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





          FDA MEDICAL DEVICE APPROVAL: IS THERE A BETTER WAY?

=======================================================================

                                HEARING

                               before the

                SUBCOMMITTEE ON HEALTH CARE, DISTRICT OF
               COLUMBIA, CENSUS AND THE NATIONAL ARCHIVES

                                 of the

                         COMMITTEE ON OVERSIGHT
                         AND GOVERNMENT REFORM

                        HOUSE OF REPRESENTATIVES

                      ONE HUNDRED TWELFTH CONGRESS

                             FIRST SESSION

                               __________

                              JUNE 2, 2011

                               __________

                           Serial No. 112-52

                               __________

Printed for the use of the Committee on Oversight and Government Reform









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

                                _____

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              COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM

                 DARRELL E. ISSA, California, Chairman
DAN BURTON, Indiana                  ELIJAH E. CUMMINGS, Maryland, 
JOHN L. MICA, Florida                    Ranking Minority Member
TODD RUSSELL PLATTS, Pennsylvania    EDOLPHUS TOWNS, New York
MICHAEL R. TURNER, Ohio              CAROLYN B. MALONEY, New York
PATRICK T. McHENRY, North Carolina   ELEANOR HOLMES NORTON, District of 
JIM JORDAN, Ohio                         Columbia
JASON CHAFFETZ, Utah                 DENNIS J. KUCINICH, Ohio
CONNIE MACK, Florida                 JOHN F. TIERNEY, Massachusetts
TIM WALBERG, Michigan                WM. LACY CLAY, Missouri
JAMES LANKFORD, Oklahoma             STEPHEN F. LYNCH, Massachusetts
JUSTIN AMASH, Michigan               JIM COOPER, Tennessee
ANN MARIE BUERKLE, New York          GERALD E. CONNOLLY, Virginia
PAUL A. GOSAR, Arizona               MIKE QUIGLEY, Illinois
RAUL R. LABRADOR, Idaho              DANNY K. DAVIS, Illinois
PATRICK MEEHAN, Pennsylvania         BRUCE L. BRALEY, Iowa
SCOTT DesJARLAIS, Tennessee          PETER WELCH, Vermont
JOE WALSH, Illinois                  JOHN A. YARMUTH, Kentucky
TREY GOWDY, South Carolina           CHRISTOPHER S. MURPHY, Connecticut
DENNIS A. ROSS, Florida              JACKIE SPEIER, California
FRANK C. GUINTA, New Hampshire
BLAKE FARENTHOLD, Texas
MIKE KELLY, Pennsylvania

                   Lawrence J. Brady, Staff Director
                John D. Cuaderes, Deputy Staff Director
                     Robert Borden, General Counsel
                       Linda A. Good, Chief Clerk
                 David Rapallo, Minority Staff Director

   Subcommittee on Health Care, District of Columbia, Census and the 
                           National Archives

                  TREY GOWDY, South Carolina, Chairman
PAUL A. GOSAR, Arizona, Vice         DANNY K. DAVIS, Illinois, Ranking 
    Chairman                             Minority Member
DAN BURTON, Indiana                  ELEANOR HOLMES NORTON, District of 
JOHN L. MICA, Florida                    Columbia
PATRICK T. McHENRY, North Carolina   WM. LACY CLAY, Missouri
SCOTT DesJARLAIS, Tennessee          CHRISTOPHER S. MURPHY, Connecticut
JOE WALSH, Illinois














                            C O N T E N T S

                              ----------                              
                                                                   Page
Hearing held on June 2, 2011.....................................     1
Statement of:
    Lasersohn, Jack, general partner, the Vertical Group; David 
      Gollaher, Ph.D., president & CEO, California Healthcare 
      Institute; and Dr. Rita Redberg, professor of medicine, 
      Director, Women's Cardiovascular Services, Division of 
      Cardiology, University of California.......................    40
        Gollaher, David..........................................    53
        Lasersohn, Jack..........................................    40
        Redberg, Rita............................................    61
    Paulsen, Hon. Erik, a Representative in Congress from the 
      State of Minnesota.........................................     3
    Shuren, Jeffrey, M.D., J.D., Director, Centers for Devices 
      and Radiological Health, U.S. Food and Drug Administration.    10
Letters, statements, etc., submitted for the record by:
    Gollaher, David, Ph.D., president & CEO, California 
      Healthcare Institute, prepared statement of................    55
    Gosar, Hon. Paul A., a Representative in Congress from the 
      State of Arizona, prepared statement of....................    35
    Lasersohn, Jack, general partner, the Vertical Group, 
      prepared statement of......................................    42
    Paulsen, Hon. Erik, a Representative in Congress from the 
      State of Minnesota, prepared statement of..................     6
    Redberg, Dr. Rita, professor of medicine, Director, Women's 
      Cardiovascular Services, Division of Cardiology, University 
      of California, prepared statement of.......................    64
    Shuren, Jeffrey, M.D., J.D., Director, Centers for Devices 
      and Radiological Health, U.S. Food and Drug Administration, 
      prepared statement of......................................    13

 
          FDA MEDICAL DEVICE APPROVAL: IS THERE A BETTER WAY?

                              ----------                              


                         THURSDAY, JUNE 2, 2011

                  House of Representatives,
Subcommittee on Health Care, District of Columbia, 
                  Census and the National Archives,
              Committee on Oversight and Government Reform,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 2:04 p.m., in 
room 2154, Rayburn House Office Building, Hon. Trey Gowdy 
(chairman of the subcommittee) presiding.
    Present: Representatives Gowdy, Gosar, McHenry, DesJarlais, 
Walsh and Davis.
    Staff present: Ali Ahmad, deputy press secretary; Brian 
Blase, professional staff member; Molly Boyl, parliamentarian; 
Drew Colliatie, staff assistant; Linda Good, chief clerk; 
Christopher Hixon, deputy chief counsel, oversight; Sery E. 
Kim, counsel; Ronald Allen, minority staff assistant; Yvette 
Cravins, minority counsel; and Christopher Staszak, minority 
senior investigative counsel.
    Mr. Gowdy. Good afternoon, and thank everyone for their 
accommodating our voting schedules. We apologize for any 
inconvenience. This is a hearing on FDA Medical Device 
Approval: Is There a Better Way?
    First I will read the mission statement for the Oversight 
Committee. We exist to secure two fundamental principles: 
First, Americans have the right to know that the money 
Washington takes from them is well spent. And second, Americans 
deserve an efficient, effective government that works for them. 
Our duty on the Oversight and Government Reform Committee is to 
protect these rights. Our solemn responsibility is to hold 
government accountable to taxpayers because taxpayers have a 
right to know what they get from their government. We will work 
tirelessly in partnership with citizen watchdogs to deliver the 
facts to the American people to bring genuine reform to the 
Federal bureaucracy. This is the mission of the Oversight and 
Government Reform Committee.
    At this point I will give an opening statement, and then I 
will recognize my distinguished colleague for his.
    I want to start by acknowledging what everyone knows, which 
is the FDA performs a necessary, vital function in or country. 
Doctors, patients, nurses, health care professionals and 
businesses rely on their work every day, whether it's a doctor 
utilizing a medical device to save the life of a patient, or a 
business introducing the latest innovation to the market. From 
bandages and pacemakers, the American people deserve and the 
Federal Government demands safe and effective medical products 
across the health care industry.
    There is a balance, an important balance, to be struck. Of 
paramount concern is always the well-being of American citizens 
in need of medical care. In an industry with such wide-ranging 
economic implications, however, efficiency and safety need not 
be mutually exclusive.
    The FDA's goals as an agency are to make safe and effective 
devices available to consumers, and to promote innovation in 
the medical device industry. Distilled down to a simple mission 
statement, this philosophy represents a proper and attainable 
goal. However, the FDA is perhaps failing to meet these 
standards for myriad reasons: inconsistent review procedures, 
unpredictability of decisionmaking, and an amorphous process 
that fosters uncertainty and inefficiency.
    And perhaps most troubling, instead of identifying the 
issues and implementing reforms designed to ameliorate the 
substantive shortcomings of the approval process, the conveyer 
belt of medical device approvals has come, in some instances, 
to a grinding halt. In the premedical application and 510(k) 
approval processes, device approval times have increased 50 to 
100 percent. Decision times, preliminary procedure durations, 
and the number of FDA requested question cycles are all on the 
rise at the cost of patients and businesses who suffer from 
these delays. As a result, medical device businesses are 
exporting products to international consumers long before 
American buyers, or they are leaving the United States 
altogether, harming both the U.S. economy and patients who rely 
on lifesaving new technologies.
    This lack of predictability hurts American businesses, 
consumers and patients. We are here today to determine what can 
be done on their behalf and ask simply whether or not there is 
a better way.
    And with that, I would recognize the distinguished 
gentleman from the State of Illinois, the ranking member of 
this subcommittee, Mr. Davis.
    Mr. Davis. Thank you very much, Mr. Chairman. Let me, first 
of all, thank you for calling this very important hearing. And 
I also want to thank you for yielding.
    I call it important because the Food and Drug 
Administration is an agency that I have watched closely for a 
number of years. As a matter of fact, one of my constituents, 
Dr. Alexander Max Smith, was the director of this agency, and 
he also was the dean of the medical school at the University of 
Illinois. And so we've looked at it for a long time.
    The Food and Drug Administration is responsible for 
ensuring the safety and effectiveness of medical devices that 
millions of Americans use to help them walk, to help their 
hearts beat, and to help their children regain their health and 
live a normal and productive life. The regulations that govern 
the approval of medical devices are, therefore, critical and 
simple reason. They save American lives and prevent injury by 
medical devices that are unsafe or ineffective.
    We all understand the importance of protecting jobs and 
fostering innovation. Illinois is home to hundreds of large and 
small medical device manufacturers, employing thousands of my 
constituents in many of these facilities I have visited. I 
applaud the technological advances being made each day, some of 
which have allowed close friends and family to lead productive 
lives. Nevertheless, I fully understand the importance of 
striking the right balance between innovation and safety.
    There are those who believe that the Food and Drug 
Administration takes too long to review medical devices. For 
its part, the FDA has offered statistics that the agency says 
shows that it is performing well in this regard.
    We will hear today from both the FDA and those involved in 
the medical device industry. As we listen to the testimony 
today and consider the views of the witnesses, we cannot lose 
sight of what is ultimately at stake: the lives of average 
Americans who rely on the FDA to protect them from faulty 
medical devices that may cause harm. It is the FDA who bears 
the awesome responsibility of protecting lives by ensuring that 
medical devices do what the manufacturers claim they do.
    There are those who have suggested that the FDA's approval 
process of medical devices should be more like the approval 
process in the European Union. That is troubling to me because 
in the European Union medical device manufacturers do not have 
to show that their product is actually effective in treating 
the particular ailment it is supposed to treat. I am sure there 
isn't anyone in this room who would want a hip implant, a heart 
stent, or any other device in their body that was not 
effective.
    In the past 5 months, at least 15 recalls of medical 
devices were announced. These recalls involve such products 
such as glucose test strips, catheters, an insulin delivery 
system, and an implantable infusion pump. Last year there were 
over 2,500 recalls of medical devices. One of the most widely 
covered device recalled the last year involved hip implants 
that had already been used in 93,000 patients before they were 
recalled by the company.
    There's no greater responsibility that our government has 
than to protect the health and lives of its citizens. That is a 
responsibility that Congress has bestowed on the FDA, and so I 
thank our witness for being here today and look forward to 
their testimony.
    And again, thank you, Mr. Chairman, for calling this 
hearing, and I yield back.
    Mr. Gowdy. Thank you, Mr. Davis.
    Members may have 7 days to submit opening statements and 
extraneous material for the record.
    It is all of our pleasure, all members of subcommittee, to 
welcome our colleague from the great State of Minnesota, 
Congressman Erik Paulsen, who represents the Third District. In 
addition to serving on Ways and Means, Mr. Paulsen chairs the 
Congressional Medical Device Caucus.
    Congressman Paulsen, the committee welcomes you and 
recognizes you for 5 minutes.

