| 1 | 1 | | 86R10694 SCL-D |
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| 2 | 2 | | By: Bettencourt S.B. No. 1765 |
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| 3 | 3 | | |
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| 4 | 4 | | |
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| 5 | 5 | | A BILL TO BE ENTITLED |
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| 6 | 6 | | AN ACT |
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| 7 | 7 | | relating to the administration and oversight of investigational |
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| 8 | 8 | | adult stem cell treatments administered to certain patients. |
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| 9 | 9 | | BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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| 10 | 10 | | SECTION 1. Subchapter B, Chapter 1003, Health and Safety |
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| 11 | 11 | | Code, is amended by adding Section 1003.0525 to read as follows: |
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| 12 | 12 | | Sec. 1003.0525. ADMINISTRATION OF SUBCHAPTER. The |
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| 13 | 13 | | department shall administer this subchapter. |
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| 14 | 14 | | SECTION 2. Section 1003.055(d), Health and Safety Code, is |
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| 15 | 15 | | amended to read as follows: |
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| 16 | 16 | | (d) An institutional review board that oversees |
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| 17 | 17 | | investigational stem cell treatments administered under this |
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| 18 | 18 | | subchapter must [be affiliated with]: |
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| 19 | 19 | | (1) be affiliated with a medical school, as defined by |
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| 20 | 20 | | Section 61.501, Education Code; [or] |
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| 21 | 21 | | (2) be affiliated with a hospital licensed under |
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| 22 | 22 | | Chapter 241 that has at least 150 beds; |
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| 23 | 23 | | (3) be accredited by the Association for the |
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| 24 | 24 | | Accreditation of Human Research Protection Programs; |
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| 25 | 25 | | (4) be registered by the United States Department of |
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| 26 | 26 | | Health and Human Services, Office for Human Research Protections, |
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| 27 | 27 | | in accordance with 21 C.F.R. Part 56; or |
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| 28 | 28 | | (5) be accredited by a national accreditation |
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| 29 | 29 | | organization acceptable to the department. |
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| 30 | 30 | | SECTION 3. Section 1003.058(b), Health and Safety Code, is |
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| 31 | 31 | | amended to read as follows: |
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| 32 | 32 | | (b) A governmental entity or an officer, employee, or agent |
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| 33 | 33 | | of a governmental entity may not interfere with an eligible |
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| 34 | 34 | | patient's access to or use of a stem cell treatment authorized under |
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| 35 | 35 | | this subchapter unless the treatment uses a drug that is considered |
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| 36 | 36 | | adulterated or misbranded under Chapter 431. For purposes of this |
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| 37 | 37 | | subsection, a governmental entity may not consider the drug to be |
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| 38 | 38 | | adulterated or misbranded solely on the basis that the United |
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| 39 | 39 | | States Food and Drug Administration has not approved the drug. |
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| 40 | 40 | | SECTION 4. Subchapter B, Chapter 1003, Health and Safety |
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| 41 | 41 | | Code, is amended by adding Section 1003.060 to read as follows: |
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| 42 | 42 | | Sec. 1003.060. CONSTRUCTION OF SUBCHAPTER. This subchapter |
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| 43 | 43 | | may not be construed to: |
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| 44 | 44 | | (1) prohibit a physician from using adult stem cells |
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| 45 | 45 | | for their intended homologous use if the stem cells are: |
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| 46 | 46 | | (A) registered by the United States Food and Drug |
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| 47 | 47 | | Administration; and |
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| 48 | 48 | | (B) commercially available; or |
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| 49 | 49 | | (2) require an institutional review board to oversee |
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| 50 | 50 | | treatment using adult stem cells registered by the United States |
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| 51 | 51 | | Food and Drug Administration for their intended homologous use. |
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| 52 | 52 | | SECTION 5. This Act takes effect September 1, 2019. |
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