[Senate Hearing 112-92]
[From the U.S. Government Publishing Office]



                                                         S. Hrg. 112-92
 
 A DELICATE BALANCE: FDA AND THE REFORM OF THE MEDICAL DEVICE APPROVAL 
                                PROCESS

=======================================================================

                                HEARING

                               BEFORE THE

                       SPECIAL COMMITTEE ON AGING

                          UNITED STATES SENATE

                      ONE HUNDRED TWELFTH CONGRESS


                             FIRST SESSION

                               __________

                             WASHINGTON, DC

                               __________

                             APRIL 13, 2011

                               __________

                            Serial No. 112-4

         Printed for the use of the Special Committee on Aging


         Available via the World Wide Web: http://www.fdsys.gov




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                       SPECIAL COMMITTEE ON AGING

                     HERB KOHL, Wisconsin, Chairman

RON WYDEN, Oregon                    BOB CORKER, Tennessee
BILL NELSON, Florida                 SUSAN COLLINS, Maine
BOB CASEY, Pennsylvania              ORRIN HATCH, Utah
CLAIRE McCASKILL, Missouri           MARK KIRK III, Illnois
SHELDON WHITEHOUSE, Rhode Island     JERRY MORAN, Kansas
MARK UDAL, Colorado                  RONALD H. JOHNSON, Wisconsin
MICHAEL BENNET, Colorado             KELLY AYOTTE, New Hampshire
KRISTEN GILLIBRAND, New York         RICHARD SHELBY, Alabama
JOE MANCHIN III, West Virginia       LINDSEY GRAHAM, South Carolina
RICHARD BLUMENTHAL, Connecticut      SAXBY CHAMBLISS, Georgia
                              ----------                              
                 Debra Whitman, Majority Staff Director
             Michael Bassett, Ranking Member Staff Director


                                CONTENTS

                              ----------                              

                                                                   Page

Opening Statement of Senator Herb Kohl...........................     1
Statement of Senator Bob Corker..................................     2
Statement of Senator Mark Udall..................................     2
Statement of Senator Kelly Ayotte................................     3
Statement of Senator Michael Bennet..............................    19

                           PANEL OF WITNESSES

Statement of Katie Korgaokar, Patient, Denver, CO................     5
Statement of Marcia Crosse, Director, Health Care, Government 
  Accountability Office, Washington, DC..........................     7
Statement of Diana Zuckerman, President, National Research Center 
  for Women and Families, Cancer Prevention and Treatment Fund, 
  Washington, DC.................................................     9
Statement of Frederic Resnic, Assistant Professor of Medicine, 
  Harvard Medical School and Director of the Cardiac 
  Catheterization Laboratory, Brigham and Women's Hospital, 
  Boston, MA.....................................................    11
Statement of Ralph Hall, Distinguished Professor, University of 
  Minnesota Law School, Minneapolis, MN..........................    13
Statement of David Nexon, Senior Executive Vice President, 
  Advanced Medical Technology Association (AdvaMed), Washington, 
  DC.............................................................    15
Statement of William Maisel, Deputy Center Director for Science 
  and the Chief Scientist, Center for Devices and Radiological 
  Health, Food and Drug Administration, Silver Spring, MD........    17

                                APPENDIX
                   Witness Statements for the Record:

Katie Korgaokar, Patient, Denver, CO.............................    40
Marcia Crosse, Director, Health Care, Government Accountability 
  Office, Washington, DC.........................................    43
Diana Zuckerman, President, National Research Center for Women 
  and Families, Cancer Prevention and Treatment Fund, Washington, 
  DC.............................................................    65
Frederic Resnic, Assistant Professor of Medicine, Harvard Medical 
  School and Director of the Cardiac Catheterization Laboratory, 
  Brigham and Women's Hospital, Boston, MA.......................    72
Ralph Hall, Distinguished Professor, University of Minnesota Law 
  School, Minneapolis, MN........................................    81
David Nexon, Senior Executive Vice President, Advanced Medical 
  Technology Association (AdvaMed), Washington, DC...............   107
William Maisel, Deputy Center Director for Science and the Chief 
  Scientist, Center Devices and Radiological Health, Food and 
  Drug Administration, Silver Spring, MD.........................   120

            Additional Statements Submitted for the Record:

Terrie Cowley, President, The TMJ Association, LTD...............   140
Kevin Fu, Ph.D., Department of Computer Science, University of 
  Massachusetts, Amherst, MA.....................................   158
Janet Holt, Texas................................................   185
Lana C. Keeton, President and Founder, Truth in Medicine, Miami 
  Beach, FL......................................................   191
Beverly J. Pennington, Roopville, GA.............................   197
Rita Redberg, MD, MSc, Professor of Medicine, University of 
  California.....................................................   200


 A DELICATE BALANCE: FDA AND THE REFORM OF THE MEDICAL DEVICE APPROVAL 
                                PROCESS

                              ----------                              


                       WEDNESDAY, APRIL 13, 2011

                                       U.S. Senate,
                                Special Committee on Aging,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 2:03 p.m., in 
Room SD-562, Dirksen Senate Office Building, Hon. Herb Kohl, 
Chairman of the Committee, presiding.
    Present: Senators Kohl [presiding], Wyden, Nelson, Udall, 
Bennet, Blumenthal, Corker, and Ayotte.

        OPENING STATEMENT OF SENATOR HERB KOHL, CHAIRMAN

    The Chairman. Good afternoon. We would like to thank the 
members as well as our witnesses for being here with us today.
    We are examining a very important topic today--the Food and 
Drug Administration's management and oversight of the thousands 
of medical devices countless Americans rely on every day. The 
overall success of this process has become even more urgent for 
seniors in recent years.
    Innovative technology has provided valuable lifesaving 
medical devices that have prolonged life and reduced suffering. 
We need to do all we can to make sure that these new medical 
products are getting to the market quickly as well as safely.
    However, the FDA must constantly strive to maintain a 
delicate balance between safety and innovation. As we will hear 
today, this is an extremely difficult assignment.
    The medical device industry has understandable concerns 
that significant changes in the medical device approval process 
contemplated by FDA could slow the rapid progress of new 
medical technologies to hospitals, patients, as well as the 
marketplace. They have also expressed concerns to the agency 
about a lack of consistent and clear guidance on how to get 
medical devices approved.
    However, the drive toward getting new technologies to 
market should not be done at the risk of patient safety. Faulty 
medical devices, especially those implanted in the body, can 
have a disastrous impact on the health of those who use them.
    Today, we will hear a firsthand account of the trauma that 
occurs when an implantable medical device must be removed due 
to a recall and device failure. As we hear about the cost to 
patients, we should not forget the cost of recalls to the 
healthcare system as a whole.
    We will have an update from the GAO, which has been 
investigating FDA's handling of the medical device approval 
process for the last several years. Somewhat disturbingly, this 
process has remained on the GAO's high-risk list of Government 
programs for 2 years now. GAO will also report on FDA's fast-
track approval process for medical devices, which accounts for 
more than 95 percent of all medical device approvals and helps 
get medium- and low-risk devices to patients faster.
    Finally, a top FDA medical device expert will discuss the 
complex and daunting challenges of overseeing medical device 
products in a time of tight budgets and exploding global 
medical technologies.
    I believe we can find ways to improve safety in medical 
devices without hampering medical innovation. We look forward 
to hearing the ideas of our witnesses on how we can improve 
postmarket surveillance, improve adverse events reporting, and 
ensure that high-risk medical devices get the safety review 
that they need.
    We look forward to hearing everyone's testimony today, and 
we turn now to Senator Bob Corker.

                STATEMENT OF SENATOR BOB CORKER

    Senator Corker. Thank you, Mr. Chairman.
    And thank all of you for being here, and I appreciate the 
breadth of panelists that we have and look forward to your 
testimony.
    I think our goal is to achieve a balance. There are 
concerns on one hand that there may be devices that end up 
making it to the market where there are problems. And then, on 
the other hand, there are a lot of concerns where, for 
instance, in the European Union, a lot of times complex medical 
devices end up making it to the market 4 years earlier and 
actually create ways for people to have better ways of life.
    There is concern about the safety, but there is also a 
concern that the FDA has become a place that is really about 
risk avoidance. I look forward to hopefully very balanced 
testimony today and hope at the end of this we are able to have 
a very good understanding of the direction the FDA ought to 
take.
    I thank the chairman for having this. Obviously, this is 
very important to every American. Almost every American has 
some type of medical device that they use. So I thank you for 
this hearing today, Mr. Chairman, and look forward to the 
testimony.
    The Chairman. Thank you, Senator Corker.
    Senator Udall.

                STATEMENT OF SENATOR MARK UDALL

    Senator Udall. Thank you, Mr. Chairman.
    I want to thank you and Ranking Member Corker for holding 
this hearing today, and I want to thank the witnesses for 
taking time out of your busy schedules to share your various 
testimony with us.
    I want to add to what the chairman said, which is we are 
here today to talk literally about life-altering and, in many 
cases, life or death issues for Coloradoans and for patients 
across the country. Our goal has to be to explore the steps 
necessary to make sure that innovative and evolving technology 
represented by medical devices is as lifesaving and life-
improving as possible.
    Ms. Korgaokar, I know that the chairman will give you a 
formal introduction later. But as one of my constituents, 
Katie, I think you are from Denver?
    Ms. Korgaokar. Yes.
    Senator Udall. I want to thank you for having the bravery 
to be here today and for sharing your story. Experiences like 
yours are why this hearing is so, so important.
    The twin goals of the FDA require a very difficult, yet 
absolutely critical balancing act. Making sure, on the one 
hand, that doctors and patients have access to safe and 
effective devices while also fostering innovation in the 
medical device industry.
    Dr. Maisel, I think in your written testimony, you assert 
that the FDA cannot ensure this balance alone, and I agree. The 
medical device industry must be a responsible and responsive 
partner in this effort. And additionally, those here behind the 
dais and the rest of Congress must vigorously exercise 
oversight role, as Chairman Kohl has brought us here to do 
today.
    I regret that I have some prior commitments that will not 
allow me to stay and listen to everybody's testimony. But I 
have reviewed your written testimony, and I look forward to 
hearing the transcript from what I hope and, actually, I know 
will be a spirited and fruitful conversation during this 
hearing.
    I don't think anyone expects that the approval, postmarket 
surveillance, and recall process for medical devices will ever 
be completely mistake free. However, the status quo needs work. 
And while I applaud the FDA for taking significant steps to 
tighten up this process with a goal of increasing safety and 
efficiency, I look forward to continued and expeditious action 
on the part of both the agency and industry to improve this 
process. We owe it to patients like Katie.
    Thank you, Mr. Chairman.
    Thank you, Senator Corker.
    The Chairman. Thank you very much, Senator Udall.
    Senator Ayotte.

