The Florida Senate
BILL ANALYSIS AND FISCAL IMPACT STATEMENT
(This document is based on the provisions contained in the legislation as of the latest date listed below.)
Prepared By: The Professional Staff of the Appropriations Committee on Health and Human Services
BILL: CS/SB 1768
INTRODUCER: Health Policy Committee and Senator Trumbull
SUBJECT: Stem Cell Therapy
DATE: April 9, 2025
ANALYST STAFF DIRECTOR REFERENCE ACTION
1. Smith Brown HP Fav/CS
2. Gerbrandt McKnight AHS Pre-meeting
3. RC
Please see Section IX. for Additional Information:
COMMITTEE SUBSTITUTE - Substantial Changes
I. Summary:
CS/SB 1768 authorizes physicians (medical doctors and doctors of osteopathic medicine) to
perform stem cell therapies that have not been approved by the U.S. Food and Drug
Administration when used for orthopedic conditions, wound care, or pain management. The bill
establishes standards for the manufacturing and storage of stem cells and requires a physician to
obtain a signed informed consent form from a patient before administering any such therapy.
The bill requires that written notice be provided to a patient prior to the performance of stem cell
therapy, disclosing that the therapy is not approved by the FDA. This disclosure must also be
included in any advertisement for the therapy. The bill directs the Board of Medicine and Board
of Osteopathic Medicine to adopt rules to implement the bill.
The bill has an indeterminate, yet negative fiscal impact on state expenditures which likely can
be absorbed within existing resources. See Section V., Fiscal Impact Statement.
The bill takes effect July 1, 2025.
REVISED: BILL: CS/SB 1768 Page 2
II. Present Situation:
Overview of Stem Cells and Stem Cell Therapy
Stem cells are undifferentiated cells with the unique ability to develop into specialized cell types
and to divide indefinitely under certain conditions.
1
They are broadly classified as either
embryonic or adult (somatic) stem cells. Embryonic stem cells, derived from early-stage
embryos, are pluripotent and capable of differentiating into nearly all cell types in the human
body. Adult stem cells are more limited in scope and typically generate only cell types consistent
with their tissue of origin.
In 2007, researchers developed induced pluripotent stem cells (iPSCs), a type of adult stem cell
reprogrammed to exhibit pluripotency.
2
These iPSCs have opened new frontiers in regenerative
medicine by offering a potential alternative to the use of embryonic stem cells.
Stem cell therapy involves administering stem cells or derivatives to repair, replace, or
regenerate human tissues. While hematopoietic stem cell transplants for blood disorders are
established treatments, many other stem cell therapies remain experimental and are not approved
by the Food and Drug Administration (FDA) for routine clinical use.
3
Federal Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products
The FDA regulates stem cell products that meet the definition of human cells, tissues, or cellular
and tissue-based products (HCT/Ps) through its Center for Biologics Evaluation and Research
(CBER).
4
CBER’s authority derives from the Public Health Service Act (42 U.S.C. § 264) and
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.). Applicable federal
regulations are found primarily in 21 C.F.R., part 1271.
Products that meet all of the criteria under 21 C.F.R. § 1271.10 – commonly referred to as
“361 HCT/Ps” – are subject to less stringent oversight. To qualify, the product must be:
• Minimally manipulated;
• Intended solely for homologous use;
• Not combined with another article (except for certain preservatives or water); and
• Either non-systemic and not dependent on the metabolic activity of living cells for its
primary function, or used autologously or in a first- or second-degree blood relative.
Products that do not meet these criteria are classified as “351 HCT/Ps” and are regulated as
biological drugs. These products require premarket approval through the FDA’s Investigational
1
Department of Health, Senate Bill 1617 Legislative Analysis (Mar. 19, 2025) (on file with the Senate Committee on Health
Policy). Note that House Bill 1617 would be substantively identical to Senate Bill 1768 except for the House bill’s exclusion
of legislative intent and the inclusion of the use of afterbirth placental perinatal stem cells in the definition of “stem cell
therapy.”
2
Id.
3
Harvard Stem Cell Institute, Frequently Asked Questions: Stem Cell Therapies, available at:
https://www.hsci.harvard.edu/faq/stem-cell-therapies (last visited Mar. 28, 2025).
