[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]
DISCUSSION DRAFT OF THE FOOD AND DRUG ADMINISTRATION GLOBALIZATION ACT
LEGISLATION: DEVICE AND COSMETIC SAFETY PROVISIONS
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED TENTH CONGRESS
SECOND SESSION
__________
MAY 14, 2008
__________
Serial No. 110-117
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
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COMMITTEE ON ENERGY AND COMMERCE
JOHN D. DINGELL, Michigan, Chairman
HENRY A. WAXMAN, California JOE BARTON, Texas
EDWARD J. MARKEY, Massachusetts Ranking Member
RICK BOUCHER, Virginia RALPH M. HALL, Texas
EDOLPHUS TOWNS, New York FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey CLIFF STEARNS, Florida
BART GORDON, Tennessee NATHAN DEAL, Georgia
BOBBY L. RUSH, Illinois ED WHITFIELD, Kentucky
ANNA G. ESHOO, California BARBARA CUBIN, Wyoming
BART STUPAK, Michigan JOHN SHIMKUS, Illinois
ELIOT L. ENGEL, New York HEATHER WILSON, New Mexico
ALBERT R. WYNN, Maryland JOHN B. SHADEGG, Arizona
GENE GREEN, Texas CHARLES W. ``CHIP'' PICKERING,
DIANA DeGETTE, Colorado Mississippi
Vice Chairman VITO FOSSELLA, New York
LOIS CAPPS, California STEVE BUYER, Indiana
MIKE DOYLE, Pennsylvania GEORGE RADANOVICH, California
JANE HARMAN, California JOSEPH R. PITTS, Pennsylvania
TOM ALLEN, Maine MARY BONO MACK, California
JAN SCHAKOWSKY, Illinois GREG WALDEN, Oregon
HILDA L. SOLIS, California LEE TERRY, Nebraska
CHARLES A. GONZALEZ, Texas MIKE FERGUSON, New Jersey
JAY INSLEE, Washington MIKE ROGERS, Michigan
TAMMY BALDWIN, Wisconsin SUE WILKINS MYRICK, North Carolina
MIKE ROSS, Arkansas JOHN SULLIVAN, Oklahoma
DARLENE HOOLEY, Oregon TIM MURPHY, Pennsylvania
ANTHONY D. WEINER, New York MICHAEL C. BURGESS, Texas
JIM MATHESON, Utah MARSHA BLACKBURN, Tennessee
G.K. BUTTERFIELD, North Carolina
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
_________________________________________________________________
Professional Staff
Dennis B. Fitzgibbons, Chief of Staff
Gregg A. Rothschild, Chief Counsel
Sharon E. Davis, Chief Clerk
David Cavicke, Minority Staff Director
(ii)
Subcommittee on Health
FRANK PALLONE, Jr., New Jersey, Chairman
HENRY A. WAXMAN, California NATHAN DEAL, Georgia,
EDOLPHUS TOWNS, New York Ranking Member
BART GORDON, Tennessee RALPH M. HALL, Texas
ANNA G. ESHOO, California BARBARA CUBIN, Wyoming
GENE GREEN, Texas HEATHER WILSON, New Mexico
Vice Chairman JOHN B. SHADEGG, Arizona
DIANA DeGETTE, Colorado STEVE BUYER, Indiana
LOIS CAPPS, California JOSEPH R. PITTS, Pennsylvania
TOM ALLEN, Maine MIKE FERGUSON, New Jersey
TAMMY BALDWIN, Wisconsin MIKE ROGERS, Michigan
ELIOT L. ENGEL, New York SUE WILKINS MYRICK, North Carolina
JAN SCHAKOWSKY, Illinois JOHN SULLIVAN, Oklahoma
HILDA L. SOLIS, California TIM MURPHY, Pennsylvania
MIKE ROSS, Arkansas MICHAEL C. BURGESS, Texas
DARLENE HOOLEY, Oregon MARSHA BLACKBURN, Tennessee
ANTHONY D. WEINER, New York JOE BARTON, Texas (ex officio)
JIM MATHESON, Utah
JOHN D. DINGELL, Michigan (ex officio)
C O N T E N T S
----------
Page
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 1
Hon. Nathan Deal, a Representative in Congress from the State of
Georgia, opening statement..................................... 3
Hon. Anna G. Eshoo, a Representative in Congress from the State
of California, opening statement............................... 4
Prepared statement........................................... 5
Hon. Gene Green, a Representative in Congress from the State of
Texas, opening statement....................................... 5
Hon. Joe Barton, a Representative in Congress from the State of
Texas, opening statement....................................... 6
Hon. John D. Dingell, a Representative in Congress from the State
of Michigan, opening statement................................. 7
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, opening statement.............................. 10
Hon. Jan Schakowsky, a Representative in Congress from the State
of Illinois, opening statement................................. 11
Hon. Marsha Blackburn, a Representative in Congress from the
State of Tennessee, opening statement.......................... 12
Hon. Lois Capps, a Representative in Congress from the State of
California, opening statement.................................. 13
Hon. Joseph R. Pitts, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 14
Hon. Tim Murphy, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 15
Hon. Edolphus Towns, a Representative in Congress from the State
of New York, prepared statement................................ 165
WITNESSES
Stephen Sundlof, D.V.M., Ph.D., Director, Center for Food Safety
and Applied Nutrition, Food and Drug Administration............ 16
Prepared statement........................................... 19
Marcia Crosse, Director of Healthcare, General Accounting Office. 35
Prepared statement........................................... 37
Stephen J. Ubl, president and chief executive officer, Advanced
Medical Technology Association................................. 75
Prepared statement........................................... 76
Kelvyn Cullimore, Jr., president and chief executive officer,
Dynatronics Corporation; secretary, Medical Devices
Manufacturing Association...................................... 80
Prepared statement........................................... 83
Ami Gadhia, policy counsel, Consumers Union...................... 90
Prepared statement........................................... 92
Elizabeth George, vice president, Quality and Regulatory Affairs,
Philips Healthcare............................................. 102
Prepared statement........................................... 104
Pamela Bailey, president and chief executive officer, Personal
Care Products Council.......................................... 116
Prepared statement........................................... 118
Jane Houlihan, vice president for research, Environmental Working
Group.......................................................... 134
Prepared statement........................................... 135
SUBMITTED MATERIAL
Discussion draft................................................. 16
.................................................................
DISCUSSION DRAFT OF THE FOOD AND DRUG ADMINISTRATION GLOBALIZATION ACT
LEGISLATION: DEVICE AND COSMETIC SAFETY PROVISIONS
----------
WEDNESDAY, MAY 14, 2008
House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:09 a.m., in
room 2123 of the Rayburn House Office Building, Hon. Frank
Pallone, Jr. (chairman) presiding.
Members present: Representatives Pallone, Eshoo, Green,
Capps, Baldwin, Schakowsky, Dingell (ex officio), Deal, Buyer,
Pitts, Murphy, Burgess, Blackburn, and Barton (ex officio).
Staff present: Jeanne Ireland, Virgil Miller, Jack Maniko,
Melissa Sidman, Chad Grant, Ryan Long, Lauren Bloomberg, and
Brin Frazier.
OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. The hearing of the subcommittee is called to
order.
Today we are having a hearing, actually the third, on the
Food and Drug Administration Globalization Act, the draft bill
that Mr. Dingell, myself, Mr. Stupak, and others have proposed,
and today this hearing is specifically on medical devices and
the cosmetic provisions as well. So I will recognize myself for
an opening statement.
Over the last few weeks, as you know, we have discussed the
various food and drug-related provisions in this draft, and the
focus today or the idea of having a separate hearing, if you
will, on medical devices and cosmetics was because we do
believe that these do not need to be basically singled out and
some emphasis put on those specific provisions as they apply to
those industries. In 2006, for example, 183,000 packages of
contact lens solution, which is classified as a medical device,
were called as a result of bacterial contamination, and this
was a product that is classified as low risk, and that simply
shouldn't be happening.
While Congress set out to address initial safety concerns
with these and similar types of products under MDUFMA, or the
Medical Device User Fee and Modernization Act, it is clear to
me that more must be done. The FDA is simply incapable of
meeting the requirements of that legislation to inspect
domestic and foreign device manufacturing establishments. In
MDUFMA, we added a 2-year inspection requirement for device
manufacturing companies. However, according to GAO findings,
the FDA inspects these establishments on average only every 3
years for high-risk devices and every 5 years for medium-risk
devices, and I would be curious to know what the inspection
frequency is for low-risk devices.
Perhaps even more disturbing are the inspection rates for
international manufacturers of medical devices, which are
estimated to be on average every 6 years for high-risk devices
and an incredible 27 years for medium-risk devices, and while
the market for these products becomes increasingly global, the
FDA has no requirement to inspect foreign establishments
manufacturing medical devices, again a clear gap in authority,
and it is up to us in Congress to act to allow the FDA to do
its job and protect the American people.
Of further concern is the FDA's use of a risk-based
classification system. While I understand that there are
inherently more risks with Class III medically implanted
devices as with the class I contact solution, this
classification is based only on the nature of the product and
does not take into account information related to the actual
manufacturers, and this is especially concerning when the FDA
appears unable to accurately report information on the number
of medical device facilities both in the United States and
internationally. Two databases exist at FDA to monitor and
track inspections and yet these systems cannot exchange
information and are fraught with inaccuracies. One system
reports that there are nearly 5,000 foreign establishments
registered with the FDA for Class II and III products while the
other system reports that there were over 25,000 such
establishments internationally. This difference is significant
and again illustrates the FDA's inability to meet current and
emerging regulatory responsibilities.
These concerns were echoed in a 2007 report issued by the
FDA's Science Board that found disparities between the FDA's
responsibilities and available resources including inadequate
inspection of manufacturers, an obsolete technology
infrastructure, an insufficient basis to access, integrate and
analyze data, and frequent system failures. These weaknesses
jeopardize the FDA's ability to fulfill its mission of
protecting the American people and must be addressed.
Now, turning to cosmetics and personal care products, it
seems to be basic logic for Congress to include this industry
in our discussion today as this industry is largely governed by
legislation established way back in 1938. Cosmetics and
personal care products are used by Americans each and every day
and yet these billion dollar industries have gone largely
unregulated. Under current Federal law, the FDA cannot require
companies to test cosmetic products for safety before
marketing. They cannot review or approve cosmetic products
before they are sold to the public. They can't regulate
cosmetic products until after they have reached the
marketplace, and they cannot require product recalls and they
can't require manufacturers to register their cosmetic
manufacturers, ingredient information or report cosmetic-
related injuries. Instead, the FDA has to rely on a voluntary
reporting system that clearly lacks the means for a systematic
examination of the safety of the cosmetic industry.
Further, this voluntary system has been used as rationale
against calls for reform in the industry. FDA estimates that
over the 3 decades during which the voluntary Cosmetic Industry
Review, or CIR, process has been in existence, only 11 percent
of the ingredients used in cosmetic products have been
reviewed. In addition, countries in the European Union have
actually banned the use of certain ingredients in cosmetic
products yet there are no restrictions in place in the United
States, and some studies suggest that there are a vast number
of products on the market that contain prohibited chemicals
that have been deemed unsafe for use by the industry's own CIR
review process. This is to me overwhelming evidence that the
FDA must be empowered with the authority to regulate this
industry to protect the public.
I just want to thank all the witnesses for appearing today.
I know we are going to have a good discussion.
Mr. Pallone. I now recognize, Mr. Deal, the ranking member,
for 5 minutes for an opening statement.
OPENING STATEMENT OF HON. NATHAN DEAL, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF GEORGIA
Mr. Deal. Thank you, Mr. Chairman.
We are each reminded every day on a regular basis of
potential holes in FDA's current inspection and safety system.
As we hear of new threats presented by certain imported
products. Just yesterday, I had an interview to discuss the
possible lead contamination of dental crowns imported from
facilities in China. Some fear these crowns may have
contributed to adverse health events in patients who
unknowingly were receiving a product made in China.
Events like this one highlight the dwindling confidence the
American public has in the FDA's ability to ensure the safety
of the products it regulates. As we discuss these issues at
today's hearing, I hope we can evaluate whether it is the case
that the FDA has adequate authorities but insufficient
resources or if the Agency does not even have the authorities
necessary to protect the American consumer. My sense from some
of our past hearings is, this problem ultimately comes down to
insufficient resources at the Agency.
While user fees may seem like the only option to some
members of this committee, these fees only further raise
questions about an inappropriate relationship between the
regulated industry and the Agency. Just last year, this
committee significantly increased the fees paid by the device
industry for product reviews and it added a facility
registration fee. Now it seems we are contemplating even
further fee increases well above those negotiated less than a
year ago. One aspect in particular of a facility fee structure
which has concerned me is the possibility the fees paid by a
domestic facility would help pay for the inspection of a
foreign facility. If there must be a fee, it seems fair to me
that the fee structure would account for the differences in the
cost to do the inspections at different facilities. It is also
my understanding some device manufacturers have expressed
concern about the requirement for a facility inspection prior
to marketing approval of certain devices. I would hope our
witnesses could elaborate further on this particular subject.
We certainly should be examining these safety issues but I
am also afraid our ability to evaluate the effectiveness of the
current authorities for the FDA is undermined by their lack of
resources to carry out these authorities. While user fees may
be the only method to provide this funding available to this
committee, we really must question whether or not our
dependence on fees from the industry is supplanting money which
more rightfully should be provided by appropriations.
With that, Mr. Chairman, I yield back my time.
Mr. Pallone. Thank you, Mr. Deal.
I recognize the gentlewoman from California, Ms. Eshoo, for
an opening statement.
OPENING STATEMENT OF HON. ANNA G. ESHOO, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Ms. Eshoo. Thank you, Mr. Chairman. I am very glad that we
are having this hearing today. I think it is an important one
to address FDA's oversight of medical devices and cosmetics,
and I want to thank the witnesses that are here today for being
with us to testify.
Medical devices, and I have done a lot of legislative work
in this whole area on medical devices to reform our practices
at the FDA relative to them. It was complicated work but I
think that we did important work on it, established user fees
for people that are a part of this. Why? Because it really
plays a very important role in healthcare in our country, and I
think it is critical that we ensure the safety of the devices
as we struggle to do that. I don't think we have accomplished
everything on it relative to food and drugs.
It is also important for us not to overlook the unique
nature of these devices, which makes them different from drugs,
and I think the Congress has come some distance on that, and
that a singular regulatory scheme might not be suitable for all
types of products. We are all painfully aware of what has made
its way into the country and how it harms Americans. The
newspapers are full of those stories, so we have a ways to go
on this, and I want to be part of getting there.
This legislation, Mr. Chairman, groups drugs and devices
and holds them to the same standard of inspection, but I think
that we have to look at the components of a device, and I think
that this is where we need to hone in, because even a low-risk
device has, I think, some other characteristics to it. A low-
risk Class II device such as X-ray equipment or an ultrasound
machine, there may be hundreds or even thousands of parts that
comprise that machine and go into making that into a device.
The devices are currently inspected and approved by the FDA as
finished products and every component has to work correctly, of
course. Otherwise the total of the device is not going to be
effective for the patient. Now, under the Globalization Act,
each facility which products every nut, each bolt and the
circuit boards that go into a device would require an FDA
inspection. I think we have to look closer at this. I don't
know if that is where we want to go. I don't have the perfect
answer but I think that in the draft of this that we have
overlooked it. So the number of facilities that would have to
come under inspection on that could be insurmountable, and I
don't know whether inspecting every nut and bolt in different
facilities is what we intend to do.
So I think that this is an important journey that we are
on. I want the highest standards for the American people and I
think that that is what we have to keep our eye on, but if we
go into semiconductor chips, circuit boards, software, flat
panel displays of these sophisticated devices across many
facilities, I don't know if that is how we want to spend our
time.
So I look forward to working with you. I have some
questions obviously for our witnesses. Thank you again for
holding this very important hearing.
[The prepared statement of Ms. Eshoo follows:]
Statement of Hon. Anna G. Eshoo
Thank you Mr. Chairman for holding this important hearing
on legislation to address the FDA's oversight of medical
devices and cosmetics and my thanks to the witnesses for
testifying today.
Medical devices play an increasingly significant role in
healthcare and it is critical to ensure the safety of these
devices as we do with food and drugs. It's also important for
us not to overlook the unique nature of these devices which
makes them different from drugs, and that a singular regulatory
scheme might not be suitable for all types of products.
I support periodic and consistent inspections of facilities
that manufacture active pharmaceutical ingredients as well as
fully constituted drugs. We know all too well the dangers of
unsafe drugs that have made their way onto pharmacy shelves and
the identification of potential hazards from the component
ingredients of a drug can be critical. This legislation groups
drugs and devices and holds them to the same standard of
inspection, requiring that all components of a device, even a
low-risk device, have their facilities inspected.
For a low-risk Class II device, such as X-ray equipment or
an ultrasound machine, there may be hundreds or even thousands
of parts that go into making that device. These devices are
currently inspected and approved by the FDA as finished
products and every component must work correctly. Under the FDA
Globalization Act, each facility which produces every nut, each
bolt, and the circuit boards that go into a device would
require an FDA inspection. The number of facilities subject to
an inspection under such a regime could be insurmountable and
cripple the FDA's regulatory process. The unintended
consequences of requiring component part inspections will be
long and debilitating delays for medical imaging devices to
come to market. It's also not clear to me that the FDA has the
appropriate expertise to inspect the high-tech equipment such
as semi-conductor chips, circuit boards, software, and flat
panel displays that go into many of these sophisticated
devices.
I look forward to hearing from our witnesses today and the
discussion we will have on ensuring the safety of medical
devices.