 STATEMENT OF HON. ERIK PAULSEN, A REPRESENTATIVE IN CONGRESS 
                  FROM THE STATE OF MINNESOTA

    Mr. Paulsen. Well, thank you, Mr. Chairman and members of 
the committee, for the opportunity to appear before the 
committee. My name is Erik Paulsen. As you mentioned, I 
represent Minnesota's Third Congressional District, and I do 
serve as cochair of the Medical Technology Caucus.
    And I would like to share with you why I believe the 
medical technology industry, an American success story, one 
that routinely revolutionizes patient care and creates 
thousands of high-tech jobs, is at risk of drying up and moving 
overseas.
    Now, I can tell that you promoting made-in-America medical 
devices and encouraging innovation is near and dear to my 
heart. Across this country there are 8,000 medical device firms 
employing 400,000 dedicated, hard-working and innovative 
people. Currently the United States is a world leader in this 
industry. Its supremacy is threatened not by cheap overseas 
labors or countries with more competitive tax structures, but 
by the bureaucracy within our own borders.
    Whether I'm meeting with medical innovators back home in 
Minnesota or across the country, I hear the same story: It's 
getting harder and harder to bring lifesaving devices to the 
marketplace in the United States because of a lack of 
consistency, predictability and transparency in the Food and 
Drug Administration's premarket review processes.
    Device companies that deal regularly with the FDA cite many 
reasons for this inconsistency. One problem is that the FDA 
seems to be routinely proposing new end points midway through 
the review process. Now, of course, if the scientific 
information calls a device into question, the FDA should 
request more information. But many of my constituency companies 
are reporting that the FDA reviewers make new arbitrary demands 
late in the product review process, and these inconsistencies 
are frustrating and costly for all innovators, but small 
companies in particular cannot keep up when the FDA continually 
moves the goalpost, which is causing some firms to go out of 
business.
    One company in Minnesota, Acorn Cardiovascular, recently 
had to close its doors due to such inconsistencies. The company 
had conversation after conversation with the FDA staff about 
how to test its device. Acorn performed a randomized trial, met 
its targets, and in the end thought it would be approved, but 
reviewers at the FDA moved the goalpost and required a new 
trial. Because of this, investors shied away, and Acorn 
couldn't raise the capital to perform another multimillion-
dollar trial and had to close its doors. Ultimately 50 jobs 
were lost, and a lifesaving technology for patients is now not 
available in the United States.
    Additionally, companies have been frustrated with what 
appear to be FDA's stalling techniques. Many entrepreneurs I 
have met with have had agency reviewers pursue one line of 
questioning early in the review process and then switch to a 
new, previously unaddressed topic after the third or fourth 
submission.
    In 2008, Xtent, a Menlo Park, California, company, coronary 
stent company, tried to gain approval to start a U.S. clinical 
trial. Over the next 2 years, the FDA asked round after round 
of questions and required long preclinical animal trials. Now, 
at the time Xtent had clinical experience and hundreds of 
European patients, some with over 3 years of followup in world-
class hospitals. But the FDA refused to consider the data, and 
as a result of the delays, the company closed, 150 employees 
were laid off, and the assets were sold to foreign interests 
for pennies on the dollar. Members, today the technology is now 
being developed in China and in Europe, with no plans to return 
to the United States.
    Now, this is just one of many examples, and if it pleases 
the committee, I would like to submit several more for the 
record.
    And thanks in part to the inconsistencies like these, we 
are starting to see our competitive edge disappear. Currently 
devices are approved 2 years earlier in Europe than they are in 
the United States, which deny our patients access to lifesaving 
technology. If this trend continues, more companies will look 
for greener pastures and take their innovations and their 
400,000 high-paying jobs with them.
    The FDA has a statutory mandate to consider the least 
burdensome means of demonstrating devices that they meet safety 
and efficacy standards, and unfortunately in recent years the 
agency has abandoned this principle. The least burdensome 
provisions should force the agency to find appropriate balance 
between patient protection and the development of new 
lifesaving products.
    I'm working on legislation to restore this balance at the 
agency and other efforts to modernize and streamline the FDA. 
It is my hope as well, Mr. Chairman, that today's hearing will 
help us find that balance and a pathway to a more consistent, 
predictable and transparent FDA premarket review process to 
help the medical technology industry continue to be a bright 
spot of our economy and ensure patient access to lifesaving 
technologies.
    Thank you again for the opportunity to appear before the 
committee today, Mr. Chairman.
    [The prepared statement of Mr. Paulsen follows:]




    Mr. Gowdy. On behalf of all of us, Congressman Paulsen, 
thank you for your testimony, thank you for your insight, thank 
you for your work in this area. And I look forward to reviewing 
your legislation forthwith. Thank you.
    We will take a quick, quick recess. In fact, I may not even 
leave so the second panel can approach and get situated. And 
when they are situated, we will start again. Until then we will 
be briefly recessed.
    [Recess.]
    Mr. Gowdy. We will now welcome our second panel of--I won't 
say witnesses--witness, singular, Dr. Jeffrey Shuren. Did I 
pronounce that correctly? Dr. Shuren is the Director of the 
Centers for Devices and Radiological Health at the U.S. Food 
and Drug Administration.
    Pursuant to committee rules, all witnesses will be sworn in 
before they testify, so I would ask you to rise and lift your 
right hand and repeat after me.
    [Witness sworn.]
    Mr. Gowdy. Let the record reflect the witness answered in 
the affirmative. Thank you.
    Dr. Shuren, we will recognize you at this point for your 5-
minute opening statement. I'm sure you have done this before. 
If you have not, there are a series of lights that may help 
direct you, but if you have a point that you want to finish 
even with the red light, feel free to finish your point.

STATEMENT OF JEFFREY SHUREN, M.D., J.D., DIRECTOR, CENTERS FOR 
      DEVICES AND RADIOLOGICAL HEALTH, U.S. FOOD AND DRUG 
                         ADMINISTRATION

    Dr. Shuren. Mr. Chairman and members of the subcommittee, 
I'm Dr. Jeff Shuren----
    Mr. Gowdy. I may get to you turn that mic on?
    Dr. Shuren. Mr. Chairman and members of the subcommittee, 
I'm Dr. Jeff Shuren, Director of Center for Devices and 
Radiological Health at the Food and Drug Administration. Thank 
you for the opportunity to testify today.
    Over the past decade most indicators of medical device 
industry success have gone steadily upwards, with solid job 
growth, venture capital investment and a positive trade 
balance. Although the medical device industry has weathered the 
recession better than most of our industries, including about 6 
percent growth last year, the economic climate has had an 
adverse impact. And as recent reports note, the recession has 
also caused companies to change their business models to be 
more risk-averse and therefore more sensitive to FDA regulatory 
uncertainties.
    We recognize that smart FDA regulation is critical to 
maintain U.S. competitiveness. We are the world's leader in 
medical device innovation, but we won't retain that position 
unless we address the challenges that face us today and assure 
that we have both a strong industry and a strong FDA.
    According to a recent PWC report, formerly Pricewaterhouse 
Coopers, ``U.S. success in medical technology during recent 
decades stems partially from the global leadership of the U.S. 
Food and Drug Administration. FDA's standards and guidelines to 
ensure safety and efficacy have instilled confidence in the 
industry's products worldwide.''
    FDA has a responsibility to both facilitate device 
innovation and assure that devices are safe and effective. Our 
data reported to Congress in February shows that about 95 
percent of the more than 4,000 medical device applications 
subject to user fees that we review each year are reviewed 
within the timeframes that were agreed to by industry under the 
Medical Device User Fee Act. In those few areas where we just 
missed some goals, our performance is generally improving.
    The data also demonstrates a program under strain, with 
limited capacity to increase performance at the current funding 
levels. However, when I became the Director of the Medical 
Device Center in fall of 2009, I had already been hearing 
concerns expressed by our constituencies. Industry complained 
that inadequate predictability, consistency and transparency 
were stifling innovation. Consumer groups, third-party payers, 
and some health care professionals believed our largest 
premarket review process, called the 510(k) program, did not 
provide adequate patient protections or generate sufficient 
information for them to make well-informed treatment decisions. 
Even my own staff complained about regulatory programs that in 
their current form were not well suited for many newer, more 
complex technologies.
    Much like a CEO of a big company with a large and diverse 
clientele, I and my team set about to identify problems and 
their root causes, starting with a comprehensive assessment of 
our premarket review programs. The two reports we released in 
August 2010 with our analyses and recommendations showed that 
we have not done as good a job managing our premarket review 
programs as we should, and that we needed to take several 
critical actions to improve the predictability, consistency and 
transparency of these programs.
    For example, we have new reviewers who need better 
training. We needed to improve management oversight and 
standard operating procedures. We need to provide greater 
clarity for our staff and for industry through guidance about 
key parts of our premarket review in clinical trials programs 
and how we make benefit-risk determinations.
    We need to provide greater clarity for industry through 
guidance and greater interactions about what we need from them 
to facilitate more efficient, predictable reviews. We need to 
make greater use of outside experts who understand cutting-edge 
technologies, and we need to find the means to handle the ever-
increasing workload and reduce staff and manager turnover, 
which is almost double that of FDA's drug and biologic centers.
    In addition, we need to assure that industry meets its 
responsibility to provide us with appropriate data. Poor 
quality submissions, such as those that do not follow current 
guidance documents or have problems with clinical data such as 
missing data, not doing the study we agreed to, or failing to 
meet endpoints, are significant contributors to delays in 
premarket reviews.
    In January of this year, after extensive public input, we 
announced 25 specific actions we're taking this year to ensure 
that our premarket review programs would foster innovation and 
assure the safety and efficacy of medical devices for American 
patients.
    In February, we proposed the innovation initiative to 
accelerate the development and evaluation of important medical 
devices and improve and strengthen the Nation's research 
infrastructure, promote high-quality regulatory science for all 
medical devices. In March, we held a public meeting to discuss 
these proposals, and in the coming weeks we will announce what 
actions we plan to take.
    Mr. Chairman, I commend the subcommittee's efforts and am 
pleased to answer any questions the subcommittee may have.
    Mr. Gowdy. Thank you, Dr. Shuren.
    [The prepared statement of Dr. Shuren follows:]




