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S. HRG. 110–830 

MARKETING OR MEDICINE: ARE DIRECT-TOCONSUMER DEVICE ADS PLAYING DOCTOR? 

HEARING 

BEFORE THE

SPECIAL COMMITTEE ON AGING 

UNITED STATES SENATE 

ONE HUNDRED TENTH CONGRESS 

SECOND SESSION 

WASHINGTON, DC 

SEPTEMBER 17, 2008 

Serial No. 110–36 

Printed for the use of the Special Committee on Aging 

( 

Available via the World Wide Web: http://www.gpoaccess.gov/congress/index.html 

SPECIAL COMMITTEE ON AGING 

HERB KOHL, Wisconsin, Chairman 

RON WYDEN, Oregon 

BLANCHE L. LINCOLN, Arkansas 

EVAN BAYH, Indiana 

THOMAS R. CARPER, Delaware 

BILL NELSON, Florida 

HILLARY RODHAM CLINTON, New York 

KEN SALAZAR, Colorado 

ROBERT P. CASEY, Jr., Pennsylvania 

CLAIRE McCASKILL, Missouri 

SHELDON WHITEHOUSE, Rhode Island 

GORDON H. SMITH, Oregon 

RICHARD SHELBY, Alabama 

SUSAN COLLINS, Maine 

MEL MARTINEZ, Florida 

LARRY E. CRAIG, Idaho 

ELIZABETH DOLE, North Carolina 

NORM COLEMAN, Minnesota 

DAVID VITTER, Louisiana 

BOB CORKER, Tennessee 

ARLEN SPECTER, Pennsylvania 

DEBRA WHITMAN, Majority Staff Director 

CATHERINE FINLEY, Ranking Member Staff Director 

(II) 

C O N T E N T S 

Page 

Opening Statement of Senator Herb Kohl ............................................................. 1 

Statement of Senator Ken Salazar ......................................................................... 59 

PANEL I 

Statement of Kevin J. Bozic, M.D., Professor of Orthopedic Surgery, University of California at San Francisco, Ca .............................................................. 3 

Statement of William E. Boden, M.D., Professor of Medicine and Public 

Health, University of Buffalo, Buffalo, NY ........................................................ 18 

Statement of George A. Diamond, M.D., F.A.C.C., Senior Research Scientist, 

Emeritus, Cedars Sinai Medical Center, Los Angeles, CA ............................... 39 

Statement of Ruth S. Day, Ph.D., Director, Medical Cognition Laboratory, 

Senior Fellow, Duke Aging Center, Durham, NC ............................................. 40 

Statement of Ami Gadhia, Policy Counsel, Consumers Union, Washington, 

DC .......................................................................................................................... 46

PANEL II 

Statement of Dr. Daniel Schultz, Director, Center for Devices and Radiological Health, Food & Drug Administration, Washington, DC ....................... 62 

Statement of Stephen Ubl, President and Chief Executive Officer, AdvaMed, 

Washington, DC ................................................................................................... 82 

APPENDIX 

Prepared Statement of Senator Robert P. Casey, Jr. ........................................... 95 

Mr. Ubl’s Response to Senator Kohl’s Question .................................................... 95 

Statement of the Sudden Cardiac Arrest Association .......................................... 97 

(III) 

(1) 

MARKETING OR MEDICINE: ARE DIRECT-TOCONSUMER MEDICAL DEVICE ADS PLAYING 

DOCTOR? 

WEDNESDAY, SEPTEMBER 17, 2008 

U.S. SENATE

SPECIAL COMMITTEE ON AGING

Washington, DC. 

The committee met, pursuant to notice, at 10:29 a.m. in room 

SD–562, Dirksen Senate Office Building, Hon. Herb Kohl (chairman of the committee) presiding. 

Present: Senators Kohl [presiding], and Salazar. 

OPENING STATEMENT OF SENATOR HERB KOHL 

The CHAIRMAN. Good morning to one and all. We’ll commence 

our hearing at this time. We thank our witnesses for being with 

us today. 

Today we’re examining issues related to direct to consumer advertising for restricted medical devices that are regulated by the 

Food and Drug Administration. This is part of an ongoing 15 

month series of oversight hearings we have held on medical device 

and pharmaceutical marketing. Unlike direct-to-consumer advertising of drugs, direct-to-consumer advertising of medical devices 

has not yet been highly scrutinized. 

Since the mid–1990’s when the Federal Government changed 

rules regulating such advertising the drug industry has spent billions of dollars advertising their products directly to consumers. 

The FDA has devoted considerable resources to the oversight of direct-to-consumer pharmaceutical advertising. There have been several Congressional hearings held on this practice. 

However, the medical device industry is just beginning to get 

into the game. Over the past four or five years their use of DTC 

ads is growing on television, in print and on the internet. Hundreds of millions of dollars have been spent on them according to 

the Congressional Research Service. 

While their spending on direct-to-consumer ads is still only a 

fraction of drug industry spending, this marketing practice is growing. In recent years a number of DTC ad campaigns have been 

launched in an effort to market specific and often complex medical 

device products, some of which require surgery to obtain. As with 

DTC drug ads the FDA has raised concerns about advertising restricted medical devices, specifically about whether appropriate 

risk and safety information is provided to consumers including seniors and the elderly. 

2 

Today we’ll hear from a variety of medical, advertising and consumer experts. They will detail for the Committee perceived shortcomings in DTC advertisements for medical devices and how these 

ads can influence consumers and patients. Our witnesses also will 

outline recommendations on how we might improve the review and 

the oversight of these ads. 

We will hear from the head of the FDA’s medical device center 

about how the Agency oversees these DTC medical device ads. As 

well as how those methods differ from the more extensive FDA efforts to track and analyze DTC drug ads. 

We’ve also invited AdvaMed to testify this morning. AdvaMed is 

the largest medical device industry organization and will weigh in 

on the question of regulating DTC medical device ads. 

We should note that in 2006 the American Medical Association 

announced its support for enhanced regulation of DTC ads by the 

FDA and went so far as to call for a moratorium on all new DTC 

ads until physicians have been appropriately educated about the 

drug or the medical device. 

Based on what we hear here today we are prepared to work with 

Chairman Dingell in the House to consider similar legislative 

measures. We want to acknowledge that DTC advertising may 

have some benefits. Responsible DTC advertising can encourage 

consumers and patients to become proactive in their own treatment 

plan and encourage a wide audience to consider preventive medicine. These are positive and potentially valuable aspects of DTC 

advertising. 

So we thank our witnesses. We welcome them here today. Introducing the members of the first panel. 

Our first witness will be Dr. Kevin Bozic. Dr. Bozic is an Associate Professor in residence in both the Department of Orthopedic 

Surgery and the Institute for Health Policy Studies at the University of California in San Francisco. He’s conducted studies on how 

direct-to-consumer advertising of restricted medical devices does 

have the potential to adversely impact the doctor/patient relationship, patient education, health care costs as well as health care 

quality. He’s speaking today on behalf of the American Association 

of Orthopedic Surgeons. 

Our next two witnesses will share their time jointly. Dr. William 

Boden is Director of Cardiovascular services at Kaleida Health System in Western New York and Chief of Cardiology at Buffalo General and Millard Fillmore Hospitals in Buffalo. 

Dr. George Diamond is a 2004 recipient of the Distinguished 

Service Award of the American College of Cardiology and is the author of hundreds of peer reviewed publications. Dr. Boden and Dr. 

Diamond are the authors of a recent article in the New England 

Journal of Medicine which offers a detailed critique of a particular 

heart stent advertisement that was broadcast to millions of Americans. 

Also joining us here today is Professor Ruth Day, the Director of 

the Medical Cognition Laboratory at Duke University and a Senior 

Fellow at the Duke Aging Center. Dr. Day has served on many 

FDA Advisory Committees and was also a Fellow at the Center for 

Advanced Study in the Behavioral Sciences. Her research is on 

3 

comprehension and memory for medical information, especially 

drugs and medical devices. 

Our last witness on our first panel will be Ami Gadhia who is 

a Policy Counsel for Consumers Union, a non-profit publisher for 

Consumer Reports magazine. Consumers Union is an independent, 

non-profit organization that advocates on behalf of consumers in 

many fields of industry including healthcare. 

We welcome you all here today. Dr. Bozic, you may testify. 

STATEMENT OF KEVIN BOZIC, M.D., PROFESSOR OF ORTHOPEDIC SURGERY, UNIVERSITY OF CALIFORNIA AT SAN 

FRANCISCO, CA 

Dr. BOZIC. Thank you. Good morning, Chairman Kohl and other 

distinguished members of the Committee. My name is Dr. Kevin 

Bozic and I speak to you today as a practicing orthopedic surgeon 

and health care services researcher from the University of California, San Francisco and a member of the Board of Directors of 

the American Association of Orthopedic Surgeons. On behalf of the 

AAOS, I thank you for providing me the opportunity to testify to 

you today on the issue of direct-to-consumer advertising of restricted medical products. 

