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IMPACT OF MEDICAL DEVICE REGULATION ON 

JOBS AND PATIENTS 

HEARING 

BEFORE THE

SUBCOMMITTEE ON HEALTH 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED TWELFTH CONGRESS 

FIRST SESSION 

FEBRUARY 17, 2011 

Serial No. 112–9 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

COMMITTEE ON ENERGY AND COMMERCE 

FRED UPTON, Michigan 

Chairman 

JOE BARTON, Texas 

Chairman Emeritus 

CLIFF STEARNS, Florida 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

Vice Chairman 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

BRIAN P. BILBRAY, California 

CHARLES F. BASS, New Hampshire 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BILL CASSIDY, Louisiana 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

CORY GARDNER, Colorado 

MIKE POMPEO, Kansas 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

HENRY A. WAXMAN, California 

Ranking Member 

JOHN D. DINGELL, Michigan 

EDWARD J. MARKEY, Massachusetts 

EDOLPHUS TOWNS, New York 

FRANK PALLONE, JR., New Jersey 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

CHARLES A. GONZALEZ, Texas 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

DORIS O. MATSUI, California 

(II)

(III) 

SUBCOMMITTEE ON HEALTH

JOSEPH R. PITTS, Pennsylvania 

Chairman 

MICHAEL C. BURGESS, Texas 

Vice Chairman 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

TIM MURPHY, Pennsylvania 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

LEONARD LANCE, New Jersey 

BILL CASSIDY, Louisiana 

BRETT GUTHRIE, Kentucky 

JOE BARTON, Texas 

FRED UPTON, Michigan (ex officio) 

FRANK PALLONE, JR., New Jersey 

Ranking Member 

JOHN D. DINGELL, Michigan 

EDOLPHUS TOWNS, New York 

ELIOT L. ENGEL, New York 

LOIS CAPPS, California 

JANICE D. SCHAKOWSKY, Illinois 

CHARLES A. GONZALEZ, Texas 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

ANTHONY D. WEINER, New York 

HENRY A. WAXMAN, California (ex officio) 

(V) 

C O N T E N T S 

Page 

Hon. Joseph R. Pitts, a Representative in Congress from the Commonwealth 

of Pennsylvania, opening statement ................................................................... 1 

Prepared statement .......................................................................................... 2 

Hon. Frank Pallone, Jr., a Representative in Congress from the State of 

New Jersey, opening statement .......................................................................... 4 

Hon. Fred Upton, a Representative in Congress from the State of Michigan, 

opening statement ................................................................................................ 5 

Prepared statement .......................................................................................... 6 

Hon. Henry A. Waxman, a Representative in Congress from the State of 

California, opening statement ............................................................................. 7 

Hon. John D. Dingell, a Representative in Congress from the State of Michigan, prepared statement ...................................................................................... 9 

Hon. Edolphus Towns, a Representative in Congress from the State of New 

York, prepared statement .................................................................................... 9 

WITNESSES

Jeffrey E. Shuren, M.D., J.D., Director, Center for Devices and Radiological 

Health, Food and Drug Administration ............................................................. 10 

Prepared statement .......................................................................................... 13 

Answers to submitted questions ...................................................................... 149 

Joshua Makower, M.D., Exploramed Development, LLC ..................................... 28 

Prepared statement .......................................................................................... 30 

Answers to submitted questions ...................................................................... 175 

Mark Deem, Managing Partner and Chief Technology Partner, The Foundry .. 81 

Prepared statement .......................................................................................... 83 

Answers to submitted questions ...................................................................... 184 

Rita Redberg, M.D., MSC., Director, Women’s Cardiovascular Services, UCSF 

Medical Center Division of Cardiology ............................................................... 87 

Prepared statement .......................................................................................... 89 

Steven E. Nissen, M.D., Professor of Medicine, Cleveland Clinic Lerner School 

of Medicine at Case Western Reserve University, and Chairman, Department of Cardiovascular Medicine, Cleveland Clinic Foundation ..................... 97 

Prepared statement .......................................................................................... 99 

Ralph Hall, Distinguished Professor and Practitioner, University of Minnesota 

Law School ............................................................................................................ 107 

Prepared statement .......................................................................................... 109 

Answers to submitted questions ...................................................................... 191 

(1) 

IMPACT OF MEDICAL DEVICE REGULATION 

ON JOBS AND PATIENTS 

THURSDAY, FEBRUARY 17, 2011 

HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON HEALTH, COMMITTEE ON ENERGY AND COMMERCE, Washington, DC. 

The subcommittee met, pursuant to call, at 9:30 a.m., in room 

2123, Rayburn House Office Building, Hon. Joseph R. Pitts, (chairman of the subcommittee) presiding. 

Present: Representatives Pitts, Burgess, Whitfield, Shimkus, 

Murphy, Blackburn, Gingrey, Latta, Lance, Cassidy, Guthrie, Barton, Upton (ex officio), Pallone, Dingell, Towns, Capps, and Waxman (ex officio). 

Staff Present: Debbee Keller, Press Secretary; Clay Alspach, 

Counsel; Cary McWilliams, Legislative Clerk; Jeff Mortier, Professional Staff; Peter Kielty, Senior Legislative Clerk; Chris Sarley, 

Policy Coordinator; Ryan Long, Chief Counsel, Health; Alan 

Slobodin, Counsel; Andy Duberstien, Special Assistant to Chairman 

Upton; Rachel Sher, Minority Counsel; Allison Corr, Minority Policy Analyst; Karen Lightfoot, Minority Communications Director 

and Senior Policy Advisor; Stephen Cha, Minority Professional 

Staff Member; and Eric Flamm, Minority Detailee. 

OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH 

OF PENNSYLVANIA 

Mr. PITTS. The subcommittee will come to order. 

The chair will recognize himself for an opening statement. 

The United States is the world leader in medical device innovation. According to a recent report, 32 of the 46 medical technology 

companies with annual sales exceeding $1 billion are based in the 

United States; and yet the United States is in danger of losing its 

preeminent status in this field. 

Multiple studies have shown that regulatory uncertainty is damaging this critical industry and hurting American patients. For example, the November, 2010, study ‘‘FDA Impact on U.S. Medical 

Technology Innovation’’ surveyed over 200 medical technology companies; and they described the FDA process as ‘‘unpredictable and 

characterized by disruptions and delays.’’ They also noted that companies are able to make their products available to patients faster 

and at a significantly lower cost in markets such as Europe. 

It already is tough for medical device companies. Only one out 

of four med tech startups succeed. Half of all reported exits are less 

2 

than $100 million, and the total pool of available investment capital is shrinking. 

Quite simply, shorter, more predictable, and more transparent 

approval processes in Europe have led many device companies to 

seek a market for their products in Europe before submitting them 

to the FDA; and they are taking good-paying American jobs overseas with them. 

In 2008, according to the Lewin Group, the medical device indus- try employed 422,778 workers nationwide, paid $24.6 billion in 

earnings, and shipped $135.9 billion worth of products. In 2008, in 

my home State of Pennsylvania, the medical device industry employed 22,223 people and paid Pennsylvania workers over $1.1 billion in earnings. These are good jobs. Nationally, jobs in medical 

technology pay almost 40 percent higher compared to the national 

earnings average. 

But this trend does not just hurt our economy. It hurts American 

patients. American patients on average have access to innovative 

medical devices 2 years later than patients in European countries 

and, in some cases, never have access to these devices. 

None of us would be concerned about longer, more arduous approval processes for medical devices in the U.S. versus Europe if 

we thought that those processes kept American patients safer than 

their European counterparts. But according to recent studies, medical devices marketed through the shorter and more transparent 

EU processes are statistically as safe as FDA-cleared or approved 

devices and have comparable patient outcomes. 

According to a January, 2011, Boston Consulting Group report, 

EU Medical Device Approval Safety Assessment, a Comparative 

Analysis of Medical Device Recalls 2005 2009, ‘‘The results of this 

study suggest little difference between absolute number of serious 

recalls between the U.S. and EU regulatory systems. The distribution of the serious recalls are similar across therapeutic areas, and 

reasons for recalls suggesting that differences between the two systems do not ultimately affect performance. In addition, given the 

expectation that the EU approves more devices than the U.S., it is 

likely that the EU recall rate may actually be slightly lower than 

the U.S. rate.’’ 

We need to ensure that our regulatory system is consistent and 

transparent so American patients have timely access to life-saving 

and life-improving drugs and devices and American workers have 

access to these goods. 

[The prepared statement of Mr. Pitts follows:] 

PREPARED STATEMENT OF HON. JOSEPH R. PITTS

The subcommittee will come to order. 

The chair will recognize himself for an opening statement. 

The United States is the world leader in medical device innovation. According to 

a recent report from Pricewaterhouse Coopers, 32 of the 46 medical technology companies with annual sales exceeding $1 billion are based in the United States. 

And, yet, the U.S. is in danger of losing its preeminent status in this field. 

Multiple studies have shown that regulatory uncertainty is damaging this critical 

industry and hurting American patients. 

For example, the November 2010 study ‘‘FDA Impact on U.S. Medical Technology 

Innovation’’ surveyed over 200 medical technology companies. 

They described the FDA process as ‘‘unpredictable and characterized by disruptions and delays.′′ 

3 

They also noted that companies are able to make their products available to patients faster and at a significantly lower cost in markets such as Europe. 

It’s already tough for medical device companies. Only one out of four med-tech 

startups succeed. Half of all reported exits are less than $100 million, and the total 

pool of available investment capital is shrinking. 

Quite simply, shorter, more predictable, and more transparent approval processes 

in Europe have led many device companies to seek a market for their products in 

Europe before submitting them to FDA. 

And they are taking good-paying American jobs overseas with them. 

In 2008, according to the Lewin Group, the medical device industry employed 

422,778 workers nationwide, paid $24.6 billion in earnings, and shipped $135.9 billion worth of products. 

In 2008, in my home state of Pennsylvania, the medical device industry employed 

22,233 people and paid Pennsylvania workers over $1.1 billion in earnings. 

These are good jobs. Nationally, jobs in medical technology pay almost 40% higher 

compared to the national earnings average. 

But this trend does not just hurt our economy, it hurts American patients. 

American patients, on average, have access to innovative medical devices two 

years later than patients in European countries, and, in some cases, never have access to these devices. 

None of us would be concerned about longer, more arduous approval processes for 

medical devices in the U.S. versus Europe if we thought that those processes kept 

American patients safer than their European counterparts. 

But, according to recent studies, medical devices marketed through the shorter 

and more transparent EU processes are statistically as safe as FDA-cleared or approved devices and have comparable patient outcomes. 

According to a January 2011 Boston Consulting Group report ‘‘EU Medical Device 

Approval Safety Assessment: A comparative analysis of medical device recalls 2005- 

2009:′′ 

′′The results of this study suggest little difference between absolute number of serious recalls between the US and EU regulatory systems. The distribution of the 

serious recalls is similar across therapeutic areas and reasons for recall, suggesting 

that differences between the two systems do not ultimately affect performance. In 

addition, given the expectation that the EU approves more devices than the US it 

is likely that the EU recall rate may actually be slightly lower than the US rate.′′ 

We need to ensure that our regulatory system is consistent and transparent so 

American patients have timely access to life-saving and life-improving drugs and devices and American workers have access to these good jobs. 

I yield the remainder of my time to the chairman emeritus, Mr. Barton. 

Mr. PITTS. I yield the remainder of my time to Chairman Emeritus Mr. Barton. 

Mr. BARTON. Thank you, Mr. Chairman. You surprised me, but 

I do appreciate it. Thank you for holding this hearing. 

Back in 1997, as the chairman of the Oversight and Investigation 

Subcommittee, I had the great privilege to work with Congresswoman Eshoo on the Medical Device Regulatory Modernization Act 

of 1997. That became part of the Food and Drug Modernization Act 

called FDAMA. We worked to ensure that the FDA operates in the 

best interest of patients by ensuring that they have access to new 

life-enhancing and life-saving technologies. We and others realized 

that the regulatory process for medical devices needed to be reformed in order to get medical devices to patients in a timelier 

fashion, to spur medical innovation, and to help draft small business job creation. 

Today, it appears to me these reforms have been successful. It 

doesn’t mean that we can’t improve on it. We do not want to backtrack on this success, and we do not want to make it harder on the 

small businesses and manufacturers to get new and vital medical 

devices into production and into the market. 

Texas is the leader in medical device innovation. There are over 

4,000 medical equipment and device companies in my State. Most 

4 

of them are relatively small. Texas and America depend on job creation in this sector with a market that is open and has reasonable 

regulations. 

Lack of transparency within the FDA and drawn-out approval 

process appear to be hurting these businesses and resulting in job 

losses. I am sure our witnesses today are going to comment on 

that. 

This is a very good hearing, Mr. Chairman. I appreciate you and 

Chairman Upton for holding it. I look forward to hearing from our 

witnesses. 

With that, I would yield to whoever I should yield to. 

I yield back to the Chair. 

Mr. PITTS. Thank you. 

The Chair recognizes the ranking member, Mr. Pallone, for an 

opening statement. 

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY 

Mr. PALLONE. Thank you, Chairman Pitts. 

I am pleased that you scheduled hearing today’s hearing on medical devices because I believe we are at an important crossroads. 

As we continue to work our way out of the recession toward a 

thriving economy that offers economic opportunities to all Americans, we must out-innovate the rest of the world. America’s competitiveness depends on our ability to innovate and keep America 

number one. However, to do that we must properly fund key agencies like the FDA that are essential to assisting in the development 

of new drugs and devices; and I am disappointed in the cuts proposed by the House Republicans. 

Research and development has an impact on all sectors of our 

workforce. I will use my home State of New Jersey as an example. 

A new report by Research America noted that New Jersey is the 

third-largest R&D employer in the U.S., with more than 211,000 

jobs supported by health R&D, including 50,000 direct jobs in 

health R&D. The same report shows the economic impact in New 

Jersey is $60 billion. 

That said, the government must be responsible for facilitating an 

environment where Americans can continue to innovate. That is 

the key to creating new, thriving industries that will produce millions of good jobs here at home and a better future for the next 

generation. 

If government abandons its role, we run the real risk of squandering too many opportunities that lead to innovative discoveries 

and great economic benefits. 

Now, I have been interested in today’s topic of FDA regulation 

for a long time, and that includes examining where the current system works well and where shortfalls might be. During this time, 

I have heard from patients, from physicians, and from companies 

about problems with the 501(k) process. Physicians and patients 

are concerned that products aren’t fully evaluated before they are 

allowed on the market, and companies are frustrated of the lack of 

predictability and transparency in the process. 

5 

In fact, as chairman of the subcommittee, we held a hearing on 

these issues in 2009; and, during that hearing, we specifically 

heard about a GAO report on the 501(k) process and in particular 

on the pre-amendment devices that have never been through the 

FDA approval process. The FDA is here today, and I hope we can 

hear about their progress with reviewing the high-risk Class III devices that have yet to ever be approved formally. 

