Florida Senate - 2025                             CS for SB 1768
       
       
        
       By the Committee on Health Policy; and Senator Trumbull
       
       
       
       
       
       588-03144-25                                          20251768c1
    1                        A bill to be entitled                      
    2         An act relating to stem cell therapy; creating ss.
    3         458.3245 and 459.0127, F.S.; providing legislative
    4         findings and intent; defining terms; authorizing
    5         physicians to perform stem cell therapy not approved
    6         by the United States Food and Drug Administration
    7         under certain circumstances; specifying requirements
    8         for the stem cells that may be used by such
    9         physicians; requiring such physicians to adhere to
   10         applicable current good manufacturing practices in the
   11         performance of such therapies; requiring physicians to
   12         provide a specified written notice to patients before
   13         performing any stem cell therapy; specifying
   14         requirements for the written notice; providing
   15         advertisement requirements; requiring physicians to
   16         obtain written consent from the patient or his or her
   17         representative before performing the therapy;
   18         specifying requirements for the consent form;
   19         providing applicability; providing for disciplinary
   20         action; requiring the Board of Medicine and the Board
   21         of Osteopathic Medicine, respectively, to adopt rules
   22         in consultation with one another; providing an
   23         effective date.
   24          
   25  Be It Enacted by the Legislature of the State of Florida:
   26  
   27         Section 1. Section 458.3245, Florida Statutes, is created
   28  to read:
   29         458.3245Stem cell therapy.—
   30         (1) The Legislature recognizes the significant potential of
   31  stem cell therapies in advancing medical treatments and
   32  improving patient outcomes and further recognizes the need to
   33  ensure that such therapies are provided using stem cells
   34  obtained in an ethical manner that does not involve stem cells
   35  derived from aborted fetuses. It is the intent of the
   36  Legislature to foster medical innovation while upholding ethical
   37  standards that respect the sanctity of life. By encouraging the
   38  use of stem cell sources such as adult stem cells, umbilical
   39  cord blood, and other ethically obtained human cells, tissues,
   40  or cellular or tissue-based products, the state will advance
   41  regenerative medicine in a manner consistent with the values of
   42  this state.
   43         (2) As used in this section, the term:
   44         (a) “Human cells, tissues, or cellular or tissue-based
   45  products” means articles containing or consisting of human cells
   46  or tissues collected from cord blood donors who are residents of
   47  the United States which are intended for implantation,
   48  transplantation, infusion, or transfer into a human recipient,
   49  including, but not limited to, bones, ligaments, skin, dura
   50  mater, heart valves, corneas, hematopoietic stem or progenitor
   51  cells derived from peripheral and cord blood, manipulated
   52  autologous chondrocytes, epithelial cells on a synthetic matrix,
   53  and semen or other reproductive tissue. The term does not
   54  include any of the following:
   55         1.Vascularized human organs for transplantation.
   56         2.Whole blood or blood components or blood derivative
   57  products subject to regulation under part I of chapter 499.
   58         3.Secreted or extracted human products, such as milk,
   59  collagen, and cell factors; except that semen is considered a
   60  human cell, tissue, or cellular or tissue-based product for
   61  purposes of this paragraph.
   62         4.Minimally manipulated bone marrow for homologous use and
   63  not combined with another article, except for with water,
   64  crystalloids, or a sterilizing, preserving, or storage agent, if
   65  the addition of the agent does not raise new clinical safety
   66  concerns with respect to the bone marrow.
   67         5.Ancillary products used in the manufacture of human
   68  cells, tissues, or cellular or tissue-based products.
   69         6.Cells, tissues, and organs derived from animals other
   70  than humans.
   71         7.In vitro diagnostic products.
   72         8.Blood vessels recovered with an organ, as defined in 42
   73  C.F.R. s. 121.2, which are intended for use in organ
   74  transplantation and labeled, “For use in organ transplantation
   75  only.
   76         9.Fetal-derived stem cells.
   77         10.Adipose-derived mesenchymal stem cells for
   78  transplantation.
   79         (b) “Minimally manipulated” means:
   80         1.For structural tissue, processing that does not alter
   81  the original relevant characteristics of the tissue relating to
   82  the tissue’s utility for reconstruction, repair, or replacement.