As you’ve indicated, over the past decade the United States has 

experienced a dramatic increase in direct-to-consumer advertising 

from medical device and pharmaceutical manufacturers, health 

plans, hospitals and physicians, all attempting to increase their 

market share by advertising their products and services directly to 

patients. The internet has created a new generation of technologically savvy and empowered health care consumers who are taking a more active role in finding the best solutions for wellness and 

health. We encourage our patients and their families to obtain and 

understand evidenced based health care information. We encourage 

patients to work with their healthcare practitioners to develop 

shared decisionmaking for treatments that promote cost effective 

healthcare. 

We believe that direct-to-consumer advertising of restricted medical products has the potential for both positive and negative consequences. Direct-to-consumer advertising may encourage patients 

to seek treatment for previously undiagnosed disease, and may destigmatize certain diseases or health conditions, help create more 

informed patients and foster true shared decisionmaking between 

patients and their physicians. 

However, we’re also aware of the potential negative consequences 

of DTCA related to medical products. Product specific advertisements which exaggerate the benefits and downplay the risks of a 

medical device may strain the doctor/patient relationship by creating unrealistic patient expectations, thus diminishing the role of 

the physician in clinical decisionmaking. Furthermore, patient 

pressure in response to direct-to-consumer ads may lead to over 

utilization of costly, at times unproven, medical devices and may 

lead physicians to venture outside their comfort zone in order to 

satisfy inappropriate patient requests for specific treatments or devices. 

In the course of today’s discussion, we would note that disease 

awareness or help seeking advertising, which seeks to raise awareVerDate Nov 24 2008 10:31 Jun 05, 2009 Jkt 000000 PO 00000 Frm 00007 Fmt 6633 Sfmt 6633 H:\DOCS\49768.TXT SAG PsN: JOYCE
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ness amongst patients regarding a specific disease state or health 

condition should be differentiated from product specific advertising. 

The AAOS holds patient education as one its most important objectives. We believe that help seeking advertising may stimulate patients to research their health conditions and discuss all available 

options with their healthcare practitioners. We recognize that delayed diagnosis and treatment of certain chronic disease conditions 

such as arthritis and osteoporosis are serious health concerns in 

the U.S., and disease awareness advertisements may play a vital 

role in bringing needed therapies to patients with chronic diseases. 

Although the effects of direct-to-consumer advertising related to 

pharmaceutical drugs have been studied extensively, there are substantial differences between pharmaceutical products and medical 

devices which make extrapolating the findings or conclusions from 

studies regarding the effects of DTCA related to drugs to the potential impact of advertising that is used to promote regulated medical 

devices inappropriate and misleading. 

First, there’s a substantial cost differential between medical devices and prescription drugs. 

Second, medical devices are usually sold to hospitals, although 

physicians are the primary decisionmakers and end users. Unlike 

prescription drugs, early adopters of new medical technologies, including physicians and hospitals, often promote their use of these 

technologies in an attempt to differentiate themselves in a competitive marketplace. However, when a physician decides to use a new 

device in their practice additional training is often recommended 

and the potential adverse consequences to the patient and the physician are considerable if an inappropriate or unfamiliar device is 

used. 

Finally, unlike prescription drugs, the choice of implant or procedure cannot easily be substituted if the result of the procedure is 

undesirable. 

We’re concerned about the lack of fair balance and risk information in direct-to-consumer ads related to medical devices. Potential 

benefit information is typically presented in layman’s terms whereas risk information is down played by using medical jargon, using 

a very small font size or increasing the speed of delivery of information in a voice over announcement. Therefore risk information 

is often not read, not comprehended nor sometimes even reasonably 

visible. 

In a 2007 published study on the impact of direct-to-consumer 

advertising in orthopedics, my colleagues and I evaluated the influence of DTCA in orthopedics by surveying practicing orthopedic 

surgeons who perform hip and knee replacement procedures and 

patients who were scheduled to undergo these procedures. The 

goals of our study were to evaluate the impact of DTCA on consumer demand, healthcare services, resource utilization and the 

doctor/patient relationship. We found that although direct-to-consumer ads had a substantial influence on both patient and surgeon 

decisionmaking, patients and surgeons differed considerably with 

respect to their opinions of the value of DTCA as a source of information regarding hip and knee replacement surgery. 

The majority of surgeons surveyed believed patients who were 

exposed to DTCA were confused or misinformed about the approVerDate Nov 24 2008 10:31 Jun 05, 2009 Jkt 000000 PO 00000 Frm 00008 Fmt 6633 Sfmt 6633 H:\DOCS\49768.TXT SAG PsN: JOYCE
5 

priate treatment for their condition, had unrealistic expectation regarding the benefits of the specific type of surgery or implant and 

requested types of surgeries or implants that were not appropriate 

for their conditions. 

In contrast, the majority of patient respondents believed that advertisements educated them about their medical conditions and 

treatment options. Only 18 percent of patients thought advertisements confused them about the appropriate treatment for their 

condition. 

The findings of our study underscore the need to improve the 

quality and accuracy of information available to patients regarding 

their health conditions and treatment options. 

As surgeons, we applaud efforts by our patients to educate themselves regarding their health conditions and their potential treatment options. However, we believe it is important for patients to 

evaluate the source and accuracy of the information on which they 

base their opinions. 

Reliable healthcare information that is supported by scientific 

evidence has the potential to enhance the dialog between patients 

and their physicians, and to improve patient satisfaction and the 

overall quality and efficiency of the care we deliver. However, as 

our research has shown biased information contained in direct-toconsumer advertisements promoting specific regulated medical devices which are not supported by scientific evidence has the potential to cause tremendous harm to the doctor/patient relationship, to 

create unrealistic patient expectations and to lead to inappropriate 

over utilization of costly, unproven medical technologies which 

could have dire public health consequences. 

In closing we offer the following specific recommendations to the 

Committee as it examines the consequences of direct-to-consumer 

advertising of restricted medical products. 

We believe that direct-to-consumer advertising of medical devices 

has the potential to create distorted markets and have adverse 

public health consequences, and therefore we support greater restraint from the medical device industry and greater oversight from 

the FDA. 

We support ongoing research into the effects of direct-to-consumer advertising on the physician/patient relationship, healthcare 

services resource utilization and spending, public safety and cognitive science. 

We support disease awareness and help seeking advertisements 

which seek to educate patients about their health conditions and 

the treatment options available to them rather than product specific advertising. Claims made in product specific advertisements 

related to medical devices are often biased, not supported by scientific evidence and contribute to unrealistic patient expectations 

and inappropriate requests for specific procedures or implants 

which could have great public health consequences. 

We support the presentation of fair, balanced and risk and benefit information in direct-to-consumer ads of regulated medical devices. We recommend that healthcare stakeholders work together 

to improve the quality and accuracy of information contained in 

consumer directed advertisements related to medical products. 

6 

We support increased resources for the FDA in the area of medical device advertising and increased oversight from the FDA’s 

Center for Devices and Radiological Health advertising review staff 

on the DTCA of medical devices. 

Finally, we support a prohibition of direct-to- consumer advertising and marketing on restricted medical products to children. 

I appreciate the opportunity to share our views with the Committee on the issues related to direct-to-consumer advertising of restricted medical devices. I look forward to answering any questions 

you may have. 

[The prepared statement of Dr. Bozic follows:] 

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The CHAIRMAN. Thank you. We’ll move on to Dr. Boden. 

Dr. Diamond, please hold your testimony to 5 minutes. 

STATEMENT OF WILLIAM E. BODEN, M.D., PROFESSOR OF 

MEDICINE AND PUBLIC HEALTH, UNIVERSITY OF BUFFALO, 

BUFFALO, NY 

Dr. BODEN. Thank you, Senator. Beg your pardon. 

Before we testify we’d like to ask your permission to play a copy 

of the broadcast advertisement that is the subject of the article 

that we recently published in the New England Journal of Medicine and which explains the dangers associated with the type of direct-to-consumer advertisements for the restricted medical devices 

that we are discussing here today. 

May we see the DVD? 

[Audience watching DVD advertisement.] 

Dr. BODEN. Thank you, Mr. Chairman and honored members of 

the Committee. We appreciate the opportunity to come before you 

this morning. To express our concerns relating to this direct-to-consumer advertising or DTCA of the intra-coronary stent to the lay 

public and to healthcare consumers. 

This advertisement appeared 10 months ago during the Dallas 

Cowboys/New York Jets nationally televised Thanksgiving Day 

NFL game. It was the first direct-to-consumer advertising campaign of a drug eluting coronary stent that was launched by a device manufacturer, that is to say Cordis, Johnson and Johnson. 

Their initial 60 second advertisement featured in this segment, 

which was boldly entitled, ‘‘The life wide open’’ on the surface is 

quite provocative, as we will maintain. We believe that this initial 

medical advertisement has crossed the line in promoting a particular coronary device to millions of individuals who are unable to 

discern many of the subtle and complex therapeutic issues that 

even we cardiac specialists continue to debate. 

The distinction between drug and device DTCA is significant. 