               STATEMENT OF SENATOR KELLY AYOTTE

    Senator Ayotte. Thank you very much, Chairman Kohl and 
Senator Corker, Senator Udall as well.
    And I want to thank all of our witnesses who are here 
today, and I look forward to hearing your testimony.
    I want to echo the comments that have already been made by 
the Senators on this panel. The FDA performs a very critical 
role. It is a critical regulatory agency that has to have a 
system that is safe, efficient, consistent, and thorough.
    One of the issues that I am looking forward to addressing 
today is making sure that we have safe products that come 
forward through the process. I am deeply troubled by reports 
that our nation's leadership in medical technology could be 
declining as medical device technology companies, due to the 
review process, are increasingly looking to other countries for 
approval on innovative products.
    We want to be on the cutting edge of making sure that we 
get the best technology that is not only safe, but the 
lifesaving products to United States consumers in as fast as 
possible process while making sure that it is safe. Medical 
device companies are a strong and vibrant part of the United 
States economy, and in my own home State of New Hampshire, we 
have over 50 medical device companies.
    Over the last recess, I had the opportunity to visit three 
medical device companies that are doing very important work in 
our State, including one--Salient Surgical in Portsmouth--that 
is making technology that reduces blood loss during major 
surgery. And one of the things I was very struck by is that, 
when you walk into their conference room, you see the pictures 
on the walls of patients whose lives that they have saved.
    Additionally, I visited another medical device company in 
New Hampshire, one called Next Step Orthotics that produces 
custom prosthetics for those who have lost a limb. Many of our 
wounded warriors, young people, old people, and even infants, 
are now being able to have that mobility and use, even though 
they have suffered situations where they have lost a limb. The 
technology is amazing. My point is that we want to make sure 
that we are on the cutting edge in this country. While 
protecting people like Katie, we must also make sure that this 
process doesn't put us behind other countries when looking at 
our global competitiveness.
    I was deeply troubled to learn that we could be a couple of 
years behind other countries in regards to approving on safe 
technologies that are coming forward. So I look forward to 
hearing about the review process today and how we can work with 
you to make that process better, more efficient, and safer for 
patients.
    Finally, I want to touch briefly on a topic that I know 
won't be the full subject of this hearing, but it is one that I 
am very concerned about and that I heard concern about from the 
medical device companies in my State. In the healthcare bill 
that was passed, there is a new tax on medical device companies 
that is actually, in my view, a tax on innovation.
    It is not only a tax on the profit of these companies, but 
actually taxes their revenue. One of the concerns I have about 
that tax is that it is not going to allow the development of 
new research and development and technologies.
    So I look forward to also working with my colleagues to 
address the onerous burden this tax places on an important part 
of our economy. The industry is not just important for the jobs 
that it creates in my State and across the country, but also 
for the important products that come forward to save and 
improve the quality of life of the citizens of our country, not 
only in New Hampshire.
    So thank you all for being here today. I look forward to 
hearing your testimony.
    The Chairman. Thank you, Senator Ayotte.
    We will now turn to our panel of witnesses. First, we will 
be hearing from Katie Korgaokar of Denver, Colorado, who 
received a DePuy ASR hip implant when she was 36 years old, but 
after a few years needed revision surgery to remove the 
recalled device.
    Next we will be hearing from Marcia Crosse, Ph.D., the 
director of the healthcare team in the U.S. Government 
Accountability Office. Dr. Crosse will discuss a forthcoming 
GAO report on medical device recalls.
    I would like to acknowledge my Judiciary Committee 
colleague Senator Grassley for allowing us to sign on to his 
GAO request on this issue and to discuss its findings here 
today.
    Next we will be hearing from Diana Zuckerman, Ph.D. She is 
currently the president of the National Research Center for 
Women and Families. After a distinguished academic career, Dr. 
Zuckerman worked in the House of Representatives and served as 
a senior policy adviser to First Lady Hillary Rodham Clinton.
    Next we will be hearing from Dr. Frederic Resnic, assistant 
professor of medicine at Harvard Medical School and director of 
a lab at Brigham and Women's Hospital in Boston.
    Then we will be hearing from Ralph Hall, who is a 
distinguished professor at the University of Minnesota Law 
School, counsel to the Indianapolis law firm of Baker & 
Daniels, and a member of the board of directors of the Food and 
Drug Institute. Previously, Professor Hall was senior vice 
president and deputy general counsel at Guidant and headed Eli 
Lilly's environmental law group.
    Next we will be hearing from Dr. David Nexon, who is a 
senior executive vice president of the Advanced Medical 
Technology Association, or AdvaMed, where he is responsible for 
the organization's domestic policy. Previously, Dr. Nexon 
served for more than 20 years as a Democratic health policy 
staff director for the Senate HELP Committee and its chair, 
Senator Edward M. Kennedy.
    And last, we will be hearing from Dr. William H. Maisel, 
who is the deputy center director for science and chief 
scientist at the Center for Devices and Radiological Health at 
the FDA, where he works to guide the agency in science-based 
decision-making. Previously, Dr. Maisel served as associate 
professor at Harvard Medical School and founded and directed 
the Medical Device Safety Institute at Boston's Beth Israel 
Deaconess Medical Center.
    Welcome to you. Welcome to you all.
    And now we will start with you.

       STATEMENT OF KATIE KORGAOKAR, PATIENT, DENVER, CO

    Ms. Korgaokar. Chairman Kohl, Ranking Member Corker, and 
members of the committee, I thank you for giving me the 
opportunity to testify today.
    I am here to give a patient's perspective of what happens 
when a defective medical device is released to the public. 
Specifically, I was one of the 96,000 unlucky people who 
received the DePuy ASR prosthetic hip that was recently 
recalled in August 2010.
    The reason I needed a new hip was because I was born with a 
congenital condition known as Perthes disease. This disease 
caused the premature deterioration of bones in my hip joint.
    Beginning in my early 30s, I began experiencing extreme 
pain on a fairly regular basis and had trouble with mobility. 
Eventually, the pain in my hip became so unbearable that I 
consulted with an orthopedic surgeon to see if there was 
anything he could do to relieve my symptoms. He recommended 
total hip replacement surgery.
    Prior to my operation, my surgeon and I discussed the type 
of hip that he would use. He told me that it was a new, state-
of-the art, metal-on-metal hip that was specifically designed 
for young active people such as myself. He told me that the 
metal-on-metal design was superior to other designs and that it 
should last at least 20 years or more. The new state-of-the-art 
hip that the surgeon used was the DePuy ASR.
    The initial hip replacement surgery was a huge success. 
Within 3 months of the surgery, I was essentially pain free and 
was able to engage in activities that had previously been off 
limits. The surgery truly changed my life.
    Three years later, I met my husband, and we were married. 
Both my husband and I had always wanted to have children and 
immediately began trying to start a family.
    However, about 8 months later, our plans changed. At this 
time, I received a letter from my surgeon advising me that the 
hip he had put in my body 4 years prior had been recalled. He 
told me that I needed to come in for an appointment so that he 
could do an examination.
    When I heard this news, I really didn't understand the 
implications of what I was being told. In my mind, recalls were 
for dishwashers and cars, not body parts.
    When I met with my surgeon, he explained that there was 
some type of design problem with the DePuy ASR that was causing 
excessive wear and tear on the metal components of the hip. As 
a result, the hip could be releasing metal debris into my body. 
My doctor told me I needed to have a blood test performed to 
see if this was happening.
    There are two metals that I was told that were used that 
they were testing, which was cobalt and chromium. If the level 
of these metals were elevated, that meant there was excessive 
wear and tear occurring.
    A few weeks later, my doctor called to tell me that the 
blood tests showed that I did have elevated levels. In fact, my 
levels were about 1,000 percent higher than they should be. At 
that time, I became very concerned. I had no idea how these 
metals would affect my body, and more importantly, I didn't 
know if they would impact my ability to have children.
    After speaking with my doctor about these concerns, I 
learned that research had shown that excessive levels of cobalt 
in the blood could potentially impact the development of a 
fetus. I also learned that excessive levels of cobalt and 
chromium had been linked to several serious health conditions, 
such as cancer and cardiomyopathy. As a result, my doctor 
recommended that I have the hip replaced as soon as possible.
    In January 2011, at age 41, I underwent my second hip 
replacement surgery. This time, the surgeon installed a more 
traditional hip with a polyethylene liner in the cup. The 
recovery from this second operation has been substantially more 
difficult than my first. The pain is much worse, and it has 
been extremely difficult to get around.
    Only recently has my mobility improved to the point where I 
no longer need crutches. For the past 3 months, I have 
essentially been confined to my home, trying to recover.
    Going forward, I have serious concerns about how this will 
affect my life. I am told that undergoing a hip revision 
surgery so soon after the first will likely result in me 
experiencing more pain, dislocations, and other problems down 
the road. This is because each operation affects the muscles, 
tendons, and bones in the hip and makes it less stable.
    I am also told that as a result of this, I may have to 
undergo one or more additional hip operations later in my life 
that could have possibly been avoided. Most importantly, 
however, I fear that given the small window I had to start a 
family, this operation may have forever prevented me from ever 
having children.
    As I learned more about the ASR and the process by which it 
was approved by the FDA, I was shocked. Prior to this, I 
thought that any medical device that was actually being put 
into people's bodies had been extensively tested before it was 
released to the public. I had no idea that devices could be 
fast-tracked by the FDA with little or no testing.
    I also assumed that the FDA had systems in place to monitor 
drugs and medical devices for potential defects so that prompt 
action could be taken if problems arose. Apparently, this did 
not happen with the DePuy ASR.
    Additionally, I am concerned that the doctors who are 
actually installing these medical devices may not be fully 
committed to the well-being of their patients. Specifically, I 
recently learned that the surgeon who recommended that I have 
the DePuy ASR installed had actually received more than 
$600,000 from DePuy in consulting income. A disclosure 
statement from DePuy is attached.
    This was never disclosed to me before my surgery. Although 
I would like to think these payments had no influence on my 
doctor's decision to use the ASR, I will always have doubts.
    Thank you, Chairman Kohl and Ranking Member Corker, for 
holding this hearing and giving me the opportunity to tell my 
story. I truly hope that you and your colleagues take a serious 
look at how medical devices are approved in this country and 
take whatever steps are necessary to make sure incidents like 
this do not happen again.
    [The prepared statement of Katie Korgaokar appears in the 
Appendix on page 40.]
    The Chairman. Thank you very much, Katie.
    Marcia Crosse.

 STATEMENT OF MARCIA CROSSE, DIRECTOR, HEALTH CARE, GOVERNMENT 
             ACCOUNTABILITY OFFICE, WASHINGTON, DC

    Dr. Crosse. Chairman Kohl, Ranking Member Corker, and 
members of the committee, I am pleased to be here today as you 
examine issues related to the regulation of medical devices.
    Americans depend on FDA to provide assurance that medical 
devices sold in the United States are safe and effective. 
Today, I will discuss GAO's findings from our recent work 
examining FDA's premarket review of device applications and 
ongoing work looking at the agency's oversight of recalls when 
medical devices are found to be defective.
    Let me first provide some general background about medical 
device reviews. While FDA is responsible for overseeing all 
medical devices, about two-thirds of medical devices are exempt 
from FDA premarket review. These are mostly low-risk devices, 
such as bandages and tongue depressors.
    The remaining one-third of devices require greater 
regulation and must be reviewed by FDA before they are 
marketed. Over 90 percent of these devices are reviewed through 
FDA's premarket notification process known as the 510(k) 
process. The remaining small percentage of medical devices are 
considered high risk, including implantable or life-sustaining 
devices like pacemakers and replacement heart valves, and these 
devices are generally subject to FDA's premarket approval, or 
PMA, process.
    The 510(k) process is less stringent than the PMA process. 
For 510(k) submissions, clinical data are generally not 
required, and clearance decisions will normally be based on 
comparative device descriptions, including performance data. 
For the more stringent PMA process, manufacturers typically 
submit clinical data, but FDA doesn't always require clinical 
data, even for implantable devices.
    In January 2009, we reported on a key area of concern 
regarding FDA's premarket reviews. When Congress established 
FDA's premarket review system for medical devices in 1976, it 
envisioned that all high-risk devices would be subject to the 
more stringent PMA process.
    Nonetheless, we found that more than 30 years after 
Congress acted, FDA had still not completed the regulatory 
steps necessary to require PMA reviews for some two dozen types 
of high-risk devices, including certain implantable devices. We 
recommended that FDA move expeditiously to address this issue.
    Since then, FDA has issued a final rule regarding the 
classification of only one of these device types and has 
started, but not completed actions on the remaining 26 types of 
high-risk devices that can still enter the U.S. market through 
the less stringent 510(k) process. These include devices such 
as implantable hip joints of the type we just heard about. 
Since our report in January 2009, FDA has cleared at least 67 
submissions that fall within these 26 types of devices that 
await final rules from FDA.
    In addition to the concerns we identified with premarket 
reviews, FDA also faces challenges in postmarket surveillance 
of medical devices. In our ongoing review of medical device 
recalls, which we are conducting at the request of Senator 
Grassley and you, Mr. Chairman, we have identified gaps in 
FDA's processes that could allow unsafe or ineffective devices 
to continue to be used despite being recalled by the 
manufacturer.
    Our preliminary analysis of medical device recalls found 
that firms initiated about 700 recalls per year. However, we 
found that firms frequently were unable to correct or remove 
all recalled devices, even those subject to the highest risk, 
or Class I recalls.
    In addition, our preliminary findings indicate that FDA 
lacks clear guidance for overseeing recalls, resulting in 
inconsistencies in FDA's assessments of whether individual 
recalls were implemented effectively. We also found that FDA's 
decisions in reviewing recalls were often slow.
    Finally, our ongoing work suggests that FDA is missing an 
opportunity to proactively identify and address the risks 
presented by unsafe devices. FDA does not routinely perform 
analyses of recall data and does not use such information to 
effectively monitor and manage its recall program.
    As a result, FDA could not provide basic information to 
explain trends, such as why the majority of recalls are medium 
risk, why high-risk recalls more than doubled between 2008 and 
2009, or why many recalls have been ongoing for 5 years. We 
believe it is essential that FDA take steps to provide a 
reasonable assurance that medical devices entering the market 
are safe and effective and that the agency's postmarket safety 
efforts are both vigorous and timely.
    Mr. Chairman, Ranking Member Corker, this concludes my 
prepared remarks. I would be happy to answer any questions that 
you or members of the committee may have.
    [The prepared statement of Marcia Crosse appears in the 
Appendix on page 43.]
    The Chairman. Thank you very much, Marcia.
    Now we hear from Diana Zuckerman.

