Before the annual session ended last week, the Florida Legislature approved a measure to improve access to some stem cell therapies that have not been approved by the Food and Drug Administration.
If enacted, the bill (SB 1768) would authorize physicians to perform the treatments, provided they are within scope of practice and focus on orthopedics, wound care or pain management with strict requirements to ensure patient safety and ethical standards.
The bill also requires that the stem cells must come from facilities registered with the FDA and certified or accredited by designated organizations. The FDA regulates stem cell products through its Center for Biologics Evaluation and Research.
The legislation prohibits the use of stem cells 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.
Physicians must follow current good manufacturing practices, prominently disclose the unapproved status of treatments in advertisements and obtain signed consent from patients.
The House and Senate each unanimously passed the bill (SB 1768). If signed into law, it would take effect July 1.
Stem cells hold great potential for medicine because of their ability to develop into different types of cells in the body, and to repair and renew tissue, experts say. Many patients seek the therapy to avoid surgery.
The bill's proponents, including sponsor Sen. Jay Trumbull, say the goal is to balance innovation with ethics and patient safety. Some see it as a national model to accelerate therapies for a variety of conditions.
Critics are concerned that the bill would remove FDA oversight while allowing the use of unapproved stem cells.
Stem cells have great potential in tissue regeneration and repair but much still needs to be learned about their biology and safety. The treatments, which can be expensive, are still considered experimental and success rates vary.
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