Florida Senate - 2025                        COMMITTEE AMENDMENT
       Bill No. SB 1768
       
       
       
       
       
       
                                Ì947004zÎ947004                         
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
                  Comm: RCS            .                                
                  04/02/2025           .                                
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       The Committee on Health Policy (Trumbull) recommended the
       following:
       
    1         Senate Amendment (with title amendment)
    2  
    3         Delete everything after the enacting clause
    4  and insert:
    5         Section 1. Section 458.3245, Florida Statutes, is created
    6  to read:
    7         458.3245Stem cell therapy.—
    8         (1) The Legislature recognizes the significant potential of
    9  stem cell therapies in advancing medical treatments and
   10  improving patient outcomes and further recognizes the need to
   11  ensure that such therapies are provided using stem cells
   12  obtained in an ethical manner that does not involve stem cells
   13  derived from aborted fetuses. It is the intent of the
   14  Legislature to foster medical innovation while upholding ethical
   15  standards that respect the sanctity of life. By encouraging the
   16  use of stem cell sources such as adult stem cells, umbilical
   17  cord blood, and other ethically obtained human cells, tissues,
   18  or cellular or tissue-based products, the state will advance
   19  regenerative medicine in a manner consistent with the values of
   20  this state.
   21         (2) As used in this section, the term:
   22         (a) “Human cells, tissues, or cellular or tissue-based
   23  products” means articles containing or consisting of human cells
   24  or tissues collected from cord blood donors who are residents of
   25  the United States which are intended for implantation,
   26  transplantation, infusion, or transfer into a human recipient,
   27  including but not limited to, bones, ligaments, skin, dura
   28  mater, heart valves, corneas, hematopoietic stem or progenitor
   29  cells derived from peripheral and cord blood, manipulated
   30  autologous chondrocytes, epithelial cells on a synthetic matrix,
   31  and semen or other reproductive tissue. The term does not
   32  include any of the following:
   33         1.Vascularized human organs for transplantation.
   34         2.Whole blood or blood components or blood derivative
   35  products subject to regulation under part I of chapter 499.
   36         3.Secreted or extracted human products, such as milk,
   37  collagen, and cell factors; except that semen is considered a
   38  human cell, tissue, or cellular or tissue-based product for
   39  purposes of this paragraph.
   40         4.Minimally manipulated bone marrow for homologous use and
   41  not combined with another article, except for with water,
   42  crystalloids, or a sterilizing, preserving, or storage agent, if
   43  the addition of the agent does not raise new clinical safety
   44  concerns with respect to the bone marrow.
   45         5.Ancillary products used in the manufacture of human
   46  cells, tissues, or cellular or tissue-based products.
   47         6.Cells, tissues, and organs derived from animals other
   48  than humans.
   49         7.In vitro diagnostic products.
   50         8.Blood vessels recovered with an organ, as defined in 42
   51  C.F.R. s. 121.2, which are intended for use in organ
   52  transplantation and labeled, “For use in organ transplantation
   53  only.
   54         9.Fetal-derived stem cells.
   55         10.Adipose-derived mesenchymal stem cells for
   56  transplantation.
   57         (b) “Minimally manipulated” means:
   58         1.For structural tissue, processing that does not alter
   59  the original relevant characteristics of the tissue relating to
   60  the tissue’s utility for reconstruction, repair, or replacement.
   61         2.For cells or nonstructural tissues, processing that does
   62  not alter the relevant biological characteristics of cells or
   63  tissues.
   64         (c) Physicianmeans a physician licensed under this
   65  chapter or under chapter 459 acting in the course and scope of
   66  his or her employment.
   67         (d) “Stem cell therapy” means a treatment involving the use
   68  of human cells, tissues, or cellular or tissue-based products.
   69  The term does not include treatment or research using human
   70  cells or tissues that were derived from a fetus or an embryo
   71  after an abortion.
   72         (3)(a)A physician may perform stem cell therapy that is
   73  not approved by the United States Food and Drug Administration
   74  if such therapy is used for treatment or procedures that are
   75  within the scope of practice for such physician and the
   76  therapies are related to orthopedics, wound care, or pain
   77  management.
