[Congressional Record Volume 148, Number 64 (Friday, May 17, 2002)]
[Senate]
[Pages S4536-S4538]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




          STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS

      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.
                                 ______
                                 
      By Mr. SMITH of Oregon (for himself and Mrs. Feinstein):
  S. 2533. A bill to amend title II of the Social Security Act to 
provide for miscellaneous enhancements in Social Security benefits, and 
for other purposes; to the Committee on Finance.
  Mr. SMITH of Oregon. Mr. President, I rise today to introduce The 
Social Security Benefit Enhancements for Women Act of 2002. I am proud 
to be joined by my colleague from California, Senator Feinstein. This 
legislation makes fiscal improvements in benefits for women under the 
current Social Security system. These improvements will increase the 
benefits for disabled widows, divorced retirees, and widows whose 
husbands died quickly after an early retirement.
  While these benefit changes are small in scope, they represent a 
bipartisan effort to provide more economic security for women who work 
hard, sacrifice much and yet still live near poverty. Women comprise 
the majority of Social Security beneficiaries, representing almost 60 
percent of all Social Security recipients at age 65 and 71 percent of 
all recipients by age 85. Those impacted by this legislation, the 
disabled, divorced and elderly widows are more likely to live near the 
poverty line.
  Clearly we would like to do more for these beneficiaries. Yet there 
is a limit in the number and scope of improvements we are able to make 
as we face broader Social Security reform issues. This small benefit 
package passed the House on May 14, 2002, by a stunning vote of 418 to 
0. We feel that a similar vote can send these changes to the President 
and we can show that bipartisanship is a route that will work when it 
comes to future Social Security reform.
  I ask unanimous consent to have the bill printed in the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 2533

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Social Security Benefit 
     Enhancements for Women Act of 2002''.

     SEC. 2. REPEAL OF 7-YEAR RESTRICTION ON ELIGIBILITY FOR 
                   WIDOW'S AND WIDOWER'S INSURANCE BENEFITS BASED 
                   ON DISABILITY.

       (a) Widow's Insurance Benefits.--
       (1) In general.--Section 202(e) of the Social Security Act 
     (42 U.S.C. 402(e)) is amended--
       (A) in paragraph (1)(B)(ii), by striking ``which began 
     before the end of the period specified in paragraph (4)'';
       (B) in paragraph (1)(F)(ii), by striking ``(I) in the 
     period specified in paragraph (4) and (II)'';
       (C) by striking paragraph (4) and by redesignating 
     paragraphs (5) through (9) as paragraphs (4) through (8), 
     respectively; and
       (D) in paragraph (4)(A)(ii) (as redesignated), by striking 
     ``whichever'' and all that follows through ``begins'' and 
     inserting ``the first day of the seventeenth month before the 
     month in which her application is filed''.
       (2) Conforming amendments.--
       (A) Section 202(e)(1)(F)(i) of such Act (42 U.S.C. 
     402(e)(1)(F)(i)) is amended by striking ``paragraph (5)'' and 
     inserting ``paragraph (4)''.
       (B) Section 202(e)(1)(C)(ii)(III) of such Act (42 U.S.C. 
     402(e)(2)(C)(ii)(III)) is amended by striking ``paragraph 
     (8)'' and inserting ``paragraph (7)''.
       (C) Section 202(e)(2)(A) of such Act (42 U.S.C. 
     402(e)(2)(A)) is amended by striking ``paragraph (7)'' and 
     inserting ``paragraph (6)''.
       (D) Section 226(e)(1)(A)(i) of such Act (42 U.S.C. 
     426(e)(1)(A)(i)) is amended by striking ``202(e)(4),''.
       (b) Widower's Insurance Benefits.--
       (1) In general.--Section 202(f) of such Act (42 U.S.C. 
     402(f)) is amended--
       (A) in paragraph (1)(B)(ii), by striking ``which began 
     before the end of the period specified in paragraph (5)'';
       (B) in paragraph (1)(F)(ii), by striking ``(I) in the 
     period specified in paragraph (5) and (II)'';
       (C) by striking paragraph (5) and by redesignating 
     paragraphs (6) through (9) as paragraphs (5) through (8), 
     respectively; and
       (D) in paragraph (5)(A)(ii) (as redesignated), by striking 
     ``whichever'' and all that follows through ``begins'' and 
     inserting ``the first day of the seventeenth month before the 
     month in which his application is filed''.
       (2) Conforming amendments.--
       (A) Section 202(f)(1)(F)(i) of such Act (42 U.S.C. 
     402(f)(1)(F)(i)) is amended by striking ``paragraph (6)'' and 
     inserting ``paragraph (5)''.