    Mr. Gowdy. At this point I would recognize the ranking 
member of the subcommittee, the gentleman from Illinois Mr. 
Davis, for his 5 minutes of questions.
    Mr. Davis. Thank you very much, Mr. Chairman.
    Thank you, Dr. Shuren.
    Congressman Paulsen just testified, and you were here 
during that period, and indicated that we might want to look at 
the way the European Union handles its process. And yet I was 
thinking that the Pricewaterhouse study determined that the 
U.S. medical device industry is the best in the world. How do 
you respond to those two assertions?
    Dr. Shuren. I do have concerns about importing the European 
model here to the United States, and I'm actually astonished 
that some in the device industry are calling for us to lower 
our standards to that of Europe. I don't think it's in the best 
interests of American patients, our health care system or the 
U.S. companies.
    In Europe you do not need to show that your device is 
effective, in fact provides benefits to patients. For example, 
you will put, let's say, a drug-eluting stent on the market. 
That device may not work. And so patients can get a device 
that's ineffective when they had alternative effective 
treatments. As a result, they put their health at risk, and the 
health care system winds up paying for it.
    In addition, in Europe you have your pick and pay for your 
private-party reviewer. Reviews are conducted by third parties 
called notified bodies. But concerns have been raised about 
them. In fact, the clinical director of the U.K. Regulatory 
agency said just last year, I am appalled at how many devices 
are brought to market with a lack of appropriate clinical data. 
Nor are notified bodies doing enough to pick up manufacturer 
shortcomings. She pointed out that many do not know how to 
adequately assess or challenge clinical data, or tell these 
companies relying on equivalence that they actually need to do 
clinical investigations. In fact, these are commercial 
organizations, ``many of whom are reluctant to challenge 
because they fear losing their clients and for their 
survival.'' And many of these concerns were pointed out 
recently in articles that came out in the British Medical 
Journal and by European Society of Cardiology.
    Mr. Davis. Do you think that there is any evidence that the 
longer and more intense process has any negative impact on the 
development of jobs and work opportunities?
    Dr. Shuren. Well, I do think that there is--we can do a far 
better job than what we are already doing, and there are steps 
that we have announced and are already taking that we think can 
actually make the process more efficient and try to get 
innovative technologies out to the market in a more timely 
manner, but not compromise our standard of safety and 
effectiveness.
    We do have a great standard that we need to stand behind, 
and if we had to take a play out of the playbook of the 
European Union, the European Commission is now getting behind 
their approval process they call the CE Marking. Here in the 
United States we beat ourselves up, and the Europeans are 
taking advantage of it. But we need to get behind a system 
that, quite frankly, has good standards. We need to make it 
more robust and efficient. And if we can promote our system as 
the gold standard, we can actually promote greater 
competitiveness for the United States and for U.S. companies.
    Mr. Davis. I know that diabetes is a major health problem 
and issue in the country, and research is being done. There's 
research relative to the creation of pancreas activity and how 
to better regulate that. Where do we stand now with this?
    Dr. Shuren. Sir, trying to promote the development of an 
artificial pancreas is a high priority for the agency. I'm a 
physician. If we can really crack the nut and have truly a 
replacement, if you will, for the pancreas for type 1 diabetes 
patients, it will be a huge advance in health care.
    We have already set up a special team, by the way, who is 
headed by someone who has Type I diabetes, very invested in the 
technology.
    We've approved already 16 clinical trials. We've worked to 
help to develop a sort of computer model that will allow the 
developers of these technologies to test drive their software 
algorithms without having to do animal studies and so speed 
development, and in just a few weeks, we will be releasing a 
guidance document that lays out expectations for bringing the 
early generation of an artificial pancreas.
    Mr. Davis. Thank you very much. I'm a big fan of research, 
and I think that we have made enormous gains, and so I wish you 
well with this one, and I yield back.
    Mr. Gowdy. Thank you, Mr. Davis. The chair would now 
recognize the gentleman from Illinois, Mr. Walsh.
    Mr. Walsh. Thank you, Mr. Chairman and Ranking Member Davis 
from Illinois.
    Dr. Shuren, thank you for appearing before us today. A 
couple quick questions, and Congressman Paulsen alluded to this 
in his testimony, and it's probably fairly common with what 
most of us hear back home. The refrain is fairly similar. It's 
getting tougher and tougher, many of these constituents and 
companies say, to deal with the FDA. Delays, issues of 
transparency, issues of confusion have become real passionate 
concerns that have been voiced to many Members of Congress. 
First quick, broad question, do you share--do you hear similar 
concerns with some of the members in the industry?
    Dr. Shuren. We do hear some of the concerns.
    Mr. Walsh. The second refrain that seems to be fairly 
common when I talk to my colleagues, because I hear this over 
and over back home, that it has become noticeably more 
difficult to work with and deal with FDA in the last 2 to 3 
years. Have you heard any sort of similar timeline concern as 
well?
    Dr. Shuren. I've heard concerns regarding interactions from 
some in industry. You know, interestingly enough, PWC did a 
survey and they had reported--their respondents reported that 
39 percent felt that interactions had actually gotten better 
between industry and the agency, and the rest of the people who 
responded were somewhat neutral.
    Mr. Walsh. Can you sort of broadly generalize, though, 
what--the feedback you've gotten in the last 2 to 3 years?
    Dr. Shuren. And I can't say in the last 2 to 3 years since 
I've only been at the Agency--the Agency--the Center for a 
little over a year and a half. So I kind of came in in the 
middle of all of this. But the concerns in terms of 
interactions go along the following lines. First of all, they 
would like more interactions with us and we agree. One of the 
challenges we have is that our request for meetings before 
doing a clinical trial or submitting an application, called 
presubmission meetings, has almost doubled in the past 5 years, 
but without the staff to actually make good on those 
commitments to have the meetings.
    We've heard, too, that there's a greater desire that when 
they get advice at the meeting, will the agency stand behind 
it, and in addition, that they have opportunities for more 
engagement with the center during the time of the review of an 
application.
    Mr. Walsh. One of the big points we've heard is that--from 
folks in the FDA is that one of the reasons for the delays in 
product approval of the last 2 to 3 years is the poor quality 
submissions that device manufacturers are sending to the FDA, 
poor quality, incomplete submissions. Are those contributing 
issues to the delay in product approval?
    Dr. Shuren. They are a contributing factor. We did an 
analysis of the letters we send to companies for 510(k) 
submissions. We call them additional information letters, and 
we looked at about a hundred of them for 2010. And what we 
found is that from a little over 50 percent of the 510(k)'s we 
were receiving we did have issues with poor quality. This would 
be that we put out a guidance document, current guidance 
document, explained what our expectations were, and the company 
didn't follow it, and also didn't justify why they didn't 
comply with the guidance because they have flexibility, but 
they would have to then provide an alternative method, or there 
was testing that they would conduct that was the same kind of 
testing you do for that kind of device.
    In some cases, a company even made that kind of device 
before, did that kind of testing, and now didn't do it, didn't 
submit it to us, no testing whatsoever. That's the kind of poor 
quality that we have seen, and it is a contributing factor but 
it's not the only factor.
    Mr. Walsh. OK. Again, according to the FDA's own data, A1 
requests rose from, I think, 38 percent in 2001 to 77 percent 
in 2010. Total review times have risen 45 percent since 2007, 
and maybe you're saying this. It just doesn't seem plausible 
that those declines in FDA performance can all be put at the 
laps of the manufacturers. How much of the problem is with the 
FDA itself in this sort of declining performance? Maybe in not 
being clear what it requires in the submission or that 
requirements are constantly changing. How much of a factor are 
those issues?
    Dr. Shuren. So, first, just to clarify, our performance 
against the goals that we committed to meet with industry had 
actually overall improved over time, and we are meeting the 
goals for 510(k). We're meeting one or close to meeting another 
goal for PMA, and that even over this time of MDUFA, we've seen 
improvement in our performance. However, there have been longer 
times overall from between our time and industry time, what we 
call total time.
    So the contributors, one, is where we get submissions that 
they don't have the information they really should have and 
they know they should have. Now, in some cases, though, we do 
ask for things that we hadn't asked for before that are 
appropriate, and there are cases where we can do a better job 
communicating that beforehand. So one of the actions we're 
taking is to put out what we call a notice to industry letter 
where we can quickly communicate if there's a change in 
expectations and the basis.
    I will tell you as well, to be frank--and that occurs about 
less than 10 percent of the time where we ask for additional 
but we think appropriate. There are times, though, when we went 
back on the analysis, where we found that we asked for 
additional information or we asked a question we shouldn't have 
asked. It's about less than 10 percent of the 510(k)'s, but 
that is concerning to us, and so we have already been starting 
to put in place changes into the program to address that 
because we'd like--we don't want to see that happen.
    Mr. Walsh. Last quick question, Mr. Chairman, and I know 
I'm running out of time. This is a pendulum. We want to make 
sure we've got quality products and we want to promote 
innovation. Do you see at all that the pendulum in the last few 
years has swung too far in one direction and it's stifling 
innovation?
    Dr. Shuren. I wouldn't exactly say the pendulum is swinging 
far one way versus the other. I think we've got multifactorial 
issues.
    Mr. Walsh. Are you concerned about innovation right now?
    Dr. Shuren. I do. I am concerned about innovation. I'm also 
concerned that we assure that the devices that come on the 
market are safe and effective. What we ultimately want is, call 
it a pendulum or anything, that the goalposts, if you will, 
aren't moving all that much. I think have a far more 
predictable----
    Mr. Walsh. Thank you, Mr. Chairman.
    Mr. Gowdy. I thank the gentleman from Illinois. The chair 
would now recognize the gentleman from Tennessee, Dr. 
DesJarlais.
    Mr. DesJarlais. Thank you, Mr. Chairman. Thank you, Dr. 
Shuren. You're a physician. When did you last practice 
medicine?
    Dr. Shuren. In the 1990's.
    Mr. DesJarlais. In the 1990's, OK. Certainly then you've 
experienced the rise in health care costs that continue to 
increase yearly to a point where we're almost unsustainable. We 
see Medicare and Medicaid, private insurance going through the 
roof to where people just simply can't continue to go on. Do 
you recall when that change really started taking place in 
terms of rising costs? What would be your opinion on that?
    Dr. Shuren. That's outside my purview at the FDA, so I 
don't have an official opinion on that.
    Mr. DesJarlais. OK. Well, I practiced for about 18 years, 
and through the 1990's, the costs certainly increased and there 
was an increase in regulation in the practice of medicine. 
There certainly has been an increase in pharmaceuticals, 
increase in devices, and you know, the FDA oversees this, and 
most people, whether it's in the medical industry or any other 
number of businesses feel that burdensome Federal regulations 
are causing increasing costs. So we were talking earlier about 
Europe, and on average, medical devices are approved 2 full 
years later in the United States, and why did you say it takes 
so much longer for the FDA to approve these devices than the 
European firms?
    Dr. Shuren. Well, actually if you look at the report from 
the California Healthcare Institute for 510(k) devices that 
don't have clinical data--and that's about 80 percent of the 
devices that we review--they come on the market in the United 
States first, as compared to Europe, at least half the time or 
more frequently, and in fact, the performance there looks like 
it's getting better in 2009 and 2010.
    Now, when we deal with the high-risk devices, the PMA 
devices, these are a lot of the implantable lifesaving 
technologies, those devices have tended to come on the market 
in Europe before the United States for a very long period of 
time, and as mentioned beforehand, the standards there are very 
different, and with the global recession, companies now are 
looking to go to the market where it's easiest to get onto. 
Companies that are looking to sell, where before you could sell 
before you got approved, now are being expected, get approved 
somewhere, and then you can get brought up. So the enticement 
to go to any country that has a lower standard is going to be 
greater.
    The solution here isn't for us to lower our standards. It's 
to get our program more predictable and efficient so that we 
can get innovative technologies to market more quickly, but we 
can assure that they're safe and effective because if not, and 
as a physician, we put patients at risk. If we give to them a 
device--I don't know anyone here who wants a device that they 
don't----
    Mr. DesJarlais. Are you familiar with Mackauer survey?
    Dr. Shuren. Yes.
    Mr. DesJarlais. It would contradict significantly what 
you're saying right now in terms of devices. Is that a credible 
study?
    Dr. Shuren. No. I have concerns with the Mackauer study. 
It's actually less than 10 percent of the industry actually 
responded to it. Even of the population, they were looking at 
is less than 20. Many of the questions had less than 10 
percent. If you compare the United States to the E.U., at most, 
less than 8 percent of the people they sent the survey to 
actually could have had the same product come on the market in 
the E.U. And in Europe, for some of the things where they try 
to----
    Mr. DesJarlais. You're saying the United States is actually 
quicker to get devices through than European companies? It 
sounds as though you're spinning it.
    Dr. Shuren. So according to some of the reports from 
industry, some of these devices are actually coming on the 
market first in the United States as opposed to the E.U., but 
for the high-risk devices, as a general matter, for many years 
they come on the market first in Europe, then in the United 
States.
    Mr. DesJarlais. Now, these delays costs these companies $20 
to $40 million. Do you know the corresponding cost--what the 
corresponding cost is to patients of having delayed access to 
medical devices?
    Dr. Shuren. The cost of the delayed access for an 
