HB 1617 — Stem Cell Therapy

9.7.

10.8.

121.2, which are intended for use in organ transplantation and labeled, "For use in organ transplantation only." 11.9.

12.10.

Adipose-derived mesenchymal stem cells for transplantation.Page 3 of 8 CODING:

(b)Words "Minimallystricken manipulated"are means:deletions;

words underlined are additions.

hb1617-01-c1 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/HB 1617 2025 transplantation.

(c) "Minimally manipulated" means:

(c)(d) "Physician""Stem cell therapy" means a physiciantreatment licensedinvolving underthe thisuse chapterof actingafterbirth inplacental theperinatal coursestem andcells scopeor ofhuman hiscells, tissues, or hercellular employment.or tissue-based products.

(d)The "Stemterm celldoes therapy"not meansinclude a treatment involvingor theresearch useusing of afterbirth placental perinatal stem cells, or human cells,cells tissues, or cellulartissues orthat tissue-basedwere products,derived whichfrom compliesa withfetus theor regulatoryan requirementsembryo providedafter inan thisabortion. section.

The(3)(a) termA doeshealth notcare includeprovider treatmentlicensed orin researchthis usingstate humanmay cellsperform orstem tissuescell therapy that wereis derivednot fromapproved aby fetusthe United States Food and Drug Administration if such therapy is used for treatment or anprocedures Pagethat 4are within the scope of 16practice CODING:for such provider and the therapies are related to orthopedics, wound care, or pain management.

(b) To ensure that the retrieval, manufacture, storage, and use of stem cells used for therapies conducted under this section meet the highest standards, any stem cells used by a health care provider for therapy provided under this section must be:

1.

Manufactured in a clean room space that has been Page 4 of 8 CODING:

hb1617-02-c2hb1617-01-c1 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/CS/HBCS/HB 1617 2025 embryocertified afterby anthe abortion.United States Food and Drug Administration for using high-efficiency particulate air filtration or ultra-low penetration air filtration to minimize nonviable and viable particulate contamination;

(3)(a) A physician may perform stem cell therapy that is not approved by the United States Food and Drug2. Administration if such therapy is used for treatment or procedures that are within the scope of practice for such physician and the therapies are related to orthopedics, wound care, or pain management.

(b)Retrieved, Tomanufactured, ensure that the retrieval, manufacture, storage, and usestored ofin stema cellsfacility usedthat foris therapiesregistered conductedand underregulated thisby section meet the highestUnited standards,States anyFood stemand cellsDrug usedAdministration byand alicensed physicianor forregistered therapywith providedone underof thisthe sectionfollowing must:entities:

1.

Be manufactured in a clean room space that has been certified by the United States Food and Drug Administration for using high-efficiency particulate air filtration or ultra-low penetration air filtration to minimize nonviable and viable particulate contamination;

2.

Be retrieved, manufactured, and stored in a facility that is registered and regulated by the United States Food and Drug Administration and licensed or registered with one of the following entities:

American Association of Tissue Banks;Banks.

and(4) PageIn 5the performance of 16any CODING:procedure using or purporting to use stem cells or products containing stem cells, the health care provider shall adhere to the applicable current good manufacturing practices for the collection, removal, processing, implantation, and transfer of stem cells, or products containing stem cells, pursuant to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.

Words stricken are deletions;

words underlined are additions.

hb1617-02-c2 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/CS/HB 1617 2025 3.

Contain viable or live cells upon post-thaw analysis and be included in a post-thaw viability analysis report for the product lot which will be sent to the physician before use with the physician's patient.

(c) A physician performing stem cell therapy may not obtain stem cells for therapies from a facility engaging in the retrieval, manufacture, or storage of stem cells intended for human use under this section unless the facility maintains valid accreditation or certification as required by this subsection.

Any contract or other agreement by which a physician obtains stem cells for therapies from such a facility must include the following:

1.

A requirement that the facility provide all of the following information to the physician:

a.

The name and address of the facility.

b.

