89th Legislature

HB 5147

Overall Vote Recommendation
Yes
Principle Criteria
Free Enterprise
Property Rights
Personal Responsibility
Limited Government
Individual Liberty
Digest
HB 5147 proposes amendments to the Texas Health and Safety Code, Chapter 1003, which governs the administration of investigational stem cell treatments. The bill updates the statutory definition of "investigational stem cell treatment" to include an additional requirement: treatments must use only adult stem cells manufactured under current Good Manufacturing Practices (cGMP) as defined by the U.S. Food and Drug Administration. This ensures a higher standard of product consistency and safety in stem cell therapies provided under the investigational pathway.

The bill also expands the types of medical facilities where investigational treatments may be legally administered. In addition to already authorized settings such as licensed hospitals, ambulatory surgical centers, and medical schools, HB 5147 authorizes administration in outpatient settings registered to provide level II anesthesia services. This change is intended to increase patient access by broadening the scope of permissible care settings, especially in community-based and specialty practices.

Further, HB 5147 modifies oversight requirements for investigational stem cell use. It expands the definition of permissible Institutional Review Boards (IRBs) to include those accredited by national organizations acceptable to the Texas Medical Board or those registered with the U.S. Department of Health and Human Services. Finally, the bill revises reporting requirements, mandating that IRBs annually report serious adverse events and related findings to the Texas Medical Board while ensuring that patient-identifying information is excluded. The Act would take effect on September 1, 2025.
Author
Ken King
Tom Oliverson
Suleman Lalani
Lauren Simmons
Co-Author
Aicha Davis
Sponsor
Tan Parker
Fiscal Notes

According to the Legislative Budget Board (LBB), HB 5147 is not expected to have a significant fiscal impact on the State of Texas. The implementation of the bill's provisions—such as modifying oversight requirements for investigational stem cell treatments and updating informed consent forms—would not require substantial new expenditures or resources from state agencies.

The agencies most likely affected by the bill, including the Texas Medical Board (TMB), the Health and Human Services Commission (HHSC), and the Department of State Health Services (DSHS), are expected to be able to absorb any administrative or regulatory costs within their existing budgets. For instance, the Texas Medical Board’s obligation to receive and review annual reports on adverse events related to stem cell therapies is seen as manageable without additional appropriations or staffing.

Similarly, there is no anticipated significant fiscal effect on local governments. The bill does not impose mandates or administrative burdens on counties, municipalities, or local health authorities that would result in measurable expenditures or require additional funding.

In sum, HB 5147 is designed to adjust the regulatory framework for investigational treatments without introducing new spending obligations, making it fiscally neutral at both the state and local levels.

Vote Recommendation Notes

HB 5147 meaningfully expands patient access to investigational adult stem cell treatments while upholding reasonable regulatory standards. By updating the statutory definition of investigational treatments to include the use of adult stem cells that conform to FDA current Good Manufacturing Practices, the bill aims to ensure product quality and safety without requiring full FDA approval. This is a notable step toward balancing patient autonomy with public health safeguards. Importantly, the bill does not create new criminal penalties or grant additional rulemaking authority, which minimizes unnecessary regulatory overreach.

The bill allows these investigational therapies to be administered not only in hospitals or medical schools but also in outpatient settings that are registered to provide level II anesthesia services. This modification makes the treatments more accessible, especially to patients who live in areas not served by major hospital systems. Simultaneously, HB 5147 strengthens oversight by permitting certification by a broader range of institutional review boards, including those registered with the U.S. Department of Health and Human Services. This decentralization of oversight—while still anchored in federal standards—represents a pragmatic shift that retains accountability while easing institutional burdens.

From a fiscal perspective, HB 5147 is cost-neutral. The LBB notes that no significant costs to the state or local governments are anticipated and that any administrative expenses can be absorbed within existing agency budgets. This is critical for preserving limited government while advancing public access to promising therapies. By enhancing individual choice, encouraging medical innovation, and minimizing new bureaucratic demands, HB 5147 aligns with the core principles of individual liberty, personal responsibility, limited government, and free enterprise.

In light of its substantive benefits, safeguards, and lack of fiscal burden, Texas Policy Research recommends that lawmakers vote YES on HB 5147.

  • Individual Liberty: This bill empowers patients—especially those with chronic or terminal illnesses—to make their own decisions about whether to try investigational adult stem cell treatments. By allowing access to promising but not yet FDA-approved therapies, the bill respects and expands personal choice in health care. It recognizes that adults should have the freedom to pursue potentially life-changing treatments when other options are limited.
  • Personal Responsibility: HB 5147 assumes that patients, in consultation with their doctors, can weigh the risks and benefits of trying investigational treatments. The required informed consent notice ensures that patients are clearly told the treatment is not fully FDA-approved, which promotes responsible, informed decision-making. It treats patients as capable adults rather than dependents of the state.
  • Free Enterprise: The bill reduces regulatory barriers that limit where stem cell therapies can be offered. Allowing outpatient clinics to provide these treatments creates opportunities for more physicians and facilities to enter the field, encourages innovation in regenerative medicine, and promotes competition—hallmarks of a free market in health care.
  • Private Property Rights: HB 5147 does not directly affect property rights. It neither restricts nor expands ownership or use of private property, making it neutral on this front.
  • Limited Government: Rather than expanding regulatory control, the bill decentralizes it. By broadening the types of oversight boards that can authorize treatments and not requiring new state spending or bureaucracy, the bill demonstrates a preference for streamlined, less centralized regulation. It avoids creating new agencies or enforcement mechanisms.
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