summary
Introduced
02/28/2025
02/28/2025
In Committee
04/28/2025
04/28/2025
Crossed Over
04/23/2025
04/23/2025
Passed
06/25/2025
06/25/2025
Dead
Signed/Enacted/Adopted
06/26/2025
06/26/2025
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 findings and intent; defining terms; authorizing 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 such physicians; requiring such physicians to adhere to applicable current good manufacturing practices in the performance of such therapies; requiring physicians to include a specified notice in any form of advertisement; providing requirements for such notice; requiring 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; providing criminal penalties; authorizing the Board of Medicine to adopt rules; providing an effective date.
AI Summary
This bill establishes comprehensive regulations for stem cell therapy in Florida, creating new legal provisions for physicians performing stem cell treatments that have not yet been approved by the United States Food and Drug Administration (FDA). The legislation allows physicians to perform stem cell therapies in orthopedics, wound care, and pain management, but imposes strict requirements to ensure patient safety and ethical standards. Physicians must use stem cells retrieved from facilities registered with the FDA and certified by recognized organizations, and the cells must be viable after processing. The bill mandates that physicians include a prominent notice in advertisements disclosing that the therapy is not FDA-approved and requires patients to sign a detailed consent form explaining the experimental nature of the treatment, potential risks, and benefits. The legislation explicitly prohibits using stem cells derived from aborted fetuses and establishes criminal penalties for physicians who violate these provisions, including potential felony charges for unauthorized research or improper use of human cells and tissues. The bill aims to balance medical innovation with ethical considerations, encouraging the use of ethically obtained stem cell sources like adult stem cells and umbilical cord blood while protecting patient interests and maintaining high medical standards.
Committee Categories
Budget and Finance
Sponsors (1)
Other Sponsors (2)
Health Policy (Senate), Rules (Senate)
Last Action
Chapter No. 2025-185 (on 06/26/2025)
Official Document
bill text
bill summary
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bill summary
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bill summary
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