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REGULATORY REFORM SERIES, PART 5—FDA MEDICAL DEVICE REGULATION: IMPACT ON AMERICAN PATIENTS, INNOVATION, AND JOBS 

HEARING 

BEFORE THE

SUBCOMMITTEE ON OVERSIGHT AND 

INVESTIGATIONS 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED TWELFTH CONGRESS 

FIRST SESSION 

JULY 20, 2011 

Serial No. 112–78 

( 

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 

Chairman Emeritus 

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 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

CLIFF STEARNS, Florida 

Chairman 

LEE TERRY, Nebraska 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

BRIAN P. BILBRAY, California 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

CORY GARDNER, Colorado 

H. MORGAN GRIFFITH, Virginia 

JOE BARTON, Texas 

FRED UPTON, Michigan (ex officio) 

DIANA DEGETTE, Colorado 

Ranking Member 

JANICE D. SCHAKOWSKY, Illinois 

MIKE ROSS, Arkansas 

KATHY CASTOR, Florida 

EDWARD J. MARKEY, Massachusetts 

GENE GREEN, Texas 

DONNA M. CHRISTENSEN, Virgin Islands 

JOHN D. DINGELL, Michigan 

HENRY A. WAXMAN, California (ex officio) 

(II) 

(III) 

C O N T E N T S 

Page 

Hon. Cliff Stearns, a Representative in Congress from the State of Florida, 

opening statement ................................................................................................ 1 

Prepared statement .......................................................................................... 4 

Hon. Diana DeGette, a Representative in Congress from the State of Colorado, opening statement ...................................................................................... 6 

Prepared statement .......................................................................................... 8 

Hon. Joe Barton, a Representative in Congress from the State of Texas, 

opening statement ................................................................................................ 10 

Prepared statement .......................................................................................... 11 

Hon. Michael C. Burgess, a Representative in Congress from the State of 

Texas, opening statement .................................................................................... 13 

Hon. Phil Gingrey, a Representative in Congress from the State of Georgia, 

opening statement ................................................................................................ 13 

Hon. Lee Terry, a Representative in Congress from the State of Nebraska, 

opening statement ................................................................................................ 14 

Hon. Marsha Blackburn, a Representative in Congress from the State of 

Tennessee, opening statement ............................................................................ 20 

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

California, opening statement ............................................................................. 20 

Prepared statement .......................................................................................... 23 

Hon. Gene Green, a Representative in Congress from the State of Texas, 

prepared statement .............................................................................................. 255 

Hon. John Dingell, a Representative in Congress from the State of Michigan, 

prepared statement .............................................................................................. 256 

WITNESSES

Robert E. Fischell, Chairman and CEO, Fischell Biomedical LLC ..................... 25 

Prepared statement .......................................................................................... 28 

Carol Murphy, Patient ............................................................................................ 33 

Prepared statement .......................................................................................... 35 

Marti Conger, Patient and Patient Advocate ........................................................ 38 

Prepared statement .......................................................................................... 40 

Pam K. Sagan, Patient ............................................................................................ 49 

Prepared statement .......................................................................................... 51 

Michael Mandel, chief Economic Strategist, Progressive Policy Institute .......... 54 

Prepared statement .......................................................................................... 56 

Sean Ianchulev, Chief Medical Officer, Transcend Medical Inc. ......................... 66 

Prepared statement .......................................................................................... 68 

Gregory D. Curfman, Executive Editor, New England Journal of Medicine ...... 73 

Prepared statement .......................................................................................... 75 

Additional comments for the record ................................................................ 257 

Jeffrey E. Shuren, Director, Center for Devices and Radiological Health, 

Food and Drug Administration ........................................................................... 184 

Prepared statement .......................................................................................... 186 

Answers to submitted questions ...................................................................... 263 

SUBMITTED MATERIAL

New York Times article, ‘‘Medical Treatment, Out of Reach,’’dated February 

9, 2011, by Andrew Pollack, submitted by Mr. Terry ....................................... 15 

Democratic Supplemental Memorandum, dated July 20, 2011, submitted by 

Ms. DeGette. ......................................................................................................... 93 

Page

IV 

Letter, dated July 15, 2011, from Gregory D. Curfman, Executive Editor, 

New England Journal of Medicine, to Mr. Waxman, submitted by Ms. 

DeGette ................................................................................................................. 99 

Letter, dated July 15, 2011, from Rita F. Redberg, Professor of Medicine, 

to Mr. Waxman, submitted by Ms. DeGette ...................................................... 102 

Letter, dated July 17, 2011, from Rita F. Redberg, Professor of Medicine, 

to Mr. Waxman, submitted by Ms. DeGette ...................................................... 105 

Letter, dated July 18, 2011, from Howard Bauchner, Editor in Chief, JAMA 

and Scientific Publications, to Mr. Waxman, submitted by Ms. DeGette. ...... 108 

Letter, dated July 18, 2011, from Jeanne Ireland, Assistant Commissioner 

for Legislation, Food and Drug Administration, to Mr. Waxman, submitted 

by Ms. DeGette. .................................................................................................... 111 

Study, ‘‘A Comprehensive Analysis of the FDA 510(k) Process: Industry Practice and the Implications for Reform,’’ dated May 25, 2011 (revised July 

19, 2011), by Northwestern University, submitted by Mr. Stearns ................. 119 

Premarket Approval record, PMA Number 92005–S038, dated September 12, 

2007, for Medtronic Sprint Leads, Implantable Cardiovascular Defibrillator, 

submitted by Mr. Gingrey ................................................................................... 235 

Statement, dated July 20, 2011, by AdvaMed on the House Energy and 

Commerce Subcommittee Hearing on FDA Device Regulation, submitted 

by Mr. Waxman .................................................................................................... 236 

Slides, undated, accompanying testimony by Mr. Shuren, submitted by Ms. 

DeGette ................................................................................................................. 239 

Letter, dated March 1, 2011, from Massachusetts Congressional Members 

to David R. Challoner, Institute of Medicine, submitted by Mr. Burgess ....... 250 

Letter, dated April 13, 2011, from Hon. John F. Kerry to Margaret Ann 

Hamburg, Commissioner, Food and Drug Administration, submitted by Mr. 

Burgess ................................................................................................................. 252 

(1) 

REGULATORY REFORM SERIES, PART 5—FDA 

MEDICAL DEVICE REGULATION: IMPACT ON 

AMERICAN PATIENTS, INNOVATION, AND 

JOBS 

WEDNESDAY, JULY 20, 2011 

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

The subcommittee met, pursuant to call, at 10:02 a.m., in room 

2322 of the Rayburn House Office Building, Hon. Cliff Stearns 

(chairman of the subcommittee) presiding. 

Members present: Representatives Stearns, Terry, Myrick, Sullivan, Burgess, Blackburn, Bilbray, Gingrey, Scalise, Gardner, Griffith, Lance, Barton, DeGette, Schakowsky, Green, Christensen, 

Dingell and Waxman (ex officio). 

Staff present: Clay Alspach, Counsel, Health; Carl Anderson, 

Counsel, Oversight; Karen Christian, Counsel, Oversight; Todd 

Harrison, Chief Counsel, Oversight and Investigations; Sean 

Hayes, Counsel, Oversight and Investigations; Sean Hayes, Counsel, Oversight and Investigations; Kirby Howard, Legislative Clerk; 

Debbee Keller, Press Secretary; Ryan Long, Chief Counsel, Health; 

Carly McWilliams, Legislative Clerk; Alan Slobodin, Deputy Chief 

Counsel, Oversight; Sam Spector, Counsel, Oversight; John Stone, 

Associate Counsel; Tim Torres, Deputy IT Director; Kristin 

Amerling, Democratic Chief Counsel and Oversight Staff Director; 

Phil Barnett, Democratic Staff Director; Stacia Cardille, Democratic Counsel; Stephen Cha, Democratic Senior Professional Staff 

Member; Brian Cohen, Democratic Investigations Staff Director 

and Senior Policy Advisor; Eric Flamm, FDA Detailee; Karen 

Lightfoot, Democratic Communications Director and Senior Policy 

Advisor; Ali Neubauer, Democratic Investigator; and Mitch Smiley, 

Democratic Assistant Clerk. 

Mr. STEARNS. Good morning, everybody, and the subcommittee 

will come to order and I will open with my opening statement. 

OPENING STATEMENT OF HON. CLIFF STEARNS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF FLORIDA 

We convene this hearing of the Subcommittee on Oversight and 

Investigations to examine FDA’s medical device regulations and 

their impact on American patients, innovation and jobs. The medical device industry has brought hundreds of thousands of highVerDate Aug 31 2005 10:36 Jul 25, 2012 Jkt 037690 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 F:\112-07~3\112-78~1 WAYNE
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paying jobs to our country and life-saving, life-improving devices to 

our Nation’s patients in a safe and efficient manner. 

Unfortunately, it appears that regulatory inconsistency and inefficiency at FDA is causing innovative medical device companies to 

move offshore and launch their products abroad, oftentimes years 

before they enter the U.S. market, if at all. These are systemic 

problems at the Center for Devices and Radiological Health, 

CDRH, that must be resolved that are not a matter of funding. 

A Congressional Research Service report issued in April 2010 

found that medical device review process funding increased from 

$275 million in fiscal year 2008 to $368 million in fiscal year 2010. 

This represents nearly a 35 percent increase in funding. Comparing 

2010 with the 2003 to 2007 time period, the average review time 

for lower-risk devices approved through the 510(k) process increased by 43 percent and the average review time for higher-risk, 

innovative devices under the premarket approval system increased 

75 percent. 

President Obama himself has acknowledged that he has gotten 

a lot of commentary about the fact that essentially FDA’s model 

was designed for the kind of medical devices you see in museums. 

In reference to his Administration’s purported commitment to regulatory reform, he noted that this would be an area where they 

should be ‘‘getting a group to think strategically about how we design these regulatory bodies so that they are up to speed and more 

responsive in a dynamic economy.’’ Unfortunately, in the eyes of 

the Administration, this group does not appear to include the innovative, job-creating companies or the very patients that these devices are designed to help. 

For example, FDA commissioned the Institute of Medicine, IOM, 

to review the current 510(k) process and consider a number of specific issues related to the improvement of device regulations. Not 

a single company or industry representative that is impacted by 

these regulations is on the panel. Judging from a letter sent by 

Senator Al Franken to CDRH Director, Jeffrey Shuren, our witness 

today, Senator Franken and others share my concerns. In it, he 

states, ‘‘I believe that the medical device industry contains a 

wealth of expertise that is too often neglected when considering 

changes to the device review process. I strongly encourage you to 

establish a clear process for soliciting and considering the suggestions and concerns of the medical device industry on any and all 

recommendations made by the IOM before finalizing or implementing any changes to the process.’’ In addition to the stunning 

lack of industry representation, there is not a single patient representative on the panel. This is not acceptable and does not comply with President Obama’s call for allowing ‘‘public participation 

and an open exchange of ideas.’’ 

In addition, CDRH is supposed to ‘‘use the least burdensome’’ 

tools for achieving regulatory ends. This is not only a key tenet of 

the President’s Executive Order on Regulatory Reform, but required by the Food and Drug Modernization Act of 1997. Specifically, in order to improve regulatory efficiency of the 510(k) and 

premarket approval process, Congress mandated that the FDA 

eliminate unnecessary burdens that may delay the marketing of 

beneficial new products and only request the least burdensome inVerDate Aug 31 2005 10:36 Jul 25, 2012 Jkt 037690 PO 00000 Frm 00006 Fmt 6633 Sfmt 6633 F:\112-07~3\112-78~1 WAYNE
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formation necessary to make those determinations. Unfortunately, 

FDA appears to be actively thwarting the mandates of Congress 

and fostering regulatory uncertainty by reducing its use of the least 

burdensome provisions. 

Now, whether this is a calculated effort or a lack of leadership 

in promoting such principles, the end result is equally unacceptable: companies closing their doors and moving abroad; patients in 

the United States waiting for innovative treatments or being forced 

themselves to go abroad to get them. 

We will hear today from several of these patients. Hopefully, Dr. 

Shuren will gain some insight from these experiences and better 

understand the fact that patient safety and public health are not 

only jeopardized by approving devices that are unsafe, but also by 

failing to approve devices that are safe. Such poor processes and 

decision-making also stifle innovation, cutting-edge American companies that create numerous badly needed jobs here in the United 

States. As FDA Commissioner Hamburg said just this past week, 

‘‘This is a critical time for innovation.’’ She acknowledged that FDA 

has played a role in the national decline in medical product innovation, adding that she felt much of the criticism of her agency was 

deserved. Hopefully we can find some solutions to reverse this 

alarming trend today and soon. Patients are waiting. 

[The prepared statement of Mr. Stearns follows:] 

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Mr. STEARNS. With that, I recognize the ranking member, Ms. 

DeGette. 

OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF COLORADO 

Ms. DEGETTE. Thank you very much, Mr. Chairman, for holding 

this hearing. 

The topic of medical devices hits very close to home with me and 

I am very, very interested in this topic, because just like Ms. 

Sagan’s daughter, my daughter, Francesca, has type 1 diabetes and 

has had type 1 diabetes for 13 years, and so I know every day what 

children living with these diseases, and young adults living with 

these diseases need to do with devices—blood sugar monitoring, 

making sure they eat healthy meals and daily exercise. For the 

generation of kids like our two kids, Ms. Sagan’s and mine, the 

short-term cure is medical devices. My daughter and probably Ms. 

Sagan’s daughter uses an insulin pump and a continuous glucose 

monitor every day and yet—Ms. Sagan, I read your testimony and 

it broke my heart because every single parent who has a child living with this disease knows the scary low blood sugars and the 

scary thought about some of the consequences that can happen 

with this disease, but for our children, good devices have been the 

cures and the treatment for them and what will continue to be the 

treatments for them in their lives. 

Now, unfortunately, some of the advances in these technologies, 

not just for diabetics but for other diseases, seem to so many of us 

to have been so slow over at the FDA, and the perfect example is 

in Ms. Sagan’s testimony where she talks about our efforts to get 

a continuous glucose monitor approved that would send a message 

to the pump and would cut off insulin flow if the blood sugar is way 

too low. 

Mr. Chairman, I want to thank you and many members of this 

committee for signing a letter by the Diabetes Caucus urging the 

FDA to look at this device because it can literally save lives, and 

we appreciate it, and this is true not just for these devices but for 

devices that millions of Americans use for countless different diseases. On the one hand, people are relying on devices, and on the 

other hand, we want to make sure that improvements and advances in those devices and new devices are approved with speed. 

But on the other hand, we need to make sure that the FDA has 

the appropriate tools to make sure that medical device approval 

process helps encourage innovation while at the same time protecting patient safety, and that’s the challenge I think that the 

FDA faces and I think that that’s the challenge that we all face on 

this committee is making sure that while we support the FDA expediting an approval process that we make sure that the reviews 

are done in a way that is safe for those patients and for those devices. We need to find the right balance and we can’t pretend that 

there aren’t sometimes tradeoffs between safety and speed. 

Now, I am sympathetic to the industry concerns we hear today 

but I also fear that too often the device industry and also people 

like me who are eager to see cures and treatments for diseases 

kind of minimize those tradeoffs between safety and speech. Two 

7 

studies funded by the medical device industry, one conducted by 

Dr. Josh Makower and the other by the California Healthcare Institute, that have been heavily cited by many of our colleagues and 

by proponents of weakening FDA regulations provide a good example of how facts can be twisted. These studies have been heavily 

cited, and so our committee staff asked a panel of distinguished 

outside reviewers to analyze the methodology of these studies, and 

at the staff’s request, officials from the FDA also submitted comments on the studies. 

Mr. Chairman, Democratic committee staff prepared a supplemental memo summarizing the expert reviews of these industry 

studies, and I would ask unanimous consent to include this memo 

and the letters from FDA and the independent experts in today’s 

hearing record. 

Mr. STEARNS. I thank the gentlelady. Can we just have a copy 

of it and we will read it and we will look at it. 

Ms. DEGETTE. You bet. 

The reviewers found the following problems with these industryfunded studies. First, the existence of ‘‘so many flaws in design and 

execution that the authors’ conclusions are rendered essentially 

meaningless.’’ Second, a ‘‘woefully inadequate’’ response rate of only 

20 percent, a biased group of respondents that included companies 

that had never gone through the process of getting a product reviewed by the FDA, a subjective, apples to oranges, and especially 

troublesome conclusion regarding the difference in approval times 

between the European Union and the United States, the failure to 

provide any evidence that a U.S. delay in approval and availability 

leads to adverse health outcomes. The journal editors concluded 

that the studies would not be fit for publication in a peer-reviewed 

journal. 

And so as we consider the role of the FDA, we have got to rely 

on the facts. The patients and their families and the industry need 

to know how can we have the quickest review process possible 

while at the same time ensuring patient safety and efficacy of the 

devices. 

So I thank you for having this hearing. I look forward to both 

of our panels of testimony, and I yield back. 

[The prepared statement of Ms. DeGette follows:] 

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Mr. STEARNS. I thank the gentlelady, and the gentleman from 

Texas, Mr. Barton, is recognized for 1 minute. 

OPENING STATEMENT OF HON. JOE BARTON, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. BARTON. Thank you, Mr. Chairman. Thank you and Ranking 

Member DeGette for holding this oversight hearing. 

The issues that we are discussing today have the ability to harm 

our sick, inhibit innovation and stifle domestic economic jobs and 

growth. On the other hand, if done properly, they have the ability 

to bring state-of-the-art medical devices quickly and efficiently to 

not only the United States citizenry but to people all over the 

world. I hate to say it, but the medical device review process at the 

Food and Drug Administration in my opinion has become overly 

burdensome, unpredictable and inconsistent under its current leadership. 

I would like to read briefly a paragraph from the document that 

was prepared for this hearing, which is common themes raised by 

the device companies seeking FDA approval include unclear guidance, high turnover of review staff, impractical clinical designs, 

changing the goalpost, reluctance to approval protocols, and duplicative or overly burdensome data requests. 

Hopefully, this hearing will lead to some soul searching at the 

FDA, and if necessary, it may lead to some legislative solutions recommended by this subcommittee to the legislative subcommittees. 

I will put the rest of my statement in the record, Mr. Chairman, 

but this is an important hearing and it has important implications 

for the country. 

[The prepared statement of Mr. Barton follows:] 

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Mr. STEARNS. I thank the gentleman. 

The gentleman from Texas, Dr. Burgess, is recognized for 1 

minute. 

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. BURGESS. Thank you, Mr. Chairman, and Dr. Shuren, thank 

you for being here. Thank you for your willingness to hear from the 

panel and of course I want to thank our panelists for being here. 

Ms. Conger, thank you for reminding us if we are not careful, NIH 

stand in the future for Not Invented Here. 

Now, the FDA is not interactive, it is unpredictable and discourages innovation, and this ultimately hurts patients. We don’t want 

the FDA to approve anything that will harm people. We don’t want 

you to simply adopt European standards. But we do want you to 

understand that a little predictability can go a long way. We want 

you held to your own standards. If you say 30 days, we shouldn’t 

have to ask how long is that in FDA days. If a company is asked 

to provide proof the device does something it wasn’t designed to do 

and they tell you that, you can’t claim that as an example of noncompliance. I know you care about the FDA. You know I care about 

the FDA. And you do have a critically important job, but don’t hide 

behind a twisted interpretation of benchmarks. 

The truth, the doctors of tomorrow are going to have tools at 

their disposal that are unlike anything that you or I imagined during our training. The ability to alleviate human suffering is going 

to be on a scale never imagined before by any other generation of 

doctors. It is our job to be certain that the tools get into their 

hands. 

Thank you, Mr. Chairman. I will yield back. 

Mr. STEARNS. I recognize the gentleman from Georgia, Dr. 

Gingrey, for 1 minute. 

OPENING STATEMENT OF HON. PHIL GINGREY, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF GEORGIA 

Mr. GINGREY. Mr. Chairman, thank you. 

I focused my opening statement during the July 11th prescription drug user fee hearing on my intent to pursue regulatory reform through PDUFA reauthorization building on the steps that 

the FDA and Dr. Hamburg have already taken. The same is true 

for medical devices. Patients, industry and the FDA can benefit 

from a more predictive regulatory framework. With limited financial resources, as outlined by the chairman, both within the FDA 

and in industry, it appears that an approval approach that is able 

to maximize effort is one that will benefit all, and I believe that 

if the FDA is going to be successful and becoming more responsive 

to new technologies and products, it is going to need the support 

of industry experts, patient advocates and other agencies. 

I look forward to working with this committee and Dr. Hamburg 

to ensure we achieve this worthy goal. I thank both panels of witnesses. We look forward to hearing from you, and I yield back. 

Mr. STEARNS. I thank the gentleman. 

The gentleman from Nebraska, Mr. Terry, is recognized for 1 

minute. 

14 

OPENING STATEMENT OF HON. LEE TERRY, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEBRASKA 

Mr. TERRY. Thank you. My statement is going to reference the 

February 9th article from the New York Times that I would like 

to submit for the record, unanimous consent to submit. 

Mr. STEARNS. Without objection, so ordered. 

[The information follows:] 

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Mr. TERRY. Biosensors International, a medical device company, 

shut its operation in southern California, which had once housed 

90 people, 90 lost jobs. The CEO is moving the manufacturing to 

Europe and says their stent ‘‘is available all over the world including Mexico and Canada but not in the United States. We decided, 

let’s spend our money in China, Brazil, India and Europe.’’ It is disappointing to hear the CEO’s statement. 

We hear later in the article a quote from a capital venture company who says, ‘‘Ten years from now, we’ll all get on planes and 

fly somewhere else to get treated.’’ That is a true indictment of our 

FDA’s inability to timely approve medical devices, and I would like 

to see us, the United States, continue to be the world leaders in 

technology development. Yield back. 

Mr. STEARNS. I thank the gentleman. 

The gentlelady from Tennessee, Ms. Blackburn, is recognized for 

1 minute. 

OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TENNESSEE 

Mrs. BLACKBURN. Thank you, Mr. Chairman, and welcome to all 

of our witnesses. We are grateful that you would take your time 

and be here with us today. 

Continuing on the theme of making these innovations, having 

the innovations here, I think it is important for us to realize that 

40 percent of the global medical technology industry is here in the 

United States, and it represents about 2 million U.S. jobs. Where 

I am from in Tennessee, we have about 10,000 individuals who are 

employed in the medical device industry and the wages and earnings are about 40 percent higher than the average earnings. So 

when you look at it from an issue of keeping those jobs here, it is 

vitally important. 

When you look at the fact that we are in a 21st century creative 

economy and innovation, intellectual property and protecting that 

is vital to jobs retention. We want to make certain that FDA is responsive and responsive in a timely manner. 

Welcome to the hearing, and I look forward to questions. 

Mr. STEARNS. I thank the gentlelady. 

The ranking member from California, Mr. Waxman, is recognized 

for 5 minutes. 

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

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

I think we can all agree it is critically important that innovation 

in the medical device industry is vibrant and healthy, and that patients have access to the best and newest technological advances. 

If FDA is unnecessarily impeding technological advances that improve the lives of patients, we should all be united in doing whatever it takes to remove these unnecessary regulatory barriers to 

public health. 

21 

But we cannot have a conversation about the impact of regulations and policies at FDA have on patient access and innovation 

without talking about the importance of ensuring the safety and effectiveness of medical devices. We should not forget that that is the 

fundamental mission of FDA. 

Practically every month, there is a new report in the papers 

about horrific patient suffering from dangerous medical devices. 

Last year, the New York Times revealed that radiation machines 

have killed and disfigured patients. The Subcommittee on Health 

held a hearing on the issue and heard from a father whose son was 

killed by an overdose from radiation therapy. We learned this year 

that malfunctioning linear accelerators have left patients nearly comatose and unable to speak, eat or walk. 

Just last month, the New York Times reported on the suffering 

caused by faulty metal-on-metal hip implants. According to the 

Times, patients were promised these hips would last longer and enable more activity. About half a million patients got these devices. 

Now they are being recalled due to high rates of failure and patients have suffered severe health effects and have been forced to 

undergo surgery to replace the defective devices. 

And these are just the most recent examples. We have also heard 

about problems with implantable heart devices that shocked patients and led to at least 12 deaths. Implantable defibrillators 

made by another company were failing for years before the manufacturer told anyone. 

Our focus in this committee should be on how we can strengthen 

our device laws to protect patients from these grievous harms. Yet 

I fear that this is not the committee’s goal today. Instead of 

strengthening our device laws, Republican members have proposed 

radical changes to our device laws that could further imperil patients. That is exactly the wrong direction for us to take. 