I am also interested to hear about FDA’s recently released innovation initiative, because I strongly believe the FDA has two very 

important parts to its mission—first, to make sure that products 

are safe for U.S. consumers and, second, to facilitate innovation. It 

is good to see FDA’s renewed focus on the latter, and I look forward 

to the Institute of Medicine, or IOM, analysis of some of their recommendations. 

Let me close by saying that today we will likely hear about two 

very different studies that have come to two very different conclusions, each with merit and limitations. In my view, this showcases 

one more reason why the upcoming IOM report due out in June is 

so critical to this dialogue. 

I look forward to our witnesses’ testimony. I hope that our discussion will inform both Congress and the FDA how to approach 

these issues in a balanced way, protecting the American consumer 

while maintaining a strong R&D basis in this country. 

Thank you, Mr. Chairman. 

Mr. PITTS. The chair thanks the gentleman and yields to the 

chairman of the full committee, Mr. Upton, for an opening statement. 

OPENING STATEMENT OF HON. FRED UPTON, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF MICHIGAN 

Mr. UPTON. Thank you, Mr. Chairman, for holding today’s hearing on the impact of medical device regulations on jobs and patients. We do need to get America back to work; and, as we talked 

about on the House floor last week, part of this involves fixing regulatory problems caused by the Federal Government. 

Our Nation has been the world leader on medical devices, using 

American innovation to bring life-saving, life-improving devices to 

American patients and create high-paying, rewarding jobs here at 

home. In 2008, the medical device industry directory employed over 

420,000 Americans. In my home State of Michigan, over 9,000. 

Unfortunately, our world leadership is being threatened. As 

Chairman Pitts outlined so well last week on the House floor, it 

does appear that a major reason for this is a lack of predictability, 

certainty, and transparency at FDA. These problems at the FDA 

are hurting American innovation, costing American jobs, and hurting American patients. 

According to recent reports and firsthand accounts from our Nation’s small businesses, device companies are being forced to market their devices first in Europe because the EU countries have 

predictable and consistent regulatory processes. Because of that, 

medical devices are available there 2 years ahead of folks here. 

That is not right. This hearing aims to try and fix that. 

I yield back my time. 

[The prepared statement of Mr. Upton follows:] 

6 

PREPARED STATEMENT OF HON. FRED UPTON

Thank you for holding today’s hearing on the impact of medical device regulation 

on jobs and patients. I also would like to thank the witnesses for testifying today 

on this important subject. 

We need to get Americans back to work. As we talked about on the House floor 

last week, part of that involves fixing regulatory problems caused by the federal 

government. 

Our Nation has been the world leader on medical devices, using American innovation to bring life-saving, life-improving devices to American patients and create 

high-paying, rewarding jobs here at home. 

Unfortunately, our world leadership is being threatened due in part to the lack 

of predictability, certainty and transparency at the Food and Drug Administration. 

These problems at FDA are hurting American innovation, costing American jobs and 

hurting American patients. 

The Medical Device User Fee Act expires in September of 2012, and this Committee will be charged with leading its reauthorization. I commit here today that 

this Committee will work hard to accomplish this reauthorization, but in doing so, 

we will demand that certainty, predictability and transparency be built into our 

process so our nation can stay as the global leader in medical device innovation, so 

we can create good-paying jobs here at home, and so we can improve the lives of 

patients. 

It is time to get Americans back to work, and I thank the Chairman for holding 

this hearing so we can identify ways to do just that. I yield back. 

Mr. PITTS. The chair yields to Dr. Burgess to continue your time. 

Dr. BURGESS. Thank you, Mr. Chairman. 

I certainly hear from device manufacturers all across the country 

about the lack of transparency and an ambiguous and constantly 

changing approval process that discourages innovation and ultimately does yield to the loss of American jobs. The inability to facilitate a predictable process is causing device manufacturers to 

move overseas and, most importantly, not allowing patients access 

to treatments here in the United States that have been found elsewhere. 

The difficulty by the FDA to ensure reliable and consistent approval process not only creates a disadvantage for current devices, 

but it is an inhibitory environment on advances in technology in 

the future. 

Earlier this week, Dr. Francis Collins, Director of the NIH, came 

and addressed a few of us at the Health Caucus. He talked about 

the changes that are occurring with genetic mapping and the new 

information that is coming online very rapidly. And this whole era 

of rapid learning can in fact lead to a multiplier effect in the development of many interventions that were never before imagined. 

Investment, yes. Congress does need to make an investment. But 

also the integration of information is going to be critical in the development of new interventions, and the FDA is the lynchpin in all 

of that. 

Certainly the National Institute of Health and the Center for 

Medicare and Medicaid Services need to be discussing with each 

other about future treatments that are going to be necessary and 

how to integrate those into the payment system. But if the pipeline 

is not unclogged at the FDA, then many of these new promises are 

never going to be kept. 

Now, President Obama talked in the State of the Union address 

and advocated for America to lead the way in technology and innovation. Unfortunately, his signature health care legislation passed 

less than a year ago, coupled with the Food and Drug AdministraVerDate Nov 24 2008 11:41 Aug 03, 2011 Jkt 037690 PO 00000 Frm 00012 Fmt 6633 Sfmt 6633 P:\MY DOCS\HEARINGS 112\112-9 021711\112-9 CHRIS
7 

tion’s confusing and sometimes disjointed approval process, has instead encouraged the offshoring of business that has brought medical discoveries to a halt. 

And let me yield the remaining time to the gentleman from New 

Jersey, Mr. Lance. 

Mr. LANCE. Thank you very much for yielding; and thank you, 

Mr. Chairman. 

The medical device industry produces $135 billion in products 

and employs at least 422,000 residents of this country. In New Jersey, over 20,000 employees in the medical device industry produce 

nearly $6 billion in products. Many are employed at incubator companies that develop new devices. 

While the United States remains the leader in innovation in the 

medical device industry, that place is not set in stone. As the chairman has indicated, a recent study found that the U.S. is slipping 

as other nations are gaining. Unpredictable, inefficient, and expensive regulatory processes are jeopardizing America’s leadership position in medical technology innovation. 

I look forward to hearing from the panel on ways we can improve 

the regulatory environment to strengthen our position as the global 

leader in medical technology. 

Thank you very much, Mr. Chairman. 

Mr. PITTS. The chair thanks the gentleman and yields to the 

ranking member of the full committee, Mr. Waxman, for 5 minutes. 

OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA 

Mr. WAXMAN. Thank you, Chairman Pitts, for holding this important hearing today. 

Let me start off with a couple of statements on which I think we 

all can agree. We all want to ensure that innovation in the medical 

device industry is vibrant and healthy so that we have access to 

the best and newest technological advances. We also want the medical devices we use to be as safe as possible and to have every confidence that they are effective. If there are factors that are preventing or inhibiting these things from occurring, we should all be 

united in doing whatever it takes to reverse these influences. 

But we cannot have a conversation about innovation and speeding new devices to the market without talking about the importance of ensuring the safety and effectiveness of those devices. So 

this hearing should be about how we can work together to meet 

these goals. 

We will hear today from witnesses invited by the Republicans 

who will express their concern that the FDA’s device regulatory 

system is inhibiting innovation, depriving patients of new and potentially life-saving devices, and costing American’s jobs. 

To focus on the other end of the equation, we have also invited 

two witnesses who will focus on FDA’s responsibility to ensure the 

safety and effectiveness of devices; and we are also fortunate to 

have the FDA itself here to respond to concerns on both issues. 

We shouldn’t be Democrats on one side of this issue and Republicans on the other. We should all be together and carefully exploring the concerns about the state of innovation of the device indusVerDate Nov 24 2008 11:41 Aug 03, 2011 Jkt 037690 PO 00000 Frm 00013 Fmt 6633 Sfmt 6633 P:\MY DOCS\HEARINGS 112\112-9 021711\112-9 CHRIS
8 

try. It is important we ask some hard questions about the facts and 

data underlying these decisions. 

Although Dr. Makower’s study, for instance, raises some important questions, it is also clear there are some significant limitations. So what it tells us about what is actually going on according 

to the study itself, it includes a very small portion of the device industry—only 204 out of some 16,000 companies registered with the 

FDA. It also includes a majority of responses from companies that 

appear to have had very little previous experience with the FDA’s 

regulatory process. 

The study asserts that it takes much longer for devices to reach 

the market as compared to the EU. Obviously, we would all be concerned if that was the case. But we need to make our judgements 

based on good data. I think there are some real questions about 

whether Dr. Makower’s study demonstrates that these EU versus 

U.S. time differentials even exist and whether Dr. Makower’s study 

was comparing equivalent measures for times to market. I look forward to hearing from our witnesses on these points. 

I will also look forward to hearing from our witnesses about the 

need to assure that devices are safe and effective when they reach 

the market. There are countless and often tragic stories of patients 

injured, even killed, by unsafe devices. The study that Dr. Nissen 

will describe today shows that many devices that were recalled for 

serious safety reasons were not reviewed by FDA under the more 

stringent premarket approval, or PMA, process. That has got to be 

a concern. We need to ask why so many unsafe devices ultimately 

harm patients and explore what can be done to prevent injuries in 

the future. 

In order to have a flourishing and innovative American device industry that puts safe and effective devices on the market, we need 

to have a strong and well-resourced FDA that is in the best interest of American patients but it is also in the interest of the device 

industry itself. If patients lose confidence in the FDA, they will lose 

confidence in industry as well. 

This is an issue that can and should be bipartisan. I look forward 

to hearing from our witnesses today and to working with my colleagues on this matter. 

Let me point out, Mr. Chairman, I wasn’t aware of the fact that 

FDA was put in as just one of the members of this panel. I think 

if anybody is coming to testify from the administration, we have a 

long tradition of giving them a separate panel. And I know FDA 

agreed to testify here today. Had I been aware of it, I would have 

objected, because I think this is a very bad precedent. But we will 

go along with what has been agreed to for today, but I want it understood that this should be an exception, not the rule. 

FDA particularly should be the focus of a lot of our inquiry. Is 

there a culture at FDA where they are slowing things down? Or is 

it a fact that they don’t have enough resources? It is ironic that on 

the House floor today we are voting on a budget that will cut 

FDA—cut a lot of other things—but cut FDA. 

So it is a little bit insincere when members talk about wanting 

to get more drugs and devices approved so that the consumers can 

get the benefits of the innovation, but, at the same time, we cut 

FDA to make it more difficult for them to accomplish that goal. 

9 

Thank you, Mr. Chairman. Yield back my time. 

Mr. PITTS. The chair thanks the gentleman. 

There is a vote on the floor, so we will recess until as soon as 

possible after the last votes, about 10 minutes after the last votes, 

and we will reconvene at that time. 

The committee stands in recess. 

[Recess.] 

[Additional statements for the record follow:] 

PREPARED STATEMENT OF HON. JOHN D. DINGELL

Thank you Mr. Chairman. 

Today’s hearing focuses on a very important topic—the impact regulation has on 

the development and approval of medical devices in the U.S., as well as the impact 

these regulations have on job creation and patient access. 

In his State of the Union President Obama called on the need for government and 

business to work together ‘‘to out-educate, out-innovate, and out-build the rest of the 

world.’’ This is a lofty goal, and a needed goal. Our peers in China, Japan, and India 

are hungry and motivated to be the leaders in the fields of education, science, and 

technological development—such as in the medical device field. 

Yet I would ask my colleagues this very important question, how can we out-innovate our neighbors when the proposed CR we are voting on this week cuts the FDA’s 

funding by roughly 10 percent—or $220 million. Our major research institutions will 

also see massive cuts—the NIH will see a cut of over $1 billion, the NSF will see 

a cut of $359 million and the Department of Energy Office of Science will see a cut 

of $893 million. How can our country out-innovate our competitors when we are 

blindly slashing the budgets of our country’s research engines? 

As my colleagues know, I have been raising concerns for years about the state 

of funding at the FDA. I find it curious that some of my colleagues who express concern about the speed with which medical products are approved in this country are 

prepared to vote to cut funding for the agency responsible for approving drugs and 

devices—an agency that has been systematically starved of resources over decades. 

Many of my colleagues have also voiced strong opposition to user fees, and increasing these user fees. I would ask these colleagues, if you will not increase funding for FDA to hire the necessary personnel to improve the medical device process, 

and you will not support a user fee to improve the process, how do you expect our 

country to compete with China and Brazil and India? 

I hope today will be an opportunity for all Members of the Committee to learn 

how very important resources are—financial and personnel—to the FDA’s ability to 

fulfill its mission. More importantly, this hearing will allow us to begin to consider 

how best we can help our businesses work with FDA to accomplish both of their 

needs—the development of successful, safe and effective devices. 

I look forward to hearing from our witnesses and I thank you for your time. 

PREPARED STATEMENT OF HON. EDOLPHUS TOWNS

Mr. Chairman, Ranking Member Pallone, thank you for holding this important 

hearing on the impact of medical device regulations on jobs and on patients. 

Let me start out by saying that I am glad to see that we are holding a hearing 

on job creation. This is what the American people want to see, and it is what people 

in my district really want to see. 

I think it is important that while we consider regulations that impact companies, 

we should take a balanced approach and consider the impact these regulations have 

on patients. We need to do what we can to speed innovative products to the market, 

while ensuring that these products are safe. These devices range in risk—from lowrisk products like tongue-depressors to high-risk products like aortic stints. It would 

be devastating to patients and their families for a defective or unsafe high-risk product to be sped to market. 

I understand the criticism surrounding the regulatory process, but certain safeguards simply must be maintained in order to protect the public. Around 98% of 

medical devices each year are approved through the 501(k) process by the FDA, yet 

these devices rarely undergo any testing in patients, and manufacturing facilities 

are not subject to FDA inspections. Partially because of this, we have seen recent 

examples of withdrawals of medical devices such as implantable defibrillators that 

10 

have frequently failed and resulted in inappropriate shocks or failure to function 

during cardiac arrest. Similarly, automated external defibrillators (AEDs) were approved 

under the 501(k) process, which have resulted in over 28,000 reports to the FDA 

of AED failures, and hundreds of deaths. 

A serious review of the safety of these devices may have prevented patients and 

their families from undergoing unnecessary suffering. 

It is clear that the review process by which FDA approves medical devices is in 

need of updated; however, let us not forget the serious public safety implications involved as we examine what needs to be done. 

Thank you, Mr. Chairman. I yield the balance of my time. 

Mr. PITTS. The hearing will reconvene with apologies to our witnesses. 

We have a panel of six. Let me introduce the witnesses. 

Dr. Jeff Shuren is the Director of the Food and Drug Administration’s Center for Devices and Radiological Health. Dr. Joshua 

Makower is a Consulting Professor of Medicine at Stanford University. He is also the CEO of ExploraMed Development and a venture 

partnership at New Enterprise Associates. Mark Deem is the Managing Partner and Chief Technology Partner of The Foundry. Dr. 

