[Congressional Record Volume 170, Number 186 (Monday, December 16, 2024)]
[House]
[Pages H7167-H7170]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SHANDRA EISENGA HUMAN CELL AND TISSUE PRODUCT SAFETY ACT
Mr. BUCSHON. Mr. Speaker, I move to suspend the rules and pass the
bill (H.R. 7188) to require the Secretary of Health and Human Services
to conduct a national, evidence-based education campaign to increase
public and health care provider awareness regarding the potential risks
and benefits of human cell and tissue products transplants, and for
other purposes, as amended.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 7188
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 ``Shandra Eisenga Human Cell
and Tissue Product Safety Act''.
SEC. 2. DEFINITIONS.
In this Act:
(1) Human cell and tissue product.--The terms ``human cell
and tissue product'' and ``human cell and tissue products''
have the
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meaning given the term ``human cells, tissues, or cellular or
tissue-based products'' in section 1271.3(d) of title 21,
Code of Federal Regulations (or successor regulations).
(2) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
(3) Tissue reference group.--The term ``Tissue Reference
Group'' means the Tissue Reference Group of the Food and Drug
Administration.
SEC. 3. HUMAN CELL AND TISSUE PRODUCTS TRANSPLANT PUBLIC
AWARENESS CAMPAIGN.
The Secretary shall support the development and
dissemination of educational materials to inform health care
professionals and other appropriate professionals about
issues surrounding--
(1) organ, tissue, and eye donation, including evidence-
based methods to approach patients and their families;
(2) the availability of any donor screening tests; and
(3) other relevant aspects of donation.
SEC. 4. REVIEW AND UPDATE OF EXISTING GUIDANCE.
The Secretary, acting through the Commissioner of Food and
Drugs, shall--
(1) not later than 1 year after the date of the enactment
of this Act, initiate an internal review of existing guidance
for determining eligibility of donors of human cell and
tissue products;
(2) not later than 3 years after the date of the enactment
of this Act, if appropriate--
(A) update the guidance titled ``Eligibility Determination
for Donors of Human Cells, Tissues, and Cellular and Tissue-
Based Products; Guidance for Industry'' issued August 2007;
and
(B) issue or update, as applicable, any guidance for
industry of the Food and Drug Administration that includes--
(i) recommendations to reduce the risk of transmission of
mycobacterium tuberculosis by human cells, tissues, and
cellular and tissue-based products (HCT/Ps); or
(ii) recommendations to reduce the risk of transmission of
disease agents associated with sepsis for donors of human
cells, tissues, and cellular and tissue-based products (HCT/
Ps); and
(3) if the Secretary determines that issuing or updating
guidance as specified in paragraph (2) is not appropriate,
provide a written statement of explanation of that
determination to the Committee on Energy and Commerce of the
House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate.
SEC. 5. CIVIL PENALTIES FOR VIOLATION OF REQUIREMENTS FOR
HUMAN CELL AND TISSUE PRODUCTS.
Section 368 of the Public Health Service Act (42 U.S.C.
271) is amended by adding at the end the following:
``(d)(1) Any person who, on or after the date of the
enactment of the Shandra Eisenga Human Cell and Tissue
Product Safety Act, violates a requirement of subparts C or D
of section 1271 of title 21, Code of Federal Regulations, (or
successor regulations) with respect to human cell or tissue
products regulated under section 361 shall be liable to the
United States for a civil penalty in an amount not to exceed
the sum of--
``(A)(i) $20,000 for each violation; and
``(ii) in the case of a violation that continues after the
Secretary provides written notice to such person, $20,000 for
each subsequent day on which the violation continues; and
``(B) an amount equal to the retail value of the human cell
and tissue products that are the subject of the violation.
``(2) The total civil penalty under paragraph (1) may not
exceed $10,000,000 for all such violations adjudicated in a
single proceeding.
``(3) In this subsection, the term `human cell and tissue
products' has the meaning given the term `human cells,
tissues, or cellular or tissue-based products' in section
1271.3(d) of title 21, Code of Federal Regulations (or
successor regulations).''.
SEC. 6. STREAMLINING REGULATORY OVERSIGHT OF HUMAN CELL AND
TISSUE PRODUCTS.
(a) Information on Human Cell and Tissue Products.--
(1) Website.--The Secretary, acting through the
Commissioner of Food and Drugs, shall publish on the public
website of the Food and Drug Administration--
(A) educational materials about the Tissue Reference Group;
and
(B) best practices for obtaining a timely, accurate
recommendation regarding human cell and tissue products from
the Tissue Reference Group.
