[Senate Hearing 107-73]
[From the U.S. Government Publishing Office]
S. Hrg. 107-73
TISSUE BANKS: IS THE FEDERAL GOVERNMENT'S OVERSIGHT ADEQUATE?
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HEARING
before the
PERMANENT SUBCOMMITTEE ON
INVESTIGATIONS
of the
COMMITTEE ON
GOVERNMENTAL AFFAIRS
UNITED STATES SENATE
ONE HUNDRED SEVENTH CONGRESS
FIRST SESSION
__________
MAY 24, 2001
__________
Printed for the use of the Committee on Governmental Affairs
__________
U.S. GOVERNMENT PRINTING OFFICE
73-395 WASHINGTON : 2001
_______________________________________________________________________
For sale by the Superintendent of Documents, Congressional Sales Office
U.S. Government Printing Office, Washington, DC 20402
COMMITTEE ON GOVERNMENTAL AFFAIRS
FRED THOMPSON, Tennessee, Chairman
JOSEPH I. LIEBERMAN, Connecticut, Ranking Democrat
TED STEVENS, Alaska CARL LEVIN, Michigan
SUSAN M. COLLINS, Maine DANIEL K. AKAKA, Hawaii
GEORGE V. VOINOVICH, Ohio RICHARD J. DURBIN, Illinois
PETE V. DOMENICI, New Mexico ROBERT G. TORRICELLI, New Jersey
THAD COCHRAN, Mississippi MAX CLELAND, Georgia
JUDD GREGG, New Hampshire THOMAS R. CARPER, Delaware
ROBERT F. BENNETT, Utah JEAN CARNAHAN, Missouri
Hannah S. Sistare, Staff Director and Counsel
Joyce A. Rechtschaffen, Democratic Staff Director and Counsel
Darla D. Cassell, Chief Clerk
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PERMANENT SUBCOMMITTEE ON INVESTIGATIONS
SUSAN M. COLLINS, Maine, Chairman
CARL LEVIN, Michigan, Ranking Democrat
TED STEVENS, Alaska DANIEL K. AKAKA, Hawaii
GEORGE V. VOINOVICH, Ohio RICHARD J. DURBIN, Illinois
PETE V. DOMENICI, New Mexico ROBERT G. TORRICELLI, New Jersey
THAD COCHRAN, Mississippi MAX CLELAND, Georgia
JUDD GREGG, New Hampshire THOMAS R. CARPER, Delaware
ROBERT F. BENNETT, Utah JEAN CARNAHAN, Missouri
Christopher A. Ford, Chief Counsel and Staff Director
Linda J. Gustitus, Democratic Chief Counsel and Staff Director
Claire Barnard, Investigator
Mary D. Robertson, Chief Clerk
C O N T E N T S
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Page
Opening statements:
Senator Collins.............................................. 1
Senator Levin................................................ 3
Senator Durbin............................................... 5
WITNESSES
Thursday, May 24, 2001
George F. Grob, Deputy Inspector General for Evaluation and
Inspections, Office of the Inspector General, U.S. Department
of Health and Human Services, Washington, DC................... 9
P. Robert Rigney, Jr., Chief Executive Officer, American
Association of Tissue Banks, Washington, DC.................... 24
William F. Minogue, M.D., Chairman of the Board of Directors,
Washington Regional Transplant Consortium, Washington, DC...... 27
Valerie J. Rao, M.D., Chief Medical Examiner, District Five,
Leesburg, Florida.............................................. 30
Kathryn C. Zoon, Ph.D., Director, Center for Biologics Evaluation
and Research, U.S. Food and Drug Administration, Washington, DC 40
Alphabetical List of Witnesses
Grob, George F.:
Testimony.................................................... 9
Prepared statement........................................... 49
Minogue, William F., M.D.:
Testimony.................................................... 27
Prepared statement........................................... 74
Rao, Valerie J., M.D.:
Testimony.................................................... 30
Prepared statement........................................... 82
Rigney, P. Robert, Jr.:
Testimony.................................................... 24
Prepared statement........................................... 58
Zoon, Kathryn C., Ph.D.:
Testimony.................................................... 40
Prepared statement........................................... 84
Exhibit List
1. G``Warning Letter'' from the U.S. Food and Drug
Administration to Lions Club of District 22-C, Eye and Tissue
Bank and Research Foundation, Inc. (Seabrook, Maryland), dated
August 25, 2000, regarding improper alteration of records...... 110
2. G``Warning Letter'' from the U.S. Food and Drug
Administration to Pacific Coast Tissue Bank (Los Angeles,
California), dated April 21, 2000, regarding inadequate written
procedures and improperly maintained records................... 112
3. a. GLetter from elderly gentleman to Dr. Valerie Rao,
District Five Medical Examiner's Office, Leesburg, Florida,
dated March 26, 2001, expressing interest in and concerns about
donating his body.............................................. 114
b. GResponse letter from Dr. Valerie J. Rao, Lake County
Medical Examiner's Office, Leesburg, Florida, to elderly
gentleman, dated May 2, 2001, responding to his concerns... 115
4. GWashington Regional Transplant Consortium (WRTC) Donor
Referral/Tissue Donor Worksheet for an 82-year-old man with
prostate cancer, indicating his unsuitability as a potential
donor.......................................................... 116
5. GLions Eye and Tissue Bank of District 22-C Donor Medical and
Social History Questionnaire, indicating the Lions' awareness
of the potential donor's prostate cancer....................... 118
6. GE-mail from John Gaston to an organ procurement
organization, dated May 16, 2001, soliciting customers for his
new tissue recovery company.................................... 119
7. GLetter from the Food and Drug Administration to Regeneration
Technology, Inc. (RTI), dated May 3, 2001, raising questions
about the safety of ``pooling''................................ 120
8. GPermanent Subcommittee on Investigations Staff Background
Memorandum, ``Tissue Banks: Is The Federal Government's
Oversight Adequate?''.......................................... 123
9. GReport of the Department of Health and Human Services,
Office of Inspector General, ``Informed Consent in Tissue
Donation: Expectations and Realities,'' January 2001, OEI-01-
00-00440....................................................... 135
10. GReport of the Department of Health and Human Services,
Office of Inspector General, ``Oversight of Tissue Banking,''
January 2001, OEI-01-00-00441.................................. 166
11. a. G``Special Investigation: The Body Brokers'' (5-part
series of articles), The Orange County Register, April 16-20,
2001........................................................... 189
b. G``Cadavers For Cash In Texas: `People Make A Lot Of Money
Selling Tissue,' '' Chicago Tribune, May 22, 2000.......... 220
12. GLetter from Senator Richard J. Durbin, dated January 9,
2001, to Dr. Jane Henney, Commissioner, Food and Drug
Administration, regarding regulations of tissue for
transplantation and new FDA rules for tissue banks............. 222
13. GStatement for the record of the College of American
Pathologists................................................... 224
14. GStatement for the record of the North American Transplant
Coordinators Organization...................................... 226
15. GStatement for the record of the Southeast Tissue Alliance,
Inc............................................................ 232
16. GStatement for the record of Regeneration Technologies, Inc.. 235
17. GLetter from Regeneration Technologies, Inc, dated June 4,
2001, to Dr. Valerie J. Rao, Lake County Medical Examiner,
regarding Rao's testimony before the Permanent Subcommittee on
Investigations on May 24, 2001................................. 245
18. GLetter from Dr. Valerie J. Rao, District Five (Lake County)
Medical Examiner's Office, dated June 7, 2001, to Regeneration
Technologies, Inc., responding to Regeneration Technologies,
Inc. June 4, 2001, letter (above).............................. 249
19. GLetter from American Association of Tissue Banks (AATB),
dated July 15, 2001, to the Permanent Subcommittee on
Investigations, responding to Senator Collin's inquiry on
number of tissue banks operating after rejection for
accreditation or after being expelled or departed from AATB.... 251
20. GStatement for the record of Lions of District 22-C Eye and
Tissue Bank and Research Foundation, Inc. received by the
Permanent Subcommittee on Investigtions on August 9, 2001...... 253
TISSUE BANKS: IS THE FEDERAL GOVERNMENT'S OVERSIGHT ADEQUATE?
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THURSDAY, MAY 24, 2001
U.S. Senate,
Permanent Subcommittee on Investigations,
of the Committee on Governmental Affairs,
Washington, DC.
The Subcommittee met, pursuant to notice, at 9:30 a.m., in
room SD-342, Dirksen Senate Office Building, Hon. Susan
Collins, Chairman of the Subcommittee, presiding.
Present: Senators Collins, Levin, and Durbin.
Staff Present: Christopher A. Ford, Chief Counsel and Staff
Director; Mary D. Robertson, Chief Clerk; Claire Barnard,
Investigator; Eileen M. Fisher, Investigator; Barbara Cohoon,
Staff Assistant; Linda Gustitus, Democratic Chief Counsel and
Staff Director; Laura Stuber, Democratic Counsel to the
Minority; Jennett Rona (Senator Lieberman); Anne Marie Murphy
and Elissa Levin (Senator Durbin).
OPENING STATEMENT OF SENATOR COLLINS
Senator Collins. The Subcommittee will come to order.
Good morning. Today, the Permanent Subcommittee on
Investigations is holding an oversight hearing to examine the
practices of the tissue industry and the adequacy of the
regulatory framework that governs this industry. This hearing
will also look at procedures for obtaining the informed consent
of families who contemplate the donation of a loved one's
tissue. Senator Richard Durbin of Illinois was the first to
recommend that the Subcommittee investigate these important
issues.
While most people are familiar with the concept of organ
donation, tissue donation is not very well understood by most
Americans. Yet the tissue industry is very diverse and growing
rapidly. The recovery and medical use of tissue, including
skin, bone, cartilage, tendons, ligaments, and heart valves,
are increasingly common and can play an essential role in
improving the quality of recipients' lives.
Tissue donation is also on the rise. In 1994, an estimated
6,000 individuals donated tissue. By 1999, however, this figure
had increased more than three-fold to approximately 20,000.
Donors now make possible as many as 750,000 tissue transplants
every year in the United States.
Nevertheless, the industry that carries out these tasks has
received little public scrutiny. The organizations that make up
the tissue industry are collectively referred to as tissue
banks. Some are engaged in tissue recovery, while others
process, store, and distribute human tissue. Some tissue banks
are nonprofits, while others are for-profit companies.
Unlike organ transplants, human tissue is not usually
transplanted ``as is'' from the donor's body into that of the
recipient. Rather, donated tissue frequently undergoes
considerable processing before it can be used. Bone from a
donor's femur, for example, may be completely reshaped into a
component designed to give support to a recipient's spine.
Technology that greatly reduces the risk of rejection now
allows surgeons to use actual bone in their patients rather
than metal or other synthetic substances. In addition, donated
tissue, once it is reshaped, can frequently be stored for an
extended period of time, unlike organs, which must be
transplanted into the recipient's body within hours of their
recovery.
Tissue donation can improve the lives of many Americans.
Just one donor, in fact, can help a large number of people in
various ways. Skin donations, for instance, can be used to help
heal burn victims or aid in reconstructive surgical procedures.
Ligaments and tendons can be used to repair worn-out knees.
Bone donations can be used in hip replacements or spinal
surgery, enabling recipients to regain mobility. Donated
arteries and veins can restore circulation, and heart valves
can be transplanted to save lives.
With the phenomenal growth and the new uses for tissue
transplants have come some problems. Just over a year ago, the
Orange County Register ran a series of articles on the tissue
industry.\1\ Several of these articles brought to light
incidents in which tissue obtained from unsuitable donors
entered the American tissue supply, raising questions about the
adequacy of Federal regulation. Other concerns have been raised
about whether the practices of some tissue banks are sufficient
to reduce the danger of spreading such illnesses as the human
variant of ``mad cow disease.''
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\1\ See Exhibit No. 11.a. which appears in the Appendix on page
189.
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Because communicable diseases such as HIV and hepatitis,
among others, can also be transmitted through tissues, it is
vital that tissues be tested effectively and that potential
donors be properly screened for suitability. It is equally
important to ensure that persons and organizations involved in
the tissue industry follow good tissue handling and processing
practices in order to prevent contamination, and that the
industry employ sound tracking procedures so that if a problem
develops, all of the affected tissue recipients can be promptly
notified.
Toward this end, the Federal Food and Drug Administration
has proposed new rules that would extend the FDA's oversight
role in the areas of donor screening, tissue testing, and good
tissue practices.
The FDA's current rules focus on screening potential donors
for suitability, testing tissue, and keeping proper records
detailing the screening process. The FDA verifies such records
through periodic inspections of tissue banks. In addition, the
FDA has begun to implement a new rule requiring the
registration of all tissue banks. Although the FDA has
inspected only 118 tissue banks since 1993, we have recently
learned that at least 350 tissue banks of various types have
now registered with the FDA. These statistics suggest that many
tissue banks may have been operating with little or no Federal
oversight.
The tissue bank industry would not exist without the
generous individuals who decide to donate tissue from the
bodies of their loved ones. Of particular concern to me,
therefore, is whether or not accurate and appropriate
information is provided to the families of potential donors
during what is always a very difficult time.
Only with adequate information can families make the right
choice for them. Potential donor families want to be assured
that their loved ones' tissues will be used to help others.
They also expect that their loved ones' bodies will be
respected throughout the tissue recovery process and that the
tissue will be treated with the dignity and respect reflecting
the generous gift that it is.
The process by which tissue banks obtain consent,
unfortunately, has not always worked well. For example, a
tissue recovery technician in Arizona removed a deceased
donor's leg bone without obtaining consent and then falsified
the records to cover it up. While this may be an extreme case,
there are other troubling examples of inadequate information
being provided to donor families.
As a lucrative tissue market has developed with medical
breakthroughs making possible new ways to use tissue,
competition for tissue has increased dramatically. By some
accounts, a single donor can yield more than $200,000 in
revenue to tissue banks. Tissue banks make this money not by
selling human tissue, which is illegal, but by charging
processing fees to the recipients of this material. Some tissue
banks have charged others with making misrepresentations and
with concealing information from potential donor families.
In response to these concerns about safety, oversight, and
consent, last year, my Subcommittee colleague, Senator Durbin,
and I asked Health and Human Services Secretary Donna Shalala
to undertake a review of the tissue industry. Today, we will
hear from the HHS Office of Inspector General about the results
of that investigation.
This morning's hearing will examine many complex issues
related to the tissue bank industry and to the adequacy of
current and proposed regulatory oversight. We will hear from
representatives of the FDA and a private accreditation
organization working to ensure the safety of our tissue supply.
We will also hear from experts who have firsthand knowledge of
tissue banks and their operations. Finally, we will discuss
ways to improve the tissue bank industry so that tissue
recipients can have confidence that the tissue supply is safe
and donor families can be assured that their concerns are
respected.
I look forward to the testimony of all of our witnesses
today and to learning more about this very important issue.
I would now like to recognize my colleague, Senator Levin,
for any opening remarks that he might have.
OPENING STATEMENT OF SENATOR LEVIN
Senator Levin. Madam Chairman, thank you. Today's hearing
will address a sensitive and important subject: Human tissue
banking and the regulation, or the lack of regulation, of the
tissue bank industry.
First, I want to thank Chairman Collins and Senator Durbin
for their leadership in this area. We are here today because of
their initiative and I think the Nation is in their debt
because of it.
Human tissue is an important resource for medical
treatment. It is used, for example, for reconstructive surgery,
cancer care, cornea transplants, burn treatment, and heart
valve replacement. Recent strides in medical technology have
expanded the use and value of human tissue, and as the demand
for human tissue increases, we must ensure that appropriate
safeguards are in place for humane and safe handling.
Today's hearing will address some of the problems that have
arisen in the tissue bank industry, which has been subject to
only limited regulation. The lack of regulation is surprising
to me, since organ donation is significantly regulated and
since both organ donation and tissue banks involve the handling
of human bodies.
