[Senate Hearing 110-830]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 110-830

   MARKETING OR MEDICINE: ARE DIRECT-TO-CONSUMER 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




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                       SPECIAL COMMITTEE ON AGING

                     HERB KOHL, Wisconsin, Chairman
RON WYDEN, Oregon                    GORDON H. SMITH, Oregon
BLANCHE L. LINCOLN, Arkansas         RICHARD SHELBY, Alabama
EVAN BAYH, Indiana                   SUSAN COLLINS, Maine
THOMAS R. CARPER, Delaware           MEL MARTINEZ, Florida
BILL NELSON, Florida                 LARRY E. CRAIG, Idaho
HILLARY RODHAM CLINTON, New York     ELIZABETH DOLE, North Carolina
KEN SALAZAR, Colorado                NORM COLEMAN, Minnesota
ROBERT P. CASEY, Jr., Pennsylvania   DAVID VITTER, Louisiana
CLAIRE McCASKILL, Missouri           BOB CORKER, Tennessee
SHELDON WHITEHOUSE, Rhode Island     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)

  

 
   MARKETING OR MEDICINE: ARE DIRECT-TO-CONSUMER 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.
    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 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 de-stigmatize 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 awareness 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 
appropriate 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-to-consumer 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.
    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:]



    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    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 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, direct-to-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 evidentiary 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:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    
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.

 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 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.
    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 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 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:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    
    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?
    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.
    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?
    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 communications 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 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:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    
    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.
    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?
    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, 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 
direct-to-consumer advertising of devices must provide truthful 
and non-misleading 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 under-treatment 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 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 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.]
                            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.
    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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