----------
Mr. Pallone. Thank you, Ms. Eshoo.
The vice chair of the subcommittee, Mr. Green from Texas.
OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TEXAS
Mr. Green. Thank you, Mr. Chairman, for holding the third
and final hearing today on the Food and Drug Administration's
Globalization Act discussion draft. This week we will be
discussing the device and cosmetic provisions in this draft.
As we found in previous hearings, it is clear the FDA does
not have the resources or the authority to effectively protect
the American people from potential health risks. The FDA is
responsible for medical device safety in the United States and
for foreign devices entering the country, but as noted in our
previous hearing on drug safety, FDA does not have ability to
require foreign facilities to allow inspectors even in the
facilities. The GAO estimates the FDA has inspected foreign
Class II manufacturers once every 27 years and foreign Class
III manufacturers once every 6 years. Clearly the FDA does not
have as many inspectors as it needs to conduct these
inspections and has not effectively adopted a third-party
inspection program.
The GAO has also noted the FDA has two separate databases
that are not compatible, which are used to provide the FDA with
information on foreign medical device establishments. This has
severely limited the FDA's ability to track medical device
establishments.
While the FDA has some authority for regulating devices,
they have very limited authority when it comes to regulating
cosmetics. In fact, the FDA does not have the ability to recall
cosmetics. It can monitor companies that issue recalls for a
product, but if a company is unwilling to recall an unsafe
product, the FDA only has the ability to issue a written
request for a recall. The FDA does have the ability to inspect
cosmetic manufacturing facilities but does not have a
comprehensive or compatible database of manufacturers of
product. Currently, registration for the database is voluntary.
This means the FDA does not know what products are on the
market and what ingredients are even in these products.
It is astounding that the FDA has relied on manufacturers
and industry to self-regulate medical devices and cosmetics for
this many years. The risk-based approach that FDA has resorted
to during this time of limited resources and restrictions seems
like a disaster waiting to happen. We need to allocate
resources and increase the FDA's authority so they can protect
Americans from potential health risks.
Thank you, Mr. Chairman. I yield back my time.
Mr. Pallone. Thank you, Mr. Green.
Our ranking member of the full committee is here. The
gentleman from Texas, Mr. Barton.
OPENING STATEMENT OF HON. JOE BARTON, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TEXAS
Mr. Barton. Thank you, Mr. Chairman.
Last evening on the House Floor, I had a very cordial
conversation with Full Committee Chairman Dingell in which he
strongly encouraged myself and other Republicans to work with
you and the other Democrats on the subcommittee to craft a
bipartisan food and drug safety bill, or I believe we talked
about a food and drug import bill, and I told him that I had
some concerns but that I would definitely encourage all
Republicans to engage in a good-faith effort to see if we
couldn't find a bipartisan bill, and I have instructed my
committee staff to do that.
So in the spirit of that, I want to start off today by
saying while it is a fact that in the draft that has been out
for several months, medical devices were a part of that draft,
so it is not that there is a surprise there, but the focus has
been in our hearings and the focus has been in our discussions,
at least my discussions with Chairman Dingell, that we were
going to focus first on food safety, then drug safety, and we
really hadn't discussed medical devices. The draft on medical
devices, in my opinion, doesn't even deserve to be a part of
the discussion. It doesn't mean we shouldn't look at medical
devices but I think there are such differences that we should
discuss the medical devices as a stand-alone issue.
I would also say that what is in the draft on medical
devices, in my opinion, seems to be overkill and probably non-
implementable in the real world. There are between 35 and 50
Class III medical devices that are approved each year. These
are complex devices and it might make some sense to require
pre-approval inspection. However, there are another 3,500 of
less complex Class II medical devices that are approved each
year. To require each of those facilities to have a pre-
approval inspection is a waste of resources. It will only
increase costs to patients and, as far as I can tell, no
demonstrable safety benefit, and would needlessly delay these
therapies getting to the patients.
The bill would also call for a pre-inspection of all device
parts. This is another example of the draft failing to
recognize the difference between drugs and devices. A medical
device part could be a circuit board. It could be a battery. It
could be even a screw. A battery is not the same thing as
heparin.
Finally, I want to reiterate a point that I made at the
hearing several weeks ago. During the debate on medical device
user fee reauthorization last year, I expressed and other
members of the Committee expressed serious concern over the
level of user fees being paid by the industry. Last year the
medical device industry doubled its funding commitment to the
FDA from $150 million to $300 million. We should pay some close
attention to the clear warnings before we made the FDA even
more reliant on the industry that it is supposed to oversee.
This bill would create, in addition to that, a new set of user
fees for medical devices. I would like to point out to the
members of the Committee that the Congress already has, as I
just said, a user fee for medical devices.
So I am not trying to be too critical, Mr. Chairman. I
just--if we are going to do a food safety bill, let us do a
food safety bill. If we want to do drug safety, let us do a
drug safety bill. I think you can combine those. I do not think
medical devices should be a part of the bill. If we are going
to really look at medical devices, I think you should split it
up and do that as a stand-alone bill.
And with that, Mr. Chairman, I yield back.
Mr. Pallone. Thank you.
Next I next recognize the chairman of the full committee,
Mr. Dingell.
OPENING STATEMENT OF HON. JOHN D. DINGELL, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN
Mr. Dingell. Mr. Chairman, I thank you for your courtesy
and I commend you for your diligence in holding this series of
legislative hearings to focus on what resources and authorities
the Food and Drug Administration needs to adequately protect
the public health.
The third and final hearing today will discuss and focus on
the device and cosmetic industry safety provisions in the
discussion draft. I want to indicate that the discussion draft
has been produced to afford us the opportunity to receive the
comments and understand the concerns and feelings of everyone
who would be affected by this legislation, from consumers to
manufacturers to importers. And I am very anxious, as I have
indicated to my good friend, the ranking Minority member, my
friend, Mr. Barton, that we are anxious to work together with
him to address this problem, which is a very real one and one
which offers real threat and peril to the American people.
The same issues that challenge FDA's ability to properly
oversee Food and Drugs in an increasingly global marketplace
also plague the Agency's ability to regulate medical devices
and cosmetics, and I want to point out that it is not the
intention of the authors of the draft to create undue burdens
on American industry but rather to see to it that foreigners
meet the same standards in terms of safety and efficacy to
American consumers as do domestic producers, and I would point
out that Food and Drug's total inability to investigate the
behavior of foreigners manufacturing goods elsewhere is a
matter which hurts American manufacturers by assuring that
American manufacturers face unfair, dangerous competition and
they face the importation of substances and devices which offer
real threat, not just to consumers but, quite frankly, to the
goodwill that our manufacturers have been trying to build for
so long. I would point out that were it not for the simple fact
that our commitments under GAT and WTO force us to treat all
marketed commodities in this country whether they are domestic
or otherwise alike, we might perhaps be able to address this a
little more focused on foreign misbehavior.
It should be noted that the FDA Science Board in 2007
reported that FDA's ability to carry out its mission in the
case of medical devices is grossly inadequate and that due to
constrained resources, lack of adequate staff, FDA is engaged
in reactive regulatory priority setting or a firefighting
regulatory posture instead of pursuing a culture of productive
regulatory science. In other words, people should be concerned
about the inadequacies of Food and Drug to carry out its
mission and to protect the American consumers, and
parenthetically, to protect American industry from unfair
competition by people who are not being regulated by FDA, which
unfortunately oftentimes doesn't even know where the people
abroad that they are supposed to be looking at might happen to
be located or, indeed, who they are.
This unfortunate news has been confirmed in recent
testimony of the Government Accountability Office, the GAO,
before the Subcommittee on Oversight and Investigations, which
found that the FDA was not able to make the required inspection
every 2 years of domestic facilities where the highest-risk
medical devices are manufactured, and I would point out that in
the hearings of this committee in time past, we found that
things like heart valves were not being properly and safely
manufactured and the result with failure of that kind of device
was an instant heart attack with total fatality being the
result to the person who happened to have that particular
device implanted.
So we need to address this. We need to understand that
currently FDA is only able to inspect medium-risk medical
device facilities once every 5 years and high-risk device
facilities only once every 3 years. American consumers, beware.
And the number of inspections for foreign producers is much
worse. The GAO estimated that FDA inspects foreign
manufacturers of Class II devices only once every 27 years, and
foreign Class III manufacturers only every 6 years. Despite the
fact that there are more registered device manufacturers in
China than in any foreign country, Chinese firms can expect FDA
to visit them only once every 50 years. And while cosmetics
currently represent 9 percent of FDA-regulated products
imported into the United States, the number of these imports is
growing, and in spite of small budget increases last year,
FDA's Office of Cosmetics and Colors has been unable to keep
pace with the increasing numbers of foreign cosmetic products,
and I would remind all that we are not talking just about
finished products but we are talking about raw materials and
components, which can offer us greater risk as can the finished
products to American consumers. Witness heparin.
We will hear from two FDA officials today, who I hope will
be forthright in their testimony about the needs of the Agency.
We want to help the Agency, and we look forward to the Agency
helping us to help them. We in Congress can do a better job for
American consumers if we receive frank, truthful testimony from
the people vested with regulatory responsibility.
I want to commend those in the device and in the cosmetic
industry who have stepped forward and voiced their willingness
to work with us to strengthen FDA, and I want to make it plain
that we understand their problems and we are desirous of coming
up with something with which they can live and which will
enable them to compete fairly in a difficult market.
And as we start this effort, we must all keep in mind that
the dire straits which FDA is in and how they impact upon
American consumers, and we need to understand that the Federal
budget along cannot support the growing demands of the Agency,
and we can find time after time where the heads of the Agency
has come in to tell us what a good job they were going to do
and how we could hope in some distant future that they would
have a new and wonderful device and methodology for addressing
these problems. We have been disappointed not only in their
failures but also in them. Industries that benefit from global
marketplace also must share the responsibility of the safety of
products that they sell to American consumers, and they must
face the same situation and the same regulatory impact that
American manufacturers confront.
Lastly, I want to thank the consumer groups and other
stakeholders who recognize the crisis at FDA and who are
committed to working with us on this effort. Following the
conclusion of today's hearing, I intend to begin to work
immediately with my good friend, Mr. Barton, and other members
of the Committee to try and build a strong, bipartisan piece of
legislation using the discussion draft that we are considering
at this particular time.
Mr. Chairman, I commend you for this. I thank you for your
courtesy. I yield back the balance of my time.
Mr. Pallone. Thank you, Chairman Dingell.
Next is the gentleman from Texas, Mr. Burgess.
OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF TEXAS
Mr. Burgess. Thank you, Mr. Chairman, and I want to thank
the chairman of the full committee, Mr. Dingell, for his draft
of the FDA globalization legislation, and I do wish that there
could have been more input from the Minority side. I understand
I am relatively new, but it seems like if we could be present
while you are drafting the draft, it would be easier to get to
a true bipartisan compromise. But nevertheless, in a year where
process and regular order seem to be jettisoned so easily, I am
grateful for this comment and review period. We have got a lot
of work to do, but I believe that this committee sincerely
wants this to be bipartisan legislation, and I stand ready to
offer my assistance to make this a reality. Obviously, while I
can't agree with all of the provisions within the chairman's
FDA Globalization Act, I do welcome the honest and open
discussion about the legislation that will transform the
system.
This year, the subcommittees of Energy and Commerce have
had hearing after hearing after hearing regarding the resources
or lack thereof of the Food and Drug Administration. We have
also had many important investigations such as the heparin
issue, the melamine issue, the ongoing investigation of lead in
dental devices, but while I sit on the Health Subcommittee,
Oversight and Investigation Subcommittee, Commerce, Trade, and
Consumer Protection, I cannot recall any discussion or any
investigation regarding the cosmetic industry. So I am sure
that there are some reforms that need to be made within the
Office of Cosmetics and Colors and the Center for Food Safety
and Applied Nutrition, but I would urge this committee, this
subcommittee to move methodically and deliberately. We
shouldn't just be passing legislation because we happen to be
here.
I would like to address the issue of resources. I respect
the fact that this bill attempts to garner more resources for
the Agency but I do question some of the attempts. We all know
that the Food and Drug Administration, which should be the
premiere Federal agency, has been underfunded for decades. It
is many administrations, both Republican and Democratic, it is
many Congresses, both Republican and Democratic, that bear
responsibility for this problem, but this bill seeks to solve
that by imposing a pass-through tax to consumers disguised in
the form of user fees. So, Mr. Chairman, I call on the
leadership of this committee, the leadership of the
Appropriations Committee and the Speaker of the House to come
together and develop a plan to get the critical resources to
this important agency. This is an authorization bill. Under the
best of circumstances, when do we expect to see one dime
delivered to the Food and Drug Administration? Yet we can do
that through the appropriations process this year if we will
simply pay attention to the process. This committee doesn't
appropriate money but every single member of this committee
knows that this year we will be lucky to pass one
appropriations bill. Chances are, most appropriations will be
passed through on a continuing resolution and so the Agency
will receive level funding yet for another year. Consequently,
unless we take immediate steps to work within the
appropriations process, the Food and Drug Administration will
continue to be underfunded regardless of the number of hearings
that we hold at the subcommittee level.
So we must act and we must act methodically and
deliberately, and Mr. Chairman, you have been generous. I will
yield back the balance of my time.
Mr. Pallone. Thank you.
The gentlewoman from Illinois, Ms. Schakowsky.
OPENING STATEMENT OF HON. JAN SCHAKOWSKY, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF ILLINOIS
Ms. Schakowsky. Thank you, Mr. Chairman. I appreciate the
opportunity to have this hearing today on such an important
issue, keeping our devices and cosmetics safe for American
consumers. I applaud your leadership on these issues as well as
other issues and concerns addressed in your draft Food and Drug
Administration Globalization Act.
Today I would like to address some of my concerns about the
regulation of cosmetic products at FDA, or rather the lack of
regulation. It is under the Food, Drug and Cosmetic Act that
FDA receives its authority to regulate drugs, devices,
cosmetics, and other products. But what many Americans don't
know and in fact, it came as a surprise to me, is that FDA has
little to no authority to actually regulate the personal care
products we use every single day. Furthermore, the original
statute under the FDCA has remained essentially unchanged since
1938. Even the measures that FDA does have the authority to
require such as safety substantiations, labeling requirements
and facility inspections but without the resources to do so,
cosmetics remain widely untested and unregulated. For example,
tests for safety are done by the manufacturers themselves and
are not overseen by the FDA. Additionally, without an actual
standard for what is considered safe, it is hard to imagine
what exactly is passing for safe and arriving on shelves across
America.
Unfortunately, even when FDA does find a deficiency or
violation, it doesn't possess the authority to issue a
mandatory recall and often does not pursue legal action because
the burden of proof rests on the FDA, which has no resources to
carry out investigations or studies of its own. So think about
it. How many personal care products does each of us use every
day? Ten, 25? My concern is that more and more studies are
coming out on the hazards of these products and we simply don't
know enough about them and their long-term effects. We are just
told that they are safe, trust that the industry's voluntary
reporting program works and assume that the FDA has sufficient
authority to act if necessary. Yet according to a letter send
by the Environmental Working Group to FDA Commissioner von
Eschenbach last September, well over 22,000 products--that is
98 percent of all products--contain one or more ingredients
that has never been publicly assessed for safety, not by the
FDA, not by the Cosmetic Industry Review, which is the industry
self-regulation panel, and not by any other publicly
accountable U.S. institution.
By contrast, the European Union has required cosmetic
companies to remove reproductive toxins, mutagens and
carcinogens from personal care products and it now bans more
than 1,100 chemicals from personal care products due to risks
associated with cancer, birth defects or reproductive problems.
In stark contrast, just nine chemicals are banned from
cosmetics in the United States.
That to me is unacceptable and I am so very grateful for
the chairman's efforts to rein in this unregulated industry by
requiring manufacturers to register their facilities, their
products, and their ingredients with the FDA and to submit
serious adverse events relating to the use of its cosmetics to
a registry. This draft legislation would also establish good
manufacturing practices, a big step in the right direction.
So I look forward to working with you, Mr. Chairman, as
well as the rest of my colleagues on the Committee to
strengthen these provisions further. I think that the improving
oversight authority of cosmetics is long overdue, and I look
forward to hearing from our witnesses today.
Thank you. I yield back.
Mr. Pallone. Thank you.
Next is the gentlewoman from Tennessee, Ms. Blackburn.
OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TENNESSEE
Ms. Blackburn. Thank you, Mr. Chairman, for having this
hearing to discuss the device and cosmetic provisions contained
in the draft Food and Drug Administration Globalization Act. I
do appreciate the goal of the legislation, which is to increase
consumer safety in the U.S. import system, and I continue to
support increased transparency and enhanced public safety to
reduce future incidences of tainted products that are entering
the country.
Of course, we have heard, debated, listened to quite a bit
of evidence on that issue in this committee this year, and as
this committee has learned through those numerous hearings,
what we have is the FDA is a broken agency. What we have
learned is, there seems to be very little interagency
communication, that there are too few inspectors, that there
are insufficient resources to complete its core mission, that
there are inadequate IT systems, and as far as we know, since
we have not heard differently, there seems to be a lack of best
practices within the Agency. It seems somewhat out of order for
this committee to legislate new requirements for FDA without
fixing what appears to be their fundamental and structural
underpinning, which is causing problems within the Agency. My
hope is that by the time we get around to the final bill, that
what we will do is prioritize consumer safety with a balanced
approach for consumers and for manufacturers. When legislating
in the name of increased consumer safety, it is critical that
this legislation achieve its desired effect and not severely
restrict the entry of life-saving medical technology into the
U.S. healthcare system. This legislation should not limit
patients' access to important preventative screenings and
diagnostic procedures.
