admitted to hospitals had 

shorter stays and were less likely to need bypass surgery or angioplasty. Said 

Dr. Sanford Schwartz, a physician and economist at the University of Pennsylvania: ‘‘This is both good medicine and good economics.’’

• A study published in The Journal of the American Medical Association showed 

that treating Type 2 diabetes with a medicine to improve glycemic control improved the quality of life for patients and helped keep them out of the hospital 

and on the job.

• A study published in Health Economics found that medical costs declined by 

$822 per employee per year and absenteeism dropped by nine days when depressed workers were treated with prescription medicines. Savings from improved productivity and the reduction in work loss and medical costs far outweighed the cost of the treatment.

Advertising Promotes Competition 

People often confuse total drug expenditures, which are going up for the publichealth reasons just outlined, and drug-price increases, which have been in line with 

inflation in recent years. According to IMS Health, total drug expenditures rose 14.7 

percent in 2000. Of that figure, only 3.9 percent represented price increases. The 

remaining 10.8 percent reflects utilization—the fact that more patients are using 

newer and more effective medicines. 

The increased use of prescription drugs is a healthy trend. Drugs not only save 

lives—they save money in many cases by reducing the need for alternative, more 

expensive care such as hospitalization, confinement in a nursing home, and surgery. 

Still, only 8.2 percent of every health-care dollar is spent on prescription medicines, 

compared to 32 percent on hospital care and 22 percent on physician and clinical 

services. 

Historically, advertising has promoted competition and increased volume of sales. 

If anything, this tends to lead to lower—not higher—prices. 

Conclusion 

In summary, DTC advertising helps to meet the increased demands of consumers 

for information about diseases and treatments. More important, however, DTC advertising can improve public health. It is intended to start a dialogue between patients and doctors that may lead to a better understanding and treatment of a patient’s condition. 

Mr. Chairman and Members of the Subcommittee, I hope that you will support 

patients and oppose those who advocate adoption of a ‘‘don’t tell, don’t ask’’ publichealth policy: don’t tell people about new medicines—and hope they won’t ask. That 

policy would be detrimental to public health. 

Instead, I hope you will stand behind the patients’ right to know about new medicines, to seek information from a variety of sources, including DTC advertising, and 

to work with their physicians to help themselves to better health. Ultimately, a physician determines the appropriate medical treatment and may or may not prescribe 

a medication that may or may not have been advertised and mentioned by a patient. 

Thank you very much. I would be happy to answer any questions.

Senator DORGAN. Dr. Glover, thank you very much. 

41

Let me ask a question or so of Mr. Calfee, and if Senator Wyden 

has a question for Mr. Calfee, and then we will allow him to catch 

his airplane. 

Mr. Calfee, you indicated that advertising makes markets work 

better, something that I agree with. Are there peculiar or unusual 

different circumstances with respect to advertising of prescription 

drugs? Others on the panel have talked about the need for regulation in this area of advertising. Do you believe that in this area of 

advertising regulation is necessary? We obviously now have some 

regulation. Some are calling for more. 

Mr. CALFEE. We have a lot of regulation. I would say the prescription drug advertising is regulated more stringently than advertising for any other products available in this country. The FDA 

is unique, I think, among agencies in the stringency with which it 

regulates advertising. Maybe the SEC is somewhat equivalent with 

securities ads, but for ordinary products, for products that people 

buy, FDA advertising is far stricter than it is for any other products. 

But in addition, the big difference, of course, is that you need a 

prescription. Two colleagues of mine and I recently did a study of 

advertising for the statin drugs, Lipitor, Zocor, et cetera, and we 

gathered proprietary data to look and see what happens in this 

market when DTC advertising goes up and down, and it does go 

up and down very rapidly. We could not find any connection between the gyrations in the advertising and changes in the prescriptions of these drugs. 

As far as we can tell, the reason for that is that an ad may get 

you to talk to your doctor about a drug, but once the drug comes 

up, once you are talking to your doctor, the doctor’s influence appears to be overwhelming over other considerations. In the case of 

statin drugs, if you talk to your doctor about a drug, the doctor 

probably will tell you: Well, how much do you weigh, what is your 

diet, and things like that, do you ever exercise, check your cholesterol, and then probably put you through to some advice for some 

lifestyle changes, and it is pretty far down the road before you may 

or may not get a prescription, and then the prescription will be 

whatever the doctor thinks you need, if anything. 

Senator DORGAN. Mr. Calfee, that conclusion seems to be at odds 

with the conclusion that Ms. Chockley talked about, saying that 

the most heavily advertised drugs in 2000 had an aggregate sales 

increase of 32 percent compared to 14 percent increase for all other 

drugs. One would expect that, A, advertising works and, if it 

works, those drugs that are the most heavily advertised would 

have the highest increase in growth in sales. That is exactly what 

Ms. Chockley was testifying to. 

You seem to suggest that is not the case. 

Mr. CALFEE. Yes. I have looked at a lot of advertising research 

over the years and it turns out that if you look at a market you 

often see that advertising follows roughly the same pattern as 

sales, but if you look very closely at the data often what you find 

is something that Nancy Ostrove of the FDA mentioned, which is 

that manufacturers tend to advertise products that are doing well. 

In other words, they have found that if a product is really doing 

well, then they may get more payoff from the advertising, at least 

42

for their particular brand, because after all what they are really 

advertising is their brand, not the entire product category. 

So often what you find is that advertising tends to follow sales 

rather than leading the sales, and whether advertising actually increases those sales is often a very iffy question. It is very difficult 

to determine, and sometimes the advertising does do something for 

the brands, but does not do it for the whole product category. 

Senator DORGAN. Mr. Calfee, you are describing something that 

is foreign to my experience of study as an MBA student, that advertising follows sales performance. That would rewrite the book on 

marketing as I knew it. 

Mr. CALFEE. You will find some books that you would not be able 

to rewrite. 

Senator DORGAN. Maybe I did not read them. 

Senator Wyden. 

Senator WYDEN. Just one if I could, Mr. Calfee, on this question 

of the ramifications for generics, because this is—we all acknowledge that there is virtually no studies at this point, there is no 

analysis, and clearly more needs to be done. But it seems to me 

that we do know that direct-to-consumer advertising is increasing 

the volume of these drugs, these brand name drugs. 

You develop the affinity with your physician and the use of that 

drug, and it just seems to me again conceptually that it is likely 

that you will be using generics at some point. 

Do you disagree with that? 

Mr. CALFEE. To the general principle that advertisement on the 

whole on average tends to increase sales of a product, I do not have 

any objection to that as a general principle. It turns out that the 

effect is usually much less than what people think it is. 

Now, in the particular case of branded versus generics, I guess 

the real question is whether or not advertising somehow heads off 

a switch to generic drugs when generics become available. There 

may be some effect in that direction. We do not really know for 

sure. What we do know, of course, is that when generics appear 

market shares shift very rapidly and prices tend to drop very rapidly. So generics do quite well when they get in the market. 

Senator WYDEN. Well, we are going to explore this. I heard Dr. 

Glover say are we getting into a do not ask, do not tell kind of relationship. I am for asking, I am for telling, but I am also for looking 

at carefully some of the ramifications here that have not been 

looked at. I think that is what troubles Senator Dorgan and I. 

I will have some more questions in a moment. I know you have 

to get a plane. 

Senator DORGAN. Mr. Calfee, thank you for joining us today and 

you are excused. 

Let me ask a couple of questions of the others. Dr. Wolfe, you in 

your testimony described part of what I was asking our first witness about, Dr. Ostrove. That is the issue of enforcement and enforcement of regulations specifically. You indicated that you felt the 

FDA has had a reduced level of enforcement even ad advertising 

has increased? 

Dr. WOLFE. According to their own data, there is almost a 50 

percent decrease in the last 3 years in enforcement actions. As Dr. 

Ostrove said, that is a combination of both direct-to-consumer and 

43

prescription, but I believe, contrary to what she said, that there 

has been as much of a falloff, particularly in the last year or so, 

in direct-to-consumer enforcement activities. 

I would be interested in seeing the data, but the point is that the 

people there that she described, the approximately 13 or 14, are 

not much more than there were before there was no direct-to-consumer advertising or virtually none in the early nineties. It is nowhere near enough. The number of venues—television, radio, print, 

and so forth—have just outstripped—and whereas we ourselves 

strongly believe, have published a number of books, some best-selling books on getting accurate information to patients, they do not 

have drug ads in them and they do not have a biased viewpoint. 

They have a review of published studies and experts in every field. 

When you start getting into the conflict of interest of putting out 

‘‘information’’ that is really primarily intended to sell drugs, not 

primarily intended to educate, it needs serious policing. The FDA 

is an agency in the public health service. It is not doing an adequate job policing. I am told they are interviewing some people now 

for some more positions. We have made requests to the FDA commissioners for 10 or 15 years to ask for more than the number of 

positions they have in this important part of the FDA. 

Again to repeat what Dr. Kessler had said long ago and what I 

agree with, everyone thinks about the drug approval process as one 

which, if it goes wrong, a drug that is unduly safe will get on the 

market and someone will die. People do not think as much as they 

should about the advertising policing process, because if people 

write a prescription, a doctor writes a prescription based on his or 

her own advertising input to patients, and it turns out that they 

could have written a prescription for a safer drug, for a less expensive drug, the patient does not do well. 

This has to be policed much more than it has. Whereas the number and amount of money being spent on direct-to-consumer advertising has skyrocketed up, the other kinds of advertising have also 

increased, not as dramatically, but the overall, as mentioned, is 

close to $16 billion a year. It is an enormous amount of money and 

the amount of money in FDA’s budget to do surveillance over it is 

inadequate. We need better policing. Otherwise whatever is being 

done which is selling drugs is being done on a sort of hucksterism 

kind of basis to the extent that the ads are misleading. 

Senator DORGAN. Dr. Glover, if in the last year there was a 19 

percent increase in the cost of prescription drugs, substantially because of increased utilization, some as a result of price inflation, 

and if one believes that advertising works and therefore, if advertising works, that has in part contributed to that 19 percent increase—you may disagree with that pretext—but if that is the experience, what do you expect will happen on behalf of PhRMA with 

respect to the cost of prescription drugs next year, the year after, 

the year after that? 

