[Senate Hearing 108-110]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 108-110

                  TISSUE BANKS: THE DANGERS OF TAINTED
                    TISSUES AND THE NEED FOR FEDERAL
                               REGULATION

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

                                HEARING

                               before the

                              COMMITTEE ON
                          GOVERNMENTAL AFFAIRS
                          UNITED STATES SENATE


                      ONE HUNDRED EIGHTH CONGRESS

                             FIRST SESSION

                               __________

                              MAY 14, 2003

                               __________

      Printed for the use of the Committee on Governmental Affairs



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                   COMMITTEE ON GOVERNMENTAL AFFAIRS

                   SUSAN M. COLLINS, Maine, Chairman
TED STEVENS, Alaska                  JOSEPH I. LIEBERMAN, Connecticut
GEORGE V. VOINOVICH, Ohio            CARL LEVIN, Michigan
NORM COLEMAN, Minnesota              DANIEL K. AKAKA, Hawaii
ARLEN SPECTER, Pennsylvania          RICHARD J. DURBIN, Illinois
ROBERT F. BENNETT, Utah              THOMAS R. CARPER, Delaware
PETER G. FITZGERALD, Illinois        MARK DAYTON, Minnesota
JOHN E. SUNUNU, New Hampshire        FRANK LAUTENBERG, New Jersey
RICHARD C. SHELBY, Alabama           MARK PRYOR, Arkansas

           Michael D. Bopp, Staff Director and Chief Counsel
              Claire M. Barnard, Professional Staff Member
     Joyce Rechtschaffen, Minority Staff Director and Chief Counsel
         Kathryn J. Seddon, Minority Professional Staff Member
                     Darla D. Cassell, Chief Clerk


                            C O N T E N T S

                                 ------                                
Opening statement:
                                                                   Page
    Senator Collins..............................................     1
    Senator Coleman..............................................     4
    Senator Pryor................................................     6
    Senator Carper...............................................    24

                               WITNESSES

Steve and Leslie Lykins, parents of Brian Lykins, accompanied by 
  daughter Tammy.................................................     6
Steven L. Solomon, M.D., Acting Director, Division of Healthcare 
  Quality Promotion, National Center for Infectious Diseases, 
  Centers for Disease Control and Prevention, U.S. Department of 
  Health and Human Services......................................    15
Jeanne V. Linden, M.D., Director, Blood and Tissue Resources, 
  Wadsworth Center, New York State Department of Health..........    17
Jesse L. Goodman, M.D., Director, Center for Biologics Evaluation 
  and Research, Food and Drug Administration, U.S. Department of 
  Health and Human Services......................................    26

                     Alphabetical List of Witnesses

Goodman, Jesse L., M.D.:
    Testimony....................................................    26
    Prepared Statement with an attachment........................    61
Linden, Jeanne V., M.D.:
    Testimony....................................................    17
    Prepared Statement with an attachment........................    55
Lykins, Leslie and Steve:
    Testimony....................................................     6
    Prepared Statement...........................................    39
Solomon, Steven L., M.D.:
    Testimony....................................................    15
    Prepared Statement...........................................    44

                                Exhibits

 1. GDeposition of James C. Vander Wyk, Ph.D., taken on January 
  21, 2003, on behalf of the plaintiff in the case of Steve 
  Lykins v. CryoLife, Inc.; Civil Action File Number 02105613-24; 
  Superior Court of Cobb County, State of Georgia; pages 1-4, 25-
  32, 69-80, and 189-192.........................................    84
 2. G``Update: Allograft-Associated Bacterial Infections--United 
  States, 2002,'' Mortality and Morbidity Weekly Report; Centers 
  for Disease Control and Prevention; March 15, 2003, at http://
  www.cdc.gov/mmwr/preview/mmwrhtml/mm5110a2.htm.................    91
 3. G``Hepatitis C Virus Transmission from an Antibody-Negative 
  Organ and Tissue Donor--United States, 2000-2002,'' Mortality 
  and Morbidity Weekly Report; Centers for Disease Control and 
  Prevention; April 4, 2003, at http://www.cdc.gov/mmwr/preview/
  mmwrhtml/mm5213a2.htm..........................................    96
 4. GLetter from Senator Susan M. Collins, Ranking Minority 
  Member, Permanent Subcommittee on Investigations, to Bernard A. 
  Schwetz, D.V.M., Ph.D., Acting Principal Deputy Commissioner, 
  Food and Drug Administration (FDA), December 21, 2001, 
  concerning the death of Brian Lykins and the status of the 
  FDA's tissue action plan.......................................   100
 5. GLetter from Senator Susan M. Collins, Ranking Minority 
  Member, Permanent Subcommittee on Investigations, to Bernard A. 
  Schwetz, D.V.M., Ph.D., Acting Principal Deputy Commissioner, 
  Food and Drug Administration (FDA), February 11, 2002, 
  concerning the status of the FDA's tissue action plan..........   101
 6. GLetter from Melinda K. Plaisier, Associate Commissioner for 
  Legislation, Food and Drug Administration (FDA), to Senator 
  Susan M. Collins, Ranking Minority Member, Permanent 
  Subcommittee on Investigations, April 3, 2002, concerning the 
  status of the FDA's tissue action plan.........................   103
 7. GLetter from Senator Susan M. Collins, Ranking Minority 
  Member, Permanent Subcommittee on Investigations, to The 
  Honorable Tommy G. Thompson, Secretary of Health and Human 
  Services, April 12, 2002, concerning the status of the FDA's 
  tissue action plan.............................................   106
 8. GLetter from The Honorable Tommy G. Thompson, Secretary of 
  Health and Human Services, to Senator Susan M. Collins, Ranking 
  Minority Member, Permanent Subcommittee on Investigations, 
  August 28, 2002, concerning the status of the FDA's tissue 
  action plan....................................................   109
 9. GResponses to questions for the record, transcript of hearing 
  on the nomination of Mark B. McClellan, to be Commissioner of 
  the Food and Drug Administration, Department of Health and 
  Human Services; U.S. Senate Committee on Health, Education, 
  Labor, and Pensions, October 2002..............................   110
10. GFDA Notice of Inspectional Observations (Form FDA-483) from 
  Inspection 3/25/2002-4/12/2002 (FEI #3001451326), issued to 
  James C. Vander Wyk, Vice-President of Quality Assurance/
  Regulatory Affairs, CryoLife Inc., dated April 12, 2002........   111
11. GLetter from James C. Vander Wyk, Ph.D., Vice-President, 
  Regulatory Affairs and Quality Assurance, CryoLife, Inc., to 
  Mr. Ballard H. Graham, District Director, HFE-SE100, Food and 
  Drug Administration, regarding ``Initial reply to Notice of 
  Inspectional Observations (483) from Inspection of 3/25/2002-4/
  12/2002 (FEI #3001451326), dated May 15, 2002..................   119
12. GSample of Complaint Record, CryoLife, Inc...................   121

 
 TISSUE BANKS: THE DANGERS OF TAINTED TISSUES AND THE NEED FOR FEDERAL 
                               REGULATION

                              ----------                              


                        WEDNESDAY, MAY 14, 2003

                                       U.S. Senate,
                         Committee on Governmental Affairs,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 9:37 a.m., in 
room SD-342, Dirksen Senate Office Building, Hon. Susan M. 
Collins, Chairman of the Committee, presiding.
    Present: Senators Collins, Coleman, Carper, and Pryor.

             OPENING STATEMENT OF CHAIRMAN COLLINS

    Chairman Collins. The Committee will come to order.
    Good morning. Today, the Committee on Governmental Affairs 
is holding a hearing on the dangers of tainted human tissue and 
the need for Federal regulation of the tissue bank industry.
    Tissue banks procure, process, store, and distribute human 
tissue for transplantation. Tissue transplants have soared in 
recent years due to advances in technology that have greatly 
reduced the risk of rejection. The American Association of 
Tissue Banks estimates that more than 800,000 tissue products 
were made available for transplantation last year in the United 
States. Yet despite the ever increasing number of transplants, 
there are serious questions about the safety of our Nation's 
tissue supply.
    Some of these concerns stem from the Food and Drug 
Administration's failure to finalize much-needed regulations 
governing the tissue bank industry. This is not a new problem. 
In fact 2 years ago this month I chaired a hearing of the 
Permanent Subcommittee on Investigations exposing the safety 
issues concerning the practices of some tissue banks. Yet in 
the intervening 2 years, the FDA has made virtually no progress 
in strengthening the regulatory requirements for an industry 
whose products are in wide use and affect human health.
    While many people are familiar with the concept of organ 
donation, tissue donation is not as well understood. Human 
tissue, including tendons, bone, and skin is unlike an organ 
transplant because it is not usually transplanted as-is from 
the donor's body into that of the recipient.
    Rather, donated tissue generally undergoes considerable 
processing before it is transplanted into a patient. Bone from 
a donor's femur, for example, may be completely reshaped into a 
component designed to give support to a recipient's spine. The 
reconfigured tissues are also known as allografts.
    Once processed, donated tissue can be stored for a period 
of time before it is used to enhance, improve, and even save 
lives. If, however, human tissue is not properly processed, it 
can pose dangerous risks to the recipient.
    Therefore, it is critical that the tissue come from 
carefully screened donors, and that it be properly processed 
and stored. Otherwise, communicable diseases such as HIV and 
hepatitis, among others, can be transmitted through the tissue 
to the recipient.
    The FDA has been aware of these public health risks for 
years. In 1997, the agency examined the health issues involving 
tissue transplantation and concluded that the existing 
regulatory framework was insufficient. The agency undertook the 
review in response to incidents in which imported foreign 
tissue had tested positive for serious diseases.
    The FDA then notified the tissue bank industry that it 
intended to make regulatory changes to strengthen the oversight 
of tissue banks. The changes were threefold. First, all tissue 
banks would be required to register with the FDA. Second, 
screening of potential donors would be expanded to require 
testing for the human variant of mad cow disease, syphilis, and 
other viruses. And third, and perhaps most important, a rule 
would be issued on the methods and controls used during the 
processing of human tissue.
    This third proposal, known as the good tissue practices 
rule is intended to help ensure that tissues are not 
contaminated as they move from recovery to distribution.
    The hearing that I held 2 years ago exposed dangerous 
practices by some tissue banks as well as the inadequacy of the 
regulatory framework. The testimony that we heard at that time 
was deeply troubling. First of all, we learned that the Federal 
Government had no idea how many tissue banks were operating in 
the country. The Department had estimated that there were about 
150, but approximately 350 tissue banks registered with the FDA 
when the registration requirement went into effect. But that 
indicated that many tissue banks were operating without any 
Federal oversight whatsoever.
    Second, there was also considerable testimony about the 
unacceptable practices of some tissue banks. For example, a 
deputy inspector general from the Department of Health and 
Human Services testified about unscrupulous tissue banks that 
engaged in a practice in which tissues that initially tested 
positive for contamination were simply tested over and over 
again until the technicians achieved the negative result they 
wanted.
    Another witness testified that a Lion's eye bank, which 
also participated in tissue recovery, accepted a donor who was 
82-years-old and had a history of cancer. That is a frightening 
example of inadequate donor screening by a tissue bank.
    Based on our findings, it was evident to the Subcommittee 
that Federal oversight of tissue banks was woefully inadequate. 
Until the necessary changes were made, gaping holes would 
remain in the safety net that protects patients who receive 
transplanted tissue. Now the FDA assured us at this hearing 2 
years ago that it would act expeditiously to remedy this 
problem by implementing the long-overdue regulations.
    Since that time, I have repeatedly pressed the FDA to 
finalize its regulations. I have offered help to the agency to 
overcome any obstacles that it might face along the way. 
Senator Durbin and I asked the FDA to provide a breakdown of 
the costs for implementation of the proposed regulations. We 
never received a response. I wrote additional letters to the 
FDA. I then wrote to the Department of Health and Human 
Services about the very troubling delays and seeking assurance 
that the implementation of the regulations was a priority. In 
its response, the Department agreed that the FDA needed to move 
as quickly as possible to finally put the regulations in 
effect.
    Unfortunately, the FDA still has not kept its commitment to 
addressing this public health risk through effective 
regulation. And, as I predicted 2 years ago, the result of this 
bureaucratic inertia has been tragedy.
    My greatest fears were realized when Brian Lykins, a 
healthy 23-year-old man from Minnesota, died in November 2001 
after receiving a tissue transplant in his knee during routine 
surgery. The tissue was infected with a deadly bacterium, and 
yet it made its way from Georgia to St. Cloud Hospital in 
Minnesota.
    Good tissue practices appear to have been totally absent in 
this case. CryoLife, the company that processed the tissue used 
in Brian's transplant, accepted a tissue donation from an 
individual who had been deceased for 19 hours and his body had 
not been refrigerated during that time. I dare say that if 
Brian had been aware of that fact alone, he would have refused 
to have a transplant of that donor.
    Brian's parents will testify before the Committee today 
about the devastating loss that their family have suffered. It 
is a tribute to them and to their daughter Tammy that they have 
agreed to come forward and testify publicly about this most 
painful and private event. They have done so in the hope that 
others will not have to endure the tragic loss that they have 
suffered.
    I just want to thank them publicly for their willingness to 
speak out and for their commitment to seeing that no other 
family suffers the tragedy that they have. So I want to thank 
you for being with us today. My hope is that their 
participation in today's hearing will finally be the catalyst 
that prompts the FDA to act.
    In the wake of the tragedy of Brian's death, 6 months later 
in May 2002, an FDA official stated on national television that 
the agency intended to make the regulations final within 1 
year. Yet here we are a full year after that, without any 
discernible progress having been made toward issuing the 
regulations. I just do not understand that. That is why I am 
holding this hearing today.
    Moreover, there is now evidence to suggest that the absence 
of regulations is being used as a legal defense for 
questionable practices. After Brian Lykins died, his family 
filed suit against the tissue processor, CryoLife.
    In a deposition, a CryoLife executive stated that the FDA 
had not imposed final regulations regarding what industry 
practices should be, but instead had issued only non-binding 
guidance. That CryoLife representative is correct on that 
point. Under the current regulations, a tissue bank is not even 
required to report situations to the FDA in which an adverse 
event--that is bureaucratic language for what happened to Brian 
Lykins--has occurred. Reporting is completely voluntary. As 
outrageous as that may seem, perhaps the industry's defense 
strategy will provoke the FDA into action.
    Recent evidence confirms that Brian Lykins' case was not an 
isolated event. Last year after his death, an investigation was 
undertaken by the Centers for Disease Control and Prevention 
along with the New York and Minnesota State Departments of 
Health, to determine what killed him. That inquiry led the CDC 
to examine other cases of allograft-related infections.
    In its March 2002 report, the CDC identified 26 cases of 
infection in donated human tissue that had been linked to 
allografts used in transplants. The CDC now reports that more 
than 60 cases of transplanted tissue infections are now being 
investigated. We will hear more about that from the CDC today.
    It is also surely significant that New York State, which 
has the most stringent tissue oversight regulations in the 
country, had not experienced the same problems. Today we will 
hear testimony from that State's top tissue oversight official 
regarding the authority that has allowed New York State 
residents to have greater confidence that the tissue 
transplants they received are free from infection.
    It is well past time for the FDA to finish what it started 
more than 6 years ago when the agency correctly identified a 
serious threat to public health and the need to improve 
regulatory oversight of the tissue industry. The remaining 
safety regulations must be completed without delay, and tissue 
banks that do not comply with the regulations must be suspended 
from doing business and punished for jeopardizing public 
health.
    Last year, Senator Durbin and I introduced a bill, the 
Tissue Transplant Safety Act of 2002. It would have required 
the FDA to impose tougher safety standards. Later today, 
Senator Durbin, Senator Coleman, and I will reintroduce that 
legislation which we, with the family's permission, are naming 
in honor of Brian Lykins. This time we will require the FDA to 
issue the final regulations within 90 days. It is obvious to me 
that without a statutory deadline, FDA will continue to delay 
and delay.
    I look forward to hearing the testimony of our witnesses 
today and at this time I would like to yield to my colleague 
from Minnesota, who has a special interest in this case, for 
his opening statement as well as to introduce our first panel 
of witnesses.