It is well known that the FDA is in need of resources. We
have heard they need hundreds of millions of dollars in
additional funding to increase inspections on both domestic and
foreign manufacturing facilities and to do those in a timely
and orderly manner. Last year, user fees, which are taxes and
they all get passed to the consumer, user fees were increased
under the Medical Device User Fee and Modernization Act, which
was authorized to help defray FDA review costs. Concurrently,
some on this committee complained that increased user fees,
there again taxes, created FDA dependence on drug and device
companies. Well, it concerns me that what we have got is kind
of a here-you-go-again with this bill with these user fees and,
again, read that as taxes, are further increased and appear to
unfairly burden domestic medical imaging manufacturers.
I look forward to discussing the rationale for increased
user fees without creating further dependence on the FDA. I
know we are going to have quite a discussion on this and I have
got more to say, but, Mr. Chairman, I am going to yield back
the balance of my time and look forward to the continuing
conversation on the legislation.
Mr. Pallone. Thank you, Ms. Blackburn.
Next recognized for an opening statement, the gentlewoman
from California, Ms. Capps.
OPENING STATEMENT OF HON. LOIS CAPPS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Ms. Capps. Thank you, Chairman Pallone. I appreciate your
holding this hearing today and I want to commend our Chairman
Dingell for his continued leadership on this very important
issue. As a public health nurse, I believe there is no greater
goal than protecting the public's health and well-being, and of
course, as part of its mission, the FDA is responsible for
regulating all medical devices that are marketed in the United
States, including those manufactured on foreign soil.
Inspections are probably the most powerful tool that the
FDA has to ensure that these devices are safe and effective,
yet growing demands on the Food and Drug Administration have
limited the resources it has available to adequately fulfill
its mission. As a result, inspections are far too infrequent
and unsafe devices have the potential of entering the market
undetected.
But device manufacturers also need to be part of this
process. We need to form a working partnership in order to
guarantee a safe supply. I am pleased that we will have an
opportunity to hear today from both FDA and the medical device
industry about how to make such a partnership work. It is
abundantly clear that the Food and Drug Administration is in
desperate need of additional resources. This fact has been
acknowledged by colleagues on both sides of the aisle, and it
was confirmed by FDA officials testifying before this committee
just this month.
Medical devices are not the only products that may be
compromised by such limitations. The FDA's authority to
regulate the cosmetic industry has been historically limited.
The cosmetic products and ingredients are not currently subject
to rigorous pre-market FDA inspection and approval. It is left
to the cosmetic industry to verify the safety of their
products. This limited oversight, combined with a lack of
product recall authority, greatly constrains the FDA's ability
to protect consumers from potential toxins hidden in cosmetic
products. Without sufficient resources, adequate staff and
robust regulatory authority, the FDA has been relegated to a
reactionary role instead of taking preventive and proactive
measures. This is no way to protect the public's health and
safety. Changes do need to be made, and in order to do this, we
must make a strong commitment to invest in the Food and Drug
Administration, something I have supported throughout my tenure
in Congress.
So I thank the witnesses for taking the time to join us
today, and I look forward to a productive discussion.
Thank you, and I yield back.
Mr. Pallone. Thank you.
I recognize the gentleman from Pennsylvania, Mr. Pitts.
OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Mr. Pitts. Thank you, Mr. Chairman, and thank you for
convening this hearing today on the device and cosmetic
provisions of the food and drug safety FDA.
I have to admit, however, I am a bit confused as to why
drugs and devices have been included in the same title of the
discussion draft. The FDA Amendments Act of 2007 recognized the
distinct differences between drugs and devices and addressed
the two separately, yet several provisions in the draft before
us apply the same requirements to both sectors.
I would like to welcome all of the witnesses, particularly
those from Avamed and Mita and MDMA. I look forward to all of
your comments on this draft legislation.
I think it is important to point out that foreign medical
device manufacturing facilities are already subject to
international quality and safety inspections at least annually
as part of the International Standards Organization, the ISO
13485 standard, a standard virtually identical to the FDA
Quality System regulations. Meeting this ISO standard is a
requirement for medical device manufacturers in 47 countries
worldwide. The FDA should make use of the valuable information
gained from these already required inspections.
Also, the discussion draft requires an inspection every
time a change is made to a medical device and requires
inspections of all component parts. Medical imaging devices,
for example, are updated or improved on average once every 18
months. This could be updated software, the device may have an
added functionality, or it may be able to image another part of
the body. I do not believe that these updates to already
approved products warrant an entirely new facility inspection.
We have all heard about FDA's lack of resources and lack of
inspectors. We can't wait until an FDA inspector comes to a
facility to complete a new assessment to give the go-ahead to a
product that has effectively an 18-month shelf life. Patients
here in the United States need those technologies.
It is also important to note that the FDA classifies
medical imaging devices as Class II, which are considered low
risk. The FDA inspects and approves medical imaging devices as
finished products. I fail to see how inspecting every single
component down to the screws used to hold a device together is
an efficient use of FDA's time or resources. Every screw,
circuit board, and screen must work correctly for the completed
device to function properly and pass its rigorous inspections.
Examining component parts individually would be duplicative and
not be a prudent use of funds. These new inspection
requirements could ultimately end up slowing down the delivery
of improved and updated technology to the U.S. market and
ultimately to patients.
Finally, medical device manufacturers currently pay a
facility registration fee of $1,700 per facility per year to
the FDA. They also pay fees for ISO inspections. However, this
discussion draft includes additional annual facility
registration fees as well as an annual $10,000 importer
registration fee. Let us remember that device manufacturers
voluntarily agreed to almost double the amount of fees they pay
to FDA last year. These new fees are duplicative and do not
provide a direct benefit to the manufacturer. I believe we need
to be careful not to cross from valid user fees into new taxes
on these manufacturers.
I would like to thank all of our witnesses for testifying
today. I look forward to your statements, and I yield back the
balance of my time.
Mr. Pallone. Thank you.
The other gentleman from Pennsylvania, Mr. Murphy.
OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Mr. Murphy. Thank you, Mr. Chairman. It seems as though
much of what can be said has been said, and some of my friends
say one thing and some another, and I agree with my friends on
this, but nonetheless, I want to emphasize here too, and thank
you for this hearing, and hope that part of what we get out of
this in shaping a bill is one that recognizes we do need to
have a more effective system of inspections, not just for its
own sake, but on devices and on these other products. I want to
make sure we are simply not adding more to the cost burden of
these products without yielding results.
In particular, some of the areas I hope our witnesses will
talk about is in the areas of finding those who may manufacture
or bypass or violate some of these rules, and when we are
dealing with foreign companies, it is not hard for them to
simply close that company and show up as another name and
therefore stay under the radar screen with this. One of the
great things about America is, we are able to still be seen as
a leader in inspection and having product safety. However, we
want to make sure that we maintain that position and not give
it up to other countries who are able to bring other products
in here that don't have that.
So I look forward to the hearing here and finding how we
can carefully balance this issue of making sure that we are
able to maintain product safety and not simply overburden the
system with regulations that are not leading to that end, and I
yield back.
Mr. Pallone. Thank you. I believe that concludes our
opening statements, so we will now turn to our first panel. I
would ask our witnesses from the FDA and the GAO to come
forward at this time.
Thank you. Let me introduce each of you. On my left is Dr.
Sundlof, who is Director of the Center for Food Safety and
Applied Nutrition at U.S. FDA. Next to Dr. Sundlof is Lillian
Gill, who is Senior Associate Director of the Center for
Devices and Radiological Health with FDA. I understand she is
not going to be testifying but will answer questions and help
us in that respect. And then next is Dr. Marcia Crosse, who is
Director of Healthcare for the General Accounting Office.
You know the drill, that we hear 5-minute opening
statements they become part of the hearing record, but each
witness may in the discretion of the committee submit
additional statements in writing for inclusion in the record,
and I will start with Dr. Sundlof for 5 minutes. Thank you for
being here.
STATEMENT OF STEPHEN SUNDLOF, D.V.M., PH.D., DIRECTOR, CENTER
FOR FOOD SAFETY AND APPLIED NUTRITION, FOOD AND DRUG
ADMINISTRATION
Dr. Sundlof. Thank you, Mr. Chairman and members of the
subcommittee. I am Dr. Stephen Sundlof, director of the Center
for Food Safety and Applied Nutrition of the Food and Drug
Administration, and as you indicated, with me today is Dr.
Lillian Gill, Senior Associate Director, Center for Devices and
Radiological Health at FDA.
Thank you for the opportunity to discuss challenges posed
by imported medical products and components of cosmetics. We
commend the members of this subcommittee and their staffs for
developing the discussion draft entitled, the Food and Drug
Administration Globalization Act of 2008. We recognize and
appreciate the Committee's efforts to include new authorities
requested by the Administration in support of the Action Plan
for Import Safety.
Foreign-manufactured medical devices must meet FDA
regulatory requirements in order to be imported into the United
States or its territories. These requirements include
establishing registration device listing, manufacturing in
accordance with quality systems regulation, reporting of
adverse events and pre-market notification or pre-market
approval. Initial importers must register with the FDA. Foreign
manufacturers must designate a U.S. agent to, among other
things, facilitate interactions between the FDA and the foreign
manufacturer. FDA inspects foreign manufacturing sites to
assess compliance with FDA requirements and help inform
decisions regarding admissibility into U.S. commerce. FDA
cooperatively works with Customs and Border Protection in
regarding imported products. Products that do not meet FDA's
regulatory requirements may be detained at the border.
Cosmetic firms are responsible for substantiating the
safety of their products and ingredients before marketing. In
general, except for color additives and ingredients
specifically prohibited or restricted by regulation, a
manufacturer may use any ingredient in the formulation of a
cosmetic, provided that the ingredient does not adulterate the
finished cosmetic and the finished cosmetic is properly
labeled.
Cosmetic manufacturers are encouraged to register their
establishments and file a cosmetic product ingredient statement
with FDA's voluntary cosmetic registration program. This
program provides FDA with the best information available about
the locations, business trade names and types of activities of
the establishments that participate in this program. If
manufacturers do not remove dangerous products from the market,
the Agency can pursue enforcement actions against violative
products or against firms or individuals who violate the law.
FDA works closely with all its partners including the
international regulatory authorities on a wide variety of
issues important to cosmetic safety including ingredient usage
and labeling, marketing surveillance, and areas of emerging
science.
The Administration's Action Plan for Import Safety presents
broad recommendations and specific action steps to promote the
safety of imported products under the organizing principles of
prevention, intervention and response. One of the plan's
premises is that the United States must transition from an
outdated snapshot approach to import safety in which decisions
are made at the border into a cost-effective preventive focus
model that identifies and targets critical points in the
import's life cycle where the risk of the product is greatest
and verifies the safety of products at those important phases.
Under the auspices of the Administration's Action Plan for
Import Safety, FDA has many initiatives underway to further
protect and promote the public health. For example, FDA's
Beyond Our Borders initiative is a multi-pronged approach to
promote and verify compliance of imported foods, cosmetics and
medical devices with the FDA requirements prior to importation.
This initiative includes increased FDA presence overseas,
increased FDA inspections, greater sharing and use of foreign
authority inspection reports and other information, use of
third-party certification and increased capacity building with
countries that have less-developed regulatory systems to ensure
product safety.
In order to target our intervention efforts related to
foreign firms, FDA has several plans to enhance its IT systems
in ways that will improve databases, enhance interoperability
of systems within the Agency and among other regulatory
agencies, and provide better analytical function to assess and
control risk.
Finally, when a health threat emerges with a regulated
product, FDA must have the tools to facilitate the timely
recovery of the violative produce, reduce the opportunity for
harm, and secure the integrity of the supply. FDA is working to
facilitate the adoption by industry of track-and-trace
technologies to identify and track the product along the
product's life cycle back to the point of origin. Under the
Food and Drug Administration Amendments Act of 2007, FDA is
working to develop unique identifiers which may support product
identification technologies.
Under new authorities, the Action Plan for Import Safety
called for providing a number of new authorities in order to
enhance the safety of imported products. It requests authority
to establish import certification programs using accredited
third parties to verify compliance of foreign products with
U.S. standards. The plan recommends authorizing FDA to refuse
admission of a foreign manufacturer's product when access to
the foreign manufacturing site is hampered. The plan also
requests authority to expedite destruction of refused medical
products, which will prevent unsafe medical products for
personal use from entering the U.S. market. Finally, asset
forfeiture remedies for certain criminal offenses involving
fraudulent or counterfeit products would allow the forfeiture
of all vessels, vehicles, aircraft, and other equipment used to
aid in the importing, exporting, transporting, selling,
receiving, acquiring, and purchasing of violated products.
We are in the process of reviewing the FDA Globalization
Act discussion draft in detail, and we look forward to working
with you on this legislation. Let me reiterate some general
principles that guided the development of the Action Plan for
Import Safety.
Mr. Pallone. Dr. Sundlof, I hate to stop the FDA witness,
in your case, but you are about a minute and a half over. But
summarize. We don't want to stop you completely.
Dr. Sundlof. Thank you. I think I can stop at this point,
Mr. Chairman.
[The prepared statement of Dr. Sundlof follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pallone. Well, now I did stop you. That wasn't my
intention.
Dr. Crosse.
STATEMENT OF MARCIA CROSSE, DIRECTOR OF HEALTHCARE, GENERAL
ACCOUNTING OFFICE
Dr. Crosse. Thank you, Mr. Chairman and members of the
subcommittee. I am pleased to be here today as you examine
FDA's oversight of medical devices.
At the request of the full committee, we have been
reviewing a number of issues related to FDA's foreign
inspection programs. A variety of medical devices are
manufactured in other countries, including high-risk devices
designed to be implanted or used in invasive procedures. Our
work points to one conclusion: FDA's programs have not kept up
with the globalization of manufacturing and the products that
FDA regulates. FDA's inspections of foreign establishments are
infrequent. The agency's data systems have been rife with
errors and lack fundamental capabilities needed to manage the
programs, and the Agency has faced several challenges unique to
conducting foreign inspections.
Since I first testified about these problems, FDA has
announced a number of initiatives to address these concerns, as
we have heard today from Dr. Sundlof. FDA's initiatives have
the potential to strength FDA's foreign device inspection
program but they do not fully address the weaknesses.
FDA is required to inspect every 2 years all domestic
establishments manufacturing medical devices classified as
being of high risk, or Class III, such as pacemakers and
defibrillators, or medium risk, or Class II, such as syringes
and hearing aids. There is no comparable time requirement for
inspecting foreign establishments, but FDA is responsible for
ensuring that they meet the same standards required of domestic
establishments. We found that FDA has not met the statutory
requirement for domestic inspections of medical device
establishments and foreign medical device establishments are
inspected less frequently, about every 6 years for Class III
devices or 27 years for Class II devices. As of September 2007,
there were about 5,000 Class II and III foreign device
establishments registered with FDA, of which fewer than 300
were inspected last year.
FDA has faced particular challenges in managing its foreign
inspection program. FDA's databases contain inaccurate
information about foreign medical device establishments and the
products they manufacture. A recent change to FDA's medical
device registration process could improve the accuracy of the
registration data. The new process includes electronic
registration with an annual registration fee currently set at
about $1,700.
Another initiative aimed at reducing duplication in its
import database is a proposal that FDA has supported to change
the data it receives from Customs and Border Protection on
products entering the United States. However, the
implementation of this proposal is not certain and would
require action from multiple Federal agencies. In addition,
inspections of foreign medical device establishments pose
challenges to FDA in human resources and logistics. FDA depends
upon volunteer inspectors, lacks independent translators and
has difficulty altering the travel itinerary if problems are
uncovered that might warrant further review. FDA has proposed
establishing a dedicated cadre of staff to conduct foreign
inspections but the overall time frame associated with this
initiative is unclear.
FDA has also announced plans to establish offices overseas
with an initial eight FDA staff to be based in China and five
Chinese nationals to provide translation and other support.
However, the impact that these offices will have on the foreign
device inspection program is unknown because these staff would
be responsible for all FDA-regulated products.
Finally, over the years there has been interest in using
third parties to supplement FDA's inspection resources. We
found, however, that few inspections have been conducted
through FDA's two accredited third-party inspection programs.
In the 4 years since FDA first cleared an accredited
organization to conduct independent medical device inspections,
a total of 11 inspections have been conducted, 6 of foreign
establishments and 5 of domestic establishments.
In conclusion, given the growth in foreign device
manufacturing for the U.S. market and the relatively few
foreign inspections conducted by FDA, the Agency will need to
devote considerable resources to this area if it to increase
the rate of inspections. The agency has recently taken some
positive steps to improve its foreign inspection program
including announcing plans to increase its presence overseas.
However, it is too early to tell whether these steps will
ultimately enhance the Agency's ability to ensure the safety
and effectiveness of medical devices marketed in the United
States.
Mr. Chairman, this concludes my prepared remarks. I would
be happy to answer any questions that you or other members of
the subcommittee may have.
[The prepared statement of Dr. Crosse follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pallone. Thank you, Dr. Crosse, and I am going to start
the questioning by recognizing myself for 5 minutes. I was
going to start with Dr. Gill because you are the device person
but I guess I am directing it to Dr. Sundlof--to Dr. Gill
through Dr. Sundlof. There has been industry interest in the
international harmonization of standards for device inspection.
Specifically, we have heard that industry would like FDA to
adopt International Standards Organization--well, the standards
of--they would like them to adopt the International Standards
Organization standards. That sounds a little weird but that is
what it is. Are there any substantive differences between the
FDA's standards and those of the International Standards
Organization? And what is your opinion on asking the FDA to
move to those standards?
