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90–049 PDF 2003

S. HRG. 108–183

DIRECT-TO-CONSUMER ADVERTISING OF

PRESCRIPTION DRUGS: WHAT ARE THE

CONSEQUENCES?

HEARING

BEFORE THE

SPECIAL COMMITTEE ON AGING 

UNITED STATES SENATE

ONE HUNDRED EIGHTH CONGRESS

FIRST SESSION

WASHINGTON, DC

JULY 22, 2003

Serial No. 108–16

Printed for the use of the Special Committee on Aging

(

SPECIAL COMMITTEE ON AGING 

LARRY CRAIG, Idaho, Chairman 

RICHARD SHELBY, Alabama 

SUSAN COLLINS, Maine 

MIKE ENZI, Wyoming 

GORDON SMITH, Oregon 

JAMES M. TALENT, Missouri 

PETER G. FITZGERALD, Illinois 

ORRIN G. HATCH, Utah 

ELIZABETH DOLE, North Carolina 

TED STEVENS, Alaska 

RICK SANTORUM, Pennsylvania 

JOHN B. BREAUX, Louisiana, Ranking 

Member 

HARRY REID, Nevada 

HERB KOHL, Wisconsin 

JAMES M. JEFFORDS, Vermont 

RUSSELL D. FEINGOLD, Wisconsin 

RON WYDEN, Oregon 

BLANCHE L. LINCOLN, Arkansas 

EVAN BAYH, Indiana 

THOMAS R. CARPER, Delaware 

DEBBIE STABENOW, Michigan 

LUPE WISSEL, Staff Director 

MICHELLE EASTON, Ranking Member Staff Director 

(II) 

C O N T E N T S 

Page 

Opening Statement of Senator Larry E. Craig ..................................................... 1

Statement of Senator John Breaux ........................................................................ 2

Statement of Senator Debbie Stabenow ................................................................ 5

Statement of Senator Susan Collins ...................................................................... 27

PANEL I 

Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, 

FDA, Washington, DC ......................................................................................... 28

PANEL II 

Marjorie Powell, Senior Assistant General Counsel, Pharma, Washington, 

DC .......................................................................................................................... 58

Nancy Nielsen, M.D., Ph.D., Speaker of the House of Delegates, American 

Medical Association, Washington, DC ................................................................ 79

Meredith B. Rosenthal, Ph.D., Department of Health Policy and Management, 

Harvard School of Public Health, Boston, MA .................................................. 98

Arnold Relman, M.D., Professor Emeritus of Medicine and of Social Medicine, 

Harvard Medical School, Boston, MA ................................................................. 110

APPENDIX 

Testimony submitted on behalf of the Henry J. Kaiser Family Foundation ...... 127

Statement of The Center for Patient Advocacy ..................................................... 138

(III) 

(1)

DIRECT-TO-CONSUMER ADVERTISING OF 

PRESCRIPTION DRUGS: WHAT ARE THE 

CONSEQUENCES? 

TUESDAY, JULY 22, 2003 

U.S. SENATE, 

SPECIAL COMMITTEE ON AGING, 

Washington, DC. 

The committee met, pursuant to notice, at 10:05 a.m., in room 

SD–628, Dirksen Senate Office Building, Hon. Larry Craig (chairman of the committee) presiding. 

Present: Senators Craig, Collins, Breaux, Stabenow, and Carper. 

OPENING STATEMENT OF SENATOR LARRY CRAIG, CHAIRMAN 

The CHAIRMAN. Good morning, everyone and thank you for joining us. The Senate Special Committee on Aging will be convened. 

We are here today to look carefully at the issue of direct-to-consumer advertising prescription drugs and ask some important 

questions. The questions would go like this. Does it drive up prices? 

Does it drive up costs? Does it lead to inappropriate prescribing? 

Does it provide useful information to consumers? Ultimately, does 

direct-to-consumer advertising of prescription drugs benefit or 

harm the health care system and especially the seniors of our country? 

This is an issue that we as legislators hear about quite often. In 

my town meetings across the State of Idaho and other places I 

have traveled where this issue becomes a topic of discussion, the 

question is why so much advertising? I know that it is increasing 

the cost of the pharmaceuticals that I am taking. Is that true? We 

thought it was important to begin to build a record to find out if, 

in fact, that is the case. 

Too many Americans, often seniors, are not able to afford prescription drugs. We know that. We are wrestling with that here in 

the U.S. Senate as we speak and in the House with the modernization of Medicare and the inclusion of a prescription drug program 

within it. 

When they see the introduction of new and expensive advertising 

campaigns on television, many ask why are pharmaceutical companies spending all of this money on ads instead of lowering the price 

of their drugs? Although direct-to-consumer advertising may not be 

the most expensive promotion drug companies do, it is by far the 

most visible. The public has noticed the dramatic increase in broadcast advertising over the last few years and many tell us that they 

2

are concerned about it. As I look at the rising cost of prescription 

drugs I can certainly understand their concern. 

I also have heard concerns about direct-to-consumer advertising 

from doctors. They have told me their patients occasionally see advertising for prescription drugs and do not understand the risks associated with taking drugs or do not recognize other treatment options that might be available. Some of those treatment options may 

be less expensive than the prescription drugs themselves. I have 

had some doctors tell me that direct-to-consumer advertisements 

negatively impact the doctor/patient relationship. 

On the other hand, I have heard that individuals who, as a result of direct-to-consumer advertising, were prompted to visit a doctor concerning a condition they would not have otherwise have 

found treatment for. There are certainly individuals, including 

many seniors, who have treatable illnesses and are not being treated. If direct-to-consumer advertising can get them to see the doctor, 

this is certainly a positive aspect of this kind of advertising. 

I support the idea of consumer-driven health care. If we expect 

consumers to be good decisionmakers, we need to assure that they 

have access to good information. Proponents of direct-to-consumer 

advertising claim that it can provide some of that information. 

These questions are especially timely in light of what I have just 

mentioned—the effort on the part of Congress and the taxpayers of 

this country to respond to the needs of many of our citizens to have 

access to prescription drugs. So that is why, in part, we are holding 

the meeting today. 

Now let me turn to the ranking member of this committee, who 

plays a key role in all of these issues and whose leadership has 

been dominant in this committee for a good number of years, my 

colleague from Louisiana, Senator John Breaux. Senator. 

OPENING STATEMENT OF SENATOR JOHN BREAUX 

Senator BREAUX. Thank you, Mr. Chairman. Thank you for having this hearing. It is an important hearing. 

I have always taken the position that good information allows 

people to make good decisions. Bad information, on the other hand, 

causes people unfortunately to make incorrect and wrong decisions. 

Therefore, the question of how information is received, where does 

it come from, how much do people get, are vital issues that need 

to be discussed and debated. 

Advertising for prescription drugs is not the same as advertising 

for deodorant or used cars. The products are much more substantial, more difficult to understand, and obviously have a much greater impact on the lives of the American people than some of the 

other products that we see advertised. 

So I am anxious to hear from some of the experts today and some 

of the industry representatives as to the purpose of advertising, 

what they hope to get from it, and how that advertising influences 

people with regard to the knowledge that they need to take better 

control of their own health care. Hopefully some of these answers 

will be found today at today’s hearing and I thank you for having 

it. Thank you. 

The CHAIRMAN. Thank you very much, Senator. 

3

Now let me recognize our colleague from the State of Michigan, 

Senator Stabenow. Welcome. 

STATEMENT OF SENATOR DEBBIE STABENOW 

Senator STABENOW. Thank you, Mr. Chairman, and welcome, Dr. 

Woodcock and others who will be testifying today. This is an issue 

that I have been extremely interested in and involved in and appreciate the opportunity to have the testimony today. 

I also think it is important that we have an opportunity to analyze all kinds of information regarding this issue and would ask, 

Mr. Chairman, as part of the record to put out a different view 

than may be reflected in some of the testimony today. There is a 

recent book out called ‘‘The Big Fix’’ by Catherine Grader and 

Chapter 5 talks about direct-to-consumer advertising and I would 

appreciate your willingness to put Chapter 5 into the record. 

[The information follows:]

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The CHAIRMAN. Certainly. That will become a part of our record 

as part of the testimony today. 

Senator STABENOW. When we analyze this issue of direct-to-consumer advertising I think it is important to look at the total impacts. There is no question that we all want to be informed consumers—no question about that—and that we make better decisions when we have good information. I think, though, that as we 

look at the rising cost of prescription drugs, the spending on prescription drugs, we should be asking questions about whether or 

not it is in the consumer’s interest. I will just pick one drug. That 

Vioxx spends more to advertise than Pepsi or Budweiser beer, is 

that necessary for us as consumers or does that just add to utilization and add to the overall cost and price of prescription drugs? 

I think common sense would tell us we do not really need to debate the increase in advertising. All we have to do is turn on the 

television set, Mr. Chairman. I was thinking as I was watching this 

morning, watching the news, that if not every commercial, every 

other commercial is for some kind of prescription drug. So common 

sense tells us that there has been a dramatic increase in advertising. Is that meaning a dramatic increase in consumer awareness 

and education or simply a dramatic increase in pricing, a dramatic 

increase in utilization? 

I am caught by the fact that the GAO in 2002 reported that most 

of the spending increase for heavily advertised drugs is the result 

of increased utilization. For example, between 1999 and 2000 the 

number of prescription drugs dispensed for the most heavily advertised drugs rose 25 percent but increased only 4 percent for the 

drugs that were not heavily advertised. So I think, Mr. Chairman, 

that is significant. 

I would just say in conclusion that we constantly, I think, struggle between more dollars for research, which we all have a great 

stake in, and dollars for advertising, marketing, other parts of the 

industry, and as a state that does a tremendous amount of that 

great research—Pfizer has facilities in Michigan and we are very 

proud of that research—I want very much to see and I think we 

have a stake in continuing policies that provide billions of dollars 

of taxpayer money through the National Institute of Health, tax 

credits and deductions for research, patents that protect companies 

to recover their costs. 

But the deal at the end of the chain for the American consumer 

is that we will be able to afford that product because, as our ranking member indicated, this is not buying a car, although coming 

from Michigan, I think we should buy new cars every year and 

they should be American-made, but if I have cancer I need my 

medication and I may have to forego that new car. 

I am very concerned that when we look at these issues we hear 

that two to three times more is spent on advertising and marketing 

than research. The industry, of course, disputes that. What I find 

interesting, Mr. Chairman, is that I put in legislation last year that 

simply said that the taxpayers of our country will subsidize 

through tax credits and deductions as much advertising and marketing as we do in research. There are two line items on tax forms, 

one for research, one for advertising, marketing, administration. 

