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FL H1617
Bill
Status
Introduced
2/28/2025
Primary Sponsor
Health & Human Services Committee
Click for details
AI Summary
- Licensed allopathic and osteopathic physicians may perform stem cell therapies not approved by the FDA for treatments related to orthopedics, wound care, or pain management, provided the therapies fall within their scope of practice
- Stem cells must be manufactured in FDA-certified clean room spaces, retrieved and stored in FDA-registered facilities that are also licensed with recognized entities (e.g., National Marrow Donor Program, American Association of Tissue Banks), and must contain viable or live cells verified by post-thaw analysis reports
- Physicians must include a mandatory notice in all advertisements stating the therapy has not been approved by the FDA and encouraging patients to consult their primary care provider; the notice must be displayed in a type size no smaller than the largest used in the ad
- Signed informed consent is required before treatment, disclosing the nature of the therapy, its non-FDA-approved status, anticipated results, serious risks and complications, alternative treatments including nontreatment, and encouraging consultation with a primary care provider
- Stem cells derived from aborted fetuses or embryos and adipose-derived mesenchymal stem cells for transplantation are explicitly excluded; violations may result in disciplinary action by the Board of Medicine or Board of Osteopathic Medicine, with an effective date of July 1, 2025
Legislative Description
Stem Cell Therapy
Last Action
Laid on Table, companion bill(s) passed, see CS/CS/SB 1768 (Ch. 2025-185)
4/30/2025
Committee Referrals
Health And Human Services4/4/2025
Health Professions & Programs Subcommittee3/5/2025
Full Bill Text
No bill text available