Moreover, unlike entities involved in organ donation, which
are non-profit, tissue bank recoverers use for-profit tissue
processing companies to process the human tissue. There are
reports that some of the non-profit tissue banks may be
receiving money from the for-profit processing companies in
order to get exclusive rights to the tissue from a particular
tissue bank.
The last thing we want is a bidding war for human tissue.
Apparently, the processing of the tissue and the development of
the technology for the processing of the tissue requires for-
profit participation, or at least it has done so up to now, and
the result is a tension between the concerns about the
appropriate treatment of human tissue and the for-profit
incentives of the companies involved. To date, the FDA has not
directly addressed this potential problem.
A number of other disturbing stories involving tissue banks
have been reported in the press recently. One witness
testifying today, the medical examiner for Lake County,
Florida, said she cut ties to a non-profit tissue bank with
ties to a for-profit company in Florida because she was
disturbed by the financial issues and the way the bank's
technicians treated donors' bodies.
Concerns have been raised over the possible transmission of
communicable diseases through tissue banks. Some news reports
have indicated that human tissue with CJD, or what we call
``mad cow disease,'' imported into this country from Germany,
was transplanted into U.S. patients in the early 1990's.
In another instance, after a 19-year-old Arizona woman died
in a car crash, the family agreed to donate body parts to a
tissue bank but expressly refused to authorize bone removal.
The tissue bank admitted in court records to altering
documents, making it appear as if consent to take bone from the
woman had been given. The bones were returned after a 2-year
legal fight, and her father said the following: ``Instead of
having some closure after her death, it just became an unending
saga. It was like she was dying over and over again.''
The Los Angeles County Coroner's Office was found to be
giving away or selling hundreds of organs and tissue from
accident and homicide victims. The body parts were sent to
researchers without ever seeking the consent of the families.
As a result, in September 2000, California enacted legislation
which bans county coroners from giving researchers body parts
from accident and homicide victims without family permission.
The FDA has reacted by proposing two new rules governing
tissue banks, one which mandates increased disease screening
and testing for tissue donors, and one which requires that
tissue banks follow a good tissue practice standard. The FDA
also finalized a rule in January of this year which requires
the registration of all tissue banks. Prior to that
registration rule, which was initially proposed in 1998 and was
not finalized until this year, we had no idea how many tissue
banks existed. I am hopeful that the FDA will expedite the two
proposed rules so that it will not take as long as the
registration rule, and today one of the questions we are going
to ask is: Why has it taken the FDA so long?
My own State of Michigan appears to have a good system in
place that could serve as a model for the rest of the Nation.
Instead of competing tissue banks in our State, Michigan has
one federally-designated Organ Procurement Organization, the
Gift of Life Agency, which also recovers tissue. The non-profit
Gift of Life Agency is affiliated with the non-profit Michigan
Eye Bank, which recovers only eye tissue, so that these
entities work together and do not compete with each other. In
many States, there are numerous tissue banks which end up
competing for human tissue, and it seems to me that this is a
source of a problem. I think we should be looking at ways to
encourage States to move towards the Michigan model.
One thing this hearing should not do, and must not do, is
discourage people in any way from becoming tissue and organ
donors. Organ and tissue donors provide the most important gift
in the world to their recipients--the Gift of Life. A half-
million people or more each year rely on tissue transplants. A
few unscrupulous tissue bank businesses should not be allowed
to harm a life-giving and a life-improving medical therapy.
Today's hearing can show us how appropriate regulation can
inspire confidence in the public, and hopefully inspire more
people to offer life-preserving tissue and organs after their
own deaths.
Again, I want to commend our Chairman and also Senator
Durbin, whose leadership in this area has brought us to this
point today and hopefully will lead to some additional advances
in this important area.
Senator Collins. Thank you, Senator Levin.
I am now pleased to call upon Senator Durbin. As I
mentioned in my opening statement, it is in large measure
through his interest in the oversight of the tissue industry
that the Subcommittee has begun its investigation in this area,
so Senator Durbin, I am pleased you can join us.
OPENING STATEMENT OF SENATOR DURBIN
Senator Durbin. Thank you very much. I want to thank
Senator Collins. When I raised this issue with her, she was
immediately interested in it and looked into it and shared my
belief that this is something that we need to address in
Washington. Her staff has done an excellent job putting
together the hearing on this topic today.
I am concerned about the safety and the ethical oversight
of the tissue donation system. It should be of interest to
every single one of us.
Last year, 6,000 people died while waiting for an organ
donation. There are over 75,000 on a waiting list for possible
life-saving organ transplants. While 6,000 people donated
organs, another 20,000 tissue donations were obtained. The
public and donor families do not usually differentiate between
the two. They expect that both donations will serve a medical
or a medical research purpose and will enhance, or in the case
of organ donations, possibly even save, a recipient's life.
My attention to this issue was called by a series in the
Chicago Tribune, and then I read subsequent to that a series in
the Orange County Register. In each case, they outlined some
very serious policy concerns. I am going to submit my entire
statement for the record, but I want to make this point as
clear as I can.
A decade ago, the tissue industry's revenues were $20
million a year. By 2003, they are expected to reach $1 billion.
I think we have a special responsibility in Washington, when it
comes to setting down rules, to make sure that there are no
abuses in this industry. I cannot even express strongly enough
my concern if we undermine the integrity of organ and tissue
donation by not accepting our Federal responsibility. People
need to understand that when they are making these selfless
gifts, that they are not doing it for a commercial purpose
unless they expressly make that decision, and to do otherwise
is, I am afraid, to discourage exactly what we should
encourage, namely organ donations. I hope that the results of
these hearings and some of the things that are brought forward
will help us reach some changes in policy.
I was happy last year when this first came up to call in
then-Secretary Shalala and she agreed to take a look at this
issue as quickly as possible. It was a bipartisan request. This
should be a bipartisan issue. I do not think there is a
Democratic or Republican approach to this. Any single one of
us, Independents alike, could end up needing a tissue or organ
donation and we have to make certain that we have policies that
serve this country.
I want to thank again the Chairman of this Subcommittee for
her response to this issue. It is going to be something, I
think, of great value in years to come. Thank you.
Senator Collins. Thank you, Senator Durbin.
[The prepared opening statement of Senator Durbin follows:]
PREPARED OPENING STATEMENT OF SENATOR DURBIN
I want to start by thanking my colleague, Senator Collins and her
staff for putting together a hearing on this topic today. Both the
safety and ethical oversight of the tissue donation system is clearly
of great interest to many including myself. It is essential that the
public have faith in the integrity of this system.
Last year more than 6,000 people died while waiting for an organ
donation and there are more than 75,000 on a waiting list for a
possibly life-saving organ transplant. While 6,000 people donated
organs, another 20,000 tissue donations were obtained. The public and
donor families do not generally differentiate between organ and tissue
donation. They expect that both donations will serve a medical or
medical research purpose and will enhance, or in the case of organ
donations, possibly save a recipient's life.
My interest in the tissue industry originally stemmed from some
news articles I read last year in the Chicago Tribune. The articles
show the ever increasing commercialization of the tissue industry. What
for donor families is an altruistic ``Gift of Life'' has become for
others a multimillion dollar business.
A decade ago, the tissue industry's revenues were $20 million a
year. By 2003, they are expected to reach $1 billion. While it is
illegal under Federal law to buy or sell either an organ or tissue for
transplantation and it is illegal to buy or sell fetal tissue for any
purpose, a tissue bank or processor may make a profit on ancillary
services such as transportation, processing, etc. The Chicago Tribune
and The Orange County Register reported that the tissue from one body
could yield up to $230,000 in revenue for a company.
Because of the profitability of tissue, a fierce competition has
broken out between companies seeking access to donated tissue. Some of
the methods used to, in essence, steer donations to a given tissue
company, I believe, make many of us very uneasy. For instance,
according to the Chicago Tribune, the head of the University of
Wisconsin Hospitals, Robert Hoffmann, was found to have been paid by a
company called Allograft, a tissue bank that Hoffmann helped create and
that received donated tissue from the university hospital. In 1996,
Hoffmann arranged to have the tissue harvested from hospital patients
delivered to the American Red Cross. In return, the Red Cross paid him
personally for those services. Two years later, several Red Cross
employees, aided by Hoffmann, set up their own non-profit tissue bank,
Allograft Resources. The hospital's donated tissue was then sent to
Allograft rather than the Red Cross and Hoffmann continued to receive a
fee. When this information was made public, Hoffmann eventually agreed
to pay his $86,000 in fees to the university for ``organ donation
education.''
Other examples reported in the media tell of medical examiners
receiving large sums of money in exchange for directing donations to a
particular tissue business. For example, a second Chicago Tribune
article reported that a Texas medical examiner was receiving $47,000 a
year from tissue banks and his assistants also received $50 from the
tissue bank each time they obtained a family's consent to harvest
tissue. These payments basically are like ``bounty payments.''
While donor families believe, in general, that the donations will
go to medically necessary transplantation, the profitability of
cosmetic uses is often higher and so a significant quantity of tissue
is instead being processed for cosmetic uses such as lip enhancement,
penile implants and face lifts. Donor families do not generally receive
an opportunity to direct the donation to medically necessary uses
including reconstructive uses, rather than cosmetic uses.
At the same time, both the Chicago Tribune and The Orange County
Register suggest that there have been shortages of skin for burn
victims. In fact, the American Association of Tissue Banks and the
American Burn Association surveyed their members involved in burn
repair and found that shortages do exist, with surgeons sometimes
having to delay surgery or to modify it to accommodate a smaller tissue
sample.
While we have, as a Nation, an allocation system for organs based
on medical necessity, we have no similar system for tissue
distribution.
Likewise, we require that all organs be procured by non-profit
Organ Procurement Organizations and we also require them to have
representatives of transplant centers, voluntary health associations,
and the general public on their board of directors. No such requirement
exists for tissue procurers.
As the Inspector General will, I believe, talk about in his
testimony, tissue donation is often solicited by phone and the
requesters tend to be far less trained than those used by Organ
Procurement Organizations. Donor families often do not receive much
information about the uses that the donation will be put to, nor do
they receive information about the companies who will be getting the
tissue and the financial arrangements of those companies. This lack of
transparency, can undermine the public trust.
Donated tissue can provide a fantastic therapeutic value to
patients, whether it be for repairing burns, or for reconstructing
those who have been injured or who have congenital problems. Many in
the industry work extremely hard to ensure that they meet the highest
standards. The American Association for Tissue Banks has a voluntary
accreditation process that sets a high standard and it has also
developed in collaboration with the Eye Bank Association of America and
the Association of Organ Procurement Organizations, a model for
appropriate informed consent.
Unfortunately, only 40 percent of the tissue banks or processors
are members of AATB. Many of the largest for-profit companies choose
not to be members.
In fact, FDA does not even know who all the companies are that are
involved with tissue processing. FDA clearly cannot be inspecting those
whose existence they are unaware of. When FDA has done inspections, in
some instances, it has found very serious deficiencies in the areas of
screening for diseases such as HIV and Hepatitis. It seems likely that
those who are not inspected may well also have similar deficiencies.
All of these problems led me to invite the previous Secretary of
HHS to meet with me and several other Senators last year. Secretary
Shalala met with Senators Wyden, Santorum, and me. After that meeting,
the Secretary directed the Inspector General to perform the two
investigations that the IG is discussing today.
Those meetings also led the Secretary to direct the FDA to speed up
the implementation of its new regulations. One regulation requires all
tissue companies to register with the FDA and to list the types of
products that they process. This will allow the FDA finally to be in a
position to inspect all facilities with some regularity. The other
rules that are in varying degrees of implementation will require
increased scrutiny regarding donor suitability and, for the first time,
``good manufacturing practices.''
All of these new rules cost money. Currently, the FDA has been
using money from other programs to pay for these new rules. It seems
unwise to be robbing one good program to pay for another. Therefore, I
asked FDA in January to provide me with budget details regarding how
much money will be needed to implement these new rules. It is now late
May and I still have not received an answer. It is difficult to help
the agency get the resources it needs if it does not respond in a
timely manner.
I agree with the Inspector General's recommendations that FDA needs
to move forward more aggressively to inspect all facilities and to
establish a regular inspection process.
I also have been concerned with the issue of prion diseases and
have been working in the food safety area to minimize the likelihood of
transmission of ``mad cow disease'' and the human counterpart, vCJD.
Similar issues arise in the tissue field. Twelve years ago, Japan
had a terrible problem with the transmission of CJD due to the mixing
or pooling of tissue samples. This led AATB to prohibit pooling or
batching for its members. Given that there is no known effective manner
to deactivate prions, I am glad to see that the new FDA rules prohibit
pooling or batching. Clearly mixing tissue samples from multiple donors
significantly increases the risk of disease transmission.
Since tissue transplantation is generally not done in a medically
urgent setting and is life-enhancing rather than life-saving, it is
very important that it not put a patient at additional risk for a
horrible and ultimately lethal disease such as CJD.
The only reason to batch-process tissue is to save money by using
economies of scale. There is no therapeutic value to batch processing.
I hope the FDA will remain firmly opposed to pooling or batch-
processing and will not get pressured by any company looking at its
bottom line into sacrificing human health and safety.
The issues involved in this area are very complex but it is now
abundantly clear that business as usual is undermining the public's
trust in the donation system. We need to move forward quickly to
develop solutions to restore that trust.
This hearing should provide a good start for the Subcommittee to
examine the issue and get input from those familiar with the tissue
industry, so that we can make improvements in the upcoming weeks.
I want to thank again, my colleague, Senator Collins, for arranging
this hearing and starting this very important dialogue. Our offices are
currently working on legislation to encourage organ donation and I hope
that we will also work together to craft solutions to improve the
tissue system.
Senator Collins. I would like to inform all of our
witnesses that we will be using a timing system today. Your
complete written statements will be placed in the hearing
record. You will be given 10 minutes for your initial
presentation and there will be a light system. When the light
turns to orange, you have only 1 minute to sum up.
I would now like to call upon our first witness this
morning, who is George Grob. He serves as the Deputy Inspector
General for Evaluation and Inspections of the Office of
Inspector General within the Department of Health and Human
Services. Mr. Grob has been with the Office of Inspector
General since 1988 and he will testify regarding the findings
in the Inspector General's reports on the tissue industry,
which are entitled, ``Oversight of Tissue Banking and Informed
Consent in Tissue Donation.'' \1\ We are very pleased to have
you with us this morning. We look forward to your testimony.
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\1\ See Exhibits No. 9 and 10 which appear in the Appendix on pages
135 and 166 respectively.
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Pursuant to Rule 6, all witnesses who testify are required
to be sworn in, so at this time, I would ask that you stand to
take the oath.
Do you swear that the testimony you are about to give to
the Subcommittee will be the truth, the whole truth, and
nothing but the truth, so help you, God?
Mr. Grob. I do.
Senator Collins. Thank you.
TESTIMONY OF GEORGE F. GROB,\2\ DEPUTY INSPECTOR GENERAL FOR
EVALUATION AND INSPECTIONS, OFFICE OF THE INSPECTOR GENERAL,
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, WASHINGTON, DC
Mr. Grob. Good morning, Madam Chairman and Senators Levin
and Durbin. It is a pleasure to be here, and I must begin my
remarks by saying that the opening remarks of all the Members
have covered all the ground that I was going to speak to today
in a very thorough way, so if you do not mind, I will repeat to
emphasize some of the points that you made and keep my remarks
short, hoping that we can cover more ground in the questions
and answers, which then may be more penetrating.
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\2\ The prepared statement of Mr. Grob appears in the Appendix on
page 49.
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Human tissue in the form of skin, bone, heart valves, eyes,
cells, and the like, is an important source of treatment,
benefitting thousands of Americans every year. For example,
donated skin can save the lives of burn victims. Donated bone
can replace cancerous bone and be used in knee and hip
replacements and for spinal surgery. As noted by the Chairman,
there has been a very rapid growth in this industry, which is
fortunate. The availability of these tissues is increasing year
by year.