   83         2.For cells or nonstructural tissues, processing that does
   84  not alter the relevant biological characteristics of cells or
   85  tissues.
   86         (c) Physicianmeans a physician licensed under this
   87  chapter or under chapter 459 acting in the course and scope of
   88  his or her employment.
   89         (d) “Stem cell therapy” means a treatment involving the use
   90  of human cells, tissues, or cellular or tissue-based products.
   91  The term does not include treatment or research using human
   92  cells or tissues that were derived from a fetus or an embryo
   93  after an abortion.
   94         (3)(a)A physician may perform stem cell therapy that is
   95  not approved by the United States Food and Drug Administration
   96  if such therapy is used for treatment or procedures that are
   97  within the scope of practice for such physician and the
   98  therapies are related to orthopedics, wound care, or pain
   99  management.
  100         (b)To ensure that the retrieval, manufacture, storage, and
  101  use of stem cells used for therapies conducted under this
  102  section meet the highest standards, any stem cells used by a
  103  physician for therapy provided under this section must be:
  104         1.Manufactured in a clean room space that has been
  105  certified by the United States Food and Drug Administration for
  106  using high-efficiency particulate air filtration or ultra-low
  107  penetration air filtration to minimize nonviable and viable
  108  particulate contamination; and
  109         2.Retrieved, manufactured, and stored in a facility that
  110  is registered and regulated by the United States Food and Drug
  111  Administration and licensed or registered with one of the
  112  following entities:
  113         a.National Marrow Donor Program.
  114         b.World Marrow Donor Association.
  115         c.Association for the Advancement of Blood and
  116  Biotherapies.
  117         d.American Association of Tissue Banks.
  118         (4) In the performance of any procedure using or purporting
  119  to use stem cells or products containing stem cells, the
  120  physician shall adhere to the applicable current good
  121  manufacturing practices for the collection, removal, processing,
  122  implantation, and transfer of stem cells, or products containing
  123  stem cells, pursuant to the Federal Food, Drug, and Cosmetic
  124  Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.; and 21
  125  C.F.R. part 1271, Human Cells, Tissues, and Cellular and Tissue
  126  Based Products.
  127         (5) A physician who conducts stem cell therapy pursuant to
  128  this section shall provide a patient who is being treated with
  129  stem cell therapy with the following written notice before
  130  performing the therapy:
  131  
  132         THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW.
  133         This physician performs one or more stem cell
  134         therapies that have not yet been approved by the
  135         United States Food and Drug Administration. You are
  136         encouraged to consult with your primary care provider
  137         before undergoing any stem cell therapy.
  138  
  139         (6)A physician who is required to provide the written
  140  notice under subsection (5) shall:
  141         (a)Provide the written notice to a patient on paper that
  142  is at least 8.5 inches by 11 inches and printed in no less than
  143  40-point type.
  144         (b) Prominently display the written notice at the entrance
  145  to the physician’s office and in an area visible to patients
  146  inside such office.
  147         (c) Include the notice in any advertisement for the stem
  148  cell therapy. In any form of advertisement, the notice must be
  149  clearly legible and in a font size no smaller than the largest
  150  font size used in the advertisement.
  151         (7)(a) A physician required to provide the written notice
  152  under subsection (5) must obtain a signed consent form from the
  153  patient before performing the stem cell therapy.
  154         (b) The consent form must be signed by the patient or, if
  155  the patient is legally not competent, the patient’s
  156  representative and must state all of the following in language
  157  the patient or his or her representative could reasonably be
  158  expected to understand:
  159         1.The nature and character of the proposed treatment,
  160  including the treatment’s United States Food and Drug
  161  Administration approval status.
  162         2.The anticipated results of the proposed treatment.
  163         3.The recognized possible alternative forms of treatment.
  164         4.The recognized serious possible risks, complications,
  165  and anticipated benefits involved in the treatment and in the
  166  recognized possible alternative forms of treatment, including
  167  nontreatment.
  168         (8) This section does not apply to either of the following:
  169         (a) A physician who has obtained approval for an
  170  investigational new drug or device from the United States Food
  171  and Drug Administration for the use of human cells, tissues, or
  172  cellular or tissue-based products.