              OPENING STATEMENT OF SENATOR COLEMAN

    Senator Coleman. Thank you, Madam Chairman. It will be an 
honor to introduce today, Steve and Leslie Lykins, and their 
daughter Tammy. I want to thank you for calling this hearing.
    Twelve years ago, the FDA first studied this issue. Two 
years ago almost to this day you held hearings on this issue. 
During those hearings the FDA promised to issue regulations 
soon. A year and-a-half ago Brian Lykins died, he did not die 
of complications stemming from the procedure. He was a healthy 
young man and his death should have been prevented.
    His death was followed by national press and CDC studies 
that once again pointed to the need for national standards. The 
FDA still has not acted. So today we are revisiting the issue. 
I suspect we will hear roughly the same testimony we heard 2 
years ago. But this time we will also hear from the Lykins 
family about the death of their son. I can only hope that 2 
years from now we do not have to revisit the issue and listen 
to the same testimony again perhaps with yet another victim 
whose friends and family had to watch their son or daughter 
die.
    I suspect the problem here is a bureaucratic desire to 
draft the perfect rule, regardless of the cost in time or 
lives. I believe in the old 80/20 rule, about 80 percent of the 
problem can be dealt with with only 20 percent of the effort. 
It is the last few bits that require the most time. We all 
agree on certain things like the ability to trace tissue from 
recipient to donor and back to other recipients, and the need 
for testing for additional diseases. We could at least get some 
components in place. No doubt there are more difficult issues 
that do take a long time to resolve, but why are we still 
waiting to do the easy stuff, the stuff we know can make a 
difference?
    New York, as the Chairman has noted, has put a law into 
place which can serve as a model. New York did not wait, nor 
should we. If nothing else, we can move forward with 
legislation modeled on the New York law setting up a simple 
system for testing and tracking. The system could be later 
augmented by further rules that would allow us to avoid having 
to return here in 2 years to hear from another family.
    Although I will reserve final judgment until I hear from 
the FDA, it appears to me that this hearing should not have had 
to be held to deal with this issue. We dealt with it 2 years 
ago.
    Madam Chairman, it is my great but sad honor to introduce 
today's first witnesses, Steven and Leslie Lykins from Willmar, 
Minnesota, and their daughter and Brian's sister, Tammy. I wish 
they did not have to be here today. Brian's death was 
especially tragic because it occurred after an elective surgery 
not from medical complications stemming from the procedure 
itself but rather from a cause that could have been presented 
if proper regulation had been in effect.
    I do not think most people can possibly understand how 
painful it would be to discuss the death of your children 
before a roomful of strangers. I want to thank the Lykins for 
their courage and their commitment for being here today. I want 
to commend the Chairman for having hearings on this issue. But 
I also want to remind ourselves that hearings are not always 
enough.
    Madam Chairman, under your leadership, the Permanent 
Subcommittee on Investigations held a hearing on tissue banks 
on May 24, 2001, 6 months before Brian's death. But again, as I 
noted before, the FDA did not take the required actions. It 
seems to me that the Lykins are doing something we should all 
admire. Faced with a personal tragedy, their first instinct was 
to use the painful lessons learned to try and make the world a 
little bit better.
    For our part, we should pledge to them that we will not 
need to relearn this issue at the cost of someone else's life. 
Hopefully, and more than hopefully, the FDA will promulgate 
final regulations that address the problem. If they do not then 
we need to, and we will move quickly forward on legislation 
that the Chairman is bringing forth. One way or another we must 
honor the Lykins' experience not just by listening to their 
story but by acting on it.
    Madam Chairman, it is, as I said, a great but sad pleasure 
to introduce Steven and Leslie and Tammy Lykins from Minnesota.
    Chairman Collins. Thank you very much, Senator. Before I 
call on Mr. and Mrs. Lykins for their testimony I want to see 
if my colleague Senator Pryor has any opening comments.

               OPENING STATEMENT OF SENATOR PRYOR

    Senator Pryor. Thank you, Madam Chairman.
    Thank you all for being here today. Madam Chairman, I am a 
recipient of an Achilles tendon from a donor bank. I must tell 
you that was about 7 years ago. I had a very rare and deadly 
form of cancer in my Achilles tendon. I had great results, but 
one thing that I took for granted was that the tendon I was 
receiving out of a donor bank, which happened to be in New 
Jersey was going to not be tainted and healthy. And it was.
    But I must tell you that what I have been reading in 
preparation for this hearing, I am bordering on outrage at some 
of the lack of control out there and the lack of supervision. 
It really is troubling to me. So I really do appreciate you all 
coming. It takes a lot of courage to be here. I know it is a 
sad story that you are going to tell. But we are going to do 
everything we can to listen and try to make the situation 
better.
    Thank you, Madam Chair, for allowing me to speak.
    Chairman Collins. Thank you, Senator Pryor. I think your 
experience shows exactly the way most people would react. You 
would never dream of getting a tissue transplant that you might 
be putting your life at risk.
    Senator Pryor. That is right.
    Chairman Collins. Yet properly done and safely done, a 
tissue transplant can save lives.
    Senator Pryor. Absolutely. It definitely saved my leg. 
Otherwise I probably would have had to have an amputation. You 
have so many other considerations at that point. Depending on 
why you are having the transplant--it could be cancer, it could 
be any number of ailments, any number of reasons why you are 
doing it. But you are so preoccupied with that. You always know 
there is a chance of some sort of tissue rejection. We all know 
the medical risks there, and the medical community has gotten 
that risk down to a very low level, a very manageable level. 
The last thing the patient needs to be concerned about is that 
he may receive some tainted tissue. Thank you.
    Chairman Collins. Thank you. Mr. Lykins, I would ask you to 
proceed with your testimony. Again, thank you so much for being 
here today with your family.

