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70–525 PDF 2011

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

(II)

COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM

DARRELL E. ISSA, California, Chairman

DAN BURTON, Indiana

JOHN L. MICA, Florida

TODD RUSSELL PLATTS, Pennsylvania

MICHAEL R. TURNER, Ohio

PATRICK T. MCHENRY, North Carolina

JIM JORDAN, Ohio

JASON CHAFFETZ, Utah

CONNIE MACK, Florida

TIM WALBERG, Michigan

JAMES LANKFORD, Oklahoma

JUSTIN AMASH, Michigan

ANN MARIE BUERKLE, New York

PAUL A. GOSAR, Arizona

RAU ́ L R. LABRADOR, Idaho

PATRICK MEEHAN, Pennsylvania

SCOTT DESJARLAIS, Tennessee

JOE WALSH, Illinois

TREY GOWDY, South Carolina

DENNIS A. ROSS, Florida

FRANK C. GUINTA, New Hampshire

BLAKE FARENTHOLD, Texas

MIKE KELLY, Pennsylvania

ELIJAH E. CUMMINGS, Maryland, Ranking

Minority Member

EDOLPHUS TOWNS, New York

CAROLYN B. MALONEY, New York

ELEANOR HOLMES NORTON, District of

Columbia

DENNIS J. KUCINICH, Ohio

JOHN F. TIERNEY, Massachusetts

WM. LACY CLAY, Missouri

STEPHEN F. LYNCH, Massachusetts

JIM COOPER, Tennessee

GERALD E. CONNOLLY, Virginia

MIKE QUIGLEY, Illinois

DANNY K. DAVIS, Illinois

BRUCE L. BRALEY, Iowa

PETER WELCH, Vermont

JOHN A. YARMUTH, Kentucky

CHRISTOPHER S. MURPHY, Connecticut

JACKIE SPEIER, California

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 Chairman

DAN BURTON, Indiana

JOHN L. MICA, Florida

PATRICK T. MCHENRY, North Carolina

SCOTT DESJARLAIS, Tennessee

JOE WALSH, Illinois

DANNY K. DAVIS, Illinois, Ranking Minority

Member

ELEANOR HOLMES NORTON, District of

Columbia

WM. LACY CLAY, Missouri

CHRISTOPHER S. MURPHY, Connecticut

(III)

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

(1)

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 deVerDate 17-JUN-2003 13:12 Nov 09, 2011 Jkt 000000 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 C:\KATIES\DOCS\70525.TXT KATIE PsN: KATIE
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mands 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 constituVerDate 17-JUN-2003 13:12 Nov 09, 2011 Jkt 000000 PO 00000 Frm 00006 Fmt 6633 Sfmt 6633 C:\KATIES\DOCS\70525.TXT KATIE PsN: KATIE
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ents 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 MinVerDate 17-JUN-2003 13:12 Nov 09, 2011 Jkt 000000 PO 00000 Frm 00007 Fmt 6633 Sfmt 6633 C:\KATIES\DOCS\70525.TXT KATIE PsN: KATIE
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nesota’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

5

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:]

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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

11

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

12

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:]

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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 proVerDate 17-JUN-2003 13:12 Nov 09, 2011 Jkt 000000 PO 00000 Frm 00029 Fmt 6633 Sfmt 6633 C:\KATIES\DOCS\70525.TXT KATIE PsN: KATIE
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mote 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

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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

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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?

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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

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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.

31

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.

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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?

33

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

34

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:]

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36

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-bycase 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.

37

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.

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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

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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.

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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 severVerDate 17-JUN-2003 13:12 Nov 09, 2011 Jkt 000000 PO 00000 Frm 00044 Fmt 6633 Sfmt 6633 C:\KATIES\DOCS\70525.TXT KATIE PsN: KATIE
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ity 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:]

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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 wellarticulated, 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

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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:]

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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 premarket 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 HighRisk 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.

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ing royalties from the manufacturer. These relationships were not

revealed to the patients who received these annuloplasty rings.

Moreover, Edwards had sold these devices for 21⁄2 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 highrisk 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

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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:]

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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.

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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

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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.

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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 everyVerDate 17-JUN-2003 13:12 Nov 09, 2011 Jkt 000000 PO 00000 Frm 00074 Fmt 6633 Sfmt 6633 C:\KATIES\DOCS\70525.TXT KATIE PsN: KATIE
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thing 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.]

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