Dr. Gill. Thank you, Mr. Chairman. We have worked for quite
a while, the Center for Devices, with the Global Harmonization
Task Force. In fact, we chaired that task force this year. We
have been working to harmonize our quality system regulation
with many of the standards under the GHTF task force. We find
that their quality system or their ISO inspection 13485 is
pretty close, very similar to ours. In fact, the most recent
FDA Modernization Act allowed us to evaluate foreign inspection
reports, 13485 ISO inspection reports. So we find them to be
very similar. We certainly are developing the criteria under
which we could get the reports in, look at them, determine
whether or not they have met the foreign standard requirements
and to see if they are similar to ours, and we look forward in
the future to figuring out how we can use these in lieu of an
inspection.
Mr. Pallone. OK. Thank you.
And then I wanted to ask Dr. Crosse, in your testimony you
mentioned the third-party inspection programs that are
currently in place and the fact that very few companies have
taken advantage of those programs, even after improvements were
made. Can you explain why this is and make any recommendations
as to how to put in place more incentives for companies to
actually partake in those programs? And then does the FDA need
additional authorities or basically are there ways to make this
work, and how would you go about it?
Dr. Crosse. Thank you. Yes, we did take a look at the
accredited inspection programs and one of the issues that we
hear from industry is that it is not clear at this point that a
single inspection can meet the requirements of both the FDA and
other foreign governments. Is it really that feasible? A few of
the companies that had explored using this program had
determined from the accredited inspectors that they would
actually conduct separate inspections to meet the U.S.
requirement from what they would conduct for, for example, the
European Union, and so at this point I think there are still
some issues to be ironed out. There also is a concern, I think,
on the part of some industry organizations that if you are
hiring an accredited inspector, you are ensuring then that
someone is coming to your door and exposing you to possible
regulatory action. Right now, FDA doesn't come that often and
so if you just sit back and wait for FDA to show up, it could
be many years. So that has worked also as a disincentive for
organizations to hire an accredited inspector, to pay for that
inspection. Right now an FDA inspection does not cost them any
money, and then to face possible penalties that might be
incurred. I think it is too soon to know whether the changes
that were made in the bill last year are going to modify that
but at this point under that accredited inspection program,
only one additional inspection has been conducted since we
testified in January on this. FDA itself has undertaken a
separate pilot program with Canada to try to determine if they
can iron out some of these problems.
Mr. Pallone. Thank you.
Let me ask one cosmetic question. Dr. Sundlof, you
mentioned several areas of concern with the rapidly growing
nature of the cosmetics industry, including increasingly
sophisticated technology and more complex ingredients. Will the
provisions included in the discussion draft, and I am
referencing the mandatory registration, mandatory adverse event
reporting, GMP regulations, will they assist FDA in fulfilling
its regulatory mission concerning cosmetics?
Dr. Sundlof. In terms of requiring that the firms register
and report all of the ingredients, it would at least alert us
to the fact that there may be new ingredients that we may not
otherwise have been aware of were in these cosmetics so in that
respect, yes. The other ones I don't think would particularly
address that issue of the widely emerging new products that are
coming out in terms of new chemicals, new ingredients, et
cetera.
Mr. Pallone. Thank you.
Mr. Deal.
Mr. Deal. Thank you.
I want to follow up on the ISO issue. First of all, how
many countries recognize the ISO 13485 inspections?
Dr. Gill. I don't have that number with me. I would be
happy to provide that. But we do know that those that are in
European Union recognize that.
Mr. Deal. Does China recognize those or do they
participate?
Dr. Gill. China has attended the last Global Harmonization
Task Force meeting. They are scheduled, according to
discussions we have had, to attend the next set of GHTF
meetings.
Mr. Deal. But I would assume it takes action on the part of
a country to incorporate the ISO inspection standards into
their way of doing business in their own country? They have to
formally adopt it. Is that correct?
Dr. Gill. That is my understanding.
Mr. Deal. How long do you anticipate it is going to take to
determine whether or not FDA standards can be harmonized with
ISO standards?
Dr. Gill. We are currently working through looking at the
standards now, looking at the differences and preparing to have
a public announcement of our adoption of some of the standards.
Mr. Deal. I would encourage you to do that as quickly as
possible.
The next question is, in the event that you determine that
ISO standards are sufficient to cover FDA responsibilities,
would it require legislation to allow you to use the ISO
inspections as a part of your mandatory, if we go to a
mandatory, time frames or numbers of inspections? Will it
require that we legislatively build in language that allows you
to accept the ISO inspections?
Dr. Gill. I think if they are harmonized inspections and we
find that they are very equivalent to ours, I am not sure the
legislative changes are absolutely necessary.
Mr. Deal. I would ask you all if you would look at that
because I personally think that is the direction we need to go
in.
Second question is, do other countries require on-site
inspections of American manufacturing facilities? In other
words, the reverse of what we do in overseas inspections.
Dr. Gill. Yes.
Mr. Deal. How do their fees compare with what we charge?
Dr. Gill. I believe many countries may use the ISO
inspectorate. I can certainly find out an answer to that. But
that would be an agreement between the third-party inspector
and the manufacturers.
Mr. Deal. In order for that to be accomplished, the reverse
of what we normally think of here, would it require formal
action on the part of the United States or of FDA to adopt ISO
standards as our standard in order for them to accept our
inspections under ISO privileges and grant reciprocity, in
effect?
Dr. Gill. I would be happy to provide a written response to
that.
Mr. Deal. All right. Thank you.
One of the issues that was mentioned was the Beyond Our
Borders initiative that FDA has undertaken. I think it is going
to be increasingly important for us to try as best we can to
harmonize with other countries that are trying to do the right
thing and be able to work cooperatively in that effort, and I
think it is also going to require that we continue to apply
pressure for those countries that do not move in that
direction, and in that regard, reference was made in Mr.
Dingell's opening statement that we could not--we have to be
careful, I guess under WTO, that we do not differentiate
between domestic and foreign inspection costs, et cetera. But
isn't it true that it is significantly more expensive to do
overseas inspections under our current system than it is to do
domestic inspections?
Dr. Gill. I do believe there are costs associated with
travel in foreign inspections that we don't have to pay for
domestic inspections but we do try to cover at least three
inspections while we are there to minimize that travel cost.
Mr. Deal. One of the things that the Administration asks us
under their safety plan, has asked Congress to grant FDA the
authority to refuse to admit for import products that were
manufactured in facilities that denied FDA inspectors or
hampered their ability to do inspections. Is it true that there
is no authority to discriminate against those countries and
products where you have been, in effect, denied or hampered in
your inspections that we don't have any authority to
discriminate against them currently?
Dr. Gill. Allowing an FDA investigator into a foreign
facility is voluntary, so we--
Mr. Deal. No, I am talking about on our end. What I read is
that apparently you are asking Congress to give you the
authority to discriminate against those products from those
countries or from those plants that have interfered with your
ability to inspect their product. Is that something that needs
statutory changes?
Dr. Sundlof. Yes, I believe it is, and right now we can
detain product if we have reason to believe that it is
adulterated but we have to establish at the port of entry that
it is adulterated. Then we can issue an import alert, and that
prevents it. But we don't have that authority just on the
basis--we can't initiate an import alert on the basis that the
country of origin refused our inspection.
Mr. Deal. Thank you.
Mr. Pallone. Chairman Dingell for questions.
Mr. Dingell. Thank you.
Does FDA currently have an accurate, verified count of how
many foreign device facilities are selling products to the
American people, yes or no?
Dr. Gill. Our new database will help us determine how many
foreign facilities--
Mr. Dingell. So the answer is, you do not have such
information?
Dr. Gill. At this time, I don't believe we have an exact
number.
Mr. Dingell. All right. Now, you have got two--is it two or
three databases?
Dr. Gill. We have about three or four databases.
Mr. Dingell. OK. How many of them talk to each other and
how many of them are integrated?
Dr. Gill. Currently, we are working to make sure that they
talk to each other, but as of--
Mr. Dingell. So at this time you have none of them are
integrated and none of them can talk to each other?
Dr. Gill. Well, we are integrating the electronic
registration database.
Mr. Dingell. So the answer to the question is yes?
Dr. Gill. We do have one or two.
Mr. Dingell. All right. Now, how much is it going to cost
and when will this be done? First of all, how much is it going
to cost, and second, when will it be done?
Dr. Gill. I can certainly provide you an answer with the
cost.
Mr. Dingell. Please submit that for the record. I have a
grand total of 5 minutes here.
Now, does FDA currently have an accurate and verified
accounting of what products these companies are making? The
answer to that question is no, is it not?
Dr. Gill. Until our new system is in and they can list
their products--
Mr. Dingell. I have a limited amount of time. Yes or no?
Dr. Gill. I believe we don't have the accurate account.
Mr. Dingell. Does FDA currently know how many foreign
facilities are actually subject to inspection, yes or no?
Dr. Gill. We are finding that out daily, Mr. Chairman.
Mr. Dingell. Now, Dr. Gill, as we move forward producing
bipartisan legislation to this concern, it would be very
helpful to have the Committee have the Agency's plan of action
for improving its device information system, both its funding
needs and timelines. Does such a plan exist, yes or no?
Dr. Gill. We are developing that plan.
Mr. Dingell. You are developing it, but you do not have it.
When will you have it and when can you submit it to the
committee?
Dr. Gill. I can certainly submit to you the dates when we
will have the plan completed.
Mr. Dingell. You will submit that to us for the record.
Now, Dr. Woodcock said that meeting the Agency's
obligations when she was here before the committee would cost
an additional $100 million. Can you tell us how much you need
to meet the required frequency for domestic device inspections?
Dr. Gill. That also could be provided for you.
Mr. Dingell. Please submit that for the record.
I am told here, according to Dr. Crosse, FDA inspects
relatively few foreign medical device establishments despite
the fact that over 4,200 foreign facilities have been
registered to sell medium- and high-risk devices to American
consumers. Is that accurate?
Dr. Gill. Could you repeat that question?
Mr. Dingell. FDA inspects relatively few foreign device
establishments, according to Dr. Crosse, despite the fact that
over 4,200 foreign facilities have been registered to sell
medium- and high-risk devices to American consumers. Is that
accurate?
Dr. Gill. Yes, that is what we have reported.
Mr. Dingell. Dr. Woodcock testified at the previous hearing
that FDA would need another $225 million to inspect foreign
drug facilities at the same rate that is required currently to
investigate domestic facilities. Can you tell us what the
figure would be for foreign device facilities?
Dr. Gill. We will certainly make that part of the answer we
supply to you.
Mr. Dingell. Now, have you seen the GAO study?
Dr. Gill. Yes, we have.
Mr. Dingell. I want you to submit any criticisms to this
committee you have with regard to the factual and other
questions associated with this study, and I will ask that the
record be kept open so that that may be done.
Now, they said this: ``In summary, we found that FDA faces
challenges in its program to inspect foreign establishments
manufacturing medical devices. In January 2008, we testified
that the two databases that provide FDA with information about
foreign medical device establishments and the products they
manufacture for U.S. market contain inaccurate information
about establishments subject to FDA inspection and could not
exchange information.'' Is that true?
Dr. Gill. According to the report, yes.
Mr. Dingell. All right. They went on to say this: ``Few
inspections of foreign device manufacturing establishments have
been conducted through FDA's two programs for inspections by
accredited third parties.'' Is that statement true?
Dr. Gill. According to the report, yes, we responded.
Mr. Dingell. All right. Now, in this, they further say
this: ``FDA faces challenges conducting inspections of foreign
establishments that manufacture medical devices,'' and they go
on to say, ``FDA lacks accurate data on the number of foreign
establishments subject to inspection.'' Are those statements
true?
Dr. Gill. I think our data is becoming more accurate with
the electronic registration and listing, and we are finding--
Mr. Dingell. Are these statements true?
Dr. Gill. As of the time of the report, yes.
Mr. Dingell. They are true?
Dr. Gill. Yes.
Mr. Dingell. All right. I have so many questions, Mr.
Chairman, I am sort of floundering in a morass.
They go on to say this: ``FDA inspects relatively few
foreign medical device establishments.'' Is that statement
true?
Dr. Gill. It is correct.
Mr. Dingell. Then they go on and say, ``FDA officials told
us it has been difficult to recruit investigators to
voluntarily travel to foreign countries. However, they added
that if the Agency could not find an individual to volunteer
for a foreign inspection trip, it would mandate the travel.
Logistically, foreign medical device establishment inspections
are difficult to extend even if problems are identified because
the trips are scheduled in advance.'' Is that true?
Dr. Gill. Yes, they are pre-announced inspections.
Mr. Dingell. Now, what are you doing about that?
Dr. Gill. Well, we are certainly cleaning up the database
and finding out the inspections that are warranted, the Class
II and Class III who actually registered with us who are
actually exporting product to the United States that we should
go inspect.
Mr. Dingell. Mr. Chairman, I am going to ask that I be
permitted to submit additional questions in writing. I thank
you for your courtesy to me, witnesses. I thank you, and I am
sorry I can't ask more friendly questions of you. Yours is a
great agency, and regrettably, you are crippled by your
inability to carry out your responsibilities.
Thank you, Mr. Chairman.
Mr. Pallone. Thank you, and without objection, so ordered
to submit those questions.
We do have a vote, 11 minutes left. I was going to ask the
ranking member, Mr. Barton, to ask his questions and then we
will recess and come back. There is just the one vote. Mr.
Barton.
Mr. Barton. I just have two or three questions, Mr.
Chairman.
As I said in my opening statement, I am a little confused
about medical devices being included in this particular bill.
We have had major problems with food imports from China, we had
major problems with drug imports from China, but I am not aware
that we have had major problems from medical device imports
from China. Dr. Gill, are you aware of any major medical device
issues in terms of medical devices that are manufactured in
China and sent to the United States?
Dr. Gill. Well, the most recent with the heparin issues
but--
Mr. Barton. Well, heparin is not a medical device.
Dr. Gill. Well, it is used on medical devices but we did
not have any serious issues with those devices.
Mr. Barton. I would ask our witness from the GAO, are you
aware of that?
Dr. Crosse. No, sir, not specifically of devices
manufactured in China, although, as Dr. Gill indicated--
Mr. Barton. Are you aware of any major medical device
issues in terms of medical devices that are manufactured in
China and sent to the United States?
Dr. Gill. Well, the most recent with the heparin issues but
we did not--
Mr. Barton. But heparin, though, is not a medical device.
Dr. Gill. Well, it is used on medical devices, but we did
not have any serious issues with those devices.
Mr. Barton. I would ask our witness from the GAO, are you
aware of that?
Dr. Crosse. No, sir, not specifically of devices
manufactured in China, although as Dr. Gill indicated, the
heparin has affected a number of devices that are now being
recalled.
Mr. Barton. But heparin is a drug.
Dr. Crosse. Yes, but it is used to coat certain things like
catheters that are sometimes used in invasive procedures to
keep clots from forming. And so there is some heparin that is
used in some of the medical--
Mr. Barton. And you are saying the heparin is coated on the
medical device in China?
Dr. Crosse. On certain medical devices. The heparin
manufactured in China has been used to coat certain medical
devices.
Mr. Barton. But if we solve the heparin problem, the device
itself is not--
Dr. Crosse. With those devices, that is correct.
Mr. Barton. OK. Now, on the issue of the number of
inspections that are done on these facilities, I think each of
you testified FDA doesn't conduct its own inspections as
frequently overseas as it does in the United States, and we
have a law that allows the company to ask for a third-party
inspection, but many companies don't do that because they say,
well, if the FDA is not inspecting me, why should I ask for a
third-party inspection that then may result in an FDA
inspection. What if we reversed that and allowed the FDA to
direct a third-party inspection as a substitute for an FDA
inspection? How would that work?
Dr. Gill. Well, certainly in the Import Safety Action Plan
we looked at what would help us to get more information about
foreign facilities, and certainly asking for those foreign
inspections reports would give us that information.
Mr. Barton. But currently the FDA can't direct a third-
party inspection. It has to be done at the request of the
facility, isn't that correct?
Dr. Gill. It is all voluntary.
Mr. Barton. So if we changed it, you could still ask for
the voluntary but if you gave the FDA the authority because of
whatever reason, limited resources, limited time, probable
cause, you name it, to direct a third-party inspector, would
that help address this issue of lack of frequency of FDA
inspections? That is my question.
Dr. Gill. I think we would want to make sure that the third
parties are trained to conduct them so we get the same quality
in the inspection that we get with our own FDA inspections. It
might help.
Dr. Crosse. I would just add that at the current time,
there aren't enough to fill the gap. There are not enough
trained, accredited inspectors to be able to fill the gap to
get inspections up to the level that is required, and also you
would be asking the company then to bear the cost of that
inspection. An accredited inspection program requires the
company to pay.
Mr. Barton. But the concept on the face of it doesn't seem
unworkable?
Dr. Crosse. The accredited inspection program is set up
with the goal that that inspection is equivalent to an
inspection by FDA.
Mr. Barton. And we wouldn't change that. That is all my
questions, Mr. Chairman.
Mr. Pallone. Thank you, Mr. Barton. We will take a recess.
There is only one vote, so we should be back fairly quickly,
and then we can take the rest of the questions for this panel.
The Subcommittee stands in recess.
[Recess.]
Mr. Pallone. The Subcommittee will reconvene, and we left
off with Mr. Barton, so I recognize the gentlewoman from
California, Ms. Eshoo, for questions.
Ms. Eshoo. Thank you, Mr. Chairman. Let me ask the
following questions. In the legislation, I believe there is a
pathway for inspections, and how we operate today and where we
want to go obviously, the legislation puts forth the way. What
I would like to examine with the FDA is, what are the ISO
standards today? How high are they? Do they meet with FDA
standards? And what you bring to inspections of devices sent
into our country, is it better to inspect in the facilities
abroad? How effective is your inspection here? And so I would
like to examine that area because most frankly I am not so sure
how it works, how well it works, and what you think of it.
