Texas Senate Bill SB1765

Texas 2019 - 86th Regular

Caption

Relating to the administration and oversight of investigational adult stem cell treatments administered to certain patients.

Impact

By establishing clear guidelines for the governance of adult stem cell treatments, SB1765 seeks to improve patient access to these investigational therapies while ensuring that they are administered safely and effectively. The bill seeks to limit governmental interference in patients' access to approved treatments, provided they comply with specific safety and regulatory standards. By doing so, it aims to strike a balance between enabling therapeutic innovation and safeguarding public health interests.

Summary

Senate Bill 1765 aims to regulate and oversee investigational adult stem cell treatments administered to specific patients. The bill introduces amendments to the Health and Safety Code which delineate the administrative responsibilities and the conditions under which these treatments can be provided. Specifically, the bill mandates that institutional review boards overseeing such treatments must meet certain criteria, including affiliation with medical schools or hospitals, and accreditation by recognized organizations. This legislative effort reflects a growing recognition of the need for regulatory clarity in the rapidly evolving field of stem cell therapies.

Contention

Notably, SB1765 stipulates that a governmental entity may not interfere with an eligible patient's access to stem cell treatments unless those treatments involve drugs that are deemed adulterated or misbranded. This provision aims to protect patients' rights to receive potentially beneficial treatments even if these have not been fully approved by the FDA, a point of contention among critics who may argue about the implications for drug safety and efficacy. The careful consideration of oversight and the regulatory framework established in this bill will likely be pivotal in future discussions regarding stem cell research and its application in clinical settings.