We will hear testimony today that FDA is imposing new restrictions to innovation. Device industry advocates often refer to two industry-funded reports, one conducted by Dr. Josh Makower and one 

by the California Healthcare Institute, that they say show that 

FDA is unduly slow, burdensome and unpredictable. Yet neither of 

these studies, as Ms. DeGette pointed out, was published in a peerreviewed journal, and both of these studies were funded by and 

conducted for industry advocates. Because of the lack of independent validation of these reports, I asked my staff to request 

that the editors of our Nation’s top medical journals, one of whom 

is a witness today, examine the methodology of these two industry 

papers. All three editors we asked agreed to participate. 

As our witness will describe today, there are serious methodological flaws in both studies—biased samples, small sample size 

and botched statistical analysis, just to name a few—rendering 

them essentially useless as part of any discussion of FDA’s regulatory system. None of the editors felt that the methodology of 

these studies was worthy of publication in a peer-reviewed journal. 

We will also hear today from six witnesses who will express their 

concerns that the FDA’s device regulatory system is depriving patients of new and potentially life-saving devices, inhibiting innovation, and costing Americans jobs. FDA can and should do better in 

many of these cases. But we can’t legislate by anecdote. 

22 

We need to ask why unsafe devices have gotten onto the market 

and harmed so many patients. Then we need to explore how we can 

strengthen the FDA review process to protect patients from these 

risks. The soon-to-be-released recommendations from the Institute 

of Medicine could provide a roadmap for how to improve FDA’s regulatory oversight of medical devices. 

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. It is also in the interest of the device industry itself. If patients lose confidence in the FDA, they lose confidence in the industries it regulates as well. 

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

to hearing from our witnesses and to working with my colleagues 

on this important matter. 

[The prepared statement of Mr. Waxman follows:] 

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Mr. STEARNS. I thank the gentleman. 

Let me say, we have seven witnesses, not six, and we welcome 

all seven witnesses to our hearing, and I call attention to the bio 

of each of these witnesses. If members will take the time to read 

that, I won’t have to go through all seven. 

Let me address all of you. You are aware that the committee is 

holding an investigative hearing, and when doing so has the practice of taking testimony under oath. Do any of you object to taking 

testimony under oath? No? The chair then advises you that under 

the rules of the House and the rules of the committee, you are entitled to be advised by counsel. Do you desire to be advised by counsel during your testimony today? In that case, if you would please 

rise and raise your right hand, I will swear you in. 

[Witnesses sworn.] 

Mr. STEARNS. You are now under oath and subject to the penalties set forth in Title XVIII, section 1001 of the United States 

Code. We welcome your 5-minute opening statement, and your 

written statement will be part of the record. 

Dr. Fischell, we will start with you. Welcome. 

TESTIMONY OF ROBERT E. FISCHELL, CHAIRMAN AND CEO, 

FISCHELL BIOMEDICAL LLC; CAROL MURPHY, PATIENT; 

MARTI CONGER, PATIENT AND PATIENT ADVOCATE; PAM K. 

SAGAN, PATIENT; MICHAEL MANDEL, CHIEF ECONOMIC 

STRATEGIST, PROGRESSIVE POLICY INSTITUTE; SEAN 

IANCHULEV, CHIEF MEDICAL OFFICER, TRANSCEND MEDICAL, INC.; AND GREGORY D. CURFMAN, EXECUTIVE EDITOR, 

NEW ENGLAND JOURNAL OF MEDICINE 

TESTIMONY OF ROBERT E. FISCHELL 

Mr. FISCHELL. Chairman Stearns, Ranking Member DeGette, 

members of the subcommittee. My name is Robert Fischell, and I 

am pleased to testify today about an issue of great importance to 

me, to patients, to physicians and to the American public. 

For more than four decades of my 82 years, I have dedicated my 

life to inventing and developing novel medical technologies including an implantable insulin pump for diabetics, heart pacemakers, 

implantable defibrillators, and co-inventing about 10 million of the 

heart stents that have improved health and saved lives of patients 

in the United States and throughout the world. I have personally 

been the inventor or co-inventor on more than 10 medical devices 

including a new external device that is effective in eliminating the 

pain of migraine headaches, which device is here in front of me on 

this table. 

These technologies have also spurred tens of thousands of jobs in 

this country and resulted in billions of dollars in U.S. exports to 

other countries that value our American medical devices. Unfortunately, the environment that exists at FDA’s Center for Devices 

and Radiological Health over the past few years is the worst that 

I have experienced in my 42-year career involving medical technologies. 

Given the success I have enjoyed over the years, some might ask 

why am bothering to testify today. It is certainly not in pursuit of 

money. I have enough to live pretty well. I am here today because 

26 

of the millions of patients and physicians who are searching for 

therapies to improve the human condition. Unfortunately, it is not 

technology, science, ingenuity or the economy that is standing in 

the way of success in developing new medical technologies. In my 

opinion, it is today the FDA. As a strong supporter of President 

Obama and his policies, that is not easy for me to say. 

Prior to 2008, CDRH division was demanding safety and efficacy 

for the many new medical devices that I had invented. At that 

time, they were reasonable in allowing clearance of devices that 

showed safety and efficacy. CDRH demonstrated the ability to 

properly weigh the benefits and risks of new medical devices as 

part of the premarket review process. CDRH leadership understood 

that medical devices may have some risks, but corresponding benefits that patients realized with the therapy they provided were 

worth the risk associated with such devices. 

Over the past few years, I have personally been aware of many 

instances where product clearances were denied or significantly delayed by CDRH when the patient benefit clearly outweighed any 

potential risk to the patient. One example of this is a device that 

I invented that relieves the pain of migraine headache with no serious side effects, this device right here. That device was not approved by CDRH even after the clinical trial proved safety and efficacy. A somewhat trivial example is a small plastic valve that I 

have in my hand that could open or close to allow liquid to flow, 

and had its approval delayed by over a year when it had already 

been approved for regular use in other equipment. 

The failure of the current CDRH to efficiently and effectively review medical devices is a serious problem for the citizens of the 

United States. Many published reports suggest that patients are 

being forced to travel outside the United States for therapies that 

were developed here. Even worse, many patients do not have the 

resources to travel abroad and are forced to suffer, waiting desperately for FDA to clear or approve therapies that in some cases 

have already been available for years outside the United States. 

Beyond the adverse impact FDA is having on patient care, it is 

weakening the U.S. leadership position in medical technology innovation, and as a result, hurting our economy. As someone who has 

enjoyed success in this industry, I have been proactive in trying to 

assist the innovators, scientists and engineers of tomorrow to be in 

this field. I recently established the Fischell Department of Bioengineering and the Fischell Institute for Medical Devices at the 

University of Maryland. Today, I am truly concerned for those scientists, engineers and innovators who study there who are about 

to embark on their careers. If I were to be starting out today, I 

would likely be unable to make the contribution to patients’ lives 

that I have made over the past 40-plus years because I would be 

unable to raise the funding or endure the delays that exist with the 

current regulatory environment at CDRH. 

In dealing with the FDA today, the reviewers appear to be slowing down or totally denying clearances for valuable medical devices 

that would be of great benefit for patients in the United States. By 

doing this, they are proud of being so conservative. I mean, look 

how good I am, I am so conservative, I am not even going to approve it. I am aware of examples where reviewers have changed 

27 

the requirements for companies during the premarket review process with no credible evidence supporting the moving goalposts. 

One such example has recently occurred with a device that I coinvented that improves the treatment for epilepsy using a tiny electrical stimulator that I have here. 

The inability for reviewers to be held accountable for their changing standards and increased risk aversion is something Congress 

and undoubtedly this committee must address if we are to improve 

patient care in this country and promote innovation and jumpstart 

our economy. While it may be difficult to legislate culture and restore the collaborative, reasonable and effective CDRH that existed 

back in 2008, I urge this committee to try. Patients, physicians, 

innovators and the American public are counting on you to step up 

and restore a reasonable and predictable CDRH that appropriately 

balances risks and benefits, works collaboratively with industry 

and understands that unnecessarily denying—— 

Mr. STEARNS. Dr. Fischell, I need you to summarize. 

Mr. FISCHELL. Two sentences. 

Mr. STEARNS. Good. OK. 

Mr. FISCHELL [continuing]. Access to medical therapy means that 

FDA is failing in its primary mission, which is to protect patients 

but also to allow clearance for devices to relieve pain and suffering 

that many patients would otherwise have to endure. Thank you. 

[The prepared statement of Mr. Fischell follows:] 

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Mr. STEARNS. Ms. Murphy, welcome. 

TESTIMONY OF CAROL MURPHY 

Ms. MURPHY. Thank you. Good morning. I am Carol Murphy. 

I have been a migraine sufferer for 40 years. I have three to four 

aura migraines a week. I have been through beta blockers, 

antidepressants, anti-seizures, abortive medications. When you 

have done that, you go on to the next step, so I have had occipital 

blocks, I had steroidals, cervical blocks, I have had Botox with minimum success. 

At Michigan Head Pain and Neurological Clinic, once you turn 

60 years old, you don’t fit any of the medical protocols for migraine 

medicine and therefore they left me with the narcotic oxycodone to 

take care of a migraine headache, and that was it. 

I finally got into the trial program at Ohio State with the 

transcranial magnetic stimulator, TMS. I was told to put the device 

on my head, activate it twice during an aura. When I did that, the 

aura cycle kept going but at the end of the aura when the pain 

should have started, it didn’t. The blood vessels did not fill up. 

There was no pain. There was no headache. For 9 months, I lived 

like a normal person, and then in June of 2006, Ohio State took 

it back because it was going to go through the FDA process for approval. Give us 9 months, give us a year, Carol. Yes. It is now June 

of 2011—July of 2011. Where is my machine? That is in England. 

That is not here. I can’t get it here. 

A lot of people think that a migraine is a headache. It isn’t. 

When blood vessels swell in the brain, every part of your body can 

be affected. For me, my feet and legs get so cold that there is absolutely no way for me to sleep so going to bed and sleeping it off 

doesn’t work. And there is no way of warming those legs until after 

the migraine stops. When I take OxyContin, it dulls the pain but 

it doesn’t break the migraine cycle. With the TMS, no headache because the blood vessels weren’t dilated. 

With migraines, I also experience urinary and bowel problems. 

By the second day, I have abdominal pain. I also have problems 

concentrating. The thoughts in my head are clear but the words 

coming out of my mouth sometimes are not right or they just don’t 

come out at all. This doesn’t happen with the TMS because we 

don’t have the dilation of the blood vessels. 

As I get older, falling becomes a major problem for me, and my 

left leg drags during a migraine. So I need to be more careful. I 

need to have the good balance. And with the TMS, again, we don’t 

have the lagging of the left foot. 

Now I live my life between a rock and a hard place. I can take 

the medication, I can deal with the fact that it is addictive or I can 

crawl up in my little hole and stay there until it is over. Either 

way, that is not quality of life. I want my device back. I will go to 

England to get it. I will rob Peter to pay Paul to get there because 

for me, it is a quality-of-life factor. 

I want to look forward to a life without any pain. I want to know 

that I am not going to wait until 3 or 4 or 5 years for the FDA 

to turn around and approve this machine. 

There are millions of migraine sufferers. Everyone has their own 

story. I am one that medication just doesn’t work for. We as AmeriVerDate Aug 31 2005 10:36 Jul 25, 2012 Jkt 037690 PO 00000 Frm 00037 Fmt 6633 Sfmt 6633 F:\112-07~3\112-78~1 WAYNE
34 

cans should not have to go to England to get a piece of machinery 

that I know that I used 5 years ago safely. This is a product that 

was made in America, by Americans, but obviously not for Americans. How long do we have to wait? Five years is a long time. How 

many more years? How many more migraines am I going to go 

through if I am going to sit and wait for the FDA to approve this 

product? 

Thank you for your consideration and time. 

[The prepared statement of Ms. Murphy follows:] 

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Mr. STEARNS. Ms. Murphy, that is very compelling. Thank you. 

Ms. Conger, you are recognized for 5 minutes. 

TESTIMONY OF MARTI CONGER 

Ms. CONGER. And I timed the 5 minutes, practicing on the airplane. 

Hello, and I thank you very much for the invitation to testify. I 

am a spine patient and a very angry one. I became livid when I 

figured out that my government was the main barrier between me 

and the best solution for my spine problem. 

I am here today as an advocate for the millions of U.S. patients 

like me who are needlessly suffering, deteriorating and sometimes 

dying while they wait for the FDA to approve medical devices they 

desperately need, devices that are often already in successful use 

in other countries. 

Briefly, a little about me. My TOS specialist identified my cervical spine issue in 2006 and quickly sent me to University of California San Francisco Spine Clinic to Dr. Dean Child, who had been 

involved in cervical spine artificial disc trials, clinical trials. 

Now, I have been dealing with multiple life-altering health 

issues, and since I can’t take narcotics or opiates, I was already 

physically and mentally drained from chronic pain and raging paresthesia. If you want to imagine that, just walk around barefooted 

on a bristle brush, and that is paresthesia in your feet. 

My neurosurgeon’s—my surgeon’s diagnosis just had me reeling. 

What else can go wrong? I already had this long list of deals. But 

he immediately started educating me. After he reviewed my films 

in detail, we discussed my options, the benefits and consequences, 

and in my case, my choices were, first, do nothing, wait for quadriplegia in the next couple of years, or have fusions, which I later 

learned meant I would likely have chronic pain in my neck and 

possibly have cervical fusion in the future. The third choice, wait 

a couple of months for an artificial cervical disc in the FDA approval pipeline, one widely used and successfully in Europe since 

2003. 

While I waited for device approval, my spine degenerated to the 

point that my doctor and I feared I was in serious danger. All my 

limbs were numb. My continence was an issue. My balance and my 

grip were unreliable. I was a prisoner in my own house for fear of 

going outside and having a paralyzing accident, and I depended on 

everyone else to take care of my needs. I knew I couldn’t living this 

way safely but I was not having fusions. Nor could I believe the 

newer clinical cervical device technology which my doctor and I felt 

was best for my problems were made 40 miles south of my house 

and I could not get them installed in my Nation. Forty miles from 

my house. By the way, those jobs have disappeared to Europe because European countries will sometimes say, if you don’t have approval in the United States or your home country, country of manufacture, you can’t sell them here. So they moved all those jobs, 

those $160,000 to $100,000 jobs to Germany. Yet these devices 

were in successful use in Europe and elsewhere. 

My only option to get the best solution for me was for me to go 

abroad. It took research and months of fundraising. We drained our 

savings, what little we had. We accepted $5,000 in gifts from 

39 

friends and family. I stripped my life insurance policy of cash 

value. We incurred credit card debt, and my 75-year-old husband 

had to return to full time, and he has been working since. 

Finally, I had my two-level ADR surgery in 2009 at the Spine 

Clinic in England. My pain relief was immediate, and my discs are 

functioning flawlessly. My U.S. neurosurgeon is delighted. He does 

my follow-up. 

And what about all the other—so I got the best solution for me 

but it shouldn’t have taken all my limited energy and money to get 

them. What about all the other Marti Congers in this country, people waiting for access to medical devices that already have foreign 

approvals and years of track record. I know, because I receive calls 

and emails every week from spine patients from auto mechanics to 

engineers to cardiac surgeons. They want to know how they might 

get the treatment they need somewhere, somehow, because they 

are not going to do the procedure here. And what about all the 

other devices common in Europe and in Asia but bogged down in 

the FDA process. Products often invented here aren’t available to 

U.S. patients for years after patients around the world already 

have them. It simply shouldn’t be this way. It shouldn’t. 

I do appreciate, Mr. Stearns, that the agencies’ challenges that 

they face right now from all directions. I appreciate their desire to 

protect people. However, our FDA needs to restart, reset their priorities back to patients’ needs and away from political risk aversion. Patients are looking for reasonable assurance and timely approval or denial—not all devices make it—but absolute assurance, 

what seems to be the goal here, is impossible, impossible, because 

every human body is unique. 

For products with strong track records, the FDA should leverage 

regulatory findings from other trusted countries and unions such 

as Japan, Australia, European Union and others, and put them 

into the marketplace or at a minimum fast-track them, then monitor—oK. Two sentences? 

Mr. STEARNS. Just if you could wrap up. 

Ms. CONGER. Yes. Monitor them in the marketplace. Requiring 

known devices to restart the approval process from the beginning 

when thousands of human already have them in their body is ludicrous. The sooner we act on these changes, the sooner U.S. patients 

will have access to the devices they need at a reasonable price instead of waiting 2 to 10 years to get the device here. 

[The prepared statement of Ms. Conger follows:] 

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Mr. STEARNS. I thank the gentlelady. 

Ms. Sagan, you are recognized for 5 minutes. I just urge everybody if possible to keep it to 5 minutes. 

TESTIMONY OF PAM K. SAGAN 

Ms. SAGAN. Chairman Stearns, Ranking Member DeGette and 

members of the committee, thank you for asking me to testify before you today. 

My husband and I have three children, the youngest of whom, 

our daughter Piper, was diagnosed with type 1 diabetes at the age 

of 2 in 1989. She has lived over 20 years with this constant, frightening, deceptive and malicious disease. 

I come before you today not only as a parent but as an advocate 

for tools and technology for my daughter and others with diabetes 

and with my enduring hope for a cure. 

Piper has always been prone to hypoglycemic events—low blood 

sugar. They seem to come on hard and fast. I remember her almost 

drowning as a youngster after becoming unconscious from low 

blood sugar while taking a bath. College also brought one or two 

incidents a year where she slept into hypoglycemia and didn’t wake 

up the next morning, requiring emergency medical care. 

There is a chilling term that is the worry of every parent of a 

child with diabetes called ‘‘dead in bed.’’ Kids are found dead in the 

morning after a completely normal evening the night before. Most 

of the time it is due to severe hypoglycemia. I don’t want this to 

happen to my daughter or anyone else with diabetes, so you can 

understand where my fire comes from. 

Just this past winter, Piper, now a 24-year old, had another severe hypoglycemic event. While working at a retail store, the last 

thing she remembers is closing the front door of the shop as she 

left to walk the 10 blocks to her apartment. My cell phone rang at 

home, and she slurred to me that she was locked out of her apartment. Upon further conversation, I realized that she was low. She 

had wandered her way home in a semiconscious state. She had 

crossed busy San Francisco city intersections at rush hour, she had 

fallen and scraped her hands as she walked, and she had lost bladder control. She finally ended up at her apartment, the keys were 

in her purse, but she didn’t know what they were. She pulled out 

her cell phone and pushed the number one, my cell phone number. 

All this time, her continuous glucose monitor was alarming, but 

her blood sugar was too low to take action, and her insulin pump 

continued to pump insulin into her body, lowering her blood sugar 

even more. 

This is life with type 1 diabetes. Type 1 diabetes occurs when the 

body’s immune system attacks the cells in the pancreas that 

produce insulin. Insulin regulates glucose in one’s body, and without it, a person with type 1 diabetes cannot live. There is no cure 

for this disease and it imposes an enormous physical, emotional 

and financial burden. On average, a child with diabetes will have 

to take over 50,000 insulin shots or infusions in a lifetime. Every 

hour of every day for the rest of her life, she will have to balance 

insulin, food and activity to try to prevent low and high blood sugars, and the devastating and costly complications: seizures, comas, 

kidney failure, heart disease, blindness and amputations. It 

50 

astounds me that diabetes costs our nation more than $174 billion 

a year and one in three Medicare dollars is spent to care for people 

with diabetes. 

Because of these burdens, people with diabetes and their loved 

ones need timely access to innovative, life-saving technologies to 

help better manage the disease. Some breakthrough tools and technologies that protect against dangerous diabetes episodes are already available all over the world, but not available here in the 

United States. 

I don’t claim to be an expert on the regulatory process at the 

U.S. Food and Drug Administration, but as a parent with a daughter with diabetes, I am extremely frustrated that better technologies to help people with diabetes are delayed here in the 

United States. Low-glucose suspend systems have been approved 

for nearly 3 years and used safely in over 40 countries worldwide, 

but they are not available here in America. This technology is one 

critical example where our Nation is lagging behind in the approval 

of devices that would make living with this disease much safer. As 

background, these pumps stop delivering insulin automatically 

when a monitor indicates that the body’s glucose levels are low. 

With this kind of pump, my daughter wouldn’t receive more insulin 

when she is already low, causing her blood sugar to drop further 

and potentially causing a seizure, coma and even death. With the 

present FDA approval process, it will require a clinical trial conducted in this country, and a delay of years to conduct the study 

and compile the data before a decision is made. Kids are dying 

from hypoglycemia now. I want, and my daughter needs, this system available in the United States today. 

In 2006, I was thrilled that the FDA recognized the importance 

of this technology and placed the artificial pancreas on its Critical 

Path Initiative. That was 5 years ago. With the funding from the 

Special Diabetes Program, for which I am so grateful to all the 

members of this committee for supporting, the artificial pancreas 

was tested favorably in a hospital setting. Now it is time to move 

to outpatient studies. 

I implore Congress to continue to urge the FDA to move forward 

on next steps relating to low-glucose suspend systems and the artificial pancreas so that people with diabetes will remain healthier 

and safer until a cure is found, and I would lead the chorus of applause for the FDA when real progress happens, but it has to happen very soon. My daughter’s life is depending on it. 

[The prepared statement of Ms. Sagan follows:] 

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Mr. STEARNS. Thank you. 

Mr. Mandel, you are recognized for 5 minutes. 

TESTIMONY OF MICHAEL MANDEL 

Mr. MANDEL. Members of the subcommittee, thank you very 

much for the opportunity to testify on medical device regulation 

and its impact on health and innovation. 

This statement draws heavily on a recent policy brief that I 

wrote for the Progressive Policy Institute where I am chief economic strategist. I am going to talk about one specific example 

where the FDA is apparently impeding innovation. I will then 

briefly discuss what we can do to boost innovation without hurting 

health and safety while expanding high-quality health care to underserved populations. 

My major focus as an economist is the link between innovation 

and jobs. U.S. job growth has been weak since 2000. Surprisingly, 

innovation has been weak as well once we look beyond IT and communications. We got the iPhone but we didn’t get gene therapy. We 

got Angry Birds but we didn’t get enough health-improving, productivity-enhancing medical technologies. The question is why. 

There are plenty of culprits. Profit-seeking companies, inflexible 

doctors, out-of-control lawyers, myopic academics, the list could go 

on and on. But today I am going to focus on the FDA. 

The FDA has a very tough and essential job: ensuring the health 

and safety of the American public. But over the years, people have 

regularly complained to me that the FDA imposes excessive requirements on the approval of new drugs and devices. No doubt the 

FDA has gotten stricter in recent years about requiring evidence of 

safety and effectiveness. However, by itself, that is not enough to 

show over-regulation. Health and safety is paramount, and no one 

wants dangerous drugs and devices put on the market. It could be 

that we were under-regulating before. However, in May 2011, I 

heard about one example that suggested over-regulation. This was 

MelaFind, a name that I had never heard before, a handheld computer vision device intended to help dermatologists decide which 

suspicious moles and spots should be biopsied for melanoma. 

Not to go into detail here, but if MelaFind worked, it was easy 

to see how it could improve health and cut costs. Moreover, 

MelaFind could be used to augment care in low-income and rural 

areas. Equally important, the device was non-invasive. That meant 

it was as safe as possible, and it was an IT-driven expert system, 

which meant that it would get better over time as the computer 

power increased. Imagine my surprise when I discovered that the 

FDA staff had deemed MelaFind not approvable, and double my 

surprise when I read the briefing document that the FDA staff prepared for a panel of dermatologists, statisticians and other experts 

who were voting on whether to recommend MelaFind for approval. 

The FDA briefing document started with a very reasonable analysis of the shortcomings of the MelaFind test results. I was initially 

quite sympathetic to FDA’s perspective but when the FDA started 

listing its broader objection to MelaFind and what it expected the 

device to do, it quickly became clear that the agency was using a 

set of standards that no first-generation device could ever reach. 

55 

Just a couple of striking ones. The FDA objected because the 

study did not find ‘‘a clinically significant difference between 

MelaFind and the examining dermatologist.’’ The agency also objected because the device was not demonstrated to make inexperienced doctors the equal of experienced dermatologists. Let me repeat that. The FDA apparently was saying that in order to be approved, that MelaFind had to beat experienced dermatologists and 

had to turn inexperienced doctors into the equivalent of board-certified dermatologists. These are great goals. These are fantastic 

goals. However, they are also goals that no first-generation device 

can ever reach. Failing to approve MelaFind is the equivalent of rejecting the first cell phone on the grounds that callers might 

mishear important emergency messages. Or think about a government body telling Steve Jobs in 1977 that the first Apple computer 

was not approvable because he had not submitted a study showing 

Apple users could be trained to produce the same results as users 

of mainframe computers. 

Because MelaFind is non-invasive, it gives us a clear window 

into the FDA’s approach that we don’t get from other devices and 

drugs that may have negative side effects. As an economist, it worries me that we are missing health-improving, productivity-enhancing devices and drugs because the FDA has too narrow a perspective. Thank you. 

[The prepared statement of Mr. Mandel follows:] 

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Mr. STEARNS. Thank you. 