  TESTIMONY OF STEVEN AND LESLIE LYKINS,\1\ PARENTS OF BRIAN 
             LYKINS, ACCOMPANIED BY DAUGHTER TAMMY

    Mr. Lykins. You are welcome.
---------------------------------------------------------------------------
    \1\ The prepared statement of Steve and Leslie Lykins appears in 
the Appendix on page 39.
---------------------------------------------------------------------------
    In September 2001, our son Brian had arthroscopic surgery 
to remove a bone chip in his knee. It went very well.
    Afterwards, Dr. Mulawka, the surgeon, showed us pictures of 
Brian's knee which revealed a quarter-size divot in the bone. 
He told us that Brian should have follow-up surgery in order to 
prevent future arthritis in his knee. He also explained that a 
piece of bone from a cadaver would be used in the procedure and 
told us about the effort and testing that went into ensuring 
the donated bone tissue would be clean and safe. It was 
supposed to be a routine surgery, one that Brian could have 
lived a completely normal life without. In other words, it was 
strictly a preventative and elective procedure. The recovery 
from the procedure was expected to take a little longer than 
the previous one, but no one expected any significant 
complications.
    On Wednesday, November 7, Brian had the follow-up surgery 
which went well. Dr. Mulawka told us that Brian would become a 
little sick from the medications and possibly experience more 
pain than the previous arthroscopic surgery, but otherwise the 
recovery should go well.
    After the operation, Brian was experiencing a lot of pain. 
He had a horrible headache, upset stomach, and felt like he was 
burning up. The nurses, however, said his temperature was 
normal. The doctor decided to keep him overnight for 
observation. Leslie and I drove home to Willmar for the night. 
We did not expect any complications so I left for work the next 
morning and was scheduled to work in Minneapolis for the 5 
days.
    Ms. Lykins. After Steve left, I drove to St. Cloud Hospital 
to pick Brian up. When I got there I found out that he was sick 
to his stomach and in excruciating pain. The pain pack the 
doctor had inserted into his knee during the operation 
apparently was not working. The purpose of the pain pack was to 
administer medication directly to the knee to help control the 
pain.
    After Brian was released from the hospital I drove him to 
the St. Cloud Orthopedic Clinic where they removed the pain 
pack. Brian was originally scheduled to go to the doctor on 
Friday, the following day, but the doctor thought that he could 
wait to see Brian until Monday morning. So instead we drove to 
my home in Willmar where Brian stayed with me overnight. 
Throughout the evening, Brian began to feel better. His knee 
was still sore and he felt warm at times, but otherwise he felt 
fine.
    On Friday morning, Brian woke up feeling much better. Of 
course his knee was still sore, which was to be expected. That 
afternoon he said he felt well enough to go home. At his home 
he rested, ate and drank a bit, used the exercise machine they 
had sent along, and occasionally iced his knee. His recovery 
was going exactly as we thought that it would. That evening we 
watched a movie together and he told me that he felt fine and 
if I wanted to go home I should, which I did.
    On Saturday, I had previous plans to be out of the house 
for most of the day so I was up early. Brian called me, told me 
that he felt fine, and asked some questions about when he was 
supposed to take his medication. He said his leg was still 
sore, but otherwise he felt fine. Then I went out, returned 
home at about 5 p.m. that night and called Brian. He told me he 
had been sick to his stomach for a while, which we had 
expected. I told him, I would come on over to his house after I 
took care of a few things and he said that was fine. I got to 
his house about 6 p.m. As soon as I arrived I realized that he 
was in worse shape than he had let on. He was throwing up, and 
told me he almost passed out twice walking to the sink. He 
complained about feeling warm but he did not feel warm to the 
touch.
    I called Dr. Mulawka's office right away and I got the 
answering service. They told me that they would call the doctor 
and have him call me back soon. Shortly after that someone else 
called from the clinic. When I explained how Brian was feeling, 
he told me to change the dosage on one of the medications which 
was likely the culprit of the stomach problems. Brian told me 
he would like to spend the night at our house so we packed up 
some of his things and we started to drive to my house which is 
only two and-a-half miles away.
    On the way Brian said he would like to stop at the hospital 
and have them check him out. We got to the emergency room about 
8 p.m. When the nurse and the doctor on duty examined Brian 
they suspected that he was simply dehydrated and they put him 
on IV. I think they also gave him something in the IV to help 
settle his stomach. He still complained about burning up, and 
he stripped off his shirt and his blankets but he still did not 
register a fever. Brian also complained about his knee hurting, 
but the nurse could not find any unusual swelling, redness, or 
hot spots. A couple of times he doubled over with an upset 
stomach before the medications seemed to kick in and help him.
    The nurse and the doctor thought he would feel better once 
he was more hydrated from the IV. His vital signs seemed to be 
OK. The doctor also ordered chest x-rays and had blood drawn. 
After that was done, Brian was back in his room and he was 
resting better. No one seemed alarmed about anything at that 
time and they told us that he would be going home soon. Brian 
finally appeared to be dozing off to sleep. I was tired and 
told the nurse that I would go out into the emergency room to 
get some rest. At that point it was about 1 a.m. in the 
morning.
    I was in the waiting room for about 15 maybe 20 minutes 
when someone came in and told me to come right away. Brian had 
suddenly taken a turn for the worse. He had been moved to a 
larger room in the ER where several people were anxiously 
working around him. He was awake at that time. After a few 
minutes, the doctor told me that Brian's vital signs had 
changed all of a sudden and that they were trying to find out 
what was wrong. Then the doctor asked me if there was anyone in 
town who I wanted to call to be with me. I began to worry.
    He told me that I should call my husband who, thankfully, 
was in Minneapolis and not on a trip as he is a pilot. I called 
Steve and the doctor explained to him that he should come to 
the hospital immediately, that things did not look good for 
Brian. I had not expected any of this when I brought Brian to 
the hospital. We thought he was just dehydrated and nauseous 
from the strong medicine. The doctors were now planning to move 
him to the intensive care unit.
    I made my way to the ICU when Brian was being wheeled into 
a room. The doctor was trying to ask Brian questions and he 
answered them in short little statements. He had not been in 
the room long when Brian had a convulsion. He sat straight up, 
gave a loud, long groan. I think that was the point that he 
went into a coma. The doctors and nurses got me out of the 
room, attended to Brian, and some time passed. A nurse came and 
got me and brought me back to Brian's room. I was not in there 
for long before he had another convulsion. It appeared as 
though he stopped breathing until the doctor put some sort of 
respirator on him. I was then led back into the waiting room.
    Steven got to the hospital about 4 a.m. The doctor filled 
him in on Brian's condition and told him they were not exactly 
sure what was happening but that it was life-threatening.
    Mr. Lykins. Brian was in a coma when I got to the hospital. 
His blood pressure had been at zero for several hours. All the 
organs in Brian's body were failing. His heart was the last 
organ to fail and at 6:21 a.m. our son died.
    Shortly after Brian's death we learned that the tissue put 
into his knee was infected with a deadly bacteria. This 
infected tissue was allowed to be implanted in Brian's knee due 
to several industry and government failures.
    First, there were no Federal guidelines for the automatic 
rejection of high-risk cadavers. The cadaver that supplied the 
tissue for Brian's operation should have been rejected for at 
least two reasons. First, he died due to suicide so the time of 
death was uncertain. Second, the body was allowed to remain 
unrefrigerated for at least 19 hours before tissue harvesting 
began.
    Second, CryoLife procedures for testing and preparing the 
tissue to make it clean and safe were flawed.
    The Centers for Disease Control began an investigation into 
the cause of Brian's death because two other men from the same 
area died within about 1 week of each other after having 
routine knee surgery. One of the men had his surgery in the 
same hospital as Brian. The CDC found that the other two men 
died from blood clots. They did not have cadaver tissue put 
into their bodies. Their knee operations were completely 
different from Brian's.
    However, due to the presence of the deadly bacteria found 
in Brian's body, the CDC continued with a lengthy investigation 
into the cause of our son's death. Over the next 6 months I 
talked on a regular basis with Dr. Kainer from the CDC who was 
running the investigation. I could not believe the things that 
I was hearing about the tissue industry as a whole and CryoLife 
in particular. How could a medical industry in the United 
States of America be allowed to operate like this? A medical 
industry allowed to operate with little or no State and/or 
Federal regulation, how could this be?
    The FDA had known about the problems in this industry for 
years and for some reason was dragging its feet in bringing 
about the necessary regulations. The CDC had clearly defined 
the problems in this industry and the FDA would do nothing 
about it.
    It became very clear at that point that the CDC had no 
power to bring about change in this industry and the FDA was 
not going to do its job. CryoLife was going to continue to 
operate in the unsafe manner that caused the death of our son. 
So at that time we decided to bring a lawsuit against CryoLife. 
The purpose of our suit was to bring about change in this 
company and this industry. Money was never the motivation for 
the suit. It was only the vehicle that would get people to pay 
attention.
    We did not sue Dr. Mulawka and we did not sue the hospital. 
We only sued the people responsible for Brian's death because 
they would not fix the problems on their own. All we ever 
wanted was for the people involved in Brian's death to learn 
from what happened and fix the problems. It became clear that 
CryoLife and the FDA would not fix the problem without the 
lawsuit. Less than 30 days after we filed the suit, the FDA 
shut CryoLife down due to their unsafe practices. 
Unfortunately, there are still no Federal regulations to 
prevent companies like CryoLife from operating in unsafe ways.
    One and a half years after Brian's death, the FDA is still 
only proposing regulations for the tissue industry. Nothing has 
changed. The tissue industry can still operate any way they 
want with little or no Federal regulations. What is taking the 
FDA so long? In our lawsuit, we listed seven areas of 
meaningful reforms that are needed in this industry. First is 
rejection of high-risk cadavers such as diseased cadavers that 
have cancer, meningitis; cadavers that are over 70-years-old; 
cadavers unrefrigerated for over 10 hours; suicide cadavers.
    Second, testing of tissue when cadaver is received.
    Third, sterilize tissue before distribution.
    Fourth, discard cadaver if any contamination is found.
    Fifth, mandatory reporting of contamination to Federal 
agencies and the end-user doctor.
    Sixth, certification of cadaver harvesting personnel, 
uniform basic qualifications and uniform training.
    And seventh, mandatory annual procedure and inventory 
audit.
    Had these reforms been in place at the time of Brian's 
operation, our son would not be dead and many other people 
would not be dealing with some very serious medical conditions. 
How much longer is it going to take the FDA to do its job and 
bring the tissue industry into the 21st Century? This industry 
has been allowed to operate like something out of the Wild West 
for too long. Too many people have had their lives ruined and 
too many people have died. We need reforms and regulations in 
this industry now, not some day. There is no question that the 
tissue industry is necessary and important for the advancement 
of quality of life. However, there is no need for it to operate 
in such a dangerous manner.
    Chairman Collins. I want to thank you both for your very 
eloquent testimony. I know I speak for everyone in this room 
when I say that I am so sorry for your loss. My hope is that by 
your coming forward that we have put a human face on this 
problem, and that it will prompt the FDA to act. I just want to 
pledge to you that I am going to ensure that they act. We have 
given them too long already and I believe that your experience 
and your moving testimony will help convince our colleagues 
that far too long an amount of time has passed already and that 
we do need prompt action.
    You mentioned that prior to Brian's surgery that there was 
a discussion with his physician about the transplanted tissue. 
Now I know that anyone undergoing any kind of surgery signs a 
standard informed consent form, but was there any discussion of 
possible risks of the tissue itself, Mr. Lykins?
    Mr. Lykins. Dr. Mulawka sat with my wife and I and Brian 
and we talked about that and he explained over--it was quite a 
lengthy explanation of all of the safety standards that went 
into ensuring that the tissue was safe. After he finished 
explaining that to us, we were very confident that the tissue 
was going to be clean, that there would be no problems. It was 
never even a consideration that the tissue may not be safe to 
be put in Brian's body.
    Chairman Collins. Did you assume at that time that as with 
organ transplants, as with medical devices, that there was 
Federal regulation of the tissue industry so that you really 
did not need to worry about the safety, Mrs. Lykins?
    Ms. Lykins. Yes, we did, at that time. We just assumed, 
which now from hindsight we know better, but that just like 
any--like the organs and such, that these things were already 
handled through the medical field and knew them to be safe.
    Chairman Collins. I think that is a very logical assumption 
for you to have made. It is one that I think most health care 
professionals made, including the physician. The surgeon who 
treated your son obviously assumed that there was a process in 
place to ensure the safety of the transplanted tissue.
    How did you learn of the cause of Brian's death, Mr. 
Lykins?
    Mr. Lykins. When Brian died, the doctor in the ICU, even 
when he died they said, we do not know what happened. So we 
talked with him and we ordered that they do an autopsy on Brian 
to find out the cause of what killed him. That is where we 
started the learning process was from that autopsy.
    Chairman Collins. When did you learn that the cadaver from 
which the tissue had been taken had been left unrefrigerated 
for at least 19 hours, clearly raising the risk of infection 
and other problems?
    Mr. Lykins. During that next 6 months after Brian's death 
when we were in contact with--first it started with the 
Minnesota Department of Health and then it went to the CDC, 
that is when we started learning things like that. It was 
sometime during that investigation that the fact that it had 
been unrefrigerated for 19 hours came up.
    Chairman Collins. During the course of your lawsuit against 
the tissue bank that procured and processed the tissue for 
Brian, which is CryoLife, did you learn of any previous 
complaints against the company or other problems that CryoLife 
had experienced?
    Mr. Lykins. Yes, there were at least two of them that we 
were familiar with. One, and I cannot remember the gentleman's 
name but he is out in the San Francisco area that a couple of 
years before Brian's death he had a knee operation where he 
received tainted tissue which caused him some real severe 
medical problems.
    Chairman Collins. Is there anything that you have learned 
from this experience that particularly concerned you?
    Ms. Lykins. I think it probably would be in the medical 
field in dealing with this is that we did not have the 
information and that our doctors did not have this vital 
information that was so needed.
    Mr. Lykins. Of course we have done a lot of talking with 
friends and family and even acquaintance at work about it and 
the thing that I really struggle with is if they had given us a 
document when we went in for this operation that said that the 
tissue that your son will be receiving is not regulated, in 
fact we do not know where it is coming from, we have no 
standards for how it is produced, we cannot guarantee it is 
going to be safe, and there is a risk of death or serious 
infection from this we would, of course, have said, no, we were 
not going to do that operation. We were not given that option 
because nobody knew that at the time.
    So the fact that we were not given that option, but we 
assumed, like every other part of the medical industry, that it 
is regulated, when it is a public safety thing--that companies 
just cannot operate like that where they can pose a serious 
health risk. I cannot think of any industry--I am a pilot and 
you look at the high regulation in the airline industry and you 
look at all the other areas where we have such good safety 
standards in place and then to see this one with none, I think 
that is the part that has bothered us the most.
    Chairman Collins. I am going to yield to Senator Coleman at 
this point because I know he is on a very tight schedule.
    Senator Coleman. Thank you, Madam Chairman. I am not going 
to ask any questions. I hope to have an opportunity to visit 
with the family a little later. My daughter and her class are 
in my office and I am going to go down there and see them in a 
couple of minutes.
    But I do want to note, in their testimony the Lykins said 
their purpose here was not to sue people for money. It is to 
fix the problem. I will say to them publicly what I said 
privately, that the Chairman is very serious about this issue, 
and that something will come from this testimony today. So your 
purposes will be achieved and I just want to again thank you 
for your courage and your commitment.
    Thank you, Madam Chairman.
    Chairman Collins. Thank you, Senator. I just have one more 
question before I yield to my colleague and one comment. When 
we met yesterday, just to expand on your last response, you 
told us that if there were a sign up in the operating room or a 
form given to a patient saying, warning, the transplant you are 
about to receive has no safety guarantee it all. The Federal 
Government does not really regulate it. Unless you are living 
in one of three States there is no State regulation. Proceed at 
your own risk. That your son would not have proceeded with this 
operation. Indeed, it would be the end of the tissue bank 
industry, which is unfortunate because there is a lot of good 
that comes from tissue transplants.
    But I think that you are absolutely right and that only 
makes the case for effective regulation even stronger, because 
we want to make sure that transplanted tissue which literally 
can save lives, does not take lives. That is what this is all 
about.
    My final question for you is, we will have a representative 
from the FDA testifying before us today. In his defense, he has 
only been on the job for a few months. He is new to his 
position. But this is an indictment of the agency for failure 
to act. I just want to ask you if there is any question that 
you want me to pose to the FDA representative today? Mrs. 
Lykins.
    Mrs. Lykins. I think what we have put in here is, how can 
the American public, the people, the patients that are needing 
this help, how can they turn their back and oppose some safety 
that these people can rely on and know that they will indeed be 
getting tissue that will be helping them in their life?
    Chairman Collins. Thank you. Mr. Lykins, do you have 
anything to add?
    Mr. Lykins. I guess I really do not. In our statement we 
have said it. We just do not understand why this is taking so 
long. We have heard at least two or three times since Brian 
died, and statements before that, just one more year, just one 
more year and we will have it done. We just heard that again 
recently, just one more year. It does not seem like it is that 
hard to get some kind of, like Senator Coleman was saying, let 
us get the basic framework in place. New York has it right now. 
If nothing else, let us adopt New York's and get it started. 
But there are people that are at serious risk today having 
these operations that do not even know about it. We have got to 
get something going here.
    Chairman Collins. Thank you. Senator Pryor.
    Senator Pryor. Thank you. Again thank you all for being 
here. I have a factual question about your case and that is, 
CryoLife, is that a private company? Is that an association? Is 
that a for-profit company? Is that a lab? What is that or what 
was that?
    Mr. Lykins. It is a for-profit corporation and they do a 
lot of different things and part of the things that they do is 
they supply this tissue.
    Senator Pryor. Did I understand what you said a few moments 
ago that they are no longer in business?
    Mr. Lykins. No. Just shortly after we filed this suit the 
FDA went in and stopped, shut down their tissue processing part 
of their business. They were stopped from doing that except in 
life-threatening circumstances until they got their house in 
order. I forget exactly how long but they eventually did comply 
with the FDA's request so they are back operating now.
    Senator Pryor. Tell me about your contacts with the FDA. It 
sounds like you had some litigation going and you have also had 
some contacts with the Food and Drug Administration. I would 
like to zero in on your contacts with the FDA. Give me a feel 
for how you have communicated with them. Is it by letter, by 
phone call, by personal visit? How have you communicated with 
FDA?
    Mr. Lykins. We have not personally communicated with the 
FDA at all. Our attorneys, during the lawsuit there was 
communication there, but we have never personally communicated 
with them.
    Senator Pryor. Has the FDA taken steps to keep either you 
or your attorneys advised about the status of the process 
within the agency?
    Mr. Lykins. Not that I am aware of.
    Senator Pryor. Have they ever been proactive in any way 
with you to try to give you any kind of assurance that they are 
working on this problem as quickly as they can? Are they going 
to try to move things out as quickly as they can to prevent 
this from happening in the future?
    Mr. Lykins. No.
    Senator Pryor. This incident occurred in 2001?
    Mr. Lykins. Yes.
    Senator Pryor. How old was your son?
    Mr. Lykins. He was 23.
    Senator Pryor. You made a statement about this industry, 
that it is analogous to the Wild West. When you say that, do 
you mean that your concern is it is totally unregulated and 
there is no government supervision about what is going on out 
there, or at least it is very limited?
    Mr. Lykins. The symbolism behind that statement was, I see 
this industry as operating like a bunch of Wild West 
gunslingers that are just shooting from the hip, doing it any 
way they want to do it, and with no laws or regulations they 
are just making it up as they go. That was the thinking behind 
that statement.
    Senator Pryor. Have you been in contact with other families 
who have had similar experiences?
    Mr. Lykins. We have had several families that have called 
us and talked to us, yes. Yes, we have.
    Senator Pryor. One last question on the nature of the 
bacterial infection. What was the origin of that bacterial 
infection? Was it because the tissue was not handled properly? 
Or was it pre-existing in the cadaver? Do you know?
    Mr. Lykins. The bacteria is called Clostridium sordellii. 
My understanding of it is it is a spore-based bacteria, which 
to me means it is in a little, kind of like an egg shell. It is 
a normal part of a decomposing body. It starts in the 
intestines and then moves out into the body over time. That is 
where the time issue is such a big deal. So it was not a pre-
existing. It was allowed to----
    Senator Pryor. It is naturally occurring if proper steps 
are not taken to prevent it?
    Mr. Lykins. That is right.
    Senator Pryor. Madam Chair, that is all I have.
    Chairman Collins. Thank you very much, Senator Pryor.
    I want to thank you so much for your very courageous and 
moving testimony. I want to thank Tammy for being here as well. 
If you have anything that you feel that your parents forgot to 
say today or that you would like to add I just wanted to give 
you the opportunity. If you feel it has been covered, that is 
fine too.
    Ms. Tammy Lykins. I think they covered it.
    Chairman Collins. Thank you. Again, thank you so much for 
sharing your story with us. All of us simply cannot imagine the 
pain and anger you must have endured. But I want to tell you 
that we are committed to working with you to make sure that no 
other family goes through what you have gone through. That is 
our goal and I know it is yours as well. So thank you so much 
for being with us today.
    Mr. Lykins. Thank you.
    Chairman Collins. I would now like to call forward our 
second panel. Our first witness on the second panel will be Dr. 
Steven Solomon. Dr. Solomon is the acting director of the 
Division of Health Care Quality Promotion at the National 
Center for Infectious Diseases which is part of the Centers for 
Disease Control and Prevention. We also will be hearing from 
Dr. Jeanne Linden, the director of Blood and Tissue Resources 
for the New York State Department of Health. We want to thank 
both of you for your willingness to participate today and, Dr. 
Solomon, I would ask that you go first.