ineffective medical device I would say would be huge, but not 
in favor of the patient. Look, as a doctor, if we have good 
technologies that are safe and effective, we want to get them 
out to patients. We also want to make sure they're safe and 
effective because we don't do ourselves, we don't do patients, 
we don't do our health care system justice if we're getting out 
devices that are not effective. And in Europe, there have been 
a number of cases since the late 1990's where they approved the 
device and then later they actually did the studies and they 
found it was ineffective or unsafe.
    Mr. DesJarlais. I have to interrupt just for a second. I 
understand that you're defending the agency you work for, but 
being a practicing physician at one time and myself being a 
practicing physician, I know that there's a line there that's 
being crossed on the Federal level and that we're driving up 
patient costs, sometimes unnecessarily, and I know that a lot 
of patients feel the same way, again, whether it's 
pharmaceutical or devices, and the United States is one of the 
most expensive places right now on health care, and we're going 
to have to do something about that.
    So, you know, the testimony that you're giving today sounds 
good from an FDA standpoint, but doesn't pass the practical 
test for me as a physician and many of my colleagues, but I 
appreciate your statement.
    Mr. Gowdy. I thank the gentleman from Tennessee. The chair 
would now recognize the gentleman from the great State of North 
Carolina, Mr. McHenry.
    Mr. McHenry. Almost as great as the State of South 
Carolina, right, Mr. Chairman?
    Mr. Gowdy. Almost.
    Mr. McHenry. Almost. Doctor, thank you for your testimony. 
We understand you've been on the job now for how long, how many 
months?
    Dr. Shuren. About 19.
    Mr. McHenry. Nineteen, that's OK. And you know, we know 
that you're taking on an active agency and so change often 
comes slow in government, and so, you know, we appreciate the 
position you're in. You know, you talked about the E.U. 
Standards versus our standards, and getting a product to market 
in the E.U. Versus here. It's just a different process, right?
    Dr. Shuren. That's correct.
    Mr. McHenry. What is the safety record? Is there a 
difference in the safety record?
    Dr. Shuren. Sir, one of the challenges with the E.U. Is 
they do not have publicly available centralized data base for 
that kind of information, as you have here in the United 
States, but we are aware of a number of cases of devices that 
got approved in Europe, that subsequently were found to be 
ineffective or unsafe, a number of them were withdrawn from the 
market----
    Mr. McHenry. Do you have any studies you could point to?
    Dr. Shuren. Studies, no, but we have the cases. I will----
    Mr. McHenry. Then my colleague here. You had a problem with 
the statistical relevance of a Mackauer study. You're saying it 
was only 10 percent, and you know, so you're saying that study 
is not statistically sound.
    Dr. Shuren. In terms of the numbers that you look at----
    Mr. McHenry. OK. Then I would question your saying that the 
E.U. Has a lower safety standard or a worst safety standard 
than United States if there's not relevant data.
    Dr. Shuren. They have a lower standard to market because 
they do not require that a device be shown effective.
    Mr. McHenry. OK. So in terms of the effectiveness of our 
regulation, because we're not arguing that we have a government 
agency allow unsafe products that are not going to be helpful 
onto the market. Likewise, I want to ensure that my 
constituents have access to the lifesaving, whether it's 
devices or health care, medicine, or procedures possible. So 
there is a balance, and I think, you know, I think we all care 
about and maintaining that.
    The difference in the Mackauer report from Stanford, it 
took 31 months from first communication to be cleared to market 
here in the United States like for low and moderate risk 
devices it took 7 months in Europe. Can we reduce that gulf? 
What are you doing to reduce that 31-month timeline?
    Dr. Shuren. The comparison is apples to oranges. When they 
went in the E.U.--first of all, it looks like it's 15 companies 
they got a response from.
    Mr. McHenry. OK. Actually, let me ask you a question then--
let me ask a question because you don't really want to respond 
to the Stanford research.
    Dr. Shuren. No, I do want to respond----
    Mr. McHenry. Well, you just want to dismiss it. So let me 
ask you this question. What is the average time from first 
communication to clearing to market for a device?
    Dr. Shuren. For first--depends what you mean on first 
communication. If it's from the application coming in the door, 
which is actually the comparison for Europe so often times for 
those devices not go to the notified body beforehand, and 
that's why it's apples and oranges. You come to us because 
you're going to do a clinical study----
    Mr. McHenry. So first application to clearing to the 
market.
    Dr. Shuren. So, if you're talking about for a 510(k), the 
average now is--and I will double-check on the exact numbers--
it's around 140 days, thereabout.
    Mr. McHenry. 140 days?
    Dr. Shuren. Uh-huh.
    Mr. McHenry. OK. And what is that in Europe?
    Dr. Shuren. In Europe we don't know. There's no publicly 
available data regarding the reviews that occur in Europe, both 
timeframes and the basis for the decisions. We have no idea 
what they even rely on when they make a decision in Europe.
    Mr. McHenry. So you're saying the Europeans are just in a 
different world when it comes to safety and soundness of 
medical devices, and there's no way for us to know a reasonable 
comparison?
    Dr. Shuren. They don't make the data available. In fact, 
the lack of transparency was recently criticized.
    Mr. McHenry. OK. So let me ask you, are you happy with the 
length of time it takes from first communication to getting a 
device on the market? Are you pleased with the track record so 
far.
    Dr. Shuren. I'm not pleased with the time, and that's why 
we're taking actions to try to make this program more 
predictable, consistent, and transparent. It will require 
several things to get there. There are changes FDA has to make. 
There are things we need from industry. We need to get the 
quality submissions to us, and we want to work with industry on 
that. We need to have adequate and stable resources to do it.
    I will tell you as comparison to the drug program--and I'm 
not suggesting the same by way of funding--but the user fees 
collected in drugs are 10 times the amount as for the device 
program, 10 times the amount.
    Mr. McHenry. OK. And also the revenue gained from that in 
the marketplace is significantly greater than that. But let me 
ask you another question. Is the length of time from 
submission--well, from first communication to getting a device 
on the market, is that longer or shorter than it was 5 years 
ago?
    Dr. Shuren. The length of time for the total--our review 
times have gotten generally shorter.
    Mr. McHenry. They have?
    Dr. Shuren. They have overall for the different goals. The 
total time, our time, industry time has lengthened for 
510(k)'s. It's over the past few years remained roughly the 
same on PMAs.
    Mr. McHenry. Interesting. OK. Is it getting less costly or 
more costly?
    Dr. Shuren. I don't know.
    Mr. McHenry. Why don't you know?
    Dr. Shuren. Because we don't do cost analyses for what the 
manufacturers are doing.
    Mr. McHenry. OK. So there is no cost estimate? The 
government would have no cost estimate of the regulatory 
hurdles that they're putting in place for industry?
    Dr. Shuren. No, I would not know of the total cost to a 
particular company, no.
    Mr. McHenry. OK. That in itself, Mr. Chairman, I think is a 
problem when a government agency doesn't realize the impact 
they're having, because it's my constituents that are going to 
be paying this, you know, this cost that's passed along to 
consumers once we get the devices on the market. I empathize 
with you, I do, but my concern is with the data that we've seen 
is that it takes longer now than it did than just a few years 
ago to get a device on the market and that is a big concern, 
and that's a big regulatory concern that--I appreciate the fact 
that you're looking at that and trying to reduce that time, but 
I would encourage you to look at the cost as well with--
industry's going to have to bear in order to comply with these 
regulations. Thank you.
    Mr. Gowdy. I thank the gentleman from North Carolina. The 
chair would now recognize the gentleman from Arizona, Dr. 
Gosar.
    Mr. Gosar. Dr. Shuren, I'm a dentist, and I'm very 
principled about process. So I'm sure you're aware of the FDA's 
regulatory procedures manual that just came out in March 2010?
    Dr. Shuren. I know of the manual, yes.
    Mr. Gosar. OK. So I mean, I'm coming back down to basics. 
Is there any other regulatory procedures manual that a case 
study on how medical devices should be approved whether they're 
a class one, class two, class three?
    Dr. Shuren. To my knowledge, I'm not aware of that.
    Mr. Gosar. See, once again, these are fundamental problems 
because what we have to do is we have to have everybody on the 
same line of expertise, what it takes for a one, two, and 
three. So I take it that the staff is not trained in those 
procedural aspects?
    Dr. Shuren. No. In terms of how to treat the different 
devices, they are, but if you want to put out what you need to 
do for a particular device, there will be some differences 
depending upon the type of device, and this is why industry 
says to us can you please put out more guidance on the specific 
types of devices to clarify what the expectations are, and we 
agree, there should be more guidance that's put out.
    Mr. Gosar. So have you a framework for these 510(k) 
reviewers?
    Dr. Shuren. We do have a framework for the 510(k) 
reviewers, and we're also right now doing a guidance in terms 
of clarifying that standard because there has been confusion on 
some of our reviewers. We found that on our own analysis, and 
we've had confusion on the part of industry, and the best way 
to deal with that is to clarify that through guidance and then 
to have training on it.
    Mr. Gosar. What kind of impact would that have on the end 
point that seem to randomly move with the reviewers?
    Dr. Shuren. Well, I think in terms of clarifying what the 
standards are and what needs to be done, you will have far more 
consistency in both what we do, and I think also what industry 
does.
    Mr. Gosar. Is there a way or do you provide interaction, 
you know, like how-to seminars where you actually have 
reviewers and manufacturers coming together and looking at this 
process? See, one of the things I'm seeing over and over again, 
I sit on Natural Resources as well as this Government 
Oversight, is this huge proliferation of agencies pending 
different checkpoints and time delays because time is money, 
OK, and I heard you say something earlier about the 
pharmaceutical aspect. You don't want to get me started there 
because out in rural Arizona we've got problems. We can't even 
get medications properly for surgeries. We're actually 
rescheduling surgeries. So, once again, we're not doing 
something good on the drug manufacturing as well.
    But when you were taking these delays--and there's--you 
know, venture capital is at a minimum here and we have to have 
a return on investment. That's what the business model is 
talking about, and that's what my good friend over here was 
talking about and alluding to--is that we're forcing people to 
go to Europe because we're becoming so antiquated. We're not 
trying to work with people. We're trying to stymie the process 
because what I see here is, if you take statistics, you can 
juggle them any way you want to. It seems to me, when the 
science is easy, you bring them here. When the science is hard 
you go to Europe.
    So something is wrong there, and I agree, we're not 
comparing apples to apples, Europe to United States. But we're 
forcing people to go to Europe because of the finances, because 
of the process. It's all of this. Does that make sense to you?
    Dr. Shuren. I understand the concern. I think to the extent 
that FDA, any unpredictability or inconsistency in our process 
that may contribute to companies making business decisions, is 
something that we are trying to address.
    There's also the impact of the global recession. I will 
take responsibility for changes in weather patterns but maybe 
not for the global recession, and that has also impacted the 
dollars that are available for investment and the decisions 
that are made, and that aspect of it is not in my control. But 
to the extent we can make the program more predictable and 
consistent, that's what we are trying to do with the actions 
that I laid out previously.
    Mr. Gosar. So wouldn't it be--I mean, no one wants a 
recall. So wouldn't it behoove us to work with industry, to sit 
down jointly in a venture to say, listen, there's limited 
capital, we definitely want to have the innovative spirit, we 
want to definitely keep that here, how do we streamline this, 
how do we work this, and it starts with basic building blocks, 
and it comes back to the basic building blocks of what business 
is about, and that's one thing I'm seeing constantly over and 
over again in government is a lack of business skills in 
understanding what it takes to actually get something to the 
market.
    Dr. Shuren. Actually, we've been going out to industry for 
a long time. This assessment that we talked about where we said 
identify the root causes, let's not do superficial surveys, 
let's do the deep dive, we went out, we had significant 
engagement with the public. We had public meetings, two of 
them; three town hall meetings. I traveled around to different 
parts of the country, both in open meetings and in closed-door 
meetings with different groups. We had three public dockets 
available for comments, and we got comments on the assessment. 
We made recommendations. We got comments on those, and based 
upon all of that input over a period of time and analyses is 
when we then put out the different actions we will take, and 
that is more guidance. That's more training for our folks. 
That's different--changes in the procedures, in the processes 
within the center.
    Mr. Gosar. Well, then, it seems like you're gathering 
information but then it's implementation. So let me give you an 
example. In July 2010, the Advancing Patient Safety Coalition 
which is made up of patients facing groups such as the American 
Hospital Association, the American Nurses Association wrote a 
letter to the FDA Commissioner Hamburg asking for a firm 
timetable for the FDA to establish a unique device identifier 
system. It is widely understood that a system of UDIs for 
medical devices would improve patient safety, improve 
clarification for medical device users, and make the recall 
process more efficient. Yet, over 9 months after this letter 
and 4 years after the passage of the FDA Amendment Act, we have 
no UDI uniform rule. When will you be putting the regulations 
for this unique device out and why is it taking so long?
    Dr. Shuren. This year. The rule is in administration 
clearance. It will be out this year.
    Mr. Gosar. Well, can you be a little bit more specific 
because, I mean, there's not--these timetables, there is no 
fixation about timetables. They just continue to be pushed and 
pushed and pushed.
    Dr. Shuren. For right now, it's in the process that's 
outside of my control. So I can't give you the exact date when 
it will come out, but it's been a high priority for us.
    Mr. Gosar. Thank you.
    [The prepared statement of Hon. Paul A. Gosar follows:]