Rita Redberg is the Director of Women’s Cardiovascular Services 

and Professor of Medicine at the University of California, San 

Francisco Medical Center. Dr. Steve Nissen is a Professor of Medicine at the Cleveland Clinic Lerner School of Medicine and Chairman of the Department of Cardiovascular Medicine of the Cleveland Clinic Foundation. And Mr. Ralph Hall is a Distinguished 

Professor and Practitioner of Law at the University of Minnesota 

Law School. Without objection, your written statements will be inserted into the record. We will ask the witnesses to summarize 

their testimony into 5 minutes. 

At this time, we will recognize Dr. Shuren for 5 minutes. 

STATEMENTS OF JEFFREY E. SHUREN, M.D., J.D., DIRECTOR, 

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH, FOOD 

AND DRUG ADMINISTRATION; JOSHUA MAKOWER, M.D., 

EXPLORAMED DEVELOPMENT, LLC; MARK DEEM, MANAGING 

PARTNER AND CHIEF TECHNOLOGY PARTNER, THE FOUNDRY; RITA REDBERG, M.D., MSC., DIRECTOR, WOMEN’S CARDIOVASCULAR SERVICES, UCSF MEDICAL CENTER DIVISION 

OF CARDIOLOGY; STEVEN E. NISSEN, M.D., PROFESSOR OF 

MEDICINE, CLEVELAND CLINIC LERNER SCHOOL OF MEDICINE AT CASE WESTERN RESERVE UNIVERSITY, AND CHAIRMAN, DEPARTMENT OF CARDIOVASCULAR MEDICINE, 

CLEVELAND CLINIC FOUNDATION; AND RALPH HALL, DISTINGUISHED PROFESSOR AND PRACTITIONER, UNIVERSITY 

OF MINNESOTA LAW SCHOOL 

STATEMENT OF JEFFREY E. SHUREN, M.D. 

Dr. SHUREN. Mr. Chairman and members of the subcommittee, 

I am Dr. Jeff Shuren, Director of the Center for Devices and Radiological Health at the Food and Drug Administration. Thank you for 

the opportunity to testify today. 

Over the past decade, most indicators in medical device industry 

success have gone steadily upwards. From 2005 to 2009, the industry has added over 45,000 jobs, according to U.S. census data. It 

is one of the few U.S. manufacturing segments with a positive 

11 

trade balance. An especially crucial indicator is the attractiveness 

of an industry to capital investors and entrepreneurs. In 2010, the 

medical device industry was fourth in attracting venture capital investment, up from 13th place 10 years ago. 

Although the medical device industry has weathered the recession far better than most of our industries, the economic climate 

has had an impact, with some companies choosing to move overseas. And as recent reports note, the recession has also caused 

companies to change their business models to be more risk averse 

and therefore more sensitive to FDA regulatory uncertainties. 

We recognize that smart FDA regulation is critical to maintain 

U.S. competitiveness. Some would say that, despite the record of 

growth and prosperity in the U.S. device industry, the European 

regulatory system is better for industry and patients. It is difficult 

to make direct comparisons between the U.S. and European systems, given their fundamental differences, including, at the most 

basic level, differing approval standards. 

The EU lacks the requirement in U.S. law that devices be shown 

effective. Device manufacturers in Europe select from a list of private companies for safety reviews and pay the chosen company for 

that review. The result is a European review process that does not 

have adequate public accountability, consistency, and transparency 

and is thus almost impossible to compare directly with FDA’s. 

This is in part why the European Commission has proposed that 

the EU regulatory framework be strengthened to better meet European public health expectations and to make European industry 

more competitive globally. 

Our data reported to this committee just last week shows that, 

in fact, FDA’s device review performance has been consistently 

strong; and even an industry funded study released just today 

shows we are beating the Europeans in the review time for lower 

risk and are in a tie for higher risk 501(k) devices. 

Perhaps the more important consideration vis-a-vis Europe, however, is our comparative safety records. As a recent industry funded 

study pointed out, the absence of a centralized public database that 

captures all EU recalls and approvals makes it impossible to accurately compare recall rates in the EU and the U.S., and yet that 

study shows that 85 percent of safety reports come from only 5 out 

of the 24 European countries examined, suggesting there is a significant underreporting of safety problems by some EU countries. 

In addition, that same study claims that both devices come on 

the market earlier in the EU and that recalls of specific devices in 

the EU and U.S. tend to occur within a few weeks of each other. 

If that were true, it would suggest that the EU takes longer to 

identify problems, exposing patients there to unsafe devices for a 

longer period of time. 

In just the past few months, a surgical sealant and a form of 

breast implants were determined to be dangerous and pulled from 

the market after being approved under the EU system and used in 

thousands of patients. The result was surgical removal and patient 

suffering. Neither of these products were sold in the U.S. 

Previously, other devices approved in Europe and not in the U.S. 

were pulled from the European market due to safety problems, in 

some cases, problems first identified in studies required by the 

12 

FDA to support approval for U.S. patients. If those products had 

been approved here, I have no doubt we would be having a different hearing today. 

FDA has a responsibility to facilitate device innovation while assuring that devices are safe and effective. The comprehensive reports we released in August of last year showed that we have not 

done as good a job managing our premarket programs as we 

should. We have new reviewers who need better training. 

We need to improve management oversight and standard operating procedures. We need to provide greater clarity for our staff 

and for industry about key parts of the 501(k) program. We need 

to provide greater clarity for industry about what we need from 

them to facilitate more efficient, predictable reviews. We need to 

find the means to handle the ever-increasing workload and reduce 

staff and manager turnover, which is almost double that in the 

drug and biologic centers. 

We need to meet all of these challenges to improve predictability, 

consistency, and transparency in premarket review programs. 

In January of this year, after extensive public input, we announced 25 specific actions we are taking this year to ensure that 

our premarket review programs both foster innovation and assure 

the safety and efficacy of medical devices for American patients. 

And just last week Commissioner Hamburg and I proposed the Innovation Initiative to accelerate the development and evaluation of 

innovative medical devices and strengthen the Nation’s research infrastructure for developing breakthrough technologies in advancing 

regulatory science. 

Mr. Chairman, I commend the subcommittee’s efforts; and I am 

pleased to answer any questions the committee may have. 

[The prepared statement of Dr. Shuren follows:] 

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Mr. PITTS. The chair thanks the gentleman and recognizes Dr. 

Makower for 5 minutes. 

STATEMENT OF JOSHUA MAKOWER, M.D. 

Dr. MAKOWER. Thank you, Chairman Pitts, Ranking Member 

Pallone, members of the subcommittee. Thank you for the opportunity to testify today. 

My name is Josh Makower, and I have dedicated the past 22 

years of my life to developing therapies and technologies to improve 

patient care. Over this time I have founded six independent medical device companies which have created several hundred jobs and 

touched the lives of hundreds of thousands of patients worldwide. 

In addition to being a physician, inventor and entrepreneur, I cofounded the Stanford Biodesign Innovation Program to teach the 

process of medical innovation to the next generation of innovators. 

I am here today because I am deeply concerned that we are in 

jeopardy of losing U.S. leadership position in medical technology innovation as a result of the current regulatory environment at FDA. 

Over the past few years, it has been increasingly more difficult, 

more time consuming, more costly, and less predictable to navigate 

the FDA. As a result, investment is drying up, companies are moving overseas or closing their doors, and U.S. patients are being denied timely access to safe and effective new medical products. If 

this situation does not improve immediately, a generation of innovation businesses will be lost, along with the jobs they would have 

created and the lives they would have saved or improved. 

These are not my concerns alone. Numerous studies and reports 

over the past year document the difficulty innovators are having 

navigating the FDA. 

In response to questions from Members of Congress and FDA officials regarding the scope of the problems, I, along with several 

colleagues from Stanford, conducted a survey of over 200 medical 

technology companies to generate data on their specific experiences. So much of what has become policy over the past few years 

has been based on anecdote and singular examples, and I felt compelled to bring data to this discussion. It is essential we use data 

to drive our decision making. Recognizing that all studies have limitation, mine is no different. However, the results of my study are 

compelling and justifiably cannot be ignored or dismissed. 

I have submitted the results of the full survey as part of my testimony but want to briefly point out some of the most significant 

findings. 

Most notably, the survey found that, on average, innovative new 

medical devices are available to U.S. Citizens 2 full years later 

than patients in other countries. In some cases, American patients 

wait as long as 6 years, longer than patients elsewhere for American-made technology. This hurts patients’ health and U.S. competitiveness. 

There is no other way to say this. Today, American innovation, 

investment, and manufacturing in medical technologies are leaving 

this country and landing in Europe, Asia, and elsewhere first. 

These findings don’t only have negative repercussions for patients. 

They hurt job creation in this country. 

29 

The most innovative products being designed today are really 

made by small and mid-sized companies. These are the very 

innovators that the President and Congress have called upon to 

lead us out of our economic challenges, but they are starving for 

funding, and they are running out of time. They are being crushed 

with overly burdensome regulation; and now, with the medical device tax, they are being taxed before they ever become profitable. 

This is wrong, and we cannot let it continue. 

We all know we need an FDA. Their mission to protect and promote the public health is a good one. We all want products that 

have a reasonable assurance of safety and efficacy, but we cannot 

make the process so difficult or so costly that we kill the very innovation we depend upon to advance the public health, the very innovation we depend upon to advance our economy. 

Today, unfortunately, this industry is at a crossroads. Driven by 

high-profile anecdotes and a fear of making a mistake, our FDA 

has become more risk averse, while becoming less predictable, less 

reasonable than in any time in our history. 

My colleagues and I who have spent our careers focused on patient care are now seeing foreign patients reaping the benefits of 

American ingenuity first before Americans ever get a chance to. We 

are seeing jobs move overseas; and, worse, we are seeing yet another one of America’s great industries brought to its knees, struggling to survive under a system we created. 

Let’s work together to make sure that American patients and 

workers reap the benefits of these amazing medical advancements 

first. Let’s work together to provide a predictable and reasonable 

regulatory environment for our Nation’s med-tech entrepreneurs, 

and let’s make sure that the generation of innovation is not lost 

forever. We owe this to the pioneering medical innovators who 

came before us, to our students, and the innovators of the future, 

to the men and women whose jobs rely upon us, and, most importantly, to the patients who depend upon us for their survival and 

their quality of life. 

Thank you. 

[The prepared statement of Dr. Makower follows:] 

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Mr. PITTS. The chair thanks the gentleman; recognizes Mr. Deem 

for 5 minutes. 

STATEMENT OF MARK DEEM 

Mr. DEEM. Chairman Pitts, Ranking Member Pallone, and members of the subcommittee, thank you for having me here today. 

My name is Mark Deem. A biomedical engineer by training, I 

spent 23 in medical device research and development. Today, I am 

a partner in a medical device incubator called the Foundry. Our job 

is to partner with physicians to investigate unmet clinical needs 

and to invent and develop technologies to create superior patient 

outcomes. 

Over the past 12 years, we have founded, funded, staffed, and 

run 14 startups. We have raised over $700 million in venture capital. We are inventors on over 250 issued and pending U.S. Patents, and we have employed over 500 people. 

Because of these startups, patients who 10 years ago would have 

had major open heart surgery for cardiac valve disease can now undergo a 1-hour catheter based procedure to have their valve repaired. 

Patients who would have been sent to a rehab facility after suffering a stroke to simply hope for the best can now have the blood 

clot responsible for that stroke removed using a tiny device threaded through their arteries. 

Patients with drug-resistant hypertension can undergo a 30- 

minute procedure that lowers their blood pressure by 3 to 5 times 

by what drugs can achieve. 

Startups are responsible for a huge percentage of the paradigmshifting breakthroughs in medical care. We are the most fragile 

end of the medical device ecosystem, and we are struggling. Over 

the last 2 years, funding for new startups has dropped by almost 

50 percent, down from 118 new companies in 2008 to 60 in 2010. 

Delays and unpredictability at the FDA are one of the primary 

risk factors impacting this investment. Over a similar time period, 

the average time to PMA approval increased by 75 percent; and 

many of those companies never get there at all. 

In 2000, we—emphasis medical to convert an extremely morbid 

open chest surgery to treat emphysema to a noninvasive scopebased procedure. Eight years and over $75 million of investment 

having met the clinical trial endpoints, the FDA denied approval 

for the therapy and recommended continuing on to new studies. 

In the face of these moving targets, the board voted to shut the 

company down in 2009. Forty employees lost their jobs, and the assets were sold at auction. The technology continues to treat patients overseas safely and effectively today. 

Also in 2000, we started a company named Satiety to develop a 

non-invasive, scope-based technology to reduce stomach volume and 

to treat morbid obesity and diabetes. Ten years and over $80 million of investment later, having met the trial endpoint but while 

still collecting long-term follow-up, we learned that the FDA was 

holding companies to a different standard than the ongoing study 

was constructed to demonstrate. Given past experience, the writing 

was on the wall for a request for new studies. Just before ChristVerDate Nov 24 2008 11:41 Aug 03, 2011 Jkt 037690 PO 00000 Frm 00087 Fmt 6633 Sfmt 6633 P:\MY DOCS\HEARINGS 112\112-9 021711\112-9 CHRIS
82 

mas of 2010, 37 entrepreneurs lost their jobs as we shut that company down as well. 

Today, it is also harder than ever to even get a trial started in 

the U.S. In 2002, we started Exstent to develop a next-generation, 

drug-eluding stent. Starting in 2004, we worked with the agency to 

plan a trial, finally submitting an I.D. in 2007. For 2 years, the 

agency requested more and more data, ultimately requiring an animal study in pigs with a 2-year follow-up. At the time, Exstent had 

data from European studies with 1-year follow-up on 220 patients, 

2-year follow-up on 100 patients, and 3-year follow-up on 30 patients. 

While certainly nobody would consider U.S. patients as guinea 

pigs, there is no justification for ignoring that kind of data. Could 

20 pigs in Michigan really provide more significant data than hundreds of patients in Europe? 

Finally in May of 2009, conditional I.D. Approval was granted to 

Exstent. But by then the company was out of money and was being 

sold at auction. Over 200 people lost their jobs. Today, development 

of that technology continues in China and Switzerland. 

Experiences like these have led us to fundamentally rethink how 

we operate. Given the relative stability and predictability of the CE 

system, we are no longer structuring our companies for first commercial release in the U.S. We develop our products here and then 

run the same large, multi-center, randomized trial overseas that 

we would have conducted in the U.S. We then commercialize in the 

EU while we decide when and if to approach the FDA. As a result, 

as you have heard, the available of new therapies in the U.S. Can 

lag the EU by up to 4 years. 

We recognize the challenges facing the FDA, and we do value its 

mission to protect and preserve public health. But we need consistency and clarity to help the FDA achieve its other mission of fostering innovation. A recent study by the Boston Consulting Group 

shows the EU’s safety record is essentially identical to that of the 

U.S. 