   TESTIMONY OF STEVEN L. SOLOMON, M.D.,\1\ ACTING DIRECTOR, 
 DIVISION OF HEALTHCARE QUALITY PROMOTION, NATIONAL CENTER FOR 
     INFECTIOUS DISEASES, CENTERS FOR DISEASE CONTROL AND 
    PREVENTION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

    Dr. Solomon. Thank you. Good morning. I am Dr. Steven L. 
Solomon, acting director of the Division of Healthcare Quality 
Promotion in the Centers for Disease Control and Prevention's 
National Center for Infectious Diseases. Thank you for the 
opportunity to report to you on CDC's activities with regard to 
the problem of infections occurring in association with the 
surgical implantation of human tissue. As a physician and as a 
parent, I want to express my sympathies to the Lykins family 
for their tragic loss.
---------------------------------------------------------------------------
    \1\ The prepared statement of Dr. Solomon appears in the Appendix 
on page 44.
---------------------------------------------------------------------------
    An allograft is human tissue which is recovered from 
cadavers and processed before being transplanted into another 
person. The most common type of allograft is bone. Tendons, 
skin, heart valves, and corneas are other common types of human 
tissue allografts. Allografts may be lifesaving and can 
substantially improve the quality of life for many patients, 
reducing disability and restoring mobility or sight. The use of 
allografts has increased dramatically in recent years.
    As with any surgical procedure, the implantation of human 
tissue allografts may be associated with complications, 
including infections at the surgical site. Although rare, some 
of these infections are associated with bacterial contamination 
of the implanted allografts, a complication that can result in 
serious morbidity and death. In collaboration with the Food and 
Drug Administration, the Health Resources and Services 
Administration, and other partners, CDC continues to 
investigate reports of infections and assess the need for 
possible changes in the processing and quality control methods 
for allografts as a means of preventing allograft associated 
infections.
    As indicated, transplanted tissue is commonly obtained from 
cadaveric material. After recovery from the cadaver, allografts 
may be either sterilized or undergo aseptic processing without 
sterilization. In aseptic processing, careful handling ensures 
that no new organisms are introduced during the recovery of 
tissues from the cadavers. Tissues may be treated with 
chemicals or antibiotics to minimize intrinsic contamination, 
that is, bacteria that contaminate these tissues following 
death and prior to, or during recovery of, the tissues. Thus, 
the tissue is not sterilized. The processing is intended only 
to reduce intrinsic contamination and prevent further 
contamination of the tissue.
    In November 2001, CDC began an investigation after 
receiving a report from the Minnesota Department of Health of a 
fatal case of infection with Clostridium sordellii bacteria in 
a young man who had recently received a bone cartilage 
allograft. Clostridium sordellii bacteria were identified in 
cultures of this young man's blood obtained prior to his death. 
Investigators at CDC contacted the tissue bank from which the 
transplanted allograft had been obtained and the tissue bank 
provided CDC with samples of non-implanted tissues from the 
same cadaveric donor. CDC laboratories identified C. sordellii 
bacteria in some of these tissues. As a result of this 
investigation, CDC concluded that this young man's infection 
had resulted from intrinsic bacterial contamination of the 
transplanted cartilage tissue.
    CDC subsequently contacted the health care providers of all 
patients who had already received transplanted allografts from 
this same donor to determine if other infections had occurred. 
CDC found that tissues had been transplanted into nine patients 
located in eight States. One of these patients developed an 
infection following the surgical procedure. This patient's 
infection was successfully treated with antibiotic therapy and 
the patient recovered.
    To follow up this investigation, CDC, in collaboration with 
FDA, requested that cases of allograft-associated infections be 
reported to CDC through State and local health departments in 
addition to the reporting of such cases to FDA. Cases reported 
to FDA were shared with investigators at CDC and State health 
departments. As of March 2003, 62 reports of allograft-
associated infections had been reported to CDC. Ninety-three 
percent of these infections were associated with 
musculoskeletal tissues. Cases of infection were reported from 
20 States and involved tissues that had been treated at 12 
different tissue processors. These surveillance findings have 
been shared with FDA, the American Association of Tissue Banks 
and others.
    In addition to investigating infections associated with 
bacterial contamination of allografts, CDC has investigated 
reports of infections caused by fungi, parasites, and viruses 
following transplantation of organs and tissues. Examples 
include the transmission of hepatitis C from a bone allograft, 
and transmissions of West Nile virus and Chagas disease, a 
parasitic infection, following solid organ transplantation.
    CDC believes that the best way to reduce the risk of 
infectious agents associated with tissue transplants is to 
develop new methods of sterilizing tissue that do not adversely 
affect the functioning of the tissue when transplanted into 
patients. Every effort should be made to use suitable 
sterilization methods. However, if that is not possible, every 
effort should be made to minimize the risk of intrinsic 
bacterial infection. Recovered tissue should be cultured before 
suspension in anti-microbial solutions, and if bacteria 
commonly found in the human bowel are isolated, all tissue from 
that donor that cannot be sterilized should be discarded.
    Other public health interventions that will greatly 
facilitate the prevention and control of infections associated 
with tissue and organ transplantation are enhanced surveillance 
and enhanced communication with clinicians. Addressing the 
problem of infections associated with tissue and organ 
transplantation is part of the larger problem of patient safety 
requiring significant changes through all parts of the health 
care industry.
    Organizations involved in organ and tissue procurement, and 
suppliers and processors of tissues must put in place 
assiduously-followed procedures to assure that any risks 
associated with tissue transplantation are greatly minimized, 
if not completely eliminated. State and Federal public health 
authorities must continue to enhance their ability to collect, 
analyze, interpret, and disseminate information about potential 
patient safety hazards due to biological products, medical 
devices, and medical procedures
    Clinicians and medical professionals must, with our help, 
increase their awareness of specific patient safety problems 
and fulfill their role in reporting such problems promptly to 
the appropriate authorities so that necessary public health 
action can be taken. CDC, FDA and other partners, as noted 
earlier, are actively engaged in ensuring that biological 
products, including tissue allografts are as safe as possible.
    Thank you so much for the opportunity to present this 
information to you today. I am happy to answer any questions 
that you may have.
    Chairman Collins. Thank you, Dr. Solomon. Dr. Linden, 
welcome.

  TESTIMONY OF JEANNE V. LINDEN, M.D.,\1\ DIRECTOR, BLOOD AND 
 TISSUE RESOURCES, WADSWORTH CENTER, NEW YORK STATE DEPARTMENT 
                           OF HEALTH