The certifying organization.

c.

The type and scope of certification.

d.

The effective and expiration dates of the certification.

e.

Any limitations or conditions imposed by the certifying organization.

2.

A requirement that the facility notify the physician within 30 days of any change in certification status, including renewal, suspension, revocation, or expiration.

(4) In the performance of any procedure using or Page 6 of 16 CODING:

Words stricken are deletions;

words underlined are additions.

hb1617-02-c2 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/CS/HB 1617 2025 purporting to use stem cells or products containing stem cells, the physician shall adhere to the applicable current good manufacturing practices for the collection, removal, processing, implantation, and transfer of stem cells, or products containing stem cells, pursuant to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.

part 1271, Human Cells, Tissues, and Cellular and Tissue-Tissue-Based Based Products.

(5)(a)(5) A physicianhealth care provider who conducts stem cell therapy pursuant to this section shall includeprovide a patient who is being treated with stem cell therapy with the following inwritten anynotice formPage 5 of advertisement:8 CODING:

Words stricken are deletions;

words underlined are additions.

hb1617-01-c1 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/HB 1617 2025 before performing the therapy:

This physicianhealth care practitioner performs one or more stem cell therapies that have not yet been approved by the United States Food and Drug Administration.

(b)(6) TheA noticehealth requiredcare underprovider paragraphrequired (a)to mustprovide be clearly legible and in a type size no smaller than the largestwritten typenotice sizeunder usedsubsection in(5) theshall: advertisement.

(6)(a)(a) AProvide physicianthe whowritten conductsnotice stemto cella therapypatient pursuanton topaper thisthat sectionis shallat obtainleast a8.5 signedinches consentby form11 frominches theand patientprinted beforein performingno theless stemthan cell40-point therapy.type.

Page(b) 7Prominently ofdisplay 16the CODING:written notice at the entrance to the health care provider's office and in an area visible to patients inside such office.

(c) Include the notice in any advertisement for the stem cell therapy.

In any form of advertisement, the notice must be clearly legible and in a font size no smaller than the largest font size used in the advertisement.

(7)(a) A health care provider required to provide the written notice under subsection (5) must obtain a signed consent form from the patient before performing the stem cell therapy.

(b) The consent form must be signed by the patient or, if Page 6 of 8 CODING:

hb1617-02-c2hb1617-01-c1 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/CS/HBCS/HB 1617 2025 (b) The consent form must be signed by the patient or, if the patient is not legally not competent, the patient's representative and must state all of the following in language the patient or his or her representative maycould reasonably be expected to understand:

The nature and character of the proposed treatment.treatment, including the treatment's United States Food and Drug Administration approval status.

That the proposed stem cell therapy has not yet been approved by the United States Food and Drug Administration.

3.

3.

The recognized possible alternative forms of treatment.

5.(8) This section does not apply to either of the following:

That(a) theA patienthealth iscare encouragedprovider towho consulthas withobtained hisapproval for an investigational new drug or herdevice primaryfrom carethe providerUnited beforeStates undergoingFood anyand stemDrug cellAdministration therapy.for the use of human cells, tissues, or cellular or tissue-based products.

(7)(b) ThisA sectionhealth doescare notprovider applywho toperforms a stem cell therapy under an employment or other contract on behalf of an institution certified by any of the following:

(a) A physician who has obtained approval for an investigational new drug or device from the United States Food and Drug Administration for the use of human cells, tissues, or cellular or tissue-based products;

or (b) A physician who performs stem cell therapy under an employment or other contract on behalf of an institution certified by any of the following:

The Foundation for the Accreditation of Cellular PageTherapy. 8 of 16 CODING:

Words stricken are deletions;

words underlined are additions.

hb1617-02-c2 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/CS/HB 1617 2025 Therapy.

The Blood and Marrow Transplant Clinical Trials Network.Page 7 of 8 CODING:

3.

The Association for the Advancement of Blood and Biotherapies.

4.

An entity with expertise in stem cell therapy as determined by the department.