But there are other changes underway, as well. Processing
has become more sophisticated and tissue is being put to new
uses. At the same time, the field is becoming more
entrepreneurial. For-profit firms are increasingly entering an
arena that was once dominated by nonprofit agencies. I wish to
emphasize that I do not intend this last remark to be taken
negatively. In fact, this may account for and contribute
positively to the development of new products and treatments.
However, as promising as these new trends are, the
standards of practice have not kept pace with the growth and
development of the industry. As a result, some donor families
have been confused and disappointed by the treatment and
disposition of the remains of their loved ones, and questions
have been raised about the quality, safety, and supply of human
tissue.
When these issues emerged last year, Secretary Shalala
asked the Office of Inspector General to examine the oversight
mechanisms and the processes whereby donors and their families
are approached for donation. We issued two reports in January,
and I believe you all have copies. At the time of our study,
the fall of the year 2000, we found shortcomings in both
aspects of the service sector.
First, with respect to oversight, the Food and Drug
Administration focuses on preventing the transmission of
communicable diseases by requiring donor screening and tissue
testing. We found that the FDA had designed and was
implementing an oversight system that was fundamentally sound.
However, due to resource constraints, it was unable to sustain
its program. Since 1993, it had inspected 118 banks. During
this period, 68 had only been inspected once instead of every 2
years, and we found another 36 that had never been inspected.
Late-breaking developments show us that there were perhaps
twice as many who were totally unknown, and, in fact, we found
that at that time, the number and location of all tissue banks
was unknown.
Also because of resource limitations, several key
regulations which were under development had not been
finalized.
The American Association of Tissue Banks conducts a
voluntary accreditation program. In addition to screening and
testing, it addresses operational practices and organizational
aspects of tissue banking, including safety, equipment testing,
labeling, and quality assurance programs. However, at the time
of our study, it had accredited only 58 tissue banks. Another
90 that we knew of at that time were not accredited.
Florida and New York are the only two States that inspect
tissue banks. Their requirements address a broad range of
practices and also require that banks report adverse incidents.
However, they only inspect those banks that do business within
their jurisdiction.
With respect to donor concerns, the expectations and
altruistic motives of donors and their families are the
foundation of tissue banking. There would be no tissue
transplantation without them. Their concerns, then, are vitally
important. Their assumptions and desires are that donated
tissue will enhance the lives of others; the donor will be
respected throughout the process, from recovery to use; the
gift will be recognized as coming from donated human tissue;
family emotional needs will be respected; the tissue banking
industry can be trusted and will act as stewards of the gift.
The reality of tissue banking raises some underlying
tensions with regard to these assumptions. These arise from the
commercialization of the service sector, the appearance of
tissue being treated as a commodity, and the use of tissue for
cosmetic purposes.
The key to meeting the donors' concerns is information and
their informed consent, but the circumstances during which the
request is made present fundamental obstacles to this. It is
the generous gift of these donors that makes it possible, but
it occurs within hours of the death of a loved one.
We found shortcomings in the oversight of requesters and in
the written information provided to families. More importantly,
at the time of our study, there were no standards or written
principles governing the manner in which the request is made
and informed consent obtained. Also, at the beginning of our
study, there was no knowledge of the adequacy of supply of
tissues, particularly of human skin. Subsequently and during
the course of our study, we learned that the supply of skin for
burn victims was somewhat tight.
Our reports include recommendations to address the
shortcomings that we found. During our study and since then,
progress was made in addressing them. FDA is now beginning to
inspect all known tissue banks. The regulation requiring the
registration of banks and their products was issued in January,
and since then, identification of a large number of tissue
banks previously unknown has occurred. A draft regulation on
good tissue handling practices was issued for comment, and
comments on a draft regulation on donor suitability and tissue
testing are now under review.
Both industry groups and donor family groups have issued
statements of principles to govern the informed consent
process. The American Association of Tissue Banks and the
American Burn Association have conducted surveys to determine
the adequacy of the supply of skin.
In short, progress is being made, but gaps remain. The
tissue banking and transplantation industry has moved from its
infancy to its adolescence. It is full of promise, but it is
experiencing some significant growing pains. I hope our studies
will be helpful in getting it through the stage, and I will be
happy to answer your questions.
Senator Collins. Thank you very much, Mr. Grob.
In one of your reports, you noted that at least 36 tissue
banks had never been inspected by the FDA, is that correct?
Mr. Grob. That is right.
Senator Collins. Now, what universe of banks were you
dealing with at that point? How many, about 118 or so?
Mr. Grob. About 150.
Senator Collins. A hundred-and-fifty?
Mr. Grob. Yes.
Senator Collins. We have recently learned that more than
350 tissue banks have registered with the FDA pursuant to the
new regulation.
Mr. Grob. Yes.
Senator Collins. So what does that suggest when you were
looking at 150 tissue banks, which presumably were all the
tissue banks that you were able to locate by using various
sources, like the FDA, the two States that regulate, is that
correct?
Mr. Grob. Yes, and a few other States that license them,
wherever we could find it.
Senator Collins. And you came up with a universe of 150,
about.
Mr. Grob. Or so, yes.
Senator Collins. And yet out of those, you found that there
were at least 36 that had never been inspected. Now we find out
that there are something like 350----
Mr. Grob. Yes.
Senator Collins [continuing]. Tissue banks. Does that not
suggest that there are literally scores of tissue banks that
have been operating with no Federal oversight whatsoever?
Mr. Grob. Or State oversight, or any oversight by the
industry accreditation group. And the significance of that, if
I could point out, is that when the Food and Drug
Administration conducts its inspections, and when the American
Association of Tissue Banks conducts its accreditation reviews,
they do find problems and some of them are significant. So we
have to assume that if they find problems in the banks that
they inspect, then there are probably those same problems, if
not more of them, in the banks that have never been inspected.
Senator Collins. I think that is an excellent point, and
that is what troubles me, as well, is that it appears that
there are scores of tissue banks that have been operating with
no oversight whatsoever, not by the FDA, not by the States, and
not by the private accreditation group, and yet in those tissue
banks that were known to FDA, there were still problems. It
seems to me it is more likely that there will be even greater
problems in the ones that no one was really aware of or
watching over. Could you tell us about some of the inspections
that the FDA has conducted and what they revealed?
Mr. Grob. Where they found problems--they found problems in
about half of the banks that they reviewed, and some of these
were serious problems that required official action. Examples
of that might have been cases where contamination had been
noted, a bank that might not have been able to successfully
recall tissue that needed to be recalled. There might have been
some problems where they could not track the tissue back to the
source, which, of course, is necessary to ensure that it is
safe. And then a couple of cases where we had what you might
call repeated testing to come up with the right result. In
other words, if the testing is positive----
Senator Collins. Can you explain that?
Mr. Grob. The testing might be positive for some
contamination. What you might then do is try to keep testing it
until the result is negative, and then at that----
Senator Collins. Let me stop you here to make sure I
understand. This case, this repeating testing, where the first
test of the tissue indicates that there is a problem.
Mr. Grob. Yes.
Senator Collins. It is contaminated or there is some other
disqualifying result that has occurred in the testing.
Mr. Grob. Exactly.
Senator Collins. So instead of that tissue being discarded
and taken out of the tissue supply, are you telling us that
what happens is the technician just repeats the test until they
get the result that they want?
Mr. Grob. Yes, exactly.
Senator Collins. That strikes me as an extremely dangerous
practice.
Mr. Grob. I would think so, yes.
Senator Collins. Could you tell us, also, were there cases
of tissue banks that failed to assure sterility of the tissue
and lacked operating procedures to prevent cross-contamination?
Mr. Grob. That is probably true. Now, the Food and Drug
Administration's inspections are primarily related right now to
the transmission to HIV and hepatitis, and their inspections
then would look at such things as whether there are records
that enable the tissue bank to be sure that the donor had been
properly screened, and then whether there had been proper
testing for those diseases, and, of course, for the general
handling of the tissues to prevent their further contamination
in the tissue bank.
So some of those general things that they would have to
look at would apply to other diseases, as well, but their look
right now is limited only to those two. The good practices
regulation, which has recently issued in draft form, would
provide additional protection for a variety of ways the tissue
is handled and the way the tissue bank is run and things of
this nature.
So right now, the Food and Drug Administration's
inspections are more limited. For example, they are more
limited now than the kind of review that is done by the
accreditation association or by the States of Florida and New
York, which have a broader set of requirements. Now, the
requirements of the Food and Drug Administration will catch up
with those and probably surpass them in detail when their new
regulation is issued in final.
Senator Collins. How extensive is the accreditation process
by the American Association of Tissue Banks?
Mr. Grob. Well, at the time we did the study, I think it
was 58 banks that were accredited out of what we now know to be
more than 350 tissue banks.
Senator Collins. So while those 50 to 75, let us say,
because I think it has gone up recently, banks may be held to
higher standards----
Mr. Grob. Right.
Senator Collins [continuing]. Than even with the FDA
standards----
Mr. Grob. Yes, right now.
Senator Collins [continuing]. There is still a vast
universe of banks that are not accredited by the private
organization, is that correct?
Mr. Grob. Yes. If we were doing our study today, the
finding would have been that we found that FDA had inspected
118 banks but there were 350 total. I mean, the numbers would
be very different, because at that time, the numbers were
simply not known. The same thing is true for the accreditation.
The accreditation is purely voluntary and there are lots of
issues about that in the sense that you have to look to the
motives of the banks to see if they have any motivation to
become accredited.
Senator Collins. Should the Federal Government or State
Governments be encouraging accreditation by this private
organization?
Mr. Grob. It is my opinion that there should be an
encouragement for accreditation by any suitable accreditor. The
American Association of Tissue Banks certainly is doing that.
Others could do it as well, or could be formed to do it.
But I do think it is important to point out the differences
between the FDA review and the accreditation. While they
currently do not overlap, they both serve important purposes.
For example, the accreditation association cannot do things
like force a recall, take action against someone who has not
been performing properly, things of this nature. So it does not
have that enforcement authority that the FDA has.
My own opinion is that some combination of the two is
always better than just doing one, and to that extent, then I
believe that it should be encouraged. Accreditation is used in
many other health care sectors effectively, but I do not think
it would be a substitute for the FDA inspection in this case.
Senator Collins. I agree with you. You found tissue banks
that had been refused accreditation by the American Association
of Tissue Banks, is that correct?
Mr. Grob. That is correct. Right.
Senator Collins. Did anything happen to those banks that
were turned down? Was there any sort of referral to FDA? Does
FDA place those banks that were denied accreditation under more
scrutiny?
Mr. Grob. No, I do not think so. I think that--although you
might want to check with your FDA witness on that particular
point. But as a general rule, the answer to your question is
that those banks that are not accredited are free to operate
without having to follow any of the rules that they would have
had to follow had they been accredited.
Senator Collins. So there are no restrictions or they are
allowed to engage in the same kind of practices as those that
successfully sought and obtained accreditation.
Mr. Grob. Right, only if they were violative of the FDA
communicable disease standards.
Senator Collins. In your judgment, to ensure public safety,
how often should the FDA be inspecting a tissue bank?
Mr. Grob. I would leave that up to FDA. Now, they have told
us and in various places they have suggested every 2 years,
which is why I referred to that. Other inspection programs or
accreditation programs, if you look at hospitals and home
health agencies and nursing homes, range from 1 to 3 years. So
2 years certainly seems to be well within the range of practice
in the health industry.
Senator Collins. And of the inspections that you found that
FDA had done, I think it was 188 inspections of 118 tissue
banks----
Mr. Grob. Yes.
Senator Collins [continuing]. What kind of time cycle were
those banks on? Were they being inspected once every 2 years,
or did it vary greatly?
Mr. Grob. It varied greatly, and as I said, only 68 had
ever been inspected more than once, and that was data that went
back to 1993.
Senator Collins. Mr. Grob, is there a difference between
the informed consent procedures for organ donations versus
tissue donations?
Mr. Grob. I think in principle, they are very similar, but
in practice, there are some significant differences. For organ
donation, all the requesting must be done by the organ
procurement organizations who do this constantly or by a
hospital or other personnel whom they train, whereas in the
tissue business, some OPOs may be involved sometime, but in
many cases, and probably more commonly, the requesting would be
done by representatives of the tissue banking industry or
different groups that work for them for this purpose. So the
requesting that is done by different groups and the level of
training, therefore, would be very, very different and not as
consistent in the tissue banking industry at this time.
Another difference, I think that is central here, has to do
with the circumstances. Generally speaking, for an organ
transplant, the patient would have had a close connection to
the hospital right before the time of the consent, because,
generally speaking, we are talking about a patient who is brain
dead and so they are under the close supervision of the
hospital. And so as a result of that, the organ procurement
organization may have had communication with the family for
several days or even a longer period of time before the actual
consent is reached, whereas for the tissue patient, that is not
limited to brain death. It could be a car accident or something
and the family must be approached within hours of the death.
I must say that the tissue banking has quite a challenge in
this respect, to balance the desire of the family for some
privacy or information and the circumstances. Often they, for
example, will make the request by telephone instead of at the
hospital, and that may be out of the respect for the family,
who may want to get back to its home setting before they are
asked.
So there is not an easy answer to that, but because it has
to occur within hours of the death, it makes it difficult, and
that also causes some of the difference.
Senator Collins. Thank you. My time has expired. Senator
Levin.
Senator Levin. Thank you, Madam Chairman.
The National Organ Transplant Act forbids the selling of
organs and tissues. However, the Act does permit a reasonable
payment which is associated with the removal, transportation,
implantation, processing, preservation, quality control, and
storage.
Mr. Grob. Yes.
Senator Levin. We have heard stories, however, that there
have been grants that have been made to some of the tissue
banks that do the recovering of the tissue, that some of the
profit-making processors that seek that tissue for processing
have made some form of grant to some of the tissue banks that
have done the recovering, which are usually not-for-profit in
theory. Have you also run into those kind of stories?
Mr. Grob. This issue of the profit making and the place at
which there is a transaction of anything of worth was one of
the issues that we struggled with more than any other, and I
think I would have to report to you right now that the struggle
continues, because I do not think that there is a consensus on
exactly what should be done with regard to trying to govern in
any way the transactions that occur during this period. So if I
may, in this case, what I would prefer to do would just be to
share with you some thoughts or ideas that we have talked about
among ourselves and that might shed some light on this.
Certainly, the intention of that Act was to prevent any
individual from offering his or her tissue for sale or for
anyone to approach an individual and offer to buy it from them,
and in our discussions, there has been almost universal
agreement on that point. What happens after that, though, is
that the tissue needs to be handled in various ways, and I
think that as the Act is written, certainly allows, as you
said, for the reasonable payment of almost anything that occurs
after that point in the sense that there is a storage or a
handling or a transportation that occurs at almost every level
there.
So really, in terms of the law, the issue turns to the
question of what is reasonable. How much is a reasonable
amount? In talking to donors, we found that they were not
upset, generally speaking, many of them, with the notion that a
profit could be made in those middle transactions or that money
should be paid, but they certainly did not want excessive
profiteering. But there was no way for any of us to get a
handle on exactly what is excessive. One could look at the
profits that a company makes, but big companies make a lot more
profit than small ones do, for example, and it is very
difficult to second-guess the cost that a company incurs
because of all the overhead that goes into the company's
operation.
We could think of no practical way to track that. We do not
even know where the tissue goes right now. There is not even a
way to sort out and track what happens to the tissue. And with
the modern tissue banking industry, there are so many new
processes coming into play all the time that it is difficult to
even define the stages through which the tissue is going. And
if one were to try to track it and consider what the price for
that would be, any system you put into effect would probably be
inaccurate within a few months of your doing it because of the
changes that are occurring in the industry. And furthermore,
there has been a long tradition of not establishing price
limits for most products in the United States, including in the
health care industry.
So we were unable to come up with any practical way to deal
with what I think is a very fundamental concern, and I think
Senator Collins referred to this in her opening remarks, about
the expectation that the tissue would not be used for
commercialization, that it would be donated for the benefit of
someone else, a very difficult thing.