    Dr. Linden. Thank you. Good morning Members of the 
Committee. My name is Jeanne Linden. I direct the New York 
State Department of Health's Blood and Tissue Resources 
Program. New York State has spearheaded development of many 
innovative programs and maintains an active regulatory 
oversight in many important areas of public health. Since 
infected tissue poses the risk of pathogen transmission to 
recipients, oversight of tissue banking activities is an 
essential component, we feel, of any comprehensive public 
health regulatory program.
---------------------------------------------------------------------------
    \1\ The prepared statement of Dr. Linden with an attachment appears 
in the Appendix on page 55.
---------------------------------------------------------------------------
    In addition to the well-known risks associated with viral 
and prion-associated diseases, bacterial infections in 
recipients of aseptically processed cadaveric tissues, and 
infections with emerging agents such as West Nile virus, 
possibly SARS, are also of grave concern.
    In New York State regulation of tissue banks began with 
adoption of standards for hematopoietic stem cell banks in 
1988, for semen banks in 1989, and for human milk banks in 
1990. In 1991, a successful comprehensive tissue bank oversight 
program was developed and instituted in New York. Comprehensive 
rules set standards for donor medical history assessment, and 
evaluation of risk factors for disease transmission, laboratory 
testing, and recordkeeping to ensure the ability to track 
disposition of donated tissue from donor to recipient and vice 
versa. These standards were formulated based on the medical 
literature, consensus of experts in the field, and existing 
standards of professional organizations such as the American 
Association of Tissue Banks, the Eye Banks Association of 
America, and the American Society for Reproductive Medicine, 
which at that time was known as the American Fertility Society.
    Technical requirements are in place for all human tissues 
intended for transplantation, also for research or education, 
including cardiovascular tissue, musculoskeletal tissue, skin 
tissue and eye tissue. Licensure requirements for tissue banks 
apply to all facilities that collect, process, store, or 
distribute, or transplant tissue in New York State. At present, 
736 tissue banks are licensed to operate in the State, 
including more than 130 facilities located outside the State. 
The table included with my written statement enumerates the 
various types of tissue banks that are licensed to operate in 
New York.
    Comprehensive tissue banks include cardiovascular, 
musculoskeletal tissue banks, skin banks, eye banks, semen 
banks, oocyte donation programs, bone marrow collection 
centers, umbilical cord blood banks, human milk banks, and non-
transplant tissue banks, which is what we call tissue for 
education and research purposes.
    In New York State, facilities that use tissues clinically, 
including hospitals, ambulatory surgery centers, and even 
physician's offices are subject to tissue bank licensure as 
well as the specific administrative recordkeeping and quality 
assurance requirements. Errors and accidents detected after 
distribution of tissue as well as adverse events must be 
reported to the Wadsworth Center of the State Health Department 
within 7 days of discovery, affording another mechanism for 
effective oversight. Licensed tissue transplantation facilities 
must report any adverse events and patients that might be 
linked to the tissue.
    From the very inception of the New York licensure program 
staff identified unacceptable practices going on in tissue 
banks. In one case, two semen bank operators were using only 
themselves as donors but through the use of fictitious names 
led physicians and recipients to believe that more than a dozen 
donors were available through the program. Testing and 
recordkeeping at this bank were virtually non-existent. We 
actually needed to wind up following the money and subpoena 
bank records to track that case.
    Another reported incident concerned a hematopoietic stem 
cell bank that transmitted the wrong component, that is the ABO 
incompatible red cells that had been removed from the bone 
marrow rather than the marrow itself. Had the marrow not been 
retrievable, the patient, who had already undergone ablative 
therapy, could have died as a result of a severely impaired 
immune system. One surgical bone bank lost the skull flap of an 
autologous donor. These cases demonstrate the crucial 
importance of thoroughly identifying tissues used for 
transplantation.
    The death of Brian Lykins in November 2001 brought the 
inherent risk of using aseptically processed allografts to 
national attention. This tragic event spurred an immediate 
investigation that has been described by my colleague. In 
cooperation with State health departments, the CDC was able to 
locate non-transplanted tissues from the same donor and 
identify the bacterium. A second recipient from the implicated 
donor also developed an infection but cultures had not been 
done. I apologize, my written statement is incorrect in that 
regard. They were not done. They were not negative. This 
patient, fortunately, responded to antibiotic treatment.
    The CDC investigation determined that CryoLife, the tissue 
bank involved, at that time routinely cultured allograft 
tissues following suspension in an anti-microbial solution, 
which was not acceptable. Such a culturing protocol can lead to 
false negative results because of the bacteriostatic nature of 
certain bacteria, particularly spore-forming anaerobes like 
Clostridium.
    In February 2002, absent its own jurisdiction or assistance 
from any other Federal agencies, CDC asked the New York State 
Department of Health's assistance in obtaining records and 
seeking additional tissue samples from the donor implicated in 
the Lykins case that remained in CryoLife's inventory, as well 
as records and tissues from donors implicated in other 
allograft-associated infection cases. The enforcement authority 
of the New York State Commissioner of Health enabled the Blood 
and Tissue Resources Program surveyors to conduct an on-site 
inspection of the tissue bank where several deficiencies were 
noted, including the failure to perform recovery culture 
testing. The Wadsworth Center, the department's public health 
laboratory, isolated Clostridium septicum in tissues from two 
donors implicated in allograft-associated Clostridium 
infections. No remaining tissues associated with the Lykins 
case donor were found.
    The department also assisted CDC in identifying potential 
additional cases of post-transplant allograft infections by 
contacting physicians who had used tissue from implicated 
donors for transplantation. Since confidentiality requirements 
prohibited us from sharing the patient names with CDC, we 
needed to contact these physicians directly.
    The number of allograft-associated Clostridium infections 
per one million population was found to be statistically 
significantly lower in New York State compared to the remainder 
of the country; 0 vs. 0.06 per million with a highly 
significant p-value of 0.0009--highly significant.
    CryoLife maintained two inventories of tissue for release; 
one suitable for New York State patients and a second one for 
patients in other States. Tissues from only two of the 
implicated donors would have met the requirements for tissue in 
the New York inventory. Tissue from six of the donors, 
including the donor in the Lykins case, would have been 
disqualified for distribution to New York. This likely 
contributed to explaining why there were no known cases of 
allograft-associated Clostridium infections in New York. We 
believe that New York State regulations have played a 
significant role in protecting the State's patients from such 
adverse transplant-related outcomes.
    Based on our experience, we believe that a mechanism to 
ensure documentation of disposition of all tissues must be 
established and enforced so that donors may be traced in cases 
of adverse events, and all recipient outcomes must be reviewed 
and followed up as necessary. The 1985 LifeNet incident, which 
was discovered and reported in 1991 in which numerous tissues 
were distributed from a donor in the window period of HIV 
infection, illustrates the need for accurate accounting for all 
allografts distributed by a tissue bank and issued for 
transplant by the hospital. In this case, 6 of 54 distributed 
tissues could not be accounted for by the transplanting 
hospitals.
    New York State's rigorous requirements for licensure and 
recordkeeping by transplantation facilities are aimed at 
ensuring accurate tracking to each recipient. States that 
operate tissue bank oversight programs complement Federal 
efforts in this most important public health area. New York 
State has established a partnership agreement in place with the 
FDA's New York District to share inspection documents, and 
other reports and documents, and minimize duplicated effort.
    We commend your endeavors to address this critical public 
health concern. While tissue banking is clearly in need of 
Federal oversight and uniform minimum standards, any 
potentially deleterious effects of imposing overly restrictive 
standards on the tissue supply, we believe must be balanced 
against the proven benefits of such standards to the public 
health. Specifically, it is unrealistic to expect tissue banks 
to be able to guarantee the absence of contamination in a donor 
when tissues are processed aseptically. It must be acknowledged 
that since some tissues are in short supply, patients' health 
could be adversely affected if potentially draconian 
regulations further diminish the tissue supply.
    The FDA's existing rules for tissue banks and progression 
toward good tissue practices represent a valuable step toward 
enhancing tissue bank oversight nationwide. The established 
benefits of such standards in this area are abundantly clear. 
The New York State program has identified several cases in 
which unsuitable donors have been rejected and recipients thus 
protected by adherence to the State's rigorous standards. 
However, we do remind you that any regulatory scheme must 
remain flexible enough to quickly adapt to the rapidly 
escalating changes in this field.
    Thank you very much for the opportunity to comment.
    Chairman Collins. Thank you, Dr. Linden. Your testimony is 
very helpful to us and I want to congratulate New York State 
for coming up with a regulatory framework that has helped 
protect patients in your State.
    There are two points in your testimony that I want to 
explore a little further with you. First, I find it astonishing 
that CryoLife actually kept different batches of processed 
tissue in its supply; those that were suitable for New York 
State and those that could be used elsewhere. That may not be 
illegal but it certainly is questionable that different batches 
of tissues are sent to a State with a good regulatory scheme 
than are made available to States, and that is the vast 
majority of States that do not have a regulatory framework in 
place.
    Do you think that this is an isolated example or do you 
think that other tissue banks may also have separate procedures 
that are followed if the tissue is going to New York State?
    Dr. Linden. The majority of tissue banks, the 130 licensed 
outside New York, use the same standards for everybody. They do 
not have separate inventories. I cannot say whether CryoLife 
was the only one. There may be a small number of others, but 
the majority just meet our standards for everyone. But from a 
legal standpoint we need to allow that because our jurisdiction 
is protecting the people of the State of New York.
    Chairman Collins. But in the case at least of CryoLife, 
CryoLife was doing different procedures to meet your stricter 
standards and thus, I would argue that the patients in New York 
State were at less risk of getting contaminated tissue, as the 
complicated study, which I am not sure I followed on p-values, 
seems to indicate. Is that a fair statement?
    Dr. Linden. We believe that is the case and we believe that 
everyone in the United States should benefit from the same 
standards. We do not encourage facilities that have two 
different inventories, but we do allow it.
    Chairman Collins. The second point that I want to follow up 
with you on to make sure that the Committee fully appreciates 
what you said is, you said in your statement that absent its 
own jurisdiction or assistance from other Federal agencies, 
that the CDC had to come to New York State public health 
officials in order to conduct the investigation into Brian 
Lykins' death; is that correct?
    Dr. Linden. For Brian Lykins' case, no, they were able to 
handle that with the Minnesota and Georgia State health 
departments, and it is my understanding the facility cooperated 
fully in the Lykins case. It is when they got into looking into 
other reported infections, which exceeded 25 eventually, at 
that point the facility was no longer willing to voluntarily 
cooperate, so an agency with authority was needed, and we in 
fact did have to use our subpoena power.
    Chairman Collins. But I think your point is, and I am 
reading from your testimony on page 3 and it actually refers to 
the Lykins case as well, that in order to get the additional 
samples that the Federal Government did not have adequate 
authority; is that accurate?
    Dr. Linden. You probably should be asking my colleague.
    Chairman Collins. Actually, why don't I ask Dr. Solomon 
that. Is it difficult for the CDC in a case like this where the 
tissue bank is under no legal obligation to report adverse 
events and to cooperate with you, to do the kind of tracing and 
careful investigation that needs to be done?
    Dr. Solomon. Yes. Throughout this investigation there was 
an obvious sense of urgency to identify any risks to health and 
safety. From the outset, CDC was working closely with a number 
of partner public health organizations, including the State 
health departments as mentioned by Dr. Linden and the FDA. At 
each stage of the investigation we had the opportunity to call 
on the resources of these public health partners who do have 
the authority, the legal authority to obtain information and 
materials.
    We were very fortunate that Dr. Linden and her staff have a 
very experienced and very proactive program so that at one 
point, obtaining some documents and specimens through the 
resources and capabilities of the New York State Department of 
Health was the most expeditious and the quickest way of 
obtaining that material. We are very appreciative of her 
efforts, as we are of the efforts of the other partners, 
including the Minnesota and Georgia health departments and the 
FDA. That kind of close collaboration is critical for all of 
our investigations.
    Chairman Collins. Dr. Solomon, you mentioned in your 
testimony that in the course of the investigation that you 
discovered that there had been tissue donation from this one 
cadaver that went to nine patients in eight States; is that 
correct?
    Dr. Solomon. That is correct, yes.
    Chairman Collins. Indeed, in just the Brian Lykins case 
there are three States involved. The tissue came from a donor 
in Utah. It was processed in Georgia, and the surgery was in 
Minnesota. Is that accurate?
    Dr. Solomon. Yes, it is.
    Chairman Collins. Does this not make a strong case for 
uniform Federal regulations?
    Dr. Solomon. We are eager to see any kind of regulation or 
other type of activity which will help reduce the risks to 
patients. We are very grateful that New York State has that 
type of regulation in place.
    Chairman Collins. One more question, Dr. Solomon, before I 
yield to my colleagues. I have a list that our Committee 
obtained from CryoLife of some 20 cases involving tainted 
tissues or allegations of tainted tissues. Eighteen of these 20 
ended up in some sort of court case in lawsuits. Under the 
existing regulations, it is my understanding that CryoLife has 
no obligation to report these 20 cases to the CDC or the FDA. 
Do you believe that there should be a Federal requirement for 
adverse events to be reported? Should there be mandatory 
reporting of adverse events by tissue banks?
    Dr. Solomon. We have dealt with the issue of mandatory 
reporting more broadly on the patient safety front for 
sometime. CDC gets most of its surveillance and other reporting 
through State health departments and directly from health care 
providers or patients as well as health care facilities. 
Manufacturers and other processors more routinely do their 
reporting to FDA. I think it would be more appropriate for FDA 
to comment on their relationship with manufacturers and tissue 
processors.
    Chairman Collins. Senator Pryor.
    Senator Pryor. Thank you. Dr. Solomon, if I can follow up 
on something you said a few moments ago about New York. You 
mentioned you are grateful that New York has standards in 
place. Are you pretty familiar with those standards?
    Dr. Solomon. I am not intimately familiar with New York 
State's standards specifically.
    Senator Pryor. Do you think that the New York standards 
should be adopted as the national standard?
    Dr. Solomon. My familiarity with the New York standards 
specifically are not sufficient for me to comment on whether 
all of those should be adapted as national standards. Clearly, 
as Dr. Linden testified, the New York standards do protect 
patients in New York State. Specifically, whether those 
standards would be applicable point by point federally is 
something that I just do not have information on at this time.
    Senator Pryor. Dr. Solomon, I know you are not completely 
familiar with them, but is there anything in the New York 
standards which you would change, or you think is unnecessary, 
or that you would strengthen? Are you aware of anything, given 
your limited knowledge of them, that you would change about the 
New York standards?
    Dr. Solomon. I am not aware of them sufficiently to be able 
to say specifically if there are elements that would not be 
adaptable. But from what I understand from Dr. Linden, many of 
those standards are consistent with what both CDC has proposed 
and FDA has proposed throughout this investigation.
    Senator Pryor. That is fair. I know that you are not 
holding yourself out to be extremely knowledgeable of those 
standards. I understand that.
    Dr. Linden, let me ask you about New York's standards. Do 
you consider them the most stringent and the most thorough in 
the country?
    Dr. Linden. We like to think so.
    Senator Pryor. Do you think they should be adopted as the 
national standard?
    Dr. Linden. They certainly could not be adopted--the 
statutory authority the FDA has is completely different from 
ours, so the format needs to be different. I think that 
certainly to the extent that our standards capture the accepted 
practice in the community, justified in the medical literature, 
that many of those elements would be important to be included 
with the FDA's approach, and indeed they are.
    Senator Pryor. Are you aware of any holes in the New York 
standards that you think the State of New York should fix?
    Dr. Linden. Certainly, we are always looking to improve our 
regulations. We, in fact, have been actively working with the 
associated medical schools in New York to strengthen 
considerably the technical standards for the use of whole 
bodies in medical education where we have had few standards in 
the past.
    On the transplant side, certainly we continue to watch for 
improvements in technology, possible availability this summer 
of testing for West Nile virus. We are always looking to 
improve. I cannot think offhand of a specific hole, with the 
exception of making the comment that we really regulate 
services, the people who collect and process and distribute the 
tissue, and the users, which we feel is a critical part of our 
program which I believe FDA might not even be able to reach 
under their authority. FDA regulates products.
    So as I said, the approach is different and they have 
emphasis on certain issues like validation that is a little bit 
different from our approach.
    Senator Pryor. Now walk us through that here for just a 
moment. Explain the point you are making about the critical 
nature of this.
    Dr. Linden. We have found that the users, that is the 
transplant sites----
    Senator Pryor. Now when you say users, do you mean the 
doctors who are performing the transplant?
    Dr. Linden. Yes, the hospitals, the ambulatory surgery 
centers, and physicians' offices that are actually 
transplanting or using these tissues, to make sure that they do 
not get them mixed up, which has happened, that they go to the 
right person, that there is adequate informed consent. I made 
the point that some of these tissues, including the type of 
femoral condyle used in Mr. Lykins' surgery, cannot withstand, 
at the present time, the types of viral and bacterial 
inactivation methods that are available, such as gamma 
radiation. Maybe there will be other processes in the future.
    But some of these tissues are very valuable. If we simply 
eliminated them, orthopedic surgeons would be very upset, and 
patients would not be able to get the type of life-enhancing 
surgeries they have. But we feel that the informed consent, so 
that the recipient knows the risks and in consultation with the 
physician can weight those is very important. So that is one of 
the emphasis of our program.
    Senator Pryor. On a typical tissue--and I know that this 
may be an unfair question because there are lots of different 
kinds of tissue. But how many tests are done, say on a bone 
that is going to be transplanted? How many tests are done on 
that? Is that an easy thing to do? Is that an expensive thing 
to do? What are we talking about here?
    Dr. Linden. Are you talking about testing of the bone 
itself or of the donor?
    Senator Pryor. That is a good question. Both of those. How 
do you do that?
    Dr. Linden. The donor's blood, and a pre-mortem specimen is 
preferable, is tested for a lot of the same things that blood 
donors are tested for, plus a few more, particularly depending 
on what the tissue is. A particular concern today since we are 
talking about bacterial contamination, a culture of a sample 
taken at the time of recovery of the tissue and before the 
tissue is subjected to antimicrobial solutions is something 
that we require and was absent in some of the cases that we 
have talked about here today. So that would be testing of the 
tissue itself.
    In the case of eye tissue, for example, there needs to be 
an analysis using a slit lamp to determine whether it is 
suitable for transplant and that sort of thing. These are 
tissue-specific tests that are done to heart valves. There are 
slightly different things.
    Senator Pryor. Thank you, Madam Chairman.
    Chairman Collins. Thank you. Senator Carper.

