[Congressional Record Volume 148, Number 64 (Friday, May 17, 2002)]
[Senate]
[Pages S4536-S4537]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Ms. COLLINS:
  S. 2531. A bill to amend the Public Health Service Act to authorize 
the Commissioner of Food and Drugs to conduct oversight of any entity 
engaged in the recovery, screening, testing, processing, storage, or 
distribution of human tissue or human tissue-based products; to the 
Committee on Health, Education, Labor, and Pensions.
  Ms. COLLINS. Mr. President, I rise today to introduce the Human 
Tissue Transplant Safety Act of 2002, which would provide a much needed 
regulatory framework to help ensure the safety of transplanted human 
tissue. In 1997, the U.S. Food and Drug Administration, FDA examined 
the public health issues posed by human tissue transplantation and 
concluded that the existing regulatory framework was insufficient and 
needed to be strengthened. Yet more than 5 years later, the agency has 
failed to implement critical regulatory changes and strengthen 
oversight of tissue processors, known as tissue banks. The legislation 
I am introducing today is designed to help remedy the gaps in the 
regulatory safety net.
  While people are familiar with the concept of organ donation, tissue 
donation is not well understood by most Americans. Yet the tissue 
industry is very diverse and is growing rapidly. In fact, tissue 
donations now make possible about 750,000 transplants per year. The 
recovery and medical use of tissue, including skin, bone, cartilage, 
tendons, ligaments, and heart valves, are unlike organ transplants 
because the tissue is usually not transplanted ``as-is'' from the 
donor's body into that of the recipient. Rather, donated tissue 
frequently undergoes considerable processing before it can be used. 
Bone from a donor's femur, for example, can be reshaped into a 
component designed to give support to a recipient's spine.
  Technology that greatly reduces the risk of rejection now allows 
surgeons to use actual bone in their patients rather than metal or 
other synthetic substances. In addition, donated tissue, once it is 
processed, can frequently be stored for a period of time. In contrast, 
organs must be transplanted into the recipient's body within hours of 
their recovery.
  The organizations that make up the tissue industry are collectively 
referred to as tissue banks. Some are engaged in tissue recovery, while 
others process, store, and distribute human tissue. Tissue donation is 
a generous, selfless act that improves the lives of many Americans. 
Just one donor, in fact, can help a large number of people in various 
ways. Skin donations, for instance, can be used to heal burn victims or 
aid in reconstructive surgical procedures. Ligaments and tendons can be 
used to repair worn-out knees. Bone donations can be used in hip 
replacements or spinal surgery enabling recipients to regain mobility. 
Donated arteries and veins can restore circulation, and heart valves 
can be transplanted to save lives.
  The phenomenal growth and increasing competitiveness of the industry 
in its search for new sources of donated tissue, however, have resulted 
in some problems. Tissue obtained from unsuitable donors has been 
allowed to enter the American tissue supply, raising serious doubts 
about the adequacy of federal regulations. Other concerns involve 
whether or not the practices of some tissue banks are sufficient to 
reduce the danger of spreading such illnesses as the human variant of 
mad cow disease. Because communicable diseases such as HIV and 
hepatitis, among others, can also be transmitted through tissues, it is 
vital that potential donors be screened for suitability and tissue be 
tested effectively, to make sure it is safe.
  FDA recognized these issues in 1997, and the agency published its 
``Proposed Approach to the Regulation of Cellular and Tissue-Based 
Products.'' The FDA proposed to: (1) require infectious disease 
screening and testing for cells and tissue transplanted from one person 
to another; (2) require that cells and tissues be handled according to 
procedures designed to prevent contamination and preserve tissue 
function and integrity; and (3) require all tissue processing 
facilities to register with the agency. Thereafter, FDA promulgated 
three separate regulations that address these requirements. But of 
those, only a registration requirement has been implemented.