What I want to say, and this is just a general observation,
and we don't have very many members here so I am going to be
speaking to three other people. Most frankly, I think if I were
the FDA Commissioner, I would bring forward a list to the
Congress and this Committee and say, these are all of the
responsibilities that you have charged us with in order to
protect the American people. We have the resources to do the
following. You know, we may have given the FDA 79 things to do,
all very, very, important, and the Agency not having the
resources to carry the rest out. I have said consistently here,
we cannot remain content with user fees. They are important. I
helped to establish them. But having said that, I don't believe
the Congress is funding the Agency the way it needs to be
funded in order to carry out these all-important mandates
including the ones that we are looking at in this legislation.
So can you take us through the inspections? How robust are
they and compare and contrast the two standards for us. I think
Dr. Gill is going to address this.
Dr. Gill. Yes.
Ms. Eshoo. Thank you.
Dr. Gill. First of all, we have our quality system
inspection that we use to conduct our G&P inspection. There is
an ISO standard that is very similar, and that is the 13485
that looks at many of the same components that our quality
system inspection looks at. Where I think the major differences
lie and it is what is covered in the FDA inspections. We
include not only G&P--
Ms. Eshoo. Is it a higher standard? That is what I want to
know.
Dr. Gill. It includes many more element--
Ms. Eshoo. It does?
Dr. Gill [continuing]. And some of the difference is also
in the depth of our inspection. We inspect to the regulation.
We of course look at whether or not they have--
Ms. Eshoo. And how often do you do that?
Dr. Gill. We do the FDA inspection every time we go, and we
have two levels of inspection. We have an abbreviated quality
system inspection and we have a full inspection.
Ms. Eshoo. This is when products are coming into the United
States?
Dr. Gill. This is the inspection technique process that we
use regardless. We use it in foreign manufacturers, we use that
in domestic manufacturers. We don't inspect product at the
border as it is coming in, we inspect the manufacturing
facility.
Ms. Eshoo. How often do you do that?
Dr. Gill. As the report says, we are conducting domestic
inspections for Class III devices about once every three years
and Class II--
Ms. Eshoo. Are you satisfied with that statement?
Dr. Gill [continuing]. Every five. According to our risk-
based scenario, it is covering our most critical high-risk
issues.
Ms. Eshoo. OK. Let me just get another question in. I still
think this still needs some more exploration. I raised in my
opening statement the whole issue of the component parts for
medical devices, circuit boards, software, et cetera. Do you
want to comment on that? I don't think FDA knows how to inspect
those things?
Dr. Gill. Our current law requires the manufacturers to be
responsible. Devices, as you stated, are made up of multiple
components, and we have, in our law, said the manufacturer is
responsible for making sure that the components that they
purchased to include in the finished product--
Ms. Eshoo. So if the device fails--
Dr. Gill [continuing]. Still qualify for--
Ms. Eshoo. If the device fails, then the responsibility is
on the company?
Dr. Gill. It is on the company. We do go in and inspect
whether or not they have looked at all components to their
product to make sure that they were acceptable according to the
standard.
Ms. Eshoo. Thank you. And my time is up. Thank you, Mr.
Chairman.
Mr. Pallone. Thank you. The gentleman from Indiana.
Mr. Buyer. Thank you. I would like to do some follow-up on
the question that Mr. Deal had asked earlier just for clarity
purposes to the FDA. During these inspections and you have a
foreign government that will not cooperate or you have a
company in a foreign country that doesn't cooperate with an
inspection, are you asking us for specific statutory authority
so that you could prevent those products from entering into the
United States market?
Dr. Sundlof. Yes, sir. The Import Safety Action Plan
specifically asks for authority to deny importation of products
if we are denied access to those foreign firms.
Mr. Buyer. And if this Committee were to take affirmative
action to include that in this bill, that provision, of course,
you would support that?
Dr. Sundlof. Could you repeat the question, please?
Mr. Buyer. If we took that and put this in the bill,
obviously that is something that you would support?
Dr. Sundlof. The administration has support--now obviously,
we would have to see exactly what the language said but--
Mr. Buyer. All right. You don't have to dance. I just want
you to know, we are trying to help you, right? OK.
Dr. Sundlof. Thank you, sir.
Mr. Buyer. You don't have to do that kind of answer. Are
you aware of any trade agreement issues that might arise from
the bill's $10,000 import registration fee on how that could be
interpreted?
Dr. Sundlof. I don't have the answer to that. We can get
you an answer in writing. I think the kind of trade agreement
concerns that we had specifically looked at having higher
standards for imported products than we do for our domestic
products. We need to make sure that any legislative language
would not interfere with our trade agreement.
Mr. Buyer. Well, that would be my hope also. To be helpful
to us and to the GAO, if you, in cooperation with other
departments or agencies, recognize that if we were to actually
put a $10,000 import registration fee and it is against any of
our trade agreements, we need to know about that. So please let
the Committee know in writing.
I have some concerns that there are approximately 3,800
pre-market notifications a year and the majority are Class II
devices, given your testimony on the drug side of this bill and
how much effort it is going to take for you to do staffing and
resources necessary to inspect on the drug provisions of this
bill, what are your concerns regarding the provisions in the
bill with regard to--how are you going to be able to do the
staffing and how are you going to be able to do all of what is
required in this bill given your present level of
appropriations?
Dr. Sundlof. I believe with all the new authorities that
this bill would offer, we would need additional resources to be
able to accomplish all of the new authorities that we would
have. And exactly what that is, the dollar amount, I can't say.
One of the things that we say in our Import Safety Action Plan
and that has been addressed in this bill as well, the use of
third parties. Depending upon how extensively we took advantage
of those third parties would have a major impact on what we
need to staff. In other words, FDA inspectors versus what we
would be relying on third parties to accomplish without us
having to fund them.
Mr. Buyer. Section 210 of the bill provides for civil
penalties, and civil penalties were placed in the Food, Drug
and Cosmetic Act of 1990. Are you aware of how many civil cases
the FDA has brought against the device industry since 1990?
Dr. Gill. I don't have that number offhand, but I know we
have taken some civil money penalty cases.
Mr. Buyer. Would you please provide in writing the number
of civil penalty cases since 1990 and at what amounts and why
they were--
Dr. Gill. We certainly will.
Mr. Buyer. --by industry? You don't have to do it by
industry, I only want it for the device industry.
At this moment, I am going to yield to Mr. Deal if he has
any further questions he may have with regard to those foreign
inspections so we can get the right and appropriate language
given the questions he had asked earlier. I yield to the
gentleman.
Mr. Deal. I thank the gentleman for yielding. I understand
that there was a letter written to the Committee by the
European Union. Do you have that here? I am trying to get a
staff to get it for us. Apparently they are claiming that any
import fee would be in violation of WTO rules. Are any of you
aware of that issue being raised by the European Union?
Dr. Gill. I am not aware of that issue.
Mr. Deal. I think it is a concern that we need to be
looking at. Dr Crosse?
Dr. Crosse. No, I am not aware of that issue, either. There
currently is a registration fee that is being charged to all
medical device firms.
Mr. Deal. And I had earlier asked if foreign countries were
also coming in and charging fees of our manufacturers, and I
have had several people during the break assure me that they
are and that the fees that they are charging to American
manufacturers are significantly more than they are charging to
their own domestic manufacturers. Hopefully I will have that
copy of the letter and we will put it in the record perhaps
before the end of the hearing. I would ask you all if you would
take a look at that issue. We don't need to do something that
is going to provoke a WTO fight or retaliation and all the
things that we know go along with those kind of disputes. If
there is a way we can achieve our purposes short of that, then
I would think we would all hopefully work toward that; and I
would follow up, too, with Mr. Buyer on that line of
questioning as to your action plan as it relates to the
statutory language. I have not personally seen any suggested
language on that. This would be the appropriate place in my
opinion for us to try to get that statutory authorization that
you think is appropriate, and I would urge you to make that
available to us as soon as possible because I assume we are
going to be marking this bill up some time in the very near
future in this committee.
I appreciate the gentleman yielding. Thank you. I will
yield back.
Mr. Pallone. The gentlewoman from Illinois, Ms. Schakowsky,
for questions.
Ms. Schakowsky. Thank you, Mr. Chairman. Do any of you know
whether or not balloon catheters are imported ever?
Dr. Gill. I will check on that and get back to you.
Dr. Crosse. According to the registration date, certain
types of balloon catheters used in angioplasty are among the
top devices imported from foreign countries.
Ms. Schakowsky. There was a Supreme Court case, Regal v.
Medtronic, where the Regals sued the medical device company for
injuries that Mr. Regal sustained when the balloon catheter
that was used by this physician burst in angioplasty. And the
Supreme Court ruled in favor of Medtronic and found that FDA
regulations preempted state civil matters. And my concern is
this. If we are doing an inadequate job of inspecting, of
assuring the safety of the devices, and yet any other actions,
either state actions or court actions, are precluded because
the FDA is the final authority, then it seems to me that we are
leaving people without options and at risk, and important
ability for states and individuals through a private right of
action that might be an incentive for these products to be
safer is precluded. So I just wondered if anybody had a comment
on whether or not the ultimate authority--if consumers can
really depend now on the FDA to be the ultimate authority on
the safety of these products.
Dr. Gill. I don't have any current comment on that. I think
many of our products of our safe. We do have a reporting system
that lets us know from all users as well as consumers when
there are problems with products, and for the most part, we are
finding devices are safe and we are actively investigating
those that are not.
Ms. Schakowsky. Would you argue, Dr. Crosse, that the GAO
report would endorse that assessment?
Dr. Crosse. I think we have concerns about the current
level of oversight that FDA is able to employ, both for medical
devices and for drugs.
Ms. Schakowsky. Let me ask about cosmetics. It is my
understanding, Dr. Sundlof, that in response to an
Environmental Working Group Petition in 2005 that the FDA
responded, ``The Food, Drug and Cosmetics Act contains no
provision that requires demonstration to FDA of the safety of
ingredients of cosmetic products prior to the marketing of the
product.'' Is that correct?
Dr. Sundlof. That is correct. There is no pre-market review
of cosmetics.
Ms. Schakowsky. But you do have a requirement that
manufacturers adequately substantiate their products for
safety, is that not correct?
Dr. Sundlof. Yes, that is correct.
Ms. Schakowsky. Are you able to provide our Subcommittee
with FDA's definition of safe?
Dr. Sundlof. I can provide that to you in writing.
Ms. Schakowsky. My understanding is that there is no FDA
definition of safe.
Dr. Sundlof. In the area of cosmetics, I will have to go
back and look into that. There certainly are definitions of
safe for foods and medical products.
Ms. Schakowsky. Check that. I would be interested because I
have been told that there is no definition for safe for these
cosmetics. Does the Agency develop guidelines for industry and
what should be done on their part to substantiate safety?
Dr. Sundlof. I am sorry, could you repeat that?
Ms. Schakowsky. Are there guidelines developed by the FDA
to substantiate safety that manufacturers have to follow?
Dr. Sundlof. The FDA participates in the international
community with programs that establish what the criteria are,
what kind of testing criteria are used to demonstrate certain
kinds of safety, and those have been in effect for a number of
years.
Ms. Schakowsky. And when the companies substantiate their
products before they are sold, who do they submit the data to,
the FDA?
Dr. Sundlof. They are not required to submit data to the
FDA. If it turns out that there is a safety issue associated
with a particular cosmetic, the FDA has the authority to
inspect that facility and determine whether or not the company
has done an adequate job of demonstrating the safety before
they entered the product in the market.
Ms. Schakowsky. Thank you. Mr. Chairman, may I ask one more
question? It is my understanding that the industry-funded
safety panel, the Cosmetic Ingredient Review Panel, has only
reviewed 11 percent of the over 12,000 ingredients in personal
care products over its 30-year history. So I am concerned that
this panel might not be up to the job. And in your testimony
you state that FDA estimates that within their voluntary
registration system, there is product information from just a
third of all domestic manufacturers. So what do you think it
would take to review all ingredients used in personal care
products, what kind of data does FDA currently have on chemical
ingredients most commonly used in personal care products, and I
guess finally, do you think that the work that is being done to
guarantee safety currently is sufficient?
Dr. Sundlof. Certainly, the law as it currently is written
allows virtually anything to be incorporated into cosmetics
with certain exceptions that are specifically prohibited under
the Act. The reminder of your questions I think we would need
to go back and we can provide you with an answer in writing.
Ms. Schakowsky. I just wondered, Dr. Crosse, if I haven't
read the whole report, if you deal with that in your report?
Dr. Crosse. No, I am sorry, we do not look at cosmetics at
all.
Ms. Schakowsky. Thank you. Thank you, Mr. Chairman.
Mr. Pallone. Thank you. And that concludes our questions of
the first panel. I want to thank you very much for answering
the questions and for your testimony. As you know, we do intend
to move toward the marking of this bill at some time in the
near future. So we will continue to get back to you. Thank you.
And if the next panel could come forward at this time?
Well, welcome again. I am going to introduce each of you.
Starting on my left, some of you, maybe all of you but
certainly a lot of you have been here before. You are no
strangers to the Committee. First is Stephen Ubl. Did I
pronounce it right?
Mr. Ubl. Ubl.
Mr. Pallone. Ubl. OK. Stephen Ubl. I have met you many
times. Stephen Ubl is president and CEO of the Advanced Medical
Technology Association. And then is Kelvyn Cullimore. He is
President and CEO of MDMA Secretary. Is that the organization?
Mr. Cullimore. I am Secretary of the MDMA--
Mr. Pallone. Oh, I see. You are President and CEO and also
Secretary of the MDMA of the Dynatronics Corporation.
Mr. Cullimore. Dynatronics is the company. We are a member
of MDMA, and I am on the--
Mr. Pallone. Oh, I see. You are doing both. OK. And then we
have Ms. Ami Gadhia with the Consumers Union. She is the Policy
Counsel. She was here recently. And then we have Elisabeth
George who is Vice-President for Quality and Regulatory Affairs
at Philips Healthcare, and Pamela Bailey who is President and
CEO of Personal Care Products Council, and Jane Houlihan who is
Vice-President for Research of the Environmental Working Group
here in D.C.
Thank you all for being here. You know the rules: 5 minutes
opening statement. They become part of the record, and we may
submit additional questions in writing that we would ask you to
get back to us about. And I will start out with Mr. Ubl.
Mr. Ubl. Thank you.
Mr. Pallone. Is that on?
Mr. Ubl. It is on now.
Mr. Pallone. OK.
STATEMENT OF STEPHEN J. UBL, PRESIDENT AND CEO, ADVANCED
MEDICAL TECHNOLOGY ASSOCIATION
Mr. Ubl. Thank you, Mr. Chairman, Ranking Member Deal. I
appreciate the opportunity to share our views on the discussion
draft of the FDA Globalization Act of 2008.
Medical technology is one of the few manufacturing
industries where there remains a strong, vibrant balance of
trade. Every day our member companies export more medical
devices that are imported to the United States. In fact, more
than three-and-a-half times more exports than imports. In 2007,
medical device exports were approximately $4.7 billion and
imports were barely a third of that at $1.5 billion.
Before I address our specific comments on the discussion
draft, I would like to first emphasize the broad range of
medical devices and the risk-based approach currently used by
the FDA to effectively regulate devices. As you know, FDA
classifies devices into three risk categories ranging from low-
risk products in Class I to high-risk devices in Class III.
Since its inception in 1976, the legislative framework, the
Medical Device Law, has been to regulate based on risk. FDA's
regulatory regime, whether it is the approval process or
setting of inspectional priorities, are based on a level of
risk associated with the device. We believe FDA's risk-based
approach effectively focuses the Agency and its resources on
the right areas to ensure public health and safety.
I would like to now address three primary issues with
regard to the discussion draft. First, we have concerns with
the proposed new broad-based industry fee, but we are open to
exploring a more targeted approach to inspections. Our view is
that inspections are a core function of the FDA, and funding
should come from the appropriations process, not industry fees.
As has been mentioned earlier, last year's FDA Amendments Act
resulted in a 91 percent increase in industry user fees,
including the establishment of the first-ever facility
registration fee. A new, broad-based user fee would impose a
potentially significant financial burden on top of the
increased user fees enacted into law last year. We also believe
there could be unintended consequences with a broad-based user
fee. Many of our members, particularly small companies, do not
even have foreign facilities. Yet, through their fees, they
would effectively subsidize inspections of foreign companies
exporting their products to the United States. Consider that
high-risk medical device imports overwhelmingly come from
countries with established regulatory systems. According to our
analysis of U.S. Customs data from 2007, 93.7 percent of
imported medical device implants come from the highly developed
countries of the European Union, Canada, Australia, and Japan.
In this category of devices, 0.01 percent come from China. I
want to emphasize that we are willing to explore a targeted
funding mechanism for inspections of foreign facilities that
are located in countries with less developed regulatory systems
and actually export products to the United States.
Our second issue is with the proposed pre-approval
inspection for Class II and Class III devices. As you know, FDA
already conducts pre-approval inspections of all new Class III
medical devices. There has been mention with regard to Class II
devices, there are more than 3,600 approved each year. Simply
put, the FDA approval process would come to a screeching halt
if this proposal were implemented. Requiring a pre-approval
inspection for this number of products before they are
permitted to be marketed could inhibit the availability of
lifesaving and life-enhancing devices.