We have seen three very healthy double-digit years of cost increases. Where is this heading? 

Dr. GLOVER. Assuming that your facts are correct, first off, we 

believe this is a difference between the price of pharmaceuticals, 

which has remained in line with inflation, and the cost of pharmaceuticals. The cost of pharmaceuticals is driven both by price and 

44

by volume. In a society where you are shifting your health care dollars from more expensive forms of care, such as physician services 

and hospital stays, to the pharmaceutical industry, it is a good 

thing and it is in the public health and it is pro-consumer to have 

more of those dollars go to prescription pharmaceuticals that keep 

people on their jobs, in their communities, and out of hospitals and 

consuming much more expensive care. 

Therefore, while I cannot predict where the number is likely to 

go in the future, we should applaud the possibility that we will 

have newer and better medicines that people will want to use, that 

physicians will want to use, in lieu of putting people in hospitals 

and sending them to physicians at a much higher cost overall to 

society. 

Dr. WOLFE. I just want to I think correct the record. PhRMA has 

repeatedly stated that the price increase—now we are talking 

about price, not the volume, but the price increase—of prescription 

drugs is in line with the consumer price index. I have heard this 

over and over again. I looked at the data on the consumer price 

index. From 1991 to 2000, a 10-year period, the consumer price 

index for prescription drugs went up 1.7 times more than the consumer price index for all items, and in the last 5 years it sent up 

almost 3 times more. 

So this statement that this overall expenditure is largely due to 

things other than price and that price is in line, to me a 1.7-fold 

increase above the consumer price index in 10 years and almost 3 

times is not exactly in line. It is out of line. It is not the only reason why we are paying more for drugs, but it is an important reason. 

Ms. CHOCKLEY. The 19 percent number is ours. It is from 

NIHCM, and so I can tell you how it breaks down actually. Between 1999 and 2000 retail prescription drug spending went up by 

$20.8 billion. What we have found is 42 percent of it was due to, 

the increase in prescription drug spending, was because of the increase in prescriptions, so 42 percent. 36 percent was due to a shift 

from less expensive drugs to more expensive drugs, and 22 percent 

was because of just pure inflation. 

Senator DORGAN. Dr. Glover, do you wish to respond, and then 

I will call on Senator Wyden. 

Dr. GLOVER. Certainly, in two respects. First off, the NIHCM 

number of 19 percent is the percent that includes costs other than 

the costs that are charged by the pharmaceutical companies. It includes costs that are added on by retail pharmacies to the costs 

that go to consumers. 

Second, with respect to Dr. Wolfe’s comments about the inflation 

rate, it is not clear until we look at the numbers whether 1.7 percent is substantially out of line. 

Dr. WOLFE. 1.7 times, not percent. 1.7 times larger than the consumer price index. 

Dr. GLOVER. Dr. Wolfe, given that the consumer price index inflation rate has been very small for the last 10 years, 1.7 times 

does not indicate the severity of any disparity that you want to 

show. 

So at any rate, our position, we maintain what I said as being 

accurate, that we did not say that it was the same as or lower than 

45

the CPI. We said it was in line with the CPI. It is not twice the 

CPI, it is not ten times the CPI. We still stand by our position that 

the majority of the price increase is due to increased utilization, 

which is something that is good. 

Senator DORGAN. Senator Wyden. 

Senator WYDEN. I will get us back to the more mundane subject 

of direct-to-consumer advertising. Dr. Glover, economics 101 suggests to me that the drugs that are going to be advertised are the 

ones that are going to be money-makers. It is just plain and simple. 

It is a marketplace economy. Those are going to be the ones that 

get advertised. So drugs that many people are going to need, but 

are ones that there is not significant profit in, are not going to get 

the same kind of attention in direct-to-consumer advertising. 

So I wonder if what you are really talking about is an ask and 

tell policy, but only with respect to drugs where you can make a 

significant profit. That would concern me as well in terms of the 

ramifications for our society. How would you respond to that? 

Dr. GLOVER. In the scheme of drugs that are patent protected, 

I do not know what the difference is between the advertising for 

those products that are more profitable than others. Your earlier 

question suggested that you were drawing a distinction between 

patent protected pioneer drugs and generic drugs. Pharmaceutical 

companies——

Senator WYDEN. I am not asking about that now. I am just talking about economics 101. You advertise where you are going to 

make money, and there are a lot of drugs folks need where you are 

not going to make a lot of money. So it seems to me that your asking and telling policy, which I happen to think makes a lot of 

sense, I think that is in the interest of empowering consumers, 

really is not one that applies across the board, but it is an ask and 

tell policy that relates only to drugs where there is a significant 

profit to be made. 

Dr. GLOVER. Well, clearly, Senator, it only makes commercial 

and economic sense for companies to advertise products that they 

are most interested in selling. But you cannot suggest that we are 

advertising profitable products in lieu of advertising unprofitable 

products that could be equally substituted for the same condition. 

As FDA has indicated and as the pharmaceutical industry will 

tell you, the products that get most of the attention are products 

that are true innovations, that are having a substantial impact on 

patient care. Those products are often the same products that patients most need because what was previously available was insufficient. 

Senator WYDEN. I am just dying to have somebody in American 

enterprise show me where they are advertising unprofitable products. 

Dr. GLOVER. I do not think any industry intentionally advertises 

unprofitable products, Senator. 

Senator WYDEN. I thought that is what you just said, that there 

is no evidence of whether you are advertising profitable products 

or unprofitable. 

Dr. GLOVER. No, what I said, Senator, is that it is unlikely to be 

the case that anyone is advertising a profitable product for which 

46

there is an alternative that is less profitable. These are drugs 

where there usually is no alternative. 

Senator WYDEN. I just think that the policy of asking and telling, 

which I support, ought to extend across the board, and I do not get 

the evidence that that is the case. If there is any information that 

you could supply us for the record that would indicate that it is applying to a variety of these other products where there are not significant profits to be made, I would very much like to see it, and 

Senator Dorgan has made it clear he is going to hold the record 

open. 

One other question——

Dr. GLOVER. You should not expect that that information exists, 

Senator. 

Senator WYDEN. Right. But you made the claim. 

Dr. GLOVER. I made the claim. 

Senator WYDEN. That is why I was interested in it. 

Dr. GLOVER. I made the claim that in every industry no one intentionally advertises unprofitable products. You should not expect 

this industry to be any different. I also made the claim that the 

products that get advertised are the pharmaceutical innovations. 

For those products there is no unprofitable alternative. 

Finally, as with every other industry, we do not force people to 

advertise things that are not in their commercial best interest. 

Senator WYDEN. Ms. Chockley, if I might, you called for an independent source to try to make sure that people got accurate drug 

information. That operation is going to be a busy one. Suffice it to 

say they would have to handle information that goes out over the 

Internet and information that is available from a variety of 

sources. 

Who do you think should be the independent source in this country for monitoring the drug information that gets out? 

Ms. CHOCKLEY. I think it has to include all stakeholders, so it 

should include the pharmaceutical industry, it should include the 

government, it should include doctors, most importantly. But I 

think that we are going to continue to see this trend increasing and 

the growth in pharmaceuticals I think everyone is predicting is 

going to continue at this high rate. 

I think it behooves us all to have an independent source of information, both for consumers and for physicians. 

Senator WYDEN. So who sets this up? I am not clear. You want 

all these various people to sit around——

Ms. CHOCKLEY. And therefore make it unworkable? 

Senator WYDEN. I thought it was an interesting concept. I was 

curious how it would work. 

Ms. CHOCKLEY. Well, I think that that is the direction that we 

should move, then, is that there are a couple of—Rinehart and 

some other researchers are talking about trying to come up with 

more of an independent group that brings together the different 

stakeholders. 

What is very interesting and kind of gets to a couple of the comments that you made is in the study where we showed that prescription drug spending went up by 19 percent, if you remember I 

said there were over 9,800 drugs. Half of the increase was in 23 

drugs, half the increase. So we could do a lot by just looking at a 

47

few number of drugs in terms of looking at how effective they are 

and when it is appropriate, etcetera, to use them. 

Senator WYDEN. I will tell you, I think the industry has a valid 

point when they say there are a lot of reasons why the cost of 

drugs are going up. 

Ms. CHOCKLEY. Sure. 

Senator WYDEN. There are a whole host of them, and we do need 

to study the implications here. There is not anybody on the planet 

today, if they were redesigning Medicare, would not include a pharmaceutical benefit. I had a physician in Washington County at 

home who put a senior citizen in the hospital not long ago for 6 

weeks because the person could not afford an outpatient benefit. So 

of course pharmaceutical spending went up in that kind of instance. But that was the government’s fault, that was not the fault 

of anybody in the prescription drug industry. 

But what I think Senator Dorgan has raised today are a variety 

of issues that we ought to be looking at. We ought to be looking 

at the implications on generic drugs. I have made it clear we ought 

to be concerned about that. We ought to be looking at the question 

of the doctor-patient relationship. We ought to be looking at the 

area Dr. Wolfe has talked about, ramifications for coupons and 

these programs that draw people in and once they have got them 

there is an affinity there. I think I made it clear to Dr. Glover that, 

while I support his ask and tell policy, I want it extended across 

the board in our society, and I am concerned about the ramifications that it may apply only to these profitable drugs. 

So all of you have given excellent testimony and I wish I could 

spend the day with Senator Dorgan because he is doing important 

work. But thank you for this time. 

Senator DORGAN. Senator Wyden, thank you very much. 

Let me just mention—let me ask a brief question, Dr. Glover, 

and Dr. Wolfe wanted to comment, then I want to go to the next 

panel. Dr. Glover, in response to questions posed by Senator 

Wyden, he was asking I think a very specific interesting question, 

and I think your answer was, understandably, that the drug companies advertise where it is profitable and in their interest to do 

so. 

But then it seems to me what Senator Wyden was getting at is 

if advertising direct-to-consumer is a public service and if it is done 

only in circumstances where it is profitable to do so for the industry, then it becomes only a public service to the extent that it profits the industry with respect to those specific drugs. Is that not the 

case? 

