[House Hearing, 112 Congress]
[From the U.S. Government Publishing Office]


 
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




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                    COMMITTEE ON ENERGY AND COMMERCE

                          FRED UPTON, Michigan
                                 Chairman

JOE BARTON, Texas                    HENRY A. WAXMAN, California
  Chairman Emeritus                    Ranking Member
CLIFF STEARNS, Florida               JOHN D. DINGELL, Michigan
ED WHITFIELD, Kentucky                 Chairman Emeritus
JOHN SHIMKUS, Illinois               EDWARD J. MARKEY, Massachusetts
JOSEPH R. PITTS, Pennsylvania        EDOLPHUS TOWNS, New York
MARY BONO MACK, California           FRANK PALLONE, Jr., New Jersey
GREG WALDEN, Oregon                  BOBBY L. RUSH, Illinois
LEE TERRY, Nebraska                  ANNA G. ESHOO, California
MIKE ROGERS, Michigan                ELIOT L. ENGEL, New York
SUE WILKINS MYRICK, North Carolina   GENE GREEN, Texas
  Vice Chairman                      DIANA DeGETTE, Colorado
JOHN SULLIVAN, Oklahoma              LOIS CAPPS, California
TIM MURPHY, Pennsylvania             MICHAEL F. DOYLE, Pennsylvania
MICHAEL C. BURGESS, Texas            JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee          CHARLES A. GONZALEZ, Texas
BRIAN P. BILBRAY, California         JAY INSLEE, Washington
CHARLES F. BASS, New Hampshire       TAMMY BALDWIN, Wisconsin
PHIL GINGREY, Georgia                MIKE ROSS, Arkansas
STEVE SCALISE, Louisiana             ANTHONY D. WEINER, New York
ROBERT E. LATTA, Ohio                JIM MATHESON, Utah
CATHY McMORRIS RODGERS, Washington   G.K. BUTTERFIELD, North Carolina
GREGG HARPER, Mississippi            JOHN BARROW, Georgia
LEONARD LANCE, New Jersey            DORIS O. MATSUI, California
BILL CASSIDY, Louisiana              DONNA M. CHRISTENSEN, Virgin 
BRETT GUTHRIE, Kentucky              Islands
PETE OLSON, Texas                    KATHY CASTOR, Florida
DAVID B. McKINLEY, West Virginia
CORY GARDNER, Colorado
MIKE POMPEO, Kansas
ADAM KINZINGER, Illinois
H. MORGAN GRIFFITH, Virginia

                                 7_____

              Subcommittee on Oversight and Investigations

                         CLIFF STEARNS, Florida
                                 Chairman
LEE TERRY, Nebraska                  DIANA DeGETTE, Colorado
SUE WILKINS MYRICK, North Carolina     Ranking Member
JOHN SULLIVAN, Oklahoma              JANICE D. SCHAKOWSKY, Illinois
TIM MURPHY, Pennsylvania             MIKE ROSS, Arkansas
MICHAEL C. BURGESS, Texas            KATHY CASTOR, Florida
MARSHA BLACKBURN, Tennessee          EDWARD J. MARKEY, Massachusetts
BRIAN P. BILBRAY, California         GENE GREEN, Texas
PHIL GINGREY, Georgia                DONNA M. CHRISTENSEN, Virgin 
STEVE SCALISE, Louisiana                 Islands
CORY GARDNER, Colorado               JOHN D. DINGELL, Michigan
H. MORGAN GRIFFITH, Virginia         HENRY A. WAXMAN, California (ex 
JOE BARTON, Texas                        officio)
FRED UPTON, Michigan (ex officio)

                                  (ii)


                             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
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


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 
high-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 information 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:]

    [GRAPHIC] [TIFF OMITTED] T3314.001
    
    [GRAPHIC] [TIFF OMITTED] T3314.002
    
    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 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 
industry-funded 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:]

    [GRAPHIC] [TIFF OMITTED] T3314.003
    
    [GRAPHIC] [TIFF OMITTED] T3314.004
    
    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:]

    [GRAPHIC] [TIFF OMITTED] T3314.005
    
    [GRAPHIC] [TIFF OMITTED] T3314.006
    
    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.

   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:]

    [GRAPHIC] [TIFF OMITTED] T3314.007
    
    [GRAPHIC] [TIFF OMITTED] T3314.008
    
    [GRAPHIC] [TIFF OMITTED] T3314.009
    
    [GRAPHIC] [TIFF OMITTED] T3314.010
    
    [GRAPHIC] [TIFF OMITTED] T3314.011
    
    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.
    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 peer-reviewed 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.
    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 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 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 
co-invented 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 Americans 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 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 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.
    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, 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-in-class 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 so-called 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 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 resum 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.
    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.
    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.
    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?
    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.
    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.
    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 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.
    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.
    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 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 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-to-date 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 two-thirds 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.
    [The information follows:]

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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 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 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 
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 for-profit 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 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 testimony 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-on-metal 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.
    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 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----
    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----
    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. 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.
    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.

 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 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 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.
    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.
    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 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 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 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 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 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.
    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.
    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 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 risk-averse. 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 
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.
    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 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 mid-game, 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 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 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 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 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 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.
    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 med-evac. 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 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.
    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.
    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, 
well-regarded 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 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 
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.
    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 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.
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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.
    [The information follows:]

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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.]
    [Material submitted for inclusion in the record follows:]

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