The third issue is with the catch-up inspections for all
Class II and Class III facilities. According to the GAO, there
are 10,600 facilities manufacturing Class II and Class III
devices. Having FDA inspect all of these facilities within the
next 2 years is an unrealistic expectation. We support FDA's
risk-based approach in determining its inspectional priorities.
Moreover, for the purpose of setting those priorities, the
recently enacted FDA Amendments Act permits FDA to accept
submissions from companies of certifications through
internationally accepted quality system standards set by the
International Organization for Standardization, or ISO. To
explain, ISO is an international standard-setting independent
organization consisting of technical experts including FDA. FDA
personnel are active participants in the ISO technical
committees developing these important standards. We support a
change in law that would go one step further by allowing FDA to
accept ISO quality system standard as equivalent to FDA's
current quality systems regulation. Doing so would allow FDA to
use a company's compliance with the ISO standards in place of
an FDA inspection. This also would bring FDA into harmonization
with the internationally recognized and accepted quality
systems regulations.
In closing, we support a strong FDA and appreciate the
Committee's leadership in offering the discussion draft under
consideration. Our members are committed to providing safe and
effective products, and we look forward to working with you.
[The prepared statement of Mr. Ubl follows:]
Statement of Stephen J. Ubl
Good Morning. My name is Stephen J. Ubl. I am President and
Chief Executive Office of the Advanced Medical Technology
Association, known as AdvaMed. I am pleased to be here today to
comment from a medical device perspective on the Committee's
discussion draft of the FDA Globalization Act of 2008. Thank
you, Chairman Dingell, Congressman Barton, and other members of
the Committee for giving us the opportunity to share our views
on this important topic.
AdvaMed represents manufacturers of medical devices,
diagnostic products, and health information systems that are
transforming health care through earlier disease detection,
less invasive procedures, and more effective treatments.
AdvaMed's members produce nearly 90 percent of the health care
technology purchased annually in the United States and more
than 50 percent of the health care technology purchased
annually around the world. AdvaMed members range from the
smallest to the largest medical technology innovators and
companies. Nearly 70 percent of our members have fewer than $30
million in sales annually.
Overview
AdvaMed very much appreciates the Committee's process of
providing the public with an opportunity to comment on the
Committee's preliminary thoughts as the Congress considers how
to address major challenges in our increasingly global economy.
I would like to begin by making several general points. First,
our members are committed to assuring that the medical devices
we manufacture are safe and effective, perform as intended, and
meet all the rigorous quality system requirements established
by the FDA.
Second, we share the Committee's view that a robust and
effective FDA inspection program is an essential element of
FDA's regulatory system. We believe that such a program can be
achieved with a multi-faceted approach by leveraging FDA's
resources and expanding FDA's existing risk-based analysis
model that currently guides device facility inspections. We are
willing to explore ways in which FDA's resources can be
leveraged with use of third party inspection information and
mechanisms for financing foreign facilities inspections.
Third, we share the Committee's goal of increasing funding
for FDA activities. This is why AdvaMed partnered with you last
year during the FDA Amendments Act, and why it is a member of
the Alliance for a Stronger FDA. We look forward to working
with the Committee on finding innovative ways to assure the
effectiveness of FDA's inspection regime. However, while we
understand the goals expressed in the Committee draft, we do
have a number of concerns about specific provisions and we
appreciate your interest in our suggestions. Our greatest
concerns relate to requirements for pre-marketing inspection of
plants making class II products, use of the two year statutory
standard rather than a risk-based approach as the guide for
frequency of FDA inspections of Class II product plants, and
imposition of a broad-based facility user fee to pay for
expanded foreign and domestic inspections.
Fourth, as additional regulatory or cost requirements are
considered by the Congress, it is important to keep the unique
story of the industry in mind. Medical devices represent one of
the few manufacturing industries where there remains a strong
and vibrant balance of trade. According to 2007 data from the
International Trade Commission, medical device exports
approximated $4.7 billion. In contrast, imports were barely
one-third of that amount, or approximately $1.5 billion.
According to a 2007 analysis by the Lewin Group, these exports
supported 357,000 domestic jobs, with average annual wages of
$45,600, based on 2002 data, versus $40,300 for the average U.
S. manufacturing job. At the same time, medical device imports
overwhelmingly come from developed countries with established
inspection systems. For example, roughly 93.7% of imported
medical device implants and 97.6% of imported medical device
instruments and appliances came from the highly developed
countries of Canada, Australia, the European Union, and Japan.
In these categories of imported medical devices, only .01% are
imported from China. This does not mean that inspections of
foreign facilities should not be increased, but it does mean
that there is no immediate cause for alarm. Clearly, in a
global marketplace, significant changes to the cost structure
of our companies could impact this very positive story for an
industry in which the United States leads the world.
Summary of Concerns
In order to properly consider changes to the FDA inspection
process for medical devices, it is important to first
understand the broad range of medical device products. This
understanding is important as it logically leads to a view that
different types of devices warrant various levels of
regulation. The law currently anticipates these differences
with respect to, for example, market access.
The FDA currently classifies devices into three risk based
categories: I, II, and III. Class I are the lowest risk devices
such as tongue depressors, bedpans, and bandages. Class II
devices are moderate risk devices such as contact lenses,
tracheal tubes, and glucose test meters. Class III are high
risk devices such as pacemakers, heart valves, and implantable
cardiodefibrillators.
There has been no demonstrated public health need for pre-
marketing inspection of facilities making Class II products.
Implementation of such a system would actually harm the public
health, by drastically slowing the introduction and
availability of improved medical devices. FDA currently
conducts pre-approval inspection of approximately 50 class III
devices a year, and pre-approval inspection is appropriate for
these high risk devices. Requiring FDA to conduct pre-approval
inspections of the 3,600 plus class II devices that are
approved every year would bring the approval process to a
grinding halt. Appropriately, FDA inspects facilities that make
class II products on a risk-based schedule.
While we understand that the goals outlined in the draft
will require a significant increase in FDA's ability to gather
inspections data, imposition of a broad-based user fee to pay
for inspections would represent a serious departure from the
principles that have governed device user fees. User fees were
assessed under MDUFMA and FDAAA, based on negotiations between
FDA and industry and approved by the Congress. These fees are
used to finance improvements in the device approval process
that benefit both industry and the public. Establishing a user
fee to finance domestic inspections would transfer financial
responsibility from the appropriations process to industry for
what has rightfully been a public function. The industry just
negotiated a new user fee agreement with the FDA and the
Congress last year that have raised total fees by 91% and
established a facility registration fee for the first time. An
important premise of that negotiation was that user fees would
remain stable for the 5-year life of the reauthorization. Under
these circumstances, the industry would find it difficult to
bear the increased burden of a new broad-based user fee
program--particularly one that shifts the financing of public
functions to its shoulders.
In addition, a proposal to assess a broad-based user fee to
fund an inspection program would raise a number of questions
for our member companies:
1. The costs of inspection would certainly vary
significantly for a domestic facility versus a foreign facility
in a developed country versus the cost of inspection in a less
developed country. Is it fair to charge one price for these
different facilities and potentially have domestic companies
subsidizing the costs of inspections for foreign facilities?
2. What guarantees would there be that the fees be additive
to FDA's current or future level of appropriated funds, rather
than financing, in part or in whole, the current level of
effort supported by general treasury funds? And what assurance
is there that this change in the philosophy of user fees to
support the device center would not, in tight budget times, be
used to shift more and more of the burden of financing the
center to industry?
3. How would fees for FDA inspections interact with the
existing third party inspection program for medical devices?
Additional Comments
The proposed pre-inspection requirement for all class II
devices. Section 202 of the discussion draft calls for a new
FDA inspection requirement for all class II medical devices.
FDA already conducts such inspections for class III products.
Under this proposal, an FDA inspection would be required prior
to the distribution of all new products, and FDA would have
just 2 years to inspect all facilities marketing such products
today. This new requirement is not justified on public health
and safety grounds, would be impractical to implement, and is
premature, given the potential benefits of the third-party
inspection program just streamlined through the FDAAA.
Since its inception in 1976, the legislative framework of
the medical device law has always been to regulate based on
risk. This risk-based philosophy is embedded within the three
classes of medical devices and particularly in the very
different risk profiles of class II and class III medical
devices. FDA already routinely conducts pre-approval
inspections of new class III medical devices, but rightfully
inspects facilities that make class II products on a risk-based
schedule. If the current provisions of the draft bill were to
be implemented, it would inevitably delay the availability to
patients of thousands of new safe and effective therapeutic and
diagnostic medical device products. To appreciate the order of
magnitude involved, FDA currently conducts pre-approval
inspections for about 50 class III devices approved annually,
but more than three thousand six hundred class II devices are
approved each year.
Moreover, the ``catch-up'' requirement for FDA to go back
and inspect the thousands of current class II facilities is
also simply not feasible. The mere process of hiring, training,
and deploying new inspectors could not realistically be
accomplished during that time.
Should more inspections of domestic medical device
facilities be needed, one approach would be for FDA to fully
implement the third-party inspection provisions of the FDAAA.
Although Congress first authorized FDA accredited third parties
to conduct inspections of medical device establishments in the
original MDUFMA legislation in 2002, legislative changes were
needed and instituted in 2007 to make that process more
attractive and feasible from both an agency and industry
standpoint. We are hopeful that this program will free up
significant FDA resources.
Finally, we do not believe that the case has been made for
an exponential increase in FDA inspections of domestic medical
device facilities, such as the discussion draft envisions.
There should be a well-documented public health and safety
benefit from this expenditure of resources. It would be a more
prudent course of action, as described further below, for
Congress to allow the opportunity for the third-party
inspection process that was streamlined in the FDAAA to work.
As with many other times when Congress considers new
legislation, we ask that any legislation addressing medical
devices be geared specifically and uniquely to the existing
legal and factual circumstances surrounding medical devices and
that medical devices not be swept in with pharmaceutical and
other products regulated by FDA.
Importer fees
We believe the annual fee of $10,000 per importer may
violate World Trade Organization (WTO) rules and respectfully
suggest that the Committee examine this issue carefully before
moving forward.
``Country-of-Manufacture'' labeling requirement
We believe additional legislation is unnecessary and
potentially counterproductive due to existing rules under U.S.
Customs law. Under existing Customs law, any company that
imports products, including medical devices, is already
required to disclose the country of origin on shipping cartons,
individual packaging, and, in some cases, the product itself.
There are already sanctions in place for violating the Customs
law, including both civil and criminal sanctions. See, e.g. 19
U.S.C. Section 1304(h) and (k), Section 1592(a) and Section
1595a.
The Customs ``Country of Origin'' marking requirement
focuses on the individual unit so that the ultimate purchaser
or user of the device can be informed of the country of origin.
In addition, the entry documents for imported products state
the country of origin. Therefore, an amendment to the Federal
Food, Drug, and Cosmetic Act (FD&C Act) that requires device
products to identify ``country of manufacture,'' as proposed by
section 206 of the discussion draft, would be duplicative,
costly, and potentially confusing if the regulations
promulgated by FDA under a new FD&C Act mandate differ in any
way from the standards used under Customs rules.
Unique facility identifier
We do not believe there is a need for additional
legislation on this subject. FDA already assigns a unique
identification number as part of its mandatory registration
process for all establishments involved in the production and
distribution of medical devices intended for commercial
distribution in the United States when those facilities
register with the FDA. This process provides FDA with the
location of medical device manufacturing facilities and
importers. To the extent that Congress wishes to authorize FDA
to use the facility registration numbers for ``purposes other
than for registration,'' as provided in the discussion draft,
FDA also does that currently. For example, FDA already requires
a medical device company to include its unique facility
registration number on the Premarket Review Submission Cover
Sheet, when being submitted to FDA's Center for Devices and
Radiological Health (CDRH), to identify where the product will
be manufactured.
Conclusion
AdvaMed appreciates the opportunity to share its views with
the Committee on the discussion draft of the FDA Globalization
Act of 2008. We share your goal of an effective, risk-based
inspection system that applies to both foreign and domestic
manufacturers and is adequately funded. As I have outlined in
my testimony, we have a number of concerns about specific
provisions of the bill, and serious questions about the concept
of a broad-based user fee to fund inspection activities.
However, we share the overarching goals of the Committee as it
pertains to safety in the global supply chain, and look forward
to working with the Committee to achieve them.
----------
Mr. Pallone. Thank you, Mr. Ubl. Mr. Cullimore?
Mr. Cullimore. Thank you.
Mr. Pallone. Mr. Cullimore, let me just say, I just wanted
to make it clear for the record that you are the President and
CEO of Dynatronics Corporation, but you are the Secretary of
MDMA, which is the Medical and Devices Manufacturing
Association.
Mr. Cullimore. Thank you.
Mr. Pallone. Did I get that right?
Mr. Cullimore. Thank you for that verification. Our
President got very nervous when you made that announcement.
Mr. Pallone. OK.
STATEMENT OF KELVYN CULLIMORE, JR., PRESIDENT AND CEO,
DYNATRONICS CORPORATION; SECRETARY, MEDICAL AND DEVICES
MANUFACTURING ASSOCIATION
Mr. Cullimore. Chairman Pallone and Ranking Member Deal,
thank you for having me here today to testify. Many of my
comments echo those of Mr. Ubl. We appreciate the opportunity
to comment on this draft legislation. We recognize and
acknowledge the sincerity of concerns that motivate this
legislation, and we really do support additional appropriations
for FDA to accomplish their assigned mission. But I would like
to spend my 5 minutes focusing on a few concerns about the
draft legislation. As was mentioned, my name is Kelvyn
Cullimore, and I am the President and Chief Executive Officer
of Dynatronics Corporation which is a small publicly traded
medical device company headquartered in Cottonwood Heights,
Utah. We also have manufacturing facilities in Tennessee.
Today I am here to testify on behalf of the MDMA, Medical
and Devices Manufacturing Association, which is a national
organization of more than 180 member companies representing the
innovative, entrepreneurial sector of the medical technology
industry. MDMA's mission is to ensure that patients have access
to the latest advancements in medical technology, most of which
are developed by small research-driven medical device
companies. MDMA was actually founded in 1992 to oppose attempts
by Congress and large manufacturers to institute a device user
fee program. While MDMA recognizes the appropriate role of
government in regulating the industry, the Association believed
that the government should fund such regulation through
appropriations, not user fees. However, in 2002, as we know,
MDUFMA I was passed and it established user fees. While MDUFMA
I did include important provisions to ensure that smaller
companies received fee relief, it did start the slippery slope
of government reliance on industry fees.
In 2007, this Committee led efforts to reauthorize the user
fee program for an additional 5 years. The result was fees paid
by industry almost doubled from $150 million under MDUFMA I to
$300 million under MDUFMA II. The reauthorization also expanded
fees beyond just device applications to include annual
registration fees of $1,700 applicable to every registered
manufacturer and fees for filing of annual reports. If we
continue to add more and more fees, it will create a
significant financial burden for the majority of small medical
device companies that could literally mean the difference
between success and failure to those companies.
In light of the doubling of the medical device user fees
under MDUFMA reauthorization last year, the current draft
legislation's proposal to seek even more fees from industry is
very alarming. While these fees may not be viewed as a hardship
for multi-billion dollar drug and device companies, I can say
for certain that it will be a hardship for the thousands of
small medical device companies in this country which are
responsible for much of the medical device innovation. Levying
additional fees will further erode R&D budgets and have a
serious detrimental effect on the operation and sustainability
of these small companies.
Enhancing FDA's stewardship and oversight of importation of
regulated products is a worthy pursuit, but such efforts that
benefit the public at large should be funded from congressional
appropriations, not additional user fees, particularly given
that proposed paradigm that requires domestic and non-importing
manufacturers to subsidize such efforts. When I testified
before this committee last year, concerns were raised about FDA
becoming too reliant on industry user fees for funding. I
shared these concerns and strongly advocate for additional
congressional appropriations to fund this proposed legislation.
I would like to take a moment to discuss the bill's
provisions dealing with inspections. Congress and FDA have
recognized the importance of establishing risk-based
classifications for medical devices based upon the level of FDA
control necessary to establish and assure the safety and
effectiveness of the medical device. However, Section 202 of
the draft legislation ignores the important distinction between
Class II and III medical devices and proposes to subject all of
these medical devices to equal, pre-approval, and pre-clearance
inspection regardless of risk. The proposed Section 202 appears
to require FDA to conduct pre-clearance inspections of all
510(k) pre-market notifications. Such a requirement would
create a logistical nightmare for FDA and would effectively
impose additional indeterminate delays on the applicant while
awaiting for an FDA inspection, regardless of whether FDA
determines that such a pre-clearance inspection was necessary.
It could also result in manufacturers being inspected multiple
times per year. Adding an additional waiting period for an FDA
pre-clearance inspection would result in unacceptable and
unnecessary delays for both patients and manufacturers, not to
mention the untold pressure on FDA resources to conduct
thousands of additional inspections each year.
Finally, let me briefly address the issue of the proposed
civil monetary penalties outlined in the draft bill. In
particular, as currently drafted, Section 210 could be read as
mandating the imposition of penalties for any violation. This
section would appear to impose penalties on situations where
FDA and manufacturers have historically worked cooperatively to
remedy minor and technical violations. The legislation should
permit FDA the flexibility and discretion to determine when
civil penalties should be imposed and should specifically
clarify that penalties would not be imposed for violations that
can be addressed by the cooperative efforts of FDA and the
industry.
Thank you for providing me with the opportunity to testify
today before the Committee. We look forward to working with you
and your staff to improve the current FDA inspection process in
an efficient and effective manner.
[The prepared statement of Mr. Cullimore, Jr., follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pallone. Thank you, Mr. Cullimore. Ms. Gadhia?