   78         (b)To ensure that the retrieval, manufacture, storage, and
   79  use of stem cells used for therapies conducted under this
   80  section meet the highest standards, any stem cells used by a
   81  physician for therapy provided under this section must be:
   82         1.Manufactured in a clean room space that has been
   83  certified by the United States Food and Drug Administration for
   84  using high-efficiency particulate air filtration or ultra-low
   85  penetration air filtration to minimize nonviable and viable
   86  particulate contamination; and
   87         2.Retrieved, manufactured, and stored in a facility that
   88  is registered and regulated by the United States Food and Drug
   89  Administration and licensed or registered with one of the
   90  following entities:
   91         a.National Marrow Donor Program.
   92         b.World Marrow Donor Association.
   93         c.Association for the Advancement of Blood and
   94  Biotherapies.
   95         d.American Association of Tissue Banks.
   96         (4) In the performance of any procedure using or purporting
   97  to use stem cells or products containing stem cells, the
   98  physician shall adhere to the applicable current good
   99  manufacturing practices for the collection, removal, processing,
  100  implantation, and transfer of stem cells, or products containing
  101  stem cells, pursuant to the Federal Food, Drug, and Cosmetic
  102  Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.; and 21
  103  C.F.R. part 1271, Human Cells, Tissues, and Cellular and Tissue
  104  Based Products.
  105         (5) A physician who conducts stem cell therapy pursuant to
  106  this section shall provide a patient who is being treated with
  107  stem cell therapy with the following written notice before
  108  performing the therapy:
  109  
  110         THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW.
  111         This physician performs one or more stem cell
  112         therapies that have not yet been approved by the
  113         United States Food and Drug Administration. You are
  114         encouraged to consult with your primary care provider
  115         before undergoing any stem cell therapy.
  116  
  117         (6)A physician who is required to provide the written
  118  notice under subsection (5) shall:
  119         (a)Provide the written notice to a patient on paper that
  120  is at least 8.5 inches by 11 inches and printed in no less than
  121  40-point type.
  122         (b) Prominently display the written notice at the entrance
  123  to the physician’s office and in an area visible to patients
  124  inside such office.
  125         (c) Include the notice in any advertisement for the stem
  126  cell therapy. In any form of advertisement, the notice must be
  127  clearly legible and in a font size no smaller than the largest
  128  font size used in the advertisement.
  129         (7)(a) A physician required to provide the written notice
  130  under subsection (5) must obtain a signed consent form from the
  131  patient before performing the stem cell therapy.
  132         (b) The consent form must be signed by the patient or, if
  133  the patient is legally not competent, the patient’s
  134  representative and must state all of the following in language
  135  the patient or his or her representative could reasonably be
  136  expected to understand:
  137         1.The nature and character of the proposed treatment,
  138  including the treatment’s United States Food and Drug
  139  Administration approval status.
  140         2.The anticipated results of the proposed treatment.
  141         3.The recognized possible alternative forms of treatment.
  142         4.The recognized serious possible risks, complications,
  143  and anticipated benefits involved in the treatment and in the
  144  recognized possible alternative forms of treatment, including
  145  nontreatment.
  146         (8) This section does not apply to either of the following:
  147         (a) A physician who has obtained approval for an
  148  investigational new drug or device from the United States Food
  149  and Drug Administration for the use of human cells, tissues, or
  150  cellular or tissue-based products.
  151         (b) A physician who performs a stem cell therapy under an
  152  employment or other contract on behalf of an institution
  153  certified by any of the following:
  154         1.The Foundation for the Accreditation of Cellular
  155  Therapy.
  156         2.The Blood and Marrow Transplant Clinical Trials Network.
  157         3.The Association for the Advancement of Blood and
  158  Biotherapies.
  159         4.An entity with expertise in stem cell therapy as
  160  determined by the department.
  161         (9) A violation of this section may subject the physician
  162  to disciplinary action by the board or the department.
  163         (10) The Board of Medicine shall adopt rules in
  164  consultation with the Board of Osteopathic Medicine to implement
  165  this section.
  166         Section 2. Section 459.0127, Florida Statutes, is created
  167  to read:
  168         459.0127 Stem cell therapy.