4
U.S. Food & Drug Administration, Center for Biologics Evaluation and Research (CBER), available at:
https://www.fda.gov/about-fda/fda-organization/center-biologics-evaluation-and-research-cber (last visited Mar. 28, 2025). BILL: CS/SB 1768 Page 3
New Drug (IND) and Biologics License Application (BLA) pathways, under
21 C.F.R., parts 312 and 600–680.
Enforcement and Oversight by FDA
The FDA requires establishments that manufacture or manipulate HCT/Ps to register with CBER
and to comply with current Good Tissue Practices (cGTPs) under 21 C.F.R. part 1271,
subpart D.
5
These practices are designed to prevent the introduction or transmission of
communicable diseases. The FDA conducts inspections, issues warning letters, and may pursue
civil or criminal enforcement actions against facilities or providers offering unapproved or
noncompliant stem cell therapies.
The FDA has issued warnings about the widespread marketing of unapproved regenerative
medicine products, noting that approval is granted only after rigorous evaluation in clinical trials
to ensure safety and efficacy.
6
The FDA has received reports of serious adverse events associated
with unapproved regenerative medicine therapies, including blindness, tumor formation, and
infections.
7
Consumers are advised to exercise caution and are encouraged to report any adverse
effects or file complaints related to these products directly to the FDA.
Oversight by the Florida Boards of Medicine and Osteopathic Medicine
8
The Florida Board of Medicine (BOM), under the Department of Health (DOH), is responsible
for licensing, regulating, and disciplining medical doctors, a.k.a. allopathic physicians, pursuant
to ch. 458, F.S. The Board of Osteopathic Medicine (BOOM), pursuant to ch. 459, F.S.,
exercises the same authority for osteopathic physicians. The BOM has the authority to impose
disciplinary sanctions, including license suspension or revocation, for violations of the standard
of care, deceptive advertising, or failure to obtain proper informed consent, under s. 456.072,
F.S., and related provisions of the Medical Practice Act. The BOOM has the authority to impose
similar disciplinary sanctions under s. 459.015, F.S., which governs grounds for disciplinary
action against osteopathic physicians.
In recent years, the BOM has reviewed complaints against physicians advertising unproven stem
cell treatments for conditions such as orthopedic pain and neurodegenerative disorders. Some of
these physicians have been subject to formal investigations, fines, and, in certain cases, license
restrictions or revocations. In 2013, the BOM revoked the licenses of two physicians in
administrative cases involving stem cells for failing to meet the standard of care. In 2015, the
BOM warned physicians and consumers that they should be aware of the risks involved
accessing stem cell therapies and regenerative medicine that was not approved by the FDA. The
5
See also U.S. Department of Health & Human Services, Current Good Tissue Practice (CGTP) and Additional
Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), available at:
https://www.hhs.gov/guidance/document/current-good-tissue-practice-cgtp-and-additional-requirements-manufacturers-
human-cells (last visited Mar. 28, 2025).
6
U.S. Food & Drug Administration, Important Patient and Consumer Information About Regenerative Medicine Therapies,
available at: https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/important-patient-and-consumer-
information-about-regenerative-medicine-therapies (last visited Mar. 28, 2025).
7
Id.
8
Department of Health, Senate Bill 1617 Legislative Analysis (Mar. 19, 2025) (on file with the Senate Committee on Health
Policy). BILL: CS/SB 1768 Page 4
BOM further warned that a physician providing stem cell treatment should do so only with an
investigational new drug application (IND) or a single patient IND for Compassionate or
Emergency Use.
Ethical Considerations and Prohibited Stem Cell Sources
Federal law does not explicitly prohibit the use of fetal-derived stem cells obtained from elective
abortions; however, such use is subject to ethical oversight, particularly in federally funded
research. The National Institutes of Health requires review by an ethics advisory board for
proposed research involving fetal tissue.
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III. Effect of Proposed Changes:
Sections 1 and 2 create ss. 458.3245 and 459.0127, F.S., to authorize allopathic and osteopathic
physicians, respectively, to perform stem cell therapies that are not approved by the Food and
Drug Administration (FDA) and to impose requirements relating to the manufacture, use, notice,
consent, and oversight of such therapies.