(8) A violation of this section may subject the physician to disciplinary action by the board.

(10) The board may adopt rules to implement this section.

Section 2.

Section 459.0127, Florida Statutes, is created to read:

459.0127 Stem cell therapy.— (1) The Legislature recognizes the significant potential of stem cell therapies in advancing medical treatments and improving patient outcomes and further recognizes the need to ensure that such therapies are provided using stem cells obtained in an ethical manner that does not involve stem cells derived from aborted fetuses.

It is the intent of the Legislature to foster medical innovation while upholding ethical standards that respect the sanctity of life.

By encouraging the use of stem cell sources such as adult stem cells, umbilical cord blood, and other ethically obtained human cells, tissues, or cellular or tissue-based products, the state will advance regenerative medicine in a manner consistent with the values of Page 9 of 16 CODING:

hb1617-02-c2hb1617-01-c1 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/CS/HBCS/HB 1617 2025 thisNetwork. state.

(2) As used in this section, the term:

(a) "Human cells, tissues, or cellular or tissue-based products" means articles containing or consisting of human cells or tissues obtained from umbilical cord or cord blood, donated by residents of the United States, which are intended for implantation, transplantation, infusion, or transfer into a human recipient.

The term does not include any of the following:

1.

Treatment or research using human cells or tissues that were derived from a fetus or an embryo after an abortion.

2.

The sale, manufacture, or distribution of computer products created using human cells, tissues, or cellular or tissue-based products.

Vascularized human organs for transplantation.

4.

Whole blood or blood components or blood derivative products subject to regulation under part I of chapter 499.

5.

Secreted or extracted human products, such as milk, collagen, and cell factors;

however, semen is considered a human cell, tissue, or cellular or tissue-based product for purposes of this paragraph.

6.

Minimally manipulated bone marrow for homologous use and not combined with another article, except for with water, crystalloids, or a sterilizing, preserving, or storage agent, if the addition of the agent does not raise new clinical safety concerns with respect to the bone marrow.

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words underlined are additions.

hb1617-02-c2 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/CS/HB 1617 2025 7.

Ancillary products used in the manufacture of human cells, tissues, or cellular or tissue-based products.

8.

Cells, tissues, and organs derived from animals other than humans.

9.

In vitro diagnostic products.

10.

Blood vessels recovered with an organ, as defined in 42 C.F.R.

s.

121.2, which are intended for use in organ transplantation and labeled, "For use in organ transplantation only." 11.

Fetal-derived stem cells.

12.

Adipose-derived mesenchymal stem cells for transplantation.

(b) "Minimally manipulated" means:

1.

For structural tissue, processing that does not alter the original relevant characteristics of the tissue relating to the tissue's utility for reconstruction, repair, or replacement.

2.

For cells or nonstructural tissues, processing that does not alter the relevant biological characteristics of cells or tissues.

(c) "Physician" means a physician licensed under this chapter acting in the course and scope of his or her employment.

(d) "Stem cell therapy" means a treatment involving the use of afterbirth placental perinatal stem cells, or human cells, tissues, or cellular or tissue-based products, which complies with the regulatory requirements provided in this Page 11 of 16 CODING:

Words stricken are deletions;

words underlined are additions.

hb1617-02-c2 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/CS/HB 1617 2025 section.

The term does not include treatment or research using human cells or tissues that were derived from a fetus or an embryo after an abortion.

(3)(a) A physician may perform stem cell therapy that is not approved by the United States Food and Drug Administration if such therapy is used for treatment or procedures that are within the scope of practice for such physician and the therapies are related to orthopedics, wound care, or pain management.

(b) To ensure that the retrieval, manufacture, storage, and use of stem cells used for therapies conducted under this section meet the highest standards, any stem cells used by a physician for therapy provided under this section must:

1.

Be manufactured in a clean room space that has been certified by the United States Food and Drug Administration for using high-efficiency particulate air filtration or ultra-low penetration air filtration to minimize nonviable and viable particulate contamination;

2.