Unlike drugs that merely require a physician office visit and an explicit prescription by a physician or provider than can be then filled 

by a patient at the pharmacy. A specialized medical device such as 

the Cypher Stent requires a very sophisticated medical understanding that few individuals in the lay public could realistically 

expect to gain from such a short 30 to 60 second TV ad campaign. 

During a diagnostic coronary angiogram during which we would 

detect the blockages or narrowings that might result in a potential 

stent procedure, a cardiac patient may be in significant pain, medicated with sedatives or analgesics, potentially acutely overwhelmed 

with the recent disclosure of obstructive coronary artery disease. 

Thus unable to fully comprehend all of the therapeutic implications 

of which type of stent would be best for him or her in the setting 

of an impending operative procedure. It seems difficult if not impossible to imagine that a patient would in the above clinical context attempt to challenge the interventional cardiologist’s judgment 

and clinical acumen by calling into question which particular stent 

type, for example, the Cypher Stent, should be used for that procedure. 

It seems equally plausible that an interventional cardiologist 

would exceed to a patient’s request for a particular stent type 

19 

based solely on a patient’s very limited information derived from a 

DTCA that touts that one particular stent over another. This 

makes it very difficult to understand what impact, if any, directto-consumer advertising directed at the lay public could in a meaningful way influence Cypher Stent usage at the patient level. The 

statutory authority for the current regulation of DTCA by the Food 

and Drug Administration actually goes back 70 years ago to 1938 

when the Federal Food, Drug and Cosmetic Act outlined the requirements for pharmaceutical products for which companies 

sought U.S. marketing approval. 

Several years later in 1962, Congress specifically granted the 

FDA statutory authority to require prescription drug labeling in 

advertising including direct-to-consumer advertising. In 1969 the 

Agency issued final regulations governing drug advertising stipulating that advertisements must not be false or misleading, must 

present a fair balance of information about both the risks and the 

benefits of using a given drug, must contain facts that are material 

to the product’s advertised uses and must include a brief summary 

mentioning every risk described in the product’s approved labeling. 

Current Agency regulations differentiate between print and broadcast direct-to-consumer advertising. 

In the former print medium all information about associated 

risks including major side effects, contraindications and precautions contained in the drug’s FDA label must be explicitly divulged. By contrast in the broadcast advertisements, only so called 

major risk information must be stated. But such broadcast ads 

must direct viewers to other accessible sources containing complete 

risk information. This distinction reflected a pragmatic recognition 

of the time limitations, typically 30 to 60 seconds of broadcast ads. 

By the way in this particular ad that we saw, if you go to the 

website shown on the ad it provided no explicit safety information 

when one attempted to elicit that. 

About 10 years ago in 1997, the FDA issued a preliminary guidance for industry that re-interpreted FDA regulations without actually changing the regulations. They reiterated that the advertising 

be non-deceptive and must present a fair balance between information about effectiveness and information about risk, include a thorough major statement conveying all the product’s most important 

risk information in consumer friendly language and must communicate all information relevant to the product’s indication including 

limitations to use in consumer friendly language. 

The CHAIRMAN. Mr. Boden? Dr. Boden? 

Dr. BODEN. Yes? 

The CHAIRMAN. Your time. Could you summarize your statement? 

Dr. BODEN. Yes, sir. So in what I would like to actually state 

then is that there are several recommendations that we would like 

the Committee to consider. 

First, that the FDA should place drugs and devices on the same 

regulatory footing. DTCA should be required to reflect the evidenced based clinical data that have demonstrated only the proven 

clinical benefit of the drug or device before being advertised. Unsubstantiated therapeutic claims or expert consensus are not eviVerDate Nov 24 2008 10:31 Jun 05, 2009 Jkt 000000 PO 00000 Frm 00023 Fmt 6633 Sfmt 6633 H:\DOCS\49768.TXT SAG PsN: JOYCE
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dentiary and should not constitute an approved basis for advertising to the lay public. 

Congress should authorize the FDA to adopt the model used to 

promote DTCAs used in New Zealand by establishing an advisory 

panel under the Federal Advisory Committee Act that would vet 

and discuss all advertising prior to final publication. This could 

comprise a multidisciplinary Committee with representative membership that would include the drug or device industry, physician 

specialists and consumer union representatives. The FDA should 

consider establishing a fund in which a certain percentage of product claim advertising revenue would be tithed and redirected to 

help seeking ads that promote public health education and heighten public awareness of a particular disease state. This would create 

a methodology for promoting fair, objective and balanced consumer 

health education to the lay public devoid of potential commercial 

bias. 

Last, the Committee might consider enacting a ban for the first 

two years on all DTCA of drugs or devices that have been FDA approved in order to assure that post marketing surveillance and 

phase four clinical data acquisition have established an appropriate 

safety record and profile before they are advertised broadly to the 

public. Thank you very much. Now I’d also like Dr. Diamond to 

also add some comments please. 

[The prepared statement of Dr. Boden follows:] 

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STATEMENT OF GEORGE A. DIAMOND, M.D., F.A.C.C., SENIOR 

RESEARCH SCIENTIST, EMERITUS, CEDARS SINAI MEDICAL 

CENTER, LOS ANGELES, CA 

Dr. DIAMOND. Mr. Chairman, thank you for inviting me to contribute to these deliberations. I concur completely with the comments of my colleague, Dr. Boden and would simply like to make 

one additional point. 

Direct-to-consumer medical advertising stands at the end of a 

long chain of regulatory processes by a series of agencies. Each of 

these agencies has its own relatively narrow aims and none of 

them communicate very well with one another. 

First, the FDA determines the treatment’s safety and efficacy. 

CMS then determines if the treatment is reasonable and necessary. 

Individual payers then determine that reimbursement is usual and 

customary. Professional organizations, such as the American College of Cardiology, issue consensus guidelines to the effect the 

treatment that is useful and effective. Finally the courts decide 

that treatment is prudent and cautious. 

At no point in this chain is there any direct focus on the ultimate 

goal of healthcare, the provision of clinical benefit. The goal of medicine is not to provide prudent, usual or reasonable treatments. It 

is to improve longevity or quality of life. 

The direct-to-consumer ad serves this higher goal no better than 

the average political ad serves the ideals of the Democratic process. 

It simply introduces another myopic link in the chain, consumer 

opinion. The direct-to-consumer problem is therefore best approached by deconstructing this chain and developing a coordinated, stream lined, regulatory approach designed to serve the dual 

goals of safety and benefit. 

From this perspective the question to be addressed by this Committee is not how direct-to-consumer ads be regulated. But at what 

point along the stream lined, regulatory chain, in our free market 

society, do such ads appropriately, effectively serve these goals. My 

answer, only when two conditions are satisfied. 

First, the treatment should target an issue of material, clinical 

importance. There is little need to regulate ads regarding the latest 

cold remedy. 

Second, the claim should be supported by rigorous, scientific evidence. That would be news we can use, so to speak. 

But advertisements are not the only way to get this news. CMS’s 

new Chartered Value Exchange network, Secretary Leavitt’s most 

significant legacy to quality improvement could become the vehicle 

for transforming policy into practice by translating the various regulatory and clinical findings into information that the public can 

understand and trust. We will thereby empower them to be informed partners in their healthcare, a worthwhile goal to be sure. 

We will know we have succeeded in reaching this goal when direct-to-consumer advertising becomes completely superfluous, if not 

unseemly. Thank you. 

The CHAIRMAN. Thank you, Dr. Diamond. Professor Day. 

40 

STATEMENT OF RUTH S. DAY, PH.D., DIRECTOR, MEDICAL 

COGNITION LABORATORY, SENIOR FELLOW, DUKE AGING 

CENTER, DURHAM, NC 

Dr. DAY. Good morning. My name is Ruth Day. I’m the Director 

of the Medical Cognition Laboratory at Duke University and Senior 

Fellow at the Duke Center for the Study of Aging. 

I’d like to direct everyone’s attention to the screens, as I will be 

showing slides throughout my testimony. 

I’m not here today to argue for or against direct-to-consumer advertising of medical devices. Instead I’m here to report research on 

how people understand and remember information in these ads. 

This research was not funded by any medical device company, ad 

agency, advocacy group or government agency. 

The basic question is, how do people understand medical device 

information? The answer is, with difficulty. There are many possible reasons for this. There’s a heavy information load, complex 

and technical information and so on. 

But today I would like to focus on ‘‘cognitive accessibility.’’ Cognitive accessibility is the ease of which people can find, understand, 

remember and use medical device information, and hopefully in a 

safe and effective manner. We look at a variety of information 

sources for these ads. Today I’ll be focusing just on the ads that 

air on television and on the internet. 

We’ve been collecting ads for a long time, since the year 2000. 

Most of our research has been on prescription drugs, but also medical devices. 

We use two basic approaches, at least, in this research. First of 

all we perform cognitive analyses of the ads. We obtain quantitative measures and calculate cognitive accessibility as I’ll show 

you in a bit. Then compare the accessibility of the benefits vs the 

risks. Then we perform cognitive experiments to test the effects of 

all of these measures on attention, comprehension, memory, problem solving, decisionmaking, behavior and ultimately health outcomes. 

