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Committee advances bill to regulate certain stem‑cell therapies in Florida, requires informed‑consent standards

April 16, 2025 | Rules , Standing Committees, Senate, Legislative, Florida


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Committee advances bill to regulate certain stem‑cell therapies in Florida, requires informed‑consent standards
The Senate Rules Committee voted to report CS/CS/SB 1768 favorably after the sponsor amended the bill to add a detailed informed‑consent and disclosure regime for certain regenerative (stem‑cell) therapies and to clarify that only licensed physicians, not general health‑care providers, may perform the treatments authorized under the bill.

Senator Trumbull, the sponsor, said the legislation is intended to give doctors and patients a clear baseline for discussing and providing stem‑cell–based treatments available under certain FDA pathways and to curb bad actors who market unproven products. The committee adopted a late handwritten amendment clarifying the bill restricts practice to physicians. A subsequent amendment specified disclosure items required before treatment and limited permissible sources of live‑cell products.

Proponents, including physician witnesses, told the committee the bill would set a high state standard and help patients avoid unsafe, unregulated clinics abroad. Dr. Scott Faulkner, an internal‑medicine physician who testified, urged the committee to set strong, enforceable standards in Florida so residents need not travel overseas to receive care and to prevent ‘‘whack‑a‑mole’’ bad actors.

Opponents raised quality‑control and safety concerns and urged tighter oversight. Committee members pressed how the Department of Health would monitor sourcing and credentialing and asked what liability and recourse patients would have if harmed; sponsors said patients would have existing medical malpractice and regulatory remedies and that the bill’s disclosure requirements were designed to inform patient choice.

With amendments that added specific consent language, limitations on permitted stem‑cell sources and a 2‑year compliance window for operators, the committee reported CS/CS/SB 1768 favorably.

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