[[Page S4538]]

       (B) Section 202(f)(1)(C)(ii)(III) of such Act (42 U.S.C. 
     402(f)(2)(C)(ii)(III)) is amended by striking ``paragraph 
     (8)'' and inserting ``paragraph (7)''.
       (C) Section 226(e)(1)(A)(i) of such Act (as amended by 
     subsection (a)(2)) is further amended by striking 
     ``202(f)(1)(B)(ii), and 202(f)(5)'' and inserting ``and 
     202(f)(1)(B)(ii)''.
       (c) Effective Date.--The amendments made by this section 
     shall apply with respect to benefits for months after 
     November 2002.

     SEC. 3. EXEMPTION FROM TWO-YEAR WAITING PERIOD FOR DIVORCED 
                   SPOUSE'S BENEFITS UPON OTHER SPOUSE'S 
                   REMARRIAGE.

       (a) Wife's Insurance Benefits.--Section 202(b)(5)(A) of the 
     Social Security Act (42 U.S.C. 402(b)(5)(A)) is amended by 
     adding at the end the following new sentence: ``The criterion 
     for entitlement under clause (ii) shall be deemed met upon 
     the remarriage of the insured individual to someone other 
     than the applicant during the 2-year period referred to in 
     such clause.''.
       (b) Husband's Insurance Benefits.--Section 202(c)(5)(A) of 
     such Act (42 U.S.C. 402(c)(5)(A)) is amended by adding at the 
     end the following new sentence: ``The criterion for 
     entitlement under clause (ii) shall be deemed met upon the 
     remarriage of the insured individual to someone other than 
     the applicant during the 2-year period referred to in such 
     clause.''.
       (c) Conforming Amendment to Exemption of Insured 
     Individual's Divorced Spouse From Earnings Test as Applied to 
     the Insured Individual.--Section 203(b)(2)(B) of such Act (42 
     U.S.C. 403(b)(2)(B)) is amended by adding at the end the 
     following new sentence: ``The requirement under such clause 
     (ii) shall be deemed met upon the remarriage of the insured 
     individual to someone other than the individual referred to 
     in paragraph (1) during the 2-year period referred to in such 
     clause.''.
       (d) Effective Date.--The amendments made by this section 
     shall apply with respect to benefits for months after 
     November 2002.

     SEC. 4. MONTHS ENDING AFTER DECEASED INDIVIDUAL'S DEATH 
                   DISREGARDED IN APPLYING EARLY RETIREMENT RULES 
                   WITH RESPECT TO DECEASED INDIVIDUAL FOR 
                   PURPOSES OF LIMITATION ON WIDOW'S AND WIDOWER'S 
                   BENEFITS.

       (a) Widow's Insurance Benefits.--Section 202(e)(2)(D)(i) of 
     the Social Security Act (42 U.S.C. 402(e)(2)(D)(i)) is 
     amended by inserting after ``applicable,'' the following: 
     ``except that, in applying paragraph (7) of subsection (q) 
     for purposes of this clause, any month ending with or after 
     the date of the death of such deceased individual shall be 
     deemed to be excluded under such paragraph (in addition to 
     months otherwise excluded under such paragraph),''.
       (b) Widower's Insurance Benefits.--Section 202(f)(3)(D)(i) 
     of such Act (42 U.S.C. 402(f)(3)(D)(i)) is amended by 
     inserting after ``applicable,'' the following: ``except that, 
     in applying paragraph (7) of subsection (q) for purposes of 
     this clause, any month ending with or after the date of the 
     death of such deceased individual shall be deemed to be 
     excluded under such paragraph (in addition to months 
     otherwise excluded under such paragraph),''.
       (c) Effective Date.--The amendments made by this section 
     shall apply with respect to benefits for months after 
     November 2002.

                          ____________________