The SEC reports show that the second line item is, on the average, 

27

21⁄2 times more than research. We are told no, there is more spent 

on research, so I simply said they should be the same, that we 

would only allow a subsidy in the advertising and marketing line 

item equal to research. I could only say that after the strong opposition of the industry, the overwhelming and tenacious opposition 

of the industry, it is hard for me to believe, based on that and the 

fact that this bill would not have affected them if, in fact, there 

was more being spent on research, I have to assume that, in fact, 

there is not. 

So I will stop there, Mr. Chairman, and welcome the testimony 

and think that this is a very important topic for all of us. 

The CHAIRMAN. Thank you very much, Senator, and thank you 

for your interest and involvement in this issue. 

Now let me turn to our colleague from Maine, Senator Susan 

Collins. Welcome. 

STATEMENT OF SENATOR SUSAN COLLINS 

Senator COLLINS. Thank you very much, Mr. Chairman. I want 

to thank you for calling this morning’s hearing to examine the effect that direct-to-consumer advertising has had on the pricing and 

utilization of prescription drugs. This issue has long been of interest to me and I appreciate having the opportunity to examine it in 

more detail. 

Prescription drug spending increased at an annual rate of about 

18 percent from 1997 through 2001 and we know that it is the fastest growing component of health care spending in the United 

States. With the increase in the cost of prescription drugs and in 

the amount of prescription drugs purchased has come the increase 

in direct-to-consumer advertising. Direct-to-consumer advertising of 

prescription drugs has tripled from $791 million in 1997 to $2.7 billion in 2001. That raises what I think is a very legitimate question: 

Has DTC advertising contributed to the spiraling cost of drugs in 

the United States? 

Now we know what both sides say about this. Critics say that 

the advertising gives consumers incomplete information, that it 

promotes false expectations, that it puts pressure on physicians to 

write unnecessary or inappropriate prescriptions. They say that the 

ads prompt patients to ask their physicians to prescribe new drugs 

that are more expensive but not necessarily more effective than 

older drugs. 

Proponents of the advertising, however, contend that it improves 

public health, that it encourages patients to seek help for untreated 

conditions, and has opened up discussion of once-forbidden topics. 

They say that the increases in the prices of prescription drugs are 

not due to advertising but rather, to appropriate increases in utilization and the high cost of research and development. 

We do know that the high cost of prescription drugs is putting 

pressures on states’ Medicaid programs and on insurance costs that 

the private sector is bearing. Rising drug costs are also important 

to us as we are drafting the new Medicare prescription drug plan. 

All of this prompted me to join a tripartisan group of senators—

Senator Jeffords and Senator Mikulski and I—in asking the General Accounting Office last year to review the effect of such advertising on the use and the cost of prescription drugs. We found 

28

through this report that while the pharmaceutical industry did 

spend significantly more on R&D than on promotional activities 

such as direct-to-consumer advertising, the drug companies have 

increased spending on advertising more rapidly than they have increased spending on R&D. 

The report also found that DTC advertising appears to increase 

utilization and spending and, perhaps not surprisingly, that the 

drugs that are most heavily advertised are often among the best 

selling drugs. In the year 2000, 22 of the 50 drugs with the highest 

direct-to-consumer spending were among the top 50 in sales. Moreover, the sales of drugs with the highest advertising spending have 

risen more quickly than the sales of other drugs. 

More troubling and an issue that I want to raise with our witness today was the fact that the report indicated that the Food and 

Drug Administration has been unable to keep pace with those 

pharmaceutical companies that were bent on bad faith advertising 

while seeming to comply with the rules. This is an issue that we 

have been pursuing with the FDA. 

So again I would ask that my full statement be placed in the 

record but thank you for holding this important hearing. 

The CHAIRMAN. Senator, thank you for that statement and thank 

you for the work that you have done and the prompting that you 

did with the development of that audit. I think that is an important template from which we work in this effort and understanding 

it better. 

Now let me turn to our panels today. We have two. Our first 

panel is panelist Janet Woodcock, M.D. from the FDA, Director, 

Center for Drug Evaluation and Research here in Washington. 

Janet, we thank you for your time before the committee. We also 

thank you for your willingness to stay on and, as my staff has said, 

participate with the second panel and respond to questions or 

interaction as we build this record. We think that is very important. We appreciate that courtesy. Please proceed. 

STATEMENT OF JANET WOODCOCK, M.D., DIRECTOR, 

CENTER FOR DRUG EVALUATION AND RESEARCH, FDA, 

WASHINGTON, DC 

Dr. WOODCOCK. Thank you. Good morning, Mr. Chairman and 

distinguished members of the committee. I am Janet Woodcock, Director of the Center for Drug Evaluation and Research at the FDA. 

The Division of Drug Marketing, Advertising and Communications, 

which is the group in FDA that regulates prescription drug promotion, is located within the Center for Drugs. 

Thank you for the invitation to discuss FDA’s oversight of what 

we refer to as DTC advertising, the promotion of prescription drugs 

directly to consumers. Depending on how it is done, DTC advertising has the potential for doing good or harm. On one hand, there 

is real potential value in patients recognizing undertreated conditions and consulting with their doctors. As you know, undertreated 

chronic diseases result in a tremendous burden of illness in our 

country and some of this burden is preventable. Ads may help by 

raising awareness of symptoms and potential treatments, as well 

as encouraging people to be more involved in their own health 

maintenance. 

29

On the other hand, there is potential for increasing inappropriate 

use of medicines for consumers who do not need them, for substituting the use of more costly medicines for older effective treatments, or for misinforming consumers about a drug’s safety and 

use. Consumers may become confused and physicians frustrated 

when valuable time must be spent correcting misconceptions. 

The purpose of FDA regulation of DTC ads is to keep the balance 

on the positive side for the public. The debate about where this balance lies has been particularly pointed over the past 5 years. Research data, rather than opinion, can best inform us all about the 

real-world impact of DTC ads, and some of the data will be discussed today. 

Now there are three important things to understand about FDA’s 

authority in this area. First, the statute and the regulations focus 

on the content, not the existence, of prescription drug promotion. 

Second, the law does not make a distinction between target audiences. The law has never prohibited advertising prescription drugs 

to consumers. However, until the early 1980’s this just was not 

done. Third, the act specifically forbids requiring preclearance of 

ads by the FDA, except under extraordinary circumstances. 

The modern era of DTC advertising really began in 1985 when 

FDA announced that the regulations for overseeing promotion to 

doctors provided sufficient safeguards to protect consumers, as 

well. After this, increasing numbers of DTC print advertisements 

appeared. 

Beginning in about 1995, spending on DTC ads began to rise 

sharply and this trend has continued ever since. The on-going debate, though, over DTC intensified in 1997 when FDA issued a 

draft guidance that addressed broadcast ads. 

DTC advertising of prescription drugs, including radio and TV 

ads, had always been legal. However, there was a feasible mechanism to make sure that consumers could get the required risk information. But by the mid–1990’s, many changes had occurred, 

both in the marketplace and in technology. Given these changes, it 

was apparent to FDA that sponsors could provide a convenient way 

for consumers to get the additional product information. 

So in 1997 we issued a draft guidance, made final in 1999, that 

gave advice on how sponsors could meet the adequate provision requirement for broadcast ads by giving reference to multiple sources 

of product information in the ad. At the time we issued the final 

guidance we stated our intent to assess the impact of broadcast 

ads, as well as the impact of DTC promotion in general on the public. 

Monitoring direct-to-consumer promotion and especially broadcast ads is a top priority of our program. We want to ensure that 

consumers can understand the claims and the product risks. We 

also want to ensure that consumers get truthful and not misleading 

information. We are very interested in better ways to communicate 

risk information to consumers. We have issued a draft guidance on 

the brief summary in 2001 and we are working on a revision of this 

guidance. 

Most sponsors voluntarily submit proposed broadcast ads to us 

for review and comment. We believe that as a result, we comment 

on proposals for most product claim broadcast ads before they are 

30

aired. FTC gives DTC enforcement letters top priority to clear and 

to issue. 

We also conduct research on DTC and keep on top of the literature. The available research shows both positive and negative 

effects from DTC. FDA is not aware of evidence that DTC promotion is increasing inappropriate prescribing. Our research shows 

that DTC promotion may encourage consumers to obtain additional 

information about the products and to talk to their health care providers about health issues they had not raised before. 

However, our research also shows that many physicians believe 

that DTC ads lead patients to overestimate benefits. In addition, 

some physicians do feel pressured to prescribe a specific brand 

name product. 

In summary, at this time we are not aware of evidence that DTC 

promotion is harming the public health. We also acknowledge that 

in some cases DTC promotion may expand the recognition and 

treatment of serious untreated conditions. However, potential for 

harmful consequences calls for on-going vigilance on our part. We 

intend to continue closely scrutinizing DTC promotion, working 

with industry to ensure that broadcast ads comply with regulatory 

requirements and taking enforcement action when appropriate. 

Thank you and I will be happy to answer any questions. 

[The prepared statement of Dr. Woodcock follows:]

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The CHAIRMAN. Dr. Woodcock, thank you very much for that testimony. A couple of questions from me before I turn to the rest of 

my colleagues here. 

I appreciate the scenario you gave of the different events that occurred that brought us to broadcast advertising and the guidance 

changes in 1997 and the rationale behind it. Was there on the part 

of the pharmaceutical companies a substantial amount of, if you 

will, lobbying or urging that a review of this particular regulation 

come about or was it a normal process of review on the part of FDA 

that brought you to a conclusion that has really spawned the kind 

of acceleration of broadcast advertising that we have seen? 

Dr. WOODCOCK. It was a confluence of factors. No. 1, companies 

were running what are called reminder ads on television. These 

simply had the name of the drug. They were originally conceived 

of for physicians, who would have been aware of what the drug 

was. This was very confusing for the consumers. 

Second, it is true that some sponsors were considering running 

ads; these broadcast ads were perfectly legal. We felt it would be 

best for us to set the parameters whereby adequate provision could 

be given for getting the consumer information, rather than letting 

this happen and then having to repair it afterward. 

So we issued a guidance on how companies could comply, since 

it was apparent it was now feasible, with 1–800 numbers, with the 

Internet, with all the print ads that had begun to occur, it was now 

feasible for companies to make this information widely available. 

The CHAIRMAN. The problem with that print ad is that while I 

have just turned 58 and I have bifocals, I get out the magnifying 

glass to read it. 

By your testimony, it is evident to me that a letter from FDA on 

a given advertisement, permission to, if you will, or recommendations of are not necessary prior to the ad being aired. They are 

purely advisory in their character, your activity? 

Dr. WOODCOCK. They are notification that we would consider 

that ad, if aired, violative, for example, if we sent it to the company 

before they air the ad. So companies follow our advise and modify 

their ads. 