  STATEMENT OF DIANA ZUCKERMAN, PRESIDENT, NATIONAL RESEARCH 
CENTER FOR WOMEN AND FAMILIES, CANCER PREVENTION AND TREATMENT 
                      FUND, WASHINGTON, DC

    Dr. Zuckerman. Thank you for the privilege of testifying at 
this important hearing.
    I am president of the National Research Center for Women 
and Families, a think tank dedicated to improving the health of 
adults and children, and I am also testifying on behalf of our 
Cancer Prevention and Treatment Fund.
    I was trained in epidemiology at Yale Med School, was on 
the faculty at Vassar and Yale, and a researcher at Harvard. I 
am currently a fellow at the University of Pennsylvania Center 
for Bioethics, and my FDA expertise started when I was a 
committee staffer in Congress.
    Today, I will talk about our recently published study in 
the prestigious Archives of Internal Medicine. We studied the 
recalls from 2005 to 2009 that FDA designated as the highest-
risk recalls because they could cause death or permanent harm 
to patients.
    We found that most of those devices were not approved 
through the PMA process. They were cleared through the 510(k) 
process or, in some cases, even exempt from review because they 
were thought to be such low risk.
    GAO has explained that FDA is ignoring the law when it 
clears high-risk devices through the 510(k) process. I will 
explain how that harms patients.
    There are three essential safeguards that the PMA process 
has that are missing from the 510(k) process. Number one: 
clinical trials. There are no clinical trials required, so it 
is not tested on patients. Number two: no required inspections 
before they can be sold, so you don't know if they are 
manufactured as they are supposed to be. And number three: when 
they are cleared for the market, the FDA can't require 
postmarket clinical trials or epidemiological studies as a 
condition of approval.
    So the FDA doesn't have the studies before they are allowed 
to be sold, and they can't require them as a condition of 
approval to make sure they are safe after they are sold.
    Defenders of the status quo have said that what is 
important is that less than 1 percent of device applications 
are later subject to a high-risk recall, and that might make 
sense from a business point of view, but it really doesn't make 
sense from a public health or public policy point of view. 
Americans are dying and being harmed because their devices are 
not being tested before they are sold and, in some cases, put 
in their bodies.
    As a scientist and a logical person, I believe that, if a 
device can kill you, it is not a low-risk or moderate-risk 
device. And I am not talking about lightning striking out of 
the blue. I am talking about an implant that deteriorates in 
the human body or a diagnostic test that is not accurate. Those 
are predictable but life-threatening problems that have caused 
recalls, and we can reduce those.
    We don't celebrate every time we eat a meal that doesn't 
poison us, and yet Congress has recently improved the food 
safety system. And I just want to say it is wonderful that 
Congress has done that, even though food is quite safe, and 
similarly, we could save a lot of lives not just in food 
safety, but also in device safety.
    Devices are common. Those of us who wear contact lenses or 
hearing aids, or have a replacement hip or knee, or had Lasik 
or Botox, or use test strips for diabetes, we rely on medical 
devices every day.
    More than 430 million devices were subject to high-risk 
recalls in just the first 6 months of last year. That is more 
than one device for every man, woman, and child in the United 
States. It doesn't make sense that standards for even the most 
innocuous drug, such as a constipation medication, are more 
rigorous than for lifesaving medical devices.
    Analyses that have been done that are similar to our study, 
such as Mr. Hall's and AdvaMed's analysis, would not meet the 
standards of a peer-reviewed medical journal or even of the 
research methods course that I used to teach. I won't go into 
statistical details, but I am happy to answer any questions 
about that.
    There were almost 8,000 moderate-risk recalls in the last 5 
years, such as Katie's hip. If you add those to the 113 high-
risk recalls and divide even by Mr. Hall's estimated 20,000 
submissions of devices, devices would not have a 99 percent 
safety record. It would be 60 percent. And if you use the 
numbers that GAO has provided, which was 700 recalls per year, 
then still the safety record would be about 82 percent. So that 
is much, much lower than the 99.5 percent that has been quoted 
and that you will be hearing about from other witnesses.
    We need to count moderate-risk recalls, not just high-risk 
recalls because, as you have heard from Katie, they are hugely 
expensive and debilitating, and there is also the risk of death 
from additional surgery.
    We don't know how many people die every year from unsafe 
medical devices because hospitals are required to report them, 
but doctors are not.
    Even so, there were almost 5,000 reported deaths from 
medical devices in 2009 and hundreds of thousands of serious 
complications, and these are considered the tip of the iceberg 
because doctors don't report them to the FDA.
    In conclusion, lives could be saved and patients would 
spend less time in the hospital if FDA implemented the law as 
required, as GAO has specified, and billions of Medicare 
dollars could also be saved.
    The 510(k) process may be acceptable for devices that are 
truly low or moderate risk, but not for implanted devices or 
those that diagnose or treat potentially deadly diseases.
    Thank you for the opportunity to testify. And I know that 
some of these numbers are rather hard to deal with, and I would 
be happy to answer any questions about them.
    [The prepared statement of Diana Zuckerman appears in the 
Appendix on page 65.]
    The Chairman. Thank you so much, Diana.
    Now we will hear from Frederic Resnic.

STATEMENT OF FREDERIC RESNIC, ASSISTANT PROFESSOR OF MEDICINE, 
      HARVARD MEDICAL SCHOOL AND DIRECTOR OF THE CARDIAC 
   CATHETERIZATION LABORATORY, BRIGHAM AND WOMEN'S HOSPITAL, 
                           BOSTON, MA

    Dr. Resnic. Chairman Kohl, Ranking Member Corker, Senator 
Ayotte, I would like to thank you so much, and as well as your 
staff, for the privilege of testifying today.
    I respectfully refer you to my submitted testimony for 
details regarding my research in the area of medical device 
safety monitoring and for further information regarding the 
issues that I will only discuss briefly today.
    To start, I am an interventional cardiologist, practicing 
at Harvard Medical School, where I use innovative medical 
devices daily in the treatment of my patients. I have, 
therefore, witnessed the tremendous benefits that medical 
devices can provide, and I have also seen the devastating 
complications that can occur when they fail.
    In addition, I lead a research program funded through the 
NIH and FDA, investigating strategies to monitor medical device 
safety through continuous surveillance techniques.
    To begin, medical devices, regardless of the approval 
pathway, will rarely, but inevitably fail, causing injury and 
even death. Despite the best-designed clinical trials and 
diligent premarket review, we can never, never know exactly how 
devices might cause harm until enough real-world experience is 
gained.
    Unfortunately, the systems currently used to assure that 
medical devices are safe after market approval are really a 
patchwork of voluntary and passive event-reporting mechanisms. 
These systems rely on individual case reports submitted to the 
FDA, which then seeks to determine whether emerging trends 
indicate real safety problems.
    Despite efforts to encourage reporting, the GAO has 
estimated that less than 1 in 200 actual device failures are 
reported to the FDA, tremendously limiting the information 
available. While these passive systems can identify previously 
unexpected safety concerns, they do not provide any information 
regarding the real-world usage of the devices or what is called 
the denominator data. Therefore, we can't understand the actual 
rate of device failure and can't compare one device to another.
    Despite the challenges of the current systems, as well as 
the unique challenges of medical devices as opposed to 
medications, I believe there is a clear path to improving 
medical device safety monitoring that would not stifle industry 
innovation. This strategy is based on using active and 
continuous surveillance of health registries to detect safety 
signals in a timely manner.
    Computerized tools are capable of monitoring hundreds of 
high-risk medical devices simultaneously, able to constantly 
watch accumulating database of clinical experience. Much like a 
smoke alarm, such systems can trigger an alert when the rate of 
a device failure or a complication rises above a threshold that 
would provide the analysts at FDA or other stakeholders with 
additional tools to drill down to explore the possible causes 
of safety alerts.
    Recent pilot studies performed by my research group and 
others have used these continuous surveillance techniques to 
detect safety risks for heart stents, as well as to identify 
device failures years before the current passive systems would 
have been able to do so. On the basis of these pilot studies, 
leading U.S. experts in healthcare safety and quality have 
called for broadly applying automated prospective surveillance 
of medical registries as a principal way to improve the medical 
device safety surveillance that is currently used in the United 
States.
    Of course, the first step in moving to this model of 
continuous safety surveillance is to address the critical need 
and current deficiency for detailed medical device registries. 
While detailed registries are mandatory in many countries, 
there is no U.S. system to assure that registries exist for 
high-risk, even very high-risk implantable devices, and no 
resources are directed to support these efforts.
    Despite this, several nonprofit professional medical 
organizations have recognized the critical need for such 
registries and have spearheaded their development in an effort 
to analyze and to improve the quality of healthcare. I would 
cite the American College of Cardiology, which has put together 
several of these registries containing over 3 million records 
from over 1,000 hospitals. Also the Society of Thoracic Surgery 
and new efforts from in orthopedics, ophthalmology, and 
surgical material implants are all in development.
    Importantly, FDA, through the new MDEpiNet initiative of 
the Center for Devices and Radiological Health, has been 
instrumental in trying to bring these dataset owners together 
with safety scientists to collaborate on device safety 
surveillance pilot projects. Another innovative effort has been 
the INTERMACS registry. It is a public-private partnership that 
involved the NIH, CMS, FDA, industry, and academia, which 
collects information on every patient who underwent 
implantation of a very high-risk device, a mechanical heart 
pump.
    As part of this registry, CMS actually requires 
participation in order to qualify for payment, and also the 
registry satisfies the FDA's postapproval condition of approval 
requirements, thus redirecting resources spent by industry 
toward a more sustainable and generally usable and valuable 
resource.
    So, in summary, the postapproval monitoring of medical 
devices in the United States, I believe, requires significant 
enhancement to avoid preventable injury and death to patients 
treated with high-risk medical devices that infrequently, but 
predictably, fail. I believe that, aligning incentives, the 
U.S. can establish a comprehensive medical device registry that 
will continuously monitor for safety signals, and I would 
respectfully ask the committee to consider the following 
recommendations.
    First, FDA, in collaboration with CMS, should mandate 
detailed information regarding high-risk medical devices be 
universally submitted to national registries.
    Number two, registries should be operated by independent 
academic or professional medical societies as part of public-
private partnerships, informed and guided by MDEpiNet and the 
FDA's Sentinel program.
    Third, the FDA should redirect the resources currently 
spent by the medical device industry on limited condition of 
approval studies to support medical device safety registries 
and surveillance.
    Fourth, automated safety surveillance should be uniformly 
applied to these registries to continue monitoring each and 
every high-risk device for safety over time.
    And the results of these surveillance efforts should be 
provided in near real time to the FDA to interpret and 
potentially relay to stakeholders, as well as to providers and 
patients, as well as to device manufacturers, to support in 
their innovation and refinements in their product design.
    Thank you so much for the opportunity to present.
    [The prepared statement of Frederic Resnic appears in the 
Appendix on page 72.]
    The Chairman. Thank you very much, Mr. Resnic.
    Now we will hear from Ralph Hall.

