By: Parker, et al. (Senate Sponsor - Bettencourt) H.B. No. 3148
         (In the Senate - Received from the House May 9, 2019;
  May 10, 2019, read first time and referred to Committee on Health &
  Human Services; May 20, 2019, reported adversely, with favorable
  Committee Substitute by the following vote:  Yeas 9, Nays 0;
  May 20, 2019, sent to printer.)
Click here to see the committee vote
 
  COMMITTEE SUBSTITUTE FOR H.B. No. 3148 By:  Perry
 
 
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 Sections 1003.0525 and 1003.0526 to read
  as follows:
         Sec. 1003.0525.  ADMINISTRATION OF SUBCHAPTER. The
  department shall administer this subchapter.
         Sec. 1003.0526.  INVESTIGATIONAL STEM CELL REGISTRY. The
  department shall establish and maintain an investigational stem
  cell registry that lists each physician who administers an
  investigational stem cell treatment under 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 Texas Medical Board.
         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.  The Department of State Health Services is not
  required to establish the investigational stem cell registry
  described by Section 1003.0526, Health and Safety Code, as added by
  this Act, until September 1, 2027.
         SECTION 7.  This Act takes effect September 1, 2019.
 
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