Many cognitive principles underlie this work such as the time 

spent on certain types of information, repetition, language complexity, speaking speed and other things as well. We study a wide 

variety of device ads, such as hip replacement, stents, cosmetic procedures and devices for weight reduction. Across all of these, the 

benefits generally have very high cognitive accessibility, with a lot 

of time spent on them. There’s also repetition of the messages, simple language, normal speaking speed, chunking, put together what 

goes together, but separate it with pauses on either side for ‘‘mental digestion,’’ few other distractions and good locations for the information. 

What about the risks? Sometimes they’re absent. Quite often 

they are absent. Other times they’re non specific. There will be 

nonspecific things said such as, ‘‘there are potential risks’’. Risks 

are sometimes present and when they are, they are generally of 

lower cognitive accessibility. So all those features we talked about 

before, are lower in cognitive accessibility for risks relative to the 

benefits. 

Now let’s focus on one type of device, joint replacement since it 

is of special interest to older people. In one ad there’s an arthritic 

41 

woman and there are no risks presented at all. In another there 

are some lovely cartoon women and all that’s said is, ‘‘there are potential risks.’’ One with a home nurse; just ‘‘potential risks.’’ Basketball coach; ‘‘potential risks.’’ Woman walking across the United 

States: ‘‘potential risks.’’ There’s one with a gymnast and potential 

risks are flushed out. They include a ‘‘loosening, dislocation, fracture and wear, any of which could require additional surgery.’’ So 

only one in six joint replacement ads has any specific risks. 

So let’s do a cognitive experiment to test the consequences of 

these presentation practices. We’ve selected a weight-loss device 

where a band is put around the upper part of the stomach and can 

be adjusted to control the flow of food. Participants in our experiment saw the ad. Then we tested their knowledge about the benefits and the risks using multiple tasks. 

A very simple thing we do is to ask, what is the name of the 

medical device? As you can see on the slide, just about everyone 

knows. When we ask, what is it used for, performance is excellent, 

96 percent correct. They know it’s for weight loss. That’s the indication, what it is used for. 

When asked about the contra indications who should not use it, 

their performance is much worse. They just don’t get this information. So the indication is a benefit and performance is excellent, 

while contra indications are a type of risk and performance is poor. 

In a free report task we asked, what were the benefits in the ad? 

Later we asked, what were the risks in the ad? Here are the results for the benefits vs. the risks. As you can see on the slide, 

knowledge of benefits was twice as good as risks. Here’s the breakdown for the specific benefits and risks. One of the risks is fatality 

or death and just about no one gets that. 

In a recognition task, we basically give one benefit at a time and 

participants decide whether each it was in the ad or it was not in 

the ad. Then we do the same thing for risks. Chance now is 50 percent correct, because they’re just saying yes or no. 

For the benefits, there is very high performance. For the risks, 

just about chance. People just don’t know the risks. We can break 

this down into those benefits that actually were in the ad, 90 percent correct vs. those that were not in the ad. Can they correctly 

say no, those are not possible risks? Still very good performance, 

70 percent correct. 

When we look at the risks, it doesn’t matter whether the risks 

we give are in the ad or not—just about chance performance for all 

of them. Very different performance for risks relatives to benefits. 

Why? We can trace it to differences in their cognitive accessibility. 

So there is an unfair balance in the presentation of risks vs. benefits, in terms of cognitive accessibility. 

Here are some recommendations. We need an evidenced-based 

approach in developing and reviewing ads. We should have these 

quantitative measures of cognitive accessibility for the benefits, 

such as location, speed, competing information and so forth. But we 

should have it for the risks as well. Then we can get both types 

of information into fair balance. 

Otherwise we will be presenting risk information that may be 

physically present, but functionally absent. Physically present, but 

functionally absent. People can’t get the risks. 

42 

So to conclude, risks can go this way, as shown in this animation—toward the person, but over the head and away. However, 

there is a way to get risk information into the heads of people. 

That is to increase its cognitive accessibility. 

Thank you. 

[The prepared statement of Dr. Day follows:] 

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The CHAIRMAN. Thank you. Ms. Gadhia? 

STATEMENT OF AMI GADHIA, POLICY COUNSEL, CONSUMERS 

UNION, WASHINGTON, DC 

Ms. GADHIA. Good morning, Chairman Kohl, Ranking Member 

Smith and members of the Committee. My name is Ami Gadhia. 

I’m policy counsel with Consumers Union, the non-profit publisher 

of Consumer Reports magazine. I’m here today to testify about 

DTCA for implantable medical devices and the safety and health 

concerns related thereto. 

Consumers Union commends the Committee for holding today’s 

hearing on this critical consumer safety issue. In addition to our 

testimony today, CU has registered its concerns about this issue 

through a petition we submitted to FDA in December of 2007. The 

petition makes the same recommendations that I make today to 

the Special Committee. 

Most people are familiar with DTC ads for prescription drugs. 

Now DTC ads for implantable medical devices such as knee and 

hip replacement hardware and heart valves are also appearing on 

our televisions. Unfortunately injuries and deaths related to medical devices are also manifesting themselves. 

In a December 2007 article entitled, ‘‘Medical Devices, Problems 

on the Rise,’’ our publication, Consumer Reports noted that ‘‘reports of deaths linked to medical devices are at an all time high 

with 2,712 fatality reports in 2006, more than double the number 

in 1997.’’ This article also notes that in September 2007, FDA 

issued its own report for its Fiscal Year 2006 saying it had seen 

a 25 percent increase in adverse events linked to medical devices 

over fiscal year 2005 including 2,830 deaths, over 116,000 injuries 

and over 96,000 device malfunctions. A number of studies show significant injury including healthcare acquired infections following 

implant surgeries. 

Both healthcare acquired infections and device failure can and do 

cause death or serious morbidity and expense. These statistics 

point to the need for regulation of the claims made in and the 

warning information transmitted through the advertising of the devices. While FDA review and regulation of DTC prescription drug 

ads are still in their infancy the Agency currently conducts almost 

no oversight of DTC ads for implantable medical devices. Consumers Union thus strongly urges Congress to require FDA to conduct the same oversight and regulation of DTC ads for implantable 

medical devices as the Agency is now authorized to do for DTC 

drug ads and to expand their review of all of these ads. 

In June 2006, Consumer Reports published an article in which 

we noted that ‘‘five percent of survey respondents reported getting 

an infection shortly after surgery, a significantly higher rate than 

reported in some major studies.’’ The CDC’s National 

Nosocomicomial Infections Surveillance System report clearly 

shows hip and knee prosthesis surgery to be a serious source of infection. In some of the NNIS reporting hospitals, the infection rate 

may run as high as 5 percent or more. 

The Agency for Healthcare Research and Quality notes that complication of device, implant or graph was the third most common 

of the principle diagnosis for hospital stays with MRSA infection in 

47 

2004. While this category includes skin graphs, devices and implants contribute to the total of 23,500 reported stays with MRSA 

infection in 2004. A 2007 Health Affairs article stated, more than 

600,000 total knee replacements are performed worldwide each 

year. This number will likely rise because of the aging population 

and the expanding clinical indications. The surgery carries risks of 

potentially life threatening complications including anesthesia related problems, wound and joint infections, deep venous 

thromboses, injury to nerves and blood vessels around the knee 

and the potential for future surgical revision. 

A Wall Street Journal article published April 10, 2007 described 

the growth of medical device DTC ads. The warnings of side effects 

are generally non-existence or minimal, as Dr. Day related. Saying 

such things as ‘‘there are potential risks,’’ potential for complications. We found no ads that advised the consumers of the very real 

possibility of deadly infection or to urge them to seek out surgical 

facilities with low infection rates. Examples of websites that offer 

relatively little or no warnings that we could easily see in clicking 

through the sites are contained within our written testimony. 

It is also important that the ads carry a warning of the potential 

for infection, morbidity and mortality as a result of surgery and implantation because the system of payments between many device 

companies and surgeons creates financial incentives to conduct the 

surgery. These same incentives to use various devices may well 

have the effect of minimizing the warnings and advice cautioning 

patients about other solutions such as weight loss, pain medication, 

physical therapy, etc. A 2007 Wall Street Journal health blog posting reported that nationally ‘‘more than 40 surgeons or groups each 

received at least one million dollars in payments’’ in 2007. 

We raise the issue of industry consulting fees. Because it calls 

into question the objectivity of a physician as a learned intermediary to fully inform patients of the downsides of such surgeries. 

This potential problem is another reason to require ads to carry robust warnings. 

Given these significant concerns we believe that oversight and 

regulation could improve consumer safety and outcomes. Specifically CU makes the following recommendations. 

FDA should be required to mandate that all print and electronic 

ads including internet ads for implantable devices warn consumers 

about one, the very real danger of healthcare acquired infections 

that can and do result from surgery and follow up care. 

Two, the expected life span of the device before failure occurs. 