(2) Public information.--Not later than 1 year after the
date of the enactment of this Act, and annually for the
subsequent 3 years, the Secretary, acting through the
Commissioner of Food and Drugs, shall publish on the public
website of the Food and Drug Administration--
(A) the number of human cell and tissue establishments that
registered with the Food and Drug Administration on or after
January 1, 2019;
(B) the number of inspections conducted by the Food and
Drug Administration of human cell and tissue establishments
on or after January 1, 2019, including a comparison of the
number of inspections for blood establishments with the
number of inspections for such human cell and tissue
establishments;
(C) the number and type of inquiries to the Tissue
Reference Group in the preceding year; and
(D) the average response time for submissions to the Tissue
Reference Group in the preceding year, including average
initial and final response time.
(3) Education.--The Secretary, acting through the
Commissioner of Food and Drugs, shall, with respect to the
regulation of human cell and tissue products--
(A) provide information to relevant stakeholders, including
industry, tissue establishments, academic health centers,
biomedical consortia, research organizations, and patients;
and
(B) conduct workshops and other interactive and educational
sessions for such stakeholders to help support regulatory
predictability and scientific advancement, as appropriate.
(b) Human Cell and Tissue Product Scientific and Regulatory
Updates.--Section 3205 of the Food and Drug Omnibus Reform
Act of 2022 (title III of division FF of Public Law 117-328)
is amended by striking ``best practices'' and all that
follows through ``other cellular therapies'' and inserting
``best practices on generating scientific data necessary to
further facilitate the development of certain human cell-,
tissue-, and cellular-based medical products (and the latest
scientific information about such products), namely, stem
cell and other cellular therapies''.
(c) Public Docket.--Not later than 60 days after the date
of the enactment of this Act, the Secretary shall establish a
public docket to receive written comments related to--
(1) the approaches recommended for discussion during the
public workshop described in section 3205 of the Food and
Drug Omnibus Reform Act of 2022 (title III of division FF of
Public Law 117-328); and
(2) modernizing the regulation of human cell and tissue
products, including considerations associated with assessing
minimal manipulation and homologous use (as such terms are
defined in section 1271.3 of title 21, Code of Federal
Regulations (or successor regulations)) of human cell and
tissue products.
(d) Report to Congress.--Not later than September 30, 2026,
the Secretary shall summarize the approaches discussed in the
public workshop described in section 3205 of the Food and
Drug Omnibus Reform Act of 2022 (title III of division FF of
Public Law 117-328) and the public docket described in
subsection (c), and develop recommendations regarding the
regulation of human cell and tissue products, including
provisions under sections 1271.10(a) and 1271.3 of title 21,
Code of Federal Regulations, taking into account--
(1) regulatory burden;
(2) scientific developments;
(3) access to human cell and tissue products regulated
under section 361 of the Public Health Service Act (42 U.S.C.
264); and
(4) protecting public health.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Indiana (Mr. Bucshon) and the gentlewoman from Florida (Ms. Castor)
each will control 20 minutes.
The Chair recognizes the gentleman from Indiana.
General Leave
Mr. BUCSHON. Mr. Speaker, I ask unanimous consent that all Members
may have 5 legislative days in which to revise and extend their remarks
and include extraneous material in the Record on the bill.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Indiana?
There was no objection.
Mr. BUCSHON. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise in support of H.R. 7188, the Shandra Eisenga
Human Cell and Tissue Product Safety Act led by Representative
Moolenaar.
This bill was drafted in response to the passing of Shandra Eisenga
of Marion, Michigan, on August 10, 2023, due to complications from a
tuberculosis infection.
Ms. Eisenga contracted TB after receiving a bone graft in April 2023
using a tissue donation from an infected donor.
She was 1 of 36 patients in seven States to contract TB from a tissue
donation originating from this donor resulting in 2 deaths.
The bill would help raise awareness about the risks and life-
transformative benefits of human cell and tissue product transplants
through a public awareness campaign. It would also require the FDA to
take additional steps to promote public health by issuing and updating
relevant guidance for industry on determining eligibility of donors of
human cell and tissue products.
This path forward will increase patient safety and public trust in
these lifesaving medical products.
Mr. Speaker, I encourage my colleagues to support this bill, and I
reserve the balance of my time.
Ms. CASTOR of Florida. Mr. Speaker, I yield myself such time as I may
consume.
Mr. Speaker, I rise today in support of H.R. 7188, the Shandra
Eisenga Human Cell and Tissue Product Safety Act, sponsored by my
colleagues, Representatives Dingell and Moolenaar.