As far as we were able to take it in our own thinking, the
key to it was information. Now, we think that the donors can
make up their own minds about what to do, or at least could do
that better, if they had more information than they have now,
and we believe that information should occur at two times, once
when the donation is being requested. The donor at that time
may not be interested in those details, but there certainly is
nothing wrong with providing written information that could be
considered later, or perhaps in some cases it could be
considered somewhat in advance if death is imminent.
But above and beyond that, a more general form of
information to inform the public about the donation process in
general and perhaps about the companies involved in particular
would be useful, perhaps an annual or periodic statement by
these companies indicating their sources of revenue, the uses
to which they put the tissue, things of this nature that could
be out there, so that as people become more informed about
tissue banking and tissue donation, they could look to those
documents, much as they look to the annual statements of
nonprofit agencies who produce an annual statement of what
happens to their funds, and then they can decide whether they
want to donate to a particular agency or not. Perhaps a similar
thing could be beneficial in this industry, as well.
So I am sharing with you a long journey of trying to come
to grips with that one.
Senator Levin. Well, there is another possibility, and it
is what is in place in my home State of Michigan, which is that
we have one organ procurement organization, one organ and
tissue procurement organization----
Mr. Grob. Yes.
Senator Levin [continuing]. So that you do not have
competition among different organizations for the tissue.
Mr. Grob. Yes.
Senator Levin. And it is that competition which then can
precipitate grants, however you want to call them, monies going
to various nonprofit recovering entities in order to get the
tissue into the hands of the people who are making profit here.
Now, one thing we could do would be to modify the Federal
law, which is to say that there is one organ procurement
organization responsible for organ and tissue donation
activities per region. Right now, we do that with organs, but
not with tissue. Why not do that with tissue and take away some
of that competitive activity which exists which could
precipitate the commercialization of tissue donation, which is
what we want to avoid?
Mr. Grob. I think there are lots of possibilities. If I
may, I would like to speak as an analyst, so I will give you
what I regard as the pros and cons of those kinds of
arrangements. This is a difficult policy choice to make.
I think I can preface it by saying that, recently, organ
procurement organizations have become more visible and active
in tissue requesting and recovery than they were in the past.
One reason for that seems to be that a couple of years ago, a
law was passed that the hospitals must inform the organ
procurement organizations of the death of patients in the
hospital. The idea was so that they would be more alert to the
possibility of organ donation. But what happened was as a
result of that was that the organ procurement organizations
became more alert for tissue recovery, as well, and as a
result, their role in tissue recovery has greatly increased.
And so that certainly is very much of a possibility.
However, it still is not the case that the organ
procurement organizations are the ones who do it all, and if
one were to switch over to that right now, then what would
happen would be those tissue banks that have been involved,
including many who have been involved for many years and are
actually pretty good at it, then they might lose ground and
then we may lose a resource in there for the tissue.
Now, another thing I will just have to say is that
different people will have different opinions as to the
usefulness of the competition. I think in an ordinary business
world, the competition is always valuable. Now, when there are
questions that come up about the allocation of important life-
saving tissue, then those things can be set aside, as they are
for organs.
Another difference, though, is this, that for organs, the
gap between what is available and what is needed is very
severe. The number of organs that are needed to save lives are
several times more that are needed than are available. As far
as we can tell, with tissue, while there is probably a gap at
times for skin, there certainly is not a gap of that magnitude
as there is for organs. And furthermore, for other tissue
types, there is not necessarily a gap. For example, for eyes,
we are not aware of any particular gap. So the tissue industry
is more diverse and the needs are different in terms of
allocations here, if you will.
So, again, I think that the ideas you are presenting need
to be on the table, as well as all kinds of other ideas. I do
not think we see a clear shot to the goal line on this one.
Senator Levin. Your report does not get into pooling.
Mr. Grob. No, it does not.
Senator Levin. I am just wondering why not.
Mr. Grob. The pooling at that time was simply not one of
the things that we were looking at as part of the general
oversight of the industry. At the time that we did our report,
there was no rule against pooling as such. The rule against
pooling will occur when the new regulations are issued. Then it
will certainly be a rule. Now, FDA has always looked at
pooling, but it really was not on the table of the oversight
system that we were looking at at the time. The States, like
New York and Florida, have rules against pooling, and I believe
that the American Association of Tissue Banking has, as well.
Senator Levin. You indicated a lack of resources, I
believe, for the inspections.
Mr. Grob. Yes.
Senator Levin. Is that still true? Does the FDA have
inadequate resources?
Mr. Grob. FDA has made it clear what their budget needs are
for the inspection program that they design. Now, those numbers
may be modified in light of the doubling of the number of known
tissue banks that have come out of the recent registration of
tissue banks. These budgets for this were recently proposed and
I do not know the disposition of them. Any additional resources
for this which FDA, I believe, says is in the order of $3 or $4
million a year for what they knew of at the time they made
those budgets, were made in the current budget session, and I
do not know what the disposition of that is in the current
budget.
Senator Levin. We will find out later today. Thank you.
Thank you, Madam Chairman.
Senator Collins. Senator Durbin.
Senator Durbin. Thank you very much, Madam Chairman, and
let me follow up on that question.
For a number of years, I have been keeping a close eye on
the Food and Drug Administration. I cannot imagine how they can
keep up with all of the responsibilities we send their way.
Mr. Grob. Exactly.
Senator Durbin. An agency which spends roughly $1 billion a
year is just being overburdened with all sorts of new
responsibilities----
Mr. Grob. Yes.
Senator Durbin [continuing]. All legitimate, as far as I am
concerned----
Mr. Grob. Yes.
Senator Durbin [continuing]. But certainly beyond their
capability with current staffing.
Mr. Grob. Yes.
Senator Durbin. We have to get honest about this. If we
want the Food and Drug Administration to perform valuable
oversight, they have to be given the resources. Otherwise, I do
not think it is fair to hold them accountable for too few
inspections if they do not even have the inspectors, and you
certainly spell out in your report to us about the inadequacy
of the inspection of these tissue banks, since 1993.
Mr. Grob. Yes.
Senator Durbin. Let me ask you to comment on a couple of
things, if you might. I want to get into the issue of informed
consent in a moment, but first, an article in the Chicago
Tribune last year \1\ suggested that in San Antonio, Texas, the
medical examiner's assistants were receiving $50 from a tissue
bank each time they obtained a family's consent to harvest
tissue. The same article also alleged that county supervisors
took bids from tissue banks on the right to bodies collected by
medical examiners. The winning bidder, South Texas Blood and
Tissue Center, agreed to pay $180,000 annually. Do you think
such payments are legal under our law that prohibits the sale
of organ and tissue?
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\1\ See Exhibit No. 11.b. which appears in the Appendix on page
220.
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Mr. Grob. We have not considered the question you are
asking, but we certainly can consider that. One of the things
that happened during the course of our study was that we became
more aware of the role of medical examiners, which was not on
the table at the beginning of the study, but it was one of the
things that we began to find out more and more about as the
study progressed. So one of the things we have done is that we
have decided that we will be conducting a study that examines
the role of the medical examiners.
Senator Durbin. But in terms of the payments, did you take,
in the course of your survey, did you review the law as it
relates to the sale of organs and tissues and whether or not
you can receive compensation?
Mr. Grob. We did examine the law quite carefully when we
began our study, and I had summarized earlier some of the
complexities we had in trying to come to grips with that law
and define exactly what is legal. Once the tissue leaves the
donor family, in other words, there is no question that at the
point where the donation is being made by the family, that
there should be no transaction from the individual to offer a
tissue or organ for sale or to be offered any money for
donating either, but after that point, then the money can be
legitimately used for almost any aspect of the handling of the
tissue. But, I guess----
Senator Durbin. I want to make sure it is clear, if I can.
Mr. Grob. It is only in exchange for the business.
Senator Durbin. I want to make sure this is clear.
Mr. Grob. Yes.
Senator Durbin. So that the family's decision to donate----
Mr. Grob. Is not affected----
Senator Durbin [continuing]. Cannot be compensated.
Mr. Grob. Exactly.
Senator Durbin. But beyond that, once the donation has been
made----
Mr. Grob. Right.
Senator Durbin [continuing]. There can be other
intermediaries who start to put price tags on the tissue
involved.
Mr. Grob. Exactly.
Senator Durbin. Is that correct?
Mr. Grob. That is correct. The current law, basically, it
actually has a list of what you can do more than that which you
cannot, and that list, just superficially, would seem to cover
almost all the products of tissue.
Now, an interesting question you are raising that I do not
have any immediate answer for, and I would not want to venture
one without consulting with others, is whether--say if the $50
were given, if that were covering a legitimate cost of the
other agency, then the law would allow it.
Senator Durbin. Yes.
Mr. Grob. But if it was simply an inducement for business,
I do not think that that is one of the things that the law
allows.
Senator Durbin. Right. That is an important distinction.
Mr. Grob. Yes.
Senator Durbin. Cost of transport and transportation, I
think that is allowed.
Mr. Grob. Exactly.
Senator Durbin. But it really does get to the heart of an
important issue here, and that is if there is a feeling that
somehow this selfless act of a family in donating tissues or
organs will relate in some commercialization, I think it is
going to inhibit a lot of people from even considering that
possibility, and I think that we have to be very honest about
that.
Now, you really address that from another angle, too, when
you talk about the consent forms.
Mr. Grob. Yes.
Senator Durbin. That is something that I think bears a
little bit of scrutiny here, as well.
Mr. Grob. Yes.
Senator Durbin. You were suggesting that the consent forms
be more complete in terms of telling people what is actually
going to happen to the tissues----
Mr. Grob. Right. Exactly.
Senator Durbin [continuing]. Donations from their loved
one.
Mr. Grob. Yes.
Senator Durbin. You also note, though, that some people
have said, I do not want to know too much about this.
Mr. Grob. Exactly.
Senator Durbin. This is a very sad moment in a life, when
someone is dying----
Mr. Grob. Yes.
Senator Durbin [continuing]. And you can tell me something,
but please----
Mr. Grob. Yes. Do not bother me with that.
Senator Durbin [continuing]. If you get into graphic detail
here, I cannot absorb all of this and handle it.
Mr. Grob. Right.
Senator Durbin. I might just walk away from the whole idea.
Mr. Grob. Exactly.
Senator Durbin. This is a tough balancing act, is it not?
Mr. Grob. It is a tightrope, and if you fall off the left
side of that tightrope or the right side, you are going to be
in trouble. So as far as discouraging donation, it is a hard
one.
I think that one idea here is, and I think that the
statement of principles that were subsequently developed by the
industry are somewhat promising in this regard because of the
flexibility they provide. They sort of show that here are
things that you definitely ought to--information that ought to
be provided to a donor, and now here are some other things that
you may want to raise, depending on the interest of the donor.
And that is exactly what we found. I think in our study, we
quoted an individual who said, ``I do not want to know any more
about it.''
We also found mixed reaction to the point you raised about
the commercialization. There was not such a strong reaction to
the idea that profit would be made or that prices would be
charged. There was concern about whether those profits would be
excessive or not, whether there would be profiteering. But
there was no practical way to define it and everyone had a
different idea.
If I could just give you an example, no one objects to the
fact that the surgeon who implants a tissue should get a
salary, and then similarly, you could take that concept and
just work it back through all the other parts of the processes.
People do seem to understand that.
But what concerned them more is if the tissue were being
used for some commercial purpose that they did not have in
mind. If they thought, well, this skin will be used for burn
victims, for example, or medical research, or even the training
of surgeons or hospital personnel, they might say that is fine.
But they probably might not have been thinking that it might be
used for some form of purely cosmetic or voluntary----
Senator Durbin. That is an important distinction.
Mr. Grob. Yes.
Senator Durbin. It is one that I have really tried to
grapple with here, because if you are talking about a tissue
donation that is going to be used by a plastic surgeon to make
an actress more beautiful, puff up her lips or whatever happens
to be the fashion statement of the day, as opposed to skin that
is being used in a transplant for someone who has been a victim
of a burn, I mean, totally different world, but both commercial
in nature.
Mr. Grob. Yes.
Senator Durbin. And drawing that line honestly so that
people know what they are getting into makes a big difference.
Mr. Grob. Yes.
Senator Durbin. I was shocked when I read the series in the
Orange County Register.\1\ It had never crossed my mind as I
got into this about the use of cadavers for test purposes. I
just never thought about a cadaver being used as a test dummy,
and yet it has been done.
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\1\ See Exhibit No. 11.a. which appears in the Appendix on page
189.
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Mr. Grob. Yes.
Senator Durbin. I am virtually certain that the person who
made that donation, signed that consent, did not have a clue
that that is what might happen. They were donating for
scientific research.
Mr. Grob. Right.
Senator Durbin. How much should they have known about what
was going to happen? I will not go into the graphic details
from that series. I invite those who are interested and have
not read it to read them----
Mr. Grob. That is right.
Senator Durbin [continuing]. Because they are troubling, to
think that people made these donations unaware of the lengths
to which that donation might go.
Mr. Grob. That is why I think that there really needs to be
two ways in which the information is provided, one at the point
of donation, but the other one more generally. I think that,
for example, if I could just reflect with you for a moment,
there are other donations we are more accustomed to. For
example, I think most of us understand the donation of blood.
Senator Durbin. Yes.
Mr. Grob. And even of eyes. And over the years, we have
been inculturated to accept this and to understand it and know
about it, and that has grown up and we are all trained from the
time we are very young. We are all trained about this and we
understand this.
The tissue that we are talking about here, though, we have
not been inculturated about as much and there are these
expectations or these surprises, as you were describing them,
of what people's expectations are.
So what I think is that we need to very gradually, but very
concretely and very deliberately, begin to get people to
understand that. I think there needs to be much more openness
about all these things. Perhaps some people would be content if
their tissue were used for cosmetic purposes. For example, for
skin surgery, they largely need very large pieces of skin, and
some of the smaller bits of skin may not be useful for that
purpose but could be used, for example, for repairing blemishes
or for some constructive type surgery of the face or other
things and people might be totally content with that.
So it is a complex matter and I do not think there is a
clear rule or a clear principle, but I think what we need is
more understanding and something that can be done to get that
out there so people can gradually learn about this. Then they
can make more informed decisions, I think.
Senator Durbin. Let me ask you this. Is it true that
current law prohibits the sale of fetal tissue for any purpose,
but only prohibits the sale of adult tissue for
transplantation?
Mr. Grob. I would rather not answer because I did not
prepare for that at all and----
Senator Durbin. That is a fact. It raises some interesting
questions.
Mr. Grob. We did not--and it was with great deliberation--
did not take on anything related to reproductive tissue at all.
The issues that were raised in the newspapers and elsewhere
dealt with what we would call conventional tissue for
transplant, and at the time, we were all trying to learn so
much, just to come to grips with all of this, that it seemed
better at the time just to keep it narrower.
Senator Durbin. Well, thank you for your report. Thanks,
Madam Chairman.
Senator Collins. Thank you very much, Senator Durbin.
Thank you, Mr. Grob. Your testimony and your work in this
area has been very careful for the Subcommittee's analysis, and
as we go forward, we will be in touch with you, so thank you.
Mr. Grob. Thank you.
Senator Collins. I would now like to welcome our second
panel of witnesses this morning. We are pleased to have with us
Robert Rigney, the Chief Executive Officer of the American
Association of Tissue Banks; Dr. William Minogue, the Chairman
of the Board of the Washington Regional Transplant Consortium;
and Dr. Valerie Rao, the Chief Medical Examiner of the District
Five Medical Examiner's Office in Lake County, Florida.
Mr. Rigney was appointed as the first CEO of AATB in June
of 1999. He has over 20 years' experience in health care
legislation and regulation in both the public and private
sector, and I understand actually began his career here on
Capitol Hill, so we welcome him back to the Hill.