STATEMENT OF RALPH HALL, DISTINGUISHED PROFESSOR, UNIVERSITY OF 
             MINNESOTA LAW SCHOOL, MINNEAPOLIS, MN

    Mr. Hall. Chairman Kohl, Ranking Member Corker, members of 
the committee, I appreciate the opportunity today to discuss 
with you the important issues of medical safety.
    I am going to concentrate on three broad topics--medical 
device safety, postmarket authorities, and recall authorities. 
My emphasis is on systems and authorities, as compared to 
individual implementation in specific cases, and what I hope to 
do is to provide information about the authorities that the 
agency currently has.
    But to start, let us talk about the safety issues. When the 
debate over the 510(k) program first began in earnest several 
years ago, I was struck by the fact that there was no good data 
assessing at a system level the performance of the 510(k) 
system. It was a collection of anecdotes and opinions on all 
sides.
    That struck me, and so, therefore, with the financial 
support of the Kauffman Foundation, which was with complete 
academic freedom, I undertook a systemic study of the 510(k) 
and PMA systems from a safety perspective. We used Class I 
safety recalls as the starting point because those are the 
high-risk safety issues. Other studies use the same starting 
point. And it is important to note that FDA, not industry, is 
the one that assigns that classification.
    We coded these for a significant number of factors. Most 
importantly, we coded these for the reason for the recall. And 
if you want to improve the premarket system by using this type 
of data, you have to understand the reason for the recall. 
Otherwise, you don't know what you are trying to solve.
    For example, if you have a manufacturing problem, a mistake 
in the manufacturing line, 7 years after the product was 
approved or cleared, that is a quality system issue. That is 
not a premarket issue.
    We also tried to establish a denominator to get an overall 
system performance. All devices have risks. Congress has 
actually established the balance point between the twin goals 
of improving public health via the availability of innovative 
devices and the safety that is so important to all patients. 
And that is, according to the statute, a ``reasonable 
assurance'' of safety and effectiveness.
    And so, my study attempted to determine whether that 
congressional standard had been met. My conclusion, based upon 
the data, is that the 510(k) system is meeting the 
congressional mandate, that it is overall performing very well. 
Greater than 99.5 percent of the submissions do not result in a 
Class I recall.
    More importantly, when you look at postmarket issues, more 
than half of all problems are from postmarket issues. And when 
you take that into account, it is greater than 99.7.
    We also did a subanalysis of the data a number of different 
ways looking at product types. What we found is that a 
significant majority of all recalls were caused by quality 
system issues, both premarket and postmarket, rather than a 
lack of clinical data.
    We also identified two concentrations of problems in 
recalls--one in AEDs, the other in infusion pumps--and the 
agency has, since then, commenced two initiatives to address 
those two product types. In my estimation, this is the type of 
data that can be used to improve the safety situation.
    Using this methodology, we did not find a significant 
difference in performance between the PMA and the 510(k) 
systems. There is a lot of other data analysis we can get into 
if the committee so desires.
    Moving to postmarket, the question that I am addressing is 
the authority the agency has. Others can address 
implementation. And I think it is clear if you look at the 
statutory authority, the agency has substantial authority in 
the postmarket realm.
    For example, they have the authority to mandate registries, 
whether a PMA product or a 510(k) product. They have the 
authority to mandate postmarket studies. They have the 
authority via Section 522 to have postmarket studies for 
certain types of products. So there are a number of authorities 
they have that are specific to products.
    They also have a wide variety of regulatory and statutory 
powers that apply universally. These are MDR reporting, recall 
reporting, inspections. And by the way, the agency can go and 
inspect a medical device manufacturer whenever the agency so 
determines. There is no requirement that they do anything in 
advance. They just show up.
    And so, the agency has substantial premarket and postmarket 
authority to implement whatever sort of postmarket obligations 
they believe. They have the authority, even in the 510(k) 
system, to get clinical data. And in about 10 to 12 percent of 
all cases, they require that.
    In terms of recalls, again, the agency has substantial 
statutory authority. There are obviously voluntary recalls, but 
they have mandatory recall powers. They can seize products. 
They can go public with any concerns that they have. They can 
ban products. They can withdraw products, et cetera.
    So, in conclusion, based upon the data that we have 
assessed, the 510(k) system is meeting the congressional 
mandate from the safety perspective, and the agency has 
substantial statutory authority in both the premarket and the 
postmarket arena, as well as in recalls.
    Thank you very much.
    [The prepared statement of Ralph Hall appears in the 
Appendix on page 81.]
    The Chairman. Thank you, Mr. Hall.
    Mr. Nexon.

  STATEMENT OF DAVID NEXON, SENIOR EXECUTIVE VICE PRESIDENT, 
ADVANCED MEDICAL TECHNOLOGY ASSOCIATION (ADVAMED), WASHINGTON, 
                               DC

    Dr. Nexon. Thank you, Chairman Kohl and Ranking Member 
Corker and members of the committee, for the opportunity to 
testify on behalf of the Advanced Medical Technology 
Association.
    We are proud that the U.S. medical device industry is an 
American success story. We employ more than 400,000 workers 
nationwide, including more than 14,000 in your home State of 
Wisconsin, Chairman Kohl. We are one of the few manufacturing 
industries with a favorable balance of trade. Our wages are 
well above average.
    A strong and vibrant medical technology industry is 
important to American growth and competitiveness. Most of all, 
it is important to American patients, who benefit from the new 
treatments and cures that our industry creates every day.
    The reason we are so interested in your hearing today is 
that we in our industry recognize that we can only succeed as 
an industry if FDA is a strong and successful agency. So we 
welcome your examination of these issues.
    I would like to make four main points for the committee. 
First, FDA has a strong record of assuring that medical devices 
and diagnostics are safe and effective. Professor Hall 
described his study showing extremely low recall rates for 
510(k) products, indicating that FDA and industry are generally 
successful in keeping unsafe products off the market.
    Other recent studies showed similar results, including one 
by Dr. Maisel. Recall rates are also very low for PMA products. 
Now I know you have heard some contradictory statistics today, 
and I would be happy to get into responding to those in the 
discussion period.
    Of course, every process can be improved. Nothing is 
perfect, and our companies and FDA share a commitment to 
safety. But I want to emphasize there is no indication, no data 
that shows systemic failures in the assurance of safety that 
the current premarket review systems provide.
    Second, the 510(k) clearance process has been criticized as 
a fast-track process that does not provide for adequate review. 
The data from the studies I mentioned show that this criticism 
is misplaced. In fact, the process is quite rigorous, but the 
data requirements are key to the nature of the device being 
reviewed and allow an effective path for rapid product 
improvement and medical innovation.
    I want to emphasize, and this is something not everyone 
realizes, that FDA can require any level of data that FDA 
thinks is appropriate for a 510(k) submission, and that can be 
up to and including clinical trials.
    Third, the biggest problem for FDA right now is the failure 
to assure that patients can have timely and consistent access 
to new treatments and cures. Since 2005, review times for 
510(k) products have increased by 45 percent. Review times for 
PMA products have increased a whopping 75 percent. Difficulty 
in getting approval to start a clinical trial, inconsistency in 
reviews, and slow approvals are drying up investments in 
promising new therapies, and they are driving clinical trials 
and first product introductions abroad.
    The result has been extremely negative for American 
industry's ability to compete. More important, it has been 
devastating for American patients, who must now wait 2 to 4 
years longer than European patients to get new treatments and 
cures.
    At the same time, the good news is that the Administration, 
from the President on down--and certainly the FDA leadership--
understands that there is a problem and is taking a number of 
positive steps to improve the situation. We are hopeful they 
will be able to turn this situation around, and it is critical 
from the industry's point of view and patient's point of view 
that improvements come quickly because the current situation 
really is not sustainable.
    Finally, let me address the postmarket issues. As detailed 
in my written testimony, and as Mr. Hall mentioned, FDA has 
robust postmarket authorities, including mandatory recall 
authorities.
    Turning to the issue of surveillance, Dr. Maisel's 
testimony describes the numerous efforts FDA has underway to 
improve the quality and timeliness of surveillance. The most 
promising, in our view, is the use of electronic medical 
records in conjunction with unique device identifiers.
    This will enable FDA to get real-time data on performance 
of individual devices across a large number of users and 
settings and will be invaluable to both FDA and manufacturers 
in identifying problems and targeting improvements. I am 
talking about the kinds of studies that Dr. Resnic identified.
    I do want to add, though, a word of caution with regard to 
attempts to rely on single-purpose registries as a major 
strategy for improving postmarket review. Registries offer very 
valuable data, not just on device performance, but other 
aspects of quality care. And AdvaMed is pleased that our member 
companies are partnering with the American Academy of 
Orthopedic Surgeons to create a hip and knee registry with 
close to universal coverage.
    But creating and maintaining single-purpose registries is 
labor intensive, costly, and requires a major commitment and 
leadership by providers since they are the ones that have the 
data on the performance of devices. In general, we think a more 
practical approach for most devices are registries based on UDI 
and electronic records, where data is collected as part of the 
normal course of doing business.
    Mr. Chairman, AdvaMed and its member companies stand ready 
to work with you and with the FDA to improve all aspects of 
FDA's device review and postmarket surveillance programs. 
Patients are our first priority, and we understand that our 
industry can only be strong when it partners with a strong and 
effective FDA.
    Thank you very much.
    [The prepared statement of David Nexon appears in the 
Appendix on page 107.]
    The Chairman. Thank you, Mr. Nexon.
    Mr. Maisel.

STATEMENT OF WILLIAM MAISEL, DEPUTY CENTER DIRECTOR FOR SCIENCE 
 AND THE CHIEF SCIENTIST, CENTER FOR DEVICES AND RADIOLOGICAL 
    HEALTH, FOOD AND DRUG ADMINISTRATION, SILVER SPRING, MD

    Dr. Maisel. Mr. Chairman, Ranking Member Corker, and 
members of the committee, I am Dr. William Maisel, Deputy 
Center Director for Science and Chief Scientist at the FDA's 
Center for Devices and Radiological Health.
    I appreciate the opportunity to be here today to talk about 
the actions we have taken and the actions we will be taking to 
enhance medical device safety and to meet our public health 
goals of assuring the safety and effectiveness of medical 
devices while fostering important innovations.
    I joined FDA's device center last summer while it was in 
the midst of arguably the most comprehensive programmatic 
review in its 35-year history. As part of that review, the 
center took a hard look at how we conduct our business, how we 
utilize new scientific information and make decisions, and how 
we can improve the health of American patients.
    We have responded by taking strategic steps to improve the 
predictability, consistency, efficiency, and transparency of 
our premarket evaluation and postmarket surveillance of medical 
devices and to strengthen our scientific decision-making.
    In January of this year, we announced 25 actions we would 
take in 2011 to strengthen the 510(k) process, including 
development of new guidance, enhancement of staff training, and 
clarification of when clinical data is required in support of 
device submissions. But these are not the only actions we are 
taking. We have been actively collecting and reviewing safety 
and effectiveness information for the 26 remaining Class III 
510(k) device types identified in the January 2009 GAO report, 
and we have committed to completing this evaluation and either 
reclassify to Class II or issuing a call for PMAs, for all 26 
device types by the end of 2012.
    Throughout the process of soliciting appropriate public 
input and conducting a thorough evaluation of devices with 
decades of marketing history, we have continued to promote 
device improvements and take actions to enhance the public 
health.
    For example, our analysis of recall and adverse event data 
identified cross-industry concerns affecting external 
defibrillators, one of the devices on this list. And we took 
action by spotlighting required design, manufacturing, and 
purchasing controls and by collaborating with the University of 
Colorado to establish a multi-city external defibrillator 
registry.
    We are also transforming the way we conduct postmarket 
surveillance. Medical devices present unique challenges for 
postmarket monitoring because of their diversity and rapid 
product evolution. In 2011, we will issue final rules to 
increase electronic adverse event reporting that will enhance 
our ability to perform data mining, use automated computer 
algorithms to more efficiently and effectively review adverse 
event reports, and establish the unique device identification 
system.
    This latter system will have a profound and positive impact 
on the Nation's ability to monitor medical device performance, 
reduce medical errors, track devices, and facilitate recalls.
    The agency has also taken action to strengthen and improve 
its recall process. We have improved internal tracking of 
device recalls and reduced long-overdue device reclassification 
decisions by over 50 percent in the past year. Our analyses of 
recall data have been used to target strategic use of our 
enforcement resources to identify poorly performing devices, 
manufacturers, or manufacturing facilities.
    We have also created a tool that better integrates analysis 
of pre- and postmarket data, including recall information, to 
provide our medical device reviewers with easier access to 
comprehensive information that spans the device's total product 
lifecycle. A similar tool has been made available to the public 
on the FDA's Web site, consistent with the agency's 
transparency efforts.
    Industry shares the responsibility for medical device 
safety and the success of our device review process. Data shows 
that some companies submit poor quality applications, ask to 
meet with us, and then ignore our feedback or conduct poor 
quality clinical studies.
    For example, a sample of 510(k) submissions from 2010 
showed that, among applications we were forced to place on 
hold, more than half lacked a basic adequate description of 
their device. In another sample of submissions that required 
multiple FDA requests for additional information from 
manufacturers, nearly 60 percent repeatedly failed to follow 
FDA published guidance or recognize published standards.
    These shortcomings waste valuable limited FDA resources and 
lead to unnecessary delays in the device review process. 
Nonetheless, under the 510(k) program, the pathway used for 90 
percent of the devices we examine each year, 90 percent of our 
reviews were completed in 90 days or less, and 98 percent of 
the reviews were completed in 150 days or less, as we committed 
to do under the Medical Device User Fee Act.
    FDA evaluates thousands of medical devices annually, and 
the vast majority of these devices perform well and improve 
patient health. We are taking actions to further strengthen our 
scientific decision-making, our premarket evaluation, and our 
postmarket surveillance of medical devices.
    The United States is the global leader in medical device 
development, and FDA's medical device center will continue to 
support this country's position as the leader in safety, 
medical device technology, and innovation, while we continue to 
make good on our commitment to promoting and improving the 
health of the American public.
    Mr. Chairman, this concludes my formal remarks, and I would 
be pleased to answer any questions of the committee.
    [The prepared statement of William Maisel appears in the 
Appendix on page 120.]
    The Chairman. Thank you very much, Dr. Maisel.
    Before we begin our questioning, I would like to call on 
Senator Bennet for a statement.