So if we are not increasing safety, why should we be satisfied 

with a system that is driving investment, innovation, and jobs 

overseas? Why should we be satisfied with a system where U.S. patients wait 4 years longer for access to care that was pioneered in 

the U.S.? Because the sad fact is many of those patients simply will 

not live that long. 

[The prepared statement of Mr. Deem follows:] 

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Mr. PITTS. The chair thanks the gentleman and recognizes Dr. 

Redberg for 5 minutes. 

STATEMENT OF RITA REDBERG, M.D. 

Dr. REDBERG. Thank you, Chairman Pitts, Chairman Upton, 

Ranking Member Pallone, Ranking Member Waxman, and others 

of the subcommittee for this invitation to present some of our work 

on medical devices. 

I am Rita Redberg. I am a professor of medicine and full-time 

faculty member at the University of California, San Francisco Medical Center in the Division of Cardiology. I am also the chief editor 

of the Archives of Internal Medicine, a well-respected peer-reviewed medical journal which publishes much research in the area 

of internal medicine as well as in medical devices. I was a Robert 

Wood Johnson Health Policy Fellow in the office of Senator Orrin 

Hatch, and I am currently a member of the FDA Cardiovascular 

Device Expert Panel as well as the California Technology Assessment Forum. 

As a practicing cardiologist, I am very grateful for the advances 

in medical technology that have allowed me to take better care of 

my patients every day. However, I have great concerns that many 

high-risk devices that are reaching the market today are doing so 

without the benefits of clinical trials which are essential to assure 

safety and effectiveness for my patients. 

Although the 501(k) process was logical and well-intentioned 

when introduced in 1976, it has in no way kept up with the increased number and complexity of medical devices now available 

today, particularly in my own field of cardiology as well as in orthopedics. 

Unfortunately, although a new device sounds very exciting and 

glamorous, it cannot be said to be innovated unless it has been 

shown in a well-done clinical trial to have actual benefit for patients. No matter how innovative a device is, if it is not showing 

benefit for patients, it is not—I will consider it innovative, and it 

can’t be considered to be beneficial. 

Unfortunately, we now have a process where more high-risk devices are going through a 501(k) clearance than are going through 

the original PMA process. The GAO report in 2009 entitled ‘‘FDA 

Should Take Steps to Ensure That High-Risk Device Types Are Approved Through the Most Stringent Premarket Review Process’’ 

found that less than 1 percent of all new devices go through the 

PMA process. That was not the intent of Congress; and, at the 

time, FDA resolved to either reclassify these high-risk devices to a 

lower-risk class or to go through an original premarket approval 

process. Unfortunately, that has not yet happened. 

I want to give you one example of the inferior vena cava filter. 

This was published in the Archives of Internal Medicine. The Bard 

Recovery and inferior vena cava filter and G2 device were approved 

by the FDA pursuant to the 501(k) process. The filter is an umbrella-like device that is put in the main vein in the heart in order 

to trap clots. This device was investigated by surgeons, including 

Dr. William Nicholson and colleagues in Pennsylvania, because 

they noted that several patients of theirs who had this device were 

coming back in with severe chest pain and shortness of breath. 

88 

Upon investigation, they discovered that this device was fracturing and moving to other parts of the body, including the heart, 

causing puncture of the heart and severe complications. These doctors took it upon themselves to investigate all of the patients at 

their hospital that had received this device over the last 5 years 

and found that fully one in four of one type and one in eight of the 

other type of this filter had fractures. They published these findings as well as notified the FDA. 

In my own research on this device, I was shocked to discover that 

this clearly high-risk implanted device had gone through FDA 

501(k) clearance without the benefit of any clinical trial data; and, 

in fact, there is no randomized data to show that inferior vena cava 

filters are superior to other methods for treatments of blood clots 

and prevention of recurrent of pulmonary emboli. 

The FDA on the day we published these studies on August 9 last 

year issued a warning reminding physicians to retrieve these filters 

because they were meant to be put in and then removed. However, 

less than 7 percent of all of these filters are currently retrieved. 

When I investigated on why the FDA waited 5 years and 921 adverse events to release this morning, I learned that the FDA did 

not know there were so many serious adverse events because, unfortunately, the computer systems available are arcane and don’t 

allow for real-time monitoring; and so I think that, in order for the 

FDA to fulfill its mission of protecting the public safety, the FDA 

needs increased resources and staffing. 

We heard that the medical device industry is $135 billion a year 

in products that are currently covered by Medicare as well as private insurance. In contrast, the Center for Devices and CDRH receives a small budget of $272 million to do all of the premarketing 

as well as post-marketing surveillance of this huge device industry. 

So I think to allow the FDA to fulfill its mission to ensure safety 

and effectiveness, and that includes adequate premarketing and 

post-marketing data, we need to give the FDA adequate resources 

to do so. 

Thank you so much. 

[The prepared statement of Dr. Redberg follows:] 

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Mr. PITTS. The chair thanks the gentlelady and recognizes Dr. 

Nissen for 5 minutes. 

STATEMENT OF STEVEN E. NISSEN, M.D. 

Dr. NISSEN. Thank you for the opportunity to testify today. 

My name is Steven E. Nissen, M.D. I am chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic. My 

testimony does not reflect the views of the Cleveland Clinic. 

I agree with the underlying premise of these hearings. For decades, the American medical products industry has been responsible 

for innovations that have saved lives, reduced suffering, and sometimes even lowered medical costs. I also agree that this industry 

creates high-quality jobs that contribute to the Nation’s economic 

health. 

The dilemma proposed by today’s hearings is how to best promote innovation, while protecting the health of the American people. Medical devices are regulated via an antiquated regulatory system originally devised in 1976 that employs two very different 

pathways to market. 

Premarket approval is a rigorous standard similar to the approach used to regulate pharmaceutical products. The 501(k) provision allows products to be cleared for market if they are deemed 

substantially equivalent to devices already marketed, many before 

1976. Surprisingly, 35 years later, the 501(k) pathway is now used 

for 98 percent of all medical devices. 501(k) cleared devices rarely 

undergo any testing in patients, and manufacturing facilities are 

not subject to FDA inspections. Often, new devices are very dissimilar to previously marketed medical products, use different materials and manufacturing processes, and have different intended 

uses. 

The abbreviated 501(k) process was never intended for Class III 

medical devices, products used for life-supporting or life-sustaining 

indications. However, FDA has sometimes cleared such devices for 

market using the 501(k) provision, a policy that was sharply criticized by the GAO in a 2009 report. 

In recent years, several high-profile withdrawals of medical devices have resulted in serious injuries or death. In a particularly 

poignant example, a faulty lead used in an implantable 

defibrillator frequently failed, resulting in inappropriate shocks or, 

worse, a failure to function during a cardiac arrest, resulting in 

death. 

When this problem was identified, patients were presented with 

an agonizing choice: to undergo an operation to remove the defective device or take their chances that it wouldn’t fail when needed 

to save their life. 

An artificial hip joint used in 13,000 patients failed rapidly, often 

releasing toxic metal debris which sickened thousands of patients. 

Again, patients faced the choice of a painful and risky operation or 

accepting the possibility of serious health consequences. 

We recently analyzed all 113 high-risk medical device recalls 

from 2005 to 2009 of products FDA deemed could cause serious injury or death. Surprisingly, 71 percent of these high-risk recalls involved devices initially cleared using the 501(k) process. Only 19 

percent had undergone full PMA approval. 

98 

This finding represents a paradox. If by Federal regulations 

high-risk devices should not be cleared using the 501(k) provision, 

there should almost never be recalls of such devices for life-threatening defects. 

The total number of devices recalled in this interval exceeded 

112 million. According to FDA data, more than 2,000 deaths are reported each year from failure of medical devices, rising to nearly 

5,000 in 2009. These statistics illustrate the need for a balanced 

approach to medical device regulation. 

Although we all want to stimulate innovation and job creation, 

we cannot allow deregulation to place the American public at risk 

for serious health consequences from defective products. A more 

nuanced approach to device regulation would appropriately balance 

the need for timely approval with patient safety. 

Components of reform should include: a more accurate definition 

of a high-risk device which takes into account the likely risks if the 

device is defective; an intermediate regulatory category more rigorous than 501(k) but short of a full PMA process for moderate risk 

devices; and, very importantly, better funding for the FDA Center 

for Devices to enable timely but thorough evaluation of the risks 

and benefits of medical devices. 

Thank you again for the opportunity to appear here today. 

[The prepared statement of Dr. Nissen follows:] 

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Mr. PITTS. The chair thanks the gentleman and recognizes Mr. 

Hall for 5 minutes. 

STATEMENT OF RALPH HALL 

Mr. HALL. Chairman Pitts, Ranking Member Pallone, members 

of the committee, I appreciate the opportunity to appear today and 

to discuss with you the 501(k) system in general and specifically 

some research I have done into the safety profile of devices cleared 

via that process. 

I serve on the faculty at the University of Minnesota Law School 

where I teach in the food and drug law area and concentrate my 

writing and my research in that area. In addition, I work part time 

with the law firm of Baker & Daniels, counseling firms in FDA 

matters; and with three other individuals we have formed a startup medical device company called MR3 Medical. 

Going back several years when the debate over the 501(k) system 

began, I observed that the debate was taking place with little data. 

There was a lot of anecdote, a lot of individual events that people 

were discussing; and at a public meeting about a year ago I commented we were involved in a ready, fire, aim situation. 

And, therefore, I conducted a study—the first of its kind I believe—to try do assess the safety profile of 501(k) products. This 

was funded by the Kauffmann Foundation out of Kansas City. I 

was given total academic freedom. 

It should be clear that I am speaking in my individual capacity, 

not on behalf of any entity, particularly the University of Minnesota. In this study, we analyzed Class I or high-risk recalls for 

over a 5-year time period. We coded these for a number of factors, 

including the reason for the recall. We think that is critical, because you need to identify events, recalls, then the cause of that, 

in order to identify what can be done to address it. 

The results of this is we had 118 Class I recalls, 112 of which 

were relevant. The other 6 involved counterfeit products, things 

like that. Of these, 89 involved 501(k) products. This has to take 

into account the number of 501(k) submissions during the time 

frame. You can’t simply look at the numerator. During this same 

time frame, the best estimates are, there were over 19,000 501(k) 

submissions. What that means is, from a safety perspective, greater than 99.5 percent of all 501(k) submissions did not result in a 

Class I recall during the study period. 

We then further delved into the data and identified which reasons for the recall related to post-market issues, as compared to 

pre-market issues. Obviously, an issue that happens 5 years after 

the product is approved or cleared, because of a labeling mistake 

or whatever, is not accountable to the approval process. And it 

turns out that less than half of all recalls relate to issues that 

could have involved pre-market activities. We further analyzed the 

data, looking at the reasons for the recall, and less than 9 percent 

of all recalls involved issues other than quality system issues. 

What this indicates to us is the system, as a whole, from a safety 

perspective, is operating very well. Can we do better? Of course. Do 

we need to do better? Of course. 

To help with that effort, then, we did a subanalysis even further 

by type of device, and we identified the concentration of recalls in 

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automatic external defibrillators and infusion pumps—28 percent 

of all recalls. Interestingly, the agency has now commenced two initiatives on those products. From our perspective, that is the right 

way to approach this: identify the issue and address the specific 

issues. The information I am talking about has been presented to 

the IOM, reviewed with FDA and other stakeholders. 

So what does our study then conclude? FDA has an excellent 

safety record in the 501(k) program. Improvements can be made. 

We need to strive for improvements. We need to always concentrate on the risk-benefit analysis. And the most effective way to 

improve the safety profile of products is to increase and further emphasis on quality systems, as compared to pre-market products. 

Stated differently, change in the pre-market clearance process, 

based upon our data, will have a minimal effect on reducing the 

number of recalls. Therefore, our conclusion is that the focus 

should be on quality systems as a primary way to improve the safety of products for the U.S. public. 

Thank you very much. I would be happy to answer any questions. 

[The prepared statement of Mr. Hall follows:] 

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Mr. PITTS. The chair thanks the gentleman, thanks all the witnesses for your testimony. 

And we will go to questions at this time. The chair recognizes 

himself for 5 minutes for questioning. 

We have heard a lot of discussion today on the medical device approval process used by the FDA. Mr. Hall, your study focused on 

recalls of medical devices approved through the 501(k) and the 

PMA process. Based on your research into the recalls, is FDA clearing unsafe products? 

Mr. HALL. In my study, FDA has an excellent record in approval 

of products, with greater than 99.5 percent of products not experiencing a recall. 

Mr. PITTS. Could you comment, please, on the study published 

this week in the Archives of Internal Medicine? How did those 

study authors end up with recall results that are much higher than 

what your study found? And can you comment on the methodology 

used in the Archives of Internal Medicine study? 

Mr. HALL. Yes, Mr. Chairman. The data that was used by both 

studies ended up with very similar numbers for what I call the numerator. I had 118 Class I recalls. I believe they had 112 or 113, 

something like that. 

Where the differences are is that we also went beyond just looking at the number of absolute recalls, but looked at the percentage 

of that compared to the number of submissions. If my daughter 

comes home and got, you know, 80 wrong out of 150, which is the 

number of PMAs, that is a problem. But in the 501(k) world, there 

are over 19,000. So we are talking about in their study 80, in my 

study 89 recalls out of over 19,000. 

We also looked at the reason for the recall. That is critical to understand what to focus on. 

Next, there is a confusion about comparing high-risk devices for 

approval process to high-risk devices for recall. Those are very different things, and it is important that the committee understand 

that. The classification for an approval is the risk for the intended 

use. The recall is the risk to the patient for the malfunction. 

And let me give you a very simple example, a tongue depressor. 

No one would consider a tongue depressor to be high-risk or needs 

a clinical study. But if the tongue depressor gets contaminated 

with a deadly bacteria, the recall for that tongue depressor should 

be a high-risk recall. And so, you cannot link the approval classification with the recall. 

A final comment on the lawyer—I am a law school professor. At 

a different environment, we should talk about—there are a number 

of statements about the law in the article, which I think need to 

be corrected. 

Mr. PITTS. Thank you. 

Dr. Makower, in your work, you find that companies spend $31 

million to bring low-risk devices to market. And, of that amount, 

$24 million is spent navigating the FDA approval process. Your 

findings for bringing higher-risk devices to market are even more 

staggering. Companies must spend $94 million, spending $75 million navigating the FDA approval process. 

Can you break down the investments that a typical company 

might make to help them navigate the FDA? How feasible is it for 

125 

a small company to come up with appropriate funding to navigate 

the process at the FDA? 

Dr. MAKOWER. Quite honestly, these are figures that are exceeding venture capital’s ability to fund startups to these levels. And, 

thus, that is why we are seeing a decrease in the number of 

startups, because people don’t want to take that big financial risk 

for getting these products all the way to market. And with those 

costs increasing, that capital just is not available. 