              OPENING STATEMENT OF SENATOR CARPER

    Senator Carper. Welcome. How are you? Thanks for joining us 
today.
    Dr. Solomon, that is a nice-looking uniform you have got 
on. I almost saluted when I came in. Are you a captain as well?
    Dr. Solomon. Yes, sir.
    Senator Carper. I used to be a captain in the Navy. 
Whenever I see your folks walking around in uniforms it brings 
back some good memories. But I was never a doctor.
    I missed your testimony. I was involved in another meeting 
right out in the anteroom with other doctors from Delaware who 
are here. We talked about an issue, actually an issue involving 
medical malpractice. The question is whether or not that is 
something that States should deal with or we should deal with 
it at the Federal level. It sounds to me, Dr. Linden, you have 
decided in New York to deal with the issue of handling of 
tissue and the safe use thereof, try to deal with it on a State 
level instead of waiting for us in Washington to come up with 
regulations. Is that correct?
    Dr. Linden. Yes. We really got started in the tissue in the 
mid 1980's, I think largely as a result of the HIV crisis which 
was particularly acute in New York and there was really 
recognition that tissues are yet another way that infectious 
diseases could be spread.
    Senator Carper. Are there other States who have followed 
suit or preceded you with development of some of the kinds of 
regulations?
    Dr. Linden. I believe we were the first, but Florida----
    Senator Carper. It is good being first. That is a motto in 
Delaware, it is good being first.
    Dr. Linden. Yes, it is good to be first. Florida also has a 
comprehensive program, although it does not cover reproductive 
tissues is my understanding. California also has a law, but 
last I heard their technical standards had not been adopted 
yet. There were some issues there. Other States such as New 
Jersey do certain of the tissues. I believe ours is the most 
comprehensive and it was the first.
    Senator Carper. In my old job as Governor of Delaware I was 
the chairman of the National Governors Association and I always 
used to say that States ought to be laboratories of democracy, 
and in some cases States will come up with a particular 
approach, could be welfare reform, could be education, that 
might serve as a role model for us on a national level. Is 
there any reason to believe that what you have developed in New 
York or in some other State could be a role model for us, or a 
model for us to try to replicate at a national level?
    Dr. Linden. I do not think it can be replicated as is, but 
certainly many of the components can be and in fact have been. 
We have shared our regulations with FDA, and I have served on 
some of their advisory committees. We have worked with them 
closely. As I mentioned, we have a partnership agreement with 
the district office. I believe that they have in fact 
considered some of our suggestions and incorporated them into 
their existing regulations and proposed regulations.
    Senator Carper. Given what you have learned in the 
development and implementation of your regulations, what 
lessons are there for us at the Federal level, major lessons 
for us at the Federal level that you would like to leave me 
with today?
    Dr. Linden. Certainly checking everything and not making 
assumptions is very important. You cannot just adopt the 
standards and just think that everybody is going to follow 
them. They might not know about them, particularly when you are 
getting into regulating physicians, which is actually an area 
we are getting into. So that everything really needs to be 
verified. We think the on-site inspection process is very 
important.
    Senator Carper. How does your enforcement mechanism work? 
Or do you have enforcement mechanism?
    Dr. Linden. Yes, absolutely. Routinely, following a survey 
we will cite deficiencies and usually they are correct. For 
egregious situations such as one that I described in my 
testimony of two young men operating a semen bank using only 
themselves as donors, we filed charges. We have filed charges 
in some cases where there are improprieties or very severe 
deficiencies that are not corrected.
    Senator Carper. Thanks. Dr. Solomon, I missed your 
testimony, as I said earlier, and I would appreciate it if you 
would just take maybe a minute or so and just recap for me the 
most important things that you would want us to garner from 
your contributions.
    Dr. Solomon. Certainly. Thank you. The main issues have to 
do with both our ability to conduct investigations, to follow 
up on investigations, and to encourage the implementation of 
the types of prevention measures that are in place in New York 
and that have been proposed by the FDA.
    Another element is the surveillance capability and the 
prevention capability that goes with the public health function 
and with the prevention research function that allows us to 
gather the kind of information and that is so useful in 
following up on these kinds of problems and implementing very 
rapid responses to protect public health.
    Senator Carper. Do I understand that the FDA has developed 
regulations of its own for our country; is that correct?
    Dr. Solomon. Certainly FDA has proposed a set of 
regulations and guidelines and I think we will be hearing about 
that later.
    Senator Carper. What is the timeline at FDA, do you know, 
in terms of accepting public comment, modifying the regs?
    Dr. Solomon. I am not familiar with that. I am sorry.
    Senator Carper. Maybe we will find out later. Again, our 
thanks to both of you for being here. Thanks for your 
contributions.
    Chairman Collins. I want to thank you both for your 
testimony and we will now turn to our third and final panel 
today. We have one witness, Dr. Jesse Goodman, who will be 
testifying on behalf of the Federal Food and Drug 
Administration. Dr. Goodman is the director of the FDA's Center 
for Biologics Evaluation and Research. He is also, I am told, a 
specialist in infectious disease and a practicing physician.
    Dr. Goodman, before I have you give your testimony today I 
so want to acknowledge the fact that I believe you have only 
been in your current position since January, so obviously this 
is a problem that you inherited as opposed to created. But 
nevertheless, I hope you understand how frustrating it is for 
me personally and for those of us who have worked on this issue 
for years now, to find that we are no closer to final 
regulations, or virtually no closer than we were when I held a 
hearing on this issue 2 years ago. To hear the tragedy endured 
by the Lykins family I know moved you as well. So with that 
introduction, I would ask that you proceed with your statement.

 TESTIMONY OF JESSE L. GOODMAN, M.D.,\1\ DIRECTOR, CENTER FOR 
       BIOLOGICS EVALUATION AND RESEARCH, FOOD AND DRUG 
  ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