Subsection (1) of each section provides legislative findings and intent, recognizing the potential
of stem cell therapies to advance medical treatment and improve patient outcomes. This portion
of the bill emphasizes the importance of using ethically sourced stem cells and expresses the
intent to prohibit the use of stem cells derived from aborted fetuses. Instead, the bill encourages
the use of adult stem cells, umbilical cord blood, and other ethically obtained human cells,
tissues, or cellular or tissue-based products.
Subsection (2) of each section defines key terms used throughout the section:
• “Human cells, tissues, or cellular or tissue-based products” includes specified articles
consisting of human cells or tissues collected from cord blood donors who are residents of
the United States and intended for implantation, transplantation, infusion, or transfer into a
human recipient. The subsection also lists exclusions from that definition, including
vascularized human organs, whole blood and blood derivatives, secreted or extracted
products (except semen, which is a human cell, tissue, or cellular-based tissue product under
the bill), certain minimally manipulated bone marrow products, ancillary products used in
manufacturing, non-human-derived tissues, in vitro diagnostic products, blood vessels
recovered with organs for transplantation, fetal-derived stem cells, and adipose-derived
mesenchymal stem cells for transplantation.
• “Minimally manipulated” is defined in two parts: for structural tissue, it means processing
that does not alter the original relevant characteristics of the tissue relating to reconstruction,
repair, or replacement; for cells or nonstructural tissues, it means processing that does not
alter the relevant biological characteristics of the cells or tissues.
• “Physician” is defined as a physician licensed under ch. 458, F.S., or an osteopathic
physician licensed under ch. 459, F.S., acting within the scope of his or her employment.
9
National Institutes of Health, Policies and Procedures for the Use of Human Fetal Tissue (HFT) in Non-Transplantation
Research, available at: https://oir.nih.gov/sourcebook/ethical-conduct/special-research-considerations/policies-procedures-
use-human-fetal-tissue-hft-non-transplantation-research (last visited Mar. 28, 2025). BILL: CS/SB 1768 Page 5
• “Stem cell therapy” is defined as a treatment involving human cells, tissues, or cellular or
tissue-based products, and explicitly excludes any treatment or research using cells or tissues
derived from a fetus or embryo following an abortion.
Subsection (3) of each section authorizes physicians to perform stem cell therapy not approved
by the FDA, if the therapy is used for treatment or procedures within the scope of the physician’s
practice and is limited to the fields of orthopedics, wound care, or pain management.
Subsection (3) of each section also establishes requirements relating to the origin and preparation
of the stem cells used. The stem cells must be manufactured in a clean room certified by the
FDA for the use of high-efficiency particulate air (HEPA) filtration or ultra-low penetration air
filtration to minimize contamination. Additionally, the facility where the stem cells are retrieved,
manufactured, and stored must be registered and regulated by the FDA and licensed or registered
with one of four specified organizations: the National Marrow Donor Program, the World
Marrow Donor Association, the Association for the Advancement of Blood and Biotherapies, or
the American Association of Tissue Banks.
Subsection (4) of each section requires physicians to comply with applicable current good
manufacturing practices for the collection, removal, processing, implantation, and transfer of
stem cells or stem cell-containing products. These practices must be consistent with the
requirements of the Federal Food, Drug, and Cosmetic Act and relevant regulations under
21 C.F.R., part 1271.
Subsection (5) of each section requires a physician to deliver a specific written notice to the
patient before performing a stem cell therapy. The notice must state that the physician performs
one or more stem cell therapies that have not yet been approved by the FDA and must advise the
patient to consult with their primary care provider before undergoing any such therapy.
Subsection (6) of each section specifies the formatting and delivery requirements for the written
notice. The notice must be printed on paper at least 8.5 inches by 11 inches in size and in no less
than 40-point type. It must be prominently displayed at the entrance to the physician’s office and
in an area visible to patients within the office. In addition, the notice must be included in all
advertisements for the stem cell therapy and must appear in a font size no smaller than the largest
font size used in the advertisement.
Subsection (7) of each section requires that physicians obtain a signed consent form from the
patient or, if the patient is not legally competent, from the patient’s representative, before
performing the therapy. The form must include, in language understandable to the patient or
representative, a description of the nature and character of the treatment, a statement about the
treatment’s FDA approval status, the anticipated results, alternative treatment options, and the
recognized serious possible risks, complications, and benefits of the proposed treatment and of
any alternatives, including the possible consequences of not undergoing treatment.