Mr. PITTS. Mr. Deem, would you care to comment on that, too? 

Have any of your companies closed because of the expense involved 

in navigating the FDA process? 

Mr. DEEM. Each of the three examples that I gave today, at the 

end of the day, ended up shutting the doors because it was the 

judgment of the board of directors that further investment to continue through the regulatory process, given the barriers that they 

had already hit and the moving milestones that they were being 

asked to hit, the further investment was just not justified. 

So it wasn’t that we didn’t think that ultimately we could get 

through the process. We thought perhaps eventually we could get 

through. But given the moving goalposts involved, the extra investment was not justified, and the companies were shut down. 

Mr. PITTS. Just one final question, Dr. Makower. According to 

your work, device approval times in the U.S. are much longer in 

the U.S., compared in Europe. And you find that those companies 

who spoke with the FDA about conducting a clinical study for their 

low- to moderate-risk device before making a regulatory submission, the pre-market process took an average of 31 months from 

first communication to being cleared to market the device. In contrast, the equivalent process in Europe took an average of 7 

months. 

And the higher-risk devices seeking pre-market approval, companies indicated, took an average of 54 months to work with FDA 

from first communications to being approved to market the device. 

In Europe, it was 11 months. 

Did your study identify any reasons as to why there is such a 

discrepancy in approval times? 

Dr. MAKOWER. The major difference is that, in Europe, a study 

run by high-quality investigators that makes clinical sense to a 

specialist in the field are generally accepted as data for approval, 

and there isn’t a lengthy negotiation over end points or study design that usually happens in the United States. 

Whereas, in the United States, that process, even just the process of obtaining an IDE, which is the approval necessary to do a 

study in the United States, that can take years. And so that, alone, 

is a reason why the two systems are different. 

Mr. PITTS. Thank you. 

The chair recognizes the ranking member for 5 minutes for questions. 

Mr. PALLONE. Thank you, Mr. Chairman. 

I am going to ask Dr. Shuren a question. But before I do, I just 

wanted to say, I think it is important that when we talk about innovation, which is what I talked about in my opening, and, of 

course, the President talks about it constantly, that when we talk 

about innovation, we talk about safety and effectiveness of devices 

126 

at the same time. Because innovation in devices can generate positive changes in the health of all Americans but only if we can properly ensure the safety of those devices. 

But navigating the FDA process, you know, shouldn’t be unpredictable and it shouldn’t be unreasonably long. So I was a little 

stunned to hear Dr. Makower’s finding that it is 2 years longer for 

approval in the U.S. As compared to Europe for low- or moderaterisk devices and 31⁄2 years longer for higher-risk devices. 

I wanted to ask Dr. Shuren, you run the center responsible for 

these approval times. And I find these numbers outrageous, this 

difference between the U.S. and Europe. How is that possible? 

What is the situation? 

Dr. SHUREN. I don’t think, with all due respect to Josh, I don’t 

think the study is an accurate reflection of what is going on now. 

And putting aside the very low reporting in this survey, which 

means it is going to be biased to the most dissatisfied, if you actually look at the data on PMAs and this long time between us for 

approval and the EU, the time frame is at 54 months versus 11 

months. 

In the U.S., you can come talk to us before you have designed 

a clinical trial. You can talk to us about what the data needs are, 

then develop the clinical trial. Regardless, you are going to come 

in at the time you are going to do a clinical trial. 

If you applied that here for the EU, look at the 11 months. It 

means you would come in to talk, you would develop a clinical protocol, you would set up your study, you would enroll your patients, 

you conduct the study, you collect your data, you analyze it, you 

put together a submission, you send it to the private company who 

reviews it, and they make a decision. In 11 months? That means 

a clinical study of 4 weeks? 

This is comparing apples and oranges. This is comparing when 

you come in to talk to us as opposed to review times. If you actually go ahead—— 

Mr. PALLONE. I am going to have to interrupt because I have to 

get my other questions in here. 

I was heartened to hear President Obama’s comments at the 

State of the Union Address about how the U.S. needs to win the 

future and promote innovation. I keep talking about it. In my own 

State, you know, we have a serious life science industry. And I 

know that FDA also places a high importance on promoting innovation. 

But you mentioned something in your testimony about the steps 

you have implemented to promote innovation. Can you tell us 

about that, what you are exactly doing to promote innovation? 

Dr. SHUREN. Certainly. Well, starting with even the actions we 

are talking under our 501(k) improvement plan, it is about increasing predictability, consistency, and transparency through guidance, 

through training, through administrative changes to make sure 

there is greater management oversight in decision-making, even 

leveraging experts outside of the agency to better inform us on 

tough scientific questions. 

But we are also announcing an innovation initiative, creating 

what we call an Innovation Pathway. It is a paradigm shift in how 

we approach breakthrough technologies, in which we forward-push 

127 

our resources. We frontload them so we are involved early on, and 

we can address some of these tough scientific questions early on. 

And we think, under that program, we can cut our review time in 

half. 

Mr. PALLONE. Thank you. 

Let me just ask you one more thing. I want to ask about resources, Dr. Shuren. As I am sure you are aware, the House Republicans have put forward a continuing resolution that would 

slash the FDA’s budget by 10 percent. And these are cuts on top 

of what is already an underfunded agency, in my opinion. 

If these drafted cuts were to be passed into law, will you have 

the resources to support new initiatives like this Innovation Pathway? And how would these cuts affect your ability to make clearances and approvals more timely and practicable? 

Dr. SHUREN. Well, the Innovation Pathway would be a non-option. And for the rest of what we do, this would result in increased 

delays in decisions. It would deny patients truly safe and effective 

innovative technologies. And it will result in jobs being lost. 

Mr. PALLONE. Well, I am just going to go down the panel. Let 

me just ask—and I have a minute left—does anyone on this panel 

think that drastic cuts to FDA make much sense right now? 

We will start—obviously, Dr. Shuren doesn’t. 

Dr. Makower? 

Dr. MAKOWER. Drastic cuts to—sorry? 

Mr. PALLONE. Well, you could say ‘‘yes’’ or ‘‘no’’ if you want. Do 

you think that drastic cuts, the cuts we are talking about, make 

sense now? 

Dr. MAKOWER. I am not sure. 

Mr. PALLONE. All right. 

Mr. Deem? 

Mr. DEEM. I haven’t looked closely at the situation. Obviously, I 

would need to look at the efficiencies that are involved in the process, as well as the overall number. 

Mr. PALLONE. Okay. 

Dr. Redberg? 

Dr. REDBERG. I think substantial investment is required for the 

FDA for resources and staffing, as well as the entire electronic infrastructure so that it can actually do pre-marketing and post-marketing surveillance, as it would like to. 

Mr. PALLONE. Thank you. 

Dr. Nissen, yes or no? 

Dr. NISSEN. No. 

Mr. PALLONE. Mr. Hall? 

Mr. HALL. My thinking, if that is what the Congress decides, the 

agency is capable of meeting its statutory and public health requirements. 

Mr. PALLONE. Okay. Thank you, gentlemen. 

Thank you, Mr. Chairman. 

Mr. PITTS. The chair thanks the gentleman and yields to Dr. 

Burgess for 5 minutes for questions. 

Dr. BURGESS. Thank you, Mr. Chairman. 

And, of course, funding for the FDA, just to pick up on Mr. 

Pallone’s point, has been an issue that this committee has looked 

at. For the 6 years that I have been on the committee prior to this 

128 

term, we have increased the authorization for FDA spending on 

multiple occasions, but with both Republican and Democratic appropriators, those funding levels have not been met. 

So it is all well and good to criticize a process that is going on 

today. It is a process that was left over from last year. It is unfortunate it looks the way it does, but I really appreciate Mr. Hall’s 

comments. It is up to us to provide the funding. It is up to the administrator at the FDA to get the job done with the tools at hand. 

Why would you pay more for what you are getting? We want 

more of this? How far away from desirable do we care to be? And 

this was really what is driving a lot of this discussion today. 

It appears that the average 501(k) decision has risen almost 20 

percent from 2002 to 2008: 97 days in 2002, 116 days in 2008. The 

director recently released a letter emphasizing, just as you reiterated this morning, the FDA’s dedication to increasing predictability, reliability, efficiency, and transparency of the regulatory 

pathways—all good things. 

Last year, when I was on another subcommittee, I wrote to you 

with my concerns that you were, in fact, altering the processes, but 

doing so independently, without consulting Congress. So I will reiterate the question I asked you in a letter last summer. How, specifically, does the FDA plan to do this? And why did you undertake 

those efforts with the IOM study still not completed? 

Dr. SHUREN. So what we plan to do is a series of actions that we 

announced. And when we put together these reports—and we undertook these reports in part because of concerns that were raised 

by industry and also concerns that were raised by consumer and 

patient groups. And we went out and we conducted comprehensive 

outreach. We had two public meetings, three public dockets, three 

town hall meetings. We put out two reports, 55 recommendations 

in the summer, and we asked for public comment on that. We came 

and we briefed staff on the Hill, both before and after we went out 

with our actions just a few weeks ago. 

Those 25 actions are based around greater clarity through guidance about the 501(k) program, about when to submit clinical data, 

about fixing what is called the de novo process—it is a process for 

the lower-risk innovative devices—because it has been broken for 

years, and it needs to be fixed; better training for my staff. I rolled 

in—we did not have core competencies. We are now putting in 

place core competency training—— 

Dr. BURGESS. Let me stop you there. And perhaps we can get 

some of this accomplished in a written exchange that I had asked 

for last summer. 

Dr. Redberg emphasized the lack of effective electronic capability 

of handling the data, the infrastructure, the architecture for the information technology. How are you doing with that? You have been 

given additional funds over the last 3 years. Are you there yet? Are 

you getting there? Have you been able to digitize your data, not 

just in the new drug application, not just the device application, 

but throughout the agency? 

Dr. SHUREN. I can’t speak for throughout the agency, but we are 

moving forward. We have made progress for setting up the new 

database for adverse event report reporting—— 

129 

Dr. BURGESS. But we kind of hear that every year. And are you 

there yet? 

Dr. SHUREN. We are not there yet. 

Dr. BURGESS. And give us a reasonable expectation of when that 

might happen. 

Dr. SHUREN. We are expecting to have the first prototype up this 

year. 

We will also be coming out this year with the unique device identification regulation, too. And that is going to be critical for linking 

a device with the clinical experience with that device we don’t have 

right now. 

Dr. BURGESS. An excellent idea and, I think, one we have heard 

before. It is just that we are all anxious for that to happen. Because, as I indicated in my opening statement, there are going to 

be real challenges for the researchers at NIH, Don Berwick and his 

crew at CMS being able to implement those new tools that they are 

given by NIH, and you guys stand in the middle. So you are either 

going to be the facilitator or the bottleneck. And I just pray that 

you are going to take that facilitator role very, very seriously. 

Let me just ask you one other question that came up about—I 

think it was Mr. Deem, or perhaps it was Dr. Makower that 

brought it up—the Newsweek article on the race to grow new organs, and organs being grown on scaffolding with the patient’s own 

cells. 

There was a doctor, Anthony Atala, at North Carolina growing 

new body parts for a particular type of difficulty that children could 

be born with. And, as a consequence, he received, I guess, an emergency designation to do this in seven, eight, or nine patients from 

the FDA. Showed some great results. Of course, no rejection because it was the patient’s own cells. Vascularization occurred after 

these devices were implanted. And when you got back to him, you 

said, ‘‘Well, we will have to show it works in animals.’’ I mean, this 

is kind of crazy stuff that just drives people nuts. 

You have a small series of 7 to 10 patients where it is working, 

and you tell this guy, ‘‘Go back to square one, spend another $5 

million, and let’s prove this will work in dogs before we do it in any 

more people.’’ That is why it goes to Europe. That is why it goes 

to Europe. 

Dr. SHUREN. We will look at it, but this may actually involve the 

other center, the Center for Biologics. 

But we do take it very seriously. And I will tell you—I am new 

at the helm, a little bit over a year. And I will tell you, during that 

time, we have been making some important changes. And our performance—and you did ask before—our performance actually has 

been improving. And that 501(k) time actually, for us, we have 

been doing very well. 

What we have found, though, is that the times are going up because industry isn’t pulling its fair share. It has been sending us 

poor-quality submissions. We have been seeing poor clinical studies. And we meet with companies, and they like to meet with us, 

and they are ignoring our recommendations in terms of what to do. 

If we are going to fix this, FDA needs to make changes. And we 

made a commitment to do that, and we are moving forward on 

130 

them. But we also need industry to be held responsible, too, for its 

failures, for the things that we cannot control. 

Dr. BURGESS. Mr. Chairman, could I just ask unanimous consent 

that industry be allowed to respond? Dr. Makower and Mr. Deem 

are sitting right there. 

Mr. PITTS. Without objection, so ordered. 

Dr. MAKOWER. I think the issue is, what is reasonable? And that 

is what this comes down to. And I think you pointed out an example of exactly the type of thing that frustrates industry. 

We are trying to help patients and we are trying to bring therapy 

forward, and sometimes the requests and the requirements—the 

reason why we can’t get agreement on a clinical trial protocol is because what is being asked may sometimes be extraordinary, beyond 

what is a reasonable requirement, and sometimes what is impossible, where you know you have an early-stage technology, it must 

evolve. 

And so, we are depriving physicians, patients the opportunity to 

get access to these things earlier. And that is the net impact, is 

that disagreement, that time frame is what is really delaying innovation reaching patients. 

Mr. PITTS. The chair thanks the gentleman, and recognizes the 

gentleman from Illinois, Mr. Shimkus, for 5 minutes for questions. 

Mr. SHIMKUS. Thank you, Mr. Chairman. 

Mr. Chairman, if you don’t keep a hold on Burgess, he will just 

consume the whole time. I learned that as ranking member last 

Congress. He is very impassioned, and we appreciate his commitment. 

Let’s just talk. The Nation sent a new Congress here to deal with 

the national debt, the deficit, and job creation. The hearings that 

we have had here in the committee are really focusing on, how do 

we create jobs without spending money? And the answer is, we 

have to ease the regulatory burdens. 

The agency is not going to get any more money. So you can ask 

all you want; there is no more money. So if you have demands of 

which you have to do, you have to talk to us and say, ‘‘You know, 

you put this demand on us’’—which we have. Part of it is our problem. Say, ‘‘This is really a stupid thing we shouldn’t be doing.’’ And 

if we jettison this, that will free up money to do what we really 

need to do. 

So, you know, I reject this argument that you all need more 

money. Just like people at home, just like businesses who are in 

lean times, they have to make difficult decisions to get back to core 

competencies. And I think there is an argument, especially in this, 

that we are slowing the process down so much in some of these devices it is nonsensical, and it hurts job creation. 

Now, I have a couple of questions that I want to talk about. In 

October, at that time, I was ranking member of this subcommittee. 