Be retrieved, manufactured, and stored in a facility that is registered and regulated by the United States Food and Drug Administration and licensed or registered with one of the following entities:

a.

National Marrow Donor Program.

b.

World Marrow Donor Association.

c.

Association for the Advancement of Blood and Page 12 of 16 CODING:

Words stricken are deletions;

words underlined are additions.

hb1617-02-c2 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/CS/HB 1617 2025 Biotherapies.

d.

American Association of Tissue Banks;

and 3.

Contain viable or live cells upon post-thaw analysis and be included in a post-thaw viability analysis report for the product lot which will be sent to the physician before use with the physician's patient.

(c) A physician performing stem cell therapy may not obtain stem cells for therapies from a facility engaging in the retrieval, manufacture, or storage of stem cells intended for human use under this section unless the facility maintains valid accreditation or certification as required by this subsection.

Any contract or other agreement by which a physician obtains stem cells for therapies from such a facility must include:

1.

A requirement that the facility provide the all of the following information to the physician:

a.

The name and address of the facility.

b.

The certifying organization.

c.

The type and scope of certification.

d.

The effective and expiration dates of the certification.

e.

Any limitations or conditions imposed by the certifying organization.

2.

A requirement that the facility notify the physician within 30 days of any change in certification status, including renewal, suspension, revocation, or expiration.

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Words stricken are deletions;

words underlined are additions.

hb1617-02-c2 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/CS/HB 1617 2025 (4) In the performance of any stem cell therapy procedure, the physician shall use stem cells or products containing stem cells produced by a facility which adheres to the applicable current good manufacturing practices for the collection, removal, processing, implantation, and transfer of stem cells, or products containing stem cells, pursuant to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.

ss.

301 et seq.;

52 Stat.

1040 et seq.;

and 21 C.F.R.

part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products.

(5)(a) A physician who conducts stem cell therapy pursuant to this section shall include the following notice in any form of advertisement:

THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW.

This physician performs one or more stem cell therapies that have not yet been approved by the United States Food and Drug Administration.

You are encouraged to consult with your primary care provider before undergoing any stem cell therapy.

(b) The notice required by paragraph (a) must be clearly legible and in a type size no smaller than the largest type size used in the advertisement.

(6)(a) A physician who conducts stem cell therapy pursuant to this section shall obtain a signed consent form from the Page 14 of 16 CODING:

Words stricken are deletions;

words underlined are additions.

hb1617-02-c2 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/CS/HB 1617 2025 patient before performing the stem cell therapy.

(b) The consent form must be signed by the patient or, if the patient is not legally competent, the patient's representative and must state all of the following in language the patient or his or her representative may reasonably be expected to understand:

1.

The nature and character of the proposed treatment.

2.

That the proposed stem cell therapy has not yet been approved by the United States Food and Drug Administration.

3.

The anticipated results of the proposed treatment.

4.

The recognized serious possible risks, complications, and anticipated benefits involved in the treatment and in the recognized possible alternative forms of treatment, including nontreatment.

5.

That the patient is encouraged to consult with his or her primary care provider before undergoing any stem cell therapy.

(7) This section does not apply to the following:

(a) A physician who has obtained approval for an investigational new drug or device from the United States Food and Drug Administration for the use of human cells, tissues, or cellular or tissue-based products;

or (b) A physician who performs a stem cell therapy under an employment or other contract on behalf of an institution certified by any of the following:

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words underlined are additions.

hb1617-02-c2 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/CS/HB 1617 2025 1.

The Foundation for the Accreditation of Cellular Therapy.

2.

The Blood and Marrow Transplant Clinical Trials Network.

3.

(8)(9) A violation of this section may subject the physicianhealth care provider to disciplinary action under the rules that have been developed by the board.applicable regulatory board, the department, or the Agency for Health Care Administration, as applicable.

(9)(10) The boarddepartment mayshall adopt rules necessary to implement this section.

Section 3.2.

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