Dr. Minogue began his distinguished career in private
practice, specializing in internal medicine and cardiology,
having served previously as the Director of Medical Education
and then Vice President for Medical Affairs at Overlook
Hospital in Summit, New Jersey. Dr. Minogue is now the Senior
Vice President for Medical Affairs at Suburban Hospital in
Bethesda, Maryland. He has also served as Chairman of a Joint
Commission on Accreditation of Health Care Organizations task
force.
Dr. Rao currently serves as the Chief Medical Officer for
several counties in the State of Florida, a position she has
held since April of last year. She is board certified in both
clinical pathology and forensic pathology and has 20 years of
experience in this field. She is also now the President-Elect
of the Florida Association of Medical Examiners.
As I explained earlier, pursuant to the Subcommittee rules,
all witnesses are required to be sworn in, so I would ask that
you please stand and raise your right hand.
Do you swear that the testimony you are about to give to
the Subcommittee will be the truth, the whole truth, and
nothing but the truth, so help you, God?
Mr. Rigney. I do.
Dr. Minogue. I do.
Dr. Rao. I do.
Senator Collins. Thank you.
Mr. Rigney, we are going to start with you this morning, so
you may proceed.
TESTIMONY OF P. ROBERT RIGNEY, JR.,\1\ CHIEF EXECUTIVE OFFICER,
AMERICAN ASSOCIATION OF TISSUE BANKS, WASHINGTON, DC
Mr. Rigney. Thank you. Senator Collins and Members of the
Subcommittee, my name is Bob Rigney. I am the Chief Executive
Officer of the American Association of Tissue Banks. I am
accompanied here today by our President, Dr. Richard Kagan. Dr.
Kagan is the Medical Director of the Ohio Valley Tissue and
Skin Center. He is also Assistant Chief of Staff at Shriners'
Burns Hospital in Cincinnati and the Director of the University
Hospital's Burn Special Care Unit. On behalf of our members and
the people we serve, I want to thank you for the invitation to
appear here. We welcome the opportunity to comment on this
rapidly changing and critically important field of tissue
banking and tissue transplantation.
---------------------------------------------------------------------------
\1\ The prepared statement of Mr. Rigney Jr. appears in the
Appendix on page 58.
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Today, human tissues are used in a host of medical
procedures and new clinical applications are constantly being
developed. In the past two decades, human cellular and tissue-
based products have improved and saved the lives of millions of
our fellow citizens. It is imperative, therefore, that we do
nothing to discourage Americans from donating their organs and
tissues.
Let me address the items on which you asked us to comment,
first, the role of the AATB and the tissue banking industry.
The AATB is a voluntary nonprofit professional scientific and
educational organization. Our mission is public health. We are
dedicated to ensuring that human tissues intended for
transplantation are safe and free of infectious disease, of
uniform high quality, and available in quantities sufficient to
meet national needs.
To further our mission, since 1984, we have published the
only private ``Standards for Tissue Banking.'' This document is
recognized as the authoritative source for the industry.
For more than 15 years, we have also operated our own
voluntary accreditation program to ensure compliance with our
standards. All of our institutional members must be
reaccredited every 3 years. Accreditation includes, among other
requirements, an on-site inspection by independent inspectors,
most of whom are former Food and Drug Administration compliance
officers and none of whom are affiliated with any tissue
facility. We offer a certification program for tissue bank
personnel, and we also operate a tissue network and hotline to
help tissue banks and hospitals in emergencies, locate
musculoskeletal allografts for orthopedic surgeons, and skin
needed to treat burn victims.
The Association's membership currently includes nearly
1,200 individual members and 74 accredited tissue banks engaged
in the recovery, processing, storage, and distribution of human
tissue. Not every tissue bank is a member of the AATB, but most
of the major tissue banks have obtained AATB accreditation. In
fact, we believe that at least a majority of the tissue banks
in the United State are AATB accredited.
With the exception of ocular tissue, we also believe that
AATB members provide most of the commonly used structural
tissues for clinical use in the United States. In 1999, the
year for which the most recent data is available, the number of
bone allografts distributed by AATB accredited tissue banks
totaled almost 524,000, more than double what was distributed 5
years ago.
In addition, tissue donations to our accredited banks are
increasing significantly. AATB accredited banks recovered
tissue from more than 17,000 donors in 1999. This represents a
274 percent increase in donations in the last 5 years.
It is important to recognize that for nearly a decade
following publication of our first edition of our Standards in
1984, the AATB was the only organization overseeing tissue
banking in the United States. Today, 17 years later, our
Standards are still the most comprehensive and authoritative
source in tissue banking, and over those years, we have
compiled a remarkable record of donor service and patient
safety.
Second, you asked us to comment on the instances in which
AATB has denied accreditation to tissue banks. At the outset, I
want to make clear that the philosophy of our accreditation
program is education, not regulatory enforcement. Our goal is
to bring tissue banks into compliance with our Standards, not
to penalize them for being out of compliance. We, therefore,
allow for corrective actions to be taken, but we also provide
for suspension, denial, and revocation of accreditation.
Since the AATB's accreditation program began in 1986, a
total of 116 tissue banks have been accredited. Of that number,
43 banks are no longer accredited. Approximately 23 of the 43
banks have either closed, merged with other banks, or for
whatever reason did not seek reaccreditation. The remaining 20
banks failed to demonstrate compliance with AATB Standards. Of
these 20 tissue banks, 14 were denied accreditation following
reinspections.
Inspections of four banks were terminated because of
obvious noncompliance at the time of the inspection and these
banks withdrew from the accreditation process. Two additional
banks would have been recommended for denial. Because their
current accreditation was about to expire, they withdrew from
the process and let their accreditation lapse. There have also
been approximately ten other banks that applied for their
initial accreditation but were denied or dropped out of the
process.
Third, you requested our views on the roles of for-profit
and not-for-profit tissue banks. AATB accreditation is open to
any tissue bank that, one, voluntarily agrees to abide by the
policies and procedures of the Association, and two,
demonstrates adherence to the Standards by successfully
completing the AATB's accreditation program. To ensure
compliance with our Nation's antitrust laws, we do not now, nor
have we ever, differentiated between for-profit or not-for-
profit tissue banks.
Next, you wanted our opinion regarding pooling tissue. In
all the private and public reporting about tissue banking and
tissue transplantation, the greatest untold story, in our
opinion, is safety. During the past 7 years, for example,
tissue banks accredited by the AATB have distributed more than
two million allografts to surgeons without a single reported
case of disease transmission from donor to recipient.
For the past 12 years, AATB Standards have prohibited the
pooling and commingling of tissues to prevent infectious
disease contamination and cross-contamination. This requirement
was adopted because of safety concerns after reports in the
1980's that linked transmission of Creutzfeld-Jacob disease, or
CJD, in Japan to human tissue that had been processed in
batches in Germany. There has never been a case of CJD
transmission from tissue processed in the United States. We
believe that this safety record is due, at least in part, to
the prohibition on pooling contained in our standards.
Fifth, you asked for our assessment of the current
regulatory oversight of tissue banking. Tissue banks have been
regulated by the FDA since the agency issued its interim
regulations in December of 1993. The agency issued its final
regulations in 1997. As detailed in our written statement, the
1997 regulations gave FDA the authority to inspect a tissue
bank's facilities, equipment, processes, the screening and
testing of donors, medical records, and products. The agency
also possesses the police power to sanction tissue banks found
in violation of the FDA regulations.
The FDA's current regulatory authority over tissue banks is
considerable and the agency has been exercising that authority.
We know, for example, that in the past few years, the FDA has
inspected approximately one-third to one-half of AATB
accredited banks each year. For us, the question is not that
FDA has no authority to regulate tissue banks, but whether it
has the resources to enforce its existing regulations.
Finally, you requested our opinion of the Food and Drug
Administration's proposed rules to expand its oversight of
tissue banks. The AATB has had a longstanding history of
support for the FDA's goal of developing a balanced, effective,
and reasoned program of tissue regulation. That support began
with the FDA's first regulatory initiative in 1993 and
continued with the 1997 final regulations.
We have also supported the FDA's concept for regulating
human tissues that was published 4 years ago. Human tissues are
not drugs, biologics, or devices, and they should not be
regulated as such.
To implement this new regulatory framework, the FDA
published its tissue action plan, the principal components of
which were the three separate regulations covering
registration, donor suitability, and good tissue practices.
Since its first publication, the AATB has always supported the
FDA's registration of tissue banks, and we are pleased that
registration and product listing are now realities.
The AATB has also strongly supported mandatory donor
screening and testing to prevent disease transmission, as
outlined in the FDA's proposed donor suitability rule. Since
1979, the AATB has had published guidelines on donor selection
criteria, and donor suitability requirements have been included
in every edition of our Standards since they were first
published in 1984.
In addition, the AATB has generally endorsed the provisions
of the FDA's proposed current good tissue practices rule. They
are specifically and directly designed to address the risk of
disease transmission to patients. We have also submitted
extensive comments to the FDA that included recommendations for
changes in this regulatory proposal.
The AATB believes that the FDA has adequate regulatory
authority at this time. The agency has proposed a regulatory
framework for human cellular and tissue-based products that is
in keeping with the unique characteristics of human tissue.
Once all three proposed rules are final, we believe that sound
public policy dictates that the new regulations are given
sufficient time to work before their effectiveness is
evaluated.
In conclusion, let me simply reiterate that the principal
focus of the AATB is the tissue donor, his or her family, and
the recipient patients. We respect and honor our donors and
their families for helping to ensure that patients receive
their life-enhancing and sometimes life-saving gifts. We are
the stewards of their gifts and we take that responsibility
very seriously. We serve patients by helping to ensure the
quality, safety, and availability of tissues and cells for
transplantation. This is our public health mission and we are
constantly reviewing and improving our standards, our programs,
and our operations to address that mission.
I thank the Subcommittee for its time and attention and I
will be happy to try to answer any questions the Senators may
have. Thank you.
Senator Collins. Thank you, Mr. Rigney. Dr. Minogue.
TESTIMONY OF WILLIAM F. MINOGUE, M.D.,\1\ CHAIRMAN OF THE BOARD
OF DIRECTORS, WASHINGTON REGIONAL TRANSPLANT CONSORTIUM,
WASHINGTON, DC
Dr. Minogue. Thank you. Good morning, Madam Chairman. I am
Dr. William Minogue, Chairman of the Board of Directors of the
Washington Regional Transplant Consortium. I would like to
thank you for this opportunity to testify before the
Subcommittee today. My goal is to share with the Subcommittee
WRTC's experience with the tissue banking industry.
---------------------------------------------------------------------------
\1\ The prepared statement of Dr. Minogue appears in the Appendix
on page 74.
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The Washington Regional Transplant Consortium is a
federally-designated organ procurement agency for the
Washington, DC area. We perform organ recovery services for 48
hospitals in Maryland, Virginia, and the District of Columbia,
a responsibility we have had since 1988. As you are aware, all
organ procurement agencies are required by Federal law to be
nonprofit. Each OPO has regulated functions, responsibilities,
reimbursement practices, and a board of directors or an
advisory board with federally-mandated representation.
I think our Board of Directors illustrates this. It is an
all-volunteer board which includes transplant surgeons, a liver
transplant recipient, a donor family member whose wife was a
donor and 4 years later, tragically, his daughter was a donor
following a serious automobile accident, and a prominent
biomedical ethicist, in fact, the senior ethicist at Georgetown
University. I think the makeup of that board avoids any
mischief that could possibly come in this industry. They give
us such wonderful support. I am an internist.
Federal law makes one OPO responsible for organ recovery
and distribution in a given geographical area and makes the OPO
responsible for approaching families regarding the option of
organ donation. This same arrangement does not exist in tissue
donation, as the Subcommittee obviously is aware. We have
chosen to offer both organ and tissue recovery services for one
purpose, to protect the integrity of both the organ and tissue
donation processes.
To the public, organ and tissue donation constitutes the
same activity. Families confronting the loss of a loved one do
not make a distinction between a person who recovers a heart,
lungs, liver, or kidneys and the person or organization that
recovers skin, bone, heart valves, and corneas. Each time a
family decides not to donate because of confusion or suspicion,
then we risk the lives of several people waiting for organ
transplants. We have one high standard for family approach,
donor screening, and tissue recovery and we have through
experience developed an approach to working with donor families
that respects their grief while offering them the possibility
of turning their loss into some greater good.
We are also responsible for the integrity of the organs and
tissues that are recovered and are entrusted with protecting
the recipient community from potentially unsafe organs and
tissues. Moreover, we are accountable to the donors and their
families to ensure that these gifts will be respected and
utilized appropriately.
For these reasons, we endorse the recommendations brought
forth by the Model Elements of Informed Consent for Organ and
Tissue Donation developed jointly by the Association of Organ
Procurement Organizations, the American Association of Tissue
Banks, and the Eye Bank Association of America. We encourage
its implementation industry-wide.
As you know, there are over 75,000 people nationwide
waiting for life-saving gifts. Tissue donation is life-
enhancing and improves the quality of life. However, there is
no comparable shortage of tissue for donation or urgency for
tissue transplants, so we impose stricter standards on tissue
donor suitability. If tissue donor evaluation and recovery
practices are unsafe, a recipient can be subjected to
unnecessary risk. Organ donation procedures are regulated while
tissue donation is not. This is why we support the Food and
Drug Administration's proposed rules on donor suitability and
good tissue practices.
WRT has chosen LifeNet, a federally-designated OPO in the
Tidewater area of Virginia, as its tissue bank to process and
distribute tissue recovered by us. Because of their high
standards, they also recognize that tissue banking and organ
donation are inextricably linked. We trust LifeNet as our
partner because of their integrity, their commitment to quality
products and services, and to donors and their families.
Regrettably, not all organizations involved in recovery
processing and distribution of tissue share our concern to
maintain and respect the integrity of the donation process and
the sanctity of the donated gift. Consider, please, the
following scenario: An elderly patient dies at a local
hospital. In accordance with the Federal regulations, the
hospital refers this case to the local OPO for potential
donation. The OPO determines that this patient is not a
candidate for organ or tissue donation and communicates this to
the hospital and the family. The decision is based on the
generally accepted suitability criteria for tissue banks.
Sometime later, the OPO receives an excited call from the
local hospital, which demands to know why this patient is now
being pursued for tissue donation. The OPO investigates this
case and determines the following: Another tissue recovery
agency obtained confidential patient information without the
knowledge of the hospital. They told the family that this
patient's tissue could be recovered for transplant purposes.
The family specifically stated they did not wish the tissue to
be recovered for use in medical research. The second tissue
recovery agency was pursuing the tissue for transplant even
though the following medical conditions existed: The patient
was outside the generally accepted age range for donation; the
patient had a history of cancer that had rendered the tissue
medically unsuitable; the patient had been dead for almost 24
hours; and there was evidence of a recent infection.
The investigation points to the following conclusions: The
fact that the family had specifically stated they did not wish
to donate for research indicates that this agency was either
pursuing donation for transplant purposes or recovering tissue
for research but not fully disclosing that intent to the
family. They were recovering tissue in our region for a
publicly-traded for-profit tissue bank. Neither the for-profit
tissue bank nor their local recovery agency had a written
agreement with the hospital to recover tissue at that facility,
nor were they authorized to talk to the family about tissue
donation.
Situations like this occur when organizations that lack
sufficient experience in tissue recovery become involved.
Furthermore, some of these organizations operate from profit
motives that supercede the public interest. Our example
illustrates the necessity for clear industry standards with
regard to the safety and soundness of donated tissue.
There are an increasing number of for-profit tissue
processing and distribution agencies entering the donation
arena. These entities need access to human tissue in order to
generate revenue and are under shareholder pressure to increase
their market position to maximize profit. They are not required
to take the overall donation interest of the public into
account, and unlike OPOs, their boards have no requirement to
represent the public interest.
In addition, we have seen for-profit tissue banks create
nonprofit recovery agencies or use local nonprofit
organizations as a conduit for human tissue into their
processing and distribution facilities. These nonprofit groups
usually have established relationships with hospitals outside
of tissue donation, which gives them access to hospital
facilities and patient information. Patients and their
families, as well as members of the local nonprofit
organizations themselves, are not aware that the donated gift
will go to publicly-traded corporations as raw material, and
these recovery agencies have also attempted to transfer bodies
out of the hospital to locations where they are able to perform
the recovery. We perform all of our recoveries in operating
rooms under clean and sterile conditions.