I joined 11 of my colleagues in sending a letter to FDA on the 

501(k) reform changes. In that letter, we asked FDA for an economic analysis of those changes so we could know if it would hurt 

American job creation. 

Dr. Shuren, if you can give me a ‘‘yes’’ or ‘‘no’’ answer, did you 

provide that economic analysis? 

Dr. SHUREN. No. 

131 

Mr. SHIMKUS. Thank you. That is typical of Federal agencies that 

I have been dealing with for the last couple of weeks. 

Mr. Makower and Mr. Deem, since the FDA didn’t provide it, let 

me ask you, what could be the economic impact of these changes 

on American device companies? 

Dr. MAKOWER. These changes being? 

Mr. SHIMKUS. The 501(k)—— 

Dr. MAKOWER. Many of them are things that make sense and, actually, I don’t really think even need much approval. However, 

there are several changes that are being proposed that could have 

a devastating impact on our ability to bring—— 

Mr. SHIMKUS. Quickly, give me a couple examples. 

Dr. MAKOWER. One example is, kind of, the definition of what is 

an intended use. And depending on how that is characterized, if 

that is characterized in one way versus another, it may require 

companies to study not only the intended use that they are actually 

pursuing to get a label on, but all other possible indications that 

doctors might use it on, which would delay access and would probably prevent many technologies from reaching the market. 

Mr. SHIMKUS. Mr. Deem, can I ask you? Did you follow the question, and do you have a response? 

Mr. DEEM. Sure. I think we are also concerned and watching 

closely what is going to happen with the designation of a Class IIb and the requirements and guidances for clinical study that will 

come out of that. And that is still yet to be determined, but we are 

watching it very closely. 

And the reason we are watching it very closely is that the FDA 

right now has the latitude to require clinical data from a 501(k). 

In fact, the only two 501(k)s that we have done out of our 14 companies, we have provided clinical data. We have provided randomized, controlled, blinded clinical data for 501(k)s. 

So it is a misnomer that that doesn’t happen. It certainly does, 

and it can, under the current system. What we worry about is how 

rigorously and how rigidly these other designations might codify 

that. 

Mr. SHIMKUS. Thank you. 

And I am going to try to get this done in my last minute. 

Dr. Shuren, I understand that you are sending seven of the most 

important 501(k) changes to a panel of the Institute of Medicine. 

I understand, also, there are serious questions as to the composition of this panel and the role you gave this panel. So I have the 

following questions. 

Does this panel have any innovators or inventors? 

Dr. SHUREN. I do not believe so. 

Mr. SHIMKUS. Does this panel have any biomedical engineers or 

technical experts? 

Dr. SHUREN. It does. 

Mr. SHIMKUS. Could you provide those names to us? Not now. 

Does this panel have any entrepreneurs and investment and venture capital experts? 

Dr. SHUREN. Not specifically. 

Mr. SHIMKUS. Does this panel have any patient or patient groups 

who are in need of products currently under the 501(k) system? 

132 

Dr. SHUREN. They do have people with connections with the patient community. 

Mr. SHIMKUS. And I would like their names, too, because I don’t 

believe you do. 

How much taxpayer money did you give this IOM panel? 

Dr. SHUREN. I will get back to you on the exact figure. 

Mr. SHIMKUS. Mr. Hall, do you believe the IOM panel is qualified 

to make decisions on the 501(k)? 

Mr. HALL. I think the current members are each individually 

very talented. I am concerned that the committee does not have patient representation, does not have representation from entrepreneurs, the people that fund this, industry groups, et cetera. And 

if you look at other IOM committees, such representation is often 

there. 

Mr. SHIMKUS. Thank you, Mr. Chairman. I yield back my time. 

Mr. PITTS. The chair thanks the gentleman and recognizes the 

gentleman from Pennsylvania, Dr. Murphy, for 5 minutes. 

Mr. MURPHY. Thank you, Mr. Chairman. 

Dr. Shuren, a couple of questions for you, and this relates to 

some areas of jurisdiction for FDA and given the limitations of 

funding and trying to stretch yourself in many ways. 

I am looking here on the Web site, the FDA states it will regulate devices used in the, quote, ‘‘cure, mitigation, treatment, or prevention of disease,’’ unquote. 

I am curious, if a kit is used by an employer to test or screen 

for the presence of drugs, would that be a ‘‘mitigate, treat, or prevent’’ disease category? 

Dr. SHUREN. Yes. And we have been regulating those devices for 

about 20 years. 

Mr. MURPHY. What kind of tests? 

Dr. SHUREN. These are both laboratory-based tests and point-ofcare tests, so tests that are actually used in the workplace. 

Mr. MURPHY. And are they used to treat or diagnose? 

Dr. SHUREN. Yes, if they are not used right, then people actually 

who should get treatment get missed. People who may have an addiction get missed, and they pose a risk then to the employees. Or 

they get false results, and they wind up losing their employment. 

Mr. MURPHY. Do those tests—are they used in such a way that 

a single test can cause them to lose employment, or are they followed up? And if there is a follow-up, is that one that really deals 

more with the employment issue or the treatment issue? 

Dr. SHUREN. Well, I was talking about consequences. But what 

follow-up is done is actually up to the place that is conducting the 

test, whether or not they do a follow-up or not. 

Mr. MURPHY. You also have situations, however, that—are they 

used to promote, on the other hand, an orderly workplace environment or to deter drug use? 

Dr. SHUREN. How it may be used by individual companies, I don’t 

know. But we have regulated it because of the safety concerns that 

occur when those tests are inaccurate. 

Mr. MURPHY. When they are inaccurate. What would be an inaccuracy level that you would consider to be acceptable? 

Dr. SHUREN. What it comes down to is, is it actually measuring 

the drug of abuse or not? And that gets set depending upon the 

133 

kind of tests we have. One of the biggest issues now is with the 

saliva test. We have one that is point of care for saliva that is actually pretty good. The rest that have come through are actually very 

poor. They have a very hard time detecting drug. 

Mr. MURPHY. What is the point-of-care test that is pretty good? 

Which one is that? 

Dr. SHUREN. I will get back to you with the actual name. 

Mr. MURPHY. Okay. Of course, we also know that if one is limited from using these tests—there are differences—collecting different types of bodily fluid—saliva, urine, blood, et cetera—and 

some more invasive in the workplace than others and require more 

staff time, et cetera. There is a difference between those or just a 

first-level screen and those that—some that are sent on to the next 

level. 

You would agree with that, wouldn’t you? 

Dr. SHUREN. Yes, there is a difference between the different 

tests. 

Mr. MURPHY. Now, I know that the FDA has threatened to shut 

down operations for several American manufacturers making this 

saliva equipment but not foreign ones. Are you familiar with that? 

Dr. SHUREN. We have actually been sending warning letters to 

a variety of different companies. I will tell you, for the companies 

now that we have looked at, one of them we had been—or, actually, 

two of them we were working with very closely. They had committed to actually get us the data. We held off taking an action for 

many months to let them get the data that they committed and 

said, ‘‘We have it, we will get it to you,’’ and then they didn’t get 

it. And some said, ‘‘Oh, yes, we had data, but it is gone.’’ 

Mr. MURPHY. Well, my understanding is some of these companies 

are asking for sufficient time, because you are asking for a lot of 

data. Will you work with them and find out if they need additional 

time, if they are indeed moving forward on that process, or is the 

door closed? 

Dr. SHUREN. We actually had been working with them. We gave 

them lots of time. In fact, we are past the time when—well past 

the time they were supposed to get back to us. We have had frequent conversations. 

But for one of them, they actually did make progress, and they 

sent us the data. For another one, we have actually seen absolutely 

no meaningful progress. 

Mr. MURPHY. I understand that part of what the guidelines that 

were sent to these companies were the guidelines for urine-based 

tests and not saliva-based tests. Now, we are getting into weeds in 

this a lot here, too, but part of the understanding that I have of 

these companies is they are—recognized there are really different 

procedures involved with both of those. I am sure you understand 

that, as well. And I would hope that there would be some—I mean, 

from what I understand, they requested fresh guidance in September of last year and wonder when you are going to get them the 

proper guidance on this saliva-based test. 

Dr. SHUREN. Well, we did one better. We have actually been talking with them and walking them through exactly what they need 

to do, because we have experience with these kinds of tests. But 

they have opted not to follow what we asked them to do. 

134 

Mr. MURPHY. That is not my understanding. And I hope that we 

can somehow bridge a communication gap here, that you will work 

with them. Because, look, none of us want to have drug abuse in 

the workplace. We are familiar with it—the drug problems, workers’ comp problems, injuries, deaths, et cetera, at the workplace, 

the high risk on all sorts of levels when people operating heavy 

equipment or dangerous equipment are involved in other things. 

And along those guidelines, what I understand is there are a 

number of snags that are perhaps not reaching your level, some of 

those communication issues. So I would hope that we could talk offline more directly and see if these problems can be mitigated themselves, along those lines. 

Dr. SHUREN. We would be happy to come and brief you on what 

we are doing further. 

Mr. MURPHY. Thank you. I would appreciate that. That you very 

much. 

I yield back. Thank you, Mr. Chairman. 

Mr. PITTS. The chair thanks the gentleman and recognizes the 

ranking member emeritus, the gentleman from Michigan, Mr. Dingell, for 5 minutes for questions. 

Mr. DINGELL. Thank you, Mr. Chairman. 

This question is to Dr. Shuren for a ‘‘yes’’ or ‘‘no.’’ 

You are familiar with the cuts being proposed by the majority in 

the FDA budget, are you not? 

Dr. SHUREN. Yes, I am. 

Mr. DINGELL. You are also familiar with the cuts proposed for 

the device center, are you not? 

Dr. SHUREN. Yes. 

Mr. DINGELL. All right. Will the cuts in the case of FDA have an 

impact on the way the Food and Drug can review devices and oversee device safety, yes or no? 

Dr. SHUREN. Yes. 

Mr. DINGELL. Will these affect the amount of time it takes you 

to review a device application, yes or no? 

Dr. SHUREN. Yes. 

Mr. DINGELL. As you know, this committee will be authorizing 

the Medical Device User Fee Act next year. Does FDA have the 

staff it needs to approve the devices in an efficient time frame, yes 

or no? 

Dr. SHUREN. No. 

Mr. DINGELL. How many does it have? 

Dr. SHUREN. In the program right now, we have about 1,250 fulltime employees, and then we have additional contract support. 

That is for the entire—— 

Mr. DINGELL. How many of those are actually involved in the review and approval of the devices and in overseeing of device safety? 

Dr. SHUREN. About 72 percent are involved in what we call the 

device review process. 

Mr. DINGELL. How many do you need? 

Dr. SHUREN. We need a lot more. And much of it will depend on 

the kind of program—— 

Mr. DINGELL. I am asking for a specific number. 

Dr. SHUREN. It will depend on the program we put together. And 

one of the things we will talk about—— 

135 

Mr. DINGELL. All right. I will submit a letter and I assume that 

you will respond, giving me an answer to the questions raised. 

Does FDA have the user fees it needs now to approve devices in 

an efficient time frame, yes or no? 

Dr. SHUREN. No. 

Mr. DINGELL. Are there any diversions in any of the proposals of 

the budget to divert money from user fees either in prescription 

pharmaceuticals, over-the-counter pharmaceuticals, or in the case 

of devices? 

You can submit that for the record. 

Dr. SHUREN. We will submit it. 

Mr. DINGELL. Would increased user fees help FDA to assure the 

safety and effectiveness of devices? 

Dr. SHUREN. Yes. 

Mr. DINGELL. Would they assist Food and Drug in providing 

more expeditious service to the people in the industry who have 

these devices up for approval? 

Dr. SHUREN. Yes. 

Mr. DINGELL. Do you believe increased fees are needed to expedite the review process to benefit the industry? 

Dr. SHUREN. Yes. 

Mr. DINGELL. Mr. Chairman, I note I have 2 minutes and 10 seconds, and I yield back. 

I will look forward to working with you some later time. 

Mr. PITTS. The chair thanks the gentleman and recognizes the 

gentleman from Kentucky, Mr. Guthrie, for 5 minutes. 

Mr. GUTHRIE. Thank you very much. 

Thank you for being here. And I was at a second committee of 

this subcommittee of this committee, so I apologize, I missed some 

of it. But I get the gist of what we are talking about. 

And I am from a manufacturing background, automotive parts, 

not medical devices, but I understand getting products to market 

and being competitive is important. And I want to go just a little 

different, because I have heard the testimony, and some questions 

I was going to ask have been answered. And it is appropriate in 

this subcommittee, because just the other day we were debating a 

bill about doctors’ conscience, and the minority side brought up an 

objection to the bill, saying, if we pass the bill, it was going to raise 

taxes and put people out of business. 

And so my question—I think it is appropriate in this committee, 

even though it is not our jurisdiction, to look at what happened 

during the health-care law. I think those of you who manufacture 

devices are aware there was a 2.3 percent tax on revenue, not on 

income, on revenue, which as an effective tax rate, I don’t know, 

you would have to recalculate, but far higher than 2.3 percent. And 

it goes into effect—and it is $20 billion coming out of the medical 

device over the next 10 years—it goes in effect in 2013. And even 

if you are growing your business and trying to put seed money 

back in your business, you are not making a profit, you still pay 

this tax. It comes off the top. It comes off the top. 

And I would like just particularly Dr. Makower or Mr. Deem or 

anybody else that is manufacturing, would you describe how this 

tax affects large and small device companies and how it affects innovation and job creation? Because there was some concern about 

136 

our bill last week about what it is going to do to job creation. I 

would just like to hear what you think this tax is going to do to 

job creation. 

Dr. MAKOWER. I am glad that you asked that question. It is absolutely imperative—absolutely imperative—for small companies that 

we find a way of modifying that tax proposal. Because, right now, 

companies that are bringing a new, innovative medical product to 

market need to get to about $70 million to $100 million in sales 

before they see dollar 1 of profit. 

This means, during the entire time, which may be over several 

years, under the current proposed law, that they would be paying 

money to the government simply for the privilege of doing business 

in the United States without earning any profit here. And that 

means that they would have to raise more money and/or cut jobs 

or reduce other ways of expenditure—research and development, 

other important things for this country. 

And so this is—I am very glad that you brought it up. It is absolutely essential for innovation, especially for medical device technology, that we address this important issue. 

Mr. GUTHRIE. Mr. Deem? 

Mr. DEEM. I would echo Dr. Makower’s comments. I think it is 

absolutely going to result in slowed company growth, delayed hiring, and delayed expansion of the company, without a doubt. I 

mean, just taking that money right off of the top, it is essentially 

shunting it right out of the operations that that company needs to 

grow. 

Mr. GUTHRIE. Are you already hearing—I mean, you have to be, 

because you have to be planning for it—are you hearing your business, businesses in your community, associations that you deal 

with, how this is affecting them today or as they prepare for it in 

2013? 