The law states that the companies need to submit the information at the time they air ads, not before, and they are not required 

to seek permission or clearance from the FDA to air an ad. But 

many companies, especially for broadcast ads, the vast majority of 

ads are sent to the FDA beforehand, probably they are so expensive 

that pulling them and correcting them would be a very expensive 

proposition. 

The CHAIRMAN. Have ads aired that you then followed prior to 

a letter going to them in which you made recommendations for 

change and the ad was pulled and those changes made, or vice 

versa, the ad continued to air against your recommendations or in 

opposition to your recommendations? 

Dr. WOODCOCK. That does not really happen. 

The CHAIRMAN. OK, that does not happen? 

Dr. WOODCOCK. No. We have additional sanctions we can take 

beyond these letters. They are just the initial notification. 

The CHAIRMAN. Thank you very much. Let me turn to my colleague, Senator Breaux. John? 

52

Senator BREAUX. Thank you very much, Mr. Chairman. 

Thank you, Dr. Woodcock, for your presentation. Is it a policy 

that the FDA has to review the ad on a pharmaceutical before it 

is shown or does the FDA see it at the same time the public would 

see it for the first time? Tell me what the requirements are and 

what happens in actual practice. 

Dr. WOODCOCK. The requirements are that firms have to submit 

the ad at the time it is aired. They do not have to seek any clearance from the FDA. They do not have to send it in and have us 

look at it. They simply have to send it to us at the time it is made 

public. 

In practice for broadcast advertising, the vast majority of ads are 

sent to the FDA and FDA is consulted before the ad is aired. 

Senator BREAUX. You make suggestions at that time or would 

you give them a warning that this ad is really not in compliance? 

Dr. WOODCOCK. Yes, we send advisory letters to them. We send 

quite a few of these letters out. 

Senator BREAUX. Before the ad is shown? 

Dr. WOODCOCK. Yes. Then those ads are modified according to 

our advice. 

Senator BREAUX. What percentage of the ads that are shown, for 

instance on television, do you think you all have a chance to review 

before they are shown? Fifty percent, more than that? 

Dr. WOODCOCK. We have estimated around 90 percent but we 

cannot give you an exact figure. 

Senator BREAUX. Of the ones that are not previewed, what percentage of them get letters of violation or whatever that letter is 

called saying you are not in keeping with what the standards 

should be? 

Dr. WOODCOCK. We do not have data cut that way. The average 

I think is about 5 percent of all——

Senator BREAUX. The total? 

Dr. WOODCOCK. Mm-hmm. 

Senator BREAUX. How rapid do the companies respond to a letter 

that would be sent by the FDA? What happens if they get—what 

do you call the letter? I am sorry. 

Dr. WOODCOCK. A notice of violation. 

Senator BREAUX. A notice of violation letter. What is the respondent rate from the companies? Do they fight you on that? Do 

they comply? Tell me what happens after they get a letter. 

Dr. WOODCOCK. Almost uniformly the companies comply immediately. 

Senator BREAUX. What would that consist of? 

Dr. WOODCOCK. Pulling the ad. 

Senator BREAUX. Do they make changes in the ad and rerun it? 

Dr. WOODCOCK. They may but it would have to conform to our 

requirements. 

Senator BREAUX. One of the witnesses to follow will talk about 

the policy of the American Medical Association. They have instituted a policy on direct-to-consumer advertising and they have a 

policy that has, in fact, been published and contains a number of 

guidelines. 

53

I understand that the FDA has not accepted those guidelines. 

Why would that be? Do you think you are already doing that or you 

disagree with them, or what? 

Dr. WOODCOCK. The legal requirements are different than recommendations, say, that ads be educational. Those might be very 

desirable characteristics and it is not that we would disagree with 

those aims, but the legal requirements, the regulatory requirements for advertising are different and we are enforcing the regulatory requirements, as outlined in the statute and regulations. 

Senator BREAUX. So you would interpret the AMA recommendation on guidelines as being other than what you do already? 

Dr. WOODCOCK. Well, there are some additional—as I understand them, there are additional goals that the AMA is looking for, 

that ads, for example, help educate patients about disease, and so 

forth. That is very desirable but it is not a legal requirement of an 

advertisement. 

Senator BREAUX. So what would establish what the legal requirements are? There is not an act of Congress that we passed and I 

did not notice it? 

Dr. WOODCOCK. Yes. 

Senator BREAUX. There is? 

Dr. WOODCOCK. It is in the Food, Drug and Cosmetic Act and the 

implementing regulations. 

Senator BREAUX. That was what your regs in 1997 were pursuant to? 

Dr. WOODCOCK. We did not issue regs in 1997. Our guidance that 

we issued in 1997 was referring to our long-ago regulations, which 

I believe are from the 1960’s, implementing the advertising provisions in the statute. 

Senator BREAUX. When is the last time Congress has acted on 

the rules are regarding to advertising of pharmaceuticals? 

Dr. WOODCOCK. 1962. 

Senator BREAUX. But we were not advertising with the media 

and we were not doing direct-to-consumer advertising in those 

days, were we? 

Dr. WOODCOCK. That is correct. It was a very different environment at that time. In fact, if you recall, from a medical standpoint 

we were coming out of an era where it was felt to be desirable not 

to inform the patient very much. 

Senator BREAUX. Sometimes that is still true. 

Let me ask you, then, if the act that Congress last enacted dealing with advertising was back in the 1960’s, has FDA further advanced what those requirements are or are you still just basically 

implementing the 1960 act, although you said the situation is entirely different? 

Dr. WOODCOCK. Right. We have continued, as our guidance 

shows, to clarify how we are currently interpreting the statute and 

regulations but we cannot obviously extend our power beyond the 

powers that are delineated, the limits that are delineated in the 

statute. 

Senator BREAUX. Do you think there is anything that you would 

recommend to the Congress that should be changed in light of the 

1960 act? 

54

Dr. WOODCOCK. I think it is a very complicated issue. We feel 

that we are doing an effective job in regulating direct-to-consumer 

advertising. We feel that the ads meet the requirements in the 

statute, except when we send them letters. So we feel the program 

in general is quite effective but we are continuing to evaluate it. 

Senator BREAUX. Final question. Is there anything that you feel 

that is lacking that the FDA ought to be doing in this area? 

Dr. WOODCOCK. We could do more surveillance and other activities which were mentioned by GAO if we had additional resources 

to do these activities. 

Senator BREAUX. But statutorily it does not seem to be a problem? It is a question of manpower, people power? 

Dr. WOODCOCK. I think statutorily we have our limits. That is 

what we are following. 

Senator BREAUX. But is that a problem for you or it is not? 

Dr. WOODCOCK. No, I do not think that is a problem. 

Senator BREAUX. Thank you. 

The CHAIRMAN. Thank you very much, Senator. We will go with 

time of arrival of our colleagues, so let me turn to you, Senator 

Stabenow. 

Senator STABENOW. Thank you, Mr. Chairman. Thank you again. 

I wonder if you might respond, in light of your answer to Senator 

Breaux, about a section in the GAO report where they indicated 

that a recent change in the Department of Health and Human 

Services policy for reviewing regulatory letters has sharply reduced 

FDA’s effectiveness in issuing untitled or warning letters in a timely manner. They have indicated this change has increased the time 

between FDA’s identification of a misleading advertisement and 

FDA’s request to remove it from dissemination, with the result that 

some regulatory letters may not be issued until after the advertising campaign has run its course. 

Would you agree with that assessment by the GAO? If you might 

speak to that. 

Dr. WOODCOCK. The change was put into place to ensure legal 

review of the letters, a thorough legal review before they went out, 

but there is no doubt they had impacted on the timeliness of the 

letters. We agree with that, based on our data. 

We have recently instituted a program in the last several months 

reforming our process of getting review through chief counsel and 

our response to those reviews and I am happy to announce that we 

have issued quite a few letters in the past month. We expect to 

issue several more warning letters this month and we expect that 

this will get our rate of output of letters back up to our goal. 

We recognize there is a balance between timeliness and legal sufficiency and quality but we feel that the legal review has improved 

the quality of the letters. 

Senator STABENOW. So are you indicating that you supported the 

change that was made in the procedures that has created this situation for you? 

Dr. WOODCOCK. We feel that it has improved the quality but we 

are going to have to do something about the timeliness. 

Senator STABENOW. So you have better quality but at this point, 

in fact, you would agree with their statement that regulatory letters, in fact, may be coming out after the ads have already run? 

55

Dr. WOODCOCK. They were taking too much time to get done and 

we have modified our procedures and we are seeing an effect of improved timeliness over the last 45 days. 

Senator STABENOW. Is that an issue also—you mentioned funding—is that an issue of staff resources, and so on, as well? 

Dr. WOODCOCK. We will have to see. We will implement these 

changed procedures and see how well we can keep up with the 

timeliness. 

Senator STABENOW. I wonder if you might also talk a little bit 

more about the findings in your research. You indicated that the 

direct-to-consumer advertising is not causing harm to public 

health. However, I wonder if you have examined if the DTC is 

causing patients to request a more expensive, newer drug when an 

older or less expensive one or generic drug might, in fact, do just 

as well for their health condition. 

Dr. WOODCOCK. Well, in our physician survey that we did, a little 

over half of the physicians who recalled a patient who came in and 

had seen an ad, that patient actually did ask for a specific brand 

name drug. In about half of the cases the physician actually prescribed that particular brand name drug. In other cases a physician 

did not prescribe it and one of the reasons given was that drug was 

too expensive, otherwise it was not right for the patient, and many 

other appropriate medical reasons for not prescribing the drug. 

Our survey was not really capable of determining whether or not 

more expensive drugs are being prescribed in individual cases. We 

did find that some physicians feel pressured during an encounter. 

Whether the patient has seen an ad or not, they feel pressure to 

prescribe a drug and that pressure was increased if the patient had 

seen an ad. 

Senator STABENOW. I certainly have had those same conversations with my own physician, who indicated she could see 15 to 20 

drug company representatives in her office every week promoting 

their newest, best, most expensive drugs if she were to allow that 

to happen. So there is a whole series of things I think that relate, 

as well as DTC. 

Is it fair to say that DTC gives consumers the impression that 

newer drugs are better drugs? Is that a reasonable statement, you 

think? 

Dr. WOODCOCK. Well, the drugs that are advertised are newer 

drugs and the physicians in our survey said that the patients had 

a better impression of the effectiveness of the drugs than how effective the physicians felt the drugs were. In other words, they felt 

the patients developed an exaggerated idea of the effectiveness of 

the drug as a result of the ad. 

The fact is that older drugs are not advertised. Older, effective 

drugs may not be advertised because they are off-patent or whatever. 