  173         (b) A physician who performs a stem cell therapy under an
  174  employment or other contract on behalf of an institution
  175  certified by any of the following:
  176         1.The Foundation for the Accreditation of Cellular
  177  Therapy.
  178         2.The Blood and Marrow Transplant Clinical Trials Network.
  179         3.The Association for the Advancement of Blood and
  180  Biotherapies.
  181         4.An entity with expertise in stem cell therapy as
  182  determined by the department.
  183         (9) A violation of this section may subject the physician
  184  to disciplinary action by the board or the department.
  185         (10) The Board of Medicine shall adopt rules in
  186  consultation with the Board of Osteopathic Medicine to implement
  187  this section.
  188         Section 2. Section 459.0127, Florida Statutes, is created
  189  to read:
  190         459.0127 Stem cell therapy.
  191         (1) The Legislature recognizes the significant potential of
  192  stem cell therapies in advancing medical treatments and
  193  improving patient outcomes and further recognizes the need to
  194  ensure that such therapies are provided using stem cells
  195  obtained in an ethical manner that does not involve stem cells
  196  derived from aborted fetuses. It is the intent of the
  197  Legislature to foster medical innovation while upholding ethical
  198  standards that respect the sanctity of life. By encouraging the
  199  use of stem cell sources such as adult stem cells, umbilical
  200  cord blood, and other ethically obtained human cells, tissues,
  201  or cellular or tissue-based products, the state will advance
  202  regenerative medicine in a manner consistent with the values of
  203  this state.
  204         (2) As used in this section, the term:
  205         (a) “Human cells, tissues, or cellular or tissue-based
  206  products” means articles containing or consisting of human cells
  207  or tissues collected from cord blood donors who are residents of
  208  the United States which are intended for implantation,
  209  transplantation, infusion, or transfer into a human recipient,
  210  including, but not limited to, bones, ligaments, skin, dura
  211  mater, heart valves, corneas, hematopoietic stem or progenitor
  212  cells derived from peripheral and cord blood, manipulated
  213  autologous chondrocytes, epithelial cells on a synthetic matrix,
  214  and semen or other reproductive tissue. The term does not
  215  include any of the following:
  216         1.Vascularized human organs for transplantation.
  217         2.Whole blood or blood components or blood derivative
  218  products subject to regulation under part I of chapter 499.
  219         3.Secreted or extracted human products, such as milk,
  220  collagen, and cell factors; except that semen is considered a
  221  human cell, tissue, or cellular or tissue-based product for
  222  purposes of this paragraph.
  223         4.Minimally manipulated bone marrow for homologous use and
  224  not combined with another article, except for with water,
  225  crystalloids, or a sterilizing, preserving, or storage agent, if
  226  the addition of the agent does not raise new clinical safety
  227  concerns with respect to the bone marrow.
  228         5.Ancillary products used in the manufacture of human
  229  cells, tissues, or cellular or tissue-based products.
  230         6.Cells, tissues, and organs derived from animals other
  231  than humans.
  232         7.In vitro diagnostic products.
  233         8.Blood vessels recovered with an organ, as defined in 42
  234  C.F.R. s. 121.2, which are intended for use in organ
  235  transplantation and labeled, “For use in organ transplantation
  236  only.
  237         9.Fetal-derived stem cells.
  238         10.Adipose-derived mesenchymal stem cells for
  239  transplantation.
  240         (b) “Minimally manipulated” means:
  241         1.For structural tissue, processing that does not alter
  242  the original relevant characteristics of the tissue relating to
  243  the tissue’s utility for reconstruction, repair, or replacement.
  244         2.For cells or nonstructural tissues, processing that does
  245  not alter the relevant biological characteristics of cells or
  246  tissues.
  247         (c) Physicianmeans a physician licensed under this
  248  chapter or under chapter 458 acting in the course and scope of
  249  his or her employment.
  250         (d) “Stem cell therapy” means a treatment involving the use
  251  of human cells, tissues, or cellular or tissue-based products.
  252  The term does not include treatment or research using human
  253  cells or tissues that were derived from a fetus or an embryo
  254  after an abortion.
  255         (3)(a)A physician may perform stem cell therapy that is
  256  not approved by the United States Food and Drug Administration
  257  if such therapy is used for treatment or procedures that are
  258  within the scope of practice for such physician and the
  259  therapies are related to orthopedics, wound care, or pain
  260  management.