    
    Mr. Gowdy. I thank the gentleman from Arizona.
    Dr. Shuren, I want to start by commending you for doing 
something that I haven't seen in the brief time I've been here, 
which is acknowledge that there may be problems with the agency 
that you sit there representing. It may not be unique, but it's 
certainly unusual to have someone do that. So, with respect to 
that, I think--and I hope I'm using your words--unpredictable, 
inconsistent, and opaque. The opaque may not be your word. It 
may. I certainly heard you use the word ``unpredictable'' and 
``inconsistent.'' I think in your written testimony you just 
simply acknowledge the FDA recognizes it can do a better job.
    My question--well, let me first ask you this first. You 
solicited input from industry on how FDA can improve itself, 
correct?
    Dr. Shuren. That's correct.
    Mr. Gowdy. And how many recommendations would you say that 
you got back that had merit?
    Dr. Shuren. I would have to go back and check. I will say 
we got a limited number of recommendations from different 
groups. Most of it was feedback to the recommendations that we 
put out.
    Mr. Gowdy. All right. Again, I stand to be corrected. It 
strikes me that of the recommendations you received or the 
recommendations that you seek to implement, you're going to use 
a ``case-by-case analysis.'' Now, I want to ask you to put on 
your other hat, your JD hat. There's nothing in the world less 
predictable in the world than a case-by-case analysis. It 
frustrates law enforcement. I suspect it frustrates industry. 
What bright line reformative measures came out of that survey--
in other words, if we're pleased to host you a year from now, 
what statistically measurable progress can we expect as a 
result of your asking for input in your own reforms?
    Dr. Shuren. First off, we're not using a case-by-case 
analysis as we go through for doing pre-market reviews. In 
those cases, we're actually looking to have more guidance on 
the expectations across a particular kind of device. We have 
many of them out now. We think there should be more of them. 
We'll be able to get a few more out with some changes in 
efficiencies that we're putting in place like a core staff to 
oversee the process and the tracking system and standard 
operating procedures. But a big increase in guidance documents 
isn't going to occur with the current resources because, right 
now, I have review staff who are getting pulled between trying 
to write a guidance document and reviewing applications. We 
need to have a core staff of technical writers, and we need to 
have enough of our own expert staff where we can spend the time 
to do the guidance and not have to pull people away from pre-
market review to slow up any of those times.
    Now, in terms of measurable progress from a year out, a 
year out most of the things we'll probably see will be on the 
qualitative side. I think, though, coming out from a year 
afterwards what we're hoping to see is some of the times in 
terms of overall times might start to come down. We will see 
actually if we go back and talk to people, you will hear less 
concerns about asking for data if data was inappropriate or 
asking for data with better clarification for why.
    Qualitatively, I think greater success with our interactive 
review with manufacturers in terms of the engagements that we 
have.
    Some of the things to make this work, we need to be able to 
get at the policies and procedures for everyone to get on the 
same page if we're going to get maximum value out of the 
system. So I think in the coming year we will see things start 
to turn around. We're going to see firmer implementation as we 
get a little bit beyond that and those policies are finalized.
    So you asked about challenges in doing things. When we put 
out guidance, we open that up for public comment. That's a good 
thing. We should get public comment. It also takes time. I got 
asked about the unique identification rule coming out. That's 
rulemaking. I have to do an economic analysis. It's required by 
law. It lays in time. People like that. But it adds time to it. 
So there are things we're doing it, some of it because of the 
process imposed on us by law will take a little bit longer. The 
internal changes will take less time.
    I will give you one last example. We have set up what we 
call a Center Science Council. It is almost senior leadership 
and experienced staff to oversee our science programs. This 
includes pre-market review. One of the issues that now comes to 
the Center Science Council is if the review team feels that 
they want to change what is going to be asked for across a type 
of device that is being brought up to senior management for 
input before a decision is made on it.
    So we get the weigh in from senior leadership and more 
experienced staff. We've already had a case come up as a result 
and that wound up changing the dialog about what we're doing. 
Those kinds of changes are already going into place, and we're 
starting to see a difference. I think that will have ripple 
effects over the coming months.
    Mr. Gowdy. Dr. Shuren, I'm sure that you can appreciate the 
concern that you've heard today from my colleagues, and your 
challenge is a large one, balancing innovation and safety. I 
don't minimize that. That is a challenge. My colleagues' 
challenge is to create an economic environment that is 
conducive with entrepreneurship and to create a regulatory and, 
in some instances, litigation scheme that doesn't bleed jobs to 
other countries. So I look forward to having you back and 
hearing about the progress that you've made, and I would yield 
a couple of seconds to my colleague from Tennessee because I 
promised I would, and I will--whatever time he consumes, I will 
give to my colleague from Illinois to balance it out. Dr. 
DesJarlais.
    Mr. DesJarlais. Dr. Shuren, I was just listening to the 
testimony as a whole, and I think that it would be fair to say 
that you believe that the FDA's oversight is superior to that 
of the Europeans?
    Dr. Shuren. I believe that the U.S. standard for approval 
is the robust standard that we should stand behind, and I think 
that the FDA needs to do a better job in terms of how we run 
the programs for that standard to make the system work. We also 
need industry to provide us with the proper and high quality 
submissions and with clinical trials of high quality. That will 
go along the way, and ultimately, though, we need adequate and 
stable resources to run this program if we're doing it right.
    You heard from industry that one of the big issues for them 
is the high turnover rate of our reviewers. We're not going to 
solve that without the resources to do it. If we're going to 
put out guidance documents, more of them, that will require 
additional resources. If we're going to have the capacity, we 
need to handle the growing workload, there will be a resource 
issue. In fact, from 2007, my workload went up 26 percent, but 
under the user fee program, the FDA assumes 100 percent of the 
risk of the increase in workload. None of that is built into 
the user fee program. None of it was considered or thought 
going to happen when we renegotiated MDUFA two, and that's had 
an impact.
    Mr. DesJarlais. As a physician moving forward looking at 
our patients which we both have great concern for, does it 
bother you at all that the Affordable Health Care Act is based 
on the European model?
    Dr. Shuren. The Affordable Health Care Act, for better, for 
worse, and I'm beginning to think maybe for better, left the 
medical device center out of it. So it hasn't--isn't an issue 
for me to talk about.
    Mr. DesJarlais. Thank you. I yield back.
    Mr. Gowdy. I thank the gentleman from Tennessee. I would 
recognize the gentleman from Illinois.
    Mr. Davis. Thank you very much, Mr. Chairman.
    You know, as we went through the discussion, I couldn't 
help but be reminded of my mother who used to tell us that 
haste sometimes will make waste and that it makes more sense to 
take the time that you need to thoroughly review whatever it is 
that you're doing with the idea that the quality of it is just 
then perhaps even more important than how quickly you're able 
to process it or get it done. I am convinced, quite frankly, 
that the process used by our Food and Drug Administration is, 
in fact, superior to what we find taking place in other places.
    I've had the personal experience of having to wait until 
something was perfected in order to have the level of comfort 
that my physician wanted to have before we did the treatment. I 
would urge you not to lower any standard or not even to think 
of lowering any standards but to continue with the intensive 
effort to make sure that the quality of the instruments, 
quality of the devices, that are going to be used on the 
American public is of the highest standard.
    And so I commend you for doing that. I commend the agency 
for doing it, and if you would care to respond, please do so.
    Dr. Shuren. I couldn't agree more that the standard we have 
in place is the right standard and the one we should rely on. 
I'm not saying that as a defender of the FDA. I'm saying that 
as a physician who has taken care of patients. I'm saying that 
as a person who has been a patient myself and the same for my 
family members and friends. I never want to give to them a 
device that isn't effective and that we don't know isn't 
effective, if we can have that data, because as a result, I put 
them at unnecessary risk and particularly when there are other 
alternatives out there for them. It's not good for our health 
care system, which does have its challenges. Why do we want to 
spend money on technologies that ultimately turn out not to 
work and the cost of care for people who wind up having 
worsened conditions because they got an ineffective treatment 
when they could have gotten an effective treatment, and that is 
what has happened in Europe with devices that had been found 
subsequently to be ineffective and yet patients got them and 
not benign treatments.
    We're talking about implantable devices. So at the end of 
the day, the U.S. system I think is the right system. We just 
need to get behind it, and we need to make sure that it's as 
predictable and efficient as it should be.
    Mr. Davis. Thank you, Mr. Chairman. Thank you very much.
    Mr. Gowdy. I thank the gentleman from Illinois. Dr. Shuren, 
we thank you. As you can tell, this issue transcends the 
typical partisanship that we see here. It's a very personal 
issue for all the Members on both sides who are, believe it or 
not, are real human beings and have children and parents and 
spouses, and I wish you luck as you balance innovation, safety, 
and time. It's a challenge, and I do look forward to checking 
back in with you in a reasonable period of time to see what 
progress you are making, and we wish you the best as you seek 
to lead the agency.
    Dr. Shuren. Thank you, and we're very happy to come by, 
talk to you, the other Members, or your staff at any time at 
your convenience.
    Mr. Gowdy. Thank you. We will take a brief recess to set up 
for the next panel, and if you have a second, some of us might 
like to come down and thank you. We'll be briefly recessed.
    [Recess.]
    Mr. Gowdy. We will now welcome our third panel of 
witnesses, and we thank you for your patience.
    With us this afternoon from my left to right, your right to 
left, Mr. Jack Lasersohn, is that close, general partner of the 
Vertical Group, a leading venture capital firm; Dr. David 
Gollaher, close? President and CEO of the California Healthcare 
Institute; and Dr. Rita Redberg is professor of Medicine at 
University of California, San Francisco, and the chief editor 
of the Archives of Internal Medicine.
    Pursuant to committee rules, all witnesses will be sworn in 
before they testify. So I would ask you if you would rise and 
lift your right hands.
    [Witnesses sworn.]
    Mr. Gowdy. Let the record reflect all the witnesses 
answered in the affirmative. You may be seated.
    I will recognize the witnesses for their opening statements 
in the order in which I introduced them. So we would start with 
Mr. Lasersohn and you are recognized for 5 minutes.