Dr. GLOVER. That is clearly going to be—it clearly is going to be 

the case that we will advertise where it seems to be in our commercial best interest. We believe, however, and I believe that other 

panelists will confirm this, that there are spillover effects from our 

advertising for the drugs that we want to, namely that we raise 

consumer awareness about certain conditions for which there are 

treatments that were not previously available; and second, what we 

think is more important is that it stimulates a conversation with 

the doctor. Where these patients go in, they do not always get the 

drug that we have been advertising. They are often told they need 

to change their health care, their lifestyle. Sometimes they are 

48

given an over-the-counter drug and sometimes they are given another prescription drug. 

So while clearly we are going to advertise where we think it is 

in our best interest, we believe there are going to be spilloff effects 

there. 

Senator DORGAN. Let me say that I think there are benefits to 

direct-to-consumer advertising and I think there are risks. I agree 

with Dr. Wolfe’s opening statement that it is not the case where 

I think the clock will be turned back on this issue, but the risk 

questions I think in addition to the benefit issues pose some very 

interested challenges for us. 

Dr. Wolfe, you wanted to make a comment. 

Dr. WOLFE. Just a comment on the now absent Senator Wyden’s 

question. One category of drugs where it is quite clear that the 

drugs with the best record in terms of preventing death from heart 

attack and stroke are the least advertised and the most advertised 

are the ones that do not have as much evidence, and that is for hypertension. Calcium channel blockers, which do lower blood pressure but do not have anywhere near the evidence of preventing 

stroke and heart attack that beta blockers and diuretics do, are 

much more advertised and have actually surpassed them in the 

number of prescriptions. 

One can say why is it not that the companies that sell beta 

blockers and diuretics, many of which are generically available, to 

repeat that point, why do they not advertise? Well, some of them 

are just small generic companies that mainly cannot keep up with 

the brand name companies. But even some of them who are brand 

name companies do not want to advertise because they can make 

more money off of the much more expensive and, at least as the 

evidence is right now, less effective calcium channel blockers. 

I think that is a good example where the advertising is not limited just to the breakthrough drug that is much better than anything else on the market. 

Senator DORGAN. Dr. Wolfe, thank you very much. This panel 

has been very helpful and I thank you for your testimony. 

I am going to call on the next panel, and as I do I want to recognize our ranking member, Senator Fitzgerald from Illinois. Next we 

are to hear from John Gilensky, Executive Director of RxHealth 

Value, Dr. Michael Shaw, Executive Director of EthicAd, and Dr. 

Richard Dolinar, an endocrinologist from Phoenix, Arizona. 

Let me welcome our ranking member, who has been on the floor 

of the Senate and is just now joining us, Senator Fitzgerald. 

STATEMENT OF HON. PETER G. FITZGERALD,

U.S. SENATOR FROM ILLINOIS 

Senator FITZGERALD. Thank you, Senator Dorgan. I appreciate 

your holding this hearing and I am sorry that it conflicted with a 

floor speech I had to give about the problems at the O’Hare Airport 

in Chicago, which I am sure you have experienced at one time or 

another. 

I think this is an important topic. I come to this debate with a 

fairly open mind. I have not previously taken a position on this 

issue. I come from a family where hardly anybody ever used prescription drugs. To this day, I think the only thing that my parVerDate 0ct 09 2002 09:10 Mar 04, 2004 Jkt 089956 PO 00000 Frm 00052 Fmt 6633 Sfmt 6601 S:\WPSHR\GPO\DOCS\89956.TXT JACK PsN: JACKF
49

ents, who are in their seventies, have in their medicine chest is aspirin. My parents were always cautious about taking any kind of 

prescription medicine, and that is the kind of orientation I have 

had in my own life with my own family, too. 

I do believe that consumers benefit by having as much information available to them as possible. I am concerned, however, that 

direct-to-consumer advertising has in its initial years stimulated 

more usage of prescription drugs than perhaps would be optimal. 

I think that consumers will have to over time develop a healthy 

skepticism about those kind of ads. They may not have had that 

same kind of skepticism with respect to prescription drug advertising a few years ago because we did not have those kind of ads 

before then. 

I know my nine-year-old child, when he was a few years younger, 

every time he saw an ad for a toy or for a cereal he would tell me 

we had to get it, that that cereal is the best cereal. I would say, 

how do you know that, and he would parrot a television ad that 

he had seen. Now as he has gotten older, he has realized that all 

those advertisements have to be taken with a degree of skepticism. 

Just as he has learned that, I think consumers probably have to 

develop a healthy degree of skepticism with respect to prescription 

drug advertisements. But I am not sure that I would ever want to 

go so far as saying that we should prohibit or ban companies from 

making those advertisements. But really I come to this with a pretty open mind, and I want to compliment Senator Dorgan for his interest in the area and for convening this hearing. 

With that, I welcome panel two. 

Senator DORGAN. Senator Fitzgerald, thank you very much. 

We have Mr. Mark—is it ‘‘CLO-tier’’? 

Mr. CLOUTIER. Correct. 

Senator DORGAN. Mark Cloutier—let me amend my earlier announcement—Executive Director of RxHealth Value; Dr. Michael 

Shaw and Dr. Richard Dolinar. Mr. Cloutier, why do you not proceed. 

STATEMENT OF MARK CLOUTIER, POLICY DIRECTOR, 

RXHEALTH VALUE 

Mr. CLOUTIER. Thank you, Mr. Chairman. Senator Dorgan, Members of the Committee: I am Mark Cloutier, Policy Director of 

RxHealth Value, which is a national coalition of consumer groups, 

labor unions, provider groups, business groups, and employers, insurers and health plans, pharmacy benefit management organizations, and academic researchers who are committed to improving 

Americans’ access to health-improving prescription drugs. 

As you can understand, a deliberative body comprised of nearly 

30 organizations will rarely arrive at a full consensus regarding 

any issue. Remarkably, our membership has achieved consensus 

regarding the recommendations I am offering regarding direct-toconsumer advertising of prescription drugs to consumers and patients. We believe safety is at stake. I believe the fact of these consensus recommendations indicates the fundamental importance of 

this issue for the members of RxHealth Value. 

It is our belief that this form of advertising affects the health 

and safety of American patients and consumers. The tremendous 

50

increase in the extent of direct-to-consumer advertising of prescription drugs since the FDA removed the requirement for brief summary of risk information in 1997 is well documented. It is almost 

impossible to open a general news magazine, view prime time television, or listen to the radio and not see or hear advertising for prescription drugs. 

Given that the prescribing physician is the decisionmaker regarding the use of these medications, it is all the more startling 

that so many resources are expended by drug manufacturers to affect the attitudes of consumers and patients. Although there is little evidence, as we heard from Dr. Ostrove, currently available regarding whether consumer and patient attitudes affect physician 

choice in prescribing, no stakeholders in the health system and 

healthy economy have suggested that the impact of such advertising is insubstantial. 

Given the FDA’s expressed interest in assessing the effects of direct-to-consumer advertising, we expect more direct evidence of impact will be available in the near-term future. While we await the 

results of planned and pending studies on the effects of advertising 

on the attitudes, behaviors, and medical outcomes of consumers 

and patients, RxHealth Value members are concerned that risk information in particular is not adequately or effectively conveyed in 

direct-to-consumer advertising. 

One of our member organizations, AARP, recently conducted a 

survey of members to assess the impact of direct-to-consumer advertising, finding that the majority of those surveyed could not recall ever seeing risk information in the ads. As you went up in age 

cohorts, there was even less recall of risk information. This poses 

a serious safety risk to consumers and patients. 

In our first public recommendation to the FDA presented 1 year 

ago at the National Press Club, RxHealth Value emphasized the 

fundamental importance of protecting safety of patients and consumers who are confronted by DTC advertising. Thus, RxHealth 

Value recommends that the Congress direct the FDA to convene a 

task force of key stakeholders, including the pharmaceutical manufacturers who advertise prescription drugs, as well as consumer 

groups, patient organizations, provider groups, payers and relevant 

experts, to develop and test standards for information disclosure in 

direct-to-consumer advertising, to more carefully define the concrete meaning of fair balance in disclosing benefits and risks of advertised medications, to include disclosure of other appropriate 

therapies in addition to alternative medications. 

As you may know, the AMA approximately a month ago passed 

a resolution calling on language ‘‘Your doctor may recommend 

other treatment options that may be equally or more effective.’’ We 

want to support that resolution. 

To further define ‘‘fair balance’’ to mean that full disclosure of 

risks and side effects be given equal print and air time as the description of benefits in the same communication. 

RxHealth Value recommends that the appropriate agencies of the 

Federal Government conduct ongoing research to evaluate the effect of direct-to-consumer advertising on the health of American 

consumers and patients. It is a given that many Americans appreciate the increased awareness of diseases and conditions and potenVerDate 0ct 09 2002 09:10 Mar 04, 2004 Jkt 089956 PO 00000 Frm 00054 Fmt 6633 Sfmt 6601 S:\WPSHR\GPO\DOCS\89956.TXT JACK PsN: JACKF
51

1Draft Guidance for Industry: Consumer Directed Broadcast Advertisements: Availability. 

Federal Register 1997; 62:43171. 2Findlay, Stephen. Prescription Drugs and Mass Media Advertising. NIHCM, Sept. 2000. 

3 Bero, Lisa A. & Lipton, Shira. Methods for Studying the Effects of Direct-to-Consumer Pharmaceutical Advertising on Health Outcomes and Health Services Utilization. (Paper to be presented at ASPE Conference on Methods to Assess Effects of DTC Advertising, May 30, 2001). 4Foley, Lisa A. & Gross, David J. Are Consumers Well Informed About Prescription Drugs? 

The Impact of Printed Direct-to-Consumer Advertising. AARO: Public Policy Institute, April 

2000. 

tial therapies which direct-to-consumer advertising makes possible. 

It is also true that such advertising can obscure potential hazards 

of the pharmaceutical advertised and neglect the relative value of 

other forms of therapy. 

Only thorough independent research can demonstrate the differential impact of such advertising upon the health choices of 

American patients and physicians. 