Mr. DEEM. We are hearing a lot of discussion about it. My companies, actually, have been taking so long to get through the regulatory process. Out of the 14, we only have one that is actually selling product right now. But that one actually is planning on trying 

to figure out what it means to them. Are they going to have to 

raise more venture capital? Which, in effect, just shunts that 

straight over to the tax. Are they going to have to try to finance 

it out of other avenues that will further slow the growth? 

Nobody really has a good answer for it. The only thing that we 

are absolutely sure of is that it will slow growth and it will delay 

job hiring. 

Mr. GUTHRIE. My understanding, too, is some States have what 

they call business purpose taxes. A lot of States who put them in 

all of a sudden take them off because their businesses move elsewhere. 

There probably are other people that get off-the-top revenue 

taxes. I am not saying there are not industries that are treated— 

but I think you all are especially treated differently than most 

businesses in this country. 

And only since the other side brought up the other day that they 

wanted to work with us to make sure that we had had a productive 

Tax Code out of this health-care bill. I think this is something— 

137 

hopefully, though, they are going to stick with us and get this fixed 

for you guys. 

I know you all answered the question, but does anybody else 

want to comment on that? 

Well, Mr. Chairman, I am about of time, so I yield back. 

Mr. PITTS. The chair thanks the chairman. 

Now, in the queue we have Lance, Cassidy, and Blackburn, in 

that order. So the chair recognizes the gentleman, Mr. Lance, for 

5 minutes for questioning, then Cassidy. 

Mr. LANCE. Thank you very much, Mr. Chairman. 

I apologize for not being at the entire hearing. There are two 

subcommittees today meeting at the same time. And since I have 

been on the full committee for a month, I try to make both subcommittees. But I certainly appreciate your being with us. 

To follow up on what Congressman Guthrie has said, Mr. Deem, 

I represent the district in this country that has more medical device and pharmaceutical employees than any other district anywhere in America. And the medical device excise tax, I think, will 

be extremely harmful, especially to the district I serve—we would 

like to think we are the medicine chest of the country and perhaps 

the world—and certainly, I think, moreover, harmful to the Nation 

as a whole. 

For example, C.R. Bard is one of the 10 largest manufacturers 

of medical devices. It is located in the district I serve. And I have 

been told by leadership there that the new 2.3 excise tax will cost 

that company $45 million a year, which is 25 percent of that company’s research and development budget. This is just one example; 

there are many across New Jersey and across the Nation. 

Could you explain in a little greater detail, following up on Congressman Guthrie, what you believe this will do to the competitiveness of the industry in this country, as it affects the entire world? 

Mr. DEEM. Thank you for the question. 

I agree with the gentleman, ladies, from C.R. Bard. I think that 

there are only a few other places where the larger companies are 

going to be able to trim that in, trim that money out. And when 

you look at the large company balance sheets, the R&D line typically involves both R&D and regulatory and clinical. And so, if you 

look at the device tax coming off of R&D, it is hitting them both 

ways. 

Mr. LANCE. And I, of course, believe we should not enact it, that 

it should be repealed. And I, along with others, were working on 

that issue. 

Do you think that the consequence might occur before the actual 

implementation of the tax, given the fact that companies will have 

to begin to calculate what is coming in another year or so? 

Mr. DEEM. Absolutely. I haven’t worked in the larger companies, 

but even in the smaller companies, as we look at sales ramps and 

we look at how quickly we are going to be able to make adjustments, you have to start planning for it now. So already we are delaying hires, and we are looking at how quickly we can grow. And 

I am sure that is happening to a much, much larger scale in the 

larger companies like Bard. 

Mr. LANCE. Thank you. 

138 

Last week, The New York Times reported on a patient who had 

traveled overseas to receive a medical device that was developed 40 

miles from her residence. 

To any distinguished member of the panel, I would like to think 

this is an isolated incident, but I am wondering what the panel’s 

view might be on that. 

Dr. REDBERG. You know, I actually am grateful to the FDA for 

doing its job in protecting the safety and effectiveness of my patients and your constituents. And I think that that device, if it had 

been shown in clinical trials to be safe and effective, would certainly be approved by the FDA. 

Unfortunately, there are numerous records of devices like that— 

I believe it was a spinal disc—and other ones that have been approved in Europe and have been subsequently shown to have severe problems. 

And, remember, we are now talking about implantable devices. 

And so, I want to know, before the FDA approves a device, that— 

before we can even talk about safety, I think the number-one goal 

is effectiveness. Because I don’t think you or I or anyone want to 

have something permanently implanted in me that has never been 

shown to be effective. 

That does cost money, to do a clinical trial to show a device is 

effective. But I think before we can even start talking about innovation or anything else, I have made a contract to take care of my 

patients by doing things that will improve their health. If I am 

going to be put in a position of having to advise them to put in devices that have never been shown to be effective or safe, that it is 

not something I can advise them on. 

So I would think that—— 

Mr. LANCE. Thank you. 

I yield back the 1 second I have left. Thank you, Mr. Chairman. 

Mr. PITTS. The chair thanks the gentleman and recognizes the 

gentleman from Louisiana, Dr. Cassidy, for 5 minutes for questions. 

Dr. CASSIDY. Thank you. 

And to whomever I speak to, if I interrupt you, I am not trying 

to be rude. We just have 5 minutes. 

To the two cardiologists, I am a gastroenterologist, so I approach 

with trepidation, okay? But in Dr. Shuren’s testimony, he speaks 

about the necessity to establish effectiveness in the U.S. versus 

EU, using the specific example that the manufacturer must show 

that the laser incises heart tissue and also treats arrhythmia in the 

United States, whereas in the EU you would only have to show 

that it incises heart tissue only. 

But I assume he is talking about some sort of AV node malformation. And, frankly, that is in anatomy and physiology, that if 

you cut that baby, you are going to interrupt the flow of current. 

That is an electrical current issue. 

So I am just tossing that out, not to challenge, frankly to understand from two cardiologists, does it matter how you cut the AV 

node? 

Dr. NISSEN. I would be happy to take that one on. 

139 

Look, it does matter. And it is not just that it cuts; it is that it 

cuts that right tissue and doesn’t cut something that it shouldn’t 

cut. 

Dr. CASSIDY. Now, there is a fairly defined—again, I am a gastroenterologist, so with trepidation I say it is my understanding there 

is a fairly defined anatomical pathway. Granted, there is variance. 

But, you know, you are going to be a millimeter deep, you are going 

to be a centimeter wide. Granted, maybe there is scarring with one 

and not with another, so there is an ancillary. But I assume that, 

as commonplace as this has been, particularly at the Cleveland 

Clinic, that you guys know this. 

Dr. NISSEN. Yes. We probably do more of these ablations just 

about than anyplace in the country. And there is a complication 

rate, and these complications are really serious. And before we 

would—— 

Dr. CASSIDY. Now, I don’t think you—but that is a different question than effectiveness, correct? 

Dr. NISSEN. Well, you know, safety and effectiveness can’t be 

taken apart. You know, if you have a device that ablates tissue but 

it causes tamponade if it perforates the heart—— 

Dr. CASSIDY. Now, but safety and effectiveness are different because if you—and I thought Mr. Hall’s comments were well-taken. 

There is an immediate, kind of, you-do-the-procedure-type complication that is one further down. Clearly, these guys are not 

going to approve something which caused a high incidence of tamponade. 

Dr. REDBERG. I would say, you know, you are talking about ablation, which, as you know, has been approved here as well as in Europe. 

Dr. CASSIDY. And I just used that example because he used it 

specifically. 

Dr. REDBERG. The Europeans, you know, just published their 5- 

year experience and shown that only 25 percent of all their patients who got the ablation by the guy who invented it are actually 

free of atrial fibrillation 5 years later. A lot of those patients have 

had adverse events, including death, as a result. There is a 1 percent incidence of death reported with that. 

And so, again, it is a great example, because you would think, 

sure, that is a defined part of tissue, easy to do. People are not that 

simple, and procedures are never perfect. Every procedure has benefits as well as risks. And unless you do a clinical trial and actually 

follow those patients to something clinically meaningful, if I burn 

that piece of tissue and you are dead, you are hardly going to have 

considered that an effective procedure. 

Dr. CASSIDY. No, I accept that. So what is the normal rate of failure of ablation, however it is done normally, whether it is scalpel 

or whatever? 

Dr. REDBERG. The 75 percent failure at 5 years. 

Dr. CASSIDY. That is with current technology. 

Dr. REDBERG. Current technology, and that is most people are 

getting two or three ablations. 

Dr. CASSIDY. By the way, several people from Baton Rouge have 

gone to Cleveland Clinic, so I am going to accept that as a commentary upon those guys. 

140 

Dr. REDBERG. One of the best in the country. 

Dr. NISSEN. We do better than most. 

Dr. CASSIDY. Okay. You are at 35 percent. But—— 

Dr. REDBERG. That is at UCSF. 

Dr. CASSIDY. Now, frankly, Dr. Nissen, it looks like Hall’s methodology in his paper is superior to yours. 

Dr. NISSEN. Actually, it is faulty. His denominator, he used all 

submitted devices. And—— 

Dr. CASSIDY. But when I go back, I was actually looking at, okay, 

he did the kind of peri-approval period as a high-risk recall. And 

then he did the late high-risk, which is unrelated, if you will, to 

the approval process. The approval process is not going to catch the 

complication 5 years down the road. 

Dr. NISSEN. It may or may not. It depends on what the mechanism, the complication is. 

Let me say that we have the same numerator. He has a different 

denominator. His denominator is all submitted devices, and that is 

not a realistic denominator. It is actually approved devices that is 

the denominator. 

Let me put it to you this way, Dr. Cassidy. If you have a 99.5 

percent success rate, that sounds very high. But tomorrow when 

you get on a plane to fly home to Louisiana, if the pilot gets on and 

says, ‘‘There is a 99.5 percent chance that the plane will take off 

and land successfully,’’ would you get off the plane or would you 

stay on the plane? 

Dr. CASSIDY. I accept that. And I am almost out of time; that is 

the only reason I interrupt. 

But, Mr. Hall, could you respond to Dr. Nissen’sdiscounting of 

your findings? 

Mr. HALL. Sure. I think the key is to try to identify the reason 

for the recall so you can try to fix the problem. And if you just look 

at the numerator, how many, that doesn’t tell you whether you 

have a big problem or a small problem, and, most importantly, it 

doesn’t tell you how to fix it. So if you have problems that are not 

related to the pre-market process, changing the pre-market process 

is going to be useless exercise. 

And the comments earlier about funding, et cetera, I don’t like 

this comment of more or less regulation. I believe in appropriate 

regulation. And, therefore, put the dollars where they have the leverage, and that is what my study attempted to do. 

Dr. CASSIDY. I thought that was a very good point. I wish I had 

more time to ask you all. Thank you for your testimony. 

Mr. PITTS. The chair thanks the gentleman and recognizes the 

gentleman from Georgia, Dr. Gingrey, for 5 minutes for questions. 

Dr. GINGREY. Mr. Chairman, thank you very much. 

I will get right to the questions. I want to address them primarily to Dr. Makower. According to a 2009 report by Ernst & 

Young, access to venture capital by medical technology companies 

dropped 18 percent in 2008 due to the United States economic crisis. 

Dr. Makower, how important is venture capital to medical device 

innovation and development? 

Dr. MAKOWER. Venture capital is the lifeblood of innovation in 

med tech, absolutely. 

141 

Dr. GINGREY. A Pricewaterhouse Coopers study released last 

month found that, and I quote them, ‘‘The innovation ecosystem for 

medical device technology, long centered in the United States, is 

moving offshore, and medical technology innovators are going outside the United States to seek first income.’’ 

What is first income, Dr. Makower? And why do companies feel 

they need to go offshore to get first income? 

Dr. MAKOWER. I think what you are referring to is the approvalof-origin requirement that many countries are requiring. In other 

words, many countries will not allow you to sell a product in their 

country unless you have at least achieved approval in your own 

country. 

And the impact of that for a U.S. manufacturer is this, that if 

we are delayed in getting approvals here, we can’t even sell other 

places in the world unless we move the manufacturing facilities to 

other countries. And that is why this is so—— 

Dr. GINGREY. If you will allow me to interrupt, I think that what 

you are referring to what have been my next question. In fact, I 

will talk about it a little bit, country-of-origin—— 

Dr. MAKOWER. Country of origin, right. 

Dr. GINGREY [continuing]. Requirements. That was not this issue 

of first revenue. But, yes, you are absolutely right. I think, by 2020, 

the authors of this Pricewaterhouse Coopers study predict that 

China, India, and Brazil will gain significantly in key device measurement areas, while the United States will continue to lose 

ground. 

And, interestingly enough, as you said, these countries also— 

many countries, not just these—but they have that country-of-origin requirement, that it requires any device manufactured in the 

United States first be approved for sale in the United States by the 

FDA before it can be approved for sale in the home market. 

Dr. MAKOWER. That is right. 

Dr. GINGREY. So this is what you were referring to in regard to 

the country of origin? 

Dr. MAKOWER. That is exactly right. And that is the reason why 

manufacturing plants and high-paid jobs are leaving the country. 

Dr. GINGREY. These jobs, by the way—that brings up another 

point. When a medical device company does pick up and move, for 

whatever reason—I think many of those reasons have been outlined by my colleagues in the questions and certainly by the witnesses. And when they move overseas, what type of jobs are we losing? Are these minimum-wage jobs? Are we losing scientist and 

other highly technical and high-paying jobs to our competitors? 

Dr. MAKOWER. Exactly. As you pointed out, they are high-paid 

jobs. They are scientists, they are engineers. They are the very, 

very sought-after jobs that are moving. 

Dr. GINGREY. Well, how do—in fact, anybody can answer this 

question—but how do EU device regulatory systems compare to the 

United States? Are the EU regulations more predictable and certain? Why does that matter to a device firm? 

Dr. MAKOWER. It is more transparent. You know what you need 

to do, and that is why it is more straightforward. 

Dr. NISSEN. They are also much weaker. They don’t require that 

you demonstrate efficacy. And we think that that is important. If 

142 

you use a device, you want to know that it is actually going to 

work. And that is not required in the EU. 

Dr. GINGREY. And I think, Dr. Shuren, you wanted to respond. 

Dr. SHUREN. Because in the EU, the public can’t—there is no 

transparency. These are what is cut between the company and the 

private company. In fact, the European Commission said—and they 

are relooking at their system—experience indicates that the current system does not always offer a uniform level of protection of 

public health in the European Union. New and emerging technologies have challenged the current framework, highlighting gaps 

and pointing to a certain scarcity of expertise—— 

Dr. GINGREY. Yes, yes, but, Dr. Shuren, I guess cutting right to 

the chase on that, and I will ask you specifically, does the EU have 

more safety problems? You are, I think, suggesting that their system is more lax, and that frightens you. But, really, statistically, 

are they having more safety problems? 