Senator STABENOW. So this really does relate and I would suggest it very definitely relates to the cost of health care in terms of 

utilization going up of the higher-priced prescription drugs going 

up and not only older drugs possibly not being asked for by consumers, even though they might be just as effective, but generic 

drugs or unadvertised drugs, basically those drugs that come about 

56

as a result of companies using information once a patent has expired—that also does not get adequately in the mix. 

I would just say as an aside, Mr. Chairman, I think one of the 

really positive things that we did in the Senate in passing as part 

of the prescription drug bill was the portion dealing with closing 

loopholes regarding unadvertised brands or generic drugs going on 

the market. I think that was a very positive bipartisan effort of the 

Senate and I hope it will become law. It is now in the conference 

committee. 

I would just also say that as you looked at your study, as you 

looked at the situation, you did not analyze those other issues. 

That really was not within the scope of your study in terms of cost, 

and so on, because when we talk about public health effect, I think 

people in Michigan would say that the inability to purchase the 

medications that they desperately need as a result of the price is 

as much of a public health threat to them as anything else. But 

I am assuming from what you said that those issues were not a 

part of the scope of your study; is that correct? 

Dr. WOODCOCK. Right. Our studies were not economic studies. 

They looked at the attitudes and responses of physicians and consumers to direct-to-consumer advertising. So we came from that 

end. 

Senator STABENOW. Thank you. 

Thank you, Mr. Chairman. 

The CHAIRMAN. Senator, thank you. 

Now let us turn to our colleague from Maine, Senator Collins. 

Senator COLLINS. Thank you, Mr. Chairman. 

Dr. Woodcock, in your survey of physicians you found that 75 

percent believed that direct-to-consumer ads caused patients to 

think that a drug works better than it did and a majority of the 

physicians surveyed also felt that patients who had seen these ads 

did not understand very well the possible risks of the advertised 

drug. 

Don’t those facts suggest the need for better scrutiny of the ads 

or for additional consumer disclaimers? If 75 percent of the physicians felt that higher expectations than justified have been raised 

by these ads, then does that not suggest a problem? 

Dr. WOODCOCK. I think that advertising in general, it probably 

would be very difficult to provide a balanced medical perspective on 

a drug. That is why there is a learned intermediary for prescription 

drugs, which is that a patient must go to a prescriber and seek better information. 

We also found that patients have an appropriately skeptical attitude toward these ads and they do not think that all information 

is being presented. Often their response is to go to their physician, 

their pharmacist, the Internet or other sources of information to 

seek more information about the drug. So they do not see it as the 

be-all-and-end-all of their drug information. 

Senator COLLINS. Nevertheless, your survey showed that 75 percent of the physicians felt that their patients were coming in with 

unrealistic expectations. 

Dr. WOODCOCK. That is right, and they also reported they felt it 

was somewhat of a problem because they had to spend time correcting those impressions. 

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If I may say so, we feel that one of the problems that we still 

have and we are working very hard on is in the print ads, the information that runs alongside of those ads, which I am sure you 

all have seen, is basically incomprehensible to the consumer and 

that information is supposed to relay the risks very clearly and lay 

out some of the problems and down sides of the drug. 

We are working very hard. In 2001 we issued a guidance saying 

that if there was improved patient label, that could be run instead, 

and that is in consumer-friendly language. So more people are 

doing that. We would like to go further with that and develop some 

kind of standard format or something for that information so that 

consumers—because when they see a broadcast ad, they are really 

supposed to go to one of these other sources of information. That 

was the whole idea, but they are not very good right now. 

Senator COLLINS. I guess I would question how effective that litany of possible side effects in a broadcast ad is, either. It seems 

like it is the same list for every drug. I am not sure that really registers with consumers and I think your survey would suggest that 

it does not. Perhaps that is something for you to look at, as well. 

Some of the opponents of direct-to-consumer advertising say that 

the decisions on the use of prescription drugs should rest with doctors to make sure that they are based on the best scientific knowledge. They say that it confuses the issues for consumers to get involved. I do not agree with that, but to what degree do you think 

that marketing directed to physicians affects utilization? After all, 

every physician has the sales reps coming to his or her office, has 

seminars offered and other free samples and enticements to use 

particular drugs. 

Dr. WOODCOCK. I am glad you asked that question because as a 

physician, I feel that is a much more powerful mechanism and it 

is the primary way of trying to move, I think, new products into 

doctors’ offices and being prescribed and there is quite a bit more 

money, of course, spent on physician detailing and sampling than 

there is on direct-to-consumer advertising. We also, DDMAC also 

regulates that aspect of drug promotion. 

Senator COLLINS. Finally, since you mentioned DDMAC, I did receive a response just this morning from the FDA to the letter that 

we sent last fall. 

Dr. WOODCOCK. Yes. 

Senator COLLINS. On the issue of the change in procedure delaying the FDA’s ability to respond quickly to a misleading ad. 

Dr. WOODCOCK. Yes. 

Senator COLLINS. We currently have a proliferation of cable stations. From what I think you said to Senator Breaux, the companies do not have to submit ads in advance, which is troubling in 

some ways because you may be missing a whole lot of misleading 

ads. 

But you are still taking 15 working days or more to work out internally the legal issues before such a letter can be issued. I think 

that is a problem because in some cases these ads will have run 

their course. It may be a 2-week media buy and if it is taking 15 

working days, that is 3 weeks before your letter comes out. 

Dr. WOODCOCK. Well, let me explain again. The companies do 

need to submit the information when it is aired, so we are reVerDate 0ct 09 2002 14:21 Nov 13, 2003 Jkt 000000 PO 00000 Frm 00061 Fmt 6633 Sfmt 6633 C:\DOCS\90049.TXT SAGING1 PsN: JOYCE
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quired—now it may be that someone will violate that requirement 

and not submit it, but companies are required to submit the broadcast when it is aired. 

Senator COLLINS. But not prior to its being aired. 

Dr. WOODCOCK. That is right. Timeliness is an important factor. 

As we said earlier, that is something we are looking at. We are 

going to do everything possible and we can prioritize. If we see an 

ad that we really feel is detrimental to the public health, is giving 

a very bad misimpression or unbalanced message, we can act much 

more quickly. 

Senator COLLINS. I would just note in closing that the GAO came 

up with two specific examples where the ad campaign for a popular 

selling drug had been run, and terminated before the FDA was 

able to issue its order. 

Dr. WOODCOCK. Yes. 

Senator COLLINS. I think we need to have a system that prevents 

that from happening and it seems to me one step would be to have 

submission prior to airing, not when the ad airs. 

Dr. WOODCOCK. Well, that would likely require statutory change. 

Senator COLLINS. Thank you, Mr. Chairman. 

The CHAIRMAN. Susan, thank you and Dr. Woodcock, thank you 

very much. We appreciate you staying on. There may be additional 

questions of you following our next panel. Thank you. 

Now let me ask our next panel to come forward and let me introduce them as they come. Marjorie Powell, Senior Assistant General 

Counsel at the Pharmaceutical Research and Manufacturers of 

America. Dr. Nancy Nielsen, Speaker of the House of Delegates of 

the American Medical Association and Senior Associate Dean of 

Medical Education at the University of Buffalo School of Medicine 

and Biomedical Science is with us. Also testifying will be Dr. Meredith Rosenthal from Harvard School of Public Health, who recently 

published a study on DTC advertising. Also—gee, Harvard gets 

double take today here—also from Harvard is Dr. Arnold Relman. 

Dr. Relman is a Distinguished Scholar and former Editor of the 

New England Journal of Medicine. 

We thank you all for your patience and your presence here today 

and we will start with Marjorie Powell, Senior Assistant General 

Counsel, the Pharmaceutical Research and Manufacturers of America. Marjorie, welcome before the committee. 

STATEMENT OF MARJORIE POWELL, SENIOR ASSISTANT 

GENERAL COUNSEL, PHARMACEUTICAL RESEARCH AND 

MANUFACTURERS OF AMERICA 

Ms. POWELL. Thank you, Mr. Chairman, members of the committee. It is a pleasure to be here. As the chairman said, my name 

is Marjorie Powell. I am the Senior Assistant General Counsel at 

the Pharmaceutical Research and Manufacturers of America or 

PhRMA for short, although those of us from New England occasionally are heard to say PhRMA. 

The CHAIRMAN. Before you start your testimony let me say this. 

All of your full statements become a part of the record. We will ask 

you to adhere to a 5-minute rule. Thank you. 

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Ms. POWELL. Thank you. I would actually like to make three 

major points because all of my supporting information is in the 

record. 

First, we think that direct-to-consumer advertising encourages 

patients to talk with their doctors about their symptoms, about 

health conditions, about their current treatments. The National 

Health Council, for example, which is an organization that includes 

the 50 leading patient organizations in the country, has said that 

they think the more information that patients have, the more effective they can be in working with their doctor to make decisions 

about their health care. 

The FDA’s study, which has been described, documents that patients think that information in direct-to-consumer advertising is 

helpful. A study by Prevention Magazine in 2002 reports that 61 

million Americans talked with their doctors about an advertised 

medicine and 25 million of those patients were diagnosed as having 

a condition that had not been previously diagnosed. There are a 

number of other studies that support this same finding, although 

the exact figures or percentages vary from study to study. 

The information that is presented in direct-to-consumer advertising informs patients about available treatments. In many cases 

it informs patients about treatments for diseases that were not 

treatable in the past, therefore encouraging them to talk with their 

doctors. It may inform them about a disease that is associated with 

a symptom that they have but they did not associate that with a 

disease or did not think it was a serious symptom. 

They also inform patients about the existence of treatments for 

their diseases, treatments that in some instances doctors may not 

have talked with them about before. For example, a recent Health 

Affairs report of research indicates that approximately a third of 

physicians indicate they do not discuss treatments with their patients if they think the treatments are not covered by their patient’s insurance. We think it is important for patients to have information about all available treatments, including ones that may 

not be covered. In many instances when the recommended treatment is a medicine, particularly a branded medicine, if the patient 

does not have insurance and cannot cover the cost of that medicine, 

all of the PhRMA member companies have patient assistance programs that will provide that medicine at no cost and many of the 

companies now have discount card programs as an interim until 

the conference committee resolves differences and both houses will 

pass a Medicare drug benefit; by the way let me congratulate you 

on moving as far as the effort has so far. 

We also think that direct-to-consumer advertising encourages patients to take medicines once they have been prescribed. There are 

a number of reports that patients who see direct-to-consumer advertising for a drug that they are taking continue to take their 

medicine. In some cases it reminds them that they need to take it 

when they have stopped taking their medicine. Given the vast expense within the health care system that is caused by patients who 

receive prescriptions but then stop taking their medications, particularly prescriptions for chronic conditions where the symptoms 

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ber to take their medication, that it is really important to encourage patient compliance. 