  169         (1) The Legislature recognizes the significant potential of
  170  stem cell therapies in advancing medical treatments and
  171  improving patient outcomes and further recognizes the need to
  172  ensure that such therapies are provided using stem cells
  173  obtained in an ethical manner that does not involve stem cells
  174  derived from aborted fetuses. It is the intent of the
  175  Legislature to foster medical innovation while upholding ethical
  176  standards that respect the sanctity of life. By encouraging the
  177  use of stem cell sources such as adult stem cells, umbilical
  178  cord blood, and other ethically obtained human cells, tissues,
  179  or cellular or tissue-based products, the state will advance
  180  regenerative medicine in a manner consistent with the values of
  181  this state.
  182         (2) As used in this section, the term:
  183         (a) “Human cells, tissues, or cellular or tissue-based
  184  products” means articles containing or consisting of human cells
  185  or tissues collected from cord blood donors who are residents of
  186  the United States which are intended for implantation,
  187  transplantation, infusion, or transfer into a human recipient,
  188  including but not limited to, bones, ligaments, skin, dura
  189  mater, heart valves, corneas, hematopoietic stem or progenitor
  190  cells derived from peripheral and cord blood, manipulated
  191  autologous chondrocytes, epithelial cells on a synthetic matrix,
  192  and semen or other reproductive tissue. The term does not
  193  include any of the following:
  194         1.Vascularized human organs for transplantation.
  195         2.Whole blood or blood components or blood derivative
  196  products subject to regulation under part I of chapter 499.
  197         3.Secreted or extracted human products, such as milk,
  198  collagen, and cell factors; except that semen is considered a
  199  human cell, tissue, or cellular or tissue-based product for
  200  purposes of this paragraph.
  201         4.Minimally manipulated bone marrow for homologous use and
  202  not combined with another article, except for with water,
  203  crystalloids, or a sterilizing, preserving, or storage agent, if
  204  the addition of the agent does not raise new clinical safety
  205  concerns with respect to the bone marrow.
  206         5.Ancillary products used in the manufacture of human
  207  cells, tissues, or cellular or tissue-based products.
  208         6.Cells, tissues, and organs derived from animals other
  209  than humans.
  210         7.In vitro diagnostic products.
  211         8.Blood vessels recovered with an organ, as defined in 42
  212  C.F.R. s. 121.2, which are intended for use in organ
  213  transplantation and labeled, “For use in organ transplantation
  214  only.
  215         9.Fetal-derived stem cells.
  216         10.Adipose-derived mesenchymal stem cells for
  217  transplantation.
  218         (b) “Minimally manipulated” means:
  219         1.For structural tissue, processing that does not alter
  220  the original relevant characteristics of the tissue relating to
  221  the tissue’s utility for reconstruction, repair, or replacement.
  222         2.For cells or nonstructural tissues, processing that does
  223  not alter the relevant biological characteristics of cells or
  224  tissues.
  225         (c) Physicianmeans a physician licensed under this
  226  chapter or under chapter 458 acting in the course and scope of
  227  his or her employment.
  228         (d) “Stem cell therapy” means a treatment involving the use
  229  of human cells, tissues, or cellular or tissue-based products.
  230  The term does not include treatment or research using human
  231  cells or tissues that were derived from a fetus or an embryo
  232  after an abortion.
  233         (3)(a)A physician may perform stem cell therapy that is
  234  not approved by the United States Food and Drug Administration
  235  if such therapy is used for treatment or procedures that are
  236  within the scope of practice for such physician and the
  237  therapies are related to orthopedics, wound care, or pain
  238  management.
  239         (b)To ensure that the retrieval, manufacture, storage, and
  240  use of stem cells used for therapies conducted under this
  241  section meet the highest standards, any stem cells used by a
  242  physician for therapy provided under this section must be:
  243         1.Manufactured in a clean room space that has been
  244  certified by the United States Food and Drug Administration for
  245  using high-efficiency particulate air filtration or ultra-low
  246  penetration air filtration to minimize nonviable and viable
  247  particulate contamination; and
  248         2.Retrieved, manufactured, and stored in a facility that
  249  is registered and regulated by the United States Food and Drug
  250  Administration and licensed or registered with one of the
  251  following entities:
  252         a.National Marrow Donor Program.
  253         b.World Marrow Donor Association.
  254         c.Association for the Advancement of Blood and
  255  Biotherapies.
  256         d.American Association of Tissue Banks.