CU supports better oversight of medical device ads as we do for 

drug ads including an FDA review process before the ads are 

issued. FDA needs more resources for reviewing DTC ads and taking enforcement action when ads are unlawfully misleading, deceptive or unbalanced. Often FDA does not issue a warning letter until 

months after a deceptive or misleading ad has been widely aired. 

Section 503b of the FDA Amendment Act of 2007 includes 

stronger authorities for the FDA to require pre-review and specific 

disclosures to ensure that consumers are warned in DTC ads about 

potential dangers and side effects. We urge FDA to use these authorities as well as its existing authorities to review device implant 

advertisements and require that they warn of the specific dangers 

48 

of infection. Advise patients to ask questions about infection rates 

and anti-infection practices at the facility where the implantation 

will take place. 

In conclusion there is no question that many implantable medical 

devices can restore high quality of life for patients who have been 

suffering. But we do believe that unintended side effects and 

deaths can be minimized if the public is better educated about the 

risks involved and about facilities that are not demonstrating the 

highest level of anti-infection practices. The law requires that for 

all DTC ads for prescription drugs the claimed benefits must be accompanied by balanced warnings of the risks of using the drug. 

The same requirement should be applied to devices. 

Thank you. 

[The prepared statement of Ms. Gadhia follows:] 

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The CHAIRMAN. Thank you. Senator Salazar, would you like to 

comment, questions? 

OPENING STATEMENT OF SENATOR KEN SALAZAR 

Senator SALAZAR. Thank you very much, Chairman Kohl. 

I have an opening statement that I will submit for the record. 

Senator SALAZAR. I have some questions and comments. 

Let me first of all say that this is a very important hearing and 

I very much appreciate your leadership in bringing this matter to 

the attention of the Committee and to the attention of the U.S. 

Senate. A question that I would have for any of you, but Ami, 

starting with you since you were the one who came up with the 

recommendations. You essentially are telling us that we ought to 

have the same kind of oversight and regulation with respect to implantation devices as we now do with the FDA and prescription 

drugs. 

Miss, my question to you is whether or not you think the kind 

of oversight and regulation that we have from FDA with respect to 

prescription drugs is working. In all sense what I hear from people 

as I travel around my state as I did during the month of August 

where I had 31 hearings on healthcare in 31 counties, is that people think that much of what we are hearing from the pharmaceutical companies with 30 second ads is in fact a huge part of our 

healthcare problem in America today. So my question is, are we 

being effective in terms of the kind of regulation that we have with 

respect to advertising on pharmaceutical drugs? If we’re not, why 

should we simply import that system over to dealing with the kinds 

of devices that we’re dealing with here today? 

Ms. GADHIA. You’re correct that there’s still a lot of work to be 

done to protect consumers with regards to drug DTC ads. The 

FDAAA Section 503b does do a lot to try to improve that regulation 

oversight. It’s still relatively new. It’s only about a year old. 

So I think we’re still seeing whether FDA is implementing it or 

not. As everyone knows they’re obviously very strapped for resources. So it’s sort of a question of even getting device DTC ads 

up to the same level. 

Senator SALAZAR. Let me ask you this. If, may I compare, I see 

what we do here in the United States verses what other countries 

do. Other countries simply prohibit it. I see Dr. Bozic’s statement 

here, it’s titled, Marketing or Medicine, Are Direct-to-Consumer 

Medical Device Ads Playing Doctor? 

When you look at the 30 second ads that we see so many of from 

the pharmaceutical industry, when we look at the devices we’re 

talking about today, why not just adopt the kinds of prohibitions 

that have been adopted in other countries? Why do we let these 30 

second ads essentially be the ones that are playing doctor to a patient? 

Ms. GADHIA. I don’t disagree with that. It’s— 

Senator SALAZAR. Then why don’t you make that as part of your 

recommendation instead of just saying apply what is probably not 

a very workable program with pharmaceuticals to put it into the 

implantable device industry. 

Ms. GADHIA. Just to make sure I understand your question. So 

why not just prohibit these ads? 

60 

Senator SALAZAR. In the way they do in other countries. 

Ms. GADHIA. Well, I guess the question is whether the wherewithal exists with the FDA and with the medical device industry 

being as large as it is in this country whether that exists as a real 

possibility. The suggestions in my testimony are meant to posit 

real immediate solutions that we feel could begin to regulate a 

largely unregulated area. 

Senator SALAZAR. On the other hand, are there benefits that 

come from the kind of advertising that does take place where consumers are made much more informed about the kinds of remedies 

that might be out there with respect to joint replacements or heart 

stents or other kinds of things we’re talking about here? Other benefits that come from the type of advertising that we see on television today? 

Ms. GADHIA. You know I would concur with, I believe it was Dr. 

Boden, who talked about, I apologize if it was Dr. Diamond, who 

talked about the confusion and the fact that patients are coming 

to doctors not knowing a whole lot about these particular devices 

and what they do. So I think it’s questionable whether whatever 

positive benefits or information are coming from these ads are actually correct. 

Senator SALAZAR. Ok. Ms. Day or anybody else want to comment 

on the question? 

Dr. DAY. I do have a comment about potential benefits of these 

types of ads, since we’ve been collecting them for over 8 years and 

been testing them all along. We have seen a growth in what consumers understand about potential side effects for any treatment. 

When you ask them, what are possible side effects, they’re able 

to generate more now. So there’s more awareness of potential side 

effects. If you compare our society with the UK, it’s a very interesting comparison—similar culture, same language. 

I was giving a presentation in the UK recently and afterwards 

I spoke with colleagues. I asked them, how do you get information 

about potential side effects for drugs and devices? They said, ‘‘side 

effects?’’ I said, ‘‘well does your physician tell you?’’ They said, 

‘‘well, it doesn’t come up.’’ That society is less aware that there are 

always potential side effects with treatments such as drugs and devices, as well as potential benefits. So I— 

Senator SALAZAR. Ruth, would you concur with Ami’s recommendations in terms of additional FDA resources to regulate as 

well as regulation extended? 

Dr. DAY. Yes. I know some of what goes on in the DDMAC group, 

that’s the Division of Drug Marketing Advertising and Communication. They do a lot of very good work. They are responsible not only 

for the drug ads we’re talking about now, but all the promotional 

materials, industry websites, the print ads and the promotional 

materials that go to the physicians. If you look at the total number 

of pieces of promotional material they’re responsible for and divide 

by the number of staff people who review—I think it’s about 25 

people. 

Senator SALAZAR. So you’d say they have a good program, but 

they’re just very understaffed? 

Dr. DAY. Absolutely. I would like to see medical devices come up 

as Ami Gadhia also said, to at least that standard as well. 

61 

Senator SALAZAR. Right. 

Dr. DAY. Then consider going beyond that level. 

Senator SALAZAR. My time is up. I thank you, Chairman Kohl. 

The CHAIRMAN. Thank you very much, Senator Salazar. I just 

want to follow up, maybe to some conclusion among all five of you. 

Would you all agree that we need to do a much better job of regulating this advertising, DTC advertising in this area? 

Anybody disagree on that? 

Dr. DAY. No. 

The CHAIRMAN. Do you all see it as a very important issue if 

we’re going to continue to advertise these devices and even increase 

the advertising on these devices that regulation not only should 

occur, but must occur? Anybody disagree? 

Dr. DAY. No. 

Dr. BOZIC. Not at all. 

The CHAIRMAN. We thank you so much. Does anybody want to 

make a comment before we go on to the next panel? 

Dr. DIAMOND. Well if I could just add one more statement with 

respect to the last comment you made. In the end we have to do 

more than just regulate. We have to link the claims to the evidence. 

We eventually have to link the evidence to reimbursement. Because there needs to be an incentive chain throughout the entire 

process that encourages the right behavior. 

Dr. BOZIC. I’d just like to add as we’ve discussed, I think there’s 

an important distinction between help seeking or disease awareness advertisements which can have some positive health effects, 

from product specific ads. I do believe that increased resources for 

the FDA could lead to increased oversight and therefore allow us 

to have some of this fair balance that we’re trying to achieve that 

we’re clearly not achieving under the current system. 

Dr. BODEN. I’d just add also that if we could perhaps model a 

system after what New Zealand has undertaken, a therapeutic, advertising preventing service, that might include multidisciplinary 

representatives of physicians, specialists, consumer advocates and 

other regulatory agencies. I think that this might help to go a long 

way toward ensuring that the content and balance is fair and appropriate for what consumers can expect to understand. 

Thank you. 

Senator SALAZAR. Mr. Chairman, may I ask one more question? 

The CHAIRMAN. Certainly. Go ahead. 

Senator SALAZAR. Would any members of the panel take the position that we ought to try to ban these kinds of ads in the way that 

other industrialized nations have done so? I’m not sure we could 

do it under the First Amendment. But would any of you take the 

position that we ought to follow the same pathway that other industrialized nations have taken to ban these kinds of ads? 

