SB 1765 by Bettencourt – Relating to the administration and oversight of investigational adult stem cell treatments administered to certain patients.
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LBB Fiscal Note Summary. No significant fiscal implication to the State is anticipated.
Bill Summary and Analysis. The bill would require that institutional review boards that oversee stem cell treatments either be accredited by the Association for the Accreditation of Human Research Protection programs, be registered by the United States Department of Health and Human Services, or be accredited by another national accreditation organization acceptable to the Department of State Health Services (DSHS). The bill would also prohibit a government entity from considering a drug adulterated or misbranded solely on the basis of the drug not being approved by United States Food and Drug Administration.
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Senator Bettencourt explained the committee substitute. During the 85th legislative session, H.B. 810, also known as Charlie’s Law, which allowed patients with certain severe chronic diseases or terminal illnesses to access adult stem cell treatments, was passed by the legislature and signed into law by the governor. Interested parties have noted difficulty in accessibility as well as operational issues relative to this statute. S.B. 1765 seeks to address these problems by clarifying that the government cannot prohibit a qualifying individual from receiving adult stem cell treatments unless the adult stem cells to be administered have been deemed to be adulterated or misbranded. It has also been observed that licensed physicians operating under the United States Food and Drug Administration’s (FDA) rules regarding stem cell treatments were affected by the passage of H.B. 810. S.B. 1765 seeks to clarify that there are no current laws or rules in existence that would prohibit a licensed physician from utilizing FDA registered, commercially available stem cells for their intended homologous use.
As proposed, S.B. 1765 amends current law relating to the administration and oversight of investigational adult stem cell treatments administered to certain patients.
The substitute increases the number of institutional review boards who can provide oversight. It clarifies that DSHS is responsible for oversight and that stem cells are not drugs.
Senator Buckingham inquired about letting the DSHS administer the program instead of the Texas Medical Board. Sen. Bettencourt stated that the best role of the TMB is to make sure that the rules are clear for the Institutional Review Board, and we need a state agency that is in charge of implementation. If we have top-down guidelines from TMB and DSHS is responsible for implementation, I think that gives us the best combination of flexibility as well as oversight.
INVITED TESTIMONY.
Michelle Wittenberg, Patients for Stem Cells stated that this does not change what is happening at the Medical Board related to IRBs and the bill clarifies the role of DSHS.
PUBLIC TESTIMONY. No verbal testimony offered.
The bill was left pending awaiting the House Bill.
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