STATEMENT OF AMI GADHIA, POLICY COUNSEL, CONSUMERS UNION
Ms. Gadhia. Good afternoon, Subcommittee Chairman Pallone,
Ranking Member Deal, and members of the Subcommittee. My name
is Ami Gadhia and I am Policy Counsel with Consumers Union, the
non-profit publisher of Consumer Reports Magazine.
I am here today to testify about the medical device and
cosmetic safety provisions of the discussion draft of the FDA
Globalization Act. Consumers Union applauds Chairman Dingell
for his leadership on the proposed legislation and commends
members of the Energy and Commerce Committee for holding
today's hearing on this critical consumer safety issue.
Some of the more high-profile failures of our medical
device and cosmetics regulatory system are well-known at this
point. The 2006 recall of 183,000 packages of contact lens
solution manufactured in China because of bacterial
contamination and the June 2007 import alert about toothpaste
made in China that contains the very dangerous chemical,
diethylene glycol, which is used in antifreeze and as a
solvent. Other frightening stories of recalls of medical
devices include balloon catheters that failed to deflate and
cause a heart attack and heparin lock flush syringes that were
contaminated with bacteria.
FDA is charged with overseeing these products, but due to a
lack of resources and political will, the Agency has dropped
the ball. There have not been enough inspections, enough
authority, or enough enforcement of existing regulations, and
consumers are paying the price.
Consumers Union believes that the discussion draft of the
FDA Globalization bill contains a number of strong provisions
that will help make consumers safer. With regards to medical
devices, CU supports the provisions of the bill that would
require mandatory inspection of both domestic and foreign
medical device facilities every 2 years. This inspection
provision, if implemented with protections against conflicts of
interest, should help improve compliance with existing FDA
safety regulations. We would respectfully recommend that this
inspection occur annually and more often if there are problems,
given the host of serious public health risks that have emerged
from foreign facilities in particular.
With regards to cosmetics, CU is in support of the
provisions addressed in the FDA's Cosmetic Adverse Event
Reporting System, CAERS. In addition to mandatory reporting of
adverse events by manufacturers, it is important that FDA's
processing and publicizing of these events occurs in a timely
manner.
With regards to both device and cosmetic safety, we are
pleased that under the draft legislation FDA would track all
registered establishments and, at least with regards to medical
devices, have a firm number of establishments subject to
inspection. Currently, the number of establishments the FDA
should be inspecting is a ballpark figure with many
establishments completely off FDA's radar.
The discussion draft would require destruction of
adulterated, misbranded, or counterfeit drugs that a company
attempts to import into the United States. However, a similar
safeguard does not exist for unsafe medical devices, and we
would recommend that it be added. We also support the
provisions in the bill creating a fee requirement for importers
of cosmetics. It is not sufficient for FDA's inspection
resources to stay at their current extremely inadequate level
with regard to imported cosmetics. This importer fee
requirement is one step toward addressing this problem.
There are, however, some provisions in the discussion draft
affecting both medical devices and cosmetics that Consumers
Union would encourage the Committee to consider strengthening.
We would recommend shortening the timeframes for
implementation. It appears that the effective dates of a number
of the bill's provisions are too far out into the future,
sometimes 2 or 3 years out. These should be shortened.
We support the provision creating a user fee schedule for
various new FDA functions. However, we urge the Committee to
ensure that the user fees do not turn into a pay-for-play
scenario. We would not want to see regulated entities have the
ability to exert undue influence over the FDA in its decision-
making or other functions.
In addition, like the user fees for food safety
importation, the fees pertaining to device and cosmetic safety
should be indexed for inflation.
Consumers Union also believes that the monetary civil
penalties for violations of the medical device protections in
the bill are set too low. For a large manufacturer, producer,
or other multi-national, a penalty of $100,000 is simply a cost
of doing business or a few hours' worth of profit. For the
penalties to serve as a true deterrent against illegal actions,
they should be set higher.
FDA must also have the ability to perform unannounced
inspections of foreign facilities. Because of advanced warning,
these foreign manufacturers, unlike domestic companies, are
able to clean up to ensure that they pass inspection, even if
they are out of compliance every other day of the year. In
addition, any provisions in the final bill that permit FDA to
outsource any agency task to a third party should include
protections against such tasks being performed by entities with
a conflict of interest.
We have a number of other concerns and recommendations
about the draft bill that we would also like to bring to the
Committee's attention. These particular concerns are presented
in detail in my written testimony.
We wholeheartedly support providing FDA with new authority
and resources. We are pleased that this discussion draft gives
FDA a number of new and very necessary powers to better ensure
the safety of our medical devices and cosmetics. We also urge
that manufacturers and others who profit from the sale of
medical devices and cosmetics to American consumers fairly
shoulder their full responsibility for improving the safety and
quality of the products that they sell.
I thank the Committee for the opportunity to testify today,
and we at Consumers Union look forward to looking with the
Committee to help move forward on the strongest FDA reform bill
possible.
[The prepared statement of Ms. Gadhia follows:]
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Mr. Pallone. Thank you again. Ms. George?
STATEMENT OF ELISABETH GEORGE, VICE PRESIDENT, QUALITY AND
REGULATORY AFFAIRS, PHILIPS HEALTHCARE
Ms. George. Mr. Chairman, Ranking Member Deal, and members
of the Committee, thank you for the opportunity to testify
today. My name is Elisabeth George, Vice President of Quality,
Regulatory, Sustainability, and Product Security at Philips
Healthcare. I am testifying today on behalf of Medical Imaging
and Technology Alliance, MITA, where I serve as a member of the
board of directors.
MITA understands and has a record of supporting the
Committee's desire to ensure that FDA is well-funded and that
medical devices imported into the United States are safe for
U.S. patients.
MITA is the collective voice of medical imaging equipment
manufacturers, innovators, and product developers whose sales
comprise more than 95 percent of the global market. Medical
imaging encompasses X-ray, CT scans, radiation therapy,
ultrasound, PET, and MRI. Our members make the products that
detect and treat serious illnesses such as heart disease,
cancer, stroke, and osteoporosis. The equipment our member
companies manufacture empowers doctors and medical
professionals to view the human body with stunning and ever-
increasing clarity and accuracy. This enables better diagnosis
and more effective medical care for patients, often reducing
the need for costly medical services and evasive surgical
procedures. In fact, it is not an exaggeration at all to say
the term exploratory surgery will become obsolete in medicine
due to the power of medical imaging.
The medical imaging industry is a net exporter economic
engine and employs tens of thousands of skilled workers here in
the United States. The research and development that led to the
innovative technologies were invented right here in communities
across America.
As we continue working together to reduce healthcare
spending, improve patient care and outcomes, MITA appreciates
the support from leadership and members of this committee to
protect medical imaging from further Medicare reimbursement
cuts. We understand that there are significant concerns about
drug ingredients and food that have been imported from foreign
countries. However, we believe the device industry, a highly
regulated industry globally, is vastly different. Medical
devices are classified into Class I, II, and III based on the
level of risk. Medical imaging devices are Class II. Our
members' foreign and domestic facilities are subject to
international quality and safety inspections at least annually
as a part of the International Standards Organization, ISO
13485 standard. This inspection is virtually identical to the
FDA quality system regulation system inspections. Meeting the
ISO 13485 standard is a requirement for medical imaging
manufacturers in 47 countries. MITA believes that the FDA
should avail itself of valuable information gained from these
inspections that are required by every other industrialized
nation.
I would like to turn to the discussion draft before us
today. We believe the discussion draft places new unnecessary
regulatory burdens on our products without taking into account
the unique nature of how our devices are manufactured and
extensively regulated. For example, the draft would require an
FDA inspection for nearly every modification of the device.
MITA believes this inspection requirement unduly stalls
delivery of improved technology that benefits patients. On
average, each medical imaging device is updated with improved
technology once every 18 months. For example, a manufacturer
may submit a device change to the FDA based on the fact that we
can image another part of the body, we have updated the
software, or added new functionality. These updates do not
warrant a new facility inspection which will halt production of
already-approved products until an FDA inspector completes the
new assessment.
Secondly, we are concerned that requiring registration and
inspection of component parts may be duplicative and imprudent.
Medical imaging devices are inspected and approved by the FDA
as finished products. Components, including screws, circuit
boards, monitors, and so forth, must work correctly for the
device to function properly.
Finally, we believe significant new fees are duplicative
and are unnecessary. Last year, FDAA Act, the industry agreed
to a 90 percent increase in user fees in order to provide
stability to the Agency and ensure the life-saving medical
devices would proceed to market. Medical device manufacturers
currently pay fees for ISO inspections as well as for FDA-
mandated facility registration fees. However, the draft
includes additional annual facility registration and importer
fees. These new fees unfairly burden domestic medical imaging
manufacturers. MITA understands the need to fund the FDA, but
any fees should be targeted at funding the actual inspection of
the foreign facilities.
In conclusion, medical imaging has become integral to best
practices across so many disease states and plays a critical
role in providing high-quality patient care. It is critical
that patients have access to innovative medical imaging
technology to help fight serious illnesses.
Again, thank you for the opportunity to testify at today's
hearing, and I welcome your questions later.
[The prepared statement of Ms. George follows:]
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Mr. Pallone. Thank you. Ms. Bailey?
STATEMENT OF PAMELA BAILEY, PRESIDENT AND CEO, PERSONAL CARE
PRODUCTS COUNCIL
Ms. Bailey. Thank you, Chairman Pallone, Ranking Member
Deal. I am pleased to be able to testify today on behalf of the
Personal Care Products Council and to discuss the longstanding
safety record of our personal care products companies.
The Council is the leading national trade association
representing the global cosmetic and personal care products
industry, and our 600-member companies are the manufacturers,
suppliers, and distributors of the vast majority of finished
personal care products marketed in the United States.
We would like to state up front that we appreciate and
support the goal of this Committee in the cosmetic section in
the pending legislation to ensure the FDA has the authority to
provide strong oversight so that American consumers can be
assured that imported products are safe. I also appreciate the
opportunity today to provide additional information to the
Committee on the existing nature of the regulatory framework
governing personal care products.
Consumer safety has always been the number one priority of
our companies. Under the Federal Food, Drug, and Cosmetic Act,
it is a crime to market an unsafe cosmetic product in the
United States. Cosmetic products imported into the United
States are subject to the same substantive standards as those
produced in the United States and face an even higher
regulatory threshold upon entry in that an appearance of
adulteration or misbranding may subject them to detention at
the border. They must be safe and contain no prohibitive
ingredients, and all labeling and packaging must be in
compliance with U.S. regulations.
In addition, all colors must be listed and are pre-approved
by FDA, and a number of color additives in addition must be
pre-approved, batch tested, before they can be added to a
personal care product either within the United States or
outside.
In addition, if a product contains an active ingredient
that qualifies it for regulation under our OTC drug rules, then
they are subjected to the stricter drug review standards that
govern drugs in the U.S. What this means, Mr. Chairman, is that
if a product is a sunscreen, an antiperspirant, and a dandruff
shampoo, toothpaste, mouthwash, it must go through the pre-
approval standards of the OTC program. In addition, any colors
added to products must be pre-approved. So a product as simple
as a lipstick that has SPF in it will be subject to pre-
approval standards both for the colors and for the SPF.
Product safety in a global marketplace is not only a matter
of law for our members, it is the primary commitment for each
of them and for our Association. For 40 years our companies
have invested millions of dollars through our trade association
in safety programs to enhance the regulatory responsibilities
at FDA including our consumer commitment code, the Cosmetic
Ingredient Review Panel, our FDA Company Registration Program,
the International Cosmetic Ingredient Dictionary, our consumer
information Web site, and our Import Safety Committee. The
result of these safety practices and initiatives, cosmetics and
personal care products are the safest category of products
regulated by FDA. This means, for example, that of the 11
billion individual personal care products sold in the United
State each year, less than 200 instances of product adverse
events are reported to FDA. It means that between the years of
2000 and 2005 of the warning letters issued by CFSAN, some
1,400 of them related to food and only three related to
cosmetics.
We recognize that ours is now a global industry and that
our products and our ingredients are manufactured and sourced
throughout the world. We agree with the Committee that FDA
needs basic information about the safety of products and where
and how they are manufactured. That is why three years ago,
when we wrote our Consumer Commitment Code, we required member
companies signing the code to register their cosmetic
facilities with FDA and to report serious and unexpected
adverse events to FDA.
We are proud that in the first 16 months of its
implementation, 80 percent of all U.S. annual sales are covered
by our board member companies who have certified to the code
and are registered with FDA and have agreed to report their
adverse events to FDA. We are proud that our industry helped
craft global manufacturing standards and have worked with
international regulatory agencies to encourage each nation to
adopt those G&P standards, and we have encouraged FDA to issue
guidance incorporating ISO G&P standards into current practice
in the United States.
The Committee and the draft bill challenge us to take the
next step. Exactly how that is done is important. We have been
working with the bipartisan staff to provide technical details
on the draft's regulatory provisions, and we appreciate the
opportunity to continue those discussions.
We believe the most effective way to enhance cosmetic
safety is to provide additional resources to FDA. The budget
for FDA for cosmetics in 1974 was $2.7 million. In real dollar
terms, that would be $14.5 million today. In reality, it was
$3.5 million last year before we successfully lobbied for an
additional $1 million in appropriations. We are going to
continue those efforts and urge the Committee to support
additional appropriations.
Mr. Chairman, I want to close with a note on the
registration and import fees. Our industry has never been
subject to fees. This is a topic of significant discussion. We
are continuing to discuss that. We are going to continue to
discuss it with the Committee, but we are going to need more
time on that and other issues.
In conclusion, we want to thank the Committee for the
opportunity to work on this legislation. Our industry has
always put safety first. We have always been aware of the
necessity to take additional steps whenever that may be, and we
look forward to discussing with the Committee the most
effective way to take the next steps so that we can continue to
ensure the American consumer that our products are safe. Thank
you.
[The prepared statement of Ms. Bailey follows:]
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Mr. Pallone. Thank you very much. Ms. Houlihan?
STATEMENT OF JANE HOULIHAN, VICE PRESIDENT FOR RESEARCH,
ENVIRONMENTAL WORKING GROUP
Ms. Houlihan. Chairman Pallone and Ranking Member Deal,
thank you for the opportunity to testify. My name is Jane
Houlihan. I am Vice-President for Research at the Environmental
Working Group. We are a non-profit research and advocacy
organization based in Washington, D.C. We appreciate the
interest of the Committee in addressing the regulation of
cosmetics for the first time in a long time.
Cosmetics, or personal care products, are essentially
unregulated under the Federal Food, Drug, and Cosmetics Act.
FDA can't require companies to test products and can't review
or approve products or ingredients before they are sold. FDA
can't require product recalls. They must go to court to remove
misbranded and adulterated products from the market. FDA can't
require manufacturers to register cosmetic establishments, file
data on ingredients, or report cosmetic-related injuries.
Instead, they rely on voluntary reporting for this data. And in
the absence of government authority, the safety of personal
care product ingredients is evaluated through a voluntary
industry program, the Cosmetic Ingredient Review.
This absence of accountability to a responsible government
agency has created a culture of ignorance. Far too little is
known about ingredient safety, and the FDA and industry
maintain that everything is safe, even without full knowledge.
In the committee discussion draft, you are taking vital
steps that we support to close some of these gaps requiring
that companies register and report their facilities, products,
ingredients, and cosmetic-related injuries to the FDA and
follow good manufacturing practices.
We look forward to working with you on additional efforts
as well. I want to tell you about seven major gaps in cosmetics
safety that show why it is important to act.
First of all, the vast majority of ingredients have not
been assessed for safety by any publicly accountable body.
Through three decades, the CIR has reviewed only 11 percent of
ingredients in products, and at this pace, it will require
another two-and-a-half centuries to complete reviews for all
ingredients.
Second, companies are free to use almost any ingredient
they choose in personal care products. FDA has prohibited or
restricted only nine ingredients in personal care products. In
contrast, 244 ingredients are restricted and prohibited in
Japan, more than 600 in Canada, more than 1,100 in the E.U.
The third major gap in cosmetic safety, these ingredients
can penetrate the skin, they can pose health risks,
particularly for children. Americans use an average of nine
products every day with 126 unique ingredients. Cosmetic
ingredients are found in blood, urine, breast milk, even in
breast tumor tissue. These ingredients are linked to birth
defects, allergies, thyroid problems and more. And children are
particularly at risk. Their skin is thinner than an adult's,
their exposures are higher, their bodies are more vulnerable.
The fourth gap in cosmetic safety, despite these potential
health risks, the FDA doesn't even know how many ingredients
are used in cosmetics. They have records of 4,100 product
ingredients. We found an additional 5,000 ingredients not on
record at FDA at all in our survey of products on the market.
The fifth major gap in cosmetic safety, FDA doesn't know
where and how many companies make and distribute personal care
products. Facility inspections are FDA's primary enforcement
tool for overseeing this industry according to GAO, and yet,
FDA doesn't even know where all these facilities are and they
can't mandate registration.
The sixth major gap in cosmetic safety is that FDA doesn't
know the extent of health impacts from harmful ingredients in
cosmetics. Companies aren't required to report adverse events,
and companies that have experienced major problems may be least
likely to report them voluntarily.
The seventh gap in cosmetic safety, consumers' right to
know, is hampered by lack of standards and labeling loopholes.
Not all ingredients appear on labels, like ingredients in
fragrance; and companies can use terms like natural and
hypoallergenic to mean anything or nothing at all. More than a
third of all children's products marked as natural in fact
contain artificial preservatives linked to allergic reactions
and nervous system problems.