Dr. SHUREN. I think the data that is out there—there are two 

very different systems. They don’t have enough data out there to 

actually make a firm comparison. But we do have some evidence 

to show that the U.S. system does provide great value. 

Dr. GINGREY. Well, I think that is kind of an anecdotal sort of 

response. 

Let me just say to this you, as I conclude. I want you to know 

that I appreciate the work that the FDA undertakes for American 

patients. I am a physician, too, an OB/GYN doctor. But I do believe 

that if we don’t undertake an immediate and very critical review 

of the FDA regulatory process, trying to identify safe and effective 

ways to improve the transparency and consistency of the approval 

process, irreversible damage to the United States-based medical innovation will result. 

And, you know, we are in a situation where we need jobs, we 

need them desperately. I realize that the balance is hugely important, but we need to smooth and streamline this process and not 

keep changing the bar. 

Mr. Chairman, thank you for your indulgence, and I will yield 

back. 

Mr. PITTS. The gentleman’s time has expired. 

The chair recognizes the gentlelady from Tennessee, Mrs. 

Blackburn, for 5 minutes for questions. 

Mrs. BLACKBURN. Thank you, Mr. Chairman. 

And I want to thank you all for being here. 

My district in Tennessee includes a city you all probably know 

a little bit about, Memphis. And, as you know, we are probably the 

number two when it comes to device implementation, creation. And 

with our companies that are there that are doing tremendous work 

in R&D, with patent holders, with the biotech R&D that is being 

done in the mid-part of Tennessee, the other end of my district, we 

hear a lot about the FDA and the problems that exist with the 

FDA. 

And we are focused on this, because we think that in the 21st 

century, when you look at the creative economy as it exists and 

look at jobs creation and jobs retention, that we have to make certain we are protecting the intellectual property of these innovators 

143 

and creating the environment that they can innovate here but also 

that they can manufacture here. 

And, Mr. Makower, I know we have talked about your study and 

everyone has focused on this in our questioning, but I think it is 

such an imperative that we create the environment that our companies and our innovators can handle that jobs growth. And I liked 

what you did when you analyzed the FDA’s impact on medical 

technology innovation and comparing the EU and the U.S., the 

time and the cost and lack of predictability. 

But what I would like to do is—we look at jobs, 400,000 Americans and over 2 million jobs that are created through this industry. 

Where is the FDA causing us problems and hindering on that? 

What other countries around the world, specifically especially in 

Europe, are trying to take our jobs? Who is trying to compete with 

us on this environment? How do we reach that standard so that we 

are responsible to consumers but we are not hampering innovation? 

So, quickly, if you will hit what you think our problems at the 

FDA are and how they get in the way of those job creation numbers that we want to see and the environment for jobs growth to 

take place; and then I am going to let any of the others of you 

weigh in, also. 

Dr. MAKOWER. The fundamental themes that we have been talking about are predictability, reasonability, transparency. Those are 

the things that allow the process to happen. Because when you go 

to raise money as a small entrepreneur, you can set out a path. 

You know what is expected. 

Mrs. BLACKBURN. And you see the FDA as a hindrance. 

Dr. MAKOWER. Right now, that is a problem. In other countries, 

it is clear. It is clear what you need to do, and it does not take as 

much time. 

Mrs. BLACKBURN. Compare to me if I were to take an implement 

for a hip to the FDA. In the U.S., the time to get it through the 

FDA would be what and in Europe it would be what? 

Dr. MAKOWER. It is a specific example, and I don’t want to misstate what the times would be for that. So I would get back to you 

on the exact numbers. 

Mrs. BLACKBURN. That would be great. I think it would be helpful. 

Mrs. BLACKBURN. Because we are looking 10, 20 years down the 

road; and we are concerned about what would happen with the 

medical device implementation industry here in this country. It is 

a lot of jobs for us here in Tennessee. 

Anybody else want to weigh in with the problems with the FDA 

or how they see the FDA as an impediment to jobs retention and 

jobs growth? 

Mr. DEEM. I think one of the things that has been touched on 

from time to time but it deserves significant thought is the risk 

benefit ratio. That has always been a concern, and that is clearly 

the most difficult job that the agency has, is determining where is 

the appropriate balance between risk and benefit. 

I think if we look over the last several years and look at the 

delays that have increased and the inconsistency that has crept in, 

I think it has a lot to do with what is our expectation of risk and 

144 

benefit. So I think that is an area that we as a people should look 

at as well. 

Mrs. BLACKBURN. Do any of you know of any specific firms that 

have chosen to move offshore for manufacturing? Could you provide 

those examples? 

Mr. DEEM. It is not one of my companies, but there is a company 

named Biosensors which is a worldwide stem company. They had 

a headquarter in—it was either Irvine or San Diego. They were 

being held back from expanding into international markets that 

they wanted to go to by the country of origin laws, and just within 

the last year they ceased all U.S. Operations and moved their jobs 

overseas. 

Mrs. BLACKBURN. How many jobs was that and how much on average do they pay? 

Mr. DEEM. I would have to get back to you on the specific number of jobs, since it wasn’t my company. But the average pays for 

the types of manufacturing that we are talking about can be in the 

40, 50,000—it is very high-paid manufacturing. And then when you 

start to look at the engineers that are involved, you are in the hundred, $150,000 jobs. So these are very, very highly sought after, 

high-pay jobs. 

Mrs. BLACKBURN. Thank you. I yield back. 

Mr. PITTS. Did any of the other witnesses wish to respond to that 

question? 

Dr. Redberg. 

Dr. REDBERG. I just wanted to point out the other side of the 

money that we spend in the over $100 billion on devices is that 

when we are approving devices that haven’t been shown to be of 

benefit to your constituents and our patients, that means we are 

spending billions of dollars. Technology is the number one driver 

of health care costs. And the reason that a lot of jobs are having 

issues in employment and State governments are because they cannot sustain the costs of health care premiums. 

So I would just consider the other side of allowing untested, expensive new technology of no known benefits, definite risks is also 

driving up health care premiums and driving businesses to close, 

because they cannot afford to pay for the health care for their 

workers. 

Mr. PITTS. Dr. Shuren. 

Dr. SHUREN. And I think it is also important to recognize, and 

we know we have a role to play, and I have mentioned there are 

actions that we are taking, but this is far more complicated. Even 

Advenet has talked about the health of the medical device industry, 

and I don’t want to put things down. But we went through the biggest recession since the Great Depression. It has affected everyone. 

But in the medical device industry, they changed their business 

models. They became more risk averse. The venture capitalists 

have decided we are not going to invest so much in the early stage 

innovative technologies. We want to see this more fully developed. 

They raised the bar on their own industry. 

I don’t think the answer to this is that we change the American 

standard that we have had in place that has served the country 

very well. We agree that we need to have the right balance beVerDate Nov 24 2008 11:41 Aug 03, 2011 Jkt 037690 PO 00000 Frm 00150 Fmt 6633 Sfmt 6633 P:\MY DOCS\HEARINGS 112\112-9 021711\112-9 CHRIS
145 

tween facilitating innovation and assuring that devices are safe 

and effective. 

We are stepping up to the plate for things that we need to do. 

If this is really going to happen, we need industry to do the other 

part of it; and we also do need to have the people do the job right. 

Even industry has said, and Josh has said, we have high turnover. 

They find that that affects reviews, and we agree. But the problem 

is we don’t have the people doing the work. Their workload is overloaded, and we need to address that. 

If we are really going to make this right, we have to invest. We 

have got to invest in the FDA. If we want to be competitive to industry, we need to be competitive about the FDA brand. 

Mr. PITTS. Thank you. 

Any other witnesses wanted to respond to that question? 

Mr. HALL. Just one thing. 

There seems to be a belief there is a yes, no, or binary aspect 

to the 501(k) system. I want to clear up. 

The agency has the authority to obtain clinical data under the 

501(k) system. They have the statutory authority, they have the 

regulatory authority in cases in which they think that is necessary 

or appropriate to make safety and efficacy determinations. So they 

have that authority right now, and probably 10 to 15 percent of 

submissions include clinical data of some sort. 

Mr. PITTS. The chair thanks the witnesses. 

Dr. BURGESS. Mr. Chairman, I ask unanimous consent just to 

ask one follow-up question. 

Mr. PITTS. Without objection. 

Dr. BURGESS. Dr. Shuren, I just wanted to point out that last 

summer when Dr. Sharfstein was here we had a hearing on bottlenecks in the pipeline, and I asked a question because I was concerned. We gave $10 billion to the NIH for the stimulus. We gave 

it. I voted against that. But Congress gave $10 billion to the NIH. 

And I asked Dr. Sharfstein, is this going to be a problem as all 

of this new stuff from NIH starts coming down the pipeline? Is 

FDA—what are you going to do? And he was dismissive and said 

that they had all of the money that they needed. 

This past summer, with the hearing on the DeCoster Egg Farms, 

with the salmonella that appeared in the eggs, that it appeared 

that in the food safety aspect, which I know is not your jurisdiction, 

but it appeared that some very basic processes were not followed, 

and communication between FDA and USDA really suffered. And 

he told me once again that funding was not the issue. It was a 

process. 

So I just wanted to make those points. Because I have asked at 

the highest levels of the FDA, are we giving you the tools that you 

need, given the fact of everything else that is going on around you? 

And was told twice by the second in command at your agency that 

that, in fact, was not an issue. 

I recognize he is no longer the second in command at your agency. 

Dr. SHUREN. I don’t know what was said. 

I will tell you that now, for the first time, in fiscal year 2010, 

the FDA, which is a lean agency, for the very first time exceeded 

its FTE counts, its full-time employees that we had on board 18 

146 

years ago in 1992. Just was coming up to speed then. And, in the 

interim, medical devices have become significantly more complex 

and challenging. 

If we honestly want to be—remain the innovators, the world’s 

innovators, we have to address all of the issues. When FDA approves a product, other countries listen. You can get a CE mark— 

and I talked to my folks over there, and their slow uptake on the 

new technologies because they don’t have full confidence on the CE 

mark. Some will use it. A lot won’t. 

But when the FDA approves a device, not only is there rapid uptake here in the U.S., other countries take notice, and the physicians over there start to use it. We need to invest in the FDA. It 

is so critical that we are working well, because it ultimately helps 

them and it helps patients. And, as a physician, I care a lot about 

that. 

Dr. BURGESS. As do I. 

The last thing. You have made a comment that industry just 

won’t talk to the FDA. Again, you do have industry there, Mr. 

Deem, Dr. Makower. You have a chance now to talk to the FDA. 

They are right there. So maybe you guys could just visit a little bit 

and get some of these things hashed out. 

Mr. PITTS. Okay. Dr. Burgess, would you yield to Mr. Pallone? 

Dr. BURGESS. Absolutely. 

Mr. PALLONE. I know we haven’t had a chance to ask many questions on this side. 

Dr. Shuren and Dr. Redberg, there was a lot of discussion on the 

study released this week about the—Dr. Nissen I said? I am sorry. 

Dr. Nissen and Dr. Redberg, there was a lot of discussion about the 

study released this week about recalled products under 501(k). I 

am not sure that you had a chance to respond to that, if you would. 

I will just give you some time to do that. 

Dr. NISSEN. You know, what I want to say is that there is a serious problem here. One hundred and twelve million devices were 

withdrawn over a 5-year period of time, more than 2,000 deaths a 

year due to device failures and more than 100,000 injuries. That 

is serious, and it needs to be looked at very carefully. And so keeping that balance between safety and rapid and speedy approval is 

really critical. 

And what I am arguing for is not to make things tough on industry. It is to make things safe for patients. Putting patients first. We 

have a motto in medicine: primum non nocere. In Latin, it means 

above all do no harm. And a device that has to be withdrawn, 

taken out of a patient’s body, whether it be a spinal disk or something else, is very serious. 

The final thing I wanted to say—I didn’t quite get a chance with 

Dr. Cassidy’s question—is this idea that there is a 99.5 percent 

success rate for 501(k). And here is what I want you all to think 

about when you go home on Friday night. 

You get on the plane and the pilot comes on and says there is 

a 99.5 percent chance that this plane will take off and land safely. 

Is that good enough or is it not good enough? I don’t think it is 

good enough, and I think we can do better. 

Dr. REDBERG. I would like to also point out that recalls, while 

they are important, they are not a way to gauge safety of medical 

147 

devices. Recalls are the tip of the iceberg. Because of the adverse 

event reporting system, it is estimated that we only know about 1 

or 2 percent of all serious adverse events that occur. 

So while recalls are an extreme example, because a device has 

not been recalled, it is not an assurance of device safety and, more 

importantly, it is not an assurance of effectiveness. 

So, again, the FDA’s primary mission, while encouraging innovation is important, but not to encourage innovation at the price of 

ignoring safety and effectiveness. And the only way to know a device that I am going to put in your body is safe and effective is to 

study it in clinical trials in humans with meaningful endpoints, 

real outcomes, and reasonable follow-up and continued post-marketing surveillance so that those rare adverse events can be reported. We have a long way to go to get to that goal. 

Mr. HALL. I think it is clear that everybody is interested in safety. If you want safety, you need to understand the reasons why the 

problem occurred; and the majority of those recalls occurred because of after-approval issues, not because of the premarket system. And I believe in targeted or focused legislation. 

If you go to the 99.5 would you get on an airplane, with that 

analogy you would never go to the hospital, because the hospital 

rates of problems are much greater. 2.3 percent of Medicare patients have a safety issue in the hospital; 15 percent of elders get 

a BIS prescription. We all need to do better. 

Mr. PITTS. Excellent testimony. 

I don’t want to cut you off. Did you have something to say, Dr. 

Shuren? 

Dr. SHUREN. All I would say is we take the safety concerns very 

seriously. And in fact, the data shows that there are problems that 

are occurring that could be addressed premarket. We have tried to 

address some of this in the actions we are taking. There are times 

when targeted manufacturing data for certain products can help us 

identify problems beforehand and in some cases doing the 

preclearance inspection. 

I will say if much of the debate is going to be on quality systems, 

I would note that in the EU you have the auditors, you have the 

third parties that go in and they look at the companies who are actually going to bring the product on the market. Here in the U.S., 

the law sets a very high bar for us to do that. If we are going to 

look at quality systems and put more of an emphasis, then we 

should sort of revisit that framework. 

And, lastly, I would say there are times when clinical data can 

actually identify safety problems. With infusion pumps it is exactly 

what we are going to impose on the manufacturers, and we are 

starting to do it. 

Mr. PITTS. All right. Thank you. 

In conclusion, I would like to thank all of the witnesses and the 

members that participated in today’s hearing. I remind members 

that they have 10 business days to submit questions for the record, 

and I ask that the witnesses all agree to respond promptly to the 

questions. 

As this Monday is President’s Day, members should submit their 

questions by the close of business on March 4. 

The subcommittee is adjourned. 

148 

[Whereupon, at 1:10 p.m., the subcommittee was adjourned.] 

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