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67–694 PDF 2011

S. HRG. 112–92 

A DELICATE BALANCE: FDA AND THE REFORM 

OF THE MEDICAL DEVICE APPROVAL PROCESS 

HEARING 

BEFORE THE

SPECIAL COMMITTEE ON AGING 

UNITED STATES SENATE 

ONE HUNDRED TWELFTH CONGRESS 

FIRST SESSION 

WASHINGTON, DC 

APRIL 13, 2011 

Serial No. 112–4 

Printed for the use of the Special Committee on Aging 

( 

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

(II) 

SPECIAL COMMITTEE ON AGING 

HERB KOHL, Wisconsin, Chairman 

RON WYDEN, Oregon 

BILL NELSON, Florida 

BOB CASEY, Pennsylvania 

CLAIRE MCCASKILL, Missouri 

SHELDON WHITEHOUSE, Rhode Island 

MARK UDAL, Colorado 

MICHAEL BENNET, Colorado 

KRISTEN GILLIBRAND, New York 

JOE MANCHIN III, West Virginia 

RICHARD BLUMENTHAL, Connecticut 

BOB CORKER, Tennessee 

SUSAN COLLINS, Maine 

ORRIN HATCH, Utah 

MARK KIRK III, Illnois 

JERRY MORAN, Kansas 

RONALD H. JOHNSON, Wisconsin 

KELLY AYOTTE, New Hampshire 

RICHARD SHELBY, Alabama 

LINDSEY GRAHAM, South Carolina 

SAXBY CHAMBLISS, Georgia 

DEBRA WHITMAN, Majority Staff Director 

MICHAEL BASSETT, Ranking Member Staff Director 

(III) 

CONTENTS 

Page 

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

Statement of Senator Bob Corker .......................................................................... 2 

Statement of Senator Mark Udall .......................................................................... 2 

Statement of Senator Kelly Ayotte ......................................................................... 3 

Statement of Senator Michael Bennet ................................................................... 19 

PANEL OF WITNESSES 

Statement of Katie Korgaokar, Patient, Denver, CO ........................................... 5 

Statement of Marcia Crosse, Director, Health Care, Government Accountability Office, Washington, DC ........................................................................... 7 

Statement of Diana Zuckerman, President, National Research Center for 

Women and Families, Cancer Prevention and Treatment Fund, Washington, DC ............................................................................................................. 9 

Statement of Frederic Resnic, Assistant Professor of Medicine, Harvard Medical School and Director of the Cardiac Catheterization Laboratory, 

Brigham and Women’s Hospital, Boston, MA .................................................... 11 

Statement of Ralph Hall, Distinguished Professor, University of Minnesota 

Law School, Minneapolis, MN ............................................................................. 13 

Statement of David Nexon, Senior Executive Vice President, Advanced Medical Technology Association (AdvaMed), Washington, DC ................................ 15 

Statement of William Maisel, Deputy Center Director for Science and the 

Chief Scientist, Center for Devices and Radiological Health, Food and Drug 

Administration, Silver Spring, MD ..................................................................... 17 

APPENDIX 

WITNESS STATEMENTS FOR THE RECORD: 

Katie Korgaokar, Patient, Denver, CO .................................................................. 40 

Marcia Crosse, Director, Health Care, Government Accountability Office, 

Washington, DC ................................................................................................... 43 

Diana Zuckerman, President, National Research Center for Women and Families, Cancer Prevention and Treatment Fund, Washington, DC .................... 65 

Frederic Resnic, Assistant Professor of Medicine, Harvard Medical School 

and Director of the Cardiac Catheterization Laboratory, Brigham and Women’s Hospital, Boston, MA ................................................................................... 72 

Ralph Hall, Distinguished Professor, University of Minnesota Law School, 

Minneapolis, MN .................................................................................................. 81 

David Nexon, Senior Executive Vice President, Advanced Medical Technology 

Association (AdvaMed), Washington, DC ........................................................... 107 

William Maisel, Deputy Center Director for Science and the Chief Scientist, 

Center Devices and Radiological Health, Food and Drug Administration, 

Silver Spring, MD ................................................................................................ 120 

ADDITIONAL STATEMENTS SUBMITTED FOR THE RECORD: 

Terrie Cowley, President, The TMJ Association, LTD ......................................... 140 

Kevin Fu, Ph.D., Department of Computer Science, University of Massachusetts, Amherst, MA .............................................................................................. 158 

Janet Holt, Texas ..................................................................................................... 185 

Lana C. Keeton, President and Founder, Truth in Medicine, Miami Beach, 

FL .......................................................................................................................... 191 

Beverly J. Pennington, Roopville, GA .................................................................... 197 

Rita Redberg, MD, MSc, Professor of Medicine, University of California .......... 200 

(1) 

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

PROCESS 

WEDNESDAY, APRIL 13, 2011 

U.S. SENATE, 

SPECIAL COMMITTEE ON AGING, 

Washington, DC. 