In conclusion, the members of RxHealth Value applaud the Subcommittee for beginning the investigation of the effects of this increasingly pervasive influence on the therapeutic choices of American consumers and patients. We pledge our assistance in implementing any of these recommendations we have offered and thank 

the Subcommittee for this opportunity to comment. 

[The prepared statement of Mr. Cloutier follows:]

PREPARED STATEMENT OF MARK CLOUTIER, POLICY DIRECTOR, RXHEALTH VALUE

Mr. Chairman, Members of the Subcommittee, I am Mark Cloutier, Policy Director of RxHealth Value, a national coalition of consumer groups, labor unions, provider groups, business groups and employers, insurers and health plans, pharmacy 

benefits management organizations, and academic researchers committed to improving Americans’ access to health-improving prescription drugs. (Our membership list 

is appended below.) As you can understand, a deliberative body comprised of nearly 

30 organizations will rarely arrive at full consensus regarding any issue. Remarkably, our membership has achieved consensus regarding the recommendations I am 

offering regarding Direct-to-Consumer (DTC) advertising of prescription drugs to 

consumers and patients. Safety is at stake. I believe the fact of these consensus recommendations indicates the fundamental importance of this issue for the members 

of RxHealthValue. It is our belief that this form of advertising affects the health 

and safety of American patients and consumers. 

The tremendous increase in the extent of DTC advertising of prescription drugs 

since the FDA removed the requirement for the ‘‘brief summary’’ of risk information 

in 1997 1 is well documented 2. It is almost impossible to open a general news magazine, view a prime time television program or listen to the radio and not see or hear 

advertising for prescription drugs. Given that the prescribing physician is the decision-maker regarding the use of these medications, it is all the more startling that 

so many resources are expended by drug manufacturers to affect the attitudes of 

consumers and patients. Although there is little evidence 3 currently available regarding whether consumer and patient attitudes affect physician choice in prescribing, no stakeholders in the health system and health economy have suggested 

that the impact of such advertising is insubstantial. Given the FDA’s expressed interest in assessing the effects of DTC advertising, we expect more direct evidence 

of impact will be available in the near term future. 

While we await the results of planned and pending studies on the effects of DTC 

advertising on the attitudes, behaviors and medical outcomes of consumers and patients, RxHealthValue members are concerned that risk information in particular is 

not adequately or effectively conveyed in DTC advertising. One of our member organizations, AARP, recently conducted a survey of members to assess the impact of 

DTC advertising 4 finding that the majority of those surveyed could not recall ever 

seeing risk information in the ads. This poses a serious safety risk to consumers and 

patients. In our first public recommendations to the FDA, presented one year ago 

at the National Press Club, RxHealth Value emphasized the fundamental imporVerDate 0ct 09 2002 09:10 Mar 04, 2004 Jkt 089956 PO 00000 Frm 00055 Fmt 6633 Sfmt 6621 S:\WPSHR\GPO\DOCS\89956.TXT JACK PsN: JACKF
52

5Policy Recommendations. RxHealth Value May 10, 2000. 

tance of protecting the safety of patients and consumers who are confronted by DTC 

advertising 5

Thus, RxHealth Value recommends that the Congress direct the FDA:

• To convene a task force of key stakeholders, including the pharmaceutical manufacturers who advertise prescription drugs, as well as consumer groups, patient organizations, provider groups, payers and relevant experts, to develop 

and test standards for information disclosure in DTC advertising.

• To more carefully define the concrete meaning of ‘‘fair balance’’ in disclosing 

benefits and risks of advertised medications to include disclosure of other appropriate therapies in addition to alternative medications.

• To further define ‘‘fair balance’’ to mean that full disclosure of risks and side 

effects be given equal print and air time as the description of benefits in the 

same communication.

RxHealthValue recommends that the Congress direct that the appropriate agencies of the Federal Government conduct on-going research to evaluate the effects of 

DTC advertising on the health of American consumers and patients. It is a given 

that many Americans appreciate the increased awareness of diseases and conditions 

and potential therapies which DTC advertising makes possible. It is also true that 

such advertising can obscure potential hazards of the pharmaceutical advertised 

and neglect the relative value of other forms of therapy. Only thorough, independent 

research can demonstrate the differential impact of such advertising upon the 

health choices of American patients and physicians. 

In conclusion, the members of RxHealth Value applaud the Subcommittee for beginning the investigation of the effects of this increasingly pervasive influence on 

the therapeutic choices of American consumers and patients. We pledge our assistance in implementing any of the recommendations we have offered and thank the 

Subcommittee for this opportunity to comment.

Senator DORGAN. Mr. Cloutier, thank you very much. 

Next we will turn to Dr. Shaw. 

STATEMENT OF MICHAEL S. SHAW, M.D., EXECUTIVE 

DIRECTOR, ETHICAD

Dr. SHAW. Good afternoon, Mr. Chairman, Senator. On behalf of 

EthicAd and the health care community we represent, thank you 

to the Subcommittee for this opportunity to comment on direct-toconsumer advertising. This is the area to which our organization 

is dedicated. EthicAd is an independent and neutral nonprofit organization composed of leaders of the academic health care community. Dr. Michael E. DeBakey is our chairman emeritus. 

EthicAd’s goal is to promote the development of DTC advertising in a manner that maximizes public health benefits. We do 

not oppose DTC advertising, we are not critics of the pharmaceutical industry. Rather, we support the idea that industry should 

work with other stakeholders to define voluntary self-regulatory 

standards for DTC. These standards should be designed to assure 

the American public that the DTC advertising they see represents 

reliable, accurate, and trustworthy medical information. 

The pharmaceutical industry has a long and honorable tradition 

of collaboration with the health care community in the development of high quality professional and patient education programs. 

This traditional relationship is usually a collaborative effort between the health care community and industry. This system provides important checks and balances on the marketer, and I am 

certain this distinguished body understands the importance of 

checks and balances. 

53

DTC represents a dramatic shift in this traditional relationship. 

DTC removes these important checks and balances. DTC provides 

an opportunity for industry to act autonomously to develop and disseminate health care information for the consumer without any 

outside input or review by the medical community. 

The issue is not the relatively innocuous television and magazine 

advertisements. These highly advertised and visible programs are 

closely monitored by the FDA. They represent only the tip of the 

iceberg. Industry is investing hundreds of millions of dollars in a 

wide variety of consumer web sites, patient informational programs 

and relationship marketing projects. 

The overwhelming majority of these arrangements are not reviewed by FDA. Who, then, assures the reliability of this information? 

Currently this DTC content is developed by marketing departments and their advertising agencies, subject only to the internal 

medical review within a given company. Most DTC programs are 

not pre-approved by the FDA. Does this current system assure consumers of reliable and unbiased health care information? Industry 

has no uniform standards other than the expectation that they will 

comply with FDA requirements. But there are an estimated 60 to 

70,000 pieces of DTC material developed each year. The FDA has 

only 13 full-time reviewers. As a practical matter, the FDA can review only a sampling of these materials. Clearly, DTC presents 

great potential for abuse. 

There is a wide disparity in how different companies approach 

DTC. Many pharmaceutical companies are socially responsible and 

ethical in preserving consumer trust. Other companies take a narrower view. They focus on DTC merely as a mechanism to drive 

sales. The consumer is often unable to differentiate between those 

DTC programs designed the promote their health and welfare and 

those programs designed merely to promote sales. There are no 

standards, best practices, or even clear goals for DTC. There should 

be. We applaud the exceptional work of FDA. The agency has balanced conflicting demands of its stakeholders to review mountains 

of promotional materials using extremely limited resources. FDA is 

the American public’s best protector in this area. It requires increased resources to manage the increased demands placed upon it 

by DTC. 

But FDA regulations alone will not solve the DTC problem. 

These regulations represent minimum legal requirements. They do 

not and cannot and many would argue should not define optimal 

behavior. Clearly, something additional is needed. We do not believe that additional legislative action is required at this time. Instead, we suggest that there is immediate need for industry collaboration with other stakeholders in the development or support 

of voluntary self-regulatory goals, standards, and best practices. 

These standards will assure the American public that the DTC 

health care information they receive is reliable, understandable, 

and trustworthy. 

Rather than wait for government or industry action, the academic health care community that EthicAd represents has developed suggested standards and best practices. These specific standards are summarized in my full written testimony. We believe that 

54

reasonable people develop responsible solutions. We welcome and 

need the active involvement of the pharmaceutical industry and 

the oversight of Congress and the FDA to implement voluntary 

DTC standards. 

Thank you for the opportunity to share these views and to answer your questions. 

[The prepared statement of Dr. Shaw follows:]

PREPARED STATEMENT OF MICHAEL S. SHAW, M.D., EXECUTIVE DIRECTOR, ETHICAD

EthicAd

EthicAd is a non-profit organization representing the neutral and independent 

views of the academic healthcare community. The EthicAd Steering Committee 

and Advisory Board is chaired by, Dr. Michael E. DeBakey, Director of the DeBakey 

Heart Center of the Baylor College of Medicine, and Donna Hill Howes, R.N., M.S., 

Director of Health Education for Time, Inc. Health. It is also composed of leaders 

in medical education. Many of those members have collaborated with the pharmaceutical industry in the development of professional educational programs and materials. EthicAd’s Executive Director, Dr. Michael Shaw, is a physician, educational 

filmmaker, former-educational media specialist at the National Institutes of Health 

National Library of Medicine and President of Shaw Science Partners, Inc. in Atlanta, GA. 

Part 1—Executive Summary 

Direct-to-Consumer Advertising and Public Health 

During the past two years, EthicAd has studied the legal, ethical and practical 

issues underlying DTC advertising. In order to better understand the needs and 

views of the various stakeholders, we obtained advice and input from the pharmaceutical industry, regulatory community, consumer groups, healthcare professionals, 

managed care providers, insurers and members of the legislative community. 

While a significant portion of the medical community and medical organizations 

are opposed to DTC advertising, EthicAd maintains a different position. We respect the pharmaceutical industry’s long tradition of developing valuable and credible professional educational programs. We believe that if industry takes proactive 

responsible steps to develop voluntary goals, standards and best practices, DTC advertising has the potential to make a significant positive contribution to public 

health. We believe that the major concern of healthcare professionals is not the existence of DTC, but the informational depth, quality and focus of the current genre 

of DTC advertising. 