A number of the patient advocacy organizations also say that 

when a new medicine is advertised for the condition for which they 

are advocating, they receive an increase in the number of phone 

calls to their 800 line from people asking for information about that 

disease, either for themselves or for other people. 

So the direct-to-consumer advertising has a benefit in educating 

patients and the general public about diseases and conditions and 

treatments that are available. 

It is also true that when a patient talks with a physician about 

a drug that they have seen as the subject of direct-to-consumer advertising, the physician does not automatically write a prescription 

for that medication. In fact, in a large number of cases—in fact, I 

think the FDA figure is 22 percent—the physician directs the 

patient to change their lifestyle, either improve their diet or stop 

smoking or exercise or some other event. 

We think that—and let me just conclude by saying that in this 

debate it is important to ask some additional questions and those 

would be, how would patients benefit if they were less likely to 

know about new treatment options, if they were less likely to report to their physician symptoms that are now untreated? What is 

both the human and the economic costs of untreated diseases within our health care system? How is it that people who oppose directto-consumer advertising propose to end the amount of undertreatment of serious conditions? 

We think it is important that patients have information about 

treatments available and that direct-to-consumer advertising is one 

mechanism. Let me stop and I will be pleased to answer questions 

when the panel is finished. 

[The prepared statement of Ms. Powell follows:] 

The CHAIRMAN. Ms. Powell, thank you very much.

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Now let us turn to Dr. Nancy Nielsen, speaker of the House of 

Delegates, the American Medical Association. 

STATEMENT OF NANCY NIELSEN, M.D., PH.D., SPEAKER OF 

THE HOUSE OF DELEGATES OF THE AMERICAN MEDICAL 

ASSOCIATION, WASHINGTON, DC 

Dr. NIELSEN. Thank you, Mr. Chairman, and thank you to the 

members of the committee. It is a pleasure to be here. 

I am Nancy Nielsen. I am an internist from Buffalo, NY and I 

am speaker of the House of Delegates of the American Medical Association. On behalf of our physician members and our medical student members, we are pleased to offer you our perspective on this 

important issue. 

I brought with me some examples but you have already referred 

to them, about the multiplicity of magazine ads. You have already 

heard from both the chair and other members of the committee 

about TV ads. Nobody can help but notice there has been a dramatic increase in these numbers. 

Patients see those ads. They then go to their physician and they 

ask for a prescription for a specific drug, even before a diagnosis 

is made. Back in 1998 the AMA developed an ethical opinion to 

help physicians deal responsibly with those kinds of ads. We also 

developed policy to help define what, to us, are acceptable directto-consumer ads. You have heard that mentioned by Dr. Woodcock 

and by the chair. Our written testimony contains the details of our 

written policy and I will not comment further unless there are 

questions. 

This kind of advertising is legal, it is widespread, and it is probably here to stay. That being said, it remains controversial and we 

have some concerns. First, most physicians believe that these ads 

are marketing, not education. The AMA absolutely supports patients’ access to information about drugs but the real question is 

whether drug advertising designed to sell a product provides the 

type of objective and accurate information that patients need. 

What about fair balance and explanation of risks? The print ads 

have to provide the full disclosure but as you, Mr. Chairman, 

mentioned, it is real tough to read. When you go to broadcast ads, 

that is very different. Only the major risks have to be mentioned. 

Remember the girl prancing through the field of flowers and 

ragweed? Do any of you recall the risks that were described when 

that ad was running? 

A 1999 study found that fully one-half of patients incorrectly believed that the ads were preapproved by the FDA and 43 percent 

incorrectly believed that only risk-free drugs were advertised. 

These misconceptions may give consumers a false sense of security 

that prescription drugs are risk-free. 

What about the impact on the doctor-patient relationship? Consumer surveys suggest that these ads do increase the number of 

visits to physicians, some of which do lead to new diagnoses and 

to a more informed discussion. That is the good news. However, 

these ads also increase demand for specific drugs. 

Last weekend CNN aired a story on a treatment for attention 

deficit disorder in adults. I do not know if any of you saw it. There 

is only one approved drug for this condition. TV and radio ads for 

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this drug center around some screening questions for consumers. 

Now hold on and see how you would answer these questions. Here 

are a few of them. 

How often do you feel restless and fidgety? When you have a task 

that requires a lot of thought, how often do you avoid or delay getting started? If you answer even sometimes to these questions, the 

ads suggest you have symptoms consistent with ADD and a visit 

to the doctor is recommended. Education or advertising? You decide. We have a hotline in the back if anybody wants to set up a 

visit to their physician right away. 

You have heard about some reports in Health Affairs. Let me 

talk about another one that I have not heard mentioned. There was 

a study reported in Health Affairs in which half of patients said 

they would be disappointed if their physician did not write the prescription they requested. A quarter said they would try to change 

their physician’s mind. A quarter thought they might go to another 

doctor to get the drug and 15 percent thought they would change 

doctors. 

You have heard about the GAO report. The question is the increased utilization and spending appropriate? Were these drugs underutilized before or is this wasteful spending and would less expensive alternatives or no drug at all work just as well. 

In conclusion, we have three recommendations for the committee. 

First, there is room to improve the educational value of these ads 

and we urge the pharmaceutical industry to follow the AMA’s 

guidelines. Second, more independent research on these ads is 

needed to determine their impact on the patient-physical relationship. Third, the FDA must be adequately funded by Congress to 

carry out its oversight role and to use enforcement when necessary. 

Thank you for the opportunity to speak before you. 

[The prepared statement of Dr. Nielsen follows:]

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The CHAIRMAN. Dr. Nielsen, thank you very much. 

Now let us turn to Dr. Meredith Rosenthal from Harvard’s 

School of Public Health, who recently published a study on DTC 

advertising. 

STATEMENT OF MEREDITH B. ROSENTHAL, PH.D., DEPARTMENT OF HEALTH POLICY AND MANAGEMENT, HARVARD 

SCHOOL OF PUBLIC HEALTH, BOSTON, MA 

Ms. ROSENTHAL. Thank you, Chairman Craig, Senator Breaux, 

distinguished committee members. Thank you for inviting me to 

discuss the consequences of direct-to-consumer advertising of prescription drugs. I have been asked to summarize the scientific literature in this area and highlight key findings for policy. I would 

also like to make note of some important missing findings, questions that are not yet answered by empirical research. 

At the risk of confusing the record, I am going to use the acronym DTCA to keep my comments to a few shorter syllables. 

My review will highlight three main points supported by research. First, while DTCA expenditures have increased rapidly in 

recent years, the share of consumers that report asking their doctor 

for an advertised drug and receiving that drug has remained quite 

stable over the same period. 

Second, DTCA clearly increases spending on prescription drugs 

but it is not the primary driver of prescription drug spending 

growth. 

Third, because most of the increase in spending caused by DTCA 

appears to be due to additional use of prescription drugs in the advertised class rather than price inflation per se or consumers 

switching to higher-cost brands within a class, the most crucial outstanding policy question that I see is what is the magnitude of the 

incremental health benefit obtained by patients who seek and obtain treatment as a result of DTCA? When I say incremental I 

think it is important that we should keep in mind that the comparison should be what the patient would have gotten either in the 

absence of DTCA if we are talking about banning it or under some 

other model of DTCA. That would not necessarily be a generic 

drug, an older drug. It might be nothing. It might be a different 

brand. 

Among the earliest studies of DTCA are those that rely on consumer surveys; you have heard these cited already. Surveys conducted by Prevention and Men’s Health Magazines, as well as the 

FDA and a number of others have shown that approximately 80 

percent of Americans can recall seeing advertisements for prescription drugs. One-quarter to one-third of consumers report that they 

spoke with their physician about the specific advertised drug. 

Roughly 5 percent of consumers surveyed say they actually received the drug that they asked for. These figure are remarkably 

similar across surveys and over time. 

The impact of DTCA on use and spending is the subject of several recent studies that rely on actual insurance claims or sales 

data, so these data actually reflect the behavior of consumers and 

physicians. A number of studies have found that DTCA increases 

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dation, suggests that DTCA accounted for roughly 12 percent of 

total prescription drug spending growth in 2000. 

DTCA by a particular brand name drug increases the size of the 

market for the entire therapeutic class. Moreover, there is no evidence that DTCA increases the market share of the advertised 

brand. That is, brands benefit from DTCA by any drug within their 

class in proportion to their existing market share. 

In combination, these findings are very important from an economist’s point of view. We look at this as some evidence that it is not 

a foregone conclusion that DTCA has a negative effect on consumer 

welfare. Because of the fact that there is increased use of drugs 

and we think there may be some positive health benefit to that use, 

it is worth looking further. If we saw this was just about shifting 

market share from drug A to drug B that are roughly substitutes, 

we could sort of close the book there. 

In most other markets we would be done and we would say that 

advertising is beneficial here. In health care, clearly because of imperfect information and the presence of insurance, we need to go 

further. 

As well, there is no current evidence to suggest that DTCA increases prices, although this is admittedly very difficult to study. 

If indeed DTCA has no effect on prices and price competition in 

particular, it stands in contrast to the published literature on physician promotion, which has been found to reduce competition and 

increase prices. This fact should be heeded, given that DTCA and 

promotion to physicians are substitutes and any constraints on 

DTCA is likely to give rise to increases in promotion to physicians. 

So in summary, I would just like to reiterate that to no one’s surprise, DTCA increases spending on prescription drugs. It does not 

appear to be the main driver, however. DTCA appears to increase 

spending through increases in utilization for all drugs in a therapeutic class, not necessarily by inducing consumers to switch from 

one brand to another. This means that DTCA motivates consumers 

to seek treatment but those decisions about what treatment they 

will actually get when they seek that treatment are influenced by 

other factors, such as physician information and health insurance 

benefit structure. 

Finally, I would like to note again I think the important outstanding question that everyone seeks to be pointing to is that we 

need to understand better the magnitude of the health effects for 

people who are using drugs as a result of DTCA. There are clearly 

cases where it is inappropriate and clearly cases where this is very 

needed treatment for chronic illness, for deceases in particular that 

are undertreated, such as depression, but the relative magnitude of 

those two phenomena is what is really important here. Thank you. 

[The prepared statement of Ms. Rosenthal follows:]

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The CHAIRMAN. Doctor, thank you very much. 

Now let us turn to Dr. Arnold Relman, distinguished scholar and 

former editor of the New England Journal of Medicine. Doctor, welcome before the committee. 

STATEMENT OF ARNOLD RELMAN, M.D., PROFESSOR EMERITUS OF MEDICINE AND SOCIAL MEDICINE, HARVARD MEDICAL SCHOOL, BOSTON, MA 

Dr. RELMAN. Thank you. Mr. Chairman and members of the Special Committee, thank you for the invitation to be here. You have 

a copy of a longer version of what I have to say so what I am going 

to do is simply touch on the highlights. 