The Committee met, pursuant to notice, at 2:03 p.m., in Room 

SD–562, Dirksen Senate Office Building, Hon. Herb Kohl, Chairman of the Committee, presiding. 

Present: Senators Kohl [presiding], Wyden, Nelson, Udall, Bennet, Blumenthal, Corker, and Ayotte. 

OPENING STATEMENT OF SENATOR HERB KOHL, CHAIRMAN 

The CHAIRMAN. Good afternoon. We would like to thank the 

members as well as our witnesses for being here with us today. 

We are examining a very important topic today—the Food and 

Drug Administration’s management and oversight of the thousands 

of medical devices countless Americans rely on every day. The overall success of this process has become even more urgent for seniors 

in recent years. 

Innovative technology has provided valuable lifesaving medical 

devices that have prolonged life and reduced suffering. We need to 

do all we can to make sure that these new medical products are 

getting to the market quickly as well as safely. 

However, the FDA must constantly strive to maintain a delicate 

balance between safety and innovation. As we will hear today, this 

is an extremely difficult assignment. 

The medical device industry has understandable concerns that 

significant changes in the medical device approval process contemplated by FDA could slow the rapid progress of new medical 

technologies to hospitals, patients, as well as the marketplace. 

They have also expressed concerns to the agency about a lack of 

consistent and clear guidance on how to get medical devices approved. 

However, the drive toward getting new technologies to market 

should not be done at the risk of patient safety. Faulty medical devices, especially those implanted in the body, can have a disastrous 

impact on the health of those who use them. 

Today, we will hear a firsthand account of the trauma that occurs when an implantable medical device must be removed due to 

a recall and device failure. As we hear about the cost to patients, 

2 

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 highrisk 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 

3 

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. 

4 

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 OfVerDate Nov 24 2008 09:55 Sep 16, 2011 Jkt 067694 PO 00000 Frm 00008 Fmt 6633 Sfmt 6633 C:\DOCS\67694.TXT SHAUN PsN: DPROCT
5 

fice. 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, 

6 

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 

7 

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 

8 

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 

9 

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. 

10 

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. 

11 

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. 

12 

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 highrisk 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 

13 

avoid preventable injury and death to patients treated with highrisk 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 

14 

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, 

15 

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. 

16 

Second, the 510(k) clearance process has been criticized as a fasttrack 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, 

17 

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 collaboVerDate Nov 24 2008 09:55 Sep 16, 2011 Jkt 067694 PO 00000 Frm 00021 Fmt 6633 Sfmt 6633 C:\DOCS\67694.TXT SHAUN PsN: DPROCT
18 

rating 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 preand 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 

19 

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. 

20 

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? 

21 

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 lifesustaining 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 preVerDate Nov 24 2008 09:55 Sep 16, 2011 Jkt 067694 PO 00000 Frm 00025 Fmt 6633 Sfmt 6633 C:\DOCS\67694.TXT SHAUN PsN: DPROCT
22 

market 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 orientaVerDate Nov 24 2008 09:55 Sep 16, 2011 Jkt 067694 PO 00000 Frm 00026 Fmt 6633 Sfmt 6633 C:\DOCS\67694.TXT SHAUN PsN: DPROCT
23 

tion 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 

24 

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 beVerDate Nov 24 2008 09:55 Sep 16, 2011 Jkt 067694 PO 00000 Frm 00028 Fmt 6633 Sfmt 6633 C:\DOCS\67694.TXT SHAUN PsN: DPROCT
25 

cause 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. 

26 

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 

27 

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 highrisk 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. 

28 

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? 

29 

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. 

30 

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 inVerDate Nov 24 2008 09:55 Sep 16, 2011 Jkt 067694 PO 00000 Frm 00034 Fmt 6633 Sfmt 6633 C:\DOCS\67694.TXT SHAUN PsN: DPROCT
31 

dexes, 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 

32 

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 

33 

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. 

34 

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, offlabel 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 

35 

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, offlabel 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 apVerDate Nov 24 2008 09:55 Sep 16, 2011 Jkt 067694 PO 00000 Frm 00039 Fmt 6633 Sfmt 6633 C:\DOCS\67694.TXT SHAUN PsN: DPROCT
36 

propriate 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. 

37 

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 numberone 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 highrisk 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 fasttracked. 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.] 

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