86R21292 SCL-D
By: Parker, Springer, Zerwas, Lucio III H.B. No. 3148
Substitute the following for H.B. No. 3148:
By: Zedler C.S.H.B. No. 3148
A BILL TO BE ENTITLED
AN ACT
relating to the administration and oversight of investigational
adult stem cell treatments administered to certain patients.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Subchapter B, Chapter 1003, Health and Safety
Code, is amended by adding Section 1003.0525 to read as follows:
Sec. 1003.0525. ADMINISTRATION OF SUBCHAPTER. The
department shall administer this subchapter.
SECTION 2. Section 1003.054(c), Health and Safety Code, is
amended to read as follows:
(c) The executive commissioner by rule shall [may] adopt a
form for the informed consent under this section. The form must
provide notice that the department administers this subchapter.
SECTION 3. Section 1003.055(d), Health and Safety Code, is
amended to read as follows:
(d) An institutional review board that oversees
investigational stem cell treatments administered under this
subchapter must meet one of the following conditions [be affiliated
with]:
(1) be affiliated with a medical school, as defined by
Section 61.501, Education Code; [or]
(2) be affiliated with a hospital licensed under
Chapter 241 that has at least 150 beds;
(3) be accredited by the Association for the
Accreditation of Human Research Protection Programs;
(4) be registered by the United States Department of
Health and Human Services, Office for Human Research Protections,
in accordance with 21 C.F.R. Part 56; or
(5) be accredited by a national accreditation
organization acceptable to the department.
SECTION 4. Section 1003.058(b), Health and Safety Code, is
amended to read as follows:
(b) A governmental entity or an officer, employee, or agent
of a governmental entity may not interfere with an eligible
patient's access to or use of an investigational [a] stem cell
treatment authorized under this subchapter unless the treatment
uses an adult stem cell product that is considered an adulterated or
misbranded drug under Chapter 431. For purposes of this
subsection, a governmental entity may not consider the adult stem
cell product to be an adulterated or misbranded drug solely on the
basis that the United States Food and Drug Administration has not
approved the adult stem cell product.
SECTION 5. Subchapter B, Chapter 1003, Health and Safety
Code, is amended by adding Section 1003.060 to read as follows:
Sec. 1003.060. CONSTRUCTION OF SUBCHAPTER. This subchapter
may not be construed to:
(1) prohibit a physician from using adult stem cells
for their intended homologous use if the stem cells are:
(A) produced by a manufacturer registered by the
United States Food and Drug Administration; and
(B) commercially available; or
(2) require an institutional review board to oversee
treatment using adult stem cells registered by the United States
Food and Drug Administration for their intended homologous use.
SECTION 6. This Act takes effect September 1, 2019.