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 tissues 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)Physician means 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 physicians 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 patients 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 treatments 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: 190 459.0127Stem 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 tissues 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)Physician means 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 physicians 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 patients 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 treatments 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.