The total spent on direct-to-consumer ads is now probably over $3 billion but that is only a small fraction of the total industry expenditure on marketing, advertising and sales promotion. You have 

already heard Dr. Rosenthal cite the evidence that these consumer 

ads nevertheless have an effect on patient demand and on prescription drug spending. The exact extent I think is open to interpretation of uncertain methodology but it clearly has some effect. That 

is not surprising, of course, because common sense dictates that industry executives would not be spending so much on direct-to-consumer advertising were they not convinced that it increased their 

sales. 

I might add parenthetically that Dr. Rosenthal’s conclusion that 

it does not necessarily increase the sale of the drug being promoted, rather, the class of drugs, I suspect would come as a surprise and a disappointment to all those executives who spend billions and billions of dollars believing that it does. 

The industry argues that DTC ads serve more than purely commercial purposes. They say such ads educate the public about illnesses and the new medicines available to treat them and thus encourage patients to consult physicians for earlier diagnosis and 

treatment, but that is simply the claim of business people whose 

sales are increased by these ads, they think, and who therefore 

hardly can be unbiased. 

I do not know of any hard scientific evidence that would pass 

critical peer review that the information that is disseminated in 

these ads really helps the health care system. I really do not and 

I would challenge the statement that there is clear evidence that 

health care is improved by these ads. There is no solid scientific 

evidence to support that contention. 

There are some medical opinions in agreement with the industry’s contention but they also lack data and unfortunately are often 

tainted by financial support from the pharmaceutical industry. I 

am glad to hear that my colleagues in the AMA clearly are skeptical, as they should be, about the medical value of these ads. 

When one considers that the majority of direct-to-consumer drug 

ads are now on television and that this means a hasty 30- or 60-

second spot, it is hard to imagine how useful educational information could ever be conveyed in this manner, even if these ads were 

not biased toward a particular product. There simply is not time 

to provide any information about side effects or complications, let 

alone to compare the cost and effectiveness of the advertised brand 

with other available drugs or other methods of treatment, which is 

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what good medical information would do. That is how we academics in medicine define useful education about drugs. You evaluate what is available, the pros and the cons, what is worth the 

money, what is safe, what is effective, as compared to everything 

else that you might do. There is none of that in these ads. 

Clearly these ads are intended simply to fix a brand name in a 

patient’s mind, with the hope that the patient will then ask the 

doctor about it at the next visit and will influence the doctor to 

write a prescription for it. Actually how often that occurs I do not 

think is important, but that is what the advertisers think. 

Given all the above, what can we conclude about direct-to-consumer advertising? I find little to recommend it and much that argues against it, particularly in these times when rapidly rising expenditures on prescription drugs are straining the budgets of all 

purchasers. 

In my judgment as a teacher of medicine for over 50 years, with 

a very large experience in medical education and in medical consulting, there are lots and lots of patients in the United States who 

are now being overmedicated, dangerously so, and take too many 

medications. I believe that these ads must, in part, be responsible. 

These ads promote only the newest and most expensive drugs, 

many of which are no better than or possibly not even as good as 

older, less expensive generic drugs or as effective as simpler, nonpharmaceutical treatments. 

As a physician, I believe that decisions about the use of prescription drugs should rest with doctors based on the best available scientific knowledge. The education of patients should be the responsibility of doctors and of governmental, public health and professional organizations. 

I do not see any basis for the industry’s assumption that they 

have the responsibility for educating patients or, for that matter, 

for educating doctors. They have no such responsibility. They are 

businessmen. Their job is to sell honest products and advertise 

them honestly. They are not educators and they should not pretend 

that they are. 

I therefore would favor a total ban on direct-to-consumer ads. If 

the law were to prevent such legislation then I would advocate at 

least a return to something like the pre-1997 FDA regulatory policy 

and would require that all DTC ads include approved consumerfriendly information. I would also strengthen the FDA’s capacity to 

eliminate the delays in reviewing ads, which you have heard about. 

I conclude. Prescription drugs simply are not like ordinary commercial goods and it is not in the public interest to advertise them 

to consumers as if they were. We need more, not less, regulation 

of consumer ads. Thank you for your attention. 

[The prepared statement of Dr. Relman follows:

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The CHAIRMAN. Doctor, thank you very much for that very provocative statement. We appreciate it. 

Now let me turn to our panelists for questions. Ms. Powell, let 

me start with you. The question that I would like at least your response to because my guess is you have had some opportunity to 

analyze it prior to this hearing—what is PhRMA’s position regarding AMA’s guidelines for DTC advertising? 

Ms. POWELL. We have looked at the AMA’s guidelines on DTC 

advertising and we think that many of them are, in fact, consistent 

with the FDA’s guidance on direct-to-consumer advertising and 

many of them represent important public policy. We have, however, 

not actually adopted any kind of formal position on what we think 

our members should include in their advertising. We do, of course, 

encourage our members to provide educational information in their 

advertising and as Ms. Woodcock from the FDA said, the vast majority of our members do, in fact, submit advertising to FDA for review before that advertising goes on the air. 

We do think it is very important, of course, that all the ads comply with the FDA requirements and one of those requirements—I 

think I am correct—is that the advertisement has to indicate that 

this is a prescription drug and that the patient should seek additional information from their physician or other health care provider about both risks and benefits because the decision does remain with the physician about what treatment a patient should receive. 

The CHAIRMAN. Is there any consideration by PhRMA for developing or adopting principles, standards or guidelines not unlike 

what AMA is proposing? 

Ms. POWELL. The AMA has actually talked with members of the 

PhRMA board of directors about that issue. It is something that 

comes up periodically. I do have to tell you realistically that right 

at the moment, PhRMA is focused on some other issues that have 

already been mentioned here and this would not be an immediate 

high priority but I certainly would be willing to go back to our executive officers and remind them of that request from the AMA. 

The CHAIRMAN. Well, I will only tell you that I think many of us 

in Congress look at the whole and not the pieces as it relates to 

prescription drugs and as government enters in and becomes much 

more the participant, cost factors, cost of total program is going to 

be an increasing focus of this Congress, I would guess, and future 

Congresses to come. I think that is a reasonable observation. 

Dr. Nielsen, what is the impact of this country’s third-party 

payor system on doctors’ prescribing habits? 

Dr. NIELSEN. It is enormous. It has been alluded to actually in 

the study that just came out a week ago cited by Ms. Powell where 

physicians do not dangle in front of their patients therapeutic options that are unavailable to them. In this country, for better or for 

worse, and Congress is right on the front line on this one, for most 

of us unless we are independently wealthy, if something is not covered as a covered benefit by our health insurance, we cannot afford 

it and we cannot get it. So that is an issue. Third-party payers 

have had a tremendous impact. 

Part of the impact may relate to what Dr. Rosenthal mentioned, 

as well. Patients come in seeking a specific drug because of an ad 

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that they have seen. They may not be able to get that drug because 

it is not on the formulary of their third-party payor. So I would say 

that that is indeed a big issue. 

The CHAIRMAN. Do you believe the fact that someone else is paying for a patient’s drug influences the behavior of either the patient 

or the physician in choosing the drug to be used? 

Dr. NIELSEN. Yes. Yes to both. 

The CHAIRMAN. Thank you. 

This will be my last question in this round. Dr. Relman, in your 

testimony you stated ‘‘There is no scientific evidence to support the 

contention that DTC advertising encourages people to consult physicians for earlier diagnoses or treatment.’’ How do you respond to 

the surveys by FDA and Prevention Magazine that indicate that as 

many as 20 million people visited with their doctor about a condition for the first time as a result of DTC advertising? 

Dr. RELMAN. Senator, one of the basic rules of all good epidemiologic research is that there be adequate controls. There are simply 

no controls for all such studies. We do not know in any systematic, 

quantitative way what the behavior would be of patients who never 

heard about these ads for the simple reason that there is hardly 

anybody who is conscious in America these days who has not heard 

about these ads. 

If you look at the data which says well, these ads are responsible 

for the behavior, it will not pass muster. It would not have been 

accepted for the New England Journal of Medicine or any other 

really rigorously peer-reviewed journal. 

The CHAIRMAN. Well, Dr. Woodcock, how do you respond to that? 

Dr. WOODCOCK. It would be a challenge in today’s environment, 

as Dr. Relman just alluded to, to design such a study. It would be 

difficult to take a segment of our population and refuse to allow 

them access to prescription drug ads so that we could determine 

what their behavior is. There are methodologic difficulties in getting to the level of scientific proof that Dr. Relman is looking for. 

The CHAIRMAN. Thank you. 

Let me turn to my colleague, Senator Breaux. 

Senator BREAUX. Thank you, and thank all the panel members 

for excellent testimony. 

Dr. Woodcock, since you are back, does the FDA regulate advertising to doctors of pharmaceuticals? 

Dr. WOODCOCK. Yes. 

Senator BREAUX. In what way? 

Dr. WOODCOCK. We have standards for all the information that 

goes to physicians. As I said in my testimony, it is the same standards and regulations that apply to consumers. The companies must 

submit their written information and other information, even the 

pens and all the promotional materials that they use, to the FDA 

at the time they are circulated to physicians. 

It is more difficult for us to regulate and really have effective 

oversight of the verbal exchanges that go on between the detailers 

and the physicians. 

Senator BREAUX. Dr. Nielsen, would AMA support a prohibition 

on pharmaceuticals advertising to doctors? 

Dr. NIELSEN. No, but any doctor who gets all their information 

about a drug from a drug salesman is a fool. 

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Senator BREAUX. The division of the expenditures on promotional 

spending shows that the spending that is labeled doctor’s office detailing, can anybody tell me what that includes? What is doctor’s 

office detailing? It is over $4 billion back in 2000. 

Dr. NIELSEN. Well, you heard Senator Stabenow address it. She 

said she spoke with her physician. Let me tell you what happened 

in my office. Let me immediately say this is not about doctors 

versus the pharmaceutical companies. I mean we need these products. They are life-improving; they are life-saving. So it is really 

not about—— Senator BREAUX. I understand. But what is doctor’s office detailing? 

Dr. NIELSEN. What really happens is the drug reps come to the 

doctor’s office and they want face time with the doctor. That is 

what it is—sitting down, explaining what the newest drug is, what 

the side effect profile is, and usually offering free samples for the 

physician to try with their patients. That is what it means. 

Senator BREAUX. Dr. Woodcock, you had a problem? 

Dr. WOODCOCK. Yes, I was going to add to that or elaborate. The 

sampling, providing the samples, which is costed out at the market 

value of the samples, is actually the largest segment of drug promotion. It is the largest proportion of drug promotion and this may 

affect what Dr. Rosenthal was talking about. A patient may come 

in requesting one drug and if the doctor has samples of another, 

free samples of another drug, the patient will start on that other 

drug. 

