Texas House Bill HB3148

Texas 2019 - 86th Regular

Caption

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

Impact

The bill amends specific sections of the Health and Safety Code to clarify the role of governmental agencies in monitoring investigational treatments. Notably, it prohibits government entities from hindering eligible patients' access to investigational stem cell treatments that meet certain criteria, thereby supporting patient access to these potentially beneficial therapies. Additionally, the bill emphasizes that adult stem cell products should not be deemed adulterated or misbranded solely based on the lack of FDA approval, which may lead to increased utilization of stem cell treatments that have not yet undergone extensive regulatory review.

Summary

House Bill 3148 relates to the administration and oversight of investigational adult stem cell treatments for certain patients. The bill aims to enhance the regulatory framework surrounding the use of adult stem cells by mandating the establishment of an investigational stem cell registry maintained by the Texas Department of State Health Services. This registry is intended to provide a centralized record of physicians authorized to administer these treatments, thereby improving oversight and ensuring better access for patients seeking innovative therapies.

Sentiment

Sentiments around HB 3148 appear to be largely supportive, particularly among proponents who see it as a significant step toward expanding access to innovative medical treatments. Advocates argue that by establishing clear guidelines and protections for the use of investigational stem cell therapies, the bill empowers patients and encourages medical advancements. However, there are also concerns from some quarters regarding the regulatory implications and the safety of treatments administered outside of strict FDA oversight.

Contention

Debate surrounding HB 3148 could center on the balance between facilitating access to cutting-edge treatments and ensuring patient safety and adherence to appropriate medical standards. While proponents advocate for patient autonomy and the expanded use of investigational therapies, opponents may raise cautions about the potential risks of unchecked treatment options. The bill's provisions that limit governmental interference could lead to contention over whether enough regulatory safeguards are in place to protect patients from unverified or unsafe practices.