              STATEMENT OF SENATOR MICHAEL BENNET

    Senator Bennet. Thank you, Mr. Chairman.
    And I would like to thank you and the ranking member, 
Senator Corker, for holding this important hearing.
    I did want to come by and recognize Katie for coming here 
and testifying, not just the inconvenience, but the courage to 
come and testify on behalf of so many people across the State 
and across the country that have suffered through some of these 
issues.
    It is a balance that we need to figure out a way to strike 
in our State, and my statement speaks to that. But your voice 
is very important to this conversation. So thank you for being 
here today.
    Thank you, Mr. Chairman.
    The Chairman. Thank you very much, Senator Bennet.
    Katie, again, we will start with you. In light of your 
difficulties, we would like to know what advice you have to 
give to people who are facing their first procedure.
    Ms. Korgaokar. Honestly, right now, it scares me because I 
thought I was making the right decision with the doctor I 
chose. But I don't know what advice to give.
    The Chairman. If you were starting over, what kind of 
precautions might you have taken?
    Ms. Korgaokar. I don't know that there is any I could. I 
mean, I researched the doctor. I picked him because of his 
standing, and the device he put in, I just had faith in it. I 
don't know what I, as a patient, could have done to prevent 
this.
    The Chairman. What advice would you give us? As we have 
this hearing and we are trying to install some procedures, some 
ideas, some thoughts, what advice would you give us?
    Ms. Korgaokar. Well, I definitely think that there needs to 
be a balance. But it still blows me away that something that 
goes into somebody's body can get approved without proper 
testing. And frankly, at least for the hips, there were hips 
that were in place that proved themselves to be good. But this 
state-of-the-art one that he put inside me, I don't understand 
why it couldn't have been tested properly and then come out 
when they knew it was good to go.
    The Chairman. So you are saying we need to do a lot more 
testing, moving forward?
    Ms. Korgaokar. Yes.
    The Chairman. To be certain that what goes inside someone's 
body is absolutely safe?
    Ms. Korgaokar. I absolutely agree with that, especially 
having to go through a second surgery.
    The Chairman. Okay. Marcia Crosse, you noted that one major 
problem in conducting recalls was finding the devices. In 
conversations with committee staff, Johnson & Johnson discussed 
the difficulty of locating all of the recalled hips that were 
implanted in patients. Some are hard to track down.
    How is it that innovative device firms cannot locate some 
customers or users? Would FDA's proposed unique device 
identifier or some similar mechanism help fix this problem?
    Dr. Crosse. Well, we are looking at the unique device 
identifier initiative that was required under the FDA 
Amendments Act, and we will be reporting on that in our 
forthcoming report on device recalls. It certainly could help, 
but it is not something that is going to be simply accomplished 
or quickly accomplished because it is very complicated.
    You think about all the bar codes that exist on products in 
your grocery store or your drug store, and that is the same 
concept here. But you can't really have a bar code that is 
going to be in somebody's body. So you have to have some other 
mechanism for tracking that device and getting it into the 
proper records, and certainly registries are one approach that 
could be used.
    But you also have to think about whether or not every 
physician's office, every hospital is going to have the 
equipment, the systems in place to be able to use any kind of a 
consistent approach and the variety that you would have to have 
for things that come in boxes of a dozen, as opposed to an 
individual device that might be implanted in somebody's body.
    So it is not simple, and it is not going to happen quickly. 
It can help.
    The Chairman. Okay. Before we turn to Senator Corker, I 
will ask you, Diana, a question of a lot of conflicting data 
was presented here about the fast-track 510(k) process and 
whether it should be changed. You have studied the medical 
device approval system for a long time. In your opinion, what 
is the most critical medical device approval issue that FDA 
needs to address?
    Dr. Zuckerman. Oh, that is a tough one. I think that 
actually what Katie said cuts to the core of the issue, and I 
should say I also had the pleasure of having a hip replacement 
last year. So I can speak as a patient, too.
    Here I have all this knowledge. I knew to look on PubMed 
and all the published medical journals. But there were no data 
on different hips and which ones would last longer and which 
ones are better. No data were available at all except some 
registry data from Scandinavia, and those were on particular 
models that aren't sold in this country.
    So I really was stuck with no safety data. And the one 
thing you can do that Katie has done after her surgery is find 
out if your doctor has taken a lot of money from a company. And 
that can make you more suspicious, but it doesn't tell you 
whether the doctor is any good or not.
    So, to me, the problem is it is not that all medical 
devices should go through a PMA process. I am not saying that. 
What I am saying is if you have an implanted medical device, 
doesn't it make sense to do a clinical trial first, to test it 
on a human being?
    And when we look at the high number of recalls, if you look 
at moderate risk as well as high-risk recalls--we didn't look 
at the low-risk recalls--how many of them there are of 510(k) 
products, as well as PMA products. But you expect high-risk 
recalls for a PMA because those are high-risk devices. If 
510(k) devices are supposed to be moderate and low risk, they 
shouldn't be killing people.
    So if you hold devices to a higher standard of having 
clinical trials beforehand and inspections, whether the FDA has 
the authority to do it or not, they haven't done it. And the 
tradition has been not to do it. And if your law doesn't 
require it, if it says ``may'' instead of ``shall,'' everybody 
in this room knows what that means.
    So you have to have a standard that is high enough to 
protect patients. And yes, that will slow things down, but it 
would also have slowed down what happened to Katie. Had that 
hip been subject to clinical trials, most likely they could 
have done the blood tests and found out about the problem prior 
to putting it on the market. At the very least, if not prior, 
then more quickly after it went on the market.
    So studies, clinical trials, either beforehand or as a 
condition of approval are the most critical issue. I don't 
think postmarket should take the place of premarket. I think 
you have to have the studies premarket for anything that is in 
the human body or life-sustaining or lifesaving, but then also 
have protections afterwards.
    The Chairman. Thank you.
    Senator Corker.
    Senator Corker. Thank you, Mr. Chairman.
    Just to follow on with that line of thinking, Mr. Hall, if 
you look at the situation Katie just talked about and Dr. 
Zuckerman just discussed, should there be testing of that type? 
Or what was it, in the case of Katie, that caused this 
particular issue to be a problem?
    Mr. Hall. Senator, I am not conversant with all the details 
of the ASR situation. So I can't comment specifically on that.
    What I can say is that, from the data that I have seen, and 
I think it is consistent across the board, quality systems, 
QSRs, quality system regulation, is the key way to have the 
greatest positive impact on device safety as compared to other 
things. And in our data, 90 percent of all recalls were because 
of quality system.
    And it is important to understand that quality systems are 
not just manufacturing. It is total product lifecycle. It 
begins with design, design input, design validation, bench 
testing, manufacturing, postmarket surveillance, et cetera. So, 
hopefully, quality system requirements would be the best way to 
identify these issues.
    Senator Corker. The two of you, I know that you all are on 
different ends of the spectrum. Your numbers are quite 
different. I mean, you are at 98 and 99.5. And you are at 60 or 
80.
    Since, obviously, I would say that Dr. Zuckerman is 
challenging your numbers, would you want to respond to that? I 
mean, it is a pretty vast difference. We are not talking about 
a percent or two.
    Mr. Hall. Sure. Let me make a couple of comments. When you 
look at the differences in the study, there are several key 
differences.
    First of all, we looked at the reason for the recall, and 
the study that Ms. Zuckerman referenced did not. We think that 
is critical because many recalls, the majority have nothing to 
do with the premarket system. And so, to use premarket, to 
analyze the premarket system using recalls that have nothing to 
do with the premarket system creates a results that has little 
validity.
    Secondly, the study, our study used a denominator. Theirs 
did not. I think what you heard from the GAO is that the ratio 
of PMA to 510(k) devices is 1-to-10 or 1-to-9. The study, both 
of the studies--and interestingly, we start with the same 
dataset, around 112, 113. You have a 4-to-1 ratio approximately 
of 510(k) recalls, all cause, compared to PMA. That is not 
surprising, given the 9-to-1 ratio that we start with.
    Next, we also do not consider that the recall 
classification should be linked to the approval classification. 
Those are two separate questions. For example, you can have a 
very low-risk device that because of the particular issue has a 
very high risk to it.
    And finally, if you look at the study that they reference, 
it contains a number of incorrect, inaccurate statements about 
the 510(k) and the PMA status and the law. What our study 
attempted to do was to look at the relevant data, recalls for 
premarket reasons, looking at Class I high safety issues, and 
with that then try to understand how the system is operating.
    Dr. Zuckerman. Yes, thank you----
    Senator Corker. Is there any validity in the argument he 
just put forth?
    Dr. Zuckerman. Sure. I would like to correct a couple of 
things he said. I used your denominator Mr. Hall. Using your 
same denominator of 20,000 and using the same numerator--sorry 
to get into this technical stuff--of recalls. You didn't look 
just at the recalls that were premarket due to design issues. 
You looked at all the recalls that were high-risk recalls.
    The difference in the statistics, the huge difference 
between 99 percent and 60 percent or 80 percent has to do with 
whether you count the moderate-risk recalls. You looked only at 
high-risk recalls and you say that any device that was 
submitted to the FDA--not even approved, but submitted--is your 
denominator, and your numerator is only the high-risk ones. If 
you are assuming that if it wasn't a high-risk recall, it is 
safe, then you get 99 percent.
    But if you consider that a moderate-risk recall also means 
a product is not safe because, as in the case of Katie's hip, 
that is a moderate-risk recall. There were over 170 knees and 
hips and joint components recalls, involving hundreds of 
thousands of devices in the last 5 years that are all moderate-
risk recalls, but all require additional surgery or rehab, or 
have other problems. If you count those moderate risk recalls, 
then it goes down to 60 percent if you use the numbers we used 
for recalls, or to 82 percent if you use GAO's numbers.
    We respect GAO's numbers. Ours differ because we looked at 
specific models, model numbers, and the GAO combined model 
numbers of the same device. So there are different legitimate 
ways to look at it. I am saying that I don't think that a 
device is safe just because it is not subject to a high-risk 
recall. A moderate-risk recall can cost $35,000 and a lot of 
pain to fix.
    Senator Corker. Dr. Maisel, and it is interesting, it seems 
that you have a patient here on the panel. You have a sort of 
more trial bar orientation on the panel. You have sort of the 
device orientation on the panel. And nobody is particularly 
happy with the FDA. And I don't know whether you consider that 
to be success--you know, a lot of times here if everybody is 
mad at you, you have kind of hit the sweet spot--or whether 
that is tremendous failure.
    I wonder if you could discuss that because, candidly, I 
don't know of anybody that is particularly happy with the FDA. 
And I am wondering if you are seeking anything from us to 
change that or if you might respond to the fact that I don't 
think anybody on this panel is really thrilled with you guys.
    Dr. Maisel. Well, Senator, thank you, first of all, for the 
opportunity to be here today and to comment.
    And I would like to personally thank Ms. Korgaokar for 
taking the time to be here and for her compelling story.
    I personally have practiced medicine for 19 years and sat 
in rooms with patients who, unfortunately, had recalled medical 
cardiac devices that also sometimes require surgery to remove. 
So I am very familiar with what patients experience and the 
challenges that physicians experience when trying to help their 
patients.
    We conducted a very thorough programmatic review over the 
last 18 months, and we have identified areas that we think need 
improvement. We would like to deliver more consistency and 
transparency in our decision-making. We would like to 
strengthen our science-based decision-making, and we have 
outlined a number of actions that we have already started 
taking to strengthen the program.
    I think one critical factor here is that we believe that 
smart and focused changes are appropriate. For example, one 
area is focusing on the Class III 510(k) devices that have 
already been identified by the GAO and that we are actively 
working on and have committed to either reclassifying or 
calling for PMAs.
    In Dr. Zuckerman's study, 13 of the 80 recalls that she 
highlights are in that group. So we certainly recognize that 
there are some focused areas we need to evaluate and 
strengthen.
    I am not going to get into the war of numbers to my right 
over here, other than to say as part of the IOM committee 
evaluation that is underway, there was detailed FDA data 
presented that was based on all of the recalls, not just one 
class or another, and showed a 510(k) recall rate of 
approximately 1 to 1.5 percent per year.
    So, from an agency standpoint, I think we find that the 
most reliable data. And that is publicly available, or we would 
be happy to provide that analysis for you.