Dr. BODEN. Senator, I think most of us would probably prefer 

such a ban, but I think that this might trigger court challenges, 

you know the First Amendment and commercial speech protections. 

So I think if there was a way to navigate that, you know it would 

be, I think, worthy of consideration. 

Senator SALAZAR. Ok. Do the rest of you agree with Mr. Boden’s 

comment? 

62 

Dr. DAY. I would just like to comment that I do not believe that 

they have been ‘‘banned’’ in other countries. They have not been 

approved. It is allowed in New Zealand. Other countries are considering it. There’s a lot of talk in the UK that it might happen, or 

it might not. They go back and forth on this. But I don’t think that 

the countries have actively banned the ads. They just have not approved direct-to-consumer advertising. 

Senator SALAZAR. Ok. Thank you very much. 

The CHAIRMAN. We thank you so much for being here today. 

Your testimony has been very useful. Thanks for being here. 

So we’ve moved off to the second panel. Second panel is Dr. Daniel Schultz. He’s the Director of the FDA Center for Devices and 

Radiological Health. That is the office responsible for among other 

things, the regulation of direct-to-consumer advertisements for restricted medical devices. 

So Dr. Schultz, what have you got to tell us this morning? 

STATEMENT OF DR. DANIEL SCHULTZ, DIRECTOR, CENTER 

FOR DEVICES AND RADIOLOGICAL HEALTH, FOOD & DRUG 

ADMINISTRATION, WASHINGTON DC 

Dr. SCHULTZ. Mr. Chairman, members of the Committee, my 

name is Dan Schultz. I’m Director of the Center for Devices and 

Radiological Health at the Food and Drug Administration. Thank 

you for the opportunity to discuss today the Agency’s role in oversight in direct-to-consumer advertising in promotion of medical devices. 

I will discuss how FDA regulates the promotion in advertising 

medical devices. Clarify some important differences from regulation 

of drug advertising and promotion. I will also review the Agency’s 

enforcement actions, outreach and compliance activities in these 

areas. 

Under the Federal Food, Drug and Cosmetic Act, FDA has regulatory authority over the labeling of all medical devices. The Federal Trade Commission regulates the advertising of medical devices 

with the exception of restricted devices. A restricted device is one 

for which the Agency has issued a regulation or otherwise imposed 

requirements restricting the sale, distribution or use of a device if 

such restrictions are necessary for its safe and effective use. FDA 

therefore regulates the advertising of restricted medical devices 

and FTC, the advertising of non-restrictive medical devices. 

Sections 502Q and R of the Act provide that a restricted device 

is misbranded if its advertising is false or misleading and in particular, does not contain a brief statement of the devices intended 

use, relevant warnings, precautions, side effects and contra-indications, excuse me. FDA has issued two draft guidances pertaining 

to advertising of restricted devices. One entitled Draft Guidance for 

Industry in FDA Consumer Direct to Broadcast Advertising of Restricted Devices describes an approach for companies in developing 

advertisements that contain a brief statement of intended uses and 

relevant warnings, precautions, side effects and contraindications. 

The second, entitled, Help Seeking and Other Disease Awareness 

Communications Buyer on Behalf of Drug and Device Firms assists 

the drug and device industries in developing such communications. 

Generally help seeking and other disease awareness communicaVerDate Nov 24 2008 10:31 Jun 05, 2009 Jkt 000000 PO 00000 Frm 00066 Fmt 6633 Sfmt 6633 H:\DOCS\49768.TXT SAG PsN: JOYCE
63 

tions do not constitute labeling or advertising and so are not regulated by FDA. 

Some of the distinctions. Generally speaking there is no statutory 

requirement that restricted device or drug advertisements be submitted to FDA for review prior to dissemination or broadcast. The 

main difference between drug and device promotion occurs at the 

time of dissemination or broadcast. Medical device companies are 

not required to submit FDA copies of promotional materials at the 

time of dissemination. Pharmaceutical companies on the other 

hand, are required to submit copies of their promotional materials 

for prescription drug products at the time of initial dissemination. 

FDA’s drug advertising regulations contain certain specific requirements regarding the content of prescription drug advertisements. For example, drug advertisements may not include false or 

misleading information or omit material facts and must present a 

fair balance between benefit and risk. Device regulations do not 

contain specific requirements regarding the content of advertisements for restricted medical devices. So regulation comes directly 

from Sections 502Q and R of the Act mentioned earlier. 

CDRH regulates restricted device advertisements directed to consumers and physicians, specifically CDRH regulates product claim 

and promotional reminder ads, product claim ads include the name 

of the product, its indications for use or make a claim or representation about a specific medical device. Promotional reminder ads 

may disclose the name of the medical device, descriptive information or price information. But do not provide indications for use or 

make any claims or representations. As I previously mentioned 

help seeking and other disease awareness ads are not generally 

regulated. 

CDRH’s Office of Compliance in conjunction with support with 

the rest of the Center is responsible for the surveillance of advertisements for restricted devices as well as promotional materials for 

all medical devices. The Office of Compliance staff reviewed trade 

complaints about promotion from competitors, health care professionals and consumers as well as promotional activities in the exhibit halls of scientific and promotional meetings. I just parenthetically would like to say that we do get a lot of valuable information 

from competitive companies. That’s actually one of our best 

sources. 

As well we do send a number of our medical officers and other 

people around the Center, not just our compliance people to scientific meetings. They’re very helpful as well in getting us useful 

information. Some of which we’ve actually used to take enforcement actions. 

We seek to increase voluntary compliance by industry through 

educational programs. These include outreach programs intended 

to improve industry’s understanding of the statutory requirements 

for medical device promotion, website postings and warning letters 

which provide examples of violations the Agency has acted against 

and helps industry understand what types of promotion are unacceptable. Guidances to help industry understand FDA’s current 

thinking, how to comply with the Act. In addition in 2005, FDA 

held a public hearing on DTC promotion to gather input on DTC 

promotion of regulated medical products. FDA is using information 

64 

from that meeting to help guide its policy on the regulation of DTC 

promotion. 

Last year CDRH undertook a major enforcement initiative in the 

area of off label promotion of medical devices directed to healthcare 

professionals. In 2007, CDRH met with 20 manufacturers of biliary 

stents to discuss increased off label promotion for vascular applications. At that meeting CDRH identified several instances in which 

companies were promoting biliary stent products for uses beyond 

those cleared by the Agency. 

CDRH requested, I think strongly requested, that firms review 

their device’s labeling to ensure it was consistent with cleared indications for use, to stop promoting biliary stents at vascular meetings, to inform their customers of the risks of serious adverse 

events when biliary stents are used off label and to conduct appropriate clinical trials in support of PMA applications for the specific 

vascular indication. CDRH worked with the companies to ensure 

that their corrective actions were fully implemented. Our Office of 

Compliance continued to monitor companies and assure continued 

compliance. 

The Agency has issued untitled and warning letters to companies 

for violated broadcasting DTC advertising and promotional labeling. Other enforcement tools that are available to address misbranded or adulterated devices include seizures, injunctions, civil 

money penalties and referrals for criminal investigation or prosecution. The Agency will maintain vigilance in this area and continue 

enforcement practices necessary to address the unique issues and 

challenges presented by consumer directed advertising of restricted 

medical devices and to target violations with the greatest public 

health impact. That is, maintain a risk based approach. 

Thank you. 

[The prepared statement of Dr. Schultz follows:] 

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The CHAIRMAN. Thank you, Dr. Schultz. Dr. Schultz, in your 

opinion is there any reason why the regulation in the oversight of 

medical devices by the FDA shouldn’t be at the same level as it is 

for pharmaceuticals? 

Dr. SCHULTZ. Mr. Chairman, I think that in terms of the level, 

I think that the question is really, you know, is it important, yes, 

absolutely. The question is how do we go about it? I think one of 

the questions that was asked earlier and one that sort of resonates 

with me is, how can I use the resources that I have and that you’ve 

provided to us in a most effective way to ensure the public health? 

Obviously we have a number of other priorities including import 

safety, product surveillance, good manufacturing, making sure that 

we have a review process that gets life saving devices to the marketplace in a reasonable timeframe. So the question to me is not 

is this important? The question is where do I put it in terms of priority? How can I best achieve the goals that we all have? 

The CHAIRMAN. Well, I appreciate that. I think what you’re saying is your not disregarding the importance of it. 

Dr. SCHULTZ. Correct. 

The CHAIRMAN. You’re suggesting the argument could easily be 

made that it’s just as important to regulate medical devices as it 

to regulate and oversee pharmaceuticals. But you do not have the 

kind of resources to enable you to do that. Is that what you’re saying? 

Dr. SCHULTZ. That, well, that’s part of what I’m saying. Yes, 

that’s correct. The other— 

The CHAIRMAN. It would not be right— 

Dr. SCHULTZ. Alright. Sorry. 

The CHAIRMAN. Correct, or fair for anybody in your opinion to 

make the argument that medical device regulation and oversight is 

any less important than oversight and regulation of pharmaceuticals in our society. 