    Dr. Goodman. Thanks very much, Madam Chairman, and Members 
of the Committee. Thank you for the opportunity to be here 
today on this important matter.
---------------------------------------------------------------------------
    \1\ The prepared statement of Dr. Goodman with an attachment 
appears in the Appendix on page 61.
---------------------------------------------------------------------------
    You really introduced me but just as you said, since 
January I have been director of the Center for Biologics at 
FDA, and I am also an infectious disease physician. So I am 
familiar with these problems and in fact have been involved in 
treatment of individuals who get infections after tissue 
transplants.
    CBER, the Center for Biologics, is the FDA center that is 
responsible for regulating many types of human tissues and 
cells transplanted during medical procedures. We also have some 
other very important public health responsibilities in terms of 
blood, vaccines, and other novel therapies. I really do 
appreciate and share the concern of the Chairman and the 
Committee Members that we do everything we can in this area. 
Let me assure you that Commissioner McClellan and I are very 
committed, while new in our roles at FDA, to doing what we can 
to advance the field of tissue safety.
    Also I really want to convey to the family and friends of 
Brian Lykins how sorry I certainly am for their loss. As a 
father, I can only begin to imagine how this has affected them. 
Again, while there is nothing that I can say here that will 
take that away, I do want them to understand the high level of 
commitment we have to do what we can to prevent problems like 
this in the future.
    In my testimony I am going to briefly provide some 
background on human tissues and their use, discuss some of the 
safety concerns and their evolution, and in fairness, describe 
some actions that we have already taken under existing 
regulations as well as the actions we plan to take to enhance 
tissue safety.
    Transplanted human tissue products have the potential to 
treat or cure a wide variety of health conditions. Over the 
past decade, advancing technology has expanded the therapeutic 
uses of tissue-based products. As we heard from Senator 
Collins, it is estimated that over 800,000 tissue transplants 
will be performed this year and, fortunately, the vast majority 
of these have very positive outcomes. In fact these products 
have dramatically increased patients' quality of life in ways 
that were previously unheard of. Senator Pryor's experience is 
a positive example and we would like to see everyone have that 
experience and certainly that is what we are working towards.
    Cells and tissue have new uses. They can also be used in 
combinations with drugs or devices for doing things like 
delivering gene therapies. So there is a lot of promise here, 
and there is a potential to provide treatment for diseases as 
diverse as cancer, Parkinson's disease, even diabetes and other 
serious conditions.
    However, with the increased uses of human tissues has come 
a heightened public awareness of the need for appropriate 
regulations. During the 1980's there were reports of multiple 
incidents of transmission of the chronic neurologic disease, 
Creutzfeld-Jakob disease by brain-covering allografts. A 1992 
report documented seven HIV infections occurring from a single 
donor. And in the 1990's, possible transmission of Creutzfeld-
Jakob disease through corneas and eye tissues was reported.
    Now most recently, and this is very relevant to the tragic 
case we are hearing about today, it has become increasingly 
apparent that tissues are also subject to contamination from 
other agents like bacteria and fungi. These are unlike the 
viruses like hepatitis and HIV which come from donors who were 
not aware, or from a system that was not aware they carried a 
disease. These risks may have little to do with the donor. 
Rather, they may relate largely to how the tissue is handled, 
processed, and then tested.
    As part of the FDA's efforts to address tissue safety, in 
December 1993 the agency published an interim rule for human 
tissue intended for transplantation. This rule provided 
specific donor suitability and testing requirements for 
relevant human tissues. Like actions we had taken to improve 
blood safety, FDA was acting primarily to counter the 
transmission of HIV, hepatitis B, and hepatitis C. This rule 
also provided for the inspection of tissue banks and the recall 
and possible destruction of unsafe human tissue. In fact events 
that later occurred with CryoLife, as we will hear.
    These efforts were part of our risk-based regulatory 
approach to tissues, recognizing the importance of these 
tissues and maximizing benefits while minimizing risks with the 
whole goal in the end being promoting public health.
    Now I would like to report on eight areas of agency 
activities since the Committee's last hearing 2 years ago on 
this subject. These include many actions taken in response to 
the need to help better prevent the types of problems that led 
to Mr. Lykins' very tragic outcome.
    First, the death of Brian Lykins and other reports of 
infections in recipients prompted collaborative investigations 
by FDA and CDC, as you have heard, and in some cases involving 
the State of New York. Extensive testing at CDC implicated 
CryoLife tissue in the fatal infection and other reported 
infections. This led to a comprehensive inspection of CryoLife, 
the tissue bank that processed the implanted tissue.
    As an urgent response to these investigations, FDA also 
decided it was critical to take additional steps now, not to 
wait for regulations necessarily, to control the threat of 
bacterial and fungal contamination during manufacturing. In 
March 2002, we issued a guidance for immediate implementation 
concerning requirements for validating procedures for 
processing human tissues under existing regulations. This 
guidance and the accompanying outreach to industry and 
professionals emphasized important steps believed necessary to 
reduce the risk of contamination.
    Second, our CryoLife inspection uncovered numerous and 
significant violations of FDA regulations. You have heard some 
of these today. When CryoLife failed to respond adequately to 
these deficiencies, FDA issued an order for retention, recall, 
and destruction of tissue in August 2002. This resulted in a 
recall of 7,913 tissue products. Further actions by FDA and CDC 
resulted in the firm committing to take appropriate steps 
necessary to ensure the safety of the tissues it supplies.
    Third, the FDA, which had conducted--if we go back to the 
year 2000--we conducted 93 tissue establishment inspections 
then. We conducted 132 in 2001, increased that to 165 in 2002, 
and in fiscal year 2003 plans call for conducting over 200 
inspections. I am pleased to be able to report that as a result 
of this activity, FDA has now inspected approximately 95 
percent of the 162 registered tissue processors. By the end of 
fiscal year 2003, our Office of Regulatory Affairs plans to 
have completed inspections of 487 of the 512 registered tissue 
establishments. This includes not just processors but 
establishments that may test or ship or distribute or store 
tissue. Again, this is about 95 percent.
    These increasing activities in recent years resulted in 
2001 to 2002, for example, 99 investigator reports noting 
compliance deficiencies that warranted attention. We believe 
that these inspections and reports are already helping to 
increase awareness, correct deficiencies, and ensure that 
better practices are followed, including proper practices to 
prevent contamination such as we have heard about today.
    Fourth, in October 2002, we created a new office, an Office 
of Cells, Tissues and Gene Therapies which coordinates 
regulatory and review activities for tissue products.
    Fifth, the emerging challenges of chronic degenerative 
neurologic diseases such as CJD and variant CJD, or mad cow 
disease, prompted us to issue a draft guidance regarding 
appropriate donor deferral for donors.
    Sixth, very related to this, on October 22, 2002 FDA issued 
a rule to classify human dura, which is brain lining, as a 
Class II device in order to establish controls to assure 
safety.
    Seventh, In order to achieve a more robust surveillance 
system, FDA is continuing to work with CDC to stimulate adverse 
event reporting and to investigate reported events. CDC, as you 
have heard, has unique capabilities to conduct such 
surveillance. And we are working on our own and with CDC to 
obtain adverse event information, including from health care 
databases.
    Eighth, working collaboratively with tissue manufacturers 
and trade and professional associations to identify new safety 
issues and improve tissue practices is also an important 
component. With this goal in mind, FDA has dramatically 
increased outreach activities in recent years in an effort to 
anticipate and avoid safety problems.
    I should mention that this includes highly productive 
interactions with some of the professional associations, 
including the one Senator Collins mentioned, the American 
Association of Tissue Banks, as well as the eye banks and 
reproductive medicine associations. These associations have 
gone a long way through their voluntary programs to improving 
standards in their industry. Many companies, but not CryoLife, 
participate in those standards.
    In addition to these activities, as you have alluded to, 
FDA advanced three regulatory proposals. The first rule 
established suitability determinations for donors of human 
cells and tissues. The second rule regards good manufacturing 
practices. And the third rule, which became final in January 
2001 required the registration and listing of the tissue 
establishment. In fact this rule has already provided important 
information to direct and manage our risk-based inspection 
activities. It is a success, I think, of the publication of 
this rule that we have been able to really enhance the 
inspections and reach the 95 percent of targeted folks.
    Under FDA's proposed regulations we would maintain this 
complete database of tissue products and establishments. We 
would provide more comprehensive detailed requirements designed 
under good tissue practices to help assure high quality during 
manufacturing, to further helping to prevent bacterial and 
fungal contamination.
    We would require establishments to maintain complaint files 
and investigate complaints, and to report adverse events and 
product deviations to the FDA; issues that have been identified 
here. The proposed rules would establish tracking requirements 
to allow the agency to find recipients of implicated tissues if 
needed. The proposed rule would also augment existing 
requirements for screening and testing of donors for relevant 
communicable diseases. This would also help us to rapidly 
respond to new infectious disease threats such as West Nile 
virus which is something we have been devoting a lot of energy 
to in our center.
    While we have made substantial progress in this effort, the 
donor suitability and good tissue practice rules, as alluded to 
here, are continuing under review and discussion. Given that 
these regulations will create significant change, we want to be 
sure both that they are effective and that we achieve the 
proper balance of enhancing safety and quality while not 
causing undue burden or complexity that would inhibit the 
development or availability of products that benefit Americans. 
In fact we want these rules also to be flexible enough to 
permit the use of new and better technologies to do things like 
sterilize tissues or improve safety.
    As you heard from some of the testimony, we want to be sure 
that as we do these rules we do not create a situation of 
shortages or non-availability of certain tissues that actually 
could hurt people if they needed the tissues. So we do want to 
get the right balance here.
    We do believe that the extensive process of comment and 
input that has taken place will help us achieve these 
objectives. We are not sitting on this. We are actively engaged 
in moving forward. We have taken significant steps to make 
tissues safer than they were 2 years ago.
    However, and even though they are rare, tragic adverse 
events like that of Brian Lykins--and as you said, it is not 
just an adverse event. This is something that really affects 
human beings. That is why I do this. Tragic events like this 
are devastating, and we are committed to doing what we can to 
prevent them. When a patient has a procedure involving a tissue 
product, we want to do our part to help make sure that patient 
can be as confident as possible that the product will be safe 
and free from any preventable risk of contamination.
    I have been very active working to resolve remaining issues 
and I am committed to doing everything I can to help in this 
effort. I would be glad to answer any questions.
    Chairman Collins. Thank you very much, Dr. Goodman. I guess 
what I was hoping to hear from you today was that the previous 
FDA officials blew it and that you were going to promise me 
that within a time certain we would have the regulations. I 
understand you might not want to comment on the actions of your 
predecessors, but I want to go through a bit of a timeline with 
you just so you can better understand the frustration that many 
of us are feeling on this issue.
    The FDA's first regulation of tissue banks actually goes 
back to 1993. But it was in 1997 that the FDA started looking 
at the very issues that we are talking about today. In May 
2001, 2 years ago almost to the day, I chaired the hearing at 
which your predecessor Dr. Zoon testified. She told me the FDA 
was committed to completing the regulations. I thought it was 
imminent at that point. There was testimony at that hearing 
that clearly said that the adequacy of tissue supply was not a 
concern, and indeed when you look at the number of transplants 
which has soared, some more than 800,000 last year alone made 
available in the marketplace, I am not sympathetic to the 
argument that somehow the FDA regulations are going to cause 
shortages.
    When I had the hearing, as I said, 2 years ago, I got a 
commitment from Dr. Zoon that the regulations would be issued. 
After repeated phone calls throughout the remainder of that 
year when nothing happened, I wrote in February 2002 to the 
FDA. I expressed my frustration, the agency was taking such an 
inordinate amount time to complete its work, because its work 
was good. It knew what to do. It had come up with a reasonable 
protocol. All we were asking was that it be made final, that it 
be made effective.
    I asked when the regulations would be completed. The 
answer--actually, I wrote again. That was in December 2001, I 
wrote to the acting principal deputy commissioner. I did not 
even receive a reply to that letter. In February 2002, I again 
wrote to FDA. This time I received a reply 2 months later in 
April and the answer was, we do not know. We do not have a date 
for publication and implementation of the final rules. Again, 
this is 5 years later at that point.
    In March 2002, we had a report from the CDC after Brian 
Lykins' death in November 2001 in which the CDC said, the 
findings in this report have important implications for patient 
safety and indicate that Federal regulations and industry 
standards on processing and quality control methods need to be 
enhanced and implemented. So here we have the CDC calling for 
implementation.
    In October 2002, I asked Commissioner McClellan at his 
nomination hearing about this issue. Over and over again I have 
asked. I have written everyone I can think of. I have a stack 
of correspondence. We have called. When is this going to 
happen? The evidence is overwhelming that the FDA has come up 
with a good approach. We have examples in three States of 
effective regulation. So if there are some issues remaining, 
could we not look to the experience of those three States? When 
are we going to finalize these regulations?
    Dr. Goodman. I share your concern and some of your 
frustration and I do appreciate it. When I started as center 
director, I know that within those first few weeks I said to 
staff, and when I was able to share it with Dr. McClellan, that 
I thought this issue and moving forward should be a very high 
priority. It is on my list of high priorities. It is not 
through lack of attention right now. I do not see a problem 
there.
    There is a new commissioner. They are complex rules. We 
want to do it right. I personally feel that the framework which 
has evolved with a lot of outside input and discussion with 
folks like the tissue banks, with our colleagues at CDC and the 
States, with a lot of comments and input I think it is a good 
direction and deals with appropriate issues in a number of 
areas that I would like to see us deal with. So I am very 
committed to doing that. We are working, the new commissioner 
and I are working actively on that now and hope to resolve some 
of those issues.
    For some of the reasons you have said and some of the past 
experience, I do not control the exact timeline and also would 
not want to give you one that is inaccurate. Also, I think that 
we want to come up with the right product, as I said here, to 
meet our common goals, the goals to deal with some of these 
areas where we could have improved standards and regulation.
    Chairman Collins. Dr. Goodman, I do not doubt your personal 
commitment and I do not doubt your sincerity, and I do not 
doubt your expertise at all. But we have to act. I cannot allow 
more Brian Lykins to die because we did not have regulations in 
place. Every expert with whom I have consulted has told me that 
they believe that had those regulations been in place and had 
CryoLife followed them, we would not have had the death of 
Brian Lykins. That is just so troubling to me.
    Dr. Goodman. Right. I would like to respond to that because 
those are very important points. One is that we too want to do 
everything we can to prevent bad outcomes from medicines, 
medical procedures, and in this case from tissues. I agree with 
that totally.
    What I do want to emphasize is that we are in agreement 
that there are areas where what can be done through regulation 
can be improved, and that some of those would help prevent 
problems like Brian Lykins' death. That is particularly what 
drives me and makes it important. I do not want to see more of 
that.
    But what I also want to point out is that FDA's actions at 
CryoLife and in response to the investigation conducted in 
collaboration with CDC where under existing regulation we did 
show that in fact CryoLife was violating existing standards and 
rules. Our view is not just a guidance but they were violating 
principles that are there in our regulations and those are the 
basis of our activities.
    Now, that said, there are ways in which elements of the 