Dr. Ianchulev, you are recognized for 5 minutes. 

TESTIMONY OF SEAN IANCHULEV 

Mr. IANCHULEV. Thank you. Mr. Chairman, Ranking Member 

DeGette and members of the subcommittee, I am Dr. Ianchulev, 

and I would like to thank you for the opportunity to share my personal experience with the FDA and the regulatory process and its 

impact on patient care, innovation and development of new technologies in this country. These are my own opinions, and I share 

them to you from the perspective of a physician, innovator and developer of some new therapeutics and devices. 

In the way of background, I am a physician, eye surgeon who 

uses medical devices and technology to treat and prevent blindness. 

I am an associate clinical professor on the faculty of UCSF School 

of Medicine, where I see firsthand the translation of research into 

patient care, and as the developer and inventor of new technologies 

in the field, I have led innovative treatments through the regulatory process with the FDA and I have direct experience with the 

drug and device side of the FDA in addition to experience with the 

European regulatory authorities. 

Physicians such as myself feel privileged to be educated, practice 

and advance medicine in the United States. The United States has 

been a leader in cutting-edge innovation traditionally, and my field, 

ophthalmology, is a bright example to that effect. In fact, the most 

common device implanted today is the intraocular lens implant for 

cataracts, and this has been one of the most successful, effective 

and safe treatments to date based on innovation of the 1980s and 

1990s and based on leadership of the FDA at that time with a 

streamlined regulatory process. 

Today more than ever, we need best-in-class technology in service to our aging population and it is unfortunate that patients are 

starting to seek care from foreign doctors who are now trained and 

have hands-on experience with technologies we see much later in 

the United States, as we heard today. As a physician who not only 

delivers the standard of care but also innovates in my field, I have 

failed a number of times to treat patients with what I think is the 

best treatment for them. In fact, I see more and more patients 

seeking the often-challenging offshore route in search of interventions that are not available here with much added cost, frustration 

and pain. When recently asked by a patient suffering from a degenerative, blinding eye disease about a therapy not approved in the 

United States but available in other countries, I had to stay silent. 

The patient ended up traveling to Canada to receive treatment for 

which he paid out of pocket. 

But I would like to go beyond the anecdotal experience and ask 

the bigger question: what innovative first-class therapies are we 

delivering to patients today? Let us take the field of ophthalmology, 

which is a good example with its high degree of technical innovation and device utilization. To check the innovation pulse prior to 

this hearing on the way here, I reviewed all of the FDA-approved 

PMA devices in my field over the past 5 years. As you aware, the 

PMA class III devices is the lifeblood of innovation and some of the 

most advanced, complex devices for life-sustaining or, in my case, 

67 

vision-sustaining, treatments are approved through this process. I 

reviewed the labels of all 12 such devices I could find on the FDA 

Web site. At the time of approval, all of them had been approved 

not only in the EU but in many as 20 to 40 countries before they 

were approved in the United States. In addition, some of the devices already had vast clinical experience dwarfing the FDA clinical 

trial numbers and in some examples those were more than 100,000 

patients treated worldwide before FDA approval. In one illustrative 

case with the cumulative world experience of more than 60,000 patients, the FDA label spoke only of 300 patients in the registration 

trials, too few and too late. 

Avoiding a long discourse on the meaning of the symptomatic 

state, it is not hard to see that we have failed to deliver best-inclass innovation. More importantly, we now see that new technologies are not only perfected abroad but are developed and commercialized to their full extent and companies now execute not only 

on small feasibility studies but implement their main validation 

studies, their clinical research programs and even product launches 

abroad, as evidenced by a recent MDVC report. What follows with 

that is the departure of talent, expertise and patients. 

The FDA is the gateway for new therapies, and as a vigilant 

gatekeeper, the regulatory process has to ensure safety and efficacy, but it has to facilitate innovation, and examples of that are 

right in the halls of the FDA. As a drug developer who headed the 

clinical research and development programs at one of the most successful approved biologic therapies for eye disease, Lucentis for 

macular degeneration, I have added comparative experience from 

the CDER, whose input and oversight were critical in the execution 

of this highly complex, rigorous therapeutic program of biologics 

and resulted in the commercialization of a groundbreaking therapeutic which helps hundreds of thousands of patients today. 

So this program was not only successful but exemplary in many 

ways of how the regulatory process should work and was referenced by the FDA itself in a published guidance to industry for 

best-in-class drug development. The key learnings from this experience—explicit guidance to companies and investigators, consistency 

and transparency of feedback in the review process, and a high 

level of in-house expertise from the FDA reviewers. 

My experience with the development of new technologies is that 

the pathway to innovation is challenging and it is necessary to take 

calculated risks in a thoughtful and deliberate way and to protect 

patients. We need safe and effective treatment for all patients and 

it is critical that we have the best-in-class regulatory process to do 

justice to the high level of passion, hope, talent and resources this 

country invests in the innovation process in helping patients. 

Thank you. 

[The prepared statement of Mr. Ianchulev follows:] 

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Mr. STEARNS. Thank you. 

Dr. Curfman, you are recognized for 5 minutes. 

TESTIMONY OF GREGORY D. CURFMAN 

Mr. CURFMAN. Thank you, Chairman Stearns, Ranking Member 

DeGette and other distinguished members of the subcommittee. My 

name is Gregory Curfman. I am a cardiologist and I am the Executive Editor of the New England Journal of Medicine. 

For nearly 200 years, the New England Journal of Medicine has 

been publishing research articles on new drugs and medical devices. We are strongly committed to innovation. Vigorous innovation in medical products is critical to the health of our Nation. But 

we have learned that innovation in medical treatments does not 

come easily. While some new drugs and devices succeed, others unfortunately fail, in many cases, owing to serious problems with 

safety. Innovation is essential to the future of our Nation but innovative medical products cannot succeed unless they are both effective and safe. Sensible quality assurance does not stifle innovation, 

it promotes it and avoids costly nightmare scenarios caused by 

flawed and potentially dangerous medical devices. 

Let me give two recent examples of innovative medical devices, 

one from the field of cardiology and the other from the field of orthopedic surgery, both of which were approved by the FDA by the 

510(k) fast-track process, but which were later found to be seriously defective even while they were being implanted in many 

thousands of patients. 

The first example, from the field of cardiology, is the Sprint 

Fidelis implantable cardioverter-defibrillator lead, which was manufactured by Medtronic. This lead, which delivered an electric 

shock to the heart in order to halt potentially fatal heart rhythms, 

was approved by the FDA by the 510(k) process without clinical 

testing. The defibrillator lead received considerable hype as a 

major innovation in defibrillator technology. However, soon after 

fast-track approval of the Sprint Fidelis, it became clear that the 

lead was prone to fracture, which resulted in inappropriate shocks 

in many patients and caused at least 13 deaths. The lead was 

eventually withdrawn, but only after it had been implanted in over 

a quarter of a million patients worldwide. Thus, inadequate premarket testing and a fast track to FDA approval, resulted in a devastating situation for patients. 

The second example, from the field of orthopedic surgery, and 

Congressman Waxman referred to this earlier, is a type of artificial 

hip implant known as the metal-on-metal design. Hip implants 

originally consisted of a metal ball inserted into a plastic cup. In 

newer models, which were widely hyped as a major technological 

innovation, the plastic was replaced with a metal alloy, the socalled metal-on-metal design. The new design was approved by the 

510(k) fast-track process and did not undergo clinical testing, only 

bench testing. Not long after FDA approval, reports of shedding of 

metallic debris and failure of the metal-on-metal implants began to 

surface, and upwards of tens of thousands of patients have thus far 

been adversely affected. 

Unfortunately, bench testing of the device did not faithfully reproduce the wear and tear of real life. Thus, an apparently minor 

74 

alteration in design—replacement of plastic with a metal alloy—resulted in nothing short of a public health nightmare. 

These are sophisticated engineering devices that we are talking 

about. These two examples vividly demonstrate that the glamour 

of innovation does not always work out well for patients. Innovation in medical devices must go hand in hand with a careful assessment their efficacy and safety. Such quality control measures do 

not imperil innovation; they advance it, they secure it. 

As for the European Union, the timelines to device approval 

there are only modestly shorter than in the United States, and it 

is of concern that in Europe, in contrast to the United States, the 

highest risk-devices, so-called class III devices, do not have to be 

shown to improve clinical outcomes prior to their approval. That is 

something to think about. 

Mr. Chairman, innovation in medical devices is a high priority 

for our Nation, but to be truly innovative and to avoid costly mistakes, there must be solid evidence that new medical devices are 

both effective and safe. Thank you, Mr. Chairman. 

[The prepared statement of Mr. Curfman follows:] 

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Mr. STEARNS. I thank you, and I thank all our witnesses. 

Dr. Ianchulev, you mentioned a capital report in your testimony. 

Do you mind submitting it for the record? 

Mr. IANCHULEV. I have it here. 

Mr. STEARNS. OK. That would be fine. 

Let me start by asking my questions. Dr. Fischell, I will start 

with you. Your re ́sum ́ obviously is very impressive. You are a physicist, an inventor. It says you have over 200 U.S. and foreign medical patents. At one time you were honored as inventor of the year 

in the United States, so you do have a high degree of credibility. 

So my question to you is, you state in your testimony that the environment that exists today at the FDA device center over the past 

few years, you specifically pointed out, is the worst that you have 

experienced in 42 years. Now, that is a pretty strong, dramatic 

statement. Can you give us specifics why you think that is true? 

Mr. FISCHELL. There is a new attitude of the reviewers at the 

FDA. They are very proud to be conservative. Conservative says oh, 

I am going to throw it back, I won’t approve it, therefore, I am protecting the American people from potential harm, and in some 

cases, they should have. One of the problems is that the reviewers 

are not expert in the field. For example, with our migraine device, 

we proved in clinical trial it cured migraine, it cured sensitivity to 

light and sound, but we didn’t reach the 95 percent certainty for 

nausea, only 88 percent certainty. They said it is therefore not approvable for pain, for migraine, which it cured in an excellent way. 

So I think it is this conservativeness that the people have that is 

encouraged and say oh, you are really a good guy, and to me, that 

is the main problem. I think we need more expertise at the reviewer level. We have a medical advisory board of eight leading migraine doctors in the world who go to the FDA and say what should 

be approved. The person there is a couple months out of college 

with no training in migraine and they stop it. 

Mr. STEARNS. Dr. Shuren is here in the audience, and I want to 

compliment him for staying and listening here. Normally sometimes the Administration speaks first. He was very confident and 

conscientious enough to say he would listen to you, so I think that 

is a credit to him, and I want to compliment him for staying and 

listening. Oftentimes the Administration comes over and speaks 

and they are out the door. So it is a compliment to him for staying 

here. 

But let us I put you in charge of FDA tomorrow, oK? What would 

you do different or what would you tell Dr. Shuren that you would 

suddenly create this new environment that would give the United 

States the answer to some of these problems that our witnesses 

have said? 

Mr. FISCHELL. I would—I have carefully thought about this and 

the problems that Congressman Waxman has raised, and what I 

think should be done is, when a 510(k), for example, goes to the 

FDA, the reviewer then should seek like three experts in that field 

to review the clinical trials suggested, and when that clinical trial 

is done, to review the results so that it is reviewed by people expert 

in the field, not just a reviewer with no experience in that field. 

I think that would change safety and efficacy. 

82 

Mr. STEARNS. So the bottom line is that people that are making 

these decisions don’t have the confidence, in your opinion? 

Mr. FISCHELL. I was with Commissioner Hamburg just a couple 

of weeks ago, who said they have a lot of trouble with retaining 

people and what have you, and I think that the FDA could easily 

call upon within a week of submission experts in the field like 

three experts in leads for defibrillators, and say please review this 

because you have spent 10 years of your life on it, I have never 

heard of it before. Does it not seem obvious that those who are expert in the field should be reviewers, not a person who happens to 

be there? 

Mr. STEARNS. But it is interesting, you are saying that in your 

42 years of experience, you have never seen it as recent in the last 

couple years like it is today, so your complaint is very serious on 

criticism of the present FDA right now. 

Mr. FISCHELL. I think there is a different attitude there than we 

have seen before. 

Mr. STEARNS. Thank you for saying that. 

Dr. Ianchulev, Dr. Shuren, who is behind you, mentions in his 

testimony that poor submission quality is a big reason behind the 

sharp increase in review times we have seen in the past 7 years. 

That is going to be his case. Now, you have a lot of experience in 

submitting device applications to the center. Do you agree with his 

assessment? 

Mr. IANCHULEV. Yes. I can make a comment on that. It is always 

hard to be self-critical. I am sure my submissions can probably be 

better, but a couple of observations that I have realized working on 

that front in the trenches. Very often, as we know, companies that 

operate in the device space especially and it is slightly different in 

the drug space with the big pharmaceuticals are smaller companies, companies that have fewer than 50 employees, so one can 

imagine that they don’t have always in-house expertise and specialization. But at the same time, a lot of them outsource all of 

their regulatory processes, especially today when they are so challenged and so complex, they outsource it to regulatory experts, and 

in my experience, that has been usually the way of submissions to 

the FDA to go through an outside consultant or expert with usually 

20-plus years of regulatory experience. So I really can’t comment 

to every submission. I am sure that they have better visibility to 

that but I can imagine that that expertise on the consulting firm 

has not changed. 

And then also, I think that is a good point because it would be 

really nice to see best-in-class examples of submissions where the 

agency proactively can give that guidance if they are concerned 

about the status and quality of those submissions, that people that 

work with them can see what the expectations are up front, see 

good examples of good submissions and really adjust their practices. 

Mr. STEARNS. I thank the gentleman. My time is expired. 

The gentlelady from Colorado, Ms. DeGette, the ranking member, is recognized for 5 minutes. 

Ms. DEGETTE. Thank you very much, Mr. Chairman. I want to 

thank all the witnesses for coming today and particularly the three 

patient advocates who have come their stories. 

83 

I just want to clarify with all three of you. Your stories are all 

compelling and they touch all of us because we all have relatives 

or friends in the same situation. By talking about how these devices could be brought to market and help you or your families, 

none of you are saying that you would sacrifice safety or thoroughness of review, correct? Ms. Murphy, you’re not saying you would 

sacrifice safety or thoroughness of review? 

Ms. MURPHY. No, I am not. 

Ms. DEGETTE. And Ms. Conger? 

Ms. CONGER. Safety and what? 

Ms. DEGETTE. And thoroughness of review to make sure that it 

is safe. 

Ms. CONGER. Within reasonable. 

Ms. DEGETTE. Right. Ms. Sagan? 

Ms. SAGAN. Absolutely. 

Ms. DEGETTE. You would not sacrifice—— 

Ms. SAGAN. I would not sacrifice safety. 

Ms. DEGETTE. And Dr. Fischell, you are not saying that either. 

You think that these devices should be safe, correct? 

Mr. FISCHELL. Absolutely, but it should be done in a timely manner. 

Ms. DEGETTE. In a timely and efficient manner. 

Now, Dr. Fischell, I don’t know if you were aware, you are an 

inventor and you submit these devices to the FDA. Now, the budget that was passed by the Republican majority in the House two 

times this spring cut the FDA’s funding by about $241 million. So 

if we are going to hope to be able to hire experts to review these 

applications quickly and to have the expertise, do you think that 

a substantial cut in the FDA budget would assist us in being able 

to expedite these reviews? 

Mr. FISCHELL. I am sure that every company involved including 

about six companies I am involved with would be happy to pay for 

the fees paid to such experts to do the job in a prompt way. 

Ms. DEGETTE. Right, but certainly budget cuts is not going to 

help us, is it? 

Mr. FISCHELL. No, but the budget—this would not increase the 

budget. 

Ms. DEGETTE. Right. 

Mr. FISCHELL. It would be paid for by the—— 

Ms. DEGETTE. OK. I actually kind of agree with that. 

Let me ask you, Ms. Sagan, because you mentioned the Special 

Diabetes Program, which makes funds available for type 1 diabetics and also American Indian populations, and last year we reauthorized that. As you said, a lot of those funds are going toward 

clinical trials for the artificial pancreas. Now, just so you know, we 

sent that letter that I mentioned that almost all the members of 

this subcommittee including the chairman signed asking about 

quick approval of the artificial pancreas, and also I spoke with 

Commissioner Hamburg about this issue of the low blood glucose, 

and I am pleased to tell you that we got a quick response to that 

letter in June and the FDA issued a guidance on that low blood 

glucose monitor stopping, so we can move forward on these things 

and we do have hope that we will move quickly. 

84 

But from your perspective and from your daughter’s perspective, 

I know you probably agree, we don’t want to approve an artificial 

pancreas if it is going to be defective because it could kill the patients, right? 

Ms. SAGAN. Yes. 

Ms. DEGETTE. So we want to make sure it is going to work. 

Ms. SAGAN. Yes, we do. 

Ms. DEGETTE. Yes. And that is kind of the same way I feel too. 

So I guess I wanted to ask you, what is your perspective as an advocate of how the FDA should balance the safety with the speed 

in approval that we need for these medical devices? 

Ms. SAGAN. Well, in terms of the low-glucose suspend, I don’t 

think there is an issue with safety. 

Ms. DEGETTE. I agree with you on that, but in general—— 

Ms. SAGAN. In general, if—I mean, I believe that there should be 

clear guidance documents and a decision made in a timely manner. 

If it is a 90-day period, it should be 90 days, and it shouldn’t be 

further delayed after that. We have to have safety and we are so 

ready to go to outpatient clinical trials with artificial pancreas. We 

have done all the inpatient clinical trials. 

Ms. DEGETTE. Now, Dr. Curfman, I just want to finish with you 

because you heard all of these stories, and in your job you do all 

the time. What can be done to make sure that we expedite safe and 

efficacious devices but at the same do the thorough reviews that we 

need? Is there something that can be improved at the FDA right 

now to do that? 

Mr. CURFMAN. We are looking for a balance. It has to be a balanced approach. On the one hand, we want to speed innovation to 

patients, absolutely. On the other hand, we want to be sure that 

the devices work, that they actually improve human health and 

that they are safe. 

Ms. DEGETTE. Do you think there is any problem at the FDA 

right now? 

Mr. CURFMAN. I think that there are two things that I would 

look at at the FDA. Number one, I do think that the 510(k) process 

needs to be looked at. I think there are issues there. Some devices 

are being looked at under the 510(k) that probably shouldn’t be. On 

the other hand, there are also inefficiencies in the process that are 

slowing down approval in some cases. My sense is that it has gotten better but I think that more work can be done to make it a 

more efficient process. 

Ms. DEGETTE. Thank you very much. 

Mr. BURGESS. [Presiding] I thank the gentlelady for yielding. 

Dr. Fischell and Dr. Curfman, let me just be sure I have some 

of my facts straight. Dr. Fischell, do I understand that you are affiliated with Johns Hopkins University? 

Mr. FISCHELL. I worked at the Johns Hopkins University for 30 

years and was on the medical faculty as well as working as a physicist at the Applied Physics Lab. 

Mr. BURGESS. So an academic at Johns Hopkins? 

Mr. FISCHELL. Yes. 

Mr. BURGESS. And Dr. Curfman, are you at Mass General? 

Where is your hospital affiliation? 

85 

Mr. CURFMAN. Yes, at Mass General Hospital and Harvard Medical School. 

Mr. BURGESS. So just on the face of it, it seems like the two of 

you are terribly similar. It appears as if your politics are similar, 

you are both academics at big Eastern facilities, and yet your conclusions are significantly different, at least as I perceive on the 

panel today. You are shaking your head no, you feel exactly as Dr. 

Fischell does. Is the difference because he is an innovator and you 

are a reviewer? I know in my days in medicine, we used to regard 

that there were two types of doctors. There are thinking doctors 

and there are doing doctors. As an OB/GYN, I was a doing doctor, 

all kinds of things we did in our practice, but I didn’t think very 

much. So you are the thinking doctor here, and Dr. Fischell is the 

doing doctor. Is that the difference here? 

Mr. CURFMAN. No, I think we are really on the same page but 

innovation requires two things. It requires fresh ideas, new ideas, 

interesting new approaches, but it also requires careful testing to 

be sure that the device works. 

Mr. BURGESS. And I don’t disagree with that. I want to get back 

to the 510(k) process in a minute, but Dr. Fischell, you said something that I just thought was so important. I mean, in this committee in 2007, we reauthorized the user fees for both the prescription drugs and medical devices here in this committee, and one of 

the big fights that we had that I lost was over the people that 

make up these advisory panels to the FDA, and at that time, of 

course, Republicans were not in charge and that is why I lost, but 

the pendulum swung so far that we cannot have anyone on a review panel that might have any appearance of a conflict of interest, 

and as a consequence, we excluded the universe of people who actually had some idea about what these products did. So in retrospect, 

I guess what I am trying to get you to say that I was right with 

those amendments that were defeated, but can you speak to that 

for just a moment? Because you were on that path a moment ago. 

Mr. FISCHELL. Yes. 

Mr. BURGESS. And I want former Chairman Waxman, Ranking 

Member Waxman to hear this. 

Mr. FISCHELL. Well, there is always—— 

Mr. BURGESS. So start out with ‘‘Dr. Burgess, you were correct.’’ 

Mr. FISCHELL. Yes, I do believe you are correct, and even though 

I am a very good friend of Congressman Waxman, and it is a matter of, there is an old saying, you can either have somebody who 

is expert in it and they—or someone who has never worked in the 

field, and if you have someone who has no knowledge of the field, 

that doesn’t work very well. And so you need people who really 

have knowledge in that field, and also the FDA seems to be exceedingly slow. They don’t even follow their own guidelines. For example also, in this device for migraine, there is no predicate device. 

We invented something new. And so we had to go to a 510 de novo 

510(k). To get a de novo 510(k), you must first say to the FDA that 

we cannot find—no, we first suggest devices that could be predicate 

devices. We knew there were none. And they said you are wrong, 

there are none. We say it is de novo. They said oh, oK, then it can 

be de novo. You cannot go to the FDA and say it is a de novo device. 

86 

Mr. BURGESS. Do you think—— 

Mr. FISCHELL. That cost us several months at the beginning. 

Mr. BURGESS. Do you think you got good advice from the FDA 

about what they would need to see from you to get this device approved in a reasonable period of time? 

Mr. FISCHELL. No. We wanted to cure migraine headache. They 

needed us to cure photophobia, phonophobia and nausea with a 95 

percent certainty. 

Mr. BURGESS. Let me ask you a question on the nausea. 

Mr. FISCHELL. We got 95 percent on two of them but only 88 percent in nausea and they therefore said, I will never forget the 

words, it is not approvable. 

Mr. BURGESS. On the nausea question, does a placebo score an 

88 percent if you—— 

Mr. FISCHELL. No, no, no. We were much better than the placebo 

but so few patients had nausea that we didn’t get the statistic. 

Mr. BURGESS. And this is a noninvasive device? 

Mr. FISCHELL. Correct, and not only that—— 

Mr. BURGESS. You don’t have to open anyone’s head and put anything inside? 

Mr. FISCHELL. A prior device made by Neuronetics for depression 

has 20 percent stronger magnetic pulse and 30,000 times more 

pulses. It is approved and working by the prior FDA. Even though 

we were a tiny fraction of that, we could not gain approval. 

Mr. BURGESS. Let me just, Mr. Mandel, if I could, just ask you 

briefly on the MelaFind. In the continuum of things that are approved, where does MelaFind fall? Is it a reasonable device for a 

practicing physician to have in their hands? 

Mr. MANDEL. I think the company is intending it to be an adjunct for dermatologists, so I think you have to distinguish between 

the first-generation device, which would be restricted, I think, to 

experts with a lot of savvy, and then the company wouldn’t say this 

but I would, if you kind of look down the path future in the future, 

you could see how the improvements would enable that it could be 

more used more broadly than that, and when I think about what 

is being lost right now, it is not only the device as it exists but it 

is the future as well. 

Mr. BURGESS. Well, I would just say from the perspective of 

somebody who used to practice general OB/GYN, to have a device, 

we are told we must do skin screenings every year when a patient 

comes in for a visit to have something that could help us determine, rather than just sending everything back to the dermatologist or off to the dermatologist to be biopsied at great cost, something to help us discriminate a little bit finer because not all of us 

remember what we learned in medical school about the irregular 

borders, the degree of coloration. 

Mr. MANDEL. The FDA says it wants to have a device. The FDA 

says that it wants the device to be able to do that, to be able to 

help an inexperienced doctor, but there is no way to get from here 

to there without the steps in between. It is like asking—it is like 

refusing to approval the initial cell phone until you can have an 

iPhone first. 

Mr. BURGESS. I understand. Well, I thank you, and I will yield 

back my time and yield to Mr. Waxman for questions. 