Dr. SCHULTZ. I’m a surgeon and I’m a device guy. So absolutely 

not. I think medical devices are as important as any other medical 

product. 

The CHAIRMAN. In terms of the need for oversight, I’m saying. 

Dr. SCHULTZ. Well, I think, yeah. I mean, I think that they need 

to be regulated appropriately for the types of devices that they are. 

Again, you know, one of the challenges that we— 

The CHAIRMAN. Do you think that’s important in our society? 

Dr. SCHULTZ. Excuse me? 

The CHAIRMAN. Do you think that that regulation and oversight 

of medical devices is an important thing to be accomplished in our 

society today? 

Dr. SCHULTZ. Absolutely. I’ve devoted the last 15 years of my life 

to that effort. So yes, I obviously think it’s very, very important. 

The CHAIRMAN. So if we even went to the point of trying to get 

some legislation on this to be sure that you’re adequately funded, 

you would be in agreement? 

Dr. SCHULTZ. Again, I think we would have to see and we would 

certainly welcome the opportunity to look at whatever ideas the 

Committee had and to be able to comment back. 

The CHAIRMAN. Yeah. 

81 

Dr. SCHULTZ. Again, I would like to make sure that we do what 

is effective. Not just do something for the sake of doing something. 

I think one of the questions that was raised earlier in terms of how 

effective some of the drug oversight is. I think, frankly, that that 

question and the answers sort of resonated. 

There’s a lot of things that could be done. The question is, what 

should be done? How could we do it in a way that effectively 

achieves its result which is better public health. 

The CHAIRMAN. As we commented on with the first panel, in 

most societies pharmaceuticals and medical devices are not advertised over television. 

Dr. SCHULTZ. Right. 

The CHAIRMAN. That’s for a reason. You know, it’s not a coincidence. That’s for a reason. 

Dr. SCHULTZ. Yeah. 

The CHAIRMAN. Now if we’re going to have that kind of advertising allowed in the United States, then isn’t it logical that we 

need to regulate it to the extent that is necessary to protect the 

public? 

Dr. SCHULTZ. I think we need to regulate it to the extent that’s 

necessary to protect the public. I think that’s absolutely a true 

statement. The question is, excuse me. The question is how do we 

do that? How do we do it efficiently? 

The CHAIRMAN. Sure. 

Dr. SCHULTZ. How do we actually address the concerns that are 

important and not spend a lot of time, frankly, having seen the 

amount of time that we spend looking at labeling and other promotional activities. You can spend an awful lot of time 

wordsmithing things in a way that sometimes I don’t think can be 

as productive as— 

The CHAIRMAN. Sure. 

Dr. SCHULTZ [continuing]. Some of the other activities that we’re 

engaged in. So I guess I’m agreeing with you that’s it’s an important problem. I would sort of put in a cautionary note in terms of 

making sure that whatever we do we think it through and make 

sure that it’s really going to meet the needs of the American public. 

The CHAIRMAN. I couldn’t agree more. Just one last observation 

that you might want to make. 

Dr. SCHULTZ. Sure. 

The CHAIRMAN. Every last dime that’s spent on advertising is 

past on to the consumer. The cost of medicine in this country, the 

cost of healthcare in this country is something that we’re agitating 

and concerned about, as you know, at least as well, if not better 

than the rest of us. Efforts to try and contain the cost of medical 

care in this country is at the level of being urgent. 

As we’ve said many, many countries don’t allow any of this advertising on television. My guess is that in those countries people 

are living to the same age as they are here in this country. Do you 

have an observation? 

Would you make an observation? Just a matter of what your long 

experience has taught you in this field? Is this advertising network 

we’re spending so much money on and charging the customer directly for, in terms of the price that they pay for pharmaceuticals 

and medical devices? 

82 

Is this something that we should be talking about too? Just a 

matter of your opinion. 

Dr. SCHULTZ. Sure. Yeah. Well, I mean I think it is obviously an 

important question. It’s one that actually have been doing some 

thinking about since receiving your invitation. You know, again, I 

haven’t seen all of the different ads for every different product. 

But I guess I would sort of comment by way of example. There 

are a number of ads that I’ve seen recently for glucose monitors for 

people with diabetes. My sense is, again, opinion, not data driven. 

My sense is that reminding diabetics that monitoring their glucose 

and making sure that they see their doctor and control their diabetes is a good thing. 

You know, whether how much those ads actually help to do that, 

you know, again, I don’t have any data. But it seems to me that 

those kinds of reminders from whatever source they come from telling people that they need to take care of their chronic disease is 

probably not a bad thing. Some of the other ads, I think there is 

a range. 

Obviously you saw a number of different ads ranging from wrinkle fillers to obesity treatments to cardiac stents. I think that within those products there’s a range in terms of how useful they are 

in informing people about options and suggesting that they go see 

their doctor verses how un-useful they are in terms of perhaps over 

promoting and suggesting treatments that may not be that helpful. 

At the end of the day, as far as I’m concerned, you know, the decision in terms of what the best treatment for an individual patient 

is rests with the doctor and with the patient. I can say that as a 

former surgeon and as a regulator, I continue to believe that that’s 

where the decision should be made. 

The CHAIRMAN. Well, thank you very much. Your testimony has 

been extremely helpful. Appreciate your being here, Dr. Schultz. 

Dr. SCHULTZ. Thank you. 

The CHAIRMAN. We’ve come down to our last panelist. That is 

Stephen Ubl. Mr. Ubl is the President and CEO of the Advanced 

Medical Technology Association, normally called AdvaMed. 

This is the world’s largest medical technology association. 

AdvaMed’s member companies produce medical devices, diagnostic 

products, as well as health information systems. Its members have 

produced nearly 90 percent of the healthcare technology purchased 

annually in the U.S. and more than 50 percent purchased annually 

all around the world. 

So we’re looking forward to your 5 minute testimony this morning. 

STATEMENT OF STEPHEN UBL, PRESIDENT AND CHIEF 

EXECUTIVE OFFICER, ADVAMED, WASHINGTON, DC 

Mr. UBL. Thank you very much, Mr. Chairman. My name is 

Steve Ubl. I’m President and CEO of AdvaMed, as you said the Advanced Technology Association. We welcome the opportunity to testify this morning on DTC advertising for medical devices. 

The medical technology industry is a critical component of the 

U.S. health sector. Constant innovation by our member companies 

leads to the introduction of new technologies that prevent illness, 

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allow earlier detection of diseases and treat patients as effectively 

as possible. 

I’ve submitted my written statement. But I’d like to focus on four 

key points this morning. 

First, AdvaMed’s member companies believe strongly that directto-consumer advertising of devices must provide truthful and nonmisleading information to consumers. As you are aware, device 

manufacturers are generally not heavily engaged in DTC advertising in comparison to the pharmaceutical industry. Most of our 

products are not sold directly to consumers. 

In fact according to a Northwestern University report, medical 

device manufacturers spent only 116 million on advertising in 2005 

compared to 4.1 billion for pharmaceutical ads. However, to further 

reaffirm our commitment we have guiding principles that will be 

presented to our board that strongly support responsible DTC advertising and compliance with the law. DTC ads should do the following in accordance with FDA policy: be truthful and not misleading, use consumer friendly language, disclose relevant risk information, encourage patients to speak with their doctors in more 

detail and follow all FDA and FTC statutes and regulations. I 

should also say we support FDA’s full enforcement authority 

against companies that run ads in violation of the law. 

In addition to complying with all relevant, applicable FDA and 

FTC policies, our principles go further. For example we share concerns about inappropriate use of celebrities in ads. That is why we 

believe such endorsements must reflect the honest opinion of the 

endorser, include statements that are substantiated as if they were 

made by the manufacturer and be representative of a typical patient experience or disclose when it is not. 

Concerns have also been raised that companies should wait until 

physicians are trained on a new device before launching an ad. We 

support providing appropriate time to educate health professionals 

before an ad is launched taking into account the nature of the 

product, the risk benefit profile and needed training. We are also 

committed to ensuring that ads can communicate risk information 

in a way that consumers can best understand. We would welcome 

guidance from the FDA on how to tailor technical language on restricted devices to consumers. Such guidance should take into account the unique characteristics of medical technology. 

The second point I want to emphasize is that DTC advertising 

in the device industry can benefit public health by informing patients of important potential therapies that they should discuss 

with their physicians. A 2005 Rand study found that patients receive the recommended standard of care only about half the time. 

The study found that 80 percent of those cases were due to undertreatment rather than over treatment. 

In May a study published by the Journal of the American Heart 

Association found that only 51 percent of patients eligible for an 

implantable cardioverter defibrillator or ICD receive it. As Dr. 

Bozic mentioned in his testimony, a 2004 NIH report found that 

only 9 to 13 percent of patients who could benefit from joint replacement actually receive it. Whether the issue is artificial hips 

and knees, implantable cardiac technologies or diabetes control, far 

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too many patients do not receive treatment even when it is clinically indicated and potentially life saving or life enhancing. 