Stem cell therapies and related products have shown tremendous
promise for delivering treatments to patients, such as bone marrow
transplants for
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certain cancer patients and therapies for patients with blood and
immune system disorders.
However, there are still rogue clinics that take advantage of
patients desperate for cures.
For example, there have been reports of some clinics peddling
unapproved treatments with exaggerated and deceptive claims. Exposure
to these unproven treatments have put the health of vulnerable patients
at risk, leading to serious adverse events, including blindness, blood
stream infections, paralysis, and tumor growth.
There are currently few meaningful repercussions in the human cell
and tissue products industry, so this legislation would change that by
providing the Food and Drug Administration with additional enforcement
tools to move more quickly and effectively to protect the public.
It provides a balanced approach to improving safety of human cell
tissue in cellular and tissue-based products. First, the legislation
provides clarity regarding FDA scientific and regulatory efforts to
oversee these products. Second, it also enables more effective
enforcement against an establishment that does not meet its donor
eligibility obligations or current good tissue practice obligations.
This would also encourage responsible manufacturers to continue to
develop and license products where the scientific evidence supports the
products' safety, purity, and potency. This is an important bill.
Mr. Speaker, I reserve the balance of my time.
Mr. BUCSHON. Mr. Speaker, I yield 5 minutes to the gentleman from
Michigan (Mr. Moolenaar).
Mr. MOOLENAAR. Mr. Speaker, I thank the gentleman for yielding. I
also thank my colleagues on the other side of the aisle, especially
Congresswoman Dingell, my fellow Michigander, who has worked very
closely with me on this.
Mr. Speaker, I rise today in support of this bipartisan legislation.
This is the Shandra Eisenga Human Cell and Tissue Product Safety Act.
In 2023, 36 patients across seven States contracted tuberculosis from
infected bone grafts. One of these patients was my constituent, Shandra
Eisenga, of Marion, Michigan, who tragically passed away on August 10,
2023, from TB.
We are joined today in the gallery by Shandra's daughter, Amber; her
husband, Brandon, and their children; Shandra's fiance, Leo; as well as
her sister, Tarin Brunink, who also serves in my office as the director
of casework.
This family has been forever hurt by the loss of Shandra, and today
we are taking concrete action to help stop more families from having
this same terrible experience.
Shandra's passing, as well as nine other patients over the past 3
years, was completely preventable if it was not for the inadequate
oversight of tissue material suppliers.
When it comes to tissue donations, the FDA requires screening for
diseases like hepatitis, syphilis, and HIV. This bipartisan bill will
require screening for tuberculosis as well and put an end to
preventable TB deaths like Shandra's.
This bill will also require HHS to conduct research and public
education campaigns on the risks of surgery requiring a tissue
donation.
Mr. Speaker, I urge my colleagues to support this vital, bipartisan
legislation.
The SPEAKER pro tempore. The Chair reminds Members that the rules do
not allow references to persons in the gallery.
Ms. CASTOR of Florida. Mr. Speaker, I yield such time as she may
consume to the gentlewoman from Michigan (Mrs. Dingell).
Mrs. DINGELL. Mr. Speaker, I thank Ms. Castor for yielding to me. I
also thank my colleagues on the other side of the aisle and, in
particular, my dear friend, John Moolenaar. We have been a team on
this from the moment that we heard about this.
Mr. Speaker, I rise today to share my strong support for H.R. 7188,
the Shandra Eisenga Human Cell and Tissue Product Safety Act.
I am proud to lead this bipartisan bill alongside my friend and
colleague from Michigan, Mr. Moolenaar.
{time} 1615
Last summer, I was contacted by the medical director of the Washtenaw
County Tuberculosis Clinic, who was treating a patient, Shandra
Eisenga, for a severe post-surgical tuberculosis infection. Shandra was
Representative Moolenaar's constituent, but she was being treated at
the University of Michigan, a medical facility in my district. After a
month of battling a severe TB infection in the intensive care unit, she
unfortunately died.
Since Shandra's passing, it has been discovered that her death was,
indeed, linked to contaminated bone graft material produced by Aziyo
Biologics. She was 1 of 36 patients who received material from the
contaminated lot. As of today, this latest outbreak is linked to the
deaths of two patients, including Shandra.
This bill requires the Department of Health and Human Services to
conduct public awareness campaigns to assist in preventing TB outbreaks
caused by contaminated human cell and tissue product donations. We have
also included an important provision to allow the Food and Drug
Administration to pursue civil penalties from establishments that
manufacture human cells, tissues, and cellular- and tissue-based
products where they put the patient at risk.