87 

Mr. WAXMAN. Thank you very much. Thank you all. As witnesses, you have been very compelling in your stories and your experiences, and all of us want to see these things move faster. We 

want to get those therapies to those who need it. The question that 

comes to my mind, the proposals that would weaken the standards 

for the Food and Drug Administration, I think a lot of the problem, 

and I look forward to hearing from Dr. Shuren after this panel, but 

I think a lot of the problem is that either the FDA does not have 

the resources or there are problems at FDA in processing what is 

going on or there are problems with the developers, the manufacturers who aren’t getting their studies done adequately. And I 

must say, when I hear about weakening the standards, it bothers 

me because we hear all the time reports about horrific patient suffering from dangerous medical devices. In the last year, the New 

York Times reported on radiation machines that have killed and 

disfigured patients, malfunctioning linear accelerators that left a 

woman nearly comatose. We have heard from the father of a patient who died due to an overdose of radiation therapy, and we 

have also heard about problems with the Sprint Fidelis 

implantable heart devices that caused at least 12 deaths. I don’t 

think devices are something that we shouldn’t take seriously as we 

do drugs. They both must meet a safety and efficacy standard. In 

the face of these reports of problems, it is hard to agree with the 

sentiment that we need to reduce FDA’s authority to make sure 

medical devices are safe and effective. 

Dr. Curfman, you testified on this subject. Should we be looking 

at strengthening or weakening FDA’s standards and FDA authority 

for medical device approval? 

Mr. CURFMAN. Thank you. It is a balance. We all want devices 

to move quickly to patients so that our patients are helped by them 

but at the same time they need to be evaluated, and the clinical 

trial, the randomized clinical trial is now the gold standard for 

evaluating drugs and devices, and we are very fortunate in our 

country to have some of the leading clinical trial centers in the 

world in the United States. This has become a very expert scientific 

discipline to run a good clinical trial, to do it right, to do it rigorously, to get the right answers. And we are very fortunate now that 

this science of doing clinical trials has become very, very sophisticated. We have in the United States among the very best clinical 

trialists in the world and they understand the importance of doing 

these trials efficiently and quickly, and we at the New England 

Journal understand the importance of publishing the results of 

these trials quickly and efficiently. 

Mr. WAXMAN. We had problems with drugs, and the concern 

about the delay of approval of drugs, so a number of years ago 

when I was chairman of this subcommittee, we put into law that 

there would be a user fee that the manufacturers of the pharmaceuticals would pay so that FDA could hire the personnel. I don’t 

like that idea. I think this is a government function and we ought 

to be willing to pay for essential government functions, and the 

FDA is one of those essential government functions. But there was 

no way we were going to get more appropriations. 

Now, in the medical device area, we do not have a user fee. We 

are relying on the money that the government appropriates for 

88 

FDA. I would be interested if anybody on this panel thinks it is appropriate, given your concerns, that we reduce FDA’s money. I 

think the Republicans are proposing to reduce FDA by $250 million, which would make them less able to approve drugs and devices and to do the other things that they need to do like food safety. Does anybody think it is a good idea to reduce the funding for 

FDA? 

Ms. CONGER. Yes, I do, because I don’t think that the FDA, the 

organization as itself is functioning as efficiently as it could be because—— 

Mr. BURGESS. Well, you think they should be—— 

Ms. CONGER [continuing]. They drag—— 

Mr. BURGESS. I only have a limited time. So you think they 

should be because FDA is not doing a good job. I want FDA to do 

a good job, but FDA has to have the resources. There is a user fee 

and there is a fight—— 

Ms. CONGER. And the right people. 

Mr. BURGESS. They need the right people. They need to pay the 

right people. You are not going to get good, competent people to 

work for the government if you underpay them. 

Ms. CONGER. And don’t—— 

Mr. BURGESS. Excuse me. I am not in a conversation. 

Ms. CONGER. I am sorry. 

Mr. BURGESS. Perhaps another time. But the fact of the matter 

is, proposals are to weaken the standards, spend less money on the 

FDA, and all this has to be put in the perspective of the Supreme 

Court decision that I think was misguided when they said some 

medical devices are immune from lawsuits at the State level. 

Dr. Curfman, do you have any view on the Supreme Court decision preempting lawsuits at the State level? 

Mr. CURFMAN. Well, it is pretty irrational because there is a different standard for drugs and devices. There is preemption of 

State-level legal action for devices. There is no preemption of State 

legal action for drugs. So it just doesn’t make any sense. There may 

be technical legal reasons why it came out that way but we need 

to do something about that to make this a more rational and logical 

system. 

Mr. WAXMAN. Well, I just want to say in closing, I don’t think 

we are going to be moving in the right direction if we reduce the 

money that goes to FDA, we don’t get a user fee to help them pay 

for the people reviewing the medical devices, and then the answer 

isn’t to say oh, just put them on the market and we will see what 

happens. If people get hurt, they won’t use them anymore. If they 

are hurt because of negligence, they can’t sue. And then the FDA 

can’t even conduct the oversight on the safety and the efficacy of 

these products. 

I know my time is expired. The chairman has been as generous 

to me as he was to himself, and I thank him for it. 

Mr. BURGESS. And I thank the gentleman for recognizing that. 

I will also point out that Dr. Sharfstein was here before our committee last year and testified that they didn’t need any more 

money, they had plenty. 

Let me yield to Mr. Terry from Nebraska for questions. 

Mr. TERRY. Thank you. 

89 

First, I mean, we on our side have been in discussions about 

FDA and these delays. I haven’t heard any of us talk about weakening the standards, so I am sorry, I don’t know where that is coming from. We are frustrated that FDA has become—the delays have 

become so difficult for the inventors and manufacturers that they 

feel that they have to set up shop in Europe in order to proceed. 

So we are trying to work through that, Dr. Curfman. I don’t know 

where you came up with the idea or you and Henry Waxman that 

we are weakening. 

But Ms. Conger, I felt badly the way that you were treated. A 

question was thrown out that you weren’t allowed to answer. If you 

would like to use a little bit of my time to answer the question? 

Ms. CONGER. The question about? 

Mr. TERRY. Mr. Waxman’s about funding. 

Ms. CONGER. The funding, yes. I have been in business, and I 

have seen organizations that stagnate and stagnate, and the big 

kahunas on the top can’t understand why their brilliant ideas 

aren’t filtering down into the little plants and the roots and why 

aren’t they going, and it is very simple. It is that you do what you 

get rewarded for. You do the things you don’t get in trouble for. 

And while we may have some very, very fresh ideas and even some 

of the things that I brought up, we still have an old, ingrained 

guard that has been taught to keep your head low and just keep 

doing it the old way, and the FDA CDRH can no longer afford to 

do it the old way. They have their competitors in other nations who 

are already bringing them tons of data about products that are successful in millions of patients—— 

Mr. TERRY. Ms. Conger, that is a really good point there. 

Ms. CONGER. Yes. 

Mr. TERRY. And one that—— 

Ms. CONGER. And then start them all over again. Excuse me. 

Mr. TERRY. Dr. Curfman, you are the defender here of the status 

quo of the FDA. 

Mr. CURFMAN. No, no. 

Mr. TERRY. So let me ask you this. Well, hold on. Her point is 

one that is going through my mind, and let us use the low-glucose 

suspend system where the conclusion of this mother, Ms. Sagan, is 

that low-glucose suspend systems have been approved for nearly 3 

years and used safely all over, 40 countries worldwide, but they are 

not available here. It seems to me that our FDA refuses to acknowledge results and data from other countries on the same device. Is that an appropriate standard? Is that appropriate? 

Mr. CURFMAN. Well, Mr. Terry, let me just comment about my 

own interaction and experience with the FDA. I know many people—— 

Mr. TERRY. Would you answer my question? 

Mr. CURFMAN. Yes, I am answering it. I know many people who 

have served on advisory committees to the FDA and they are highly expert. They are the best experts in the world. They are providing the very best advice that the FDA can get, the best advice 

anywhere in the world, and in the end, decisions about what devices are going to put in the market have to be based on evidence, 

not on feelings, not on impressions. 

90 

Mr. TERRY. So are you saying that the—feelings and not real 

data? 

Mr. CURFMAN. Data from anywhere needs to be judged on its 

merits, and that is what advisory committees do, and that is why 

the FDA brings in the very best people from the medical community, the scientific community—— 

Mr. TERRY. And start all over. 

Mr. CURFMAN [continuing]. And make these judgments, and to 

evaluate the clinical trial data—— 

Mr. TERRY. With my 48 seconds, let me ask you—— 

Mr. CURFMAN [continuing]. And to see if it really supports—— 

Mr. TERRY. Well, I appreciate you trying to run out the clock 

here, but you were very critical of the European system of approval. Can you detail their inadequacies? 

Mr. CURFMAN. Sure. I have several concerns about it. First of all, 

as you know, Mr. Terry, the European system is based on 76 private bodies, 76 in Europe, six in the UK, that make the decisions 

about which products go on the market. So it is very diverse. It is 

very spread. It is not a unified process. And there is a lot of inconsistency among these 82 private bodies that make these decisions. 

So that is one concern that I have: inconsistency of standards 

across all of these regulatory bodies. 

Secondly, there is very little or almost no transparency to the approval process in Europe. The FDA has a beautiful Web site. All 

of the information about new devices and drugs is available there. 

Anybody can find it. It is available to the public. This is not true 

in Europe, and if you try to get information in Europe, they tell you 

that is proprietary and you can’t get it. 

Third, and I think of most concern, in Europe, for class III devices, these are the most complex medical devices, it is not necessary to show that that device is going to improve a person’s 

health before it goes on the market. That is of great concern to me. 

We are living in an era now where outcome-based medicine is what 

it is all about. This is core to medicine and health today, to show 

that something improves a person’s health, and that isn’t a requirement for putting a device on the market in Europe. I think that 

is of great concern. 

Mr. BURGESS. The gentleman’s time is expired, and I see several 

people have their hands up, but we do need to go to the chairman 

emeritus of the full committee, Mr. Dingell, for questions. 

Mr. DINGELL. Thank you very much, Mr. Chairman. My questions are going to require yes or no answers, and I am sorry about 

that but there is a very limited amount of time and a lot of questions to be asked. 

These questions will go to Dr. Curfman. Your testimony references two examples of innovative devices that were approved 

without a clinical trial. As you know, new drug applications require 

clinical trials for approval. Do you believe that the two examples 

referenced in your testimony were inappropriate for the 510(k) 

process? Yes or no. 

Mr. CURFMAN. Yes. 

Mr. DINGELL. Now, Doctor, there have been reports of some class 

III devices being reclassified as class II devices, allowing them to 

gain approval through the 510(k) process without need for clinical 

91 

trials. In your work at New England Journal of Medicine, have you 

found this to be a common industry practice? Yes or no. 

Mr. CURFMAN. Yes. 

Mr. DINGELL. Doctor, as you know, class III devices are devices 

by their nature that should require a stricter review by FDA. These 

devices are often necessary to sustain the life of a patient and are 

in some instances implanted into the patient’s body. Is it true that 

a device that goes through premarket approval process can be approved based on a single clinical study? Yes or no. 

Mr. CURFMAN. Generally, no. 

Mr. DINGELL. Should they be approved on the basis of a single 

clinical trial? 

Mr. CURFMAN. No. 

Mr. DINGELL. Do you believe that the clinical trial standards laid 

out by FDA in the premarket approval process are rigorous enough 

to prove safety and effectiveness of class III devices? Yes or no. 

Mr. CURFMAN. Most often, yes. 

Mr. DINGELL. Do you believe that a single study is sufficient to 

approve a class III device? Yes or no. 

Mr. CURFMAN. No. 

Mr. DINGELL. As you know, device manufacturers are required to 

conduct postmarket surveillance. Do you believe that the current 

postmarket surveillance requirements are adequate? Yes or no. 

Mr. CURFMAN. No, but they are getting better. 

Mr. DINGELL. So you think that is something we ought to have 

a look at? 

Mr. CURFMAN. Indeed. 

Mr. DINGELL. Now, Doctor, do you believe that the device manufacturers have met their responsibility to conduct rigorous 

postmarket surveillance to ensure the safety of their devices? Yes 

or no. 

Mr. CURFMAN. No, that is a big problem. 

Mr. DINGELL. Your testimony references the EU medical device 

approval process and the timelines to approval are only modestly 

shorter in the EU. How much shorter is the timelines for approval? 

Can you give us some kind of a horseback guess on that? 

Mr. CURFMAN. Depending on what you are measuring, it can be 

a few months to a year. In the lifespan of a drug or a device, that 

is a small fraction of the total. 

Mr. DINGELL. Now, as you know, the standards for approval in 

the United States and EU are different. Do you believe that the EU 

approval process adequately takes into consideration the success of 

a device in treating a patient? Yes or no. 

Mr. CURFMAN. No. 

Mr. DINGELL. Do you believe that the approval process in the EU 

is transparent to the public when approving devices for use? Yes 

or no. 

Mr. CURFMAN. No. 

Mr. DINGELL. Should be more transparent, should it not? 

Mr. CURFMAN. Much more transparent, yes. 

Mr. DINGELL. Thank you very much for this. This goes to Dr. 

Fischell and Dr. Ianchulev. I would like to end my questions with 

you regarding your experience with FDA regarding the medical device approval process. Please again answer yes or no. Are you 

92 

working with the FDA review staff and the approvals of your device? Did you find that the FDA review staff was responsive to 

questions or concerns? Yes or no. 

Mr. FISCHELL. No. 

Mr. DINGELL. Now, were the requirements for the approval of 

your device made clear to you by the FDA review staff in the beginning? Yes or no. 

Mr. IANCHULEV. No. 

Mr. FISCHELL. No. 

Mr. DINGELL. Have you found the review process to be consistent? Yes or no. 

Mr. IANCHULEV. No. 

Mr. FISCHELL. No. 

Mr. DINGELL. Do you believe that the review staff at the FDA are 

adequately trained to review the devices based on the most up-todate science? Yes or no. 

Mr. IANCHULEV. No. 

Mr. FISCHELL. No. 

Mr. DINGELL. Now, I would just like to comment in the 26 seconds left to me, Mr. Chairman. 

Mr. STEARNS. Will the gentleman yield just for question? You 

might want to give them a chance to—it looked like some of them 

didn’t have a chance to answer. 

Mr. DINGELL. My time is running. 

Mr. STEARNS. OK. No problem. 

Mr. DINGELL. My time is running, Mr. Chairman. 

Way back, we had a nasty experience in this country. It related 

to a substance which caused problems with regard to babies given 

to mothers for morning sickness. It was approved in Europe but it 

was not approved over here. It resulted in a whole big change in 

our food and drug laws, and it was a matter of very special concern. The precise name of the pharmaceutical, I don’t remember. 

Mr. FISCHELL. Thalidomide. 

Mr. DINGELL. Thalidomide. Thank you very much. It caused a 

huge stir and a tremendous amount of difficulty because of the way 

the Europeans went into these matters as opposed to the way that 

we went into them, and I am very loathe to see us weakening our 

laws to simply carry forward the goals of the Europeans, who occasionally make mistakes too. 

Mr. Chairman, you are most gracious. Thank you. 

Mr. STEARNS. The gentleman yields back. 

I would like to put into the record—the gentlelady, the ranking 

member, has asked the supplemental memorandum July 20th be 

put into the record. By unanimous consent, so ordered. 

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Mr. STEARNS. Mr. Terry wanted to put this New York Times article in, the ‘‘Medical Treatment, Out of Reach.’’ So ordered. 

Then I have a 510(k) survey results researchers from Northwestern University into the record. The Northwestern researchers 

surveyed more than 350 medical device development specialists on 

their experience with FDA and medical device review process compared with that of the European Union, and they show that twothirds of the small medical device and diagnostic companies are obtaining for new products in Europe first and the survey shows that 

76 percent of the respondents said preparation requirements for 

510(k) submission were uncertain or unclear, and I think this is a 

good study to be part of the record, and FDA needs to provide predictability and certainty for companies or they will continue to go 

to Europe. With that unanimous consent, so ordered. 

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Ms. DEGETTE. Mr. Chairman. 

Mr. STEARNS. Yes? 

Ms. DEGETTE. Also, just to clarify, attached to our memo are two 

letters, one from the—five, sorry—four—some number—five letters 

supplementing that. 

Mr. STEARNS. All right. By unanimous consent, that is so ordered. 

And now we will go to the gentlelady, Sue Myrick is recognized 

for 5 minutes. 

Mrs. MYRICK. Thank you, Mr. Chairman. 

Dr. Fischell, I would like to just cover a couple things with you. 

Thank you, all of you for being here today and your testimony, by 

the way. You have been doing this for a long time, not just innovating but helping patients, et cetera, and a comment was made 

a little while ago about European inconsistencies and standards, I 

believe by Dr. Curfman. You have been talking, all of you, kind of 

about the fact that, you know, the Europeans are doing things 

quicker and we are taking a lot longer. Do you feel from what you 

have had experience with over the years and looking at the European standards that there is a lot of inconsistencies and that they 

are not doing a good job? 

Mr. FISCHELL. No, I don’t think that is the case, and I would like 

to once give the example of the migraine device. When we showed 

to the European notified body that we had done a clinical trial that 

proved it was safe and effective in the treatment of migraine, when 

we showed that there was already an FDA-approve device used for 

many years that had 20 percent stronger pulses and 30,000 times 

more and that was approved, it seems to me that the Europeans 

were logical in saying it is now approved for use in Europe. That 

seems logical to me. 

Mrs. MYRICK. Well, and the other thing was, and Dr. Curfman, 

you said sometimes they are just a few months to a year behind. 

They have been waiting since 2006 for approval of that particular 

machine, which is a little longer than a few months to a year. But 

anyway, I wanted to ask you another question because you mentioned when you talked about the innovation and people going 

overseas and whatnot, if you were starting out today, would you 

still be able to find the same availability of funding for what you 

are doing? Because you mentioned something about funding in 

your remarks. 

Mr. FISCHELL. We have—a month ago a venture capitalist said 

they would not give us the last money we need to get this product 

approved, the migraine product in the United States, because the 

FDA approval process is so risky that they would not risk the capital. We have worked with VCs over many years and we were well 

funded to do our stents, to do our defibrillator and pacer. They are 

no longer funding us. It is a real struggle now to get the funds to 

do the innovation, to make the jobs in America because the FDA 

has scared the venture capitalists. 

Mrs. MYRICK. Well, and that brings me to another point. We 

have got over 40 device manufacturers in Charlotte alone, where 

I am from. North Carolina has a tremendous number because of all 

the medical there, you know, device manufacturers which is creating jobs. They pay well and, you know, the delays in approval are 

173 

keeping these jobs from being created here in America and so, you 

know, to me, this has a tremendous impact on what is happening 

here, what the FDA does relative to us being able to create those 

jobs that are obviously being created in other countries instead of 

here. 

Mr. FISCHELL. You know, a migraine company only has 12 people 

employed and yet we are now hiring people in Europe to get it out 

into the population there. That doesn’t make an American happy. 

Mrs. MYRICK. No, it doesn’t make any of us, very frankly. 

Ms. Conger, I would like to ask you because of, you know, we 

know that the job of FDA is to make things safe. None of us are 

trying to say you shouldn’t have safe devices and they should be 

effective, but they are supposed to also foster innovation, and just 

from our perspective, what do you think the balance should be between those two in how the FDA is running. 

Ms. CONGER. Based on my research about other approval methods and their successes and failures, and I compare it to our current overly bureaucratic, overly politically worried system. We can 

have all three. We can have safety, reasonable safety, efficacy and 

innovation if we were using parts of models of other countries that 

are doing it so well. We have the opportunity to take the learnings 

of others, add it to the gems we know we do well, and come out 

with a better system. As it is set up now, it is not going to work. 

Mrs. MYRICK. Can I quickly ask, Dr. Ianchulev, you worked in 

both systems relative to the European standards. I would just like 

your comment. 

Mr. IANCHULEV. Yes. Actually, I am licensed in Europe as well 

as a physician and to me that has been—when I came to this country almost 20 years ago, I came here to innovate and practice cutting-edge medicine, and I have seen to my surprise that a lot of my 

European colleagues now have more advanced experience than 

what I can get here and deliver to my patients. And I have experienced the review process on the regulatory side in Europe and I 

would say that I haven’t noticed it to be irrational nor have I heard 

from my colleagues or patients in Europe to feel that the environment is unsafe. At the same time, I should say that we don’t have 

to rubber stamp something. It is a matter of looking at this is not 

a bearing point and another way to benchmark ourselves to find 

something that works for us and for our patients. 

Mrs. MYRICK. I appreciate it. Thank you, Mr. Chairman. 

Mr. STEARNS. I think just to confirm what you indicated to the 

gentlelady, over in Europe they have more advanced experience, 

you said? 

Mr. IANCHULEV. In my field, for example, we have a lot of medical devices that we use, mainly new types of intraocular lenses, 

and to be more specific, there are other ones right now, new minimally invasive treatments for eye diseases such as glaucoma, and 

it is interesting that on the device side on the European side, you 

can see access to those technologies and experience in the hands 

of physicians, which is probably the only true way to appreciate not 

just read an article in a journal but really to have experience with 

the device. That is what physicians need to understand it. 

I think on the drug side, it is opposite. I have noticed a lot more 

experience happens first here and then travels to Europe, and that 

174 

was my experience with Lucentis why we got it approved here and 

followed one year later there. It is just my personal experience 

is—— 

Mr. STEARNS. OK. Thank you. 

The gentleman from Texas is recognized for 5 minutes, Mr. 

Green. 

Mr. GREEN. Thank you, Mr. Chairman, and I would like unanimous consent to have a statement placed into the record, and I do 

have concerns because I know medical device companies who 

produce in our countries but there are rules particularly in Europe 

that they can’t market a device there that is not admitted into the 

home country so they end up having to move their production facilities to another country. We may not want to lower our standards to the European standards, because I am going to ask Dr. 

Curfman some questions about that, but Dr. Curfman, I understand actually in some cases FDA is much quicker than in Europe 

on the reviews. Can you outline some of the concerns with the medical device approval system in the European Union? 

Mr. CURFMAN. Well, I think again the most important thing in 

a review process is to ensure that a new device or a new drug is 

actually going to result in a better health outcome for the patient. 

Mr. GREEN. And Europe doesn’t require that? 

Mr. CURFMAN. Europe doesn’t require that. We do. And I think 

that that is really a fundamental difference in the two processes. 

Mr. GREEN. And the structural way that the FDA does our approval but in Europe from what I understand, there are 74 for-profit entities that actually can be—you can almost cherry pick who 

you want to take your device to. Is that correct? 

Mr. CURFMAN. That is correct. 

Mr. GREEN. And the European Union allows any of those 74 to 

make that determination that the FDA does in our country? 

Mr. CURFMAN. That is correct. 

Mr. DINGELL. If the gentleman would yield, those things are 

called forum shopping over here. 

Mr. GREEN. Oh, I understand. But that gives the companies— 

and I am amazed that Europe doesn’t have some more quality control on what they do, but that is beside the point. Can you continue 

about the difference between us, the United States requirements 

under FDA and in Europe? 

Mr. CURFMAN. Well, I think another point that we touched upon 

briefly is the issue of transparency, and that is putting information 

out to the public, getting it up on a Web site. The FDA does a 

beautiful job of that. The FDA’s Web site is highly sophisticated, 

very deep in information. That doesn’t exist in Europe. 

Mr. GREEN. In our country, if someone is wanting to use a device, it is available, the information from the FDA because it is 

public record. 

Mr. CURFMAN. That is correct. 

Mr. GREEN. But those 74 entities, I understood from earlier testimony that that is proprietary information. 

Mr. CURFMAN. That is proprietary information, and there is no 

information about who the decisions are being made, what the 

process was, who the people were who were involved in making 

175 

those regulatory decisions. In the FDA, that is all very transparent. 

You know exactly who did what. 

Mr. GREEN. Well, I understood a statement earlier, and you 

wouldn’t believe it from our panel today that the FDA is actually 

faster then the European Union on devices. Do we have a percentage or has anyone looked at that? And if somebody has some 

other—I want to hear Dr. Curfman first because he is in the business right now. Is that information that is readily available? 

Mr. CURFMAN. I would imagine that Dr. Shuren would have that 

information probably more than I would. 

Mr. GREEN. Well, Mr. Chairman, hopefully we can get that. 

Again, it sounds like we are comparing apples and oranges with results. 

What are the problems with abandoning the effectiveness criteria 

for medical device approval in moving to the European standard? 

Mr. CURFMAN. Well, you know, in medicine and health care 

today in the United States, we talk about evidence-based medicine. 

This is the core of our process in finding new therapies. New therapies need to be supported by real evidence, by clinical trials, by scientific data, not just casual impressions that they work in that patient so they will work in every patient but real solid clinical trials, 

and doing clinical trial is very difficult but we have gotten in the 

United States very good at it. It has become a very refined science 

so that we can get very good and precise answers to these questions about whether new drugs and devices really work by helping 

people’s health. We can do that today. 

Mr. GREEN. I only have about 26 seconds. In Europe, if I was a 

medical device company and hired one of those entities, those forprofit entities to do it, that patient wouldn’t be able to know anything about how the clinical went. Is that proprietary information 

in Europe? 

