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A BILL TO BE ENTITLED
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AN ACT
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relating to the administration and oversight of investigational |
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adult stem cell treatments administered to certain patients. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Subchapter B, Chapter 1003, Health and Safety |
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Code, is amended by adding Sections 1003.0525 and 1003.0526 to read |
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as follows: |
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Sec. 1003.0525. ADMINISTRATION OF SUBCHAPTER. The |
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department shall administer this subchapter. |
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Sec. 1003.0526. INVESTIGATIONAL STEM CELL REGISTRY. The |
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department shall establish and maintain an investigational stem |
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cell registry that lists each physician who administers an |
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investigational stem cell treatment under this subchapter. |
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SECTION 2. Section 1003.054(c), Health and Safety Code, is |
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amended to read as follows: |
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(c) The executive commissioner by rule shall [may] adopt a |
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form for the informed consent under this section. The form must |
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provide notice that the department administers this subchapter. |
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SECTION 3. Section 1003.055(d), Health and Safety Code, is |
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amended to read as follows: |
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(d) An institutional review board that oversees |
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investigational stem cell treatments administered under this |
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subchapter must meet one of the following conditions [be affiliated
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with]: |
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(1) be affiliated with a medical school, as defined by |
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Section 61.501, Education Code; [or] |
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(2) be affiliated with a hospital licensed under |
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Chapter 241 that has at least 150 beds; |
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(3) be accredited by the Association for the |
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Accreditation of Human Research Protection Programs; |
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(4) be registered by the United States Department of |
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Health and Human Services, Office for Human Research Protections, |
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in accordance with 21 C.F.R. Part 56; or |
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(5) be accredited by a national accreditation |
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organization acceptable to the Texas Medical Board. |
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SECTION 4. Section 1003.058(b), Health and Safety Code, is |
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amended to read as follows: |
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(b) A governmental entity or an officer, employee, or agent |
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of a governmental entity may not interfere with an eligible |
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patient's access to or use of an investigational [a] stem cell |
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treatment authorized under this subchapter unless the treatment |
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uses an adult stem cell product that is considered an adulterated or |
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misbranded drug under Chapter 431. For purposes of this subsection, |
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a governmental entity may not consider the adult stem cell product |
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to be an adulterated or misbranded drug solely on the basis that the |
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United States Food and Drug Administration has not approved the |
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adult stem cell product. |
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SECTION 5. Subchapter B, Chapter 1003, Health and Safety |
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Code, is amended by adding Section 1003.060 to read as follows: |
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Sec. 1003.060. CONSTRUCTION OF SUBCHAPTER. This subchapter |
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may not be construed to: |
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(1) prohibit a physician from using adult stem cells |
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for their intended homologous use if the stem cells are: |
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(A) produced by a manufacturer registered by the |
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United States Food and Drug Administration; and |
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(B) commercially available; or |
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(2) require an institutional review board to oversee |
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treatment using adult stem cells registered by the United States |
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Food and Drug Administration for their intended homologous use. |
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SECTION 6. The Department of State Health Services is not |
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required to establish the investigational stem cell registry |
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described by Section 1003.0526, Health and Safety Code, as added by |
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this Act, until September 1, 2027. |
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SECTION 7. This Act takes effect September 1, 2019. |
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* * * * * |