Shandra Eisenga Human Cell and Tissue Product Safety Act

Mr. Speaker, I rise today to share my strong support of H.R. 1082, the Shandra Eisenga Human Cell and Tissue Product Safety Act.

I am very proud to lead this bill with my good friend and colleague from Michigan, Representative John Moolenaar. Both of us have been very personally involved with the family and learning where there are serious deficiencies within our government.

In the summer of 2023, I was contacted by the medical director of the Washtenaw County Tuberculosis Clinic and head of public health who was treating Shandra for a severe postsurgical tuberculosis infection. She was Representative Moolenaar's constituent but was being treated at a medical facility in my district. After a month battling a severe TB infection in the intensive care unit, Shandra unfortunately died.

Since Shandra's passing, it has been discovered that her death was, indeed, linked to contaminated bone graft material. She was 1 of 36 patients who received material from the contaminated lot, and this latest outbreak is linked to the deaths of two patients, including Shandra.

It had been preceded 2 years before by an outbreak, again, linked to contaminated bone allografts, which resulted in multiple deaths. The outbreak then infected 113 patients across 18 States, and it led to at least 3 confirmed TB-related deaths with some sources citing a total of 8 deaths.

This has to stop. Too many people get bone grafts and have no idea, including the doctor that did a bone graft on me, that they even needed to worry about this.

This bill requires the Department of Health and Human Services to conduct research and education campaigns to prevent TB outbreaks caused by contaminated human cell and tissue product donations.

Through the markup process, we have also included an important provision to allow the Federal Government to pursue civil penalties from providers who caused an outbreak of the infectious disease. Patients deserve to know the risks associated with tissue donations and companies that make and distribute contaminated products must be held accountable for their actions.

Mr. Speaker, I thank the Energy and Commerce Committee Chair Guthrie, my dear friend Mr. Bilirakis, and Ranking Member Pallone for fighting for this important piece of legislation.

Again, I thank Representative Moolenaar for being such a great bipartisan partner. We owe it to Shandra, her family, and every other patient who has been affected by contaminated bone grafts to ensure we are doing everything we can to prevent these unnecessary tragedies from ever happening again.

Mr. Speaker, I urge my colleagues to vote ``yes'' on this important bill.

Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 1082) 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.

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 this particular bill.

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I rise today in strong support of H.R. 1082, the Shandra Eisenga Human Cell and Tissue Product Safety Act, led by my good friend Chairman Moolenaar from the great State of Michigan. This bill was borne out of a heartbreaking tragedy that we hope will never be repeated again.

In 2023, a Michigan constituent died from tuberculosis caused by a contaminated bone graft. This bill would require the HHS Secretary to conduct a national educational campaign to increase public and healthcare provider awareness regarding the risks and benefits of human cell and tissue transplants.

It would also require FDA to streamline the regulatory oversight of these particular products, including by publishing educational materials and best practices and by conducting workshops and public stakeholder sessions.

Ultimately, H.R. 1082 will increase public awareness, patient safety, and public trust in these lifesaving medical products to help ensure that preventable tragedies, like the unfortunate death of Ms. Eisenga, do not ever occur again.

This bill passed the House unanimously last December, and I look forward to its timely passage once again so that we can get it to the Senate.

Mr. Speaker, let's pass this very critical bill, H.R. 1082, and I reserve the balance of my time.

Mr. Speaker, I yield such time as he may consume to the gentleman from Michigan (Mr. Moolenaar), my good friend and the chairman of the select committee on China. I am very proud to serve under his leadership.

Mr. Speaker, in closing, I encourage a ``yes'' vote on this particular piece of legislation, and I yield back 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. 1082, the Shandra Eisenga Human Cell and Tissue Product Safety Act, sponsored by my colleagues Representative Dingell and Representative Moolenaar.

Mr. Speaker, 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. Yet, there are still rogue clinics that take advantage of patients who are desperate for cures.

For example, there are reports of some clinics peddling unapproved treatments with exaggerated and deceptive claims. Exposure to these unproven treatments has put vulnerable patients' health at risk, leading to serious adverse events, including blindness, bloodstream infections, paralysis, and tumor growth.

There are currently few meaningful repercussions in the human cell and tissue products industry. This bill would change that by providing the Food and Drug Administration with additional enforcement tools to more quickly and effectively protect the public. It provides a balanced approach to improving safety of human cell tissue and cellular and tissue-based products.

First, it provides clarity regarding FDA's scientific and regulatory efforts to oversee these products. Second, it

also enables more effective enforcement against an establishment that does not meet their 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 product's safety, purity, and potency.

I support this bill, Mr. Speaker, but continue to have concerns regarding the chaos at HHS broadly and FDA specifically. While this bill provides the FDA with additional enforcement tools, the Trump administration has made massive cuts to both funding and staffing at

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

Mr. Speaker, I urge support of this important legislation on a bipartisan basis, and I yield back the balance of my time.

Mr. Speaker, I thank the gentleman from Florida (Mr. Bilirakis) for yielding and for his strong support for this legislation. I also thank my colleagues on the other side of the aisle, Mr. Pallone, and especially my friend and fellow Michigander, Congresswoman Debbie Dingell, who has worked very closely with me on this legislation.

Mr. Speaker, I rise in support of this bipartisan legislation, H.R. 1082, the Shandra Eisenga Human Cell and Tissue Product Safety Act.

In 2023, 36 patients across 7 States contracted tuberculosis after receiving bone grafts containing infected donor material.

One of these patients was my constituent, Shandra Eisenga, of Marion, Michigan, who tragically passed away on August 10, 2023, due to complications from TB.

I was proud to have Shandra's family here last year when this legislation was first considered by the House. This family has been forever hurt by the loss of Shandra. Her daughter, Amber, said: Nothing can erase the heartbreak of my mother's passing, but she would be proud that we have helped make a positive difference in her name.

Today, we are taking concrete action to prevent more families from having the same experience as Amber and to honor her mother's legacy.

Shandra's passing was completely preventable. So were the deaths of nine other patients who have passed away from TB since 2021 because of 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.

The 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 in honor of Shandra and her family.

Mr. Speaker, I rise today in strong support of the Shandra Eisenga Human Cell and Tissue Product Safety Act, which is a critical piece of legislation aimed at preventing tuberculosis infections linked to tissue transplants.

In 2023, 36 patients across seven States contracted tuberculosis from infected bone grafts.

One of these patients was Shandra Eisenga, who tragically passed away on August 10, 2023, from tuberculosis, or TB.

This bipartisan 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.

Shandra's death was a preventable tragedy, and we will honor her memory by strengthening guidelines and improving education for these medical products, so no other family has to suffer through this again.

Mr. Speaker, I encourage my colleagues to support this bill.