Mr. CURFMAN. Yes, not only the patient but physicians. Nobody 

would really know that. There is no way to get it. And if you try 

to get it, they simply say it is proprietary information, we won’t release it. It is astonishing that that would be allowed to happen because it is so strikingly different here. 

Mr. GREEN. Thank you, Mr. Chairman. 

Ms. SAGAN. Mr. Chairman, I feel compelled to ask to be able to 

make a statement. I am sorry. In terms of the low-glucose suspend 

insulin pump, there is no safety issue. It is not safe to not allow 

the low-glucose suspend system to come into being, into practice in 

the United States. If you understand type 1 diabetes, it is too dangerous to allow insulin to be pumped into a body that is experiencing low blood glucose, more dangerous than running a 90- 

minute period of running high glucoses. My daughter’s glucose 

level has been at 500 many, many, many times, and the long-term 

complications of high sugars are far diminished by the short-term 

complications. 

Mr. GREEN. I thank the gentlelady. 

We have a request that we recess our committee. We are doing 

some votes in another subcommittee, and the chairman has asked 

that I recess the committee temporarily so that all members could 

go to this other committee, so with your indulgence and forbearance, I would appreciate your waiting, and I tell all members that 

176 

we are going to recess the committee and we will try to get back 

shortly. 

[Recess.] 

Mr. STEARNS. The subcommittee will reconvene, and I thank all 

of you. If the witnesses would please come to the table again, we 

will start the questions here, and we were able to receive a unanimous consent agreement that the votes at this other committee will 

be rolled until after our votes in the House, which will probably 

occur between 1:15 and 1:30. So I don’t want to hold up the witnesses here anymore. 

Are Mr. Mandel and Dr. Ianchulev close by? I just want to make 

sure—they can’t be far. I think under the time constraints we have, 

I think we will start with the gentleman from Georgia, Mr. 

Gingrey, for questions and we will just keep moving forward here. 

So the gentleman is recognized for 5 minutes. 

Mr. GINGREY. Mr. Chairman, thank you. Thank you very much. 

I am going to confine my questions and remarks to Dr. Curfman. 

Dr. Curfman, of course, as executive director of the New England 

Journal of Medicine and a cardiologist, I too am an M.D., as you 

know, and certainly it is an honor have you come before the committee to testify, and we thank you for being here today, as we do 

the other witnesses. I think you have been very patient and you 

have been very good with us. 

Dr. Curfman, in your testimony, you state your support for, and 

I quote ‘‘high-priority innovation in medical devices’’ but conclude 

that the glamour of innovation does not always work for patients 

if we cut corners in quality control. Is that a fair assessment? 

Mr. CURFMAN. Yes, that is exactly right. 

Mr. GINGREY. As examples of cutting corners in quality control, 

your testimony focuses on two products that you say ran through 

the 510(k) fast-track process versus the more rigorous premarket 

approval process. Had the Sprint Fidelis defibrillator gone through 

the more rigorous PMA, that premarket approval, versus the 

510(k), do you believe that some patient injuries might have been 

avoided? 

Mr. CURFMAN. I think that probably the way to have done that 

would be to phase it in rather than doing a clinical trial, that instead of launching this into many thousands of patients in a short 

period of time, to set some benchmarks for the lead in a limited 

number of patients and try to see if any problems were emerging 

there. The problem with this lead was that it was made quite a bit 

thinner than previous leads, and it was—— 

Mr. GINGREY. And in your testimony, you said that that approval 

process of Medtronic’s Sprint Fidelis lead was fast-tracked, it was 

through that 510(k) process. 

Mr. CURFMAN. Yes. There was no clinical testing. So what I 

would propose is that there be some clinical testing—— 

Mr. GINGREY. Right. Well, I understand that. 

Mr. CURFMAN [continuing]. In a limited number of patients. 

Mr. GINGREY. I want to ask you this, because I am holding in my 

hand a PMA record, premarket approval record, number P920015 

for the Medtronic’s Sprint Fidelis lead dated 2007, which in fact 

means that the Sprint Fidelis product did go through the more rigorous PMA supplement process and not the 510(k) as your testiVerDate Aug 31 2005 10:36 Jul 25, 2012 Jkt 037690 PO 00000 Frm 00180 Fmt 6633 Sfmt 6633 F:\112-07~3\112-78~1 WAYNE
177 

mony suggests. Are you aware that your testimony on this is factually wrong? 

Mr. CURFMAN. I don’t think it is wrong. 

Mr. GINGREY. Well, here it is. 

Mr. CURFMAN. Well, I would have to—— 

Mr. GINGREY. Let me just follow up on that, and maybe you can 

check your notes or maybe talk with your secretary or whomever 

gave you this information. Your testimony also cites the federal 

preemption for medical devices that prevented U.S. patients from 

suing Medtronic. Doctor, the federal preemption for medical devices 

only applies to class III products that go through the PMA process, 

not those that go through 510(k). The fact that this reality did not 

raise a red flag for you when drafting and reviewing your testimony here today is troubling, to say the least. 

The second example you cite in your testimony as proof of 510(k) 

failure is this metal-on-metal hip. Dr. Curfman, the Safe Medical 

Devices Act of 1990 directed the FDA, and I will say that again, 

this act directed the FDA to review certain class III devices and to 

ascertain whether they should be reclassified and go through this 

premarket approval process, so-called PMA, as I held up on the 

other one with Medtronic. One of these devices is the metal-onmetal hip yet 20 years later the FDA has yet to conduct a review. 

So it appears that the failure of this product is not due to 510(k) 

process but to regulatory inaction by our own FDA. So Dr. 

Curfman, do you believe that the FDA should follow the direction 

of Congress and implement the Safe Medical Devices Act of 1990 

in order to better protect patient safety? 

Mr. CURFMAN. Well, I think that it is important for some of these 

previously approved devices to be looked at again, and—— 

Mr. GINGREY. Indeed, that is what the 1990—— 

Mr. CURFMAN [continuing]. I would support that. 

Mr. GINGREY [continuing]. Act called for. 

Mr. CURFMAN. That is correct. Yes, exactly. So I think that it 

should be done selectively but I think that some of these previously 

approved devices do need to have another look. 

Mr. GINGREY. Well, absolutely, and I agree with you completely, 

Dr. Curfman, and I think we could have avoided some huge problems if that had been done. Both instances you cite to support the 

failure of this 510(k), the fast-track process, appear to be either inaccurate or factually incorrect, and with all due respect, these inaccuracies call into question, I hate to say it, but, you know, as a distinguished doctor and executive editor of one of our most distinguished medical journals, the New England Journal of Medicine, 

these little simple inaccuracies call into question what you describe 

as your careful analysis of these two studies you reference in your 

testimony. 

Mr. CURFMAN. No, I disagree, Dr. Gingrey. I think that everything that I have said is accurate. I point out to you that the Sprint 

Fidelis lead was removed from the market in 2007. This document 

that you have given me is dated 2007. So something doesn’t quite 

add up here. It was pulled from the market in 2007 by Medtronic. 

So I am not sure what this document—— 

Mr. GINGREY. Well, I would be happy—I think my time is expired. 

178 

Mr. STEARNS. The time has expired. 

Mr. GINGREY. Doctor, I would be happy to have you follow up 

with written testimony to the committee. 

Mr. CURFMAN. I would be happy to do that. 

Mr. STEARNS. I think the gentleman from Georgia—— 

Mr. GINGREY. If there are some corrections that you would like 

to put into the record, we would be glad to put that into the record. 

Mr. CURFMAN. I would be happy to do that. 

Mr. STEARNS. Dr. Gingrey, if you feel comfortable, you could also 

ask him questions and we can ask him to reply for our record too. 

With that, I recognize Ms. Christensen—— 

Mr. GINGREY. Thank you, Mr. Chairman. I yield back. 

Mr. STEARNS [continuing]. For 5 minutes. 

Mr. CHRISTENSEN. Thank you, Mr. Chairman, and I want to 

thank the panelists, especially those who are patients or representing patients. I think everyone up here felt your pain. And 

just before I ask my question, I just wanted to say that I understand that despite all of the comparisons between Europe and the 

United States, I still understand that the U.S.-based companies 

dominate the industry globally, medical device industry, and it is 

also interesting to note that the medical device industry is one of 

the few sectors with a positive trade balance today in our struggling economy. 

Dr. Curfman, it seems like you are getting all of the questions 

today. I would like to ask you about the effect of regulation on innovation within the medical device technology field. In your written 

testimony, you stated that innovation is essential—I am quoting 

you here—‘‘innovation is essential to the future or our Nation’s 

health but innovative medical products cannot succeed unless they 

are both effective and safe.’’ Can you explain how innovation in the 

medical field is fostered by sensible quality safeguards? 

Mr. CURFMAN. Yes. Thank you, Dr. Christensen. I think that real 

innovation, real innovation needs to involve products in which the 

efficacy has been clearly demonstrated and the safety has been 

clearly demonstrated. Otherwise it is not real innovation. We have 

talked about creating jobs in the medical device industry, and I 

think we all feel that that is a very important goal, but we don’t 

want jobs to be created to create defective medical devices that 

don’t work, that cost a lot of money, that pull money out of our 

health care system that could be better used in other ways on 

things that do work or on devices that are not safe. So this is why 

I have tried to make a case that an important part of innovation 

is to really establish that the product works and that it is safe and 

that if you don’t do that, it is not real innovation. 

Mr. CHRISTENSEN. FDA must—and we have to support them in 

protecting the health and safety of millions of patients in our country, and the agency can only accomplish this when novel drugs and 

new devices are rigorously evaluated for safety and efficacy. In 

your opinion, do manufacturers always take appropriate premarket 

steps necessary to protect patient safety? 

Mr. CURFMAN. In my experience, they do not always do that, and 

that is why oversight is necessary. That is why regulation is necessary. That is why it is important for third parties to be taking 

179 

a look at these products and doing some oversight and ensuring 

that efficacy and safety are really established. 

Mr. CHRISTENSEN. So that must contribute to some of the delays 

as well? 

Mr. CURFMAN. It does. There is a process involved. It does take 

time. I am sure that these delays can be reduced. I think that that 

should be a goal of the FDA. But that doesn’t mean that the process should be eliminated. 

Mr. CHRISTENSEN. Well, many have criticized, and we have heard 

it today, FDA for stifling innovation with their rules and regulations concerning medical devices. In your opinion, has FDA made 

the approval process for medical devices too onerous for medical device manufacturers? 

Mr. CURFMAN. My experience with the FDA is that they are 

keenly interested in innovation. They are keenly interested in improving the lives of patients. They want to get products to market. 

That is my sense. At the same time, they know that a process establishing efficacy and safety is a critical part of that process. 

Mr. CHRISTENSEN. Well, are there ways that the FDA could 

strengthen some of the aspects of their approval process? 

Mr. CURFMAN. Well, as Congressman Waxman said, in order to 

do that, they need resources. So I think that the first thing is that 

we can’t cut their budget and expect them to improve their processes. There is just a disconnect there. So I think we need to look 

at the budgeting process and be sure that they have the resources 

that they need to do the job. 

Mr. CHRISTENSEN. Thank you. And I think more than ever now, 

we need to make sure we are making smart choices on the budget 

and cuts to FDA as we have done already make no sense. They 

really hurt patients. They hurt companies that want to bring innovative drugs and medical devices to the market. Thank you. I am 

out of time. 

Mr. STEARNS. I thank the gentlelady. 

I think by mutual agreement, we are going to the gentleman 

from California, Mr. Bilbray. You are recognized for 5 minutes. 

Mr. BILBRAY. Thank you, and I appreciate the doctor’s questions. 

I think the delegate from the Virgin Islands has a background 

here. You know, we have got some indicator species here as we say 

in the environmental community that are not being observed, and 

that is, the venture capital that goes into this innovative technology. It is not—you know, by the time it gets to the FDA, it is 

at the end of the line, and I just want to say right now, July 11, 

everybody is put on notice, 50 percent of the venture capital investment in medical devices and research has dropped off in my region. 

Now, that is the krill of medical breakthroughs, and, you know, 

when the krill dies, in a few years you are going to say well, what 

happened, why isn’t there any new information. Because the big 

guys use that krill to feed on. So there is a concern here that we 

may be contributing to the extinction of a species that we take for 

granted but it essential in the food chain of medical breakthroughs. 

Dr. Curfman, I have got a question for you. Do you believe the 

defibrillators that we have got out in the public are as effective in 

the hands of a layman as they would be in a trained physician? 

Mr. CURFMAN. You are talking now about defibrillators—— 

180 

Mr. BILBRAY. The defibrillators—— 

Mr. CURFMAN. The manual defibrillators? 

Mr. BILBRAY. The manual defibrillators. 

Mr. CURFMAN. Well, the automatic external defibrillators can be 

operated by a layperson with only a small amount of training, and 

they are designed to do that and they can certainly be lifesaving. 

Mr. BILBRAY. But they can be lifesaving. We agree with that. 

Mr. CURFMAN. Yes. 

Mr. BILBRAY. But do you think that they are just as effective in 

a layman’s hands as it would be in a trained cardiologist’s hands? 

Mr. CURFMAN. Well, you need some training to use these. They 

are not totally intuitive. If you have never, never used one, you are 

going to have to figure it out. They are certainly a lot easier than 

older ones. 

Mr. BILBRAY. Do you have any idea how long it took us to finally 

approve this and get it out in the field? 

Mr. CURFMAN. Well, it took some years, yes. 

Mr. BILBRAY. OK. Do we have any idea of how many people died 

of cardiac arrest in public during that period? We don’t have any 

idea at all. But we can only imagine. 

You know, I have just got to say, we talk about the morning sickness medicine of the 1950s that caused birth defects, and that is 

what you remember as the chairman emeritus said. They don’t 

think about Benedictine in the 1980s that was perfectly safe but 

driven off the market, and a lot of it was because you remember 

the stuff when it goes bad but you don’t think about all the savings, and I think we all agree. Aspirin, classic example, hundreds 

of people die every year, and it has probably done more to help 

with health of probably any device 

My question is this. When we talk about the device that Mr. 

Mandel talked about and with 3 percent increase annually in child 

melanoma annually since the 1970s, we have got a device that physicians could use that may help in that application but because it 

cannot be proven to as effective as a dermatologist, don’t you think 

we have got to start talking about reality, that early detection is 

the most essential part of surviving melanoma. Wouldn’t you 

agree? 

Mr. CURFMAN. Absolutely. 

Mr. BILBRAY. And why would we say that we do not want to give 

a device to general practitioners that see the overwhelming majority of children—why would we as an agency say this should only 

be used at the back end of the process, dermatologist, after the general practitioner has sent them over? 

Mr. CURFMAN. Like any device, the efficacy needs to be established. This is a device where there are probably not going to be 

any safety issues but there are efficacy issues. It is a device that 

costs money. It has to be shown to be accurate. 

Mr. BILBRAY. Costs money. 

Mr. CURFMAN. It has to be accurate. It has to work and it has 

to be shown to work. 

Mr. BILBRAY. But—— 

Mr. CURFMAN. And the evidence has to be there, and if you don’t 

have the evidence, you can’t just approve the device. 

Mr. BILBRAY. But if you have the evidence to apply—— 

181 

Mr. CURFMAN. You need the evidence. You need the evidence in 

a real clinical study. 

Mr. BILBRAY. Excuse me. But if the technology works for a dermatologist, OK—— 

Mr. CURFMAN. Who says? That is the point of doing clinical studies, to get the evidence. 

Mr. BILBRAY. OK. Let us back up then. The same clinical trials 

that say you apply, why would you shift it? If it works good for a 

dermatologist and it works, why would a bureaucracy, why would 

a government agency say we don’t want this to be applied at the 

general practitioners, we are going to make a judgment call that 

we want it to be applied for dermatologists. Now, don’t you agree 

as the manual defibrillators but especially with melanoma, that 

early detection, if there is an opportunity, early detection with general practitioners, that is an essential part of treating that disease 

and addressing that disease and that is prevention. The earlier the 

better, right? 

Mr. CURFMAN. Absolutely. 

Mr. BILBRAY. OK. 

Mr. CURFMAN. So what you need to do is show that the device 

detects it earlier and improves patient outcomes. 

Mr. BILBRAY. OK. If you wanted to prove that, then why would 

you not allow a review board to look at this and review it? Why 

would you say we are not going to allow a review board to take a 

look at this and review it? 

Mr. CURFMAN. I think that you have to have the proper data in 

hand for the review board to look at, and I am not completely familiar with this device so I can’t really say how much data they 

had, but I am assuming that they don’t have enough data for the 

review board to review it. 

Mr. BILBRAY. And let me just mention, Mr. Chairman, I think 

the one we asked about that has been brought up here, do you 

agree that we had a great success in the 1990s with AIDS by allowing patients to sit on the review boards? Do you think that diabetics and cancer patients should have the same opportunity in 

this century as we gave in the last century to AIDS patients? 

Mr. CURFMAN. Yes. 

Mr. BILBRAY. Thank you, Mr. Chairman. 

Mr. STEARNS. I thank the gentleman. His time is expired. 

Panel, we are going to ask one more 5 minutes and then you will 

be excused, so we will finish. 

Mr. Griffith is recognized for 5 minutes. 

Mr. GRIFFITH. Thank you, Mr. Chairman. I would like to yield 

3 minutes of my 5 minutes to Mr. Gingrey and then 2 minutes to 

Mr. Lance. 

Mr. STEARNS. So ordered. 

Mr. GINGREY. Well, I thank the gentleman for yielding time to 

me. I wanted to, during the last discussion when my 5 minutes expired and I was talking with Dr. Curfman, I had a question for Mr. 

Fischell. On that note, I want to return to you fairly quickly. Given 

my concerns, Mr. Fischell, with the testimony of Dr. Curfman, I 

was wondering if you could share your thoughts on the veracity of 

those two studies that were outlined in Dr. Curfman’s testimony. 

182 

He didn’t think too highly of them. Could you give us your opinion 

on those studies? 

Mr. FISCHELL. I am not an expert on that, and I think that they 

were PMA supplements, which are treated differently from PMAs, 

and I think that may account for some of the difference here. But 

I am by no means an expert on that subject. 

Mr. GINGREY. Well, I appreciate your honesty on that. The PMA 

supplement is reviewed in those articles using the same standard 

as the original postmarket analysis, PMA. So I want that to be in 

the record and I want that statement to be in the record. 

In the last minute or so that I have before I think my friend 

wants to yield to another colleague on this side of the aisle, look, 

I think we are all here for the right reasons. There is certainly a 

difference of opinion on one end of the table from most of the other 

witnesses in regard to the FDA and are they doing their job in a 

most efficient, timely manner that is safe for patients. Obviously, 

as Dr. Curfman pointed out, safety is hugely important, but to 

make it so difficult losing venture capitalists, we are losing research and development, we are losing new products to the European Union, and then they come back over here and finally get to 

our market but all the jobs—— 

Mr. STEARNS. The gentleman’s time has expired. 

Mr. GINGREY [continuing]. Are gone. That is what this is all 

about, and I thank the gentleman for yielding to me and I yield 

back. 

Mr. STEARNS. The gentleman, Mr. Lance, is recognized for 2 minutes. 

Mr. LANCE. Thank you very much. I will take 1 minute, and I 

appreciate the courtesies of my colleague, Mr. Griffith. 

Dr. Fischell, I represent a district that is really the medicine 

chest of the country in north central New Jersey, more pharmaceutical and medical device employees than any other district in 

the United States. In your testimony, you state that beyond the adverse impact FDA is having on patient care, it is weakening the 

U.S. leadership position in medical technology innovation and as a 

result our economy. Would you comment briefly on that statement 

with which I agree and is so terribly important to the district I 

serve? 

Mr. FISCHELL. Well, it has been very clear to me personally by 

the fact that from 20 to about 5 years ago, venture capitalists 

would come to me and say Dr. Fischell, I would like to support 

your latest innovation, tell me what it is. Now I have recently gone 

to venture capitalists and said we have this great new cure for migraine and I need another $2 million to finish it. They said because 

of the FDA, we can’t give it to you, it is too risky. That is the difference. 

Mr. LANCE. Well, thank you very much, and I appreciate having 

the opportunity to speak with you on that, and I yield back the balance of my time. 

Ms. DEGETTE. I am wondering if Mr. Griffith would just yield to 

me for one brief moment? 

Mr. GRIFFITH. One brief moment, I yield to the gentlelady. 

Ms. DEGETTE. Thank you very much. 

183 

I just want to point out, there was a Bloomberg News article 

today that said venture capital funding for medical device and 

equipment makers gained 20 percent to $840 million in 90 deals 

over the last 3 months, so I think the record needs to reflect that 

there is still ample venture capital for medical devices as well as 

for all of biotechnology, and anything this committee can do to encourage that—— 

Mr. GINGREY. Mr. Griffith, would you yield to me for unanimous 

consent? 

Mr. STEARNS. No, I think we are just going to wrap up here. 

Mr. GINGREY. Mr. Chairman, I do have a UC request. 

Mr. STEARNS. OK. Go ahead. 

Mr. GINGREY. I would like to for unanimous consent request to 

submit for the record these materials that I am holding be inserted 

into the record, and it is important because these materials show 

that the Medtronic device that Dr. Curfman was talking about—— 

Mr. STEARNS. OK. I think what we will do is—— 

Mr. GINGREY [continuing]. Was approved through PMA and not 

the 510(k) process. That is all this does. 

Mr. STEARNS. The minority needs to see it, and we also have 

here a quote from the New York Times—— 

Ms. DEGETTE. Reserve the right to object. 

Mr. STEARNS [continuing]. And the LexisNexis also, so we have 

three items. 

Let me close, and we are going to recess the committee and 

thank the panel for their very compelling testimony and we appreciate your forbearance, and so we will take up the second panel 

after the set of votes, and so the subcommittee is temporarily in 

recess. 

[Recess.] 

Mr. STEARNS. The subcommittee will come to order, and now we 

will proceed to our second panel, and Dr. Shuren, you have been 

very patient with us and we appreciate that, and we are glad to 

have Mr. Waxman with us as we proceed to the second panel. 

With that, I will swear you in. Let me start by saying you are 

aware that the committee is holding an investigative hearing, and 

when doing so has had the practice of taking testimony under oath. 

Do you have any objection to testifying under oath? 

Mr. SHUREN. I do not. 

Mr. STEARNS. The chair then advises you that under the rules of 

the House and the rules of the committee, you are entitled to be 

advised by counsel. Do you desire to be advised by counsel during 

your testimony today? 

Mr. SHUREN. I do not. 

Mr. STEARNS. In that case, if you would please rise and raise 

your right hand? 

[Witness sworn.] 

Mr. STEARNS. You are now under oath and subject to the penalties set forth in Title XVIII, section 1001 of the United States 

Code. You may now give a 5-minute summary. Your written testimony will be part of the record. Proceed. Thank you. 

184 

TESTIMONY OF JEFFREY E. SHUREN, DIRECTOR, CENTER FOR 

DEVICES AND RADIOLOGICAL HEALTH, FOOD AND DRUG 

ADMINISTRATION 

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

I am Dr. Jeff Shuren, Director, Center for Devices and Radiological 

Health, or CDRH, at the Food and Drug Administration. Thank 

you for the opportunity to testify today, and I would like to thank 

the participants on the first panel, who raised many important 

points that I agree with. 

The mission of the FDA is to protect and promote the public 

health, to protect the public health by assuring that the devices 

that come on the market are safe and effective, and to promote the 

public health by facilitating innovation. Striking the right balance 

is challenging but also critical. 

In September 2009, soon after I came to CDRH, we initiated a 

review of our medical device premarket review programs in response to concerns expressed by industry and others. We conducted 

and honest and frank self-assessment of these processes including 

the 510(k). In 2010, we released two reports which concluded that 

we had not done as good a job managing our review programs as 

we should, and proposed potential solutions for improvement. The 

number one problem we found was that there was insufficient predictability in our premarket review programs which contributes to 

inconsistent decisions and longer terms to market. We identified 

several root causes. They including changing, unnecessary, inappropriate and/or inconsistent data requirements imposed on device 

sponsors, insufficient guidance for industry, insufficient interactions between the agency and industry, very high reviewer and 

manager turnover at CDRH, turnover that is almost double that of 

FDA’s drugs and biologic centers, insufficient training for reviewers, insufficient oversight by center managers, CDRH’s rapidly 

growing workload due to the increasing scientific and technological 

complexity of the devices we reviewed and the number of submissions we received, and poor quality submissions by industry. 