  STATEMENTS OF JACK LASERSOHN, GENERAL PARTNER, THE VERTICAL 
   GROUP; DAVID GOLLAHER, PH.D., PRESIDENT & CEO, CALIFORNIA 
   HEALTHCARE INSTITUTE; AND DR. RITA REDBERG, PROFESSOR OF 
 MEDICINE, DIRECTOR, WOMEN'S CARDIOVASCULAR SERVICES, DIVISION 
            OF CARDIOLOGY, UNIVERSITY OF CALIFORNIA

                  STATEMENT OF JACK LASERSOHN

    Mr. Lasersohn. Thank you for the opportunity to be here 
today. My name is Jack Lasersohn. I'm testifying today on 
behalf of the National Venture Capital Association.
    During my 30-year career as a health care venture investor, 
our government has partnered with entrepreneurs to safely speed 
innovative new devices to market. Over this time, the United 
States became the undisputed leader of global medical 
innovation. Americans have been first in line for the 
lifesaving devices that U.S. companies produce, and throughout 
this period, patient safety has always been paramount, and 
safety must continue to be paramount even as we strive for the 
next lifesaving innovation.
    Although revolutionary research is ongoing, fewer 
groundbreaking medical devices are making it to the U.S. 
marketplace, and those that do make it are taking longer and 
costing significantly more. At the same time, other countries 
have emulated our successful model and have begun to draw 
innovators and capital away from the United States, and as a 
result, we are starting to see stagnation within the U.S. 
innovation ecosystem.
    A growing body of research suggests that the performance of 
the FDA has played some role in this decline. For many 
entrepreneurs, the FDA process has grown unpredictable, if not 
inscrutable. Working on very short resources to fulfill a broad 
set of responsibilities, FDA personnel struggle to keep up with 
their workload.
    This research shows that review and clearance times for 
medical devices has significantly increased since 2007. U.S. 
medical innovation is beginning to migrate overseas, and 
patients in foreign markets are benefiting before American 
patients, without a corresponding gain in overall U.S. health 
or safety.
    The central problem is that the FDA's risk-benefit analysis 
for novel medical devices, as well as drugs, has grown out of 
balance relative to its past practices and to current practices 
in other countries. FDA now weighs risks too heavily and 
demands unrealistic levels of assurance of benefit, 
particularly for first generation therapies.
    As you know, under current law, all medical devices and 
drugs must be both safe and effective, but in medicine safety 
does not mean the absence of risk. It means a reasonable 
assurance that the probable benefits of using a device exceed 
its probable risks. Effectiveness requires that the benefit be 
clinically significant, which means it must produce a 
clinically meaningful improvement in the health of a 
significant portion of the population.
    We believe that the FDA should establish as a guiding 
principle a more flexible risk-benefit analysis. This means 
that while the general requirement for safety and efficacy will 
always continue to apply, the specific threshold for each 
element within the equation will change depending on the 
clinical context. Incidents and severity of disease, urgency of 
need in the marketplace, prior medical knowledge, and the 
relative safety of a device should all be considered to 
explicitly adjust the variables in the safety and efficacy 
equation. These adjustments might include, for example, 
reducing the level of evidence required to provide a reasonable 
assurance or what constitutes a, ``clinically meaningful 
improvement in health,'' or what portion of a population is 
deemed to be significant.
    The flexible safety efficacy paradigm that we are proposing 
is already implicit, and maybe even explicit, at the heart of 
current FDA law. We already have very different review 
standards for low versus high-risk devices, but research data 
suggests that this has not been applied correctly or uniformly. 
A legislative mandate would help FDA senior management 
implement this commonsense principle more broadly within the 
agency.
    In addition, the FDA should continue to measure probable 
benefits against probable risks, instead of an emerging 
practice of requiring a higher absolute level of evidence of 
benefit to ensure against a hypothetical or possible risk to 
health. Medical breakthroughs begin with only a small advantage 
over the status quo and then dramatically improve over time. 
This has been true for the past 50 years. Angioplasty is a 
perfect example. Requiring that all novel products initially 
demonstrate a high absolute threshold of benefit versus risk 
will derail away on many promising new ideas.
    For devices with low to moderate potential risks, the FDA 
should significantly expand the use of certified third party 
entities for review, as the research suggests this practice is 
widely used in Europe without sacrificing safety, and we 
continue to believe in the safety and efficacy standard.
    We are also advocating for a number of broader reforms, and 
mending the statutory mission to include acceleration of novel 
therapies to the marketplace, ensuring that individuals with 
significant expertise can sit on advisory panels, and 
streamlining the regulation of cost-cutting innovation, 
including a pathway for personalized medicine are very, 
veryimportant. If we act now to implement reforms that bring 
the FDA risk-benefit equation back into balance, we can revive 
the U.S. medical innovation ecosystem and ensure that seriously 
ill patients continue to have access to breakthrough therapies 
and technologies in a safe and timely fashion.
    Thank you for your attention.
    Mr. Gowdy. Thank you, Mr. Lasersohn.
    [The prepared statement of Mr. Lasersohn follows:]




    Mr. Gowdy. Dr. Gollaher.

