[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
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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
U.S. GOVERNMENT PRINTING OFFICE
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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
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Debra Whitman, Majority Staff Director
Michael Bassett, Ranking Member Staff Director
CONTENTS
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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
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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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