As a result of our research, we offer the following observations about DTC advertising:

1. The Pharmaceutical Industry Has Become a De Facto Member of the 

Healthcare System

DTC represents a dramatic departure from the traditional relationship of the 

pharmaceutical industry to the healthcare professional and patient. Prior to 

DTC, industry communicated directly to the healthcare professional through 

the common language of scientific studies and clinical data. When industry 

sponsored patient education materials, these were distributed to patients only 

after being screened by ‘‘learned intermediaries.’’ DTC fundamentally changed 

this dynamic by enabling industry to provide healthcare information directly 

to patients. Because no tradition or common language exists for industry to 

communicate complex medical information to consumers, by default the ‘‘language’’ used is predominantly one of merchandise advertising. This emphasizes product image and brand awareness more than education. While this 

mode of advertising is appropriate for most types of consumer goods, society 

holds medical practice to higher standards. EthicAd believes that there is an 

important rationale for asking industry to adhere to similar high standards. 

Through DTC, the pharmaceutical industry has become a healthcare provider 

and a de facto member of the healthcare community. In all other instances, 

society requires that healthcare providers undergo extensive training and licensure as a prerequisite for the privilege of providing healthcare to the public. EthicAd believes that, when industry exercises the privilege of becoming 

a provider of healthcare information, industry must take similar self-regulatory steps to assure that the information it develops, sponsors and/or proVerDate 0ct 09 2002 09:10 Mar 04, 2004 Jkt 089956 PO 00000 Frm 00058 Fmt 6633 Sfmt 6621 S:\WPSHR\GPO\DOCS\89956.TXT JACK PsN: JACKF
55

vides adheres to ethical standards comparable to those of other healthcare 

providers.

2. DTC—The Tip of the Iceberg

While DTC advertising is the most visible form of industry involvement in the 

delivery of healthcare information, the scope of this new relationship between 

industry and consumers goes far beyond television and print advertising. In 

recent years, industry has been systematically extending the ‘‘reach’’ of its 

marketing into less apparent direct and indirect forms of healthcare information delivery to consumers. These activities take various forms, from creating 

and sponsoring disease-state Internet sites, to creating and sponsoring patient advocacy groups whose goal is to promote patient information in a manner that is consistent with product marketing strategy. These activities do not 

necessarily fall within the category of ‘‘direct-to-consumer’’ programs but 

under the headings of:

• Relationship marketing;

• Industry-funded patient support programs; and

• Direct-to-patient marketing.

The scope and extent of these alternate forms of healthcare information delivery 

to consumers are not necessarily reflected as DTC spending. They can fall into other 

less apparent categories. Industry’s involvement in communicating directly with patients through these more ambiguous channels is likely to expand exponentially 

given the rate of industry’s growing investment in consumer data mining sources 

such as healthcare Web sites, online patient medical record systems, and pharmacy 

benefits management databases. These forms of patient data sources provide industry with the opportunity to market directly to patients within a specific disease category in a manner that may not be recognized as commercial advertising by patients 

and patients’ families.

3. The Consumers’ Need for Trustworthy Information

Based upon discussions with consumers, we believe that the public may be 

uncertain and confused about the reliability and impartiality of DTC 

healthcare information. As alternate forms of advertising, such as ‘‘infomercials,’’ expand, it will become increasingly difficult for consumers to separate valid and unbiased medical information from commercial product advertising. They are also confused about educational efforts represented as ‘‘independent’’ but actually funded by industry. Activities such as disease-state 

Web sites may be represented as ‘‘independent’’ but may not necessarily be 

unbiased. For example, an ‘‘independent’’ consumer Web site about a cholesterol-lowering treatment may discuss the relative benefits of a particular 

class of drug used to treat high cholesterol in a medically accurate manner. 

But while the materials may be factually correct, they may not provide sufficient emphasis upon the fact that lifestyle modification (proper diet and exercise) might entirely eliminate the need for medication. Thus, while consumers 

and patients have enormous need for healthcare information, they are uncertain about whether they can trust material developed though industry funding.

An important question is, if industry is going to play the role of healthcare 

information provider, how can consumers trust that the information provided 

is independent, unbiased, medically reliable, and represents the patients best 

interest... not just the commercial best interest of the sponsor.

4. The Need for Voluntary Best Practices for DTC

There is enormous variability in the methodologies used by different pharmaceutical companies in the development of DTC campaigns and materials. 

Some companies take extraordinary steps to assure that the DTC programs 

they sponsor provide significant public health benefits. Those companies take 

systematic steps to gain input and suggestions from independent medical experts, consumers, and patient advocacy groups. Some companies develop comprehensive DTC campaigns that include patient education and patient care 

materials developed in collaboration with reputable independent third-party 

organizations and institutions. Other companies have a more restrictive view 

of DTC. They limit DTC activities to product advertising and promotion. Currently, there is no set of standards or best practices, or even agreed upon 

goals for DTC. Moreover, the consumer has no way to differentiate programs 

developed using these ‘‘best practices’’ from those that employ only a narrow 

commercial bias.

56

5. FDA Regulations Represent the Legal Requirements, Not the Highest 

Ethical Standards

We recognize that the FDA has ultimate regulatory authority and commend 

DDMAC for its excellent performance in balancing the complex needs of its 

stakeholders. However, there are limitations to the FDAs role given limitations in its regulatory scope and its finite manpower. While current FDA regulations are necessary to protect the public, they are not sufficient to assure 

that DTC programs promote the public good. The FDA has no regulatory authority to require that industry develop DTC programs in a manner designed 

to promote public health. For example, FDA regulations require that sponsors 

include a ‘‘Brief Summary’’ to accompany a product advertisement. The term 

Brief Summary refers to complex, exhaustive labeling traditionally used to inform physicians about the myriad of potential side effects and complications 

associated with a given product. While the FDA ‘‘encourages’’ pharmaceutical 

companies to modify this Brief Summary into a form that is understandable 

to patients, FDA regulations do not ‘‘require’’ pharmaceutical companies to do 

so. This is but one example of how current FDA regulations protect the public 

interest but do not require industry to act according to optimum standards.

We believe that there is enormous and immediate need for industry to develop voluntary self-regulatory DTC goals, standards, and best practices that 

promote development of consumer healthcare information that is reliable, understandable and trustworthy. 

Part 2

Goals and Standards in Direct-to-Consumer Advertising of Ethical Pharmaceutical 

Products 

Background

Advertising prescription drug products to consumers is a relatively recent phenomenon. The most visible form of DTC advertising, television commercials for prescription products where the indicated use of the product was identified, has only 

been in existence since 1997 when the FDA released its draft Guidance to Industry. 

Because DTC advertising is so new, there has not been enough time to fully assess 

its impact upon public health, or to evolve standards and best practices for DTC advertising. EthicAd has been studying this issue for more than a year. It has obtained input from representatives of the pharmaceutical industry, advertising industry, healthcare professionals, regulatory agencies, patient advocates and, most importantly, consumers. The ideas for DTC Standards described below are based upon 

this research. 

The pharmaceutical industry has a long and honorable tradition of collaboration 

with the medical community and government agencies in the development of new 

therapies and sponsorship of educational programs designed to promote public 

health. DTC advertising represents a fundamental shift in the nature of the pharmaceutical industry’s relationship to healthcare providers, patients, and the public 

(‘‘consumers’’). Prior to DTC, industry made information available to healthcare professionals who then served as learned intermediaries in educating patients with information they deemed relevant. By permitting industry to provide health information directly to consumers, DTC advertising allows industry to function in a role traditionally reserved to trained and licensed healthcare professionals. 

EthicAd is not opposed to DTC advertising. We believe that providing the public 

with reliable, balanced, and understandable information about diseases, treatments 

and prevention can result in consumers developing more responsibility for their own 

health and well-being. EthicAd believes that it is possible for the American people 

to derive public health benefits from DTC advertising if industry takes positive, responsible, and constructive steps to reduce the potential for bias in DTC information. Such voluntary efforts would also reduce the need, or likelihood, of systematic 

government regulation. 

The Need for DTC Best Practices 

The FDA has sole regulatory authority for promotional materials involving prescription pharmaceuticals. However, FDA regulations represent the minimum legal 

requirements, not optimal behavior. Professional organizations, consumer groups 

and the legislative community have raised serious questions about whether the current form of DTC advertising contributes to public health and well-being or merely 

raises the cost of pharmaceutical products and contributes to public confusion. 

EthicAd believes that it is critical for the pharmaceutical industry to take voluntary constructive steps to assure that DTC advertising develops in a responsible 

manner. 

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Just as all healthcare professionals are trained in a set of ethical standards and 

their behavior monitored for adherence to those standards, we believe that industry 

must take concrete positive steps to assure that DTC information is consistent with 

the ethics of good medical practice based upon the following principles:

• By virtue of providing the public with health information through DTC advertising, the pharmaceutical industry has become a de facto healthcare information provider. As with any other health care provider, this is a privilege and 

carries community responsibilities.

• In enjoying this privilege, industry must exercise social responsibility to ensure 

that the information they provide to patients and the public is honest, fair, balanced, and comprehensive.

• In addition, industry should accept responsibility for using DTC advertising as 

an opportunity to collaborate with the medical community, patient advocates 

and government agencies to improve public health by dedicating a significant 

portion of DTC budgets to providing the public with non-promotional educational materials. 

A Vision for DTC 

EthicAd is committed to promoting constructive change in the field of DTC advertising. One of the first steps is to develop a clear vision for DTC advertising.

We envision the next generation of ‘‘ethical DTC advertising’’ to be Direct-to-Consumer programs developed by the pharmaceutical industry in 

collaboration with other stakeholders (the medical community, consumer 

groups, government agencies) that are designed to meet the needs of the 

public for reliable, relevant and trustworthy information while also meeting industry’s need to build brand awareness and promote appropriate use 

of its products.

There are several important elements to this vision. First, it acknowledges the 

fact that the pharmaceutical industry is, and has long been, an active participant 

in the health care system. Second, it recognizes and accepts the fact that the pharmaceutical industry is a business and not a charity. Industry participates in DTC 

because it expects a return on investment. There is nothing inherently wrong with 

this, but by definition, it does mean that industry has an inherent bias. In order 

to create ‘‘socially responsible’’ DTC, it is important to recognize, accept and adjust 

for that bias. This is the third component, the need for collaboration and for systems 

of checks and balances. 