  257         (4) In the performance of any procedure using or purporting
  258  to use stem cells or products containing stem cells, the
  259  physician shall adhere to the applicable current good
  260  manufacturing practices for the collection, removal, processing,
  261  implantation, and transfer of stem cells, or products containing
  262  stem cells, pursuant to the Federal Food, Drug, and Cosmetic
  263  Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.; and 21
  264  C.F.R. part 1271, Human Cells, Tissues, and Cellular and Tissue
  265  Based Products.
  266         (5) A physician who conducts stem cell therapy pursuant to
  267  this section shall provide a patient who is being treated with
  268  stem cell therapy with the following written notice before
  269  performing the therapy:
  270  
  271         THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW.
  272         This physician performs one or more stem cell
  273         therapies that have not yet been approved by the
  274         United States Food and Drug Administration. You are
  275         encouraged to consult with your primary care provider
  276         before undergoing any stem cell therapy.
  277  
  278         (6)A physician who is required to provide the written
  279  notice under subsection (5) shall:
  280         (a)Provide the written notice to a patient on paper that
  281  is at least 8.5 inches by 11 inches and printed in no less than
  282  40-point type.
  283         (b) Prominently display the written notice at the entrance
  284  to the physician’s office and in an area visible to patients
  285  inside such office.
  286         (c) Include the notice in any advertisement for the stem
  287  cell therapy. In any form of advertisement, the notice must be
  288  clearly legible and in a font size no smaller than the largest
  289  font size used in the advertisement.
  290         (7)(a) A physician required to provide the written notice
  291  under subsection (5) must obtain a signed consent form from the
  292  patient before performing the stem cell therapy.
  293         (b) The consent form must be signed by the patient or, if
  294  the patient is legally not competent, the patient’s
  295  representative and must state all of the following in language
  296  the patient or his or her representative could reasonably be
  297  expected to understand:
  298         1.The nature and character of the proposed treatment,
  299  including the treatment’s United States Food and Drug
  300  Administration approval status.
  301         2.The anticipated results of the proposed treatment.
  302         3.The recognized possible alternative forms of treatment.
  303         4.The recognized serious possible risks, complications,
  304  and anticipated benefits involved in the treatment and in the
  305  recognized possible alternative forms of treatment, including
  306  nontreatment.
  307         (8) This section does not apply to either of the following:
  308         (a) A physician who has obtained approval for an
  309  investigational new drug or device from the United States Food
  310  and Drug Administration for the use of human cells, tissues, or
  311  cellular or tissue-based products.
  312         (b) A physician who performs a stem cell therapy under an
  313  employment or other contract on behalf of an institution
  314  certified by any of the following:
  315         1.The Foundation for the Accreditation of Cellular
  316  Therapy.
  317         2.The Blood and Marrow Transplant Clinical Trials Network.
  318         3.The Association for the Advancement of Blood and
  319  Biotherapies.
  320         4.An entity with expertise in stem cell therapy as
  321  determined by the department.
  322         (9) A violation of this section may subject the physician
  323  to disciplinary action under the rules that have been developed
  324  by the board or the department as applicable.
  325         (10) The Board of Osteopathic Medicine shall adopt rules in
  326  consultation with the Board of Medicine to implement this
  327  section.
  328         Section 3. This act shall take effect July 1, 2025.
  329  
  330  ================= T I T L E  A M E N D M E N T ================
  331  And the title is amended as follows:
  332         Delete everything before the enacting clause
  333  and insert:
  334                        A bill to be entitled                      
  335         An act relating to stem cell therapy; creating ss.
  336         458.3245 and 459.0127, F.S.; providing legislative
  337         findings and intent; defining terms; authorizing
  338         physicians to perform stem cell therapy not approved
  339         by the United States Food and Drug Administration
  340         under certain circumstances; specifying requirements
  341         for the stem cells that may be used by such
  342         physicians; requiring such physicians to adhere to
  343         applicable current good manufacturing practices in the
  344         performance of such therapies; requiring physicians to
  345         provide a specified written notice to patients before
  346         performing any stem cell therapy; specifying
  347         requirements for the written notice; providing
  348         advertisement requirements; requiring physicians to
  349         obtain written consent from the patient or his or her
  350         representative before performing the therapy;
  351         specifying requirements for the consent form;
  352         providing applicability; providing for disciplinary
  353         action; requiring the Board of Medicine and the Board
  354         of Osteopathic Medicine, respectively, to adopt rules
  355         in consultation with one another; providing an
  356         effective date.