Shandra Eisenga Human Cell and Tissue Product Safety Act
Floor Speech
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.
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.
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