                  STATEMENT OF DAVID GOLLAHER

    Mr. Gollaher. Thank you, Chairman Gowdy and Ranking Member 
Davis.
    My name is David Gollaher. I'm the president and CEO of 
CHI, the California Healthcare Institute, and I appreciate the 
opportunity today to address several important issues 
concerning the review and approval of medical devices by the 
FDA.
    My testimony is based on a recent report CHI produced with 
the Boston Consulting Group, BCG, called Competitiveness in 
Regulation, the FDA in the Future of America's Biomedical 
Industry. One major theme of this report is that the FDA has a 
de facto industrial policy, for better or worse, and its 
operations shape the future of the medical device industry.
    Now, history shows that a strong, science-based FDA and 
well-articulated, predictable, and consistent regulatory 
processes are essential to medical device investment, 
innovation, and patient care. Unfortunately, in recent years, 
there has been a significant deterioration in the environment 
for medical device innovation.
    Beginning in approximately 2007, evidence clearly confirms 
that regulation of medical devices has become increasingly slow 
and unpredictable for both 510(k), as well as more complex pre-
market approval, PMA, products. As documented by the FDA's own 
data and our competitiveness and regulation report comparing 
2010 with the period from 2002 to 2007--that's the period of 
the first medical device user fee law--we note two things: 
First, the 510(k) clearances have slowed by 43 percent during 
those two periods and that PMA approval times have increased by 
75 percent.
    Clearly, part of the problem for the slowdown lies beyond 
the direct control of the FDA and its leadership. In recent 
years, for example, Congress has enlarged the Agency's scope 
into new fields, like tobacco, and added to its 
responsibilities and authority. Yet Federal appropriations have 
largely failed to keep up with new mandates, forcing greater 
reliance on industry-funded user fees.
    But perhaps the most important factor in the Agency's 
recent history has been a change in its culture. Faced with 
accusations from the press, from consumer groups, and some in 
Congress, that its reviews were too lax and failed to protect 
public safety, the FDA has shifted emphasis on product reviews 
from benefits of new devices to focus increasingly on their 
possible risks.
    Meanwhile, outside the FDA, another form of risk has 
darkened the prospects for medical technology investment. 
Beginning in 2008, the Great Recession devastated investment 
portfolios, including the pension funds and institutional 
endowments that historically have been the main source of life 
sciences venture capital. Against this background, levels of 
regulatory uncertainty, delays, missed timelines, doubts about 
eventual approval, uncertainty that was uncomfortable in good 
economic times became intolerable after the economic downturn, 
especially because investors and executives came to realize 
that there were practical and more efficient routes to the 
market outside the United States.
    Today, complex medical devices approved via the PMA process 
in the United States are approved in Europe on average nearly 4 
years ahead of the United States, up from just a year earlier 
over a decade ago, and no evidence exists to suggest that these 
faster rule times in Europe lead to patient safety-related 
problems. In fact, a recent promising consulting group study 
comparing the period from 2003 to 2009 comprehensively in 
Europe and the United States found virtually no difference in 
product recalls and safety problems.
    Today, Congress, the FDA, industry, patient groups, and 
other stakeholders can come together with the will and ideas to 
improve agency performance, to rejuvenate support, and sustain 
a strong science-based FDA and efficient, consistent, and 
predictable review process to approve safe and effective 
medical technologies.
    Critical to this effort is the need to address through 
constructive congressional oversight more appropriate balance 
between benefit and risk. Today, the FDA, the press, Congress, 
consumer groups, and others overwhelmingly focus on direct 
risk, product side effects, adverse events, technical product 
failures, but just as important, perhaps even more important, 
to consider are indirect risks, the distortions in the 
regulatory process, for example. How should we calculate the 
public health loss to patients if investors and companies avoid 
entire diseases and conditions because the FDA's standards for 
data are so extensive and its standards for approval so 
uncertain?
    Similarly, we need to understand the cost of regulation, 
again, both direct and indirect. As this committee and Congress 
look for ways to create jobs and create a more business 
friendly environment, the full cost of the regulatory system 
should be fully weighed. As the global economy grows ever more 
connected, American leadership in medical device faces intense 
competition for capital, for markets, for talent, and for jobs. 
As these competitive forces gather momentum, investors, 
managers, and policymakers ignore them at their peril. If FDA 
regulation is just one factor among several, it nonetheless can 
be pivotal.
    Thank you, again, for this opportunity to testify. I would 
be happy to answer any questions you may have.
    Mr. Gowdy. Thank you, Dr. Gollaher.
    [The prepared statement of Mr. Gollaher follows:]




    Mr. Gowdy. Dr. Redberg.

                STATEMENT OF RITA REDBERG, M.D.

    Dr. Redberg. Thank you, Chairman Gowdy, Ranking Member 
Davis, and other distinguished Members for inviting me to 
submit testimony on medical devices at this important hearing.
    I am Rita Redberg, M.D., professor of medicine and full-
time faculty and cardiologist at the University of California 
San Francisco Medical Center for the last 21 years. I'm also 
chief editor of the Archives of Internal Medicine, one of the 
most preeminent, peer-reviewed journals of scientific research 
and internal medicine. The journal frequently publishes 
articles related to use of medical devices.
    As a practicing cardiologist, I appreciate the advantages 
that medical devices offer in care of my patients every day. I 
also know the problems and heart aches that can occur when an 
implanted device is found not to be effective or has been found 
to be defective and is recalled.
    My first priority is high quality medical care of my 
patients. Thus, it is critical to me that any approved high-
risk device first have been shown to be safe and effective. 
Unfortunately, this standard is too frequently not currently 
being met.
    First of all, only 1 percent of all devices goes through 
the pre-market approval pathway. Congress envisioned that all 
class three devices, those with greatest risk, would be 
approved through the more rigorous pre-market approval process. 
However, the 2009 GAO report entitled, FDA Should Take Steps to 
Ensure that High-Risk Device Types Are Approved Through the 
Most Stringent Review Market Process found that this 
congressional directive was not being followed. The report 
found that the majority of high-risk devices do not go through 
the original PMA process and, instead, are commonly approved 
with no clinical study data.
    Even the PMA process itself has been found to need 
improvement in its clinical data requirements. The gold 
standard for clinical data is randomized, controlled trials. 
Yet our recent study that was found in JAMA found that fully 
two-thirds of PMA cardiovascular devices were approved on the 
basis of only a single study. Moreover, only 27 percent of 
these studies were randomized, and only 14 percent were 
blinded. Only half had a comparison control group. Thus, the 
majority of high-risk implanted devices were approved without 
the support of high quality data on safety and effectiveness.
    For example, as chronicled in the Chicago Tribute last 
week, the Myxo valve, an annuloplasty ring permanently 
implanted as a heart valve replacement, was approved through a 
510(k) process. This valve clearly falls within the definition 
for a class three device and was originally classified as such 
by the FDA. However, according to the Tribune, the FDA ``rubber 
stamped'' the device industry's request to downgrade from class 
three to class two in 2001. The petition for reclassification 
cited studies finding that the rings were safe and effective. 
However, none of the studies were randomized clinical trials, 
and there were other problems.
    Many of the study investigators were heart surgeons who 
invented the devices and had financial relationships and were 
receiving royalties from the manufacturer. These relationships 
were not revealed to the patients who received these 
annuloplasty rings. Moreover, Edwards had sold these devices 
for 2\1/2\ years without FDA 510(k) clearance as the company 
had determined from an FDA document that a new 510(k) was not 
needed. However, shortly after press reports on this missing 
FDA clearance, the company submitted a new 510(k) and FDA 
ultimately cleared the device in April 2009. There were no 
penalties to the company for this infraction.
    In the most recent 5-year period, there have been more than 
3,400 adverse events reported involving annuloplasty rings, and 
these rings have been linked to only 56 fewer deaths than heart 
replacement valves, yet the annuloplasty ring went through a 
510(k) clearance without benefit of clinical trials. This 
number is especially disturbing as it's estimated that only 5 
percent of all adverse events are ever reported. Adverse event 
reporting is voluntary for hospitals and doctors.
    Manufacturers are required to report deaths and injuries. 
However, there are an unknown number of delays in adverse event 
reporting by the manufacturer. For example, last April, an FDA 
inspection of medical device maker Edwards Lifesciences 
identified six complaints of adverse events related to use of 
mitral annuloplasty rings and pericardial prosthetic heart 
valves that were not reported to the FDA within the required 
30-day window.
    The FDA is sorely underfunded for its enormous mission of 
protecting the public health by assuring food, drug, and device 
safety. FDA device review is partially supported by industry 
user fees, but currently, device user fees are lower than 
pharmaceutical user fees, even though drug trials are much more 
expensive to conduct than device trials. The PMA user fees 
provide less than one-fourth of the estimated $870,000 average 
cost of the review in terms of FDA staff and resources, thus, 
creating a disincentive for FDA to use the PMA process even 
when Congress had intended its use for high-risk devices.
    Increasing the budget for the Center for Devices would help 
speed up device approvals by allowing more FDA staffers to 
review applications more expeditiously, but the process cannot 
and should not be speeded up by foregoing the requirement for 
data of safety and effectiveness.
    Finally, the device approval process has been compared to 
the European process, but a recent review in the BMJ found that 
while European conditions may be more favorable for industry, 
they are not necessarily best for patients.
    The decisionmaking process in Europe occurs behind closed 
doors. There is no publicly available reason for granting a CE 
mark, the European approval. The BMJ editors attempted to 
contact 192 manufacturers to get evidence of the clinical data 
used to approve their devices in Europe, and everyone denied 
access, stating that, ``clinical data is proprietary 
information.''
    True innovations are welcome, but cannot be recognized as 
such without clinical trial evidence to show that new 
technologies are beneficial for patients. Only high-quality 
clinical trials can assure safety and benefit, especially for 
invasive devices from which patients incur risk of infection, 
bleeding and even death. It is well worth the time up front to 
gather data of safety and effectiveness so that my fellow 
cardiologists and I can confidently tell our patients that 
implantation of a device is in their best interest.
    Thank you for your attention. I would be happy to answer 
any questions.
    Mr. Gowdy. Thank you.
    [The prepared statement of Dr. Redberg follows:]