Patients and their healthcare providers deserve to know the risks
associated with tissue donations, and companies that make and
distribute contaminated products must be held accountable for their
actions that put patients in harm's way.
Mr. Speaker, when this happened, I had had multiple bone grafts
because of osteomyelitis. I never once was warned of any danger, and my
doctor was unaware of these dangers. We cannot let that ever happen
again. We must protect patients and educate patients.
I thank Energy and Commerce Chair Cathy McMorris Rodgers and Ranking
Member Frank Pallone for fighting for this important piece of
legislation. Again, I would not be here without my colleague,
Representative Moolenaar.
We owe it to Shandra and her family, who is here and to whom we made
a commitment last August that we would not let this happen to anybody
else again. I am happy that they see us here fighting for them on this
floor. We are also here for any other patient who has been affected by
contaminated bone grafts. We are going to prevent these unnecessary
tragedies from happening again.
Mr. Speaker, I urge my colleagues to vote ``yes,'' and I reserve the
balance of my time.
Mr. BUCSHON. Mr. Speaker, I yield myself such time as I may consume.
I am glad we are here today. I was a healthcare provider before I was
in the Congress for 15 years, and I find when you have legislation like
this that comes up, it is surprising that we have to, literally, as
they say, have an act of Congress to protect patients, but today is one
of those days.
In the healthcare space, it always disappoints me when you see,
whether it is providers or whether it is organizations that provide
tissue, like this, where it seems like their moral character is
compromised by the quest for profit. To me, it couldn't be worse.
One of the goals that I have had since I have been here--and this
will probably be my last time on the House floor managing a bill since
I am retiring--is to put patients first. Any legislation that we
propose, bipartisan legislation that we do, that is the number one
goal.
The number one goal should not be talking about the finances or other
things related to legislation. We do have to talk about some of those
things, but at the end of the day, the goal here is to make sure that
the American people get quality, affordable healthcare that is safe and
that they don't get transplants like this that have contaminated tissue
that, in this case, has resulted in her death and the death of one
other person, plus who knows how many other people of the 36 have
struggled with their medical care based on this.
The other thing is, I wish this was an isolated incident in the
healthcare space. Let me say that the vast majority of people across
the healthcare space, from providers on down to companies, do things
right. They do things the right way, but every once in a
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while, you will find organizations or people who do not.
Mr. Speaker, it is surprising to me that we have to address this with
the FDA because you would think that already--this is part of the
problem when you put specific diseases in for what the FDA has to look
at. They have to look at HIV and syphilis and other things, but these
tissues can have almost anything there. We need to make sure that they
have the power and, honestly, the legislative authority to accomplish
the goal that we all have, and that is to protect patients.
Mr. Speaker, I think this is a very important piece of legislation,
and it is bigger than just this legislation. This is something that
will, in perpetuity, protect patients so we don't end up having
situations like this.
Mr. Speaker, I don't have any other speakers on the legislation, and
I reserve the balance of my time.
Ms. CASTOR of Florida. Mr. Speaker, I yield myself the balance of my
time to close.
It has been a pleasure to work with Dr. Bucshon. He has brought great
intellect and passion to his service on health issues, especially at
the Energy and Commerce Committee. I also thank Representative
Moolenaar and Representative Dingell for their leadership on this
effort.
Mr. Speaker, I am pleased that Shandra Eisenga's tragedy will be
turned into progress and prevention for other families across the
United States.
I urge a ``yes'' vote on H.R. 7188 and yield back the balance of my
time.
Mr. BUCSHON. Mr. Speaker, I yield myself the balance of my time to
close.
I thank the gentlewoman for her kind words. The Energy and Commerce
Committee is a committee that works in a broad, bipartisan way to
accomplish all kinds of things. I think if you look back at this
Congress or previous Congresses, the number of pieces of legislation
that come to this floor that have gone through our committee in a
bipartisan way, you would find that is a substantial percentage of
bills that come across this floor. It has been an honor and privilege
to work with all of my colleagues on both sides of the aisle.
Mr. Speaker, I encourage a ``yes'' vote on this really important
legislation, and I yield back the balance of my time.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from Indiana (Mr. Bucshon) that the House suspend the rules
and pass the bill, H.R. 7188, as amended.
The question was taken; and (two-thirds being in the affirmative) the
rules were suspended and the bill, as amended, was passed.
A motion to reconsider was laid on the table.
____________________