U.S. GOVERNMENT PRINTING OFFICE

73–395 DTP WASHINGTON : 2001

S. Hrg. 107–73

TISSUE BANKS: IS THE FEDERAL GOVERNMENT’S

OVERSIGHT ADEQUATE?

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

(

For sale by the Superintendent of Documents, Congressional Sales Office

U.S. Government Printing Office, Washington, DC 20402

(II)

COMMITTEE ON GOVERNMENTAL AFFAIRS

FRED THOMPSON, Tennessee, Chairman

JOSEPH I. LIEBERMAN, Connecticut, Ranking Democrat

TED STEVENS, Alaska

SUSAN M. COLLINS, Maine

GEORGE V. VOINOVICH, Ohio

PETE V. DOMENICI, New Mexico

THAD COCHRAN, Mississippi

JUDD GREGG, New Hampshire

ROBERT F. BENNETT, Utah

CARL LEVIN, Michigan

DANIEL K. AKAKA, Hawaii

RICHARD J. DURBIN, Illinois

ROBERT G. TORRICELLI, New Jersey

MAX CLELAND, Georgia

THOMAS R. CARPER, Delaware

JEAN CARNAHAN, Missouri

HANNAH S. SISTARE, Staff Director and Counsel

JOYCE A. RECHTSCHAFFEN, Democratic Staff Director and Counsel

DARLA D. CASSELL, Chief Clerk

PERMANENT SUBCOMMITTEE ON INVESTIGATIONS

SUSAN M. COLLINS, Maine, Chairman

CARL LEVIN, Michigan, Ranking Democrat

TED STEVENS, Alaska

GEORGE V. VOINOVICH, Ohio

PETE V. DOMENICI, New Mexico

THAD COCHRAN, Mississippi

JUDD GREGG, New Hampshire

ROBERT F. BENNETT, Utah

DANIEL K. AKAKA, Hawaii

RICHARD J. DURBIN, Illinois

ROBERT G. TORRICELLI, New Jersey

MAX CLELAND, Georgia

THOMAS R. CARPER, Delaware

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

(III)

C O N T E N T S

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. ‘‘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. ‘‘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. Letter 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

Page

IV

3. a. Letter 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 —Continued

b. Response 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. Washington 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. Lions 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. E-mail from John Gaston to an organ procurement organization, dated

May 16, 2001, soliciting customers for his new tissue recovery company ... 119

7. Letter from the Food and Drug Administration to Regeneration Technology, Inc. (RTI), dated May 3, 2001, raising questions about the safety

of ‘‘pooling’’ ........................................................................................................ 120

8. Permanent Subcommittee on Investigations Staff Background Memorandum, ‘‘Tissue Banks: Is The Federal Government’s Oversight Adequate?’’ ............................................................................................................... 123

9. Report 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. Report 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. ‘‘Special Investigation: The Body Brokers’’ (5-part series of articles),

The Orange County Register, April 16–20, 2001 ....................................... 189

b. ‘‘Cadavers For Cash In Texas: ‘People Make A Lot Of Money Selling

Tissue,’ ’’ Chicago Tribune, May 22, 2000 .................................................. 220

12. Letter 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. Statement for the record of the College of American Pathologists ............... 224

14. Statement for the record of the North American Transplant Coordinators

Organization ...................................................................................................... 226

15. Statement for the record of the Southeast Tissue Alliance, Inc. .................. 232

16. Statement for the record of Regeneration Technologies, Inc. ....................... 235

17. Letter 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. Letter 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. Letter 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. Statement 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

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TISSUE BANKS: IS THE FEDERAL

GOVERNMENT’S OVERSIGHT ADEQUATE?

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

2

1See Exhibit No. 11.a. which appears in the Appendix on page 189.

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.’’ 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

3

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.

4

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

5

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 federallydesignated 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.

6

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 thenSecretary 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 comVerDate 11-MAY-2000 10:09 Aug 31, 2001 Jkt 000000 PO 00000 Frm 00010 Fmt 6633 Sfmt 6621 73395.TXT SAFFAIRS PsN: SAFFAIRS
7

mercialization 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.

8

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 BankVerDate 11-MAY-2000 10:09 Aug 31, 2001 Jkt 000000 PO 00000 Frm 00012 Fmt 6633 Sfmt 6601 73395.TXT SAFFAIRS PsN: SAFFAIRS
9

1See Exhibits No. 9 and 10 which appear in the Appendix on pages 135 and 166 respectively.

2The prepared statement of Mr. Grob appears in the Appendix on page 49.

ing and Informed Consent in Tissue Donation.’’ 1 We are very

pleased to have you with us this morning. We look forward to your

testimony.

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.

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. Forprofit 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

10

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

11

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

12

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

13

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.

14

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

15

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

16

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

17

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

18

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.

19

1See Exhibit No. 11.b. which appears in the Appendix on page 220.

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?

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.

20

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.

21

1See Exhibit No. 11.a. which appears in the Appendix on page 189.

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.

22

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

23

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.

24

1The prepared statement of Mr. Rigney Jr. appears in the Appendix on page 58.

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.

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 onsite 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 distribVerDate 11-MAY-2000 10:09 Aug 31, 2001 Jkt 000000 PO 00000 Frm 00028 Fmt 6633 Sfmt 6601 73395.TXT SAFFAIRS PsN: SAFFAIRS
25

uted 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 notfor-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

26

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 frameVerDate 11-MAY-2000 10:09 Aug 31, 2001 Jkt 000000 PO 00000 Frm 00030 Fmt 6633 Sfmt 6601 73395.TXT SAFFAIRS PsN: SAFFAIRS
27

1The prepared statement of Dr. Minogue appears in the Appendix on page 74.

work 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.

The Washington Regional Transplant Consortium is a federallydesignated 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

28

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

29

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

30

1The prepared statement of Dr. Rao appears in the Appendix on page 82.

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.

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

31

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

32

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

33

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.

34

1See Exhibit No. 19 which appears in the Appendix on page 251.

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

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

35

1See Exhibit No. 4 which appears in the Appendix on page 116.

2See Exhibit No. 5 which appears in the Appendix on page 118.

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?

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

36

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?

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

37

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.

38

1See Exhibit No. 3 which appears in the Appendix on page 114.

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?

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

39

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

40

1The prepared statement of Ms. Zoon appears in the Appendix on page 84.

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.

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

41

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

42

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.

43

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

44

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 followup 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

45

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

46

1See Exhibit No. 2 which appears in the Appendix on page 112.

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.

[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 propVerDate 11-MAY-2000 10:09 Aug 31, 2001 Jkt 000000 PO 00000 Frm 00050 Fmt 6633 Sfmt 6601 73395.TXT SAFFAIRS PsN: SAFFAIRS
47

1See Exhibit No. 2 which appears in the Appendix on page 112.

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.

er 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?

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

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

48

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.]

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