We solicited public comment on these reports from stakeholders 

and heard a wide range of perspectives. This past January, we announced 25 specific actions that CDRH will take in 2011 to improve the predictability, consistency and transparency of our premarket review programs, and have since announced additional actions. For example, we have made a commitment to develop a 

range of updated and new guidances to clarify CDRH requirements 

for timely and consistent product review including device-specific 

guidance in several areas such as mobile applications and artificial 

pancreas systems. We are also working to revamp the guidance development process to make it more efficient. We are enhancing the 

interactive review process and streamlining the review program for 

low- to moderate-risk novel devices called the de novo process. We 

are streamlining our clinical trial program to assure that clinical 

trials can start in a timely manner. We have already established 

a new center science council to help ensure consistency and predictability in our scientific decision-making, and we are creating a network of experts to help us resolve complex scientific issues and 

product assessment, which we hope will ultimately result in more 

timely reviews of device submissions. We are instituting a reviewer 

185 

certification program and a pilot experiential learning program to 

provide review staff, especially our newer review staff, with necessary training and real-world experiences. 

These efforts signify our commitment to improving our premarket review programs to ensure that patients have timely access 

to safe and effective devices and the U.S. device industry remains 

strong and innovative. 

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

pleased to answer any questions the subcommittee may have. 

[The prepared statement of Mr. Shuren follows:] 

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Mr. STEARNS. I thank you, Dr. Shuren. 

Just so there is no lingering uncertainty with respect to 

Medtronic Sprint Fidelis approval that was discussed on the first 

panel, I think you were here to listen to that, was the Medtronic 

device at issue approved as a 510(k) as Dr. Curfman stated in his 

testimony? 

Mr. SHUREN. No. 

Mr. STEARNS. Well, then that and other factual inaccuracies that 

also included in Dr. Redberg’s letter to Ranking Member Waxman, 

which is attached to the Democrats’ supplemental memo, throws 

into serious doubt Dr. Curfman’s and Dr. Redberg’s conclusions. I 

ask the gentlelady, does the minority still wish to include that supplemental memo in the record? 

Ms. DEGETTE. Yes, it has already been included. 

Mr. STEARNS. OK. We just wanted to establish that. 

Dr. Shuren, you have been at the FDA not just the 2 years in 

this present position, how many years were you before that? 

Mr. SHUREN. I first started in 1998 but I also worked over at the 

Medicare program, and I came back in 2003 and had been there 

since then. 

Mr. STEARNS. So that is 8 years from 2003, and before that how 

many years were you there? 

Mr. SHUREN. About—— 

Mr. STEARNS. Two? 

Mr. SHUREN. Approximately two. 

Mr. STEARNS. So our records show you actually have been there 

10 years. Would that be a fair statement? 

Mr. SHUREN. That would be a fair statement. 

Mr. STEARNS. OK. And I think in your opening statement here, 

you say that the FDA needs to take steps to improve predictability, 

consistency and transparency. So the question is, since you have 

been there 2 years, I guess rhetorical, why hasn’t all that been 

done, and maybe more specifically, your comment that FDA needs 

to improve management oversight and standard operating procedures, and I guess the question is, since you have been there for 

2 years have you done that? 

Mr. SHUREN. So the answer is yes, we have actually already 

started to make improvements. When I first came in, there were 

a lot of questions from different sides about were the programs not 

working well, were we too risk-averse. Others were saying we are 

too risk-permissive. And what we said we needed to do is a thorough assessment of the programs first, understand the problems, 

identify the root causes, and then determine the appropriate solutions. That is what we spent much of 2010 doing. We went around 

the county to hear from different people, not just asking people to 

come to us but our going out to them, and that is what is contained 

in our two reports. We put out the recommendations of what we 

would do, and we wanted to get public input first to make sure we 

were doing what was right before we proceeded, and in fact, we 

had heard from industry and even some in Congress, please don’t 

rush into making changes, we want to make sure you finish your 

process first. 

So we did that, but we moved quickly so that we could wrap up 

and start putting improvements in place, and one of them already 

208 

set up is the center science council that I mentioned. This is a body 

of our senior managers and experienced scientists, and to them are 

brought some of the important issues to be decided by the center. 

For example, where in the past a decision to—— 

Mr. STEARNS. Would it be fair to say what you are talking about 

is what you intend to do? 

Mr. SHUREN. No, no, no. The center science council is already set 

up. 

Mr. STEARNS. OK. Let us say all the things you said are good 

things. You heard Dr. Fischell, didn’t you, in which he said the 

‘‘FDA’s device center over the past few years is the worst I have 

experienced in 42 years,’’ so then I asked him to narrow it down, 

is it 4 years ago, 5 years ago, the last 2 years. He indicated, as you 

heard, it is really under your watch. Isn’t that what you heard 

from him? 

Mr. SHUREN. That is what I heard from him but—— 

Mr. STEARNS. So we both agree, that is what he said. So under 

your watch, here is a very competent inventor of the United States 

award 200 patents in Europe and the United States, he said it is 

the worst experience he has seen in 2 years. Do you agree with 

him? 

Mr. SHUREN. No, I don’t think we are the worst in terms of running the center. I do think in terms of performance, we have seen 

performance worsen. 

Mr. STEARNS. So performance has worsened in the last 2 years? 

Mr. SHUREN. No, it has but it started before then. If I could 

show, actually I can show you the data if you would like to see it. 

First off, if you would just go to chart number 4. 

Mr. STEARNS. So he is saying in his opinion, it is worse. You are 

saying in a sense that it has been bad but it is not the worst. 

Mr. SHUREN. Well, what I—— 

Mr. STEARNS. Would you agree the last 2 years are bad? 

Mr. SHUREN. What I would like to explain is that performance 

has gotten—I think some things are actually now starting to improve. For example, if you look at the chart here, this is for 

510(k)s. When we have deficient applications or we have questions, 

we send out what is called an additional information letter. If you 

look at the chart here, the percent of 510(k)s that we are sending 

letters out on actually started to increase in 2002. If you next put 

up the chart for number two, you actually see our performance on 

510(k)s over time, and what I want to lay out for you is that there 

have been issues here going on many years that have been increasing. 

So what you will see on the chart here is our average time for 

a decision. The top line is what we call total time. This is the time 

it takes FDA and the time it takes industry. The middle line is 

FDA’s performance. The bottom line is industry time. What you 

will see here is that starting in 2005, total time is going up. In fact, 

if you overlaid even our first chart, which you don’t have to do, but 

from 2002 recall those letters going up. Now watch industry time 

going up and then followed after it while our performance started 

to improve, total time goes up. If you look at the very end and the 

numbers at the end are not done yet, the applications we are looking at the very end shows 2010. 

209 

Mr. STEARNS. So in your opinion, things are changing? That is 

what you are arguing? 

Mr. SHUREN. That is what I am trying to say. Things are starting to change. We have a long way to go. 

Mr. STEARNS. Long way to go, but you do admit that the last 2 

years have been not as, shall we say, competent and—— 

Mr. SHUREN. No, I wouldn’t say that. I think for some indicators 

in terms of times, those numbers—— 

Mr. STEARNS. Let me get to this quote here. Is FDA Commissioner Hamburg your boss? 

Mr. SHUREN. Yes. 

Mr. STEARNS. You have said that the level of criticism the device 

center has received has only compounded the problem. FDA Commissioner Hamburg, however, acknowledged last week that ‘‘much 

of the criticism was deserved.’’ Has Commissioner Hamburg expressed this concern to you? Yes or no. 

Mr. SHUREN. Yes. 

Mr. STEARNS. If so, when did she give you that criticism to you? 

Mr. SHUREN. For over the past year, we have been aware of—— 

Mr. STEARNS. So she has criticized for the last year to you. Is 

that correct? 

Mr. SHUREN. What she is conveying is the criticism she has 

heard from others and that she and I both agree with, that many 

of the concerns raised are accurate. 

Mr. STEARNS. Did she specifically tell you to do something about 

it after she gave this criticism to you? 

Mr. SHUREN. I started to do something about it from the day I 

hit the center. I had heard of these and known about the problems 

before I ever took on my job, and one of the very first things I did 

when I started was to announce, we need to look at this. In fact, 

when I first started the job, I was acting. I didn’t know I would be 

permanent, and I told the commissioner, look, if you are going to 

give me this job, I am not going to be here and just be a guardian, 

there are things we need to do and this is one of the things we 

need to do, we need to get to the bottom of what the problems are, 

and I asked permission to do that and was told yes, you can proceed—— 

Mr. STEARNS. I think my only concluding comment is that from 

our perspective, it looks like you are on the go right now but you 

weren’t necessarily on the go 2 years ago, and we have this lag of 

which Dr. Fischell has talked about and which a lot of our people 

in the first panel just complained about, and so you heard them. 

So my time is expired. 

The gentlelady from Colorado is recognized for 5 minutes. 

Ms. DEGETTE. Dr. Shuren, thank you very much, from my perspective, for your patience today with the very, very long day we 

have had. In my short time, I have a lot of ground to cover so I 

want to try to keep this flowing as much as possible. 

It looks to me from the two charts that you put up that the number of device applications is increasing. Is that correct? 

Mr. SHUREN. The number of device applications has been increasing. In fact, since 2004, it has increased through 2010 about 

26 percent. 

210 

Ms. DEGETTE. And has the staff in your division of the FDA increased to keep pace with that? 

Mr. SHUREN. It hasn’t kept pace with the increase in our workload. If you look from 2007 to 2010, and actually we have a chart, 

number six, it will show the increase in workload is about 27 percent but we have not had the staff increase for premarket review 

to handle all that work. 

Ms. DEGETTE. And that is even including the user fees or the 

PDUFA fees that are coming up, right? 

Mr. SHUREN. That is correct. 

Ms. DEGETTE. OK. Now, you said that the 510(k) letters are 

going up. Why is that? Is that because of insufficient applications 

or the increase in applications, or both? 

Mr. SHUREN. So we did an analysis of the letters we sent out in 

2010. We looked at about 100 of them and then we looked at follow-up letters if the manufacturer didn’t respond to all of the deficiencies. The causes for those letters are multifactorial. In some 

cases, it is our fault. We found that 8 percent of the time when we 

sent out letters, we asked for—— 

Ms. DEGETTE. I don’t mean to stop you, so there are a lot of reasons why the number of letters are going up? 

Mr. SHUREN. Sometimes we ask for things we shouldn’t. Other 

times companies didn’t provide information they knew they should 

have provided. 

Ms. DEGETTE. OK. Now, you heard me say, and you knew this, 

I am the chair of the Diabetes Caucus, and I know that you are 

aware of the guidance that the FDA is working on towards artificial pancreas and also towards these low-glucose suspending systems that Ms. Sagan was talking about. Are you familiar with 

that? 

Mr. SHUREN. Yes, I am. 

Ms. DEGETTE. Is the agency still on target to have the guidance 

on the artificial pancreas approved by December? 

Mr. SHUREN. Yes. 

Ms. DEGETTE. And can you tell me how the agency is going to 

be working with the manufacturers of both the artificial pancreas 

and also the pump and glucose monitor combinations on both of 

these systems, the artificial pancreas and the low-glucose suspend 

systems? How are you going to be working with manufacturers so 

we can move these issues along? 

Mr. SHUREN. So we allow for meetings with the companies before 

they are even at a point to actually—— 

Ms. DEGETTE. Is that happening? 

Mr. SHUREN. Yes. 

Ms. DEGETTE. OK. 

Mr. SHUREN. We do meet with companies, and when we actually 

deal with the clinical trial, we have set out for an interactive review so there is a rapid turnaround. In fact, one company right 

now, I just got told by the head of my artificial pancreas group, he 

has spoken with the company five times this week. 

Ms. DEGETTE. OK. Good. So you feel like we are on track with 

all of those systems. Because that is important to a lot of us. 

Now, beyond diabetes devices, I want to ask you more generally, 

because all of us on this committee on both sides of the aisle are 

211 

concerned. You know, you heard the first panel, we are concerned 

about all these devices. What other actions is the FDA taking to 

improve device review and safety? 

Mr. SHUREN. So to get the program back on track, we need to 

have clearer policies. We need to put clarification of what companies need to do and our expectations. We need to train our people 

and to have training to industry. We need to have the procedures 

in place in our center to make sure that the decisions are made at 

the right level so that we make the right call. 

Ms. DEGETTE. And do you think that your staff has sufficient 

training or could they need more? 

Mr. SHUREN. Oh, they do need more. 

Ms. DEGETTE. And is that going to require adequate funding? 

Mr. SHUREN. We will need to have sufficient funding, not just to 

have the training but for the people to take the time from not doing 

premarket review so that they can go off and do the training, and 

one of the challenges when you have limited capacity in your staff 

is that they have to pick and choose between do I do the training 

but it is going to take longer on the premarket review and we 

would like to have sufficient number of staff to do the work and 

ensure people can do the training and ensure that they can develop 

the guidance documents which are so helpful to industry. 

Ms. DEGETTE. Now, you heard Dr. Fischell’s idea on the first 

panel of just having peer review by people in the field like putting 

three people on. What is the FDA’s position on that? 

Mr. SHUREN. I think the FDA still has responsibility to review 

those applications but we need to make far better use of outside 

experts, which is why we are setting up four of these networks of 

experts so we can go out to people who understand the new technology, experts in the field, and try to answer important scientific 

questions. We will never and can never and should not expect to 

have all the expertise in house but we need to have sufficient expertise in-house so we can reach outside and have the right kind 

of conversations to learn from those outside experts. I am a neurologist. I can talk to another neurologist. You are not going to 

send me out to talk to an orthopedist 

Ms. DEGETTE. OK. Thank you, Doctor. 

Mr. STEARNS. Dr. Burgess is recognized for 5 minutes. 

Mr. BURGESS. Submit for the record that no one can talk to an 

orthopedist. 

Mr. SHUREN. My brother is an orthopedist, and I agree with you. 

Mr. BURGESS. Dr. Shuren, you have been very good to speak to 

me several occasions about some of these problems, and we have 

talked about some of the issues regarding the FDA’s regulation, 

your regulation of laboratory-developed tests. Of course, we already 

have the CLIA structure in place that does that regulation currently. If we are going to talk about improved safety standards, 

about thousands of new tests and many more coming down the 

pipeline, how do you propose that FDA, if it going to take on this 

task and take it away from CLIA, how do you propose to be able 

to do that with all the other stuff that you have got to do? 

Mr. SHUREN. Well, first off, CLIA doesn’t get to the oversight of 

the tests, it gets more to the quality of the laboratory and the ability of a laboratory to perform those tests, whereas the FDA handles 

212 

the safety and effectiveness of the tests. We have been looking at 

how could we handle that workload if it were to come in, and that 

is why any policy we would put out would be phased in over time 

to try to address incoming workload. Secondly, we would be looking 

at leveraging our third-party review program we already have to 

help on reviewing some of the lower-risk devices, and in addition, 

we look at some of the tests to say with experience, maybe we don’t 

need to look at them premarket, we can down-classify them, and 

in fact, just the other week, we down-classified 30 devices that we 

no longer will be asking for premarket review on. 

Mr. BURGESS. I appreciate you being here while we heard the 

testimony from all the panelists because I do think it was important that you hear that. I mean, this is the type of thing that we 

hear in our offices or I hear in my office week in and week out— 

we have got this thing, we have got this stuff, we have got this test 

and it has been in the pipeline for 3 years, 5 years, 17 years and 

we are no closer today than we were when we started. So I think 

it was important that you heard and felt some of that frustration. 

And you and I have talked about some of these things specifically 

in the past. At some point I would like to know what we have done 

at the FDA to improve that process, but can you give us any idea 

of the volume of work that is there bottled up at the FDA right 

now? 

Mr. SHUREN. Well—— 

Mr. BURGESS. If you put everybody at every desk and said no 

holidays, you don’t even get to go home at night until all this work 

is finished, would you be able to get that done? 

Mr. SHUREN. No. Actually—— 

Mr. BURGESS. Since the trial lawyer next to me brought it up, 

if this were a plaintiff’s firm and this were a product liability suit 

or a class action suit, they would have no trouble sifting through 

a whole basement full of data, digitizing it and getting it available 

to their attorneys in a relatively short period of time. They would 

hire enough people to get that done because it would be important 

to them, and what it suggests to me is, this is not important to the 

FDA. 

Mr. SHUREN. No, it is important to us, and if I had the ability 

to hire more people, I would do so. And we can push our people, 

I can chain my people to their desks 24/7, but it is not like I have 

one case before me. I have a growing workload and it doesn’t go 

away. 

Mr. BURGESS. Now, Mr. Waxman brought up the issue of funding 

but it looks like from the information that we have with the user 

fee tax that it out there that your funding has significantly increased over time. So Dr. Sharfstein said he had plenty of money 

when I asked him that question a year ago. Are you telling us differently today? 

Mr. SHUREN. I think—and I am very happy to go back to the 

record. I think what Dr. Sharfstein was saying is that resources 

along was not enough to handle it, and I think it was the context 

of globalization, but we do need adequate resources, but let me be 

clear. Resources are not the only thing at issue. There are a lot of 

things at the center that need to be fixed. We know what the problems are, we know what to do, and we are on it. We are already 

213 

making changes. There are some things we have to work with with 

industry on. We need to get the data that they are supposed to 

send to us, and we are already in discussions with industry about 

that. In fact—— 

Mr. BURGESS. I am going to have to interrupt you because I am 

going to run out of time, but I don’t think there is any question 

the device times have significantly increased, the approval times 

have significantly increased. I am glad to hear you say it is not just 

solely due to funding, but we have to improve. 

Now, Michael Mandel was here on our panel earlier. He was 

from the Progressive Policy Institute, and he had a story to tell 

about this MelaFind, and do you think that the FDA was impeding 

the implementation of being able to use this device that he was describing? 

Mr. SHUREN. I think in the case, there were issues with the data 

that was sent to us. What we are doing now is going through the 

data provided, and keep in mind, the manufacturer then more recently a few months ago changed the indication they were looking 

for. We are trying to see, does the data support what the manufacturer would like to do or something close to it, and if so, then we 

would approve that device. 

Mr. BURGESS. But the fact remains that it has taken so long, and 

the rules seem to be changing. Is the FDA causing us to lose our 

edge in the development of these new devices? 

Mr. SHUREN. I think the FDA needs to do a better job to ensure 

that we keep our edge as the world’s leader in medical device innovation. 

Mr. BURGESS. Thank you, Mr. Chairman. I will yield back. 

Mr. STEARNS. He asked you, do you think we are losing our edge. 

Just yes or no. 

Mr. SHUREN. I don’t think we have lost our edge. I think if there 

are steps we don’t take, we are at risk for losing it in the future. 

Mr. STEARNS. Thank you. And the gentleman from California, 

Mr. Waxman, is recognized for 5 minutes. 

Mr. WAXMAN. Thank you very much. 

Dr. Shuren, I want to ask you about a statement that Advanced 

Medical Technology Association, known as AdvaMed, the medical 

device industry trade association, issued today. I would like to ask 

that this statement be made part of the hearing record, Mr. Chairman. 

AdvaMed is the leading device industry trade group. According 

to their Web site, their members produce 90 percent of the medical 

devices sold in the United States. Here is what AdvaMed had to 

say: ‘‘The medical technology industry has long recognized that a 

strong and well-functioning FDA is vital to maintaining America’s 

preeminence in the medical technology innovation and we support 

the current regulatory framework in the United States.’’ Do you 

have any reaction to this statement? 

Mr. SHUREN. I am glad to hear it. Actually, recently I was in a 

meeting with senior officials from AdvaMed and they had said to 

me that they support the current approval and clearance standards 

for the United States. 

Mr. WAXMAN. Well, their press release says that ‘‘we believe that 

any steps necessary to address the situation can be taken without 

214 

changing the current robust statutory standards for clearance and 

approval of medical devices.’’ Earlier today, we were hearing from 

member after member on the Republican side insisting that the 

FDA and the regulatory standards required by the agency for device approval are destroying innovation and causing device manufacturers to move overseas. But the leading device manufacturer 

trade group puts out a press release that says the best way to 

maintain America’s preeminence in this area is, and I quote, ‘‘a 

strong and well-functioning FDA requiring industry to comply with 

robust statutory standards for clearance.’’ Now, I assume they don’t 

want the statutory requirements changed, but when they talk 

about a robust FDA, I am sure they are talking about a well-funded one. 

I must take exception to the comment that was made if FDA 

really cared, they would hire more people. You are hiring as many 

people, I presume, as you can afford. Isn’t that correct? 

Mr. SHUREN. That is correct, and we also suffer from a high 

turnover rate, which makes it so much harder to try to keep up 

with our losses. 

Mr. WAXMAN. Well, if the Republican budget as proposed passes, 

it would provide a 10 percent cut over $200 million in the FDA 

budgets. Cut of this magnitude would affect every facet of FDA operations. You have a tough job to do, balancing the desire of manufacturers and patients to get quick approval for devices with your 

statutory requirements to make sure they are safe and effective. I 

think this is shortsighted to make these kind of budget cuts. Do 

you differ with me on that? 

Mr. SHUREN. I am deeply concerned that budget cuts would 

cause us to not only lose people but our performance will worsen, 

and that will not be in the best interest of industry, it won’t be in 

the best interest of patients. 

Mr. WAXMAN. Do you have difficulty attracting the best people? 

Mr. SHUREN. We do have a challenge attracting the best people. 

The circumstances are, it is a high workload for people. People get 

burned out. And the pay for our people, particularly our frontline 

managers, doesn’t compare to what they get in industry. In fact, in 

some respects, it is not necessarily even the same for other parts 

in the agency and so we have a very high turnover rate. 

Mr. WAXMAN. So you have a high turnover rate, you have got a 

difficult balancing job to do. You recognize other internal problems 

that you are trying to deal with in the medical device area in terms 

of, I will say it, culture or inability to move as quickly as we would 

hope they would, and you are trying to address those issues? 

Mr. SHUREN. I am. And in fact, these same problems were seen 

in the drug program 10 years ago, same thing in PDUFA where 

they had high turnover rate, there were concerns about slow review 

times, and the drug program was able to get on top of it. I think 

people may have heard Dr. Woodcock the other week testify, talk 

about how now they are so much faster than Europe and there was 

a health affairs article out about it recently and what made it, they 

had to make some internal changes but ultimately the drug industry got behind the program. They provided additional funding and 

that program took off. In fact, right now the drug program, and I 

am not saying it should be the same size but it is three times the 

215 

size of the device program. They have five times as many medical 

officers. They get 10 times the amount in user fees, and in fact, 60 

percent of their larger program is supporter by user fees whereas 

20 percent of my smaller program is supported by user fees, and 

that ultimately made a big difference in being successful. I hope ultimately our program is much more successful like the drug program. 

Mr. WAXMAN. Well, we hope so too, and I hope this hearing will 

lead to a very constructive approach by a Congress that has not 

very well performed so far this year. We have done practically 

nothing. We may not even raise the debt ceiling and allow our 

economy to go over the cliff, and we are telling you how to run an 

agency, but I hope as we do our job and improve in our job performance that we can help you, not cause more problems for you. 

I see my time is expired and I yield back, Mr. Chairman. 

Mr. STEARNS. The gentleman’s time has expired. The gentleman 

from Nebraska is recognized for 5 minutes. 

Mr. TERRY. Thank you, Dr. Shuren, and I appreciate that you 

have outlined some of the areas that you have identified as needing 

improvement, so I appreciate that you are willing to do that. Lisa 

Jackson is much more fun that you are, frankly, up here. At least 

she fights with us instead of coming and recognizing that there are 

issues and problems that need fixing. 

Mr. SHUREN. I save it for my wife. 

Mr. TERRY. We share something. 

But on the money part, let us start with that, and then I want 

to tag along on what Diana was talking about with some of the artificial pancreas and how we can work through it maybe even faster, but as I understand from a Congressional Research Service report, funding from 2008 to 2010 increased 35 percent for the medical device review process. So it has gone from in 2008 $275 million 

to $368 million. So I find it hard to really grasp that the 2-year 

period that we are talking about, funding was increased, delays increased, problems occurred and it is all related to the lack of 

money. So my question to you is, the 2 years you have served 

there, there has been an increased of dollars, you have had a turnover. Is the turnover related to pay? 

Mr. SHUREN. Turnover is related to pay and to workload. I will 

say in terms of the funding we got—and I haven’t seen that report 

to look at percentages—but we did get increased appropriations 

from Congress. Congress also tells us how that money should be 

used, and that money predominantly was directed towards 

postmarket safety and globalization, some science. We really didn’t 

get the big boost for premarket review. We did get an increase in 

user fees, which we focused on premarket review, and if you are 

talking about the years 2008 to 2010, the enacted user fees that 

we can get in 2008 were for my center, $26.6 million, and they 

went up to $32.8 million in 2010. So between those two years, I 

had about an increase in $6 million in user fees, enacted user fees, 

and those while I have been on the job, and recall, I came in in 

late 2009, so I am dealing with money coming in for 2010, I tried 

to direct more money to premarket review. Twenty eleven was a bit 

of a challenge because, as you know, I understand the challenges 

you all go through. 

216 

Mr. TERRY. Oh, that is right. We did pass a budget, didn’t we? 

It is the Senate that hasn’t. 