    I do think that a number of the challenges we face in 
postmarket monitoring have been outlined here, and there are 
some unique issues with devices that are different than drugs 
that are worth mentioning. Number one, it is sometimes very 
difficult to even know whether an adverse event is due to the 
device or due to the surgical procedure that was used to 
implant the device.
    Now in the case of the hips, that wasn't the issue. But 
sometimes, based on some of the data we get, it is not so clear 
whether the device is malfunctioning or whether it is a 
complication of a medical procedure. Oftentimes, the adverse 
event reports we get are cryptic and don't contain enough 
information. Sometimes we don't even know what device or what 
model of device has caused the problem.
    And so, we think that the changes we are implementing with 
electronic medical device reporting of adverse events and with 
the unique device identifier system will really revolutionize 
the way that we can perform postmarket surveillance.
    With regard to hips in particular, we have also undertaken 
efforts to form an international consortium of orthopedic 
registries. And in fact, in the Federal Register today is the 
notice for a meeting that is occurring next month where 
representatives of more than a dozen orthopedic registries from 
around the world, including from the UK, Australia, and other 
countries, come together so that we can make a better system 
for monitoring these important products. And other efforts will 
be underway as well.
    Senator Corker. I know we have other folks that have 
questions. I have a number of other questions. I thank all of 
you for your testimony.
    The Chairman. Thanks, Senator Corker.
    Senator Blumenthal.
    Senator Blumenthal. Thank you very much, Mr. Chairman.
    I want to thank Senator Kohl for having this hearing today 
on this critically important topic and Senator Corker for your 
leadership as well.
    You know, let me just state very bluntly, my time is 
limited, and I want to ask some additional questions as well. 
But my experience as a State law enforcer for 20 years leads me 
to conclude, particularly my interaction with patients like 
Katie Korgaokar--and thank you for your courage in being here 
today--that this system simply isn't working. It is inadequate. 
It is broken, needs to be fixed. And I thank Dr. Maisel for 
your recognition, the agency's recognition that the system 
right now is not performing acceptably to protect people from 
unacceptable levels of risk and injury.
    I am reminded of the statement that a minor procedure in 
surgery is something done to somebody else's body. And a minor 
risk of severe injury, when we are talking about these kinds of 
devices, is something that happens to somebody else.
    So I think there are a range of areas that really need very 
close scrutiny and action. I mean action now, immediately--not 
postponed to the future--that have to do with the need for 
clinical trials more often, more thoroughly. Instead of the 
expedited 510(k) procedures when it is currently used, the need 
for more robust postmarket surveillance and quicker action so 
that the doctor who may have believed in good faith that 
Katie's device worked and would not cause the kinds of metals 
released into her system that happened can be warned about it 
more quickly and can be compelled--through proper incentives, 
liability, if necessary; heightened penalties--to stop using 
that kind of device.
    And let me just ask Dr. Maisel whether the FDA is prepared 
to expedite the kinds of improvements that you have been 
discussing here today and what can be done to expedite them and 
whether there needs to be action from the Congress to expedite 
them?
    Dr. Maisel. Well, I thank the Senator for your question.
    We have exerted a considerable amount of our resources and 
manpower over the last 18 months to evaluate the program 
because we recognize how important it is to the American public 
and their health. We are expediting a number of efforts. We 
outlined 25 actions we are taking in 2011 that will be 
completed in 2011. These aren't actions that we are talking 
about over the next 5 years or 10 years. These are things we 
are doing right now to improve device safety for the American 
public.
    They include things like issuing guidance on what type of 
changes to devices require clinical data. They include things 
like training our staff and industry so that the quality of the 
submissions we get and the quality of the reviews can improve. 
We are taking actions in the postmarket surveillance setting as 
well.
    So in answer to your question, I would say we are 
expediting a number of these changes. Now other changes 
admittedly take time, such as the implementation of the unique 
device identifier. We are issuing a final rule this year. We 
have been talking with industry and stakeholders about the 
implementation of that because it is a sea change in how we 
will conduct business.
    And so, it will be implemented in phases, focusing first on 
the highest-risk devices. So, again, in answer to your 
question, we are expediting the changes to the program that are 
necessary.
    Senator Blumenthal. And what can we do to encourage those 
kind of changes so that there is a consistency and a 
steadfastness in implementing them and so that they are even 
accelerated?
    Dr. Maisel. Well, I think, in all seriousness, you took a 
very good step this week in passing a budget for FY 2011 or the 
continuing resolution.
    Senator Blumenthal. Do you need more staff? Is that the 
problem? You know, by the way, when I say the system isn't 
working, I am not talking about the people who work with you 
and for you, because the system is not of their making. But I 
am wondering whether more resources are the problem?
    Dr. Maisel. Well, the number of device submissions that we 
have to evaluate has increased, and the complexity of devices 
has increased. And we are a strained organization.
    We certainly appreciate the funding, and we are in 
negotiations for reauthorization of the Medical Device User Fee 
Act that will be coming before Congress in Fiscal Year 2012, 
and through that process, we will certainly make clear what our 
needs are so that we can have the strongest possible 
organization.
    Senator Blumenthal. Thank you very much.
    I thank everyone here for your testimony. My time has 
expired. I am hoping to stay for another round of questionings.
    Thank you, Mr. Chairman.
    The Chairman. Thank you very much, Mr. Blumenthal.
    Senator Ayotte.
    Senator Ayotte. Thank you, Mr. Chairman.
    Dr. Maisel, I just wanted to follow up. You had mentioned 
an Institute of Medicine study on the safety of the 510(k) 
process and looked at all classes of recalls. Before you joined 
the FDA, did you participate or assist in that study?
    Dr. Maisel. I was commissioned by the Institute of Medicine 
prior to my joining FDA to conduct a study on recalls for the 
510(k) program.
    Senator Ayotte. So that Institute of Medicine study which 
you looked at that came up with an overall range of 1 to 1.5 
percent in terms of the recall rate, is that one you have 
confidence in?
    Dr. Maisel. I have confidence in that study, yes.
    Senator Ayotte. First, I'd like to address questions both 
to Dr. Nexon and Dr. Maisel. There was a study that I am 
familiar with that was done called the Makower study which 
found that the United States is at risk of losing its global 
leadership position in medical technology innovation.
    The study found that the unpredictability and 
inefficiencies of the U.S. regulatory process are making it 
difficult for companies to get life-changing medical products 
into the hands of clinicians and patients. On the other side, 
as Senator Blumenthal mentioned, there is the piece of ensuring 
safety, but also getting these products that can save lives in 
the hands of patients in an appropriately expedited fashion.
    One of the issues I raised in my opening statement is that 
some studies that have, are saying that, on average, devices 
are available to United States citizens two full years later 
than patients in other countries.
    So I guess I would direct my question to both of you, 
really to Dr. Nexon. What can we do to improve the regulatory 
processes and increase patient safety at the same time to be 
competitive with other countries? I would hate to have us be in 
a position where we cede our global leadership in this area or 
deny patients access to technology that could be lifesaving.
    Dr. Nexon. Well, thank you very much for your question, 
Senator.
    I think there are a couple of steps that need to be taken. 
FDA has identified a number of them themselves in their review 
of the 510(k) process and their new science reports. There 
needs to be better training of reviewers. The study revealed 
that large proportions of reviewers didn't have understanding 
of the basic regulatory terms.
    There needs to be greater guidance and consistency for 
industry so that when industry submits a product for approval, 
it knows what the data standards are and then doesn't find out 
after the submission is in that they had to redo the trial 
because they didn't get clear guidance in advance of what FDA 
expected.
    There needs to be better management at FDA just to enforce 
consistency of review and that their speed of review--the FDA 
recently did an analysis where they found out that one of the 
greatest sources of delays in PMA products, getting PMA 
products approved, was a situation where the reviewer would 
change in the middle of the review, particularly if the lead 
medical reviewer went on vacation. You know, that is a 
management issue to schedule vacations better or to see that 
there needs to be specific attention to cases where those 
things occur.
    There is a huge problem in terms of the IDEs, the 
investigational device exemptions, which you need to get before 
you can ever begin a clinical trial that involves human 
subjects. And it takes an inordinate amount of time to get 
those approved. Sometimes it is a matter of years before you 
can even start the clinical trial, six months or more to get a 
meeting with FDA to discuss the nature of the trial.
    So I think that there are a number of steps that FDA needs 
to take to really make the process work better for companies 
and for the agency. I think this will help the agency as well 
if there is more consistency and better management of reviews.
    I don't think that there are fundamental changes that need 
to be made in sort of the legal structure or the requirements 
for different types of devices. I think those are pretty well 
set out, and it is a matter of applying them consistently and 
using good judgment when a device comes in for review.
    And where there are problem areas identified, and there 
have been. Dr. Maisel, I think, alluded to--or Professor Hall 
alluded to AEDs and infusion pumps. They found specific 
problems from their reporting system, and they instituted new, 
very clear requirements for those products.
    Now whether the industry agreed with all those requirements 
or not, it is a case where the FDA saw a problem, took action, 
and they did it in a way so that industry knew what was 
expected of them for the future.
    Senator Ayotte. Dr. Maisel, I would appreciate your comment 
on this. The other follow-up would have for both of you is, in 
looking at the comparisons with European approval versus the 
United States, is there an issue in terms of discrepancy in 
safety that we should be looking at? Safety is obviously 
important to consider as well.
    Dr. Maisel. Yes. So the Makower study that you referred to 
surveyed a very small percentage of the medical device 
industry. They got about 200 respondents out of a device 
industry that includes more than 10,000 individual companies. 
So we have to understand that this is a very biased, small 
representative study.
    There was another study put out by the California Health 
Institute that looked at the review times for the U.S. compared 
to the European community. And for the 510(k) program, which is 
90 percent of the devices that are reviewed in the U.S., the 
U.S. was faster and the device got to market sooner for the 
low-risk devices. It was about the same for the medium-risk 
devices. And for the high-risk devices, the EU was faster than 
the U.S.
    So we need to understand what the issues are and what the 
timing is, and it is I think not accurate to say that every 
device gets to the EU market more quickly. I think the hip 
example is a great example because there were actually two hips 
that were recalled by DePuy. Both were on the market in Europe. 
Only one of them was on the market in the U.S.
    And so, the ``delay'' in getting products to market in the 
U.S. is not necessarily a bad thing for products that aren't 
performing well, if we are asking for more rigorous data to 
support their approval.
    Senator Ayotte. I just wanted to add, obviously, I haven't 
done a scientific study, but just in speaking to many 
companies, particularly startup companies, large and small, 
I've been getting similar feedback in terms of concerns about 
where they are going to locate their companies and where they 
are going to develop new products. And so, that is where I come 
from in asking those questions.
    Dr. Maisel. And I think it is a great point, and we have, 
earlier this year, announced our innovation initiative, which 
is a comprehensive program to try to promote device development 
and innovation in this country, by strengthening the research 
infrastructure within the United States, identifying clinical 
trial centers that are particularly expert in medical device 
development. And we certainly recognize the importance of that 
as well.
    Senator Ayotte. Dr. Nexon, you had a comment?
    Dr. Nexon. Yes, if I could just add a couple of things. I 
mean, the Makower study has come in for a lot of criticism from 
FDA. It was really a pretty large sample of companies. Two 
hundred small companies is a lot of companies reporting on 
almost very similar experiences.
    It is also only one of three studies that has looked at 
this issue. There was a study at PricewaterhouseCoopers that 
used a different sample, primarily a large company sample, that 
found that the U.S. ranked seventh out of nine countries in the 
speed of regulatory approval.
    And then there was also the California Health Institute 
study, which was just mentioned, which did find a substantial 
lag for the more complex devices and more innovative devices 
which are really the ones that are greatest issue for 
competition. So I think there is a big problem.