In order for DTC to meet the consumers desire for reliable and trustworthy information, industry can correct its inherent bias through collaboration with outside 

and independent advisors or organizations willing to assure the credibility, reliability, and balance of the information being presented. 

EthicAd Recommended Goals for DTC Advertising

The EthicAd goals for Direct-to-Consumer advertising of pharmaceutical products are:

1. To provide consumers with substantive and reliable information about pharmaceutical products and the diseases that they treat.

2. To provide materials that increase consumer awareness of the signs, symptoms and treatment options for medical conditions.

3. To provide a mechanism for industry to develop and deliver materials to patients/consumers that can be useful in the patients’ care or improve consumers’ 

ability to ask more informed questions of their healthcare provider. 

Best Practices for Development of Quality DTC by Pharmaceutical Industry 

EthicAd has determined that many, but not all, pharmaceutical companies take 

constructive steps to develop socially responsible DTC. The following are industry 

best practices that some pharmaceutical companies are already successfully employing in the development of DTC programs:

1. Ethical DTC advertising should provide consumers with reliable and accurate 

pharmaceutical products available for the treatment of a disease or medical condition without creating misimpressions or unrealistic expectations regarding,

a. The specific patient population for which the product is indicated,

b. The availability of non-pharmacologic means of therapy,

c. Results that patients can expect from treatment, and

d. Possible negative consequences from treatment.

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2. All materials developed through direct or indirect industry influence and/or 

financial support should explicitly state the nature of such support and the nature of influence exercised by industry over the subject matter.

3. When designing a DTC campaign, industry should develop an advisory board 

of independent health care professionals and patient advocates at the formative 

design stage of a DTC campaign. The goal of this advisory board is to help identify the needs of patients and to assure that the approach being developed is 

consistent with public health interests. This best practice helps industry to create DTC programs that balance the needs of the company with the needs of the 

public and the healthcare community.

4. In DTC campaign development, industry should conduct a formal needs assessment of the informational and educational requirements of individuals who 

have a particular disease. In essence, this is a step to define what specific benefits a DTC campaign can provide for consumers and patients.

5. Industry should formally test DTC materials with consumers in order to validate the materials educational efficacy. DTC materials go through a rigorous 

process of focus group testing to assess how well they convey the sponsor’s message. This testing can be expanded to evaluate whether the advertisements are 

conveying medical information clearly and effectively, and to assure that the advertisement is not creating any misimpressions.

6. Industry should develop consumer-friendly versions of the current professional ‘‘Brief Summaries.’’ Not only has the FDA allowed industry to revise this 

material, they have encouraged industry to do so. From a best practice perspective, there is no reason why industry cannot revise the Brief Summaries of each 

and every product that is promoted through DTC by the end of 2002. These revisions should also be tested to assure that they are understandable to the average consumer.

7. Recommendations for DTC Content Design

a. Content accuracy is more than just lack of factual errors. Often materials 

can be misleading by omission of information that can provide objectivity and 

balance. The review process established by industry should include outside 

independent advice from medical experts to look for such important omissions 

or potential areas of confusion.

b. Responsible DTC should include information about behavioral and nonpharmacologic approaches to treatment and/or prevention. In many common 

diseases and conditions, such as hypertension and Type II diabetes, diet and 

exercise are the first-line therapy. DTC materials have the responsibility to 

inform patients of these important public health measures.

c. The use of statistics or data in DTC advertisement can be inherently misleading and, if used, must be presented in a manner that assures accurate 

understanding by the target audience. For example, stating that a drug reduces risk of a disease by 50% may be factually correct. But, that benefit may 

only be a reduction from 2% risk to 1% risk. To simply state a ‘‘50% reduction’’ is inherently misleading unless accompanied by a full and understandable disclosure of the meaning of the data.

d. Industry typically assesses DTC advertising materials by means of field 

tests and focus groups. These tests should be expanded beyond just marketing 

efficacy to include questions that measure whether the content is understandable to consumers and to assure that the content does not create 

misimpressions. That data should be made available to the internal DTC reviewers and should be available for submission if requested by the FDA.

8. Recommendations For DTC Design and Visual Presentation

a. Industry must recognize that patients, especially those with serious or 

chronic medical conditions, may be emotionally vulnerable to information that 

can be interpreted as suggesting unrealistic hope for improvement.

b. Print advertisements and broadcast commercials are expensive to develop 

and disseminate. Obviously, industry has the right to make these materials 

visually attractive so that consumers will pay attention. However, there is a 

point where the application of visual design that appeals to consumers’ ‘‘inner 

self’’ and ‘‘inner desires’’ may become misleading to consumers by creating unrealistic hope. While this area is admittedly subjective, the main area of concern relates to the selection and portrayal of ‘‘role model’’ patients and the 

activities they are represented as performing.

c. Industry should establish a process for including outside medical advice regarding the selection and characterization of actors cast to depict patients sufVerDate 0ct 09 2002 09:10 Mar 04, 2004 Jkt 089956 PO 00000 Frm 00062 Fmt 6633 Sfmt 6621 S:\WPSHR\GPO\DOCS\89956.TXT JACK PsN: JACKF
59

fering from a condition or disease. Every effort should be made to assure that 

actors portraying patients are appropriate in age, sex, race, national origin, 

body habitus, and physical characteristics. Actors portraying patients become 

‘‘role models’’ for how patients see themselves. They should be shown with 

performance and activities that represent realistic expectations for individuals 

who suffer from the respective disease or condition. 

Part 3

EthicAd

EthicAd is non-profit organization dedicated to helping to promote increased 

public health benefits from DTC information about prescription pharmaceutical 

products. EthicAd is a coalition of leaders from academic medicine and the 

healthcare community who are committed to working as a neutral and impartial 

body in collaboration with regulatory agencies, professional organizations, consumer 

groups, advertising agencies, and the pharmaceutical industry. Dr. Michael E. 

DeBakey is Chairman Emeritus of EthicAd. 

Our goal is to maximize the public health benefits of DTC information by providing the consumer with substantive, understandable and reliable information 

about pharmaceutical products. We will achieve this goal through the development 

and continuous improvement of ‘‘Ethical DTC Standards’’ for the development of 

DTC material. EthicAd will focus upon the educational quality of DTC material, 

while taking into account the concerns of manufacturers and regulators. The role 

of EthicAd is not to judge or evaluate individual products, but to promote high ethical standards and effective educational techniques for communicating information 

about those products. In addition, EthicAd will review DTC materials and provide 

an ‘‘EthicAd Seal’’ for DTC pharmaceutical information that demonstrates use of 

the Ethical DTC Standards.

Senator DORGAN. Dr. Shaw, thank you very much. 

Dr. Dolinar. 

STATEMENT OF RICHARD DOLINAR, M.D., ENDOCRINOLOGIST, 

ENDOCRINOLOGIST ASSOCIATES 

Dr. DOLINAR. Senator Dorgan, Senator Fitzgerald: Thank you for 

allowing me to testify today. I am an endocrinologist in private 

practice in Phoenix, Arizona. I specialize in the treatment of diabetes. I received my undergraduate degree at SUNY College in Albany, New York, I went to medical school at State University of 

New York at Buffalo, and I did my training in diabetes and endocrinology at Duke University down in North Carolina. 

I am also a retired Air Force colonel, Vietnam veteran, former 

flight surgeon. I mention my flying experience for the following reason: I want to use it as an example to make the case for directto-consumer advertising and to show you the value thereof. 

When you are flying in an airplane and you smell smoke in the 

cockpit, you have got to address that issue immediately and aggressively. Otherwise that plane is going to come down sooner than you 

planned, at a location other than an airport, and the wheels are not 

going to be the first thing to touch the ground. 

Likewise with diabetes. High blood sugars indicate the smoke of 

diabetes in a patient. If that is not treated immediately and aggressively, that patient is going to crash, and the crash is going to be 

in the form of a heart attack, a stroke, kidney failure, amputation, 

blindness. What direct-to-consumer advertising is doing is bringing 

patients into my office early so that I can treat them, can intervene. 

We know that by treating diabetes, bringing the blood sugars 

under control, we can decrease the complications down the road. 

When you look at diabetes, it is the complications that really cost. 

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For example, if you do not treat the sugars and they get a heart 

attack, then they come into the hospital with a heart attack or 

stroke, very expensive. 

In fact, your diabetes patients, they represent 6 percent of the 

population; they consume 15 percent of the health care dollar. On 

the other hand, if we can get them early and treat them, I am confident we can decrease the amount of dollars spent on the diabetes 

patient. 

Direct-to-consumer advertising brings these people in for treatment. The other thing it does, it helps to reach out to those who 

are not diagnosed. The ADA estimates there are 6 million people 

out there with diabetes that do not realize it. By getting the word 

out to them and reaching out to those people and bringing them 

in, we can significantly help them. They really represent smoke in 

the cockpit of our health care system. There is an avalanche of diabetes that is now affecting our population. 

I also think direct-to-consumer advertising is critically important 

today, especially in light of managed care. Managed care has 

changed the doctor-patient relationship. I started medical school in 

1968 and over the last 30 years I have seen the changes. The doctor is now often faced with the problem of attempting to meet the 

needs of two masters: on the one hand the patient, on the other 

hand the managed care plan, the HMO, the insurance company. 

On the one hand, he is trying to provide care. On the other hand, 

incentives and disincentives are set up to withhold care. In a situation like this, the doctor-patient relationship becomes an adversarial one. We have drugs available to treat diabetes that can save 

money down the road, but unfortunately many of the managed care 

plans have incentives in place not to treat these patients. So consequently the patient is in a very difficult situation, in a situation 

where you are in an adversarial relationship with your physician, 

you need everything you can to help you. Information is critical. 

DTC provides information to those patients. 

I personally do not think that advertising burdens the physicians 

or negatively impacts on the doctor-patient relationship. In fact, I 

find that patients who have seen these ads on diabetes, hypertension, etcetera, are easier to work with. They know the seriousness of the disease, they know there are treatments out there, and 

they come asking for help. So I have found it to be a benefit actually. 