Our recommendations, then, are that both donor and
recipients must be protected, the former by implementing an
approach such as the Model Elements of Informed Consent for
Organ and Tissue Donation, and the latter by the swift adoption
of the Food and Drug Administration's two proposed rules
expanding donor screening and testing and on standards for good
tissue donation practices. We also endorse the institution of
an annual reporting mechanism for all entities involved in
tissue donation processes, both for-profit and not-for-profit,
to ensure transparency.
We are pleased that tissue banks have begun registering
with the FDA in accordance with its newly implemented rule and
hope that comprehensive inspection of all tissue banks by the
FDA will soon follow. Moreover, we agree with recent actions
taken by the FDA in urging a tissue processing and distributing
organization to stop its practice of pooling from multiple
donors during processing. The experience with a CJD
contaminated dura mater allograft is adequate evidence of a
need to ban this practice.
WRTC would like to highlight two additional recommendations
for consideration. First, we recommend giving OPOs oversight
authority over all donation activities, including family
contact, donor evaluation, recovery, processing, and
distribution.
Second, ensure that tissue recovery organizations are
nonprofit and that relationships with for-profit organizations
are held at arm's length. It is neither wise nor possible to
eliminate for-profit companies from all processing and
distribution activities resulting from tissue donation. In
fact, new patient care technologies based on donated human
tissue may well be developed by for-profit or jointly between
nonprofit agencies and for-profit companies.
In conclusion, society does not distinguish between organ
donation and tissue donation. Organ donation is well regulated
and closely controlled in the public interest. The task before
us now is to ensure that the tissue banking industry is held to
the same high standard. We look forward to the day when our
citizens completely accept the benefits of organ and tissue
donation as a common, dignified, and valuable contribution to
the quality of life and to death with dignity. Thank you.
Senator Collins. Thank you, Doctor. Dr. Rao.
TESTIMONY OF VALERIE J. RAO, M.D.,\1\ CHIEF MEDICAL EXAMINER,
DISTRICT FIVE, LEESBURG, FLORIDA
Dr. Rao. Good morning, Chairman Collins and Members of the
Permanent Subcommittee on Investigations. My name is Dr.
Valerie Rao. I have been appointed by the Governor of the State
of Florida to hold this position as District Five Medical
Examiner. The district involves five counties running from
Central Florida all the way to the Gulf, so it is a very, very
large area. I also sit on the Medical Examiner Commission, and
that is also a Governor-appointed position. I have been there
since April 2000, prior to which I was in Dade County for 18
years and 9 months.
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\1\ The prepared statement of Dr. Rao appears in the Appendix on
page 82.
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I would like to thank you for inviting me to appear today
before the Subcommittee and I am very pleased to discuss this
most important issue to me. I believe that human donation is a
selfless and invaluable gift, and as such, would like to see
that all tissue recovery organizations are required to adhere
to standards that promote safety and respect for donation.
Unfortunately, my observations tell a very different story and
I would like to share my experience with this Subcommittee.
The role of the medical examiner in organ and tissue
transplantation results from government-mandated investigation
into sudden and unexpected or traumatic deaths to determine the
cause and manner of death. The manner includes natural,
accident, suicide, or homicide. A medical examiner death
investigation includes documentation and evaluating the scene
of death or the injury as well as the body at the scene.
Included is the determination of the terminal episode and the
medical history of the decedent.
In Miami-Dade County, where I spent 18 years and 9 months
as an associate medical examiner, when a case arrives, it is
initially screened by a tissue bank coordinator for
consideration as a potential donor. If the quality appears
suitable, the next-of-kin authorization is received. In the
meantime, the medical examiner performs a careful external
examination. The body is transported to a sterile autopsy suite
where a tissue bank pathologist participates in the tissue
excision process. During this procedure, blood and lymph node
tissue are retained for screening. The body returns to the
medical examiner for an autopsy. For the non-medical examiner
case, the tissue bank pathologist performs the autopsy. At any
time during this procedure, should testing raise doubt, the
donor material is removed from the preparation and distribution
pipeline.
Most medical examiner donor cases are people of prior good
health who experience violence, 24 percent; sudden, unexpected,
non-infectious cardiac dysrhythmia or stroke, 76 percent. These
are the statistics from Miami-Dade County, Florida, from 1995
through 1999. The very nature of such cases of previously
healthy individuals with sudden death creates a donor pool
where infection and malignancy are minimized.
The protection against transmittal of infection and
malignancies must be the primary principle in all
transplantation programs, and the shortage of donor materials
and business pressures should not work against this principle.
Therefore, it is recommended that tissue bank physicians and
coordinators become aware of their own State medical examiner
guidelines in order to understand the investigative process and
its relationship to quality assurance.
As the medical examiner determines the cause of death, a
complete autopsy and tissue for subsequent microscopic
examination serves as a quality assurance step in the
transplantation process. Medical examiners are charged, in
addition to forensic investigation into death, also with public
health issues, particularly with regard to the possibility of
transmission of infectious disease. Autopsies are required for
donor acceptance, and medical examiners believe that autopsies
should be done routinely on all donor cases. Autopsies are the
only means by which diseases such as tuberculosis,
histoplasmosis, degenerative disease of the brain, unsuspected
malignancy, viral myocarditis, non-A, B, or C hepatitis,
diseases of unknown etiology, and other potential transmissible
diseases can be detected and those donors excluded from the
donor pool.
The entire issue of medical examiner participation in the
acquisition of tissues from cadaver donors must also be
considered in light of the recent developments. As I stated,
medical examiners are the guardians of public health interest
and should be in a position to make a determination which
tissue bank serves both the interests of the recipient patient
as well as to satisfy the medical examiner's statutory duties.
Certainly, a trust in the professional competence and
reputation of the tissue bank personnel is an important factor
in making such a determination.
Last April, I became concerned regarding several
questionable practices by a tissue bank. My first concern was
when Regeneration Technologies, Inc., through its association
with the University of Florida Tissue Bank, would accept donors
with non-metastasizing malignant tumors of the breast, colon,
cervix, and lung. They also accepted donors with septicemia,
pneumonia, and intestinal obstruction. To the best of my
knowledge, they do not perform routine blood or bone marrow
aspirate cultures, which is done to detect for possible
disease. They do not require an autopsy and, hence, do not know
the cause of death in the donor.
Tissue excisions are performed by technicians without
physician supervision or participation, and the use of sterile
precautions are not observed during the excision and the
retrieval process. The technicians do not have sufficient
training and knowledge to observe changes which would be noted
by a pathologist, yet they performed an autopsy removal of the
brain which would obviously impair further medico legal
investigation into the death of the deceased. Finally, the
customary care and respect for the body of the deceased are not
observed. I believe that the dead have rights, too.
In contrast, the University of Miami Tissue Bank has
demonstrated quite the opposite. All of their excisions are
performed aseptically by trained physicians in an operating
room environment. Blood cultures and bone marrow cultures are
also routinely performed.
As I stated before, I believe that public trust in the
professional competence and reputation of those involved in the
donation process is vital to its continued success. Thank you
very much, Madam.
Senator Collins. Thank you, Dr. Rao.
Mr. Rigney, I want to start by asking you some questions.
You mentioned in your testimony that the Association has
accredited 74 tissue banks, is that correct?
Mr. Rigney. That is correct. Our current membership is 74.
Senator Collins. And according to the FDA, we know that at
least 350 tissue banks have registered to date under the
agency's new mandatory registration rule, and perhaps your
testimony was written before that fact became available. I am
trying to reconcile your testimony saying that most of the
tissue banks in the United States have obtained AATB
accreditation. In fact, we believe that at least a majority of
the tissue banks are AATB accredited. If you have accredited
74, yet we know that 350 have registered with the FDA, you are
a long ways from accrediting the majority of banks, are you
not?
Mr. Rigney. That would be correct, Senator. The testimony
was written when the only figure we knew was what the OIG had
reported. We received the list that the OIG reported and
compared it against our own banks and our knowledge of the
existence of other banks. What we found in our review was that
of the 90 banks that were not accredited and cited in the OIG
figures, about 30 of those, as we counted them, were either
double-counted because they were listed both under a former
name of the bank and their current name, or they had gone out
of existence and closed their operation, or they had merged
with another bank, or they were now accredited by the AATB.
Another third of that number were banks that we knew that did
exist and were not accredited members. And the final third was
a group of banks that we had never heard of before, quite
frankly.
Senator Collins. But you are talking about the OIG's
report.
Mr. Rigney. Right.
Senator Collins. Were you surprised to learn that there
were 350 tissue banks that registered with the FDA?
Mr. Rigney. I just learned that yesterday, the number that
had registered with the FDA. What I am told is that that number
includes a number of reproductive banks, who are not required
to actually register until the year 2004. It also includes a
number of stem cell banks, a number of laboratories, and others
that we would not necessarily consider a traditional type of
tissue bank, but that would meet the regulatory definition
under the registration rule.
Senator Collins. I would inform you that the Subcommittee
staff raised that issue with the FDA and that was not the case.
Mr. Rigney. OK.
Senator Collins. The vast majority of these are tissue
banks----
Mr. Rigney. Then that number would, indeed, surprise us.
Senator Collins. And one of my concerns suggests that there
are an awful lot of tissue banks out there that have been
operating without accreditation by your Association, without
oversight by State regulators--very few States have an
effective regulation of tissue banks--and flying under the
radar of the FDA, as well. We did get a breakdown of the
numbers and there were actually 368 banks. We took out those
that were the stem cell ones that you mentioned or reproductive
and you still get close to 350.
So it seems to me that the industry is far more extensive
and there are far more organizations involved in the recovery
and processing of tissues than any of us would have guessed,
which is troubling to me in terms of proper oversight.
The HHS Inspector General's report mentioned that there are
differences between your required standards for accreditation
and the FDA's current requirements. Could you describe those
differences for us?
Mr. Rigney. Let me describe them, if I can, Senator, in
general terms. If you want a specific side-by-side, we will try
to prepare that.
Senator Collins. Just general will be fine.
Mr. Rigney. Generally speaking, our current Standards are
much more detailed and much more extensive than FDA's current
final rule under which it is operating. That is sort of the
long and the short of it. We go into many more areas in terms
of accreditation of the tissue bank than FDA's current
regulations would cover. Generally speaking, as a follow-on,
their proposed rule, that good tissue practices proposed rule,
is patterned in many respects off of our Standards.
Senator Collins. Do you require more testing than the FDA
does for specific pathogens?
Mr. Rigney. We require basically the same testing, except
one that immediately comes to mind in terms of living donors.
We would also require a hepatitis B core antigen test.
Senator Collins. Do you require screening for CJD, because
I do not believe the FDA does.
Mr. Rigney. We do have screening requirements for CJD in
our Standards.
Senator Collins. Has the AATB ever suspended or revoked its
accreditation of a tissue bank?
Mr. Rigney. Yes, and I cited some of those numbers in my
statement.
Senator Collins. When that occurs, however, there is
nothing that prevents that tissue bank from continuing to
operate, is there?
Mr. Rigney. No. Our Association and our accreditation is
voluntary. You submit to it. The only power we have,
essentially, is to revoke one's accreditation once it is
granted, or to deny it if they are applying for it.
Senator Collins. Do you know if any of the banks for which
you have revoked or denied accreditation are still operating?
Mr. Rigney. I personally cannot answer that for you right
now. I would be glad to check that out and report back to
you.\1\
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\1\ See Exhibit No. 19 which appears in the Appendix on page 251.
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Senator Collins. I would appreciate your doing so. Based on
our investigation, there are indications that some of the banks
that have been denied or revoked accreditation by your
organization are still operating.
When you do act to revoke an accreditation, do you report
that action to the FDA or share that information with the FDA?
Mr. Rigney. Generally speaking, no.
Senator Collins. Do you think that would be helpful to the
FDA in its inspection and evaluation of tissue banks that might
be problematic?
Mr. Rigney. The problem we have, Senator, is that our
accreditation program provides certain assurances of
confidentiality as the bank is moving through the process.
Senator Collins. Do you believe that the FDA should
prohibit pooling of tissues, as your members are prohibited
from doing?
Mr. Rigney. Right now, based upon what we know, we have, as
I noted, had standards prohibiting pooling for 12 years and
think that the FDA should probably have the same standards----
Senator Collins. Thank you.
Mr. Rigney [continuing]. If they do not already.
Senator Collins. Dr. Minogue, your testimony is very
interesting to me because you have tremendous experience in
overseeing organ transplants in the donation process, which
seems to me, as your testimony suggests, to be much more
regulated, much better understood. Processes are far more
established. One area that concerns me as I have been examining
this issue is the differences between organ and tissue
donation. Do you think that the procedures for obtaining
informed consent for tissue donation should be more like those
that are used for organ donation?
Dr. Minogue. Yes, I do. I believe that the organ
procurement process has matured over time. I happen to have
been one of the founding members of this board 14 years ago and
it was pretty much made up of transplant surgeons and the
hospitals they represented trying to get our act together. Now
it is so wonderful and mature and it sounds to me, and I am
learning more today than I ever did know about the tissue side,
that tissue has to mature in a similar fashion. But it needs
this oversight. I strongly favor the not-for-profit, altruistic
model of my board. There is just no possibility for us to get
into, as I mentioned before, some mischief of this type. There
must be oversight. Also, of course, favor that there be one
regional tissue procurement organization, whatever that may be,
so that this competition goes away.
Senator Collins. Modeled on the OPO----
Dr. Minogue. Modeled on the OPO arrangement.
Senator Collins. I would like to talk to you further about
a local nonprofit organization that you referred to in your
testimony, because I think it illustrates some of the
underlying issues that you have identified and that we are
discussing today. It is my understanding that the organization
involved is a local service club and that it provides tissue to
a large for-profit tissue company called Regeneration
Technologies, Inc., or RTI.
It is further my understanding that RTI uses tissue
pooling, or has been using tissue pooling, which many experts
tell me, and you have testified this way, also, that the risks
far outweigh the benefits. Is that an accurate statement?
Dr. Minogue. That is a perfectly accurate statement, yes,
ma'am.
Senator Collins. I would like to refer to a specific
exhibit, which is Exhibit No. 4,\1\ and I think you have it in
the book before you, also. Now, as you probably recognize, this
is a WRTC donor referral and tissue bank donor worksheet, and
it is my understanding that this is used to establish the
medical history of a potential donor in order to evaluate the
suitability. I would note that we have redacted any personal
information that could identify the individual involved. Is
that what this is used for, to work up whether or not this
person may be suitable as a donor?
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\1\ See Exhibit No. 4 which appears in the Appendix on page 116.
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Dr. Minogue. That is correct.
Senator Collins. Now, as I look at this worksheet, it seems
pretty clear to me that WRTC rejected this individual as a
donor for skin, bone, heart valves, and eyes, and the reasons
why that the WRTC found the donor unsuitable were two reasons,
primarily, one, that he was 82 years old, and second, that he
had a history of prostate cancer. In your view, would those two
factors make it too risky to transplant tissue from this donor
to someone else?
Dr. Minogue. The age is problematic because of the
suitability of the tissue and the likelihood of an effective
transplantation later on. And as you have heard earlier, since
there is not a great shortage of tissue, as there is with solid
organs, why in the world take these risks, even if we do not
have scientific evidence that prostate cancer, which may well
be very localized, would be harmful to the patient or to the
recipients downstream. This sort of case, and it sounds quite
like the case that I illustrated in my testimony, was rejected
by us and would continue to be.
Senator Collins. I would like to switch to Exhibit 5,\2\
which--this is a worksheet that was produced by the local
nonprofit organization that I mentioned that was acting as a
tissue bank, and as you can see in the first question, has the
deceased ever had cancer, tumors, leukemia, lymphoma, received
radiation therapy or drugs for cancer, and the answer is yes to
that. It further goes on to ask some other questions, which
also identify problems. But the very first question indicates
that this tissue bank knew that the individual had prostate
cancer, so there is no doubt that that was known to the tissue
bank based on this document, is there?