    
    Mr. Gowdy. The chair would recognize the gentleman from 
Illinois Mr. Davis for his 5 minutes of questions.
    Mr. Davis. Well, thank you very much, Chairman.
    Mr. Lasersohn, I assume that you and your colleagues help 
people with all of these great ideas find the resources to 
develop some of the products that they manufacture and put 
together. Is that----
    Mr. Lasersohn. We certainly try to, yes, sir.
    Mr. Davis. And every conversation almost that you have 
about health care, there's the whole issue of costs, the issue 
of liability, the issue of risk. If standards are altered, 
let's say, perhaps downward, would that pose a problem for the 
people in your business?
    Mr. Lasersohn. Well, we don't think the standards should be 
lowered, as a matter of fact. We support the safety and 
efficacy standard. The question--and I think this is the point 
Dr. Shuren was making--is--it's the question of how it is 
implemented and the how the agency manages it.
    So we're not at all suggesting a reduction in the standard. 
We're recommending, in fact, what the agency does already in 
some cases when it works very well, which is to change the 
balances within the standard, the levels of evidence, for 
example, what is believed to be significant, what's meaningful, 
depending on the context and all--and other factors that may be 
relevant. The agency does this already in many, many cases. It 
is really the commonsense thing to do. I'm sure Dr. Shuren 
would agree. It's just a question of how do we make this a 
consistent practice within the FDA.
    Mr. Davis. So, then, the higher the standards, the more 
comfort you and your colleagues have relative to the likelihood 
of trial lawyers getting involved in your business, lawsuits 
and all of those kinds of things.
    Mr. Lasersohn. You know, we think there really is value in 
the FDA setting a rational bar for approval. All of the points 
Dr. Shuren made we agree with in that respect. It's really a 
question of the internal balance in the last few years, we 
believe, has really gotten out of whack, and that the risk side 
of this equation has come to really dominate the culture of the 
FDA. And we don't suggest the basic risk-benefit idea should be 
abandoned in any sense or safety and efficacy. It's really just 
bringing it back into balance.
    Mr. Davis. Dr. Gollaher, part of the discussion this 
afternoon has centered around some comparisons between what we 
do with our Food and Drug Administration, what's done in the 
European Union. Given the discussion, if you had to say let's 
maintain and perhaps even maybe intensify, would that be your 
position, or would it be, well, we probably could get away with 
becoming more like them?
    Mr. Gollaher. I think that the idea of the FDA being the 
gold standard is what we should aspire to. I think that 
regulation can be a competitive tool, as it has been in the 
past in the United States, and that our goal should be to make 
the regulatory process the best in the world, which also means 
the most efficient and the highest performing. I think the 
industry's goal is exactly that; in other words, to have clear 
communications on standards between industry and the agency, 
and to see a process in which those standards are clearly 
applied and implemented.
    The comments earlier about changing goalposts, about not 
knowing what's required, is something that bothers many, many 
companies. I think there are enormous opportunities for 
performance improvements, many of which Dr. Shuren in his 
comments focused upon.
    Mr. Davis. Dr. Redberg, you expressed a great deal of 
affinity for innovation and for being able to come up with new 
approaches, new techniques, new technology, but pretty much it 
seems to me that you're saying at the end of the day that we 
really need to have as much assurance as we can possibly have 
that whatever it is that we've come up with is going to work in 
the best interests of the patient, and that they are going to 
be able and should be able to feel safe, secure and comfortable 
with what we've got. Is that an interpretation of what you were 
saying?
    Dr. Redberg. That's correct, Mr. Davis, absolutely. As I 
said, innovation--we've had great advance in medical care, but 
a new technology, just because something is new doesn't mean 
it's good for patients. And so every new--and we've gotten to 
an era where we have a lot more devices and a lot more complex 
technology, but that means there's a lot of down side. We're 
now mostly talking about implanted devices that are going 
inside someone's body. And so it's really incumbent upon us to 
know that before I recommend that device to be implanted in my 
patient, that I have clinical data, high-quality clinical data, 
showing safety and effectiveness. And really it's 
effectiveness, because we don't need to talk about safety if 
there is no benefit to implanting that device. As Dr. Shuren 
pointed out, the EU's standard does not include effectiveness.
    We all know, I mean, we've heard about the metal on metal 
recall, the ICD lead recalls; there was just the Boston 
Scientific recall a few days ago. I mean, these devices have 
been implanted and lead to serious adverse events, including 
death. And so I do embrace innovation, but it has to be shown 
to be beneficial.
    Mr. Davis. Well, let me thank all three of you for sharing 
your expertise with us, your willingness to come and testify.
    I thank you very much and yield back, Mr. Chairman.
    Mr. Gowdy. I thank the gentleman from Illinois.
    Mr. Lasersohn, if you're going to change the risk 
structure, are you also advocating changing the litigation 
structure that we have in this country?
    Mr. Lasersohn. Wow, that's a hard one. I think that 
litigation absolutely does contribute to excess use of a lot of 
medical technology, and I think that is a factor that we really 
have to consider. So I think reasonable litigation reform is 
something to think about.
    In terms of the risk side of it, I don't think that the 
view is at all to accept greater risk in the sense that a 
device has no--that the risk-benefit has become undesirable. 
The argument is that you accept a higher level of risk only if 
there is a higher level of benefit to balance it out. So 
obviously----
    Mr. Gowdy. How do you know----
    Mr. Lasersohn. Sorry.
    Mr. Gowdy [continuing]. That balancing?
    Mr. Lasersohn. That's the job of the FDA and then 
ultimately the medical community. It's a decision that a 
physician makes every day. Every decision a physician makes 
involves some level of risk averseness.
    Mr. Gowdy. But the physician doesn't do it for devices. 
Physicians aren't well equipped to go do their own research, I 
would not imagine. So how do you suggest that physicians who 
wind up using these products and devices, how do they balance 
risk with efficacy?
    Mr. Lasersohn. So they don't do it across the board. First 
of all, the FDA really does make that decision ultimately, 
right? And we believe in that system. So the FDA is ultimately 
responsible for deciding that a particular device, the risk-
benefit is favorable. That's why it's approved.
    But what a physician does is when that approval happens, 
it's approved for a very broad population of patients, it may 
not actually be an appropriate use of a device in a particular 
patient. And that's really what the physician does. It 
decides--a physician might decide that the use of the drug-
eluting stent, even though it is technically for a particular 
use in a particular patient with a particular set of 
comorbidities and risk factors, perhaps age, perhaps diabetes, 
other unfavorable factors, that in that particular case the 
risk-benefit is not worthwhile to use it.
    So even though the FDA is primarily responsible for this, 
putting a device onto the market, ultimately a physician really 
exercises fine-tuned judgment about whether to use a particular 
device in a particular patient.
    Mr. Gowdy. I'm with you, and I have to confess, I'm just a 
prosecutor in South Carolina that made very poor grades in math 
and science. So say it slow for me to get it. The FDA doesn't 
do their research, though, correct?
    Mr. Lasersohn. No, but it relies on the research provided.
    Mr. Gowdy. All right. To Dr. Redberg's point, what in your 
paradigm eliminates physicians who have a fiscal stake in the 
outcome of the research? Where would you factor that into it?
    Mr. Lasersohn. First of all, it has to be disclosed. The 
industry has taken a very, very strong position on this that 
any conflicts of interest must be disclosed. If they are not 
disclosed, that's, I think, a mistake. I think they should be 
disclosed so that people like the FDA can weigh that in their 
analysis of the validity of the data that's being provided to 
them. In certain cases is may be completely inappropriate for a 
physician to conduct, for example, a clinical trial if they are 
the inventor of the technology and there are other 
alternatives, and they very well may not be appropriate in that 
case.
    Mr. Gowdy. Dr. Gollaher, let me see if I can qualify you as 
an expert in contrasting our system with the European system. 
Are you aware of any studies that suggest the recall rate is 
higher in Europe than in the United States?
    Mr. Gollaher. No.
    Mr. Gowdy. Are you aware of any studies that indicate the 
bad outcome rate is higher in the European Union than in the 
United States?
    Mr. Gollaher. No.
    Mr. Gowdy. Is the litigation rate higher in the European 
Union than in the United States?
    Mr. Gollaher. No.
    Mr. Gowdy. Is there anything about the U.S. system that you 
think is superior to the European system?
    Mr. Gollaher. Yes.
    Mr. Gowdy. What is it?
    Mr. Gollaher. I think that on balance the centralized 
approach with a stronger publicly funded science base is a 
better system than a completely distributed system. However, I 
think that there is some balance to be struck, and that there 
are lessons that we can learn from the European system in 
addition to that.
    Mr. Gowdy. If Dr. Shuren were to go on vacation for 2 weeks 
and appoint you the head of FDA for this section, what are the 
first three things you would do before he got back?
    Mr. Gollaher. We'd all be in trouble, but I think one of 
the things that would be interesting to know is much--to gain a 
deeper understanding of what's happening in Europe. Quite 
clearly there has been a major migration of medical technology 
companies, technologies invented in America that are being 
introduced first in Europe. There is an economics of that, and 
we understand part of it.
    What we don't understand nearly well enough is the taxonomy 
of the European system. We need more information. That would be 
a high priority, because right now Europe is outcompeting us 
with respect to the regulatory process, and it's exerting an 
economic cost in terms of jobs and innovation in the United 
States.
    The second thing is to decide which things can be done 
immediately from a managerial perspective in the agency to 
improve its performance. And the third thing is a corollary to 
that, which is what needs legislation. Right now we're in the 
MDUFA negotiation process. There's some things that Congress 
needs to legislate in order to promote agency improvement, and 
we need a better understanding of what's managerial, and what 
the leaders can do, and what needs congressional support. And, 
of course, part of that, which Dr. Shuren mentioned, is 
providing adequate resources for the agency. I think all of us 
believe that's a fundamental principle.
    Mr. Gowdy. Dr. Redberg, your passion and advocacy for your 
patients is palpable, and I would commend you for that. But I 
think you would agree that patients who either die or get 
sicker because they're waiting on the approval process to work, 
that's not any more fair to them if the delay is unnecessary 
than patients who are subjected to devices that are either 
unsafe or just don't work.
    So how do you strike the balance between the risk, which 
is--I would imagine is impossible to zero it out, but what 
level of risk is acceptable given the fact that for lots of 
patients time is the greatest risk that they face?
    Dr. Redberg. Sure. I agree that we do have to strike a 
balance. And so certainly I want some clinical data, human data 
of benefit, particularly for a high-risk implanted device.
    But I think it is possible, you know, to have a sort of 
followup period for studies, because obviously the longer the 
followup, the longer for the time to approval. I think a 
shorter period is fine, assuming that we have actual 
postmarketing data, because frequently the FDA mandates 
postmarketing data means we're going to follow that device for 
the next year to 3 years, but that data actually is not ever 
coming. So then if we had a more robust postmarketing system, I 
think that there's less onus on getting everything up front 
preapproval to FDA. And so I think we can strengthen the 
evidence both premarket and postmarket, kind of like the 
accelerated approvals for drugs that we do, to have that system 
with a real postmarketing registry where we follow. We have so 
many new carotid stents and defibrillators, but we have very 
little data on how patients are doing 1, 2, 3, 4 years later.
    Mr. Gowdy. In your testimony you stated, and others, I 
think, have stated today, that the European model does not 
include efficacy as part of the analysis, which, again, those 
of us that don't practice medicine and are not experts, that 
was surprising, because I wouldn't know what else you would 
consider. I guess safety. I guess it can be safe and still a 
placebo. Is that what you meant by that?
    Dr. Redberg. That's right. And actually unfortunately, 
especially with devices, there is a lot of placebo effect. For 
example, recently vertebroplasty is the spinal procedure for 
back pain that has been FDA approved on the basis of a trial 
that did not have a sham control. A year or 2 after FDA 
approval, the New England Journal of Medicine published two 
randomized trials where they did vertebroplasty and they did a 
sham control, and there was no difference in the outcomes of 
those patients certainly. And some insurance companies then 
reevaluated their approval.
    Medicare spends over a billion dollars on vertebroplasty, 
for this procedure that has never been shown to be more 
beneficial than a sham control. So it is an excellent point. In 
order to see benefit, especially for a device, you have to have 
an adequate control group. But once you've established benefit, 
then the level of risk is going to depend on the patient, the 
population, and I think that can be better determined after FDA 
approval when you have widespread use.
    The other point about legal is for PMA approval. As you 
know better than I do, the Supreme Court by Riegel v. 
Medtronic, that is the only patient protection for patients 
that have PMA devices. They cannot sue in State court for 
Riegel v. Medtronic for devices.
    Mr. Gowdy. I think we all agree we don't want our capital, 
our jobs, our companies fleeing the United States because our 
system is second-rate. Nor do we want to trade safety for 
expediency. So thank you for helping educate the committee, the 
subcommittee, and we look forward to hearing from you again. I 
appreciate, again, your patience as we had to vote and go 
through two other panels. And I applaud your knowledge, your 
acumen, your professionalism, and your civility toward one 
another and to the subcommittee.
    Anything else, Mr. Davis?
    Mr. Davis. No, sir.
    Mr. Gowdy. With that, the subcommittee hearing is 
adjourned, and I will come down there and thank you. The 
hearing is adjourned.
    [Whereupon, at 3:55 p.m., the subcommittee was adjourned.]
    [Additional information submitted for the hearing record 
follows:]





                                 
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