I do not think it puts pressure on me to order drugs that are not 

necessary. If that patient does not require the drug, I do not order 

it. 

If any of us were to go out and buy a house or buy a car or buy 

a stereo set, would we not get information from various sources before we made that decision? Yet when it comes to health care we 

seem to keep the patient in the dark. I think knowledge is power. 

I think it is critically important that patients have that knowledge, 

have that power, because currently they are trapped in their health 

care systems. They do not have choice. They have to take their employer’s health care system. So we have limited choice, and now if 

we limit direct-to-consumer advertising we limit knowledge, and if 

we limit choice and limit knowledge how is that patient going to 

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work their way through the health care maze to get the care that 

they need? 

Direct-to-consumer advertising provides information that is filtered through the FDA. It is regulated by the FDA. It is a better 

source of information than on the unregulated Internet or whatever 

hearsay the patient picks up from somebody down the street. 

For the sake of the patients, I would ask you to vote against ignorance. I think anyone against direct-to-consumer advertising is 

really in favor of ignorance. I would ask you to vote against ignorance. I would ask you not to place any further constraints on direct-to-consumer advertising. 

Thank you. I would be happy to take any questions. 

[The prepared statement of Dr. Dolinar follows:]

PREPARED STATEMENT OF RICHARD DOLINAR, M.D., ENDOCRINOLOGIST, 

ENDOCRINOLOGIST ASSOCIATES

Mr. Chairman and Members of the Committee: 

I am Dr. Richard Dolinar, an endocrinologist in private practice in Phoenix, Arizona, specializing in the treatment of diabetes. I earned my undergraduate degree 

at Siena College in Albany, New York, and my medical degree from the State University of New York at Buffalo. I did a fellowship in endocrinology and diabetes at 

Duke University. I am co-author, with Betty Breckenridge, of a book entitled Diabetes 101, a patient-oriented guide to this disease. It is in its 3rd edition and has been 

published in several languages. I am also a retired Air Force Colonel, a Vietnam 

veteran, and a former flight surgeon. 

I mention my flight experience because I want to use an airplane analogy to make 

the case for the value of direct to consumer advertising of prescription drugs. 

When you’re flying and you smell smoke in the cockpit, you know that this is 

something that has to be addressed immediately and aggressively. If this problem 

is not addressed, the plane is likely to come down sooner than planned, at a place 

other than an airport, and the wheels are not going to be the first things that touch 

the ground. 

If a patient’s blood sugar is high, that’s the smoke that warns of diabetes. Unless 

the problem is addressed immediately and aggressively, there will certainly be a 

crash—in the form of a heart attack, a stroke, kidney failure, amputation or blindness, all of which are complications of diabetes. 

In my experience as an endocrinologist, direct to consumer advertising of prescription medicines is getting patients with diabetes into my office sooner, so they can 

be treated with effective medicines and avoid the dire complications of this disease. 

According to the American Diabetes Association, an estimated six million Americans 

have undiagnosed diabetes. This constitutes smoke in the cockpit of our health care 

system that, unless addressed, will lead to deadly, and costly, crashes. 

People with diabetes make up about 6 percent of the U.S. population but account 

for 15 percent of health care costs—15 cents out of every health care dollar. For 

Medicare, the percentage is even higher because 1 out of 5 people over age 65 has 

diabetes. Twenty-five percent of Medicare costs go toward diabetes. The majority of 

this expenditure goes to the complications of diabetes, complications that put patients in the hospital or on the surgery table and can make them disabled for life. 

If we can get diabetes under control, we can avoid these complications, saving 

lives and money. That’s why it’s critical to diagnose diabetes promptly and treat it 

aggressively. Direct to consumer advertising is helping us reach this important goal. 

Direct to consumer advertising is bringing diabetes to the attention of people who 

might have it. It’s pointing out the seriousness and possible complications of the disease. It’s prompting people who may have diabetes in the family or may be feeling 

unusually tired, to see their doctors and be checked out. For people who are already 

diagnosed, the ads reinforce the fact that this is a chronic disease and that patients 

need to stay on their medicines. 

Direct to consumer advertising is particularly critical in this era of managed care. 

Sadly, in many cases, the physician can no longer act as the patient’s advocate. In 

health maintenance organizations, or HMOs, the physician is often forced into the 

uncomfortable position of being an adversary rather than an advocate. The way the 

system works, the physician makes more money if he or she provides less care. Although medicines, by helping avoid complications from diabetes, can save money in 

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the long run, HMOs, unfortunately, focus on the short run, the bottom line for the 

current quarter. And, since patients tend to change insurers every two or three 

years, there is always the hope that when the patient crashes, it will be on another 

HMO’s watch. 

In this environment, the patient needs all the help he or she can get. Specifically, 

the patient needs information about disease and possible treatments. Armed with 

such information, a patient may be able to successfully navigate the HMO maze and 

get needed treatment. Direct to consumer advertising is an excellent source of information. Since it’s regulated by the Food and Drug Administration, it’s a far better 

source of information than the neighbor down the street or the unregulated Internet. 

I dispute the notion that direct to consumer advertising burdens physicians. I find 

that patients who have seen ads for diabetes medicines are informed and easier to 

work with. They are aware of the disease, and they know that it can be treated. 

Perhaps more important, they know that treating the disease now can make a difference down the road. They’re ahead of the game and willing to take new medicines 

that can help them avoid the complications of diabetes. 

Nor do I feel that direct to consumer advertising puts pressure on doctors to prescribe unnecessary medicines. Quite often, patients with Type 1, or 

insulindependent, diabetes come in with an advertisement for a pill they hope will 

enable them to stop insulin injections. I simply level with these patients and tell 

them that these new medicines work only for Type 2 diabetes. They are disappointed, but accept the reality that these pills are not appropriate for them. I do 

not consider taking the time to explain this to patients an inconvenience, and I resent any implication that I would allow pressure from direct-to-consumer advertising to influence my prescribing decisions. 

If any of the Members of this Committee were buying a car or a house or even 

a television, I’m sure you would gather information about the purchase from a variety of sources. When it comes to health care, a much more critical decision, however, 

we seem to want to keep consumers in the dark. We need educated and informed 

consumers of health care. It’s not right to withhold information about health care 

from patients. Direct-to-consumer advertising is an easily accessible, user-friendly, 

and FDA-regulated source of information about diseases and possible treatments. 

To be against direct to consumer advertising is, in my mind, to be in favor of ignorance. Knowledge is power. That’s why we’re at this hearing, so we’ll gain the 

knowledge to make the right decisions. Don’t take knowledge away from them, too. 

How are patients to defend themselves and get the best care possible, if we limit 

both choice and knowledge? 

For the sake of patients, I ask that you vote against ignorance and refrain from 

placing further restrictions on direct to consumer advertising of prescription medicines. 

Thank you very much. I would be happy to take any questions.

Senator DORGAN. Thank you very much. You have provided interesting and in some cases different testimony about the same 

issue. 

I recall an ad that has been on television for some long while 

about a young man what lost I think 140 pounds eating Subway 

sandwiches. Do you recall that ad? 

Dr. DOLINAR. I do not recall that one, no. 

Senator DORGAN. Well, do you recall it? Some guy walking 

around holding up the pants he used to wear. He dropped I think 

100, 140 pounds by eating a certain deli sandwich at a franchise 

store. 

I was thinking about advertising. You know, I am smart enough 

to understand that the proper weight loss program does not include 

going to a fast food store. But it seems to me in advertising it is 

kind of let the buyer beware, you make whatever claims you can 

make and let people assess those claims. 

It is different, however, with respect to prescription drugs. I expect or I would expect that all of you would agree that there are 

risks that one must be cognizant of, and that is the reason we have 

a regulatory regime with respect to prescription drug advertising. 

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We want to make sure that what people are representing about the 

drugs is accurate, number one, and number two that we are giving 

some basic information about the risk of the drugs and so on. 

There has been testimony today that the regulatory responsibility is not being met, not sufficient resources exist at the FDA. 

You have heard some of that discussion. Mr. Cloutier, what is your 

impression of that? 

Mr. CLOUTIER. I would echo the support of Sidney Wolfe and others saying that, given the volume and the rate of increase, we have 

not seen a commensurate increase in staff and resources at the 

FDA to oversee and regulate this. 

Senator DORGAN. Dr. Shaw? 

Dr. SHAW. We actually have a very good relationship with the 

FDA and it is interesting that a lot of times there is internal pressure placed on them not to come to the Hill and ask for additional 

funding. But I think that if one took the individuals aside within 

FDA they would almost uniformly say that they are in desperate 

need of additional funding and staff. 

Senator DORGAN. Dr. Dolinar, as a practicing physician you may 

not deal with that question day to day, but what is your impression 

of that? 

Dr. DOLINAR. I would be happy to respond to it. First of all, the 

Subway sandwiches, I will have to get the reference on that so I 

can start using it in my practice. 

But think about it. If we had the same constraints on advertising 

for Subway sandwiches and hamburgers, probably at the end of the 

advertisement there would be a disclaimer: This food could cause 

obesity, heart attack, high cholesterol, et cetera. 

Senator Fitzgerald I thought made a very good point earlier 

when he said he had a nine year old boy who saw an advertisement 

and wanted something. But actually Senator Fitzgerald, being the 

parent, had control over whether that child was going to get that 

or not. I have a nine year old boy, Mark, and Mark came to me. 

He wanted me to build him a pipeline. I said, a pipeline? That is 

one of those things where you go flying on your skateboard, you go 

up in the air and flip around. I am the parent. I am not going to 

do that. 

But my point is these are prescription drugs. What DTC does, it 

brings the patient in, it starts the process. Then the physician evaluates, is this an appropriate drug, is it not appropriate, is there 

something else we should be using. So I think that is important. 

