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Bill > H1617


FL H1617

FL H1617
Stem Cell Therapy


summary

Introduced
02/28/2025
In Committee
04/24/2025
Crossed Over
Passed
Dead
06/16/2025

Introduced Session

2025 Regular Session

Bill Summary

An act relating to stem cell therapy; creating ss. 458.3245 and 459.0127, F.S.; providing legislative intent; defining terms; authorizing allopathic physicians and osteopathic physicians to perform stem cell therapy not approved by the United States Food and Drug Administration under certain circumstances; specifying requirements for the stem cells that may be used by allopathic physicians and osteopathic physicians; requiring allopathic physicians and osteopathic physicians to adhere to applicable current good manufacturing practices in the performance of such therapies; prohibiting allopathic physicians and osteopathic physicians from obtaining stem cells for therapies from facilities failing to meet certain requirements; requiring allopathic physicians and osteopathic physicians to include certain terms in contracts or agreements with facilities producing stem cells for therapies; requiring allopathic physicians and osteopathic physicians to include a specified notice in any form of advertisement; providing requirements for such notice; requiring allopathic physicians and osteopathic physicians to obtain a signed consent form from the patient or his or her representative before performing the therapy; specifying requirements for the consent form; providing applicability; providing for disciplinary action; requiring the Board of Medicine and the Board of Osteopathic Medicine to adopt rules, respectively; providing an effective date.

AI Summary

This bill establishes comprehensive regulations for stem cell therapy in Florida, focusing on ethical and safe practices for allopathic and osteopathic physicians. The legislation allows physicians to perform stem cell therapies not yet approved by the FDA, specifically for orthopedics, wound care, or pain management, but with strict requirements. These requirements include using stem cells manufactured in FDA-certified clean rooms, retrieved from facilities registered with recognized medical organizations, and maintaining cell viability after processing. Physicians must obtain stem cells only from accredited facilities and must include a mandatory notice in any advertisement stating that the therapy is not FDA-approved. Before performing the therapy, physicians are required to obtain a detailed, signed consent form from patients that clearly explains the experimental nature of the treatment, potential risks, and anticipated results. The bill explicitly prohibits the use of stem cells derived from aborted fetuses, emphasizing ethical sourcing from sources like umbilical cord blood and adult stem cells. The legislation aims to foster medical innovation while maintaining high safety standards, with potential disciplinary actions for physicians who violate these guidelines. The law will take effect on July 1, 2025, giving medical professionals and facilities time to prepare for the new regulations.

Committee Categories

Health and Social Services

Sponsors (2)

Other Sponsors (2)

Health & Human Services Committee (H), Health Professions & Programs Subcommittee (H)

Last Action

Laid on Table, companion bill(s) passed, see CS/CS/SB 1768 (Ch. 2025-185) (on 04/30/2025)

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