    It is also the case that there was a study by the Boston 
Consulting Group, which was the only systematic study I know of 
the relative safety of the two systems, and found that the 
recall, incidence of recalls was about the same in Europe and 
the United States. Didn't seem to be much difference.
    Now we are certainly not advocating for a European system 
of review. As Jeff Shuren, the head of the center, said, there 
is no inherent reason why the U.S. system has to be slower than 
the European system. And what the California Health Institute 
study showed that I think it was six years ago, on average, it 
took a year longer to get a product to patients than Europe. 
Now it takes four years longer. We ought to be able to do 
better than that.
    And I can tell you my own experience when I am telling you 
this is not systematic, but it is from talking to lots of 
companies and lots of particularly of venture capitalists who 
invest in small companies that the problems at FDA are a huge 
deterrent.
    I had one venture capitalist tell me that he was a fellow 
who has got investments in seven or eight small device 
companies. He used to take a case where he had an engineer, a 
doctor, and an idea, and he would be able to put money so they 
could bring that idea to fruition into products that would 
benefit patients.
    Now his investors, which are often big pension funds, won't 
allow him to invest in any company that hasn't already got an 
FDA approval because the uncertainties of the approval process 
are so great. And that is not a system we can sustain if we are 
going to maintain American leadership.
    Senator Ayotte. I would add to Senator Blumenthal's 
question to you, Dr. Maisel, obviously to ask the committee how 
you think that we can help by taking action and to improve the 
process. And I would follow up to ask you, Dr. Nexon, do you 
have any thoughts in terms of whether there is a legislative 
fix that is needed?
    Dr. Maisel. Well, again, as I stated earlier, I think we 
are an increasingly busy center with an increasing number of 
applications and increasing complexity of devices. We have 
certainly committed to strengthening our scientific evaluation 
of these products, and the continued support from Congress for 
our program, as you have done, is certainly welcome.
    Senator Ayotte. Do you have anything to add, Dr. Nexon?
    Dr. Nexon. Yes, I think the fundamental legislative 
structure is pretty sound. So I don't think additional 
legislation is required. I do think, as Dr. Maisel has pointed 
out, you need to maintain at least stable funding for the FDA, 
even in this time of tight budgets, if they are to meet these 
challenges.
    And I think that the key really is the kind of attention 
that this committee and other members of Congress show to the 
FDA is important really to give it a priority. We were very 
heartened by the President's op-ed on the importance of 
streamlining regulations, and I think he even mentioned in the 
State of the Union the device industry as one area where FDA 
needed to do well if the United States was to remain 
competitive.
    And I think those kinds of comments and that kind of 
attention is very helpful for the industry, and I think it is 
helpful for FDA to show that their work is valued.
    Senator Ayotte. Thank you both, and thank you all for 
coming to testify today. Appreciate the insight that you have 
given this committee.
    The Chairman. Thank you, Senator Ayotte.
    Senator Wyden.
    Senator Wyden. Thank you, Mr. Chairman.
    And without making this a bouquet-tossing contest, let me 
just tell you how much I appreciate particularly your tenacity 
in being willing to stay at these issues, and this is an 
important hearing.
    Dr. Nexon, let me start with you. The longer that I am 
involved in the issues of public policy and healthcare, the 
more convinced I am that transparency and getting good 
information out to the public is one of the most important 
steps we can take as public officials. In terms of creating 
choice and competition and holding costs down, it is one of the 
best steps we can take.
    For example, recently Senator Grassley and I introduced 
legislation that would allow, after 30 years, the opening up of 
the Medicare database so as to get information to the public 
about various claims and patterns. And as you know, there have 
been some extraordinarily abusive practices, and we have worked 
with the Center for Public Integrity, and Wall Street Journal 
has done yeoman reporting on this.
    I want to ask you about how it relates to another matter, 
and it was triggered in my mind by a letter that the Group 
Purchasing Association wrote recently. And essentially, what 
they are concerned about, their assertion is the drug 
manufacturers enter into relationships with--excuse me, device 
manufacturers enter into relationships with doctors. These 
relationships are protected through what amount to gag clauses, 
contractual confidentiality agreements, and this prevents 
hospitals, according to them, from disclosing the price they 
pay for a device.
    And their assertion is that, when you have these gag 
clauses, you go right to the heart of what I am talking about. 
There is no price transparency, and people aren't going to be 
able to look at the cost of various medical devices. And third-
party groups can't find out. Patients can't find out. It is a 
very vexing problem.
    So my question to you is--and you can tell me what you 
think of the Group Purchasing Association--what would you think 
about the idea of opening up and releasing price data on 
purchasing agreements to the public? It is Government money. 
There is Government money involved here.
    Senator Grassley makes the point, colleagues, that I think 
is really the ballgame. Senator Grassley says people know about 
its farm payments. They know about defense contracting 
payments. He says we have got to find out this claims 
information.
    So tell me what you think about the idea of industry 
opening up and releasing price data on purchasing agreements.
    Dr. Nexon. Well, we are generally in favor of transparency. 
We are strongly in favor of releasing quality data to the 
American people. We think the FDA should be more transparent. 
We supported Senator Kohl's Physician Payment Sunshine Act 
because we think that was good for the public and good for the 
industry.
    I will say, however, we are strongly opposed to releasing 
pricing data, and let me tell you why. Because it has to----
    Senator Wyden. So your position, though, is everybody else 
ought to have their data released, but you all wouldn't----
    Dr. Nexon. Well, no, the fact is--the sad fact is, Senator, 
that, when you are talking about commercial transactions 
between institutional buyers, there are often confidentiality 
clauses. It is not unique at all to the device industry.
    Auto manufacturer sells a car to a dealer, you know, what 
the prices and the discounts he provides are not generally 
available to the public. And that is true with many large 
transactions.
    It is important to remember that the Government in the 
Medicare program--it is not true in something like the VA--and 
the public do not buy medical devices directly. Medical devices 
are bought largely by hospitals, large institutional 
purchasers, and then, when a patient goes to the hospital, he 
pays a price for a procedure which includes in some sense the 
cost of that device. But it is not that he is buying the device 
directly or necessarily that the price he pays has anything to 
do with the price the hospital negotiates for that device.
    As a patient, I want to know what I have to pay. I am not 
concerned with what the hospital pays for electricity or 
gasoline or some other component of the procedure.
    Now the question is if we release that price data, would it 
have a positive effect for the public or not? And the fact is 
that the current arrangements, which involve negotiations 
between relatively sophisticated buyers and relatively 
sophisticated sellers, have created an extremely competitive 
industry.
    There has been a study by Guy King, the former chief 
actuary of the Medicare program, of prices in the medical 
device industry. And what he found was that, over an 18-year 
period, our prices have gone up one-quarter as fast as the 
typical medical price indexes, so one-quarter as fast as 
everything else in the healthcare sector.
    And we have gone up half as fast even as the general CPI, 
which, as you know, has been quite low in recent years. So we 
have a pretty good record of keeping prices low through 
competition under this negotiation between informed buyers and 
informed sellers.
    There have also been studies, a study that was done by Bob 
Hahn and another--Bob Hahn is a regulatory specialist. And 
there is concern that if the prices were released not only 
would it inhibit our ability to enter negotiations, but it 
might end up resulting in actually higher prices paid across 
the board because of antitrust issues.
    Senator Wyden. I can tell you certainly with the example 
you gave of automobile companies and manufacturers, you are 
talking about private sector money. Here, despite the kind of 
chain of purchasing you have described, there is a lot of 
Medicare money.
    I have other questions I want to ask, but my sense is that 
the Group Purchasing Association at least warrants our looking 
at these confidentiality agreements. These are gag clauses, and 
they prevent hospitals from disclosing the price that they pay 
for a device. I think that is right at the heart of it, and I 
think it warrants some further attention.
    One question for you if I might, Dr. Maisel. What is your 
sense about the FDA review process and making it more 
transparent as you go forward with striking the balance between 
safety and speedy approval?
    Dr. Maisel. Well, as you know, FDA is very interested in 
providing transparent information to the American public, and 
we have an ongoing transparency initiative. And that carries 
over to the Center for Devices, where we have posted a variety 
of documents and provided access to public data increasingly 
over the last years.
    For example, as I alluded to earlier, there is now a public 
Web site where you can go and type in a device type and find 
out about all the recalls and adverse events that have been 
submitted for that type of device.
    We are bound because we do deal with confidential 
commercial information. So there are some limitations on the 
type of information that we can provide to the public. But we 
are certainly interested in providing decisional information as 
much as possible and have done so.
    Senator Wyden. All right. Thank you.
    Thank you, Mr. Chairman.
    The Chairman. Thanks, Senator Wyden.
    Senator Bill Nelson.
    Senator Nelson. Thank you, Mr. Chairman.
    I want to ask you two gentlemen, Dr. Maisel and Dr. Nexon, 
if you would comment on the tension between safety and the need 
to innovate new technologies. This industry is real big in my 
State, and I would like to get your two perspectives.
    Dr. Maisel.
    Dr. Maisel. We often talk about it being a tension, but it 
doesn't have to be a tension. A good device evaluation for an 
innovative product promotes safety. There can be innovative 
devices that improve safety. So there is a tension in the sense 
that longer evaluation of devices that requires more data has 
the potential to slow down getting an innovative product to 
patients. And if that product would improve public health, then 
taking a longer time actually has a net negative impact on the 
public health.
    So that is the tension. The tension is striking the right 
balance in our risk analysis so that we can get a product to 
market to help patients in the right time.
    Senator Nelson. Dr. Nexon, you are sitting on the other 
side and----
    Dr. Nexon. Well, I actually agree with Dr. Maisel. I think 
there is a balance to be struck. I think the balance in the 
law, which Professor Hall mentioned, a reasonable assurance of 
safety and effectiveness is a reasonable standard. Device 
manufacturers should be held to a high standard of safety.
    They should be able, before a device goes on the market, to 
present the data that gives a reasonable assurance that their 
devices will be safe and effective. The problem is that 
sometimes that can be interpreted in a way that makes the bar 
so high that products that can save lives or improve health 
don't get to market because test after test is required.
    But we have no disagreement with the general approach that 
FDA takes. What we want is consistency, rapidity, ability to 
get answers, and reasonable standards, and I think those are 
goals that FDA and the industry share. And in the public, too. 
The patients as well.
    Senator Nelson. Do you think there are undue delays?
    Dr. Nexon. Pardon me?
    Senator Nelson. Do you think there are undue delays in the 
approval?
    Dr. Nexon. Yes.
    Senator Nelson. Amplify.
    Dr. Nexon. Well, as I think before you came in, I mean, 
what we have seen is a very severe deterioration in FDA 
performance over the last five years, and performance was not 
super before that. The time it takes in terms of elapsed time, 
not time on the FDA clock. The time, a recent study by the 
California Health Institute showed that the time it takes to 
get a 510(k) product approved has increased 45 percent since 
2007, and the time it gets to get a PMA product approved has 
increased a whopping 75 percent. And that is from a base that 
was really not that fast to begin with.
    And beyond the actual approval times, particularly on these 
more complex devices, we are finding a terrible difficulty. Our 
companies are finding terrible difficulty in getting in to see 
FDA so they can even agree on a protocol so they can do the 
clinical studies necessary to support an application.
    I have been around this industry for many, many years, 
first with Senator Kennedy and then in my current capacity. And 
I have never--in talking to the companies, I have never seen 
the degree of angst and upset that we have right now. You 
always have a certain amount of griping between the regulated 
industry and the regulators. But it is really immense right 
now, and I think that FDA recognizes the problem and is working 
hard to do something about it. But it really does need to be 
fixed.
    Senator Nelson. Is there earlier testimony on the record as 
to the increased cost as a result of these delays?
    Dr. Nexon. We don't have a solid cost estimate of the 
change. The closest thing we have got is the Makower study, 
which we would be happy to submit for the record, that tries to 