We support the Committee's discussion draft with mandatory
reporting and manufacturing standards, but we also support
safety standards for cosmetics and enforcement authority for
FDA. These should be brought up to par with FDA's authority
over pesticides and food and color additives which meet a
safety standard under the Act. Cosmetic ingredients are found
in cord blood, they pollute the bodies of almost everyone in
the population, and they should be as safe as pesticides, food,
and color additives. FDA needs the mandate to ensure that
ingredients are safe and the authority to demand the study it
needs to make this finding.
Thank you very much.
[The prepared statement of Ms. Houlihan follows:]
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Mr. Pallone. Thank you, Ms. Houlihan. OK. We will have some
questions from the members, and I will start out with myself.
I wanted to first ask some questions relative to cosmetics,
and I will start with Ms. Bailey. You mentioned the Cosmetic
Industry Review, CIR. Actually, several of you mentioned it,
but you mentioned it in your testimony. Can you elaborate a bit
on this CIR? For example, how is the panel determined? How are
the conflict-of-interest considerations made? How are decisions
disseminated?
Ms. Bailey. Sure. Thank you, Mr. Chairman. The panel was
set up in 1976, and at that time it was designed to mirror the
same standards supplied for OTC drug reviews at FDA. In fact,
my understanding is it was set up by the industry because the
FDA did not then have the resources to do it itself. The
conflict of interest standards are indeed as strict if not
stricter. Nobody on the expert panel can have any tie
whatsoever to the industry. The panelists are all chosen by
existing panelists. The Chair, Dr. Wilma Bergfeld, is
considered first lady, if you will, of dermatology and chairs
the Department of Dermatology at the Cleveland Clinic.
Mr. Pallone. OK. I am still with you, Ms. Bailey. Now, Ms.
Houlihan mentioned the CIR as well and also noted that they
have identified 9 unsafe ingredients that are actually
different from the 9 or 10 unsafe ingredients that the FDA has
identified. What has been the response from the cosmetic
industry in reaction to those restriction recommendations, both
from the CIR as well as the FDA, and are those ingredients
found in products on the market today?
Ms. Bailey. I am sorry, are those ingredients found--
Mr. Pallone. Found on the market today in products that are
on the market today?
Ms. Bailey. An ingredient that is unsafe, Mr. Chairman,
should not be in any cosmetic product because the company
cannot substantiate the safety of it. So the ingredients FDA
has found to be unsafe should not be in any product, nor should
the ones CIR has deemed unsafe.
Mr. Pallone. OK. Did Ms. Gadhia or Ms. Houlihan, do you
want to add anything to what Ms. Bailey said or comment
further? Go ahead.
Ms. Houlihan. I would say that one shortcoming of the CIR
process is that it is dominated by dermatologists who are
primarily interested in allergic reactions and irritations with
ingredients, and that means that a huge wealth of health
impacts doesn't get proper consideration by that panel. And it
is one reason, in addition to many others, that we feel like
the authority for assessing ingredient safety needs to be
mandatory, needs to belong with FDA so we have a consistent,
national standard, an FDA authority over cosmetic safety.
Mr. Pallone. Did you want to add anything, Ms. Gadhia?
Ms. Gadhia. I would concur with what Ms. Houlihan said. The
only thing I would add is that there is only one dedicated
consumer representative on CIR representing that standpoint.
Mr. Pallone. All right. Let me ask Ms. Houlihan, do you
think the provisions included in our discussion draft will
assist the FDA in regulating the cosmetic industry which is
growing rapidly?
Ms. Houlihan. I do and we support the provisions in the
discussion draft that would make mandatory the registration of
facilities, ingredients, products, and adverse effects. I think
it is a great first step to get FDA that very basic data that
it needs to determine the range of unsafe products that might
be on the market and take action.
Mr. Pallone. With regard to ingredients, how many
ingredients do you estimate are currently being used in
cosmetic products, currently being used by American consumers?
In other words, of those ingredients, how many would you say
have been tested by FDA or other independent bodies for their
safety?
Ms. Houlihan. There is no mandatory reporting of
ingredients to FDA, so it is not known the full range of
ingredients that are on the market. FDA has estimated 12,500,
but cosmetic industry officials have estimated it is only
between 2,000 and 4,000. When we surveyed products on the
market, we found 8,800 unique ingredients. It is an open
question, and it is one reason that mandatory ingredient
reporting needs to happen so that FDA has an understanding of
what is on the market. We do know that of the estimated 12,500
ingredients that FDA thinks are on the market, the industry has
reviewed only about 1,400 or 11 percent.
Mr. Pallone. OK. I wanted to get one more thing in but--
that is all right. Go ahead, and then I will ask the other.
Ms. Bailey. Thank you, Mr. Chairman. The number 12,500
indeed refers to the number that the discreet ingredient names
that are listed in the cosmetic dictionary that we in fact
publish. Not all of those ingredients are used in cosmetic
products. By our count, 5,500 ingredients are commonly used in
U.S. products. Of them, some 3,000 are ingredients such as
botanicals. They would not reach the threshold of risk for the
full peer-reviewed study. That leaves 2,500. By the end of this
year, 2008, CIR will have reviewed 2,000. They are chosen by
level of risk and complexity and by use on the common use. So
that would leave some 500 that would be of lower risk, and CIR
as I understand it is now reviewing how the best way would be
to review those ingredients. But they are now reviewing them at
the rate of 200 a year. If I could add, the issue of how many
ingredients and what is commonly in use is also a reflection of
the database problem that FDA has because until 2005, all of
these files were made by paper and they have yet been able to
complete the transfer of the paper filings into their new
electronic system.
Mr. Pallone. I had a medical device question, but let us
hear from the other two members, and then we will see if we
have time. Mr. Deal?
Mr. Deal. I will try to go quickly. You all do the same.
Going down the list of all of you there, do any of you disagree
with the proposition that FDA needs greater resources in order
to carry out the responsibilities they currently have and would
particularly need more resources if they were given the
responsibilities under this proposed legislation? Anybody
disagree with the concept that they need more money? Apparently
not. Let me go down the list, though. What should be the source
of that revenue? Should it be further appropriations by
Congress or should it be user fees or some combination thereof?
Mr. Ubl, I will start with you.
Mr. Ubl. We believe inspections are a core function of the
Agency and as a result should be funded by appropriated
dollars. In addition, I think FDA's risk-based approach,
together with greater reliance or leveraging of the ISO
standard that has been discussed is our preferred approach for
addressing the legitimate gap that has been raised as a result.
Mr. Deal. So primarily appropriations then?
Mr. Ubl. Yes.
Mr. Deal. Mr. Cullimore?
Mr. Cullimore. We agree, appropriations are the way to do
it. We feel that user fees have the risk of undermining a very
essential element in regulatory prioritization and that is
fiscal restraint. When there is no fiscal restraint, the
regulatory prioritization is much more difficult to do.
Mr. Deal. Ms. Gadhia?
Ms. Gadhia. Some combination of appropriations and user
fees with the conflict of interest protections would be best in
our judgment.
Ms. George. I think one of the first ways better would be
to leverage all of the ISO certificate reports that we are
already paying for as an industry and get annually, and that
would be a significant amount of information and data to the
FDA to help them make that risk determination and determine
whether they need to do further inspections of us.
Ms. Bailey. As I pointed out, we have a long way to go on
the federal side of funding of cosmetics. The fee issue is one
that is new to the industry, and we are under discussion about
that right now. But it is a very difficult issue, and certainly
the federal funding side needs to be significantly increased.
Mr. Deal. Ms. Houlihan?
Ms. Houlihan. We would agree with Consumers Union on this
point that a combination of appropriations and user fees would
be appropriate with conflict of interest protections.
Mr. Deal. Most of you have sort of I think agreed that
appropriations needs to be one of the primary, if not the
primary source. I'm going to get Mr. Pallone to agree to sign a
letter with me I am sure to our appropriators asking that they
consider that proposition.
Before I go further on questions, I do now have the
European Union letter that I mentioned earlier. I would ask
unanimous consent that it be admitted for the record.
Mr. Pallone. Without objection so ordered.
[This information was unavailable at time of printing.]
Mr. Deal. Let me go back to the proposition that several of
you have alluded to and I asked questions about and that is
ISO. First of all, understand there are 47 countries and China
is not one of them as I understand, those 47 countries that
already require each of you to comply with ISO standards, I
assume that they, in many instances, if you are exporting, they
send inspectors to your facilities here in the United States
and charge fees associated with that. Is that true? Yes, yes,
yes. All right. Now, it would seem to me that we do need
harmonization of these efforts, and I think if you could all
help us in later responses or written documentation as to how
do we harmonize what FDA is trying to do with what ISO
regulations are already doing? That would be very helpful. That
seems to me to be a great way of saving a lot of money on both
sides of the ocean, so to speak, in terms of what it costs to
get products to the consumer.
Now, Ms. George, your company has a lot of experience
dealing with this, and you indicated that you participated in
the ISO standard-making process, is that correct?
Ms. George. Yes, we do. We have members that are on the
committees that actually help define those as well as our
members are on the Global Harmonization Task Force along with
the FDA as well as other country members.
Mr. Deal. So FDA is also participating in that process
already?
Ms. George. Yes, they are.
Mr. Deal. I would just hope that all of us would work
toward trying to achieve this purpose. I think it would safe a
lot of money.
The last thing I want to make mention of is I understand
that since we did electronic registration that there have been
like 11,000 facilities that have electronically registered with
FDA. Ms. Gadhia, am I pronouncing that correctly?
Ms. Gadhia. Yes.
Mr. Deal. You indicated that you felt that everybody ought
to be inspected at least once every 2 years. If there are
11,000 of those, and I don't think that even includes what this
bill would contemplate on component manufacturers that would be
added to that list, is that a realistic thing that we can
achieve or is it just pie in the sky to think we can inspect
them all within a 2-year period?
Ms. Gadhia. Something that is in my written testimony but
for time purposes I could not fit in my oral testimony, we
recognize that there are a lot of differing devices out there,
a lot of things are classified as devices. We would support an
approach that differentiates between say tongue depressors and
how often those facilities are inspected versus, say, cardiac
pacemakers. We recognize that there is a difference in--
Mr. Deal. A risk level?
Ms. Gadhia. I don't know if I would go as far as saying a
risk assessment basis, but we recognize the differences of
different types of devices.
Mr. Deal. OK. My time is up. Thank you.
Mr. Pallone. The gentlewoman from Illinois.
Ms. Schakowsky. Thank you, Mr. Chairman. Ms. Bailey, you
were talking about the large number of personal care products
that are used. I was told you said something like billions? I
mean, there are a lot. I use a lot of them myself. And you said
that of that number, only 200 adverse events were reported.
First of all, where would they be reported?
Ms. Bailey. I am talking about to FDA, and this is a number
that has remained fairly consistent over any number of years.
Ms. Schakowsky. OK. Do you really think that that is the
extent of adverse effects? Do you think it is representative of
a true number?
Ms. Bailey. We do because in fact, adverse events are very
rare with these products because they are inherently safe. And
let me also point out that OTC cosmetics, for example,
sunscreens, antiperspirants, anti-dandruff shampoos that have
an active ingredient are regulated. It is over the counter,
drugs are, and those adverse reactions would be reported to the
drug side of FDA on a mandatory basis.
Ms. Schakowsky. Well, none of the research--does anybody
else want to comment on that, that the 200 represents in fact a
reasonable assessment of adverse reactions? Ms. Houlihan?
Ms. Houlihan. Thank you, Representative. It is an absolute
underestimate because adverse event reporting is not mandatory,
and the GAO found that companies that experience the most
serious effects from their products may be disinclined to
report voluntarily, and until we have mandatory reporting, we
won't see the full scope. I will just give you one example is
that fragrance in personal care products is considered one of
the top allergens in the world, and we are certainly not seeing
all allergic reactions to fragranced personal care products
reported to FDA's database.
Ms. Schakowsky. Yeah, I would really caution against using
that number. I mean, even when there are adverse effects, so
few people actually end up reporting at all. But are you aware,
Ms. Bailey, of any studies that have been done on the lifetime
effects of your company's products? Do we know how safe it is
to use any one personal care product over the course of a
person's life, every single day?
Ms. Bailey. In fact, companies are obligated to
substantiate the safety of individual ingredients and the
safety of the product before it is marketed, and those
assessments taken into account the knowledge that these
products were used in combination with other products and may
be used over the lifetime.
Ms. Schakowsky. OK. I have other questions that I wanted to
ask. Ms. Houlihan, in your testimony you state the cosmetics
industry review only 11 percent of the ingredients or 1,400 out
of the 12,500. And you go on to say that at this pace, it will
require two-and-a-half centuries to review all the products,
assuming nothing new is introduced. So what can we do to reduce
this timeframe of two-and-a-half centuries for reviewing the
safety of these ingredients?
Ms. Houlihan. Well, clearly, one thing we need is a
consistent safety standard and a law that would mandate pre-
market safety testing of cosmetic ingredients and products
before they go on the market, and that testing could be done by
manufacturers. It should be public, it should be reviewed by
FDA, and with so many ingredients on the market, one thing that
can be considered is a prioritization system that would target
first ingredients that might pose the highest risk, that would
cross the placenta would be a risk to developing children that
are known or suspected hazardous chemicals. But we certainly
need to see the pace picked up to have an assurance that
products on the market are safe.
Ms. Schakowsky. And I wonder if anybody wants to comment on
this. The European Union has required cosmetics companies to
remove reproductive toxins, mutagens and carcinogens from
personal care products and now bans 1,100 chemicals from the
personal care products due to serious adverse effects, cancer,
birth defects, reproductive problems, and just 9 chemicals, not
900 or 90, but 9 chemicals are banned from cosmetics in the
United States. How do we account for this difference and does
that mean that personal care product consumers are at risk in
the United States? Why has the E.U. banned 1,100 and we only
nine? How do we explain that?
Ms. Bailey. Well, in fact, the list of chemicals that you
are referring to includes many ingredients that aren't even
used in cosmetics either in Europe or in the United States. The
reality is in the United States and Europe, there is the same
principle that a company must substantiate the safety of its
product before it is put on the--
Ms. Schakowsky. How do we get the--OK. So what do we
subtract?
Ms. Bailey. Yes, and so if there is an ingredient that has
been proven under a peer-reviewed science-based basis to cause
cancer or be a toxin and cannot be substantiated for safety, it
cannot be included in a finished product. And FDA has the
authority to ban certain ingredients any time it wants to. It
has a list. The CIR findings are peer reviewed, published in
peer-reviewed journals, and there is a substantial body of
science in the United States behind every ingredient that is
included in a finished product.
Ms. Schakowsky. How do we get that big difference? Does
anybody want to speak to that? It would seem like even if we
don't use all those, that it is not explained sufficiently.
Ms. Houlihan. What has happened in the United States is
that for the past three decades we have had a voluntary
industry system for evaluating ingredient safety, and FDA has
stepped back and let that be the de facto safety standard in
the United States. And one of the major problems is yes, there
is a requirement in the law that ingredients and products be
substantiated for safety, but there is no definition or
guidance that FDA has provided to industry for what that means.
And so when we look at ingredients that are on the market here
in the United States, we see one in five products contain
ingredients of chemicals linked to cancer. We see 60 percent of
all products contain estrogenic chemicals that can cause
hormone problems, we find lead contamination in lipstick and
cancer-causing impurities in baby products and in natural
products. So companies are making very different decisions
about what is safe enough to sell because they don't have FDA
guidance on the issue.
Ms. Schakowsky. Thank you. My time is more than expired.
Thank you.
Mr. Pallone. Thank you, and the bells have run for our
votes, so I guess we just finished up in time to go to the
floor. And I just wanted to thank all of you again. As you know
and I said before, you have the discussion draft and it is
still a work in progress, and so we may very well get back to
you with additional questions or comments as we move forward to
a markup. If we get additional questions submitted in writing,
they will be submitted within the next 10 days and then we will
get back to you so that you can hopefully answer them.
Thank you again. This is a very important issue, and this
concludes our third and final hearing on the discussion draft.
And without objection, this meeting of the Subcommittee is
adjourned.
[Whereupon, at 1:15 p.m., the Subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
Statement of Hon. Edolphus Towns
I thank Chairman Pallone and Ranking Member Deal for
today's hearing and applaud Chairman Dingell, Ranking Member
Barton, and my colleagues for these much needed efforts to
protect the American public from unsafe products manufactured
outside of the United States.
I find it interesting that in 2006, FDA-regulated
manufacturers of medical devices sold $110 billion dollars
worth of medical device products. Medical device imports to the
United States have steadily increased since 2005. In 2007, the
U.S. imported roughly $1.5 billion dollars worth of medical
devices. The domestic cosmetic industry is also doing well and
increasing use of foreign ingredients. The cosmetic industry
has annual U.S. sales which are now exceeding $62 billion,
according to current FDA figures. World imports have lifted the
U.S. economy and supports U.S. jobs. But it hasn't lifted all
boats and may be responsible for sinking a few, since lives
were lost because of bad products. We should proceed with
caution. It's also unfortunate that the FDA can't keep pace
with globalization and is not having success with two databases
that supply inconsistent information about foreign
manufacturers. FDA inspections of class 2 foreign manufactured
medical devices, or mid-level risks devices, happen once in 27
years, but for class 3 medical devices that pose the greatest
risks, the FDA inspects about every 6 years. Clearly, these
inspection times are inadequate and do not come near what the
U.S. has set as the bar for domestic standards.
Today, I hope to hear more about user fees, third party
certification and use of international standards organizations
for product certification and inspections. I hope we are taking
small business considerations into account, as well. I remain
open to solutions and am committed to working with this
committee, the administration, the industry, our foreign trade
partners, consumers, and the public to get the FDA fully
functional and actively protecting the safety of the American
public. I thank the chairman and yield back.
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