So that is also a very powerful mechanism by which patients can 

be initiated on a certain therapy, which they often might stay on, 

and that is a very high expenditure in the promotion realm. 

Senator BREAUX. It seems to me that no consumer can write 

their own prescription. Unless they are a doctor, none of them can 

legally write their own prescription. So a consumer who sees an ad 

for a particular pharmaceutical and may not clearly understand 

the potential side effects of that drug, whether that particular drug 

is suitable for their particular condition, that individual consumer 

still has to go to the doctor. The doctor is the gatekeeper. Only the 

doctor can write a prescription that is suitable for that individual 

patient. 

So I have less of a concern about the advertising, detailing, all 

the medical consequences of a drug that is advertised because I 

know that behind that advertisement and before the consumer can 

ever get the drug he has to go through the gatekeeper. The doctor 

looks at that patient. If the doctor has a patient that says I would 

like this the doctor makes a medical decision whether or not that 

drug is suitable for you. 

Is that not the protection that consumers have? No consumer can 

write a prescription. 

Dr. NIELSEN. That is correct. That is absolutely correct. Doctors 

do do that, but remember the study that said one-quarter of patients whose doctors did not give them the drug would go to another doctor to try to get it and 15 percent of them would totally 

change doctors. 

Senator BREAUX. That is important but Dr. Rosenthal also points 

out that about 80 percent of consumers remember a drug ad and 

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of the 80 percent that even remember a drug ad, somewhere between a fourth or a third ever request their doctor to give them 

that particular pharmaceutical. Then the doctor responds positively 

to that request only 5 percent of the time. I would be concerned 

that if my advertising was only getting my product requested 5 

percent of the time, I would say gee, I had better get a new advertising agency. 

So it does not seem to me from what Dr. Rosenthal said that you 

have a real problem if only 80 percent remember the ads and only 

a third to a fourth of them ever make a request and then only 

about 5 percent of those that make the request ever get what they 

requested. That means 95 percent are either turned down by their 

doctor or presumably would be turned down by another doctor who 

would make the same medical decision that this was not the appropriate prescription for that particular person’s condition. 

So I do not know that you have a problem with direct-to-consumer advertising in an overrequest of a particular drug that has 

been advertised with a connected compliance with that request by 

physicians. Is that your compilation of the studies you have looked 

at? Am I correct in reading it like that? 

Ms. ROSENTHAL. You are correct. I think in the overall picture 

that you have painted, that is the impression I tried to leave. I just 

want to correct perhaps your impression of those consumer survey 

numbers. The 80, a quarter to a third and 5 are all off the same 

denominator, so talking about all surveyed consumers. So those 

numbers could be translated, but it is 5 percent of all surveyed consumers say they followed through the whole chain. They saw the 

ad, they went to their doctor, asked about the drug, and received 

the drug. 

But I think that you make a very important point, that many 

other factors intervene before a consumer actually gets to a decisionmaking process where they can purchase a prescription. 

Senator BREAUX. I have one other question, if I may. 

Ms. Powell, the argument is that if the drug companies are spending $2.5–3 billion annually on advertising that somehow if you were not doing that that somehow drugs would be $2.5–3 billion annually less expensive. Now I do not know that that would 

be correct. Can you comment on that? This is maybe not your area 

but it would seem to me that to a large extent if we eliminated direct-to-consumer advertising and you saved $3 billion, I doubt 

whether the companies would automatically reduce the price of 

drugs by $3 billion. You would probably look at different forms of 

advertising. You may hire more people to do research and development. You may do a lot of things with that other than reduce the 

price of the retail pharmaceuticals. I do not know if this is your 

area or not but can you comment on that? 

Ms. POWELL. Well, the information that we have, which is collected by IMS Health, on the allocation of——

Senator BREAUX. IMS Health, just for the record? 

Ms. POWELL. IMS Health is a third-party independent organization which collects information and then there are a number of 

other groups that look at drug spending information. We do not, as 

a trade association, actually collect drug marketing information but 

the information that we have is that the majority of the money 

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that is now spent on broadcast advertising or print advertising to 

consumers is money that had been spent on either marketing to 

physicians by sending sales people to their offices or money that 

was spent on advertising in professional journals. 

So the money has not come from other research and development 

or has not come from price increases but has been pulled from 

other marketing activities. I would have to presume that companies, if they were prohibited from advertising directly to consumers, would go back to advertising not only to physicians, but 

also let me point out that everybody else within the physician’s office may be giving information to patients about how to use their 

medications and they need information about what the contraindications or the risks would be, as well. 

Senator BREAUX. Thank you, Mr. Chairman. 

The CHAIRMAN. Senator Breaux, thank you. 

Senator Stabenow. 

Senator STABENOW. Thank you, Mr. Chairman, and thank you to 

all the panelists. I have many questions, as all who are listening 

to this will have. 

I will just start by saying I think it is unfortunate if we, in fact, 

eliminate advertising and prices would not go down. That is a very 

unfortunate thing because I think that the biggest risk to American 

consumers today is the fact that we are paying such high prices 

and Americans, in fact, pay the highest prices in the world, even 

though we greatly invest in research and development and support 

of the industry, which I support. 

According to a July 2003 Families USA report, the prices of the 

50 most prescribed drugs to seniors rose, on average, nearly three 

and one-half times the rate of inflation last year. I believe that is 

an incremental cause of concern to people’s health, their ability to 

be able to have access to medicine. 

Regarding advertising, I believe in public information, consumer 

information in many, many ways and support many efforts for people to be well informed, for all of us to be well informed as consumers, but I wondered if any of the panelists might want to speak 

from not just a statistical standpoint but from common sense, common sense. This is something that the average person does not 

need a study to look at; they just need to turn on their television 

set. It is very clear what is happening. 

What I think is important to reemphasize is that we are not seeing ads on television with words from a physician explaining the 

pros and cons of various kinds of ailments and what people should 

think about in going to the physician’s office and what questions 

to ask. We are seeing the woman in the field, the lilies. When we 

look at all of the possible things we would educate people on, certainly Viagra is educating us over and over again about a series 

of things through pretty pictures. 

Again I do not mean to pick on Vioxx but since they have huge 

advertising, we are seeing just all kinds of pretty pictures. We are 

not seeing objective information explaining to people the differences 

in products and that is for a good sound business reason—folks 

who advertise want to make sure their brand name is out there 

and they are trying to have us all buy their product, and that is 

the American way and I think we should not pretend that there is 

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anything else going on here other than the attempt to advertise in 

order to increase their share of the market. 

The question I have though, relates to a supposition that we are 

educating people when, in fact, the majority of drugs that are being 

advertised are for things that millions of people have because you 

want larger market share; you want more people buying your product, as opposed to advertising regarding orphan drugs or rare diseases, where that person sitting at home may, in fact—they know 

they have a headache; they may know they are a little tired; they 

may know that they are not feeling well but may not be aware of 

a rare disease, may not be aware of something that involves an orphan drug. Yet that is not what we are seeing on telephone. We 

are not seeing advertisements or educational promotions for those 

things that people may not know about. We are seeing it for the 

most common, the painkiller, even though on Peter Jennings they 

indicated on a show last year that—again unfortunately to pick on 

Vioxx—Vioxx has not been proven to be any more effective at treating pain than tried and true over-the-counter drugs, such as Alleve 

and Advil, but yet that is what we are seeing on television. 

So I wonder if any of you might speak to if you were going to 

put together an advertising campaign that encourage consumers 

and is helpful in terms of health education, what would you do and 

what about the fact that some of the most important rare diseases 

that we as consumers should learn about are not advertised because it is not, I assume, beneficial from a profit standpoint to advertise that? Dr. Nielsen and then Dr. Relman? 

Dr. NIELSEN. I will take a stab at it. I think it is unrealistic to 

expect a pharmaceutical manufacturer to be altruistic primarily 

and I think that is just an unrealistic expectation. On the other 

hand, we wish they did more of that, obviously. The orphan drugs 

are a problem because they are very high cost and the manufacturers are not going to reap a profit from them. So you understand 

why they do not choose to advertise those. 

But let me go back to a little bit different aspect of what you are 

getting at because I think you have hit on something really important. We as physicians do appreciate when there is an educational 

part of the ads, and the way you go about that is make the ad disease-specific. Give screening questions for depression. If someone 

has not sought treatment for depression perhaps they will indeed 

seek such treatment. We like those ads and, in fact, that is the 

very first of our principles in our policy, to keep it disease specific 

when possible and to be educational. 

But I have to say that while I would love to believe that we 

would encourage them or maybe even mandate them to spend a little bit of their money on this altruistic sort of maneuvering, I doubt 

that it fits into the big scheme of what their advertising is going 

to be. 

Senator STABENOW. I appreciate that. Obviously I understand 

that and agree with that. It is a business. I think we should just 

recognize that in the context of all of our discussions, that it is a 

business decision and I very much appreciate that. Unfortunately, 

it is a business decision based on a product that may be life or 

death to someone, so I think it is a different product than other 

products that people can choose to purchase or not purchase. 

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Yes, Dr. Relman. 

Dr. RELMAN. Senator Stabenow, I would like to add to what my 

colleague Dr. Nielsen said. Of course the pharmaceutical manufacturers are business people and they are not expected to be philanthropists. They are expected to want to sell their products and that 

is what they do. In response to Senator Breaux’s question, it is more than $3 billion now. It passed $3 billion and that $3 billion 

is paid for by the patients who buy the drugs. 

Now the way he framed the question, would they go out and lower their prices by $3 billion? No, they will not do that but clearly in order for them to maintain their expected level of profits, 

which are enormous, they have to price accordingly and part of 

their expense, which reduces their profit, is the $3 billion plus for 

direct-to-consumer ads. 

But the point I want to make here is that Senator Breaux is absolutely right. The main responsibility for the proper prescribing of 

drugs and for the proper use of drugs and the evaluation of drugs 

rests with our profession. Doctors are the only ones really qualified 

to know what is worth the money and what is not, what works in 

a particular case or in general, as compared with all the other 

choices that are available. Doctors should advise patients about 

that. 

Unfortunately, however, they do not do it enough. The reason is 

quite simple. The pharmaceutical industry spends so much money 

‘‘educating doctors’’ as to what they ought to think about the newest drugs, and on being nice to doctors. There are many different 

ways in which the pharmaceutical industry influences the doctor’s 

professional judgment. It is too bad; it is a disgrace. I feel embarrassed for our profession that we allow it to happen. 

