Shandra Eisenga Human Cell and Tissue Product Safety Act

Floor Speech

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 FDA.

The President's budget doubles down on this chaos by proposing an 11 percent cut to the FDA budget and eliminating 2,000 jobs. This hinders the FDA's ability to actually protect the public.

Again, I call on my Republican colleagues to join me in conducting proper oversight of the Trump administration's actions. Otherwise, bipartisan efforts like this one will be rendered meaningless. If we are giving the agency new statutory tools and enforcement authority because we think there is a risk to the public, then the agency must be prepared to carry out those duties.
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Mr. PALLONE. Mr. Speaker, I urge support of this important legislation on a bipartisan basis, and I yield back the balance of my time.

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