Also, just to share with you, as I have been sitting here listening 

to the proceedings I just could not help but think back to the 

1950’s. I was a child in the 1950’s and at that time polio was a very 

big problem, in the early 1950’s. Then the vaccine came out. I wonder, if this were the 1950’s, whether we would be sitting here today 

pointing out that the amount of money spent on vaccines is skyrocketing and that this is a very bad thing and that we should not 

be advertising about polio because it is bringing all these people in 

to ask for this vaccine, when in reality there would be another 

chart with the number of iron lungs going in the opposite direction. 

I think drugs are the solution, not the problem. I think when it 

comes to the world of diabetes, high blood pressure, heart attack, 

and stroke, it is not as obvious as that polio example I just gave 

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you, but I can assure you by using these drugs I can decrease blood 

pressure, blood sugars, cholesterol. I can decrease the chance of 

complications coming down the road. 

So I find this to be very important. 

Senator DORGAN. I would just observe that in the 1950’s they 

could not advertise prescription drugs, and of course in the 1950’s 

when Dr. Salk gave us the vaccine it became a matter of public 

health for us to deliver that vaccine to virtually everyone, especially all children in this country. 

Yes, Dr. Shaw. 

Dr. SHAW. Mr. Chairman, if I could follow up on your Subway 

sandwich analogy, as long as you have offered it. I think that what 

I have heard here is almost universal agreement that DTC has the 

potential to do great good and the pharmaceutical industry in the 

United States and globally is one of the best assets for health care 

that exists, period. It is just a question of a squandered opportunity. 

With your Subway analogy, there is an opportunity to talk to the 

American people, not just about which lipid-lowering drug is best, 

but the fact that if you went back to Subway and started using 

their low-fat sandwiches or other modifications that in fact you 

could reduce or eliminate the potential for heart disease or atherosclerotic that two-thirds of the American citizens are going to die 

from, approximately, and two-thirds of the world’s population does 

not have this entity. 

Why can this opportunity be used also, not just to promote drugs, 

but to promote public health? 

Senator DORGAN. Let me just make one quick comment. I do not 

dispute at all that there is good that can be achieved by direct-toconsumer advertising. The issue we have not discussed in great detail because that is not what the hearing is about is the substantial 

increased cost and pricing of prescription drugs, which I think one 

could have a hearing or several hearings just on the question of 

pricing and whether that pricing is fair. 

But let me call on my colleague Senator Fitzgerald. 

Senator FITZGERALD. Thank you, Mr. Chairman. 

Thank you, all of you, for your testimony. It is all very good. I 

wondered really if our tort system in your opinion does not provide 

a sufficient check on rogue behavior on the part of prescription 

drug advertisers. I do not know if either of the first two witnesses 

had any particular ads that they have seen for prescription drugs 

that they thought went too far. If you do, I would be interested, if 

there are any specific ads that you could cite that you thought went 

too far. 

But also, does not our legal system in this country present some 

liability for any advertiser of pharmaceuticals or, for that matter, 

anything else that goes too far? Either of you, Mr. Cloutier and Dr. 

Shaw? 

Mr. CLOUTIER. I would just actually draw your attention to the 

ads that the chairman showed at the beginning. Our concern is 

about the amount of risk information and the availability of that 

in terms of comprehension relative to other information that is 

being presented. I think it is a complicated picture. 

65

We are about to release some research next week on use of drugs 

in the over 65 population. One of the things that we have found 

is that 10 percent of people over 65 use 8 therapeutic classes or 

more. That means that they are treating eight separate conditions 

simultaneously. What we know about that is there is a 100 percent 

probability of polypharmacy, in other words some adverse health 

consequence of using all those drugs. 

As we see direct-to-consumer advertising driving up volume and 

usage, some of which is very appropriate, some of which is less 

clear, that consumers as we empower them to seek these prescription drugs need to have the information available to them. We believe that it is lacking and the voluntary regulations that are in 

place do not require appropriate disclosure of those risks. 

Senator FITZGERALD. Dr. Shaw. 

Dr. SHAW. Well, in our opinion the overwhelming majority of 

pharmaceutical companies are extremely responsible in the way 

they approach direct-to-consumer advertising. It is sort of the 80–

20 rule, that perhaps 20 percent of the companies are causing 80 

percent of the problems. 

Earlier testimony by Dr. Wolfe cited the fact that in some instances companies have been cited 13 and 14 different times for essentially the same violation, with little or no consequences, and it 

has just become sort of a cost of doing business. In the mean time, 

it provides incremental revenue. 

Senator FITZGERALD. How is this really any different than just 

about any other area? You have ads out there all over the place, 

say, to invest in a mutual fund and you are not going to have all 

the information you really need in the ad, which will probably show 

their last year’s return or something like that, just as you are not 

going to have all the information on both sides of the story in an 

ad for a prescription drug. Why is this any different than any other 

area? 

The consumers out there who undertake research on their own, 

try to get educated as best as possible, and view a variety of 

sources are always going to come out better, whatever the area. 

Dr. SHAW. Senator, I think from our perspective the key is this: 

through direct-to-consumer advertising the pharmaceutical industry has become a de factor health care information provider. Frankly, I think the health care providers——

Senator FITZGERALD. What is wrong with that? 

Dr. SHAW. Nothing necessarily. The issue is the essence of standards and are they going to assume the same ethical levels of behavior that we expect from other health care professionals. We think 

that they are capable of that, but we think that there is a need to 

push in that dimension. 

Senator FITZGERALD. Back to my liability question, do they not 

have liability if they are misleading people? 

Dr. SHAW. What behaviors would you expect from your physician? Would you expect your physician to merely act within the 

bounds of the law or do you expect something different? With due 

respect——

Senator FITZGERALD. I think they have a fiduciary duty. I expect 

them to take extra care, a physician. But they are always worried 

about their own liability for medical malpractice. I would think 

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that there would be many potential tort causes of action for misleading advertising for a prescription drug manufacturer. That is 

kind of a free market check on the whole system. 

Mr. CLOUTIER. I would like to respond to that. I think there is 

a dimension of public health protection here that is being missed. 

To go back to my example of eight therapeutic classes being used 

by 10 percent of the over 65 population, there simply is no evidence 

of what three drugs or more does when someone is taking them. 

So part of it is that we actually lack the science, that the science 

is out of pace with the promotional activity of loading on all these 

pharmacologic agents in one person, that we need to pay attention 

to and that we need to be cautious about. 

Senator FITZGERALD. Now, that patient who is taking eight or 

more pharmaceuticals at the same time—you said 10 percent of the 

seniors are doing that? 

Mr. CLOUTIER. Yes. 

Senator FITZGERALD. They are getting those prescriptions from 

doctors, are they not? 

Mr. CLOUTIER. They are, and those doctors do not have information about any more than there of those drugs interacting with 

each other. So what will typically happen is that someone will be 

taking eight or nine drugs and they will come in they will have a 

number of moderate side effects—dizziness, nausea. 

Senator FITZGERALD. That doctor could be liable for malpractice 

if he prescribes those conflicting medicines, could he not? 

Mr. CLOUTIER. There is that potential, yes. 

Senator FITZGERALD. I know Dr. Dolinar has been chomping at 

the bit. I do not know if I mangled your name there. If I did, I 

apologize. 

Dr. DOLINAR. That is fine. 

I am a doctor. I treat patients. Some of them require that many 

medications. In fact, in the over age 65 group one out of five has 

diabetes and they are taking up 25 percent of the Medicare budget. 

The other point I would like to make, this issue of empowering 

the patient I think is critical. I touched on it in my introductory 

statement. Many times the doctor is in an adversarial relationship 

with the patient. In a setting like that, you need a patient who is 

educated. 

Let me give you a quick example. A drug came out a few years 

ago that was a pill for the treatment of diabetes. It would allow 

people who were on insulin who had type 2 diabetes, it would allow 

them to come off the insulin shot. They could go on this pill. Many 

of them could go on this pill, stop the insulin. 

There was an HMO, I spoke with the physicians there. They 

were happy with the drug. They could not use it. They could not 

use it because, the way their finances were structured, if the physician wrote for that drug the patient would get it, but the cost of 

that drug would come out of that physician’s pay check that month. 

So if the drug costs, let us say, $100 for the month, that doctor’s 

pay check would be $100 less that month. 

In a situation like that, I doubt if there would be more than a 

handful of physicians who would offer to the patient, let us try this 

pill and take you off of insulin. On the other hand, an empowered 

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patient could go in there and say: I have seen this drug, I think 

this could help me; can we try it out. 

I cannot emphasize enough how the doctor-patient relationship 

has changed. The doctor is in an adversarial role. 

Senator FITZGERALD. Well, thank you. Thank you all for your testimony. 

Senator DORGAN. Let me just observe, my colleague raises the 

question of tort liability. It is the case, I think, however, with respect to food safety and safety of prescription drugs and so on, 

there is a separate class. I was thinking to myself as you were asking those questions about Upton Sinclair’s work in Chicago, as a 

matter of fact, where he was going into these meatpacking plants, 

and they had rat problems, so they were lacing slices of bread with 

poison and then the rates would eat the poison and die and they 

would throw the bread and the rats right down the same chute 

where the mystery meat came out the other end. 

He wrote a book about it and of course that led to the Food and 

Drug Administration and dramatic standards about food safety. 

There are some things where let the consumer beware and let 

the courts respond to it do not work. I think medicine is one of 

them, in the sense that you must have standards. I think the question you raise is important, what kind of standards should you 

have with respect to advertising, and that is less—that is a little 

less clear. 

It is quite clear what standards you ought to have when you 

manufacturer prescription drugs in an FDA-approved plant. But it 

is a little less clear, and that is one of the reasons for the hearing, 

what the standards one must have to deal with advertising of prescription drugs. It is a most interesting discussion. 

Senator FITZGERALD. By the way, the stockyards are no longer in 

Chicago. I think they moved them out West, your way. 

Senator DORGAN. That is true. 

I want to thank the panel. The testimony we have received has 

been most interesting and I think sheds different opinions and 

viewpoints on a very interesting question. As the price and the cost 

of prescription drugs continues to increase and as new and exciting 

prescription drugs are developed to deal with dread diseases and 

other conditions, I think all of these issues will continue to be ones 

that will be discussed in I hope a thoughtful and a serious way by 

the Congress. 

This hearing is adjourned. 

[Whereupon, at 4:33 p.m., the Subcommittee was adjourned.]

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