(1) The Legislature recognizes the significant potential of cellular and tissue-based products in advancing medical treatments and improving patient outcomes and further recognizes the need to ensure that such treatments are provided using cellular or tissue-based products obtained in an ethical manner that does not involve 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 cellular or tissue-based products, the state will advance regenerative medicine in a manner consistent with the values of the state.
(2) As used in this section, the term:
(a) “Cellular or tissue-based products” means products containing or consisting of human cells or tissues which are intended for implantation, transplantation, infusion, or transfer into a human recipient. The term does not include:
1. Vascularized human organs for transplantation;
2. Whole blood or blood components or blood derivative products;
3. Secreted or extracted human products, such as milk, collagen, and cell factors, other than semen;
4. Minimally manipulated bone marrow for homologous use and not combined with another article other than 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;
5. Ancillary products used in the manufacture of human cells, tissues, or cellular or tissue-based products;
6. Cells, tissues, and organs derived from animals;
7. In vitro diagnostic products;
8. Blood vessels recovered with an organ which are intended for use in organ transplantation and labeled “For use in organ transplantation only”; or
9. Harvesting and reimplantation of autologous tissue.
(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) “Procedure using cellular or tissue-based products” means a treatment involving the use of human cells, tissues, or cellular or tissue-based products which complies with the regulatory requirements provided in this section. The term does not include treatment or research using human cells or tissues derived from a fetus or an embryo after an abortion.
(3)(a) A podiatric physician may perform a procedure using cellular or tissue-based products that are not approved by the United States Food and Drug Administration if such products are used for treatment or procedures within the scope of practice for such podiatric physician and the treatment or procedures are related to connective tissue, ligament, and tendon repair; wound care; or pain management.
(b) To ensure that the retrieval, manufacture, storage, and use of any cellular or tissue-based products pursuant to this section meet the highest standards, any cellular or tissue-based products used by a podiatric physician for a procedure provided under this section must meet all of the following conditions:
1. Be retrieved, manufactured, and stored in a facility that is registered and regulated by the United States Food and Drug Administration.
2. Be retrieved, manufactured, and stored in a facility that is certified or accredited by one of the following entities:
a. The National Marrow Donor Program.
b. The World Marrow Donor Association.
c. The Association for the Advancement of Blood and Biotherapies.
d. The American Association of Tissue Banks.
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 must be sent to the podiatric physician before use with the podiatric physician’s patient.
(4)(a) A podiatric physician who performs a procedure using cellular or tissue-based products pursuant to this section shall include the following in any form of advertisement:
THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW. This podiatric physician performs procedures using cellular or tissue-based products 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 procedure using these products.
(b) The notice required under paragraph (a) must be clearly legible and in a type size no smaller than the largest type size used in the advertisement.
(5)(a) A podiatric physician who performs a procedure using cellular or tissue-based products pursuant to this section shall obtain a signed consent form from the patient before performing the procedure.
(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 procedure uses cellular or tissue-based products that have 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 the procedure.
(6) This section does not apply to the following:
(a) A podiatric 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 podiatric physician who performs procedures using cellular or tissue-based products under an employment or other contract on behalf of an institution certified or accredited by any of the following:
1. The Foundation for the Accreditation of Cellular Therapy.
2. The Blood and Marrow Transplant Clinical Trials Network.
3. The Association for the Advancement of Blood and Biotherapies.
(7) A violation of this section may subject the podiatric physician to disciplinary action by the board.
(8) A podiatric physician who willfully performs, or actively participates in, the following commits a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084, and is subject to disciplinary action under this chapter and s. 456.072:
(a) Treatment or research using human cells or tissues derived from a fetus or an embryo after an abortion; or
(b) The sale, manufacture, or distribution of computer products created using human cells, tissues, or cellular or tissue-based products.
(9) The board may adopt rules necessary to implement this section.