  Five years later, the majority of the proposed regulatory changes 
still have not been adopted, and, remarkably, FDA officials recently 
advised me that the agency cannot even tell me when the remaining 
regulations will be made final.
  The FDA's failure to act in this area that affects public health and 
safety is simply inexcusable. It is a case, apparently, of bureaucratic 
inertia at its worst.
  I have long been concerned about the vulnerabilities that exist in 
the tissue industry and the adequacy of the Government's oversight.
  Last year--exactly a year ago--as the chairman of the Senate 
Permanent Subcommittee on Investigations, I held a hearing to look at 
tissue banks and the efficacy of the current regulatory framework. The 
testimony was deeply troubling.
  For example, one witness testified that some unscrupulous tissue 
banks have engaged in a practice in which tissues that were initially 
tested positive for contamination were simply tested over and over 
again until the technicians achieved the negative result they wanted.

[[Page S4537]]

  Let me explain that again. This is human tissue that has tested 
positive for contamination, and the reaction to that was to keep 
testing it until a negative result came up. You cannot keep testing 
into compliance. Obviously, there is a problem if, even once, the 
tissue tests positive for contamination; and it should not be used.
  The FDA official in my hearing called this ``testing tissue into 
compliance'' a practice that is obviously unsafe and must be stopped.
  The hearing also revealed that scores of tissue banks have never once 
been inspected by the FDA. And of those that have been inspected, some 
were found to have had deficiencies, but they were never reinspected to 
see that the problems had been corrected.
  Moreover, the FDA had no concept, prior to the registration 
requirement, of how many tissue banks were actually operating. The FDA 
thought there were possibly 150. More than 350 registered as a result 
of the one requirement that the FDA did put into effect.
  As a result of the subcommittee's in-depth investigation, I concluded 
that serious gaps existed in the FDA's regulation. But I also thought, 
and hoped, and have received promises from the agency, that it would 
act. After all, it had developed a good, sound strategy back in 1997.
  So last year, in the hearings that I held a year ago this month, the 
FDA promised me that the regulations would be made final.
  Unfortunately, I have been proven wrong about the FDA's commitment to 
reform. And the lack of action has had serious, indeed, tragic 
consequences.
  In November of last year, a 23-year-old man died in Minnesota after 
undergoing routine knee surgery in which tissue was transplanted into 
his body. It contained a deadly bacteria which ultimately killed this 
young man. Others have fallen seriously ill because of the tainted 
tissue transplants.
  In March of this year, the Centers for Disease Control and Prevention 
released findings that linked bacterial infections in donated human 
tissue to allografts that had been used for transplants in 26 cases. 
And the number, undoubtedly, is going to increase since the CDC's 
investigation is still ongoing.

  I have tried to work with the FDA to expedite the implementation of 
the proposed regulations. I have asked, repeatedly: What does the FDA 
need? Are more resources needed? Just tell us what you need. But, 
unfortunately, the threat to public health that the FDA identified so 
long ago continues to exist today.
  In an effort to prevent any further tragedies, I am today introducing 
legislation to require the FDA to go forward and issue these much 
needed regulations.
  First, my legislation will explicitly authorize the FDA to regulate 
any entity that engages in the recovery, screening, testing, 
processing, storage, or distribution of human tissue, or human tissue-
based products. In other words, all tissue banks would be required to 
adhere to the standards that the FDA has identified as necessary for 
ensuring public safety. This provision would remove any doubt about the 
FDA's authority to regulate tissue banks.
  Second, the legislation will make it mandatory for all tissue banks 
to register with the FDA. If any tissue bank is out of compliance with 
FDA requirements, the agency will be authorized to suspend and, if 
necessary, revoke the tissue bank's registration, to prevent the bank 
from operating.
  Third, the legislation will require tissue banks to report adverse 
incidents, including the detection of an infection within 15 days. 
Currently, tissue banks are not required to report adverse incidents to 
the Federal Government. And if they do not voluntarily report 
incidents, it is very difficult for the Federal Government to take 
effective action.
  Finally, the bill also requires the Secretary of Health and Human 
Services to develop a database to store the adverse incident reports. 
That central repository of information would be very useful to the CDC.
  I want to emphasize that the vast majority of tissue banks operate in 
a safe, professional manner. We are now very fortunate that advances in 
technology allow tissue to be used in ways that truly enhance lives for 
thousands of Americans.
  This legislation will help ensure that the transplantation of human 
tissue saves lives, not ends them.
                                 ______