The pharmaceutical industry that says well, they spend more on 

R&D than on advertising and marketing and promotion than they 

do on R&D is simply not telling the truth. Look at the SEC filings. 

They say that on the average, 35 percent of their income is sales 

promotion and administration. They do not want to separate out 

what they call administration but one major pharmaceutical company does; that is Novartis. They list their administrative costs 

separately and that is 5 percent, and common sense tells you that 

is about the right kind of number. 

So what we are seeing is that the pharmaceutical industry, 

which now is selling about $200 billion worth of drugs this year, 

is spending roughly 30 percent, or $60 billion, on marketing. That 

is much more than they admit to, but it includes the enormous 

amount of money they spend on an estimated 314,000 ‘‘educational’’ occasions when the pharmaceutical industry sponsors 

meetings and seminars and conferences and symposia. They spend 

a huge amount of money and most of that goes to influencing the 

opinion of doctors. 

Unfortunately, there are very few professors of medicine who are 

teaching the students not to pay attention to that. It is very hard 

when people are so nice to you and want to give you all these 

goodies free and give you free samples for your needy patients, and 

so on; it is very hard not to pay attention to the pharmaceutical 

industry. But that is the secret and that is the dirty secret of our 

profession, that they are kept by the pharmaceutical industry and 

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that dulls their willingness to be critical about what is really worth 

the money and what is not. 

Senator STABENOW. Mr. Chairman, thank you. I would just ask 

that we consider holding a hearing on the broader marketing 

issues. I think it is a worthy discussion to have. I would urge that 

we consider that and understand again from my own physician, 

who is a person of great integrity who talks about the daily and 

weekly pressures on her and the opportunities for computers and 

gifts and all kinds of things that constantly come that have a component related to that as it relates to marketing for the industry. 

I think that the biggest concern I have had is the increased pressure or requests that doctors receive to have the drug rep in the 

examining rooms, which I find extremely concerning. 

Dr. NIELSEN. Senator Stabenow, you anticipated just what I was 

going to say. We just passed a resolution about that at our last 

meeting in June. I will say the AMA not only has ethical guidelines 

for how to evaluate direct-to-consumer ads but we also have ethical 

guidelines for our own members for how they intersect with the 

pharmaceutical industry and we sincerely hope that they will follow those. 

Senator STABENOW. Thank you. Thank you, Mr. Chairman. 

Dr. RELMAN. Unfortunately, those guidelines are voluntary. 

The CHAIRMAN. Let me turn to our colleague from Delaware, 

Senator Tom Carper, who has joined us. 

Senator CARPER. Twice. 

The CHAIRMAN. Twice you have and are you here to stay now? 

Senator CARPER. Not for long, no. 

The CHAIRMAN. Not for long, all right. Do you have any questions 

for our panelists? 

Senator CARPER. Actually, I do. 

I want to thank you all for being here today and for your testimony. Most of my colleagues have a lot going on today; you probably do, too. You are nice to spend your morning with us. 

What would probably be most helpful to me in the short time 

that I have is to ask you a question or some questions. There are 

some things that you agree on with respect to direct-to-consumer 

advertising and there are probably some things you do not agree 

on. Where do you agree? Where are the common points of agreement that you have stumbled across during the course of this discussion this morning? I do not care who goes first. 

Dr. NIELSEN. Let me start. I think we agree that education of the 

public is a good thing and educating them about possible conditions 

that they might not know about is a good thing, so I think there 

is not anybody around the table that would disagree about that 

one. 

I can speak for myself. I believe and the AMA believes that the 

FDA is doing a good job. They need more resources. I will let Dr. 

Woodcock expand on that, but we do believe that they have worked 

hard to try to make sure that there are not excesses in some of the 

broadcast media and certainly the print media. 

So let me start with that and ask the other colleagues around the 

table what we agree on. I could give you a long list of what we do 

not agree on. 

124

Dr. RELMAN. I think everybody agrees that education is a good 

thing. Nobody can argue that consumers should not have as much 

information as they can usefully use. The question is not whether 

education is a good thing for consumers. The question is who 

should have that responsibility for giving them the kind of education they need. 

Now as a professional educator, my idea of education has not the 

remotest resemblance to the kind of drivel that is put out in the 

ads. It is not education. It is marketing. So the question is who 

should do that? Then we would differ. The industry thinks we 

should do it—we, the industry, should do it. They say that. If we 

do not educate doctors in continuing medical education, who is 

going to educate the doctors? That is absurd. That is clearly a professional educational responsibility. 

I believe that doctors and their professional organizations, as 

well as public health organizations, and government organizations, 

that have the facts and would be dispassionate and unbiased in 

serving the public interest should be the educators of our patients. 

The pharmaceutical industry simply doesn’t belong there. 

That is why I am so mad at our profession for allowing the pharmaceutical industry to pretend that they are our educators, and 

our patients too. They are not. They are our seducers. 

Senator CARPER. Well, that is not a word we hear every day here 

in hearings, not lately. 

Ms. Powell. 

Ms. POWELL. Senator, if I could respond, I think that all of the 

PhRMA members would agree that education is important and that 

FDA regulation of direct-to-consumer advertising and physician advertising or education or marketing is appropriate. We have always 

supported funding for FDA that is at least equal to and in many 

instances greater than the administration has asked for or Members of Congress have been willing to fund. We think it is a vital 

agency and one that is fully worthy of support. 

We think that the FDA regulations are appropriate in providing 

balance between the statement of risk and the statement of benefits in both direct-to-consumer advertising and in print advertising, 

although personally I would have to agree that some of the print 

advertising statements require not only the bifocals but also more 

of a medical education than I have, but many of our companies are 

moving to make that much more informative to the nonmedical 

consumer. 

We also think that it is really important that members of the 

public become aware of diseases that are underdiagnosed and there 

are a great many of them, some of which are the subject of directto-consumer advertising. For example, there are many, many people with high blood pressure. I think the estimate is 30 million people with high blood pressure who are not diagnosed. There are people with high cholesterol, people with diabetes who are not diagnosed, and we think that direct-to-consumer advertising is helpful 

in getting those people in to see a physician. 

We also think that physicians or other prescribers if a state allows, for example, a nurse-practitioner to prescribe some subset of 

drugs, are the appropriate people to be making the decision about 

whether a patient needs and should have this drug, another drug, 

125

or any drug at all, and that is why we note that many physicians 

first say, have you tried diet and exercise? In fact, in many instances FDA requires the advertisements to include that information. 

Senator CARPER. Thank you. 

Ms. Rosenthal, Dr. Woodcock. 

Ms. ROSENTHAL. Senator Carper, may I just add? I was actually 

struck by just how much common information we all drew upon in 

our written testimonies and how we all took different interpretations of the same numbers, all the same studies. 

Senator CARPER. We sometimes do that, too. 

Ms. ROSENTHAL. I would say for those of us who are able to express the opinion, I think we all agree that marketing is not education. I think we all agree on the general direction of the impact 

of DTCA, that it is increasing spending, increasing use, and that 

we probably do not need too much more information to understand 

that that is an important effect. 

I think where we disagree is whether the evidence is really all 

in for us to make a decision on whether the benefits exceed the 

costs or vice versa and I would suggest that the evidence is not in 

and that further research is needed to understand where the 

health benefits may be real and where they may result in waste 

in the system. 

Senator CARPER. Thanks. 

Dr. Woodcock, you can give the benediction if you want. 

Dr. WOODCOCK. I think the classic, I believe, is true, what Dr. 

Rosenthal just said. We do not believe the evidence is all in. There 

needs to be more independent research carried on in this area on 

these specific questions that you have. What is the public health 

impact? What is the economic impact to consumers and to the 

health care system, and so forth? I do not think we have enough 

information. It has not been that long and it is in a changing environment where other things have changed, as well, such as the advent of managed care, at the same time. I think even with such expert researchers as Dr. Rosenthal, it is very difficult to sort out a 

lot of these factors. 

Senator CARPER. Thank you all. 

Mr. Chairman, I do not know that it is going to answer the question of what our course should be but that is pretty good input here 

and I want to commend you and our staffs for putting this together. Real timely discussion on a real important issue. 

I say that as a son of a mom who turns 81 years old next month 

and who has Alzheimer’s disease, congestive health failure, and all 

kinds of maladies. The kind of education that my mom would 

glean, even in the years before we had to put her in a health facility, her ability to sit in front of a TV or read a print advertisement 

and to be able to really take away from that what she needs to 

know was limited and has been for some time. 

On the other hand, there are other people who at that age are 

doing just fine and they can really glean the educational information they need from a variety of disparate sources. Thank you, Mr. 

Chairman. 

The CHAIRMAN. Thank you, Senator. 

126

Let me thank all of you for your time with us today and your 

testimony and your involvement in this issue. I might suggest that 

at least it is my observation that this is an issue that will not go 

away and it will not go away for a very important reason—your 

taxpayers have just become involved in it. As agents of America’s 

taxpayers, we will have a fiduciary responsibility and that will be, 

as we have in the past with Medicare, to begin to micromanage 

that portion of the pharmaceutical market that we affect by the 

programs that we are now developing. That micromanagement will 

come with, I would trust, reasonable and effective oversight that 

will ultimately determine different subsets of policy that Congress 

will prescribe to this program and to this public benefit. 

I have watched in the past. It is not that we are good at it; it 

is just that we do it because we are the board of directors. Certainly that was true of Medicare when, in fact, costs kept going up 

as to the given practice we were leveraging down those costs because we capped a certain amount of money on an annualized basis 

and tried to fit America’s Medicare population into it. 

That could well happen here and as a result of that, while I 

know that many in the pharmaceutical industry have applauded 

our entry into this health care arena, my suggestion to that industry is that the magnifying glass has just come out. We will read 

the fine print to attempt to understand why these costs, are rising. 

Recognizing at the same time the tremendous benefit that the 

American consumer from a health care standpoint gets from today’s modern medicine and pharmaceuticals being at the cutting 

edge of that modernness, if you will, and to the health care of our 

country. 

Dr. Relman, you are before us today at 80 years of age? 

Dr. RELMAN. Yes, sir. Yes, I am. 

The CHAIRMAN. I think that is not only remarkable; it is now becoming normal. 

Dr. RELMAN. I hope so. 

The CHAIRMAN. I just turned 58 Sunday and I am trusting that 

at 80 years of age I will not be here—I do not want to be here at 

80 years of age—but that I will still remain active and involved, 

as many of our aging Americans are. I noticed that—or I should 

not say I noticed it; Senator Breaux noticed that in your resume 

and we were both commenting that you are a very youthful, involved 80-year-old, in part probably because of your genes but also 

it could well be because of modern health care and your understanding of it. 

We thank you all very much. The committee will stand adjourned. 

[Whereupon, 1 p.m., the committee was adjourned.] 

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