  261         (b)To ensure that the retrieval, manufacture, storage, and
  262  use of stem cells used for therapies conducted under this
  263  section meet the highest standards, any stem cells used by a
  264  physician for therapy provided under this section must be:
  265         1.Manufactured in a clean room space that has been
  266  certified by the United States Food and Drug Administration for
  267  using high-efficiency particulate air filtration or ultra-low
  268  penetration air filtration to minimize nonviable and viable
  269  particulate contamination; and
  270         2.Retrieved, manufactured, and stored in a facility that
  271  is registered and regulated by the United States Food and Drug
  272  Administration and licensed or registered with one of the
  273  following entities:
  274         a.National Marrow Donor Program.
  275         b.World Marrow Donor Association.
  276         c.Association for the Advancement of Blood and
  277  Biotherapies.
  278         d.American Association of Tissue Banks.
  279         (4) In the performance of any procedure using or purporting
  280  to use stem cells or products containing stem cells, the
  281  physician shall adhere to the applicable current good
  282  manufacturing practices for the collection, removal, processing,
  283  implantation, and transfer of stem cells, or products containing
  284  stem cells, pursuant to the Federal Food, Drug, and Cosmetic
  285  Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.; and 21
  286  C.F.R. part 1271, Human Cells, Tissues, and Cellular and Tissue
  287  Based Products.
  288         (5) A physician who conducts stem cell therapy pursuant to
  289  this section shall provide a patient who is being treated with
  290  stem cell therapy with the following written notice before
  291  performing the therapy:
  292  
  293         THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW.
  294         This physician performs one or more stem cell
  295         therapies that have not yet been approved by the
  296         United States Food and Drug Administration. You are
  297         encouraged to consult with your primary care provider
  298         before undergoing any stem cell therapy.
  299  
  300         (6)A physician who is required to provide the written
  301  notice under subsection (5) shall:
  302         (a)Provide the written notice to a patient on paper that
  303  is at least 8.5 inches by 11 inches and printed in no less than
  304  40-point type.
  305         (b) Prominently display the written notice at the entrance
  306  to the physician’s office and in an area visible to patients
  307  inside such office.
  308         (c) Include the notice in any advertisement for the stem
  309  cell therapy. In any form of advertisement, the notice must be
  310  clearly legible and in a font size no smaller than the largest
  311  font size used in the advertisement.
  312         (7)(a) A physician required to provide the written notice
  313  under subsection (5) must obtain a signed consent form from the
  314  patient before performing the stem cell therapy.
  315         (b) The consent form must be signed by the patient or, if
  316  the patient is legally not competent, the patient’s
  317  representative and must state all of the following in language
  318  the patient or his or her representative could reasonably be
  319  expected to understand:
  320         1.The nature and character of the proposed treatment,
  321  including the treatment’s United States Food and Drug
  322  Administration approval status.
  323         2.The anticipated results of the proposed treatment.
  324         3.The recognized possible alternative forms of treatment.
  325         4.The recognized serious possible risks, complications,
  326  and anticipated benefits involved in the treatment and in the
  327  recognized possible alternative forms of treatment, including
  328  nontreatment.
  329         (8) This section does not apply to either of the following:
  330         (a) A physician who has obtained approval for an
  331  investigational new drug or device from the United States Food
  332  and Drug Administration for the use of human cells, tissues, or
  333  cellular or tissue-based products.
  334         (b) A physician who performs a stem cell therapy under an
  335  employment or other contract on behalf of an institution
  336  certified by any of the following:
  337         1.The Foundation for the Accreditation of Cellular
  338  Therapy.
  339         2.The Blood and Marrow Transplant Clinical Trials Network.
  340         3.The Association for the Advancement of Blood and
  341  Biotherapies.
  342         4.An entity with expertise in stem cell therapy as
  343  determined by the department.
  344         (9) A violation of this section may subject the physician
  345  to disciplinary action under the rules that have been developed
  346  by the board or the department as applicable.
  347         (10) The Board of Osteopathic Medicine shall adopt rules in
  348  consultation with the Board of Medicine to implement this
  349  section.
  350         Section 3. This act shall take effect July 1, 2025.