Shandra Eisenga Human Cell and Tissue Product Safety Act

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.

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.

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.

Mr. Speaker, I yield 5 minutes to the gentleman from Michigan (Mr. Moolenaar).

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

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.

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.

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.

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. 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

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. Speaker, I yield such time as she may consume to the gentlewoman from Michigan (Mrs. Dingell).

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. 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.