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\2\ See Exhibit No. 5 which appears in the Appendix on page 118.
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Dr. Minogue. None whatsoever.
Senator Collins. Do you know whether this tissue bank,
despite this information, tried to persuade the donor family to
give permission to recover various tissues from the body
anyway?
Dr. Minogue. I do not, as personal knowledge, know. A
colleague of mine, from WRTC, who directs all of this tissue
donation process, is here today and he might be able to
comment, if you wish, but I do not know.
Senator Collins. Is that individual available?
Dr. Minogue. Yes, he is.
Senator Collins. Would you like to consult and relay?
[Pause.]
Dr. Minogue. David DeStefano, my colleague, says he does
not believe there was persuasion per se, and I believe that was
part of the question, but they were indeed pursuing this
patient for donation and the patient had already been rejected
by WRTC.
Senator Collins. It is unclear to me why any tissue bank
would pursue this individual as a potential donor--not pursue
the individual, but discuss this with the individual's family.
Do tissue banks face pressure to produce a certain amount of
tissue?
Dr. Minogue. That is the perception that we are working on.
Again, I do not have firsthand knowledge of that, but there
seems to be quite a bit of aggressiveness in some parts of that
industry and that is disturbing to us.
Senator Collins. And it is your opinion that the for-profit
sector of the tissue bank industry is particularly subject to
pressure to recover more tissue?
Dr. Minogue. It seems logical, particularly on the recovery
side. As I mentioned in the testimony, the for-profit
processing end of the equation and that whole industry may well
do creative works and research and so forth if properly
regulated and motivated, but to tie the donation itself to
profit is very disturbing to us for the reasons I mentioned,
that these are very delicate situations at the bedside, as you
can imagine, and to have any suggestion of aggressiveness in
this regard is just destructive to the whole process.
At our board, we look very carefully at all of our
hospitals and do death review, for example, and any time we see
that there was an opportunity missed for solid organ
transplantation, we treat that and investigate it and encourage
the hospital to investigate it, because as many as five or six
lives could have been saved by that proper donation. Why did it
go wrong? That is how seriously we take one single loss of an
opportunity. So in any way tainting this terribly complex
dynamic at the bedside is just wrong.
Senator Collins. What characteristics does WRTC look for
when developing a relationship with a tissue bank?
Dr. Minogue. A high degree of integrity, that they have the
same feeling and passion for protecting the donation process
and that they remain at arm's length as far as all of the
business, if you will, of their organization, and just have the
same philosophy of integrity and ethics.
Senator Collins. Do you at times refuse to do business with
certain tissue banks?
Dr. Minogue. We do.
Senator Collins. Thank you. Just one final question for
you. Do you believe that tissue banks--you have testified that
there needs to be a better regulatory structure for tissue
banks. Do you believe as part of that that there needs to be
regular inspections of tissue banks to ensure compliance with
good procedures?
Dr. Minogue. Absolutely.
Senator Collins. Thank you.
Dr. Rao, I would like you to explain further about your
experiences with RTI and tell me more specifics on what
troubled you about this particular tissue bank.
Dr. Rao. Yes. When I took the job initially, I had to find
out what was going on in the district and there were several
tissue banks that came in and were taking tissues and my
technicians were telling me that there were some very strange
goings on, and so I waited to see for myself, and the first
case I saw, as soon as I saw the case, this was a lady whose
upper extremities were taken and the incisions run all the way
down the arm to take out the long bones and the incisions were
not even closed and the body was--it just took me aback. I was
not used to this. I just looked at them, like, no, these people
are not coming back here. That was it. I had made my decision.
I received a lot of political pressure because of that
decision, but I just could not be associated with that kind of
business, because a medical examiner--what will happen is they
will say it came from District Five and then it reflects on the
medical examiner that was involved in that transaction. So I
told all the tissue banks that there had to be a moratorium on
tissue recovery in District Five until I could look at
everything that was going on. That was one incident.
The other incident, they took bones prior to it becoming a
medical examiner case. Initially, it was not a medical examiner
case, and then the family called with some history which then
brought it under the jurisdiction of the medical examiner. And
the issue that was to be discussed by the medical examiner was
did this lady have a stroke? So when I opened the body and the
head, I found that they had taken the brain and they had placed
the cerebral hemispheres in the chest cavity, and then they
took a dowel to replace the spine that was removed and pushed
it up into the foramen magnum, as a result of which the entire
cerebellum was all squashed. So there was no way I could
determine, did this lady have a stroke. But they did not
realize it was going to come to the office.
So there was a second incident that I saw this happened,
and after that, of course, I was determined not to allow them
to come into the office.
The above examples all pertain to the University of Florida
Tissue Bank, an affiliate of RTI.
Senator Collins. In the first case that you gave us as an
example of inadequate respect for the dignity of the donor and,
undoubtedly, the family would have been very upset to see the
body left in that condition, and I want to indicate that is not
typical, that most tissue banks do a very good job and are very
respectful, as are the OPOs and those involved in organ
donation, but that was an example where there was inadequate
respect for the donor's body.
The second case sounds like the haste to recover tissue
caused you to be unable to perform your duties as a medical
examiner, is that accurate?
Dr. Rao. Exactly.
Senator Collins. Could I ask you about a third issue, and
that is have you ever been concerned about whether there were
sufficient screenings performed on tissue to make sure that
they were safe for donation?
Dr. Rao. Yes. At one of the ME committee meetings I had,
the director of the University of Florida Tissue Bank came to
me and talked to me and asked if he could come back into the
office, and I said to him, ``If you agree to these standards
and these tests, then yes.'' And he looked at me and he said,
``Well, that will not be essential,'' and then I said, ``Well,
then you cannot come back.'' So he did not want to comply with
what was required, as a result of which I thought even more
that he should not be allowed to take tissue from District Five
cases. So they do not want an autopsy on every case because it
is expensive and it will cut into the profit margins, but I am
not concerned about profit margins. I am concerned about the
public health, safety in the recipients that get this bone
donation.
Senator Collins. What kind of research can a family, which
is considering donation of a loved one's tissues, do to ensure
that they are dealing with a reputable tissue bank? Is there
any advice you can give us? I actually think that is a very
difficult burden to put on the family. I mean, the family is
going through a time of incredible grief and difficulty, which
is one reason why I think we have to look to the Federal
Government to perform that kind of role.
But assuming we do not have a good regulatory structure in
place right now, or a sufficient one, what kind of advice could
you give to families that are considering donation, that very
much want to make a gift that is going to enhance the quality
of life for others, yet want to make sure that they do not run
into the kinds of problems that you have identified?
Dr. Rao. Actually, to answer that, there was a letter
received, which is part of your exhibit package,\1\ from an
elderly gentleman, and you can see that he is keeping up with
the literature and with the press releases out there, and I was
pretty surprised to get that letter from him. You see the
giving nature of this individual. He is a pretty elderly man,
84 years old, and he still wants to give of himself but he is
very concerned. Am I doing the right thing? How should I go
about this?
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\1\ See Exhibit No. 3 which appears in the Appendix on page 114.
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Being unaware of the many agencies out there, my advice
would be to do some research as to which bank is going to take
this, what is their reputation out there, and research it on
their own, then make a decision, hopefully they will talk to
the medical examiner, if it is a medical examiner case, and
think, am I comfortable with this tissue bank, and go from
there.
Senator Collins. Thank you. I just have one final question
for all three of you. This morning, we heard some very
disturbing testimony from the Office of Inspector General on
practices that the FDA had caught during its inspections, which
we have learned have not been as frequent or as widespread as
we would all like to see, which identified tissue banks engaged
in the practice of repeat testing in which tissue is repeatedly
tested until the tissue bank obtains the result that it wants
of no disease, even after previous tests have identified
problems.
Are either of you familiar with that and could you comment
on that practice? Dr. Minogue, we will start with you.
Dr. Minogue. Certainly, I was as startled as you were to
hear that today, and I am not aware of any test in medicine
that goes from positive to negative just through repetition. So
there is something very strange about that piece of
information.
Senator Collins. I thought it was one of the most
disturbing statements made at this hearing. It just seems to me
that if a negative test, or a positive, in this case, a
positive test indicating a problem is reached, that tissue
should immediately be discarded. The idea that, instead, the
technician just tests it again and tests it again and tests it
again in hopes of getting an all-clear result is very troubling
as far as the safety of the tissue in the system.
Dr. Minogue. Repeated testing, we will do confirmatory
tests often. If we have a suspicion, let us say, and we get a
negative, we might test to be darn sure. But to repeatedly, and
that was the testimony, to repeatedly test until it is
negative, that is just awful.
Senator Collins. Mr. Rigney, have you heard of this before?
Mr. Rigney. Certainly. Senator, every manufacturer's test
kit, be it for living donor sera or for cadaveric sera,
contains test kit instructions specifying how you are supposed
to conduct that test. Without going into the details of how
these tests are run, repeated testing that would in any way be
different than what is in the manufacturer's instructions would
be a violation not only of our Standards, but I think of FDA
requirements. It would certainly, in our case, trigger a
mechanism to suspend or revoke accreditation, or to deny it if
it was somebody applying initially.
Senator Collins. Thank you. Dr. Rao, have you heard of that
before, and given your extensive experience as a physician,
could you give me your opinion of that practice?
Dr. Rao. I am not familiar. I was pretty disturbed, too,
because in blood banking, we did blood banking during our
training, if there was a unit which had anything, any little
thing, the unit was discarded, and I think blood banking and
tissue banking should both be on a similar par when you think
of standards, because this is somebody's life one is dealing
with.
Senator Collins. Thank you.
Mr. Rigney. Senator, I would simply note that the stories I
have heard and the reports that I have seen of such cases would
not be limited to tissue banking. They also involve blood
banks, where there have been a number of recalls precisely for
those reasons, as well as other types of laboratories.
Senator Collins. Thank you. I want to thank all of you for
your testimony and your assistance to the Subcommittee. Thank
you.
Senator Collins. Our final witness today will be Dr.
Kathryn Zoon, the Director of the Center for Biologics
Evaluation and Research within the Federal Food and Drug
Administration. She has been with the FDA since 1980. Dr. Zoon,
we are very pleased to have you with us today. Before you get
too comfortable, I do have to swear you in.
Do you swear that the testimony that you are about to give
to the Subcommittee will be the truth, the whole truth, and
nothing but the truth, so help you, God?
Dr. Zoon. I do.
Senator Collins. Thank you. Please proceed with your
testimony.
TESTIMONY OF KATHRYN C. ZOON, PH.D.,\1\ DIRECTOR, CENTER FOR
BIOLOGICS EVALUATION AND RESEARCH, U.S. FOOD AND DRUG
ADMINISTRATION, WASHINGTON, DC
Ms. Zoon. Thank you. Good morning, Madam Chair and Members
of the Subcommittee. Thank you for inviting me to participate
in this hearing concerning human tissue banking. I am Kathryn
Zoon, the Director of the Center for Biologics in the FDA. My
Center is responsible for the regulation of many different
types of human tissues and cells used in transplantation.
Today, I will provide background information on the regulation
of human tissues for transplantation and FDA's current and
future actions to help ensure the safety and availability of
these important products.
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\1\ The prepared statement of Ms. Zoon appears in the Appendix on
page 84.
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No medical product is risk-free. The FDA regulates tissue
under the authority of the Public Health Service Act and the
Federal Food, Drug, and Cosmetic Act. Several categories of
human tissue used for transplantation are being regulated as
medical devices under the 1976 Medical Device Amendments. Many
cellular and tissue base products are regulated as biological
products under the Public Health Service Act and the Food,
Drug, and Cosmetic Act, and other cells and tissues are
regulated for communicable diseases under the PHS Act.
FDA's goals with regard to human tissues are to: One,
prevent the spread of communicable disease; two, to ensure the
safety and efficacy is demonstrated for cellular and tissue-
based products; and finally, enhance public confidence in these
products. FDA plans to accomplish these goals through
implementing regulations in a manner that will not discourage
the development of new products. Human tissues for
transplantation include skin replacement for severe burns,
tendons and ligaments for injury repair, and corneas to restore
eyesight, as well as bone for replacement.
The increased use of human tissues has heightened public
awareness of the need for appropriate regulation to minimize
potential risks. Developments in the 1980's and 1990's prompted
FDA to examine our approach to the regulation of tissue.
Several incidents illustrated the risks of disease transmission
when adequate precautions were not taken.
In 1991, it was discovered that seven people had been
infected with human immunodeficiency virus through the
transplantation of organs and some tissue from a donor who
tested negative for HIV. This led to intense discussions within
the tissue bank community and the Public Health Service on how
to reduce the risk of infectious diseases from transplanted
human tissues, and ultimately to the comprehensive approach
that I will describe.
In 1993, FDA learned that human tissue from foreign sources
was being offered for sale in the United States with little or
no documentation of the source. There was little, if any,
information on the medical condition of the donor, the cause of
the donor's death, or the results of donor screening and
testing. This raised significant concerns about the safety and
quality of that tissue. The agency quickly confirmed that the
tissue was not adequately screened and tested for infectious
diseases. The agency acted promptly by promulgating a
regulation and exercising its enforcement powers.
In December 1993, FDA took action to minimize the risk of
disease by issuing an interim rule for human tissue for
transplantation, which required donor screening, infectious
disease testing, and recordkeeping to prevent the transmission
of infectious disease. Under this regulation, FDA could also
conduct inspections, and when necessary, could order tissue to
be detained, recalled, or destroyed. This interim rule was made
final, with some modification, on July 29, 1997.
After careful consideration of the health issues and
extensive public discussion, FDA published the proposed
approach to the regulation of cellular and tissue-based
products in 1997. This document described FDA's planned
regulatory framework for human cellular and tissue-based
product regulation. Subsequently, FDA has accomplished many of
the regulatory goals described in the February 1997 document
through publication of a series of proposed and final rules.
The 1997 proposed approach provided a framework for the
regulation of both traditional and new products. This framework
detailed the type of regulation necessary to protect the public
health and provide a risk-based tiered approach to cell and
tissue regulation. For human cells and tissue products where
the risk is limited to disease transmission, FDA's proposed
regulation is intended to prevent transmission of disease
through the use of these products. For products that pose
greater risk, the framework additionally provides for pre-
market review and approval of product applications.
To accomplish the implementation of the proposed approach,
the agency developed a tissue action plan that contained a
description of the steps and time frames the agency would use.
Many of these steps have already been accomplished, including a
final registration and listing rule and the proposed rules on
donor suitability and good tissue practices.
The registration and listing rule requires establishments
to register and list with the agency their human cell tissues
and cellular and tissue-based products. Under this final rule,
establishments engaged in the recovery, screening, testing,
processing, storage, or distribution of tissues, with
conventional tissues such as bones, skin, and corneas, are
required to register and list their products. Other
establishments that manufacture nonconventional or new cellular
and tissue-based products, such as hematopoietic stem cells,
are required to register and list by January 2003, although I
might add that they can register voluntarily now.
In September 1999, FDA published a proposed rule regarding
the donor suitability for cellular and tissue-based product.
Disease agents, such as HIV, hepatitis B virus, hepatitis C
virus, syphilis, and CJD have been detected in human tissue.
The proposed rule, when final, will expand current screening
and testing requirements to include donor screening for CJD and
donor testing for syphilis and would apply broadly to cellular
and tissue-based products. A donor who tested repeatedly
reactive for a particular disease agent or who posed clinical
evidence of or had risk factors for such a disease will be
considered unsuitable and cells or tissues from that donor will
not ordinarily be used. The agency is currently reviewing
public comments on the proposed rule.