proposed rules provide additional layers of protection and 
augment that existing authority in substantive and real ways 
that I think could add value to the public health process. 
Those are the things that I am committed to trying to move 
forward.
    Chairman Collins. My time on this round has expired so I am 
going to yield to my colleague, Senator Pryor. But when we come 
back, I am going to direct to the deposition of CryoLife in 
which it said it did not have to report to the FDA of adverse 
events. It did not have to follow the regulations because they 
were just guidance and they were not effective, they were not 
in effect. I think that is very troubling and should be to you 
as well.
    Dr. Goodman. I agree. We can discuss that, for sure.
    Chairman Collins. Senator Pryor.
    Senator Pryor. Thank you, Madam Chairman. I must tell you, 
Dr. Goodman, I am not really satisfied with most of your 
answers today. The reason I am not is because, by and large, 
you have given us answers related to process, not action. I 
want to know what you are going to do to get these regs out.
    Dr. Goodman. Again, I appreciate your concern. I am not 
somebody--sometimes we have processes that we need to assure we 
take the right action and to assure we get the action done.
    Senator Pryor. This has been pending at your agency for a 
long time.
    Dr. Goodman. Right. I appreciate the frustration over that. 
As I said, in answer to your second question, I have engaged 
the commissioner and his office, I am working very diligently 
and deliberatively to resolve any issues so that we can move 
forward on the key things here. So I agree with you on that. 
Without in any way diluting the importance of that work we need 
to do, I also would like to say that it has been very important 
to me looking at this issue even in the time since I have been 
center director to assure also and to let you know that under 
our existing authority we have not been doing nothing. We have 
dramatically gone out there and increased inspections.
    The inspectors we have out there have been trained in 
procedures and issues related to exactly the kind of problems 
that led to this tragic outcome. As a result we are seeing, for 
instance, more voluntary recalls, more actions, and we believe 
that even our ongoing actions, which are contributing to 
improving quality and helping prevent such events.
    Do they achieve all the things that would have been 
achieved under the proposed rules if they were finalized? No. 
For that reason your comment is very important and I 
acknowledge and share your interest in moving forward.
    Senator Pryor. What issues are left to be resolved at the 
agency before you get these out?
    Dr. Goodman. Again, we have just recently briefed and 
engaged Dr. McClellan and staff, and the commissioner, who is 
new, and his staff in the commissioner's office, on these 
issues. There are quite a number of elements of these rules. It 
is not one single thing or another. We want to be sure we are 
placing the priorities in the right place, the things that will 
enhance patient safety while not causing undue burden, get the 
right balance here and move forward.
    Senator Pryor. But specifically, what obstacles are left 
within the agency to do that?
    Dr. Goodman. I think the only obstacles are identifying 
issues where those kinds of concerns are and then resolving 
them in a way that can get us to the satisfactory end point. I 
think I do not have a specific list here. This process has been 
moving forward and quite a number of unresolved issues I think 
people have come up with solutions for them.
    Senator Pryor. Is there any reason why these regulations 
cannot be released in the next 90 days?
    Dr. Goodman. I think that we at FDA--again, I understood 
Senator Collins' point of view too in terms of moving these 
forward. I think we do have some work to do on them. Again, I 
am going to work on those, and work with the commissioner on 
those within the next 90 days and try to do everything we can 
to move forward in a constructive way.
    We are not, also, the only parties to this obviously. 
Everything we do is reviewed legally within the agency and the 
Department, and at a policy level in the Department. Now we are 
trying, and we plan to engage collaboratively in that process 
to make this more effective and move it forward. But I agree 
with you. We are going to do everything we can during the next 
90 days to move things forward.
    Senator Pryor. Do you need any additional statutory 
authority to move forward?
    Dr. Goodman. I am not aware at this time that statutory 
authority is at issue here. We feel under the Public Health 
Service Act, in terms of protecting people from communicable 
diseases that we have authorities, and that the proposed rules 
largely build on those authorities. So we do feel we have the 
authority.
    Senator Pryor. I am interested in Senator Collins' 
questions here in a few moments about the deposition relating 
to CryoLife and I would really like to hear and delve into that 
and know what is said. But one question I have for you is, 
given the violations that CryoLife was engaged in, and I guess 
has admitted to at this point I guess, why are they still in 
business?
    Dr. Goodman. I think that is a good question. What I would 
say is that FDA has taken a number of actions with respect to 
CryoLife. Included in those actions in terms of permitting them 
to continue to release tissue were a number of steps in an 
agreement reached with them. First of all, just let me say that 
as I mentioned, they were required by our action to recall a 
large number of their tissues and they entered into agreement 
with us to take the needed steps to assure better safety in 
their tissue processing.
    Also during the interim period while they were taking these 
steps, a number of extra safeguards were put into place through 
this agreement including many of the things that CDC and Dr. 
Linden from the New York State Health Department alluded to. 
This includes the things we wanted to see valid, I say valid 
pre-processing culture of these materials, appropriate 
disposition of materials which failed, valid culturing of 
materials after processing, and again, appropriate disposition 
of material that failed, and a commitment to create and 
validate their own procedures to do this.
    So there was quite a significant discussion and a 
substantive agreement reached in order to, what we felt was to 
ensure needed elements that a safety program was in place there 
and that overcame what we felt were, as I said, quite serious 
violations even of the existing standards.
    Senator Pryor. I am out of time. Thank you, Madam Chair.
    Chairman Collins. If you need additional time, feel free to 
proceed.
    Senator Pryor. I was just going to ask with regard to 
CryoLife, as part of the agreement that the agency reached with 
this company, is there an ongoing monitoring to assure that the 
FDA has assurance that they are complying?
    Dr. Goodman. Yes, there are ongoing inspections, there are 
meetings. So the answer is yes. We are still concerned. They 
have steps in the right direction, but these interim procedures 
are still in place in terms of the additional culturing and 
other procedures with their materials. But they have taken 
steps. Those steps are not finished, and we are going to watch 
this carefully as this goes forward. We are quite concerned 
about this.
    Just getting back to the availability issue, this is one 
area where we did hear from a number of surgeons and others who 
use certain of their products for what they felt were essential 
and lifesaving issues. Part of what we did with CryoLife was 
make sure--this again addresses Senator Collins and the Lykins 
family comments. Part of what we did in CryoLife was work with 
them to be sure that users were also informed about some of 
these issues with their products and could themselves help make 
an informed risk-benefit situation in the situation they are 
in.
    Again, I think we have taken substantive action in this 
case. But again, as I said, I think some of the components of 
the proposed rules will, we hope, prevent and better deal with 
future situations like this.
    Senator Pryor. Madam Chairman, I will make this the last 
question. You mentioned a minute ago that you still have some 
concerns about CryoLife. They are taking some steps. They are 
not completely there yet. Yet the agency is allowing them to 
still be engaged in the business. Why not force them to clean 
it up first before they re-enter the business?
    Dr. Goodman. There are two components to that. One is, 
because they have not completely finished all their progress on 
the various things in their agreement with the agency, they are 
taking additional steps that would not normally be required in 
terms of these outside cultures and oversight and agreements of 
what they will do in response to these cultures with us. So 
there are additional measures in place to provide assurance 
that these kinds of problems are dealt with. So that is the 
first component of that.
    The second is just to state--and I do not want to equate 
these problems with all problems observed in all FDA 
inspections or whatever, but in most cases there are different 
kinds of levels of concerns and observations in different kinds 
of inspections, and very frequently when FDA makes observations 
of concerns like this a company will move quickly to correct 
those in a manner that gives us assurance that the product is 
safe and will remain safe. In this case some of those steps 
have been taken but not all, so there is a need to have 
additional steps in place.
    Senator Pryor. Thank you.
    Chairman Collins. Thank you very much, Senator Pryor.
    Dr. Goodman, CryoLife was well aware of problems related to 
infections of some of the tissue that it was providing long 
before Mr. Lykins died in November 2001. The corporation's 
internal reports reflect that in May 1998 the company received 
a report from a surgeon indicating that a patient had a problem 
with an allograft. Cultures indicated the growth of Clostridium 
bacterium. The patient then required the removal of the 
allograft due to continued problems with infection. In the year 
2000 there were at least six complaints to CryoLife regarding 
bacterial infections. In 2001 there were 10 complaints at least 
regarding bacterial infection, and one of hepatitis C 
transmission from an allograft. I mentioned earlier that I have 
a list of 18 lawsuits that have been filed against the company 
as a result--each case involving tainted tissues.
    Now the details of each of these complaints vary but there 
is clearly a pattern indicating a problem. There is one common 
notation made by a CryoLife employee on each of the complaint 
reports. I want to quote it to you. It says, ``orthopedic 
allografts are not classified as medical devices as defined by 
FDA regulations and therefore are not reportable.'' So CryoLife 
was all too aware that the serious problems that had been 
reported by surgeons, and other health care providers to the 
company did not have to be reported under current FDA 
regulations.
    Should it not be mandatory for tissue banks to report 
adverse events such as these to the FDA?
    Dr. Goodman. I would like to see reporting of adverse 
events that the tissue banks and processors are aware of to the 
FDA. I think it could be helpful, as you allude to, in 
identifying problems ahead of time, and it is an element of the 
proposed rules. I agree with you.
    I cannot comment on the motivation or anything like that, 
but you are right. And not just adverse events. It is important 
that another component of what has been proposed is that 
complaints are investigated and records kept of those 
complaints. So even if something is felt not by a company or a 
surgeon even not to be due to a graft or some other medical 
procedure, it is information that can be helpful to FDA who may 
have information from other companies, other sectors of 
industry to identifying a problem. It might not even be a 
problem at one company. It might be a problem with something 
being done elsewhere.
    So we do feel this is information that is helpful. It has 
been helpful in helping make other kinds of medical products 
safe. So I share your desire that we have such information and 
that we get it in an effective way.
    Chairman Collins. Again, I think that proposed requirement 
for mandatory reporting just makes good sense and needs to be 
put into effect. That is not a complicated requirement to put 
into effect.
    Dr. Goodman. Frankly, I think a lot of the issues about 
complaints, etc., these are good quality practices that 
irregardless of the FDA any good company should be following. 
But I agree with you, we cannot always count on that.
    Chairman Collins. After Brian Lykins died his family filed 
a lawsuit against CryoLife and during that process, as I 
alluded to earlier, an executive of the company was deposed. 
During his deposition he made reference to the fact that the 
FDA had not imposed final regulations regarding what industry 
practices should be, but instead had issued what he called only 
non-binding guidance. Does it trouble you to learn that a 
tissue bank like CryoLife, which clearly does not follow ideal 
practices, is citing the FDA's failure to issue regulations as 
a defense?
    Dr. Goodman. Of course it troubles me. One comment I would 
make is it is not infrequent for firms under FDA investigation 
or with whom actions have been taken that a firm might not 
like, it is not uncommon for them to question those actions or 
question the authority for those actions. Everybody loves us.
    Irrespective of those kinds of comments I would say that we 
believe or we would not have taken the recall action, that we 
have clear and strong legal authority to do that irregardless 
of their comments. I am disturbed by their comments and I want 
to do everything we can to be sure that people do not believe 
that and to, in the ways we need to, enhance our activities, 
but I do not buy that.
    Chairman Collins. When FDA did its inspection and issued a 
form 483, FDA inspectors noted 12 objectionable conditions 
identified at CryoLife. CryoLife's written response to the FDA 
does challenge FDA's authority. When questioned about that in 
the deposition the executive said, ``there was a guidance 
document issued. They were not formal regulations. They were 
opinions, and they were not in effect at the time.''
    One of my frustrations is I do not want there to be any 
doubt about your authority. I do not want a bad actor to be 
able to tie the FDA up in court because you have not gone 
through the final steps of issuing all the regulations. We need 
to clear this up. We need to end any doubt about your 
authority. We need to have clear regulations in place, and I 
believe the FDA has the right approach.
    It is interesting that in the 6 years that these proposals 
have been pending, it is not as if FDA has proposed changing 
them in any formal way. In fact the American Association of 
Tissue Banks, the American Red Cross have endorsed the 
regulations. We need to get on with the job.
    Dr. Goodman. I hear you and I appreciate those comments. I 
appreciate all of them and I understand your concerns. I do 
want to emphasize that while CryoLife may have questioned our 
authority in this case, this authority is the interpretation of 
the chief counsel of the FDA and the actions of the FDA, and we 
do not think there is question about authority in this case. 
That does not in any way mean that many of the proposals in the 
proposed rules are not helpful, will not help industry do a 
better job, will not help FDA do a better job. That is what we 
want to aim for, Dr. McClellan and I, helping industry and the 
FDA do a better job to help make tissues safer. I agree with 
that.
    Chairman Collins. Dr. Goodman, I do want to thank you for 
coming today. I appreciate the fact that you sat through the 
entire hearing so that you heard firsthand the Lykins family 
testimony which I am sure you will agree that the death of 
their son is such a tragedy. If by acting to implement these 
regulations the FDA can prevent future cases like Brian Lykins, 
or future cases of disease and infection, we need to help you 
get that job done. If there are obstacles I ask again for FDA 
to come to us. That was a request that Senator Durbin and I 
made 2 years ago. If there is some new statutory authority that 
you need, as Senator Pryor asked you about, or if there are 
more resources, come to us. But let us get the job done.
    I hope I have from you today, or else I will not let you 
go, a commitment, a personal commitment to work with us to get 
these regulations, which I view as absolutely vital to public 
health, implemented without further delay.
    Dr. Goodman. First of all, thank you. I am personally 
committed and will make a commitment to you to do everything 
that I can and is within my power, which is not, as you know, 
everything in the world. But I will do everything I can that is 
within my power to move this forward. This is a high priority 
to me.
    I think as we look at the proposed rules and as I work with 
Dr. McClellan and the commissioner's office we really do want 
to identify for sure what are the key things that we can do and 
we need to do to help improve safety here and move those 
forward. So I am giving you my commitment that I am going to do 
everything I can to try to do that.
    Chairman Collins. I thank you for that commitment and you 
can be assured that I am going to hold you to it. I know again 
that you have only been on the job for a short time, but 
working together I am convinced that we can make a difference 
in this area. Again, thank you for being with us this morning.
    Dr. Goodman. Thank you.
    Chairman Collins. Before adjourning the hearing, I also 
want to say a special thank you to the Lykins family. Steve, 
Leslie, and Tammy spent time with me in my office yesterday as 
well as having talked to the staff. I am so impressed and moved 
by their courage and their determination to make something good 
out of the very worst tragedy that any family could suffer 
through. I just want to publicly again thank them for their 
courage and for their commitment, and to assure them that we 
will continue to work on this important issue.
    I also want to thank my staff for its hard work. I am 
optimistic today that we are going to move forward, but I felt 
that way exactly 2 years ago, so this is an issue we will 
continue to follow.
    The hearing record will remain open for 15 days for the 
submission of questions or any additional materials. I want to 
thank my colleague, Senator Pryor for sharing his personal 
experience and for being here for this hearing. The Committee 
hearing is now adjourned.
    [Whereupon, at 11:56 a.m., the Committee was adjourned.]


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