Let me get to the low-glucose suspend systems and artificial pancreas. Do you know how long those have been before the FDA medical devices for approval? 

Mr. SHUREN. Well, there is no true artificial pancreas. No one 

has developed it. There is nothing commercial. The low-glucose suspend, the company has come to us, I believe, and this is my understanding from my staff, but I believe it is just been in the past 

year, and we have been working with them to get up to do the 

studies they need and ultimately, hopefully if things turn out right, 

then approve it and have it on the market. 

Mr. TERRY. And the process that has been there for a year, what 

information is required at this stage? 

Mr. SHUREN. So at this stage is to show it is safe and effective. 

The device is available in other countries, but from what we were 

able to see and particularly in Europe, it wasn’t approved for the 

low-glucose suspend. It has that as a feature but it is not in its indications for use, and then we asked, did you do any of the prospective clinical studies to show that that feature works, and they 

hadn’t. They didn’t need to do that for Europe, so that is what we 

are asking for here in the United States. 

Mr. TERRY. All right. 

Mr. SHUREN. And I would like to see such a device out there, and 

I will tell you, the head of my artificial pancreas group, he is a type 

1 diabetic. He has said to me, if we have something out there that 

worked that was safe and effective, he would use it. 

Mr. TERRY. In my last 30 seconds, what do we need to do to get 

this done? You have got the JDRF out here, others that are listening. What is necessary right now? 

Mr. SHUREN. So right now, we need to get the next guidance out 

there. We need to finalize the one we put out on low-glucose suspend. We need to get the next one out on artificial pancreas. That 

will be out on December 1. In the best of all possible words, I 

would be able to beef up and have a stronger staff to focus on this. 

We deal with so many disease disciplines that we don’t have 

enough of the people to do all of that work, and I will tell you in 

the case of this guidance that we just put out, I actually pulled 

endocrinologists from my other centers and asked them, would you 

be willing to give up your time on reviewing drugs and biologics to 

help us out on this just so we have the capability to get it done 

as soon as possible. 

Mr. TERRY. My time is up. 

Mr. STEARNS. The gentleman’s time is expired. The gentleman 

from Michigan, Mr. Dingell, is recognized for 5 minutes. 

Mr. DINGELL. Mr. Chairman, I thank you. 

Would you please submit us a list of measures you are taking to 

improve the consistency of the review process, please? 

Mr. SHUREN. Yes. 

Mr. DINGELL. How many FTEs in your center work on device review? 

Mr. SHUREN. The device review process under our user fee program is 949 FTEs as of 2010. 

217 

Mr. DINGELL. In your tenure at the center, have you witnessed 

a high turnover among the review staff? Yes or no. 

Mr. SHUREN. Yes. 

Mr. DINGELL. What is your turnover rate? Would you submit 

that for the record, please? 

Mr. SHUREN. Yes. 

Mr. DINGELL. Amongst the review staff currently employed by 

FDA, what is their average tenure in that position? Please submit 

that to the record. 

Mr. SHUREN. Yes. 

Mr. DINGELL. Now, as I am sure you are well aware, the House 

recently passed H.R. 2112, the fiscal year ’12 agriculture appropriations bill, which would cut the FDA budget by roughly 11 percent, 

or $285 million. Please submit for the record what is the result of 

that on your efforts to improve the handling of new permits for the 

devices that we are talking about. Would you do that, please? 

Mr. SHUREN. Yes. 

Mr. DINGELL. Now, if the proposed cuts to the FDA budget included in H.R. 2112 are enacted, will FDA have to lay off employees? Yes or no. 

Mr. SHUREN. Yes, there is a likelihood we may have to lay off 

employees. 

Mr. DINGELL. How many will have to be laid off? Will you submit 

that for the record, please? 

Mr. SHUREN. Yes. 

Mr. DINGELL. And I want that. I don’t want it strained through 

OMB. I want that delivered to this committee. 

Now, will the proposed cut jeopardize the number of review staff 

that FDA is able to employ at the center? Yes or no. 

Mr. SHUREN. Yes. 

Mr. DINGELL. By what order of magnitude? Submit that for the 

record, please. 

Mr. SHUREN. Yes. 

Mr. DINGELL. Will the proposed cut have a detrimental impact 

on any efforts to improve reviewer training at the center? 

Mr. SHUREN. Yes. 

Mr. DINGELL. Now, I would note that one of the complaints that 

my office consistently receives is that medical device approval process has a certain inconsistency from reviewers at the Center for 

Devices and Radiological Health. Have you taken steps to improve 

reviewer training? Yes or no. 

Mr. SHUREN. Yes. 

Mr. DINGELL. Would you please define what those are for the 

purposes of the record? 

Mr. SHUREN. Yes. 

Mr. DINGELL. And would you also submit to us, please, what 

steps you are taking to improve the capability of your reviewers 

there? 

Mr. SHUREN. Yes. 

Mr. DINGELL. Now, there are some areas of improvement in the 

current medical device approval process but I would ask my colleagues here, does anybody remember the Dalkon Shield? Anybody 

around here? Well, 3 million American women used that device. 

They were assured it was safe in the early 1970s. Yet the result 

218 

was widespread cases of pelvic inflammatory disease, spontaneous 

abortions, ectopic pregnancies and infertility. I was here when this 

committee created a medical device law in 1976 at the urging of 

my good friend, now deceased, President Ford, a Republican. 

So is there anybody around here that wants to return to what 

President Ford called the horse and buggy days of device regulation? Do you want to do that? 

Mr. SHUREN. No. 

Mr. DINGELL. Now, I want to remind everybody here that first 

of all, we face huge risks. We talked earlier about pharmaceuticals 

that kill people and cause children to be born with flippers, but I 

would like to have you tell us what you have found to be your experience with the money that you have gotten in terms of having 

your staff financed in good part by the funding of your agreements 

with industry for paying for the cost of that. Would you submit 

that for the record, please? 

Mr. SHUREN. Yes. 

Mr. DINGELL. And I would ask you to just tell us yes or no, are 

you more able to provide the services that you need to do now that 

you have that particular program? 

Mr. SHUREN. Yes. 

Mr. DINGELL. And of course, that is true in the case of pharmaceuticals, is it not? 

Mr. SHUREN. Yes. 

Mr. DINGELL. Mr. Chairman, I thank you. 

Mr. TERRY [presiding]. Thank you, Mr. Dingell. 

Mr. Bilbray, you are recognized for 5 minutes. 

Mr. BILBRAY. Doctor, the gentleman from California was pointing 

out that, you know, you could have been facing a 10 percent cut 

in your budget. Are you aware that venture capital in medical device research is down almost 40 percent? That is about 30 percent 

more than the reduction of other venture capital in high tech. 

Mr. SHUREN. I don’t know the actual figure right now for investment. 

Mr. BILBRAY. Would you have any explanation of why those investors who traditionally went to research in medical devices would 

have such a large reduction in proportion to maybe those who are 

investing in other high-tech devices that don’t relate to medical? 

Mr. SHUREN. What I can say in terms of what I have been told, 

and told by industry or industry reports, it is multifactorial. I 

mean, one is with the global recession, venture capital investment 

went down across the board, and the VCs have become more riskaverse. They are looking for investing in technologies that are further along in development. At the same time, there are some things 

on our end. 

Mr. BILBRAY. OK. What—— 

Mr. SHUREN. Insufficient—— 

Mr. BILBRAY. Go ahead. 

Mr. SHUREN. I was going to say, insufficient predictability from 

FDA is something that can also—— 

Mr. BILBRAY. Because that is a huge gap, 30 percent between 

venture capital for an iPhone as opposed to venture capital for a 

melanoma scanner is a huge gap, and you do say that you think 

219 

that the regulatory oversight is one of the major—or a major problem that we need to address with that discrepancy? 

Mr. SHUREN. Well, I think having sufficient predictability is an 

issue we need to address regardless. I mean, when I looked at VC 

investment, and like I said, it was down, some of the figures from 

2010 showed that devices were still the fourth leading area for investment and had held that way, but I do understand from the VCs 

and I do take this seriously that if we can improve predictability, 

we can lead to more investment in device technology. 

Mr. BILBRAY. OK. Let us talk about a device that was brought 

up in the testimony and, you know, there is a lot of people that 

don’t want their devices or their items brought up because they are 

concerned about it affecting their review process, which I think is 

a concern in itself, but we are not here to talk about that. We are 

talking about something that was brought up in the first panel, 

and that is this remote scanner for melanoma. When we are facing 

a situation with 3 percent annual increase, annual increase on 

child melanomas, 8,700 people die a year from this, that we have 

a device that may be practical for a general practitioner to use to 

detect melanomas that may not be following the regular description, why was that device basically denied the ability to go through 

a review process, a review panel? 

Mr. SHUREN. The decision the first time around not to have the 

device go to the advisory panel was wrong. The staff made the 

wrong call. It should have been allowed to go to the advisory panel. 

It eventually was. It was supported. It was a very slim margin. It 

was 8–7. We went back—— 

Mr. BILBRAY. How much of a delay did that put in? 

Mr. SHUREN. I don’t know. 

Mr. BILBRAY. Let me just say this. And I don’t blame you. I just 

blame that—I hope both sides of the aisle understand that some of 

us that have worked in government long enough understand, there 

is an inherent problem with bureaucracy, and just accept it. It is 

just one of those things. There is a problem with capitalism but 

there is a problem with government bureaucracy, and that is, it is 

too comfortable to say no. It is too comfortable to show up to the 

office and go through basically review stuff, and there is not the 

push or the uncomfortable getting something done that you may 

get at a different angle, and Doctor, the challenge is, what is the 

accountability to the people who said no and how long was this 

delay, and I will say this. If you take how many months, and I will 

challenge how many months, that this device was slowed down, 

how many people died during that period in the United States from 

melanoma that could have been avoided possibly if not just dermatologists but general practitioners had the ability to detect this 

down the line, and how do we get the bureaucracy to understand, 

this is not about time and it is not about money, it is about people’s 

lives. 

There was a comment made this morning about the delay. Who 

was the doctor who was over in the corner, Mr. Chairman? 

Fischell. He made the comment that the delay of a few months is 

not that big a deal when you consider the life span of a drug or 

a device, OK? Would you agree with that statement? 

Mr. SHUREN. Yes, I do. 

220 

Mr. BILBRAY. See, my problem is, the people down the aisle were 

saying the life span of a device, how about the life span of a patient, and a couple months, 10 months, 12 months delay, when you 

talk about a 12-month delay, how many? Is there 8,700 people that 

are not going to be detected in this country because we didn’t get 

a device out to the general practitioners that might have been able 

to use it? That is the kind of concern I would like you to transfer 

to your rank and file that every day they say no, every day they 

say let us study it a little more, that may be the cause of people 

dying because there are two ways of killing somebody in medicine: 

improper triage and denying proper triage. And the people that say 

no are just as liable, but you don’t read about it, and I will just 

close with this. 

You don’t read about those things, you read about the chairman 

emeritus talking about a morning sickness medicine in the 1950s 

that caused birth defects, and we all talk about that. We don’t talk 

about in the 1980s when there was a morning sickness medicine 

driven off the market and people died because that was driven off. 

Nobody hears about those people that died from not having access 

to a product. We only hear about those that die because of inappropriate, and the balance needs to be there, Dr. Shuren. 

Mr. SHUREN. And let me say first off from my people, they will 

actually get more grief for taking too long, being too conservative. 

We are looking at review times, and quite frankly, if things are 

moving along quickly, there aren’t issues. When they are moving 

slowly, that is when management is coming back and saying we 

have a problem, and that is when staff get more grief actually. And 

in terms—— 

Mr. TERRY. Thank you. 

Dr. Green—Dr. Green? I just assumed. 

Mr. GREEN. I am just an old city lawyer. 

Mr. TERRY. Juris doctorate, the best kind. Right, Mr. Burgess? 

The gentleman from Texas, you are recognized for 5 minutes. 

Mr. GREEN. Thank you, Mr. Chairman. 

First of all, I want to reiterate and associate myself with the 

comments that our ranking member on the studies and how important the work on the artificial pancreas is, and hopefully the time 

frame that I am seeing will be met by December, and 245 Members 

of Congress actually urged the agency to consider the draft guidance, so hopefully we will meet those deadlines. 

Dr. Shuren, I note that in testimony at other hearings on the 

same topic, you stated that delays in the device reviews and declines in FDA performance are due to poor quality submissions 

from the medical device industry. While I agree with you that not 

every submission is created equal and there are certainly some 

variations in quality, I find it hard to believe that the dramatic 

growth we have seen in review times for both PMA devices and 

510(k) devices can be fully explained by the sudden decline of the 

quality in submissions. What other factors explain the dramatic increase in the review times? 

Mr. SHUREN. So I agree, that is not the explanation, complete explanation for everything. Some of it is fault on our end, when we 

ask for things we shouldn’t ask for, and as I mentioned, that is 

about 8 percent of those letters we send out, so about 5 to 6 percent 

221 

of the 510(k)s we are asking for things we shouldn’t ask for, so we 

are putting in procedures to actually make sure that doesn’t happen because it should never happen, but we do have companies 

who are submitting applications that are deficient. I am talking 

about big concerns where we put out guidance document, it has 

been out for years, and says exactly what to do, and the company 

doesn’t do it and doesn’t provide a justification not to do it. 

At the same time, we also need to have better clarity on expectations. I would like to have more guidance out there. We know when 

there is guidance, you are more likely to get your device cleared 

and cleared quickly, but we need the capability to do that. I need 

a core team of writers and I need sufficient number of experts to 

do the reviews and do the guidances and get them out quickly. 

That can make a big difference. 

Mr. GREEN. And you don’t have that ability right now? 

Mr. SHUREN. We do not have sufficient ability. 

Mr. GREEN. Is it just based on funding? I know others members 

have asked questions about that. 

Mr. SHUREN. It is funding. To the extent we can make our own 

systems more efficient, we are doing that. We are doing what we 

can with what we have. We can do more if we have more, and we 

can do it right. 

Mr. GREEN. What some of us are hearing, particularly medical 

device companies are saying there is a lack of consistency and predictability in the process and sometimes the rules change in midgame, and believe me, the FDA would not be the only federal agency that does that. I can talk about a lot of agencies. Certainly it 

is hard to put a quality submission together, but is that also a 

problem that sometimes once a submission is made, like you said, 

you may be requesting information that you don’t really need or do 

the rules actually change once somebody submits? 

Mr. SHUREN. Sometimes the rules change and it is justified, 

there is a new safety concern and we go back to the company and 

say we have new information and based upon that we need additional information, or based on the company’s own data, we have 

found a problem and we send them back. What we are now instituting is, when the rules of the road change and they need to 

change quickly where we can’t take time to get public comment because of major public health concerns, we are now going to put out 

a notice to industry to say things are changing, here is why and 

get it out quickly, where before companies wouldn’t find out until 

they came in the door with their submission and they wasted their 

time and effort when they could have been notified earlier, and we 

are fixing that. 

Mr. GREEN. I guess just the certainty and consistency, that is 

what anybody wants. 

I have heard you say previously that the FDA is meeting its user 

fee goals for 95 percent of the submissions. When I looked at the 

charts from the most recent quarterly update on the medical device 

performance goals, there was an awful lot more goals in the 5 percent that were not being met, and I know that the 510(k) submissions account for about 95 percent of the device reviews that FDA 

does each year but all these red boxes where the FDA is not meeting its user fee goals are concerning to me. I also note that goals 

222 

aren’t being made, largely the PMA goals. In the previous panel, 

we heard from patients who could not access these breakthrough 

technologies and had to leave the country to get access. What are 

you doing right now to rectify that situation and what steps is FDA 

taking to ensure that patients have access to this cutting-edge 

medical technology? 

Mr. SHUREN. So in addition to the actions I already mentioned 

about making these systems more predictable, more consistent and 

more efficient, the other things we are doing are, we need to adjust 

clinical trials in the United States. If we can start clinical trials 

earlier here, we get the technology earlier here, companies then 

keep the technology with our doctors, so we are going to putting 

out a policy soon to actually allow for the first time you give it to 

a patient, to let those studies start earlier than we did in the past 

and to allow for the manufacturer to make changes, to innovate 

and test without necessarily coming back to the FDA. We heard 

this is a big deal for the VCs, it is a big deal for the companies. 

We will putting out that policy. 

The other is being very clear about the factors we take into account when we make benefit risk determinations. We had been inconsistent in some cases when we do that. We are for the very first 

time going to put out what those factors are. We are going to get 

public comment on it, things like taking into account a patient’s 

tolerance for risk. Serious disease patients are going to be willing 

to tolerate more risk. Serious disease, we may allow for a treatment, particularly if there is not an alternative out there. That 

guidance will go out. We will require that our viewers go through 

those factors. They lay out what the answers are and they put in 

the record. I consider that so important that actually I chair that 

working group personally. 

Mr. GREEN. One quick question. I would like to know, we have 

heard a lot of comparisons to the European system and ours. If 

there is a device in Europe that has been approved even with those 

74 or whatever they do, can the FDA assess the success or failure 

of that device in Europe and do you give any substance to the quality of any studies that come out of those that are actually being 

used in Europe? 

Mr. SHUREN. So we absolutely will use data from Europe or from 

other countries. We do use that data all the time. In some cases, 

we have even approved devices that are based predominantly or, to 

my understanding, completely on data outside the United States, 

but it has to be the data that actually answers the question, and 

one of the challenges with Europe and other countries is, they will 

let a device on the market without showing it is effective. So they 

actually never generated the data to show it is effective to meet the 

U.S. standards, and a lot of those studies are not so robust. In fact, 

the British medical journal in a series of investigative articles, the 

European Society of Cardiology, a group of European health technology assessment agencies all came out and said for high-risk devices, you should be more like the United States. You should show 

you are effective. You need to have more robust clinical studies like 

the United States. You need to be transparent like the United 

States. Tell doctors and patients the basis of those decisions and 

put out more guidance explaining what you need to do. As much 

223 

as we need to do more guidance, the EU puts out nothing near 

what we do to clarify what kind of studies you have to perform. 

Mr. GREEN. Thank you for your patience. 

Mr. TERRY. Mr. Scalise, or is it Dr. Scalise? 

Mr. SCALISE. I am not a—— 

Mr. TERRY. You are recognized for 5 minutes. 

Mr. SCALISE [continuing]. Juris doctor or a medical doctor. I just 

play a Congressman on C–SPAN occasionally here. 

I do want to ask a few questions going back to your testimony, 

and in a few different sports you talk about the success of the FDA, 

and specifically in relation to what is happening in Europe, and of 

course, we had a full panel this morning that was giving I think 

some very eye-opening, riveting and not real positive glowing endorsements of FDA’s performance, especially compared to Europe, 

and you say here ‘‘In terms of time to market, data shows that the 

United States is performing as well or better than the European 

Union,’’ and then you go on to say, ‘‘The EU typically approves 

higher risk devices faster than the United States because unlike in 

the United States, the EU does not require the manufacturer to 

demonstrate that the device actually benefits patients.’’ You had a 

whole panel of patients sitting here at this table talking about devices they have access to in Europe that they would have to go to 

Europe to get that would actually improve their lives. Some actually did it. They went to Europe to get the device. You had Dr. 

Fischell sitting right there with a device sitting in front of him that 

has been waiting on FDA approval for years that relieves migraine 

headaches and yet there is data, there is devices, there is real testing, there are patients that use it and there are people that are 

using it in Europe, and you are implying that Europe has just got 

some of Wild West mentality that they are just giving out approval 

for things when in fact you have got Americans that right now 

have to go to Europe to get the treatment that actually would and 

has in some cases improved the lives of those patients. So how can 

you make those comments, especially after you sat here and heard 

the statements from these patients and the mother of a patient? 

Mr. SHUREN. So I can have chart 3, first of all, I empathize with 

the patients. I am a physician and a patient myself. I have loved 

ones who are patients. I want to get safe and effective devices but 

emphasis on safe and effective devices to patients, patients even 

like myself. 

You asked in terms of the data for performance. This isn’t my 

study, this is an industry study. They looked at the 510(k)s without 

clinical data. That is about 80 percent of the devices that we review, and the products came on the market first in the United 

States as often or more often in the United States than they did 

in the EU, and in fact, if you looked at the top chart, the performance, the likelihood of coming on the U.S. market first actually has 

improved more recently in time. 

Now, for the smaller group of high-risk devices, they have come 

on the market first in other countries for years. We can do better 

on that. We can get a lot closer. But we will never be completely 

as fast because of that difference in effectiveness. Does it have 

ramifications? Yes, because you do put on the market devices that 

don’t benefit patients, patients get in some cases when they have 

224 

alternative that works so they missed out on good therapy. The 

health care system paid for ineffective treatments. And in fact—— 

Mr. SCALISE. I want to go back to something, though, because 

again, we had testimony not just from patients but from doctors 

who have actually invented devices. I mean, Dr. Fischell, this is 

somebody who has been inventing devices for decades, has been nationally recognized, inventor of the year, has put out more devices 

than most doctors in this country, and he first talked about the 

change he has seen in the attitude in the FDA is the last 2 years 

is the worst he has seen in his 42 years of inventing, and then he 

further went on to say there is a different attitude at the FDA than 

we have ever seen before. This isn’t—you know, you can show 

metrics all day long but instead you have patients who are sitting 

here and you have got inventors who are sitting here saying the 

problem they are seeing in the last 2 years isn’t something that 

they have seen before at the FDA, and they surely aren’t agreeing 

with your glowing metrics that you can go find somebody to say 

how great you are doing when you have got real inventors, real patients sitting here saying the job is not getting done. You know, 

they will tell you if you want to look at data and compare it to Europe and say what Europe has or doesn’t have. They will say that 

firms are willing to submit whatever data you want but they can’t 

get the certainty in the regulatory process from your agency. They 

want to know how to comply. They can’t even get the certainty 

from you to know how to comply. 

And so you can sit here and talk about all the data you are not 

getting and all the money you are not getting and all the turnover 

you have got. I can tell you, I mean, I have looked at your budget. 

Congressional Research Service actually issued a finding that the 

medical device review process funding in your agency has increased 

35 percent in the last 2 years. You show me a family out there as 

families are cutting back you have got a 35 percent and you have 

the nerve to sit here and say you are not getting enough money 

and the reason you can’t move things fast enough is because you 

all have too much turnover. Let me tell you, I have looked at agencies and especially if you talk to people in the private sector, they 

will tell you, if you have got turnover problems, that is a management problem. You can’t blame that on somebody else. You can’t 

say you are not getting enough money. You got a 35 percent increase over the last 2 years, and oh, by the way, during that time, 

the average review time increased by 43 percent. So maybe cutting 

back to what you were at when you were actually getting some 

things done might be the most prudent approach as some of the patients here said, and so to say that you don’t get enough money, 

you got a 35 percent increase. The delays are increased. You have 

got some management problems I think you have to recognize before you blame the patients and the inventors who are sitting here 

and some have to go to Europe to get the relief that they have gotten. They actually went to Europe and got the relief and you still 

haven’t approved the devices here. 

So real changes have to occur and you can’t just show metrics 

that say how great you are doing or say you need more money. I 

mean, you know the environment here. We are broke. We are trying to figure out how to do more with less because we don’t have 

225 

the money. We can’t borrow it from China anymore and, you know, 

there has got to be real changes. But you can’t blame other people 

either. 

Mr. TERRY. Thank you. 

Mr. SCALISE. I will yield back the balance of my time, whatever 

that balance is, Mr. Chairman. 

Mr. TERRY. Dr. Christensen, you are recognized for 5 minutes. 

Mr. CHRISTENSEN. Thank you, Mr. Chairman, and Dr. Shuren, 

thanks for your patience today. 

Let me at least try to help you answer the question about what 

is happening with venture capital because the ranking member 

earlier reported that Bloomberg News today reported that in the 

first quarter of this year, venture capital for medical device and 

equipment makers went up 20 percent. That was $841 million in 

90 deals, so the first quarter it went up. 

But let me try to ask you a question about some other things 

that have been discussed today. In this hearing and in previous 

hearings before the committee, we have heard from a variety of industry sources and supporters of weaker or less rigid regulation 

about a flawed FDA regulatory process for medical devices. We 

have heard a lot about two industry-funded studies in particular, 

one by Dr. Josh Makower and one by the California Healthcare Institute. These studies were critical of your agency, purporting to 

show that the FDA process causes undue delay in approvals. We 

asked leading medical experts to provide us with their views on the 

methodology of these studies, and we asked FDA to provide the 

views of the agency. So Dr. Shuren, first, can you tell us about the 

FDA’s views on the findings of the Makower and the California 

Healthcare Institute studies? 

Mr. SHUREN. So we did have concerns about the methodologies 

that were used. For example, in the Makower study, he sent out 

a survey to 1,000 companies, not to the full industry. Of that, he 

got 204 who responded, and then on particular questions trying to 

compare the United States to the EU, at most, the number of people who could actually had a device in both might have been 60 to 

80. So very underreporting, and in those cases, we know the people 

who are most dissatisfied, that is who reports. Most of these companies did not have much experience with the FDA. Only 55 percent brought a 510(k) through the process, only 32 percent a PMA. 