Tissue establishments perform various procedures that may
affect the safety or quality of tissue products. Therefore, in
January of this year, FDA published a proposed rule for good
tissue practices for manufacturers of human cellular and
tissue-based products. With this proposed rule, FDA completed
the set of proposals that, when finalized, implement the new
regulatory framework. The proposed rule will require
manufacturers to follow good tissue practices, which include
practices involving methods, facilities, and controls used in
tissue manufacturing, tracking, process validation, and the
establishment of a quality program. FDA is in the progress of
carefully reviewing all comments received in response to this
proposed rule.
In 2002, FDA estimates that the agency will dedicate $4.35
million to the regulation of human tissue. This is part of the
President's Fiscal Year 2001 budget request for FDA, which
represents a 10 percent increase for the agency over the Fiscal
Year 2000 level. Estimates of the implementation of the tissue
regulation will be developed as part of the 2003 budget process
and may be revised as we garner additional information for
future establishment registrations. Such additional information
will help us determine with greater accuracy the amount of time
and resources that will be needed to conduct inspections and
other compliance-related activities.
FDA conducts on-site inspections of tissue establishments
to determine compliance with FDA regulations. As a result of
these inspections, FDA has taken the following actions: Fifteen
orders for retention or recall, six warning letters, and nine
opportunities for voluntary corrective action letters. Further,
the number of voluntary recalls of banked human tissue have
increased over the past 7 years, from approximately three in
1994 to 24 in the year 2000.
FDA is concerned about pooling of tissues from multiple
donors during processing. In general, FDA believes that the
risks associated with pooling tissues from multiple donors at
this time appears to outweigh any identified medical benefits.
Risks include possible exposure and cross-contamination from
one tissue to another, such infectious disease agents as
viruses, bacteria, fungi, and prions. FDA currently can address
these issues based on our communicable disease provisions of
Section 361 of the Public Health Service Act.
In order to successfully implement agency plans for the
regulation of human tissues, FDA has involved tissue
establishments and medical professionals in many of our public
discussions. In the future, FDA intends to provide opportunity
for additional public discussions on issues related to cellular
and tissue-based products.
FDA can assure the Subcommittee that we are committed to
establishing a regulatory framework which will not only help
ensure the safe use of human tissue for transplantation, but
also allows the development of this technology and instills
public confidence. While FDA has taken many steps towards this
end, we realize that more remains to be done. We look forward
to working with this Subcommittee regarding the regulation of
tissues and I am happy to answer any questions you may have
today.
Senator Collins. Thank you, Dr. Zoon.
I want to talk to you further about two issues that have
arisen today. One is pooling, the other is repeat testing. You
mentioned in your statement that you have just concluded that
the FDA believes that the risks of pooling outweigh the
benefits. Could you explain further why pooling could be
problematic from a safety standpoint?
Ms. Zoon. Yes, I would be happy to. When you pool products,
if there is just one component of a mixture of components, that
component could have the ability to raise the infectious
disease or communicable disease risk to the entire batch of
product processed together, and that is why we are concerned
about this. It is very important in those considerations to
make sure that risks such as this are minimized.
Senator Collins. So it is a cross-contamination issue?
Ms. Zoon. That is correct.
Senator Collins. The FDA has recently proposed regulations
that would require tissue banks to employ specific good tissue
practices. As part of those good tissue practices, has the FDA
banned pooling or prohibited pooling?
Ms. Zoon. The current proposed regulation states that the
agency does not permit pooling, although it does give an
opportunity for exemption or a waiver for this if one can
validate that their procedure would inactivate certain
infectious agents.
Senator Collins. With regard to repeat testing, we have
heard very disturbing testimony today from the Office of the
Inspector General that some tissue banks, when they do not like
the first result that they get on a batch of tissues, they just
keep testing it in the hopes of getting the all-clear result.
That, to me, is just incredible and totally unacceptable. Has
the FDA proposed anything that would deal with that issue?
Ms. Zoon. Yes. You cannot test a piece of tissue into
compliance.
Senator Collins. That is a good way to put it. Is there any
specific regulation, though, or part of the good tissue
practices that speaks to that issue?
Ms. Zoon. Yes. Under our current regulation, which is the
1997 final rule on tissue, that addresses at least this issue
with respect to HIV and hepatitis B and hepatitis C, and the
same would be true with respect to the donor suitability
proposed regulation that would expand the infectious agent
testing. But that provision is true. You cannot test a piece of
tissue into compliance.
Senator Collins. Dr. Zoon, if you find that a tissue bank
is engaged in these questionable practices, does the FDA have
the authority to prohibit the tissue bank from operating?
Ms. Zoon. Well, we have the authority--under our current
regulation, we can deal with the products. In the proposed
regulation, it also allows the agency to deal with the
establishment itself.
Senator Collins. We had testimony today from the private
accreditation association AATB in which I asked the CEO whether
or not there is any reporting from the AATB when they revoke an
accreditation, whether that information is conveyed to the FDA,
because, clearly, there is a serious problem with a tissue bank
if it loses its accreditation. Now, I recognize that there is a
difficult balance here because the accreditation is voluntary
and we want, presumably, to encourage more tissue banks to
become accredited. But it seems to me that once a tissue bank
is accredited, if the AATB finds grounds that are serious
enough that causes the Association to revoke its accreditation,
that there should be some sort of report to the FDA. Would you
agree, or what would your views be on that?
Ms. Zoon. Well, certainly, if the AATB wanted to provide
that information to the agency, the agency would certainly look
at that information and weigh that in on terms of prioritizing
some of our inspectional proceedings.
Senator Collins. Would it be helpful for you to get that
information? Would it be a red flag to you that perhaps you
need to send an FDA inspector in? The problem here is AATB may
discover a problem way before the FDA does, yet AATB's
revocation of accreditation does not do anything to prevent
that tissue bank from operating, whereas the FDA has the
ability to stop the tissue bank from operating.
Ms. Zoon. Right. Well, we would welcome any information
that could and would help facilitate our jobs.
Senator Collins. Let me talk to you a bit more about the
FDA's inspection process. According to the HHS Inspector
General, FDA performed 188 inspections which identified 98
problems and they resulted in 26 notices of official action.
There were also 72 notices calling for voluntary corrective
action. Could you explain to us what a notice of official
action is and how serious that is on the scale of approaches or
responses that the FDA could take?
Ms. Zoon. Right. Well, there are three levels of evaluation
of an inspection. One is the one you would hope for, which is
no action indicated, and that is called NAI.
And then you have a voluntary action indicated, which means
that there were observations of concern that required the
particular sponsor to take corrective action on their own in
order to facilitate remedying these, and these would be checked
as follow-up on the next inspection and they would address
those issues to the agency in the interim.
OAI is the most serious classification of an inspection. It
means official action indicated. And generally, this can result
in a number of things. The most normal follow-up from something
like this might be a warning letter that the agency would then
issue to the company in which this was observed. They would
need to respond to this, as well.
Senator Collins. Could you give us some examples of the
kinds of violations that would trigger a notice of official
action?
Ms. Zoon. Yes. Improper infectious disease testing and
issues related to quarantining tissues that might lead to
increased risk of improperly using those tissues. Those are two
examples. There could be many others, depending on the proper
screening of a particular tissue. As you know, most of our
regulations and issues are focused on communicable disease
testing. So really those things that would increase the risk of
infectious disease transmission would be the things that we
would focus on.
Senator Collins. So these are pretty serious violations
that could pose a significant threat to public health or to at
least the recipient of the donated tissue, is that a fair
assessment?
Ms. Zoon. Yes.
Senator Collins. You mentioned that FDA has included a 10
percent budget increase to assist with tissue inspections and
your expanded regulatory process. Given the large number of
tissue banks that have registered with FDA, which, based on our
conversations with FDA and other experts, exceeded what was
expected, do you believe that the FDA can conduct adequate
inspections of these tissue banks?
Ms. Zoon. Well, as you know, there is not enough resources
to inspect tissue banks biennially, which is where ultimately
we would like to be, and we have diverted some of our blood and
plasma inspectional resources to do some of the tissue
inspections that we are currently doing today. So we are trying
to balance many responsibilities to do the best job we possibly
can. And in order to do this, we really have developed a risk-
based strategy for doing tissue inspections, so those that we
believe are the highest risk get the most attention and those
with the lower risk are not.
So the risk strategy that we are currently using are those
banks that have had a violative inspection have the highest
priority. The next-highest priority are those which are tissue
banks that have not been accredited and have not been inspected
yet. Then the next level is the laboratories that actually do
the infectious disease testing of these. And then it goes down
to those tissue banks that have voluntary action indicated, and
then tissue banks that are accredited and not inspected, and
then finally the last tier is those banks that have not had
problems.
Senator Collins. The problem is, it is difficult for you to
set those priorities and say that the last tier are tissue
banks that have not had problems when nobody even realized that
there were so many tissue banks out there, and when scores and
scores of tissue banks, perhaps 100 tissue banks, have never
been inspected or regulated by anybody. So how can you tell
that there are no problems? I mean, unless you have a plan to
inspect every tissue bank once every 2 years or once every 3
years, how can you conclude that--how can you even rank them?
Ms. Zoon. Well, no. The ranking was based on--your point is
well taken, that you would like to have the database of having
biennial inspections for a while. But with the existing
resources, we wanted to use our resources most wisely to make
sure that when we have a problem--and I forgot to mention, the
second priority is actually for-cause inspections. I misspoke
in the previous one. So the first is those with violative. The
second is for cause, where that means we get a report from
somebody who says that there is a problem in a particular bank
so we can respond to that.
But your point is that with the registration and listing
rule, we will now have the opportunity to have actually an
inventory of what is out there, so now we will be in a position
to finish the inspections of those banks that we have never
inspected that are now registered. Our goal for this fiscal
year is to do the remaining banks that were identified by the
IG that had not been looked at by the FDA and any other banks
we may find from the registration and listing provisions that
have not yet been inspected by the FDA. So those are our two
areas where we are really going to focus.
Senator Collins. The problem is that OIG identified 118
banks that have been inspected, if memory serves me correctly.
OIG thought that the total universe was about 150. We now know
it is about 350. It is over double what anyone expected. It
seems to me until you have a plan to inspect every one of those
350 tissue banks, that it is just a shot in the dark. It is
just throwing darts as far as trying to figure out what are the
high-risk tissue banks.
Ms. Zoon. I might just make a comment that the 368
registered components actually includes each location of a
tissue bank. So if a tissue bank has more than one location, it
will register based on the number of locations. So I just want
to make sure, some of those numbers--and there is also, if
there are distributors or procurers, they will have to list
separately and register separately. So when we use the term
tissue banks, we need to be a little bit careful because there
may be multiple locations in some of these, and I just thought
I would point that out, so the numbers may not be as off as
they might indicate.
Senator Collins. It still strikes me that is an enormous
undertaking for FDA and yet an absolutely critical one in terms
of protecting the public health and also in ensuring that the
families of potential donors feel comfortable about donating
tissue and do not experience some of the problems that we have
heard today that are very disturbing.
Ms. Zoon. I think we would agree that we believe this is an
important part of our program, and I think the inspectional
programs have been extremely valuable in helping us deal with
the scope of issues with respect to the tissue banks that are
important to the Congress.
Senator Collins. I want to just ask you about one specific
inspection that led to a warning letter, and it is going to be
Exhibit 2 \1\ in your book, also the notebook that is right
there should have it. I will give you a moment to find it.
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\1\ See Exhibit No. 2 which appears in the Appendix on page 112.
---------------------------------------------------------------------------
[Pause.]
Senator Collins. It is a warning letter that the FDA sent
to a particular tissue bank, Pacific Coast Tissue Bank, on
April 21 of last year. The letter documents Pacific Coast's
failure to develop and follow written operating procedures, its
failure to ensure proper donor testing, its failure to maintain
complete records. In this letter, the FDA also sets out its
disagreements with Pacific Coast's response to a prior letter
and requests that the tissue bank notify FDA of the corrective
measures it will take to prevent a recurrence of similar
violations.
What worries me about this case is it seems to me that this
tissue bank has been found wanting on very serious grounds,
such that this is the second letter that the FDA has had to
send to this particular tissue bank. Could you tell me if the
FDA has inspected Pacific Coast Tissue Bank for compliance
since this letter was sent in April 2000?
Ms. Zoon. I am aware that the FDA will be inspecting
Pacific Coast Tissue Bank this year, and it is inappropriate
for me to tell you when in public.
Senator Collins. I can understand that. But what concerns
me is it is over a year later and we do not have any guarantees
that this tissue bank has corrected some very serious
deficiencies that the FDA inspection identified. What process
does the FDA use to make sure that serious problems are
remedied?
Ms. Zoon. There are several. The company must respond to
the warning letter, so that information comes back to the
agency for review, and certainly the response of that will be
evaluated and looked at, and any follow-up issues, such as the
issues pointed out in this warning letter, will have direct
follow-up with respect to the Pacific Coast Tissue Bank on
their next inspection. So then there can be a series of other
actions that the agency can take with respect to this
particular company and we will be looking into our options,
depending on the finding.
Senator Collins. One final question on behalf of Senator
Durbin, who is unable to attend this part of the hearing.
Senator Durbin sent a letter in January to Dr. Henney, who I
realize is no longer Commissioner, but asking for a breakdown
of costs for implementation of the new rules.\1\ Are you
familiar with that letter?
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\1\ See Exhibit No. 2 which appears in the Appendix on page 112.
---------------------------------------------------------------------------
Ms. Zoon. Yes, I am.
Senator Collins. Has the FDA responded to that request?
Ms. Zoon. The FDA has prepared a response to that request.
It has been cleared by the FDA and now it is being reviewed
within the Department.
Senator Collins. I would ask that you share that request
with the Subcommittee.\2\
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\2\ As of July 2001, the Subcommittee staff was informed by the
Food and Drug Administratoin that the response letter to Senator
Durbin's January 2001 letter, has not yet been cleared for external
release by the Department of Health and Human Services.
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In closing, I just want to encourage you, if you need more
resources to make sure that our Nation's tissue supply is safe,
you should ask for them. We know that this is a big task. We
know that there are far more tissue banks than ever was
anticipated, that the registration process would bring forth,
and there is a certain frustration on the part of the Members
of this Subcommittee that the FDA has been very slow in acting
in this area.
If we want to increase the supply of tissue, and that is a
goal that many of us share, of encouraging more donations for
life-enhancing procedures, we need to make sure that we can
both assure the public that the donated tissue will be treated
with dignity and respect, and also that it is safe for the
recipient. And until we have a vigorous regulatory structure in
place, I do not think we can make those assurances, and that is
troubling to me because I want to see this very positive trend
of more tissue and organ donations increase.
So we look forward to working with you and making sure that
you have the support that you need. I would also ask that you
provide the Subcommittee in writing any suggestions for
legislative changes that you might have. We have heard a number
of suggestions this morning, of making the law more similar to
that for organ donation, and we would welcome your suggestions.
Ms. Zoon. Thank you very much.
Senator Collins. Thank you. I want to thank all of our
witnesses for coming today and sharing their perspectives on
the tissue bank industry and the adequacy of Federal regulatory
oversight. We entitled this hearing, ``Tissue Banks: Is the
Federal Government's Oversight Adequate?'' and based on what I
have heard today, I think the answer to that question is no,
that it is improving, that the new regulations are going to
make a big difference, but until we match the new regulations
with an aggressive inspection process and until we in Congress
work with the administration to provide the resources
necessary, it appears to me that there are still going to be
holes in the safety net of regulation.
I especially want to thank the Health and Human Services
Office of Inspector General for its very comprehensive and
helpful reports, which have shed some light on the state of the
tissue bank industry and which formed the starting point for
our discussions today. But the testimony of all of our
witnesses has been extremely helpful.
I finally would like to thank the Members of my
Subcommittee staff who have helped prepare for these hearings,
especially Claire Barnard, Barbara Cohoon, Eileen Fisher, Chris
Ford, and Mary Robertson. They have worked very hard on this
area. Thank you.
The Subcommittee is adjourned.
[Whereupon, at 12:03 p.m., the Subcommittee was adjourned.]
A P P E N D I X
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