do some estimates of the cost of the additional time that FDA 
takes, imposes on companies.
    But there are some--it is a difficult question to answer in 
terms of cost.
    Senator Nelson. Dr. Maisel.
    Dr. Maisel. Well, I guess I would take issue with the 
characterization of our performance as a ``severe 
deterioration'' because the numbers simply don't support that. 
We have continued to meet 95 percent of our MDUFA goals, 
meeting the time that we have agreed to and industry has agreed 
to for our device evaluations.
    As I mentioned earlier, 90 percent of the time we review 
510(k) applications within 90 days, 98 percent of the time 
within 150 days. Our PMA Tier 1 MDUFA goals, we have met. And 
so, I agree that the total time to market has increased. FDA's 
evaluation time has continued to meet its performance goals.
    And so, what that speaks to is partially a quality issue. 
The quality of applications that we receive is sometimes 
substandard, and that takes time for industry to respond to 
requests from FDA staff to complete an application 
appropriately.
    There is no question that, for some of the devices, the 
complexity has increased. And, undoubtedly, that contributes as 
well.
    Dr. Nexon. Well, I think Dr. Maisel made a good point, 
which is that there is a difference for time on the FDA clock, 
which is where the current goals are set, which is the time an 
application is in the hands of the FDA and it has not been sent 
back to the manufacturer to answer additional questions or 
provide additional data. The clock stops when that occurs.
    From the point of view of the manufacturer, the point of 
time on the FDA clock isn't really important. It is the time 
between when you submit the product and the time you get it to 
market. Now, obviously, FDA often has legitimate questions. But 
the fact that the total time has risen so dramatically over 
this time period indicates to me that FDA is being much less 
consistent in the things it asks manufacturers.
    I do believe that the quality--certainly the quality--of 
our applications could be improved in many cases, but I don't 
believe that the quality of our applications has deteriorated 
75 percent since 2007.
    Senator Nelson. Thank you, Mr. Chairman.
    The Chairman. Go ahead.
    Dr. Zuckerman. Yes, thank you.
    I just want to say that I think it is a problem when we 
talk about performance only in terms of speed of getting 
something to market. And I have criticized FDA, but I want to 
defend what CDRH has been doing lately. I think they have done 
a better job of requiring better data.
    And Senator Nelson, I happen to know that you have some 
constituents in the audience today who have been harmed by 
medical devices, and in the same way that you have constituents 
who make medical devices in your State, you have a lot of 
patients who use them.
    So I think, when we talk about performance, and I am sure 
you will agree, we need to talk not just the speed of getting 
things to market, but making sure they are safe when they get 
there.
    Senator Nelson. And is their testimony being recorded in 
some way through some of you all, Ms. Zuckerman?
    Dr. Zuckerman. I am sorry. I don't understand the question.
    Senator Nelson. You spoke of people in the audience who 
have been harmed by these devices.
    Dr. Zuckerman. Yes.
    Senator Nelson. Has their matter been presented in some of 
the testimony here?
    Dr. Zuckerman. It hasn't been presented as testimony, but I 
am happy to provide it for the record.
    Senator Nelson. Please.
    Dr. Zuckerman. I am very happy to do that.
    Thank you.
    Senator Nelson. Thank you.
    The Chairman. Senator Blumenthal, will you have another 
comment or question?
    Senator Blumenthal. I do. Thank you, Mr. Chairman.
    In fact, I have a whole--I have a ton of questions and 
interest in areas that I think really need scrutiny. In 
particular, let me name a few, and I am going to follow up 
after this hearing with this panel. And each of you has added 
very importantly to our knowledge and really just want to thank 
every one of you for being here.
    But going back to the doctor who treated Katie, and I don't 
mean him in particular, I mean the doctors who use these 
devices. To what extent are, number one, relationships, 
financial relationships, consulting relationships an important 
factor for us to consider in decisions by that doctor to use a 
device that at some point either is of doubtful value, in his 
view, or questionable value or is simply of equal value.
    In other words, to what extent do the financial incentives, 
sometimes hidden, sometimes not so hidden, factor? And second, 
off-label marketing clearly a problem. What do we do about it?
    So those are two areas I am going to sort of invite your 
observations on them, and I apologize for sort of tossing a big 
question at the end of the hearing, two big questions.
    Dr. Zuckerman. I could just say that some of the companies, 
some of the largest companies, including Johnson & Johnson, 
which makes the DePuy implant, have been penalized by the 
Justice Department for kickbacks. Kickbacks are kickbacks. 
Sometimes it is unclear whether funding is a consulting fee or 
a kickback. But in this case, they were found guilty of 
kickbacks. So that is something.
    I also had a hip replacement. I also have a DePuy hip. I am 
happy to say not the same kind. Mine hasn't been recalled, yet. 
But I was able to look up my doctor, thanks to the Sunshine 
Act, and I was able to find that my doctor did not get any 
money, at least listed, from the company.
    But one of the problems is there are legitimate fees that 
can be provided and there are kickbacks, and there is a lot in 
between. But we know from research, and there is a lot of good 
research on this, that, when doctors have consulting 
relationships and financial relationships with companies that 
make the product that they prescribe, they are more likely to 
prescribe them, sometimes to the detriment of patients.
    So the Justice Department has actually been doing a very 
good job of going after this in the last few years, more so 
than previously. But there is that gray in-between area where 
doctors can get research funds, or consulting fees, that may be 
legitimate. We know that speaker fees are very often just 
disguised ways of providing support for doctors who will then 
like your company and prescribe your products.
    Senator Blumenthal. Dr. Resnic.
    Dr. Resnic. I think this is a really critical issue that 
you bring up and gets to sort of the fundamental question of 
sort of the necessary trust in the physician-patient 
relationship. And I work in interventional cardiology, which is 
heavily device oriented, and it is a significant problem I 
think in ways that Katie, our patient who testified earlier, 
described.
    She doesn't know if the relationship between her doctor and 
the manufacturer in any way impaired or affected the judgment 
of the doctor to use the device. But he probably doesn't 
either. At best, he doesn't know whether it affects. At worst, 
he knows and doesn't admit that it might. And I think that this 
is something that the professional societies in each of the 
specialties needs to address in concordance with the 
legislative efforts and programs like the Sunshine Act.
    I do think, as a patient advocate, I would not want to find 
out that my family member or myself treated by a doctor, I 
would wonder whether their decision-making was some way 
impaired. Having said that, I think we have to be careful to 
not throw the baby out with the bath water completely, and 
there are important relationships, I think, that device 
innovation requires the clinical feedback from practitioners. 
But these should be very transparent and out for patients to 
see as well.
    And my institution and the medical school where I work 
require this, such that we do need to tell our patients about 
any relationships that we may have, and I think that that is 
probably what needs to evolve. But it is a sort of ugly 
underbelly of medicine is these potential relationships.
    Senator Blumenthal. Yes?
    Mr. Hall. You also asked a question about off-label use, 
which is a very interesting and complex question. In many 
situations, off-label use is actually the standard of care and 
what any patient would want. And, in fact, Congress has 
recognized that by explicitly talking about the legality of 
off-label use of medical devices.
    And this also raises questions of transparency and patient 
benefit when often the manufacturer has the most information 
because the company is in receipt of information from patients, 
from studies, whatever, and you have this perfectly legal and 
often very appropriate use taking place in the field for 
patient benefit. And how do you allow the transmission of 
information on clinical use, risk, benefits, whatever, when the 
use is standard of care, but off-label?
    Senator Blumenthal. I appreciate your comment, Mr. Hall. 
But actually, I think my reference was to off-label marketing. 
Off-label use is perfectly legal and may be appropriate in the 
view of the treating physician. Off-label marketing is against 
the law, and for good reason.
    Mr. Hall. Correct. What I was trying to point out, perhaps 
not articulately enough, is that there is this interesting 
balance between what is marketing and what is providing 
important clinical, scientific information for the benefit of 
the patient and the physician in that use.
    Senator Blumenthal. Right.
    Mr. Hall. And that is what I was trying to reference.
    Senator Blumenthal. Mr. Nexon.
    Dr. Nexon. The issue of consulting is a very complex one in 
the device area because the development and improvement of 
device is so intertwined with medical practice. Many, if not 
most, devices are initially invented by physicians so that 
there are obviously royalty arrangements.
    All companies, because there is this--devices typically 
have an 18- to 24-month lifecycle, and then an improved version 
comes along, and that improved version is based on feedback 
from practicing physicians. So there are a lot of legitimate 
consulting and royalty arrangements.
    AdvaMed has put forward what I think is a very rigorous 
code of ethics, which we would be happy to share with you, that 
lists what we think is permissible payments and what is 
impermissible. And, of course, we were proud to support Senator 
Kohl's Sunshine Act, which provided for full disclosure of any 
payment, whether legitimate or illegitimate, to physicians. But 
it is a difficult problem.
    On off-label use, as you said, off-label promotion is 
illegal, and companies shouldn't do it.
    Senator Blumenthal. And again, I want to thank all of you 
for your testimony and come back to the comment that Dr. Resnic 
made. Full disclosure, transparency are very important, and 
your hospital may require it. I am not sure whether 
Massachusetts law also requires it. But in many instances, the 
law fails to provide for--in my view at least--fails to provide 
for adequate and full disclosure.
    So the physician knows in advance that that hip implant is 
being used by a physician who has some relationship. It may be 
a speaker's fee. It may be consulting. It may be royalties. But 
one way or the other, the patient deserves to know, I think.
    Dr. Resnic. I agree. I think Massachusetts did enact in 
2009----
    Senator Blumenthal. Right.
    Dr. Resnic [continuing]. One of the most stringent public 
disclosure requirements, as well as prohibition of certain 
relationships between industry and physicians, both for 
pharmaceutical device, any medical product. And then within 
those stringent guidelines, there are certainly institutions 
that have had their share of challenges and that have moved 
beyond even the restrictions that Massachusetts has imposed.
    There is, in fact, there is always some sort of pendulum or 
balance in the equation. The one thing that I am concerned 
about with ever-increasing stringency of relationships, which I 
think is not a good thing between physicians and industry, is 
the potential loss for education and even participation by 
those physicians in the appropriate feedback of clinical 
insight to medical device manufacturers.
    It is just a hard balance. We talked at the beginning of 
the meeting about the critical balance that FDA needs to strike 
between safety and innovation. These types of questions also 
need to strike a balance. Clearly, transparency is paramount, 
but through transparency, if it is unbalanced, that is, if it 
is only Massachusetts that stands alone, then device 
manufacturers tend to move elsewhere.
    And I think that perhaps there needs to be more national 
recommendations regarding these relationships and transparency, 
as Mr. Kohl's Sunshine Act has recommended and implemented.
    Senator Blumenthal. Thank you.
    Thank you, Mr. Chairman.
    The Chairman. Thank you very much, Senator Blumenthal.
    Thank you so much for being here today. And this has been a 
great panel. You have given us excellent testimony from several 
different points of view, which is extremely helpful.
    We all agree that the FDA must make patient safety a 
number-one priority, but also we want to do that without 
stifling innovation. And I think we all believe that we can 
find a balance. That is what we are here to do.
    We are encouraged by the numerous initiatives that FDA is 
implementing for more effective medical device approval and 
postmarket surveillance. However, we are still concerned that 
the agency's oversight of medical products remains on the GAO's 
high-risk list more than two years now after earning that 
infamous designation, and that is not acceptable.
    We intend to keep a close eye on how FDA changes the fast-
track approval process. We will also be monitoring improvements 
that have been promised by the agency and the industry to 
better track devices and speed the removal of defective or 
failed devices from the market.
    We are particularly concerned about high-risk devices being 
fast-tracked. FDA has had over 20 years to tackle these high-
risk devices. As we have seen with the Johnson & Johnson hip 
implant today, it is past time to protect patient safety and 
correctly classify these devices.
    I also believe that the FDA needs to develop a more robust 
postmarket surveillance program and improve its management of 
recalls.
    We thank you all for being here today. We look forward to 
continuing this dialogue in the public interest.
    Thank you so much for coming.
    [Whereupon, at 4:00 p.m., the hearing was adjourned.]
                                APPENDIX
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