Much of the methodology to compare time frames was apples to 

oranges. They didn’t look at the same point in time between the 

EU and the United States. They compared a first communication 

with the United States which could occur before you even do a clinical study where in the EU your first communication may be before 

you actually submit the application. And therefore I could reduce 

those times dramatically if I didn’t meet with companies and just 

say give me the submission and our times would dramatically improve. In fact, the best way to compare is, if we had the data from 

the EU and comparable times for reviews, and in fact it doesn’t 

exist because the EU doesn’t keep it and doesn’t report it. 

Mr. CHRISTENSEN. Thanks. Well, your views are really similar to 

the views of the outside experts that are described in the supplemental memo that was shared today. These experts also identified 

a variety of problems. One reviewer concluded that there so many 

226 

flaws in the design and execution that the author’s conclusions are 

rendered essentially meaningless. Another reviewer concluded that 

the CHI study reflects little or no understanding of the complexity 

of medical devices. All reviewers indicated that these studies would 

not stand up to basic scientific peer review. 

So Dr. Shuren, would you agree that these industry studies are 

so flawed that they should not be used as the basis to justify a radical change to the FDA device safety standards? 

Mr. SHUREN. I would not be using them in terms of the actual 

numbers and data behind them, and that is why we tried to actually go and pull what the real numbers look like. On the flip side, 

in some of the studies that have come out, they raised what concerns are and some of the problems that are raised like high turnover rate, insufficient guidance, those are issues that we agree 

need to be addressed. That is why we are taking the steps that we 

are taking, but we shouldn’t base decisions based on flawed data. 

That doesn’t serve anyone well. 

Mr. CHRISTENSEN. I agree. 

Mr. Chairman, we have important decisions to make on this committee as we work towards reauthorizing the Medical Device User 

Fee Act, and we can’t really afford to base these decisions on fatally flawed and biased studies. 

Mr. SHUREN. If I may just say quickly, by the way, that chart 

is from one of the flawed studies, and I put it up because, you 

know, if you put it out there, it is out there. It is not my data, that 

even industry in their own study reported what comparisons between the United States and the EU, so just that is on the record. 

Mr. CHRISTENSEN. I am just curious. I understand that Europe 

might be forming some kind of unified committee to more standardize their review of their medical devices and probably medication. Do you know anything about that and how close they are, and 

might that not make a difference in how FDA might accept some 

of the data? 

Mr. SHUREN. Ultimately, I don’t know what the EU will decide. 

We should find out in 2012. But they have been going through a 

whole process to review their own system because of complaints 

that were about it, about not uniform, inconsistent, not providing 

adequate patient protections. In fact, the clinical director for the 

UK counterpart to my agency just last year said I am appalled at 

how many devices are brought to market with a lack of appropriate 

clinical data. The fact that much more clinical data and evaluation 

is needed and the notified bodies, there are over 70 private companies, do not know how to adequately assess or challenge clinical 

data or tell those companies relying on equivalents that they actually need to do a clinical investigation. These are commercial organizations, many of whom are reluctant to challenge because they 

fear losing their clients and for their survival, and these are one 

of the things leading to that review in the EU and maybe potentially changes over there, and that is the call you heard from the 

European Society of Cardiology and the British medical journal to 

actually in some respects make some things more like the United 

States. 

Mr. CHRISTENSEN. Thank you. Thank you, Mr. Chairman. 

227 

Mr. STEARNS. The gentleman from Virginia, Mr. Griffith, is recognized for 5 minutes. 

Mr. GRIFFITH. Thank you, Mr. Chairman. 

I was pleased to hear you talk about tolerance for risk, and if you 

have a high-risk patient, they are more willing to take—you know, 

the patient who has got a serious illness willing to take some risk. 

I am wondering if the reverse is true in relationship to the treatment, and it sounds like it isn’t, because I heard you talk about the 

European and some of the doctors said on a high-risk device they 

wish it was more like the American systems. But I am thinking 

about low-risk devices. I am thinking about Ms. Sagan’s testimony 

when I say this, because, you know, as long as there is a caveat 

or a statement that says, you know, this hasn’t been through 50 

years of marketing or testing on humans, her daughter would be 

in a much better shape to have something that would shut off the 

insulin pump and the daughter would know and her mom would 

know that, you know, even if it doesn’t work, it is better than what 

they have got right now. Even if it doesn’t work 100 percent, it is 

better than what they have right now. 

Every human being is different, and I would point that out to 

you because we had testimony from the other lady that she had the 

migraine fix for her 5 years ago, if I remember correctly—I may be 

off on the number of years—but years ago because she was part of 

a trial, and for 9 months she had a normal life, and it sounds like 

in listening to that testimony this morning that that was a fairly 

low-risk medical device that could have been brought to bear, and 

everything isn’t going to work for everybody, and having a huge 

study that says it is effective for 99 percent of the population isn’t 

always going to be the way to go. 

I did a little data research, you know, on accidents in ambulances, and I am not going to ambush you with it but I will just 

tell you about it. Because if you take the theory that I was hearing 

this morning that we have a certain number of deaths, we had 300 

deaths in an 11-year period in automobile accidents while people 

were in ambulances. We had 24 deaths in a single year with medevac. Well, if you took that and applied it to what the FDA has 

been doing from what I heard in testimony today, that means you 

wouldn’t allow the med-evacs or the ambulances to be out there because notwithstanding the fact that it might help thousands of people, some people died. And I understand that you have to be careful 

but you have to take that into account. And so I would have to say 

to you that you might want to look at a risk-versus-benefit analysis 

and if the risk is low and the benefit might be great, get that thing 

out there quicker because, you know, we heard testimony from people who are suffering who could really use some help, and I understand, if you are putting something inside somebody’s body that is 

going to be there for hopefully 20 years, that is a different situation. I understand what the Europeans are saying about high-risk 

devices. But we were hearing testimony this morning about devices 

that sounded like to me—now, I am a lawyer, not a doctor, and 

maybe I wrong, but it sure didn’t sound like they were high-risk 

devices to me, that it seemed more high risk not to have, for Ms. 

Sagan’s daughter not to have something that at least—you know, 

even if it worked most of the time would shut that insulin off. That 

228 

doesn’t mean she still wouldn’t have risk because she is diabetic 

but it would seem to me that that would be the better course, and 

I don’t know how you fix that, and if you need us to help, come 

see me, I will do what I can. 

That being said, I would also say in regard to venture capital 

that Chris Coburn, the head of the Cleveland Clinic Innovation, 

stated last week raising capital is harder, given the current economy and health care reform creates a lot of unknowns. Raising capital is harder. Health care reform creates a lot of unknowns in the 

current timeline. You add in regulatory delays and all of a sudden 

the arithmetic of developing products domestically starts to break 

down. So it is not just folks coming in here with some kind of a 

political agenda, this was just a talk that he was giving somewhere, and I am just wondering if you would submit them later because my time is almost up what steps you might be taking on all 

of these things that I have mentioned. 

And then also I would say apparently at a recent hearing of the 

Committee on Oversight and Government Reform, you mentioned 

that sometimes reviewers ask for data that might not be necessary, 

and I am wondering what you are doing about that because the industry indicates that is a relatively recent phenomenon. We heard 

testimony this morning that one of the parts on the migraine invention that Dr. Fischell was talking about, he said he had a plastic valve he showed us, and he said this is already used in all kinds 

of different devices but now I have to show them it works again, 

even though it has already been approved in other devices, just 

that valve, and I am just wondering what steps you are taking to 

correct that. Where would people have gotten the idea that asking 

questions like that is acceptable, and do you have a process in your 

industry if you have different teams looking at different things to 

say well, wait a minute, team A already approved this valve and 

it looks like it is pretty good. 

So I would ask you to submit those to us for the record and so 

that I can review those as well, and I know I fired a lot at you and 

I only have 19 seconds for you to respond, but anything you want, 

you can say. 

Mr. SHUREN. Well, I will give you an example of some of the 

things we are doing to ensure we make the right decision and consistent. So if you are going to the review team says we want to ask 

for a new kind of study for a type of device, that is being brought 

to this new center science council so rather than a decision made 

low down in the organization, it is coming up to the senior managers and experienced scientists and medical officers to review to 

make a call as to whether or not that is right. That allows for looking over the program for consistency, to make sure that decision is 

well informed because we may turn around and say we disagree. 

Those are the kinds of changes we are putting in place that if you 

are going to make a change, it has to be made at the right level 

in the organization. I still want to give my reviewers flexibility, but 

when big decisions are being made, I need the right people to be 

involved in making that call. 

Mr. GRIFFITH. Thank you, Mr. Chairman. 

229 

Mr. STEARNS. All right. The gentleman’s time is expired. I think 

we are going to do a second round and then you are free to go, so 

we appreciate your waiting here. 

Just to be clear, you are citing what appears to us as a flawed 

study in your testimony, what you said in your opinion in your testimony and on the report here. Is that right? Does that make sense 

to you? 

Mr. SHUREN. Oh, yes, for the California Healthcare Institute? 

Mr. STEARNS. Right. 

Mr. SHUREN. Yes, I do think there are parts in terms of some of 

the data they provided that I would disagree with and how it is 

presented. 

Mr. STEARNS. OK. I just wanted to put that on the record. 

The gentleman from Texas, Dr. Burgess. 

Mr. BURGESS. Thank you, Mr. Chairman. 

Dr. Shuren, thank you for staying with us so long. Part of the 

review of the 510(k) process, the FDA allocated $1.3 million to the 

Institute of Medicine to convene a committee to evaluate the 510(k) 

effect on patient safety and innovation. The IOM committee will 

have a very influential role including reviewing seven of the FDA’s 

most controversial recommendations. Now, in February of this year 

at a Health Subcommittee hearing, you seemed to have some concern that the IOM committee itself would lack the patient advocates, innovators and inventors who are familiar with the 510(k) 

system. Critical omissions raise questions as to credibility of the 

IOM recommendations and why the FDA would pay $1.3 million in 

taxpayer money for such recommendations. Is that a fair observation? 

Mr. SHUREN. I don’t think I had raised concerns about it. I think 

some of the members were raising concerns in terms of the panel 

makeup. And what I did try to put out at the time is—— 

Mr. BURGESS. Are not our concerns your concerns? 

Mr. SHUREN. Concerns by the members, some of the members 

who are on the committee. 

Mr. BURGESS. They should be your concerns. If they are our concerns—— 

Mr. SHUREN. Well, I understand, and what I tried to say too is, 

we contract with the IOM. We don’t make a decision in terms of 

who are on the panels or what they look at. I will tell you, though, 

that, what comes back from them are recommendations. They are 

not making a decision; they are recommendations. And if they 

make a recommendation, if we are thinking of adopting it and it 

would have an impact, a big impact on industry or others, we will 

go out and seek public comment first. If it is a recommendation 

that pertains to legislation, that is not our call. 

Mr. BURGESS. Have they made recommendations to the FDA? 

Mr. SHUREN. No, I have not seen anything from the IOM yet. 

Mr. BURGESS. Now, there is a lawyer from the University of Minnesota named Ralph Hall who has concerns that the IOM committee violates the Federal Advisory Committee Act. Are you aware 

of that opinion from Dr. Hall? 

Mr. SHUREN. Yes. 

230 

Mr. BURGESS. And if that is the case, it would be illegal for you 

to implement the recommendations of the IOM committee that violated the Federal Advisory Committee Act, correct? 

Mr. SHUREN. I think he raised the concern of, is the committee 

fairly balanced, and there are people on that committee who have 

experienced developing 510(k)s to come to the agency, there are 

people with experience dealing with 510(k)s within the agency. 

Mr. BURGESS. Did the IOM committee certify that it had complied with section 15 of the Federal Advisory Committee Act? 

Mr. SHUREN. I don’t know if they certified. 

Mr. BURGESS. Well, but you are telling us today that you will not 

institute any of the IOM committee recommendations until some of 

these questions are resolved? 

Mr. SHUREN. I will not implement any of the recommendations 

if we wanted to adopt, there would be recommendations we may 

decide we are not going to adopt. But if there are recommendations 

that would have a big impact on industry or others, we would seek 

public comment before we would proceed. 

Mr. BURGESS. But why spend $1.3 million to a committee that 

doesn’t have patients and doesn’t have anyone with any medical 

device-related experience, especially innovators? 

Mr. SHUREN. The Institute of Medicine is a well-respected, wellregarded organization that government has turned to, Congress 

has turned to many times for outside—— 

Mr. BURGESS. But shouldn’t they have at least one patient representative on those committees? 

Mr. SHUREN. I would direct to the Institute of Medicine in terms 

of the decisions made. 

Mr. BURGESS. And again, I would direct your attention to the 

overall legality of whether or not they complied with section 15 of 

the Federal Advisory Committee Act. 

Let me ask you this. There are complaints that the FDA has not 

communicated with companies what is needed in the submissions. 

The FDA is not telling companies in advance, and what will happen is, 50 to 75 days later after the submission you all will come 

back with what was needed in the submission, so obviously that 

upsets and frustrates the companies because of the added time, 

and I think we heard Mr. Bilbray comment on that fact. What are 

you doing to ensure that companies are notified in advance about 

what is needed and then thereby included in the submitted applications? 

Mr. SHUREN. First, I would say there are other occasions where 

companies know what to do, we have told them what to do, and 

they don’t do it, and I appreciate the fact of hearing that companies 

will provide us what we need to receive, and I have heard that before, but we have companies that actually don’t do that. They don’t 

give us, even in spite of laying out what they need to do. I will give 

you a very quick example, something called the pulse oximeter that 

actually—— 

Mr. BURGESS. I know what it is. 

Mr. SHUREN. And you know what it is, just for the other members. It is a sensor you can put on your finger and it will tell you 

how much oxygen is in the blood. We have had guidance since, I 

believe, 1992. We updated it in 2007. It said you need to do a very 

231 

simple clinical study. It is sort of you use this and you measure 

from the blood and see if it is accurate. We recently had a company 

come in, didn’t send us any clinical data, and we go back to them, 

why not, and we ask again, where is the clinical data, we have laid 

this out for years. We do deal with those circumstances, so it goes 

back and forth. 

For the cases where we can provide more clarity, I would like to 

be able to put out more guidance for industry and to update our 

guidances more quickly. I would like to have the capacity to go 

ahead and do that. 

Mr. BURGESS. And I think we would like for you to do that. I 

would like the assurance that a company comes to you with a novel 

device and says what are we going to need to do to comply with 

your guidelines to get the submission completed in a timely fashion. I would like to be certain that they are getting that information upfront the first time and it doesn’t change throughout the 

submission of that application. 

Mr. SHUREN. Well, one of the things we are doing are what we 

call pre-submission meetings if you come in, let us say, before you 

are going to do a clinical trial or before you submit your application. We are going to be putting out guidance probably by November that now for the first time it lays out here are the expectations 

for company, what they have to give to us, here are the expectations of what you can expect to see from the agency, and that includes our putting down what is our advice, and then standing behind it, assuming that device doesn’t change in an important—you 

change what the use is for, you change the technological characteristics that may have been. But if not, then we should be standing 

behind it and that is going to be put out in our guidance later this 

year. 

Mr. BURGESS. And on your Web site? 

Mr. SHUREN. The guidance will be on our Web site. In fact, it will 

be out for public comment before we finalize it. All the things I am 

talking about from guidance, all go for public comment. In fact, 

some of the things we don’t normally put out for public comment 

we are doing like that notice to industry letters, which is an internal action, we put out standard operating procedures of what we 

would do and when, we asked for public comment on it. It is out 

right now for folks to weigh in. 

Mr. STEARNS. The gentleman’s time is expired. 

The gentlelady from Colorado is recognized for 5 minutes. 

Ms. DEGETTE. Thank you very much, Mr. Chairman. 

I just want to ask you a couple of follow-up questions, Dr. 

Shuren. The first one is, the question about the funding levels because the chairman had said in April 2010 there was a CRS report 

that said the medical device review process funding increased from 

$275 million in fiscal year 2008 to $368 million in fiscal year 2010, 

but that funding as I understand it includes user fees. Is that correct? 

Mr. SHUREN. Yes, and I believe that is more than for my center 

because my numbers for my center are a little bit lower. 

Ms. DEGETTE. What are your numbers? 

Mr. SHUREN. What I have from my enacted and my total budget 

for 2008 is $225 million, and this is what I am given from my 

232 

budget people, and from 2010, it is $272.7 million, and that is comprised of appropriations and user fees. 

Ms. DEGETTE. How much of that is user fees? Do you know? 

Mr. SHUREN. So in 2008, the enacted amount is $26.6 million, 

and the amount in 2010 is $32.8 million. And I say enacted because 

under the law, if we collect more than we are supposed to in the 

first 4 years, we have to give it back by lowering our fees in 2012, 

and in fact we are going to be doing that. Fees will go down in 

2012. 

Ms. DEGETTE. Now, when we enacted the user fees in the 

MDUFA legislation in 2002, that allowed the funding to increase 

in better proportion to the costs of the agency. Is that right? 

Mr. SHUREN. That is correct. There was an adjustment factor 

after our workload went up we could increase accordingly. That 

was taken out in I think 2005, 2006. It remains in for the drug program. They can adjust accordingly. 

Ms. DEGETTE. Would that be something that would be worth 

having the larger committee look at when we go towards the reauthorization next year? 

Mr. SHUREN. We should look at how to account for increasing 

workload. I would like to provide user fees predictability for industry. I know that is important. But we also need to make sure that 

if our workload goes up, we get the sufficient resources to meet the 

workload. Otherwise we are not going to be able to meet our timeframes. 

Ms. DEGETTE. So a lot of the device companies have expressed 

to me concern that if the user fees are too high and if we—and this 

is same thing actually the drug people say is—if they are too high, 

that that freezes out a lot of innovation and a lot of the kinds of 

creative devices that we might really want to see. What is your reaction to that? 

Mr. SHUREN. Well, you have the ability to actually adjust the 

fees accordingly, dependent upon even for the type of company. I 

will tell for a 510(k), full fee right now is about $4,300. For a small 

business, and a small business is $100 million or less in annual 

sales receipts, it is about $2,100 for a 510(k). 

Ms. DEGETTE. So that is not really an onerous fee. 

Mr. SHUREN. PMA is higher. It is about $236,000 for full. For a 

small company, it is $59,000. A lot of the PMAs tend to come from 

the bigger companies. More of the 510(k)s come from the smaller 

companies. 

Ms. DEGETTE. OK. 

Mr. SHUREN. Which is why we developed the fees as we did. That 

is what we worked out with industry to spread that cost. 

Ms. DEGETTE. Now, in the budget that some of my colleagues 

were talking about that was approved by the House and not the 

Senate earlier this year, the overall FDA was cut by about 10 percent under H.R. 1. Were you given any indication if that budget 

went through how much of those cuts would go to your agency? 

Mr. SHUREN. For my center, my understanding is that if you 

take how much would be cut plus not getting the increases for a 

fixed cost like my rent goes up every year that I have to pay but 

it is out of my control, it is about 12–1/2 percent. 

233 

Ms. DEGETTE. You would be cut by 12–1/2 percent. Do you think 

this would have an effect even with some of these user fees on your 

ability to expedite some of these applications? 

Mr. SHUREN. Yes, it would have an impact on our ability to do 

reviews. I mean, we can cut the funding. We cannot increase user 

fees but then people have to manage their expectations as to what 

kind of device program they are going to get. The drug industry 

said you know what, it is worth it to us. A robust FDA gets us better performance and we can see that today. 

Ms. DEGETTE. And that was proven to be correct, right? 

Mr. SHUREN. That was proven to be correct, and I understand 

the unique circumstances of the device industry. I honestly do. But 

then we have to figure out some way to have the right program, 

and if it is not there, then people need to understand, you know, 

what you get in return. 

We need to do a better job at the FDA. We know that. We are 

doing it. That is what I am talking about today. There are some 

things we need industry to work on and then we need adequate resources to do it right. That is good for companies. It is ultimately 

good for patients, and that is what this is all about. 

Ms. DEGETTE. I think that is kind of a good place to end it, Mr. 

Chairman. 

Dr. Shuren, I appreciate your candor with this committee and 

your ability and willingness to discuss the deficiencies at the agency, and I think all of us really need to sit down with you as we 

move towards the reauthorization next year of the user fees to talk 

about what we really need to do to make it work because there are 

a lot of devices out there that can save lives and we want to make 

sure that they are reviewed quickly, that they are reviewed thoroughly, that they are safe and they are approved. So thank you 

very much. 

Mr. SHUREN. I appreciate that, and I would like to have the ability to work with you all, and I also hope that if the things we are 

talking about are right, to also have your support as we move forward. 

Mr. STEARNS. Dr. Shuren, I would expect, you know, maybe we 

will have another hearing sometime in the future just to follow up 

with all these things you are saying. You know, obviously you mentioned all these things you are doing, and I think the turnover rate 

is something you have to figure out too because I think lots of 

times organizations where you work, turnover rate is low even 

though they are not paid a lot of money because of esprit de corps, 

because of the mission and the patriotism and whatever else, leadership is involved, so—— 

Mr. SHUREN. Well, we actually did an assessment in my center. 

The esprit de corps is actually off the charts compared to the rest 

of my government. My people are very committed. 

Mr. STEARNS. I don’t know if that is good or bad. 

Mr. SHUREN. It is good in the right way. I will say, we have the 

same problem in the drug program. They had a high turnover rate. 

They were able to cut it and they have been able to maintain it 

low, and they did it with targeted retention allowances, by having 

enough staff to do the work, get away from a sweatshop mentality 

234 

and have enough managers and project managers to run that program. 

Mr. STEARNS. Are all the guidances on FDA’s Web site the current state of the thinking at FDA staff? If we go to that site, will 

we find the latest and the greatest state of thinking? 

Mr. SHUREN. I would not be surprised if we have guidances that 

are probably not fully up to date. 

Mr. STEARNS. So your Web site is not up to date? 

Mr. SHUREN. No, the Web site is up to date as to the current 

guidance. I will say that we do run into cases where our thinking 

for that kind of device may chance and the guidance hasn’t gotten 

updated in time. 

Mr. STEARNS. All right. 

Ms. DEGETTE. Mr. Chairman, just before we adjourn, some 

housekeeping. You had asked unanimous consent to put this 

Medtronic case into the record. Mr. Waxman had asked UC for this 

AdvaMed press release, and then we had asked UC for Dr. 

Shuren’s slides. Are those all agreed to? 

Mr. STEARNS. By unanimous consent, so ordered. 

[The information follows:] 

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Ms. DEGETTE. Thank you. 

Mr. SHUREN. May I just clarify one thing? 

Mr. STEARNS. Yes. 

Mr. SHUREN. But if the thinking has changed with the guidance, 

what we are trying to do is update the guidance first so people 

know but if not and we need to make a quick change because there 

is new information, there really is a risk you have to deal with, 

then we are going to these notice to industry letters, so that—— 

Mr. STEARNS. You have heard a lot of our panel today. I would 

think they would help you, and you are going to go to private industry first too. You are going to go there too, right? 

Mr. SHUREN. For feedback on the process? 

Mr. STEARNS. Yes. 

Mr. SHUREN. We have already—it is out for anybody to comment 

on. 

Mr. GRIFFITH. Mr. Chairman? 

Mr. STEARNS. Congressman Griffith. 

Mr. GRIFFITH. I was wondering if I could have just a minute to 

ask a question. 

Mr. STEARNS. Sure, sure. 

Mr. BURGESS. But before you do, because I have got—I just wanted to ask unanimous consent to put these two letters from Senator 

Kerry and the Massachusetts delegation into the record on the 

IOM study of the 510(k) process. 

Mr. STEARNS. While you are looking from that, the gentleman 

from Virginia for 1 minute. 

Mr. GRIFFITH. I heard you talk about your lease, so I am switching gears on you into something I am a little more comfortable with 

than medical devices, and I guess my question is, you said your 

rent goes up every year. I was wondering how long your lease was 

for and when was the last time you went and renegotiated with 

your landlord. Because I think it is something the federal government doesn’t do. I am not picking on you all. I don’t have any idea. 

But a lot of times they just got locked into a lease and circumstances in the economy have changed, and when I took office 

I was able to cut the lease cost of actually more square footage, not 

as pretty but more square footage for about half the cost, and I am 

just wondering as your costs are going up, you might want to take 

a look at your lease and see if you can’t renegotiate. Even if you 

are locked into a multi-year lease, you might be able to renegotiate. 

Mr. STEARNS. That is good. That is experience talking. 

We will put this in by unanimous consent. 

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Mr. STEARNS. Thank you very much for your patience. The subcommittee is adjourned. 

[Whereupon, at 6:08 p.m., the subcommittee was adjourned.] 

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