Third, concerns about DTC advertising that have been raised in 

the drug context are in many cases, less relevant when applied to 

devices. Some have raised concerns that unknown side effects can 

appear when a drug is expanded beyond a clinical trial period. Unknown side effects can appear in devices too, but they are much 

less likely because devices, typically, do not act systemically and 

because the eligible population for a particular device is far smaller 

than for drugs. 

In addition, whatever the validity of the concern that DTC advertising of drugs will cause doctors to ignore their professional best 

judgment and write a prescription the patient does not need or 

which is inferior to a competing treatment, it seems misplaced for 

devices. Unlike drugs, medical device treatments often entail complex procedures including surgery to replace body parts like hips 

and knees, connecting batteries to the heart or implanting the 

equivalent of metal scaffolding in a blood vessel. The idea that a 

patient would decide to undergo complex and invasive procedures 

based on an advertisement or that a physician would agree to perform them, even when it’s inappropriate for the patient, is difficult 

to imagine. 

My final point is that the FDA and FTC already have ample 

legal authority to regulate false or misleading advertising for medical devices. We believe that manufacturers are responsive and 

take action to address any issues raised by the FDA regarding an 

ad. For those who violate the law, the FDA has a broad range of 

remedies they can bring to bear from issuing a warning letter to 

removing a product from the marketplace. 

We look forward to taking the feedback from this hearing to our 

board and working with you as you continue to explore this issue. 

I’d be happy to answer any questions the Committee might have. 

[The prepared statement of Mr. Ubl follows:] 

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The CHAIRMAN. Thank you, Mr. Ubl. You heard this morning 

about some of the shortcomings that are believed to be associated 

with DTC ads for restricted medical devices, both panels. As representative of the largest association of manufacturers of such devices, how do you respond to such concerns? What are you intending to do about them? 

Mr. UBL. Well, I mentioned at the outset all the conditions that 

we believe should be a part of DTC ads. We’ve taken the additional 

step of developing principles we’re presenting to our board. They go 

beyond FDA law and regulations in several respects—notably in 

the endorser issues that I raised, and the timeframe for education 

of practitioners before an ad is launched. We’re open to taking the 

feedback of the Committee in terms of additional areas. 

I would point out, however, that under-use was not mentioned in 

any of the earlier panels. It’s a significant issue in terms of many 

medical technologies that patients could benefit from and DTC ads 

are an important source of that information. 

The CHAIRMAN. Mr. Ubl, in your testimony you argue that manufacturers of the devices being discussed here today should adopt 

advertising practices to ensure that commercials featuring celebrity 

endorsers are representative of a typical patient experience. So I’d 

like to get your opinion of the following advertisement as we’ll run 

it now. While you watch it, please keep in mind what we heard 

from the first panel with regard to the overly optimistic assumptions patients tend to form after seeing such advertisements. Let’s 

look at the ad. 

[Panel watching video.] 

The CHAIRMAN. Mr. Ubl, is it typical for hip replacement patients 

to be able to play basketball, jump rope and surf as we saw depicted in this advertisement? 

Mr. UBL. I’m not a physician. I think I would be best if I refrained from commenting on individual ads. I’d be happy to restate 

our views on these types of endorsements. 

The CHAIRMAN. Go right ahead. 

Mr. UBL. They should reflect the honest opinion of the endorser. 

They should include statements that are substantiated as if they 

were made by the manufacturer. They should be representative of 

a typical patient experience or disclosed when it is not. 

The CHAIRMAN. Should medical devices be subject to the same 

kind of oversight as pharmaceuticals? 

Mr. UBL. Sir, we believe, if you take a look at the FDA law regulations and guidance combined with the FTC equivalent that on 

the whole, the regulation on the pharmaceutical side compared to 

restricted devices is comparable, but for the exception that Dr. 

Schultz mentioned earlier in terms of submitting the ad concurrent 

with its launch. We will consider that issue. 

But our view is that there are very few medical device and technology companies who are doing these ads. Those that are, are trying to do the right thing. We believe that the resources of the FDA 

are better trained where the need is most critical, which is on the 

enforcement side. 

The CHAIRMAN. What comment would you be making to Dr. 

Schultz if he were sitting at the table and he said we need to have 

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the same kind of oversight and regulation for medical devices as 

we have for pharmaceuticals? 

Mr. UBL. As I said, I think that I found much to agree with in 

Dr. Schultz’s testimony. In reading it, I believe that, again, taken 

on the whole the types of requirements that apply to restricted devices and pharmaceuticals are quite similar, but for the exception 

that I mentioned. So I assume we could find much common ground 

in terms of the level of regulation. 

I totally agree with his comment in terms of it’s not whether, it’s 

how, and the need to focus the Agency’s limited resources on the 

most effective use for those resources and in our view that would 

be on the enforcement side. I should add that we’re not aware of 

any company that when an FDA representative raises a concern 

with an ad that it’s not addressed in a timely fashion. 

The CHAIRMAN. Thank you very much, Mr. Ubl. We’d like to 

thank you as well as the rest of our witnesses for their presence 

here this morning. Clearly we have a subject and an issue that demands a lot more oversight and thought, ideas about where we 

need to go to be sure that people who are thinking about using 

medical devices get as much information as they need from the 

proper sources and that they’re in a position to make the right decisions. 

We’re not yet of a mind to propose legislative solutions. It is not 

to say that we won’t. But clearly this is something that we need 

to look at. 

I’ve instructed my Committee staff to be very, very much on top 

of the issue. I would expect that we will be putting forth our opinions and issuing our suggestions so that we can stay on top of this 

issue. Thank you so much for being here. 

[Whereupon, at 11:50 a.m., the hearing was adjourned.] 

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A P P E N D I X 

PREPARED STATEMENT OF SENATOR ROBERT P. CASEY, JR. 

I would like to thank Chairman Kohl for calling this important hearing to examine direct to consumer advertising (DTCA) for restricted medical devices. As this 

field continues to grow with advances in science and medical technology, we must 

ensure consumers receive the best and most accurate information available. 

The United States is one of two industrialized nations, New Zealand being the 

second, allowing direct to consumer advertising for restricted medical devices. These 

are devices that require physician approval for uses such as artificial knees and 

hips, heart stents and implantable defibrillators. Other nations, such as Great Britain, restrict the provision of treatment information for patients to physicians only. 

Canada and the European Union require that advertising be reviewed by regulating 

agencies. Indeed, the United States may soon be the only nation to allow this practice as New Zealand is looking to strengthen its limitations on direct to consumer 

advertising and bring it more into line with Australian law. 

In the United States, the Food and Drug Administration (FDA) has the responsibility of regulating direct to consumer advertising for restricted medical devices. 

Under the FDA guidelines advertising must not be false or misleading, it must be 

appropriately balanced between the risks and benefits of the device, it must include 

facts that pertain to how the product is used and it must mention every risk described in the product’s approved labeling. The advertisements do not require approval by the FDA before being aired and the medical device section of the Federal 

Food, Drug and Cosmetic Act states that no regulations issued under that provision 

may require the Secretary to approve an advertisement’s content before it is aired. 

All patients should play an active role in their medical treatment plans and 

should be able to act as informed consumers asking questions about specific medical 

devices and technology. However, there is a concern that some direct to consumer 

advertisements give people false hope and lead them to believe that with this knee 

or that heart stent they will be able to lead a completely changed life and perhaps 

accomplish things that had never before seemed possible. 

Modern medicine and the human body are both amazing things, but consumers 

must have the facts and a realistic prognosis of the potential that medical devices 

may offer them individually. I look forward to hearing the testimony of our witnesses and working with Chairman Kohl and other members of this committee on 

this issue. 

In closing, Mr. Chairman, I want to again thank you for calling this hearing 

today. I look forward to continuing to work with you and with our colleagues next 

year. 

MR. UBL’S RESPONSE TO SENATOR KOHL’S QUESTION

Question. Mr. Ubl, at the Committee’s September 17 hearing I played for you a 

copy of an advertisement for Depuy’s artificial hip product, which features celebrity 

endorser basketball coach Mike Krzyzewski of Duke. The advertisement depicted, 

among other things, people jumping into rivers, surfing, and playing basketball. You 

have represented to the Committee that AdvaMed is implementing a new policy 

with respect to direct-to-consumer advertisements for restricted medical devices, 

which include artificial hips. Is the Depuy advertisement that you viewed at the 

hearing in compliance with that new policy? 

Answer. I cannot make a judgment about the accuracy of the ad nor whether the 

endorsements and testimonials depicted are representative of a typical patient. Such 

judgment would depend on knowledge of the product and patients’ experience with 

the device, which is why we believe patients should talk to their physicians about 

their medical conditions and treatment options. I can tell you that I know people 

who have resumed their lifestyle, active or otherwise, after receiving artificial hips. 

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As mentioned at the hearing, we also believe that ‘‘endorsements and testimonials 

must be representative of a typical patient experience or the advertisement should 

contain a clear and conspicuous disclosure.’’ AdvaMed is in the process of reviewing 

guiding principles on DTC device advertising and we will keep the Committee apprised of developments. 

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