Subsection (8) of each section identifies two categories of physicians to whom the requirements
of the section do not apply. The first exemption applies to a physician who has obtained FDA
approval for an investigational new drug or device for the use of human cells, tissues, or cellular
or tissue-based products. The second exemption applies to a physician who performs stem cell BILL: CS/SB 1768 Page 6
therapy under an employment or other contract on behalf of an institution that is certified by one
of the following organizations: the Foundation for the Accreditation of Cellular Therapy; the
Blood and Marrow Transplant Clinical Trials Network; the Association for the Advancement of
Blood and Biotherapies; or another entity with expertise in stem cell therapy as determined by
the Department of Health (DOH).
Subsection (9) of each section provides that a violation of any provision in the section may
subject the physician to disciplinary action. The appropriate regulatory board or the DOH may
enforce compliance and impose sanctions.
Subsection (10) of section 1 requires the Board of Medicine to adopt rules to implement the
section in consultation with the Board of Osteopathic Medicine. Conversely, subsection (10) of
section 2 requires the Board of Osteopathic Medicine to adopt rules to implement the section in
consultation with the Board of Medicine.
The bill authorizes physicians to administer stem cell therapies that have not been approved by
the FDA. This action may expose physicians to federal regulatory enforcement. If a physician or
supplier administers or distributes stem cell products in violation of FDA requirements, the FDA
may take a range of enforcement actions, including issuing warning letters, initiating civil or
criminal proceedings in coordination with the U.S. Department of Justice, seeking injunctions to
prevent continued noncompliance, and disqualifying parties from participating in clinical
investigations. In addition, the FDA has authority to issue orders for the retention, recall,
destruction, or cessation of manufacturing of human cells, tissues, or cellular- and tissue-based
products (HCT/Ps) when it has reasonable grounds to believe the products were manufactured in
violation of applicable regulations.
The bill takes effect July 1, 2025.
IV. Constitutional Issues:
A. Municipality/County Mandates Restrictions:
None.
B. Public Records/Open Meetings Issues:
None.
C. Trust Funds Restrictions:
None.
D. State Tax or Fee Increases:
None. BILL: CS/SB 1768 Page 7
E. Other Constitutional Issues:
None.
V. Fiscal Impact Statement:
A. Tax/Fee Issues:
None.
B. Private Sector Impact:
None.
C. Government Sector Impact:
The bill has an indeterminate yet negative fiscal impact on state expenditures. The
Department of Health (DOH) will incur nonrecurring costs associated with rulemaking
and updating systems, and these costs can be absorbed within existing resources.
According to the DOH, there may be an indeterminate fiscal impact on its Bureau of
Enforcement to develop criteria for exemption determinations, monitoring compliance,
and investigate violations. These costs can likely be absorbed within existing resources.
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VI. Technical Deficiencies:
None.
VII. Related Issues:
None.
VIII. Statutes Affected:
This bill creates the following sections of the Florida Statutes: 458.3245 and 459.0127.
10
Department of Health, Senate Bill 1617 Legislative Analysis (Mar. 19, 2025) (on file with the Senate Committee on Health
Policy). BILL: CS/SB 1768 Page 8
IX. Additional Information:
A. Committee Substitute – Statement of Substantial Changes:
(Summarizing differences between the Committee Substitute and the prior version of the bill.)
CS by Health Policy on April 1, 2025:
The underlying bill defined “health care providers” as physicians licensed under
chs. 458 and 459, F.S. The CS replaces the term “health care providers” with
“physicians” and relocates the new section from ch. 456, F.S., which generally applies to
all health care practitioners, to chs. 458 and 459, F.S., which apply specifically to
allopathic and osteopathic physicians, respectively.
The CS establishes that the Board of Medicine and Board of Osteopathic Medicine must
adopt rules to implement the new sections, rather than the Department of Health (DOH).
The CS also clarifies that enforcement authority rests with the boards and the DOH, not
the Agency for Health Care Administration.
B. Amendments:
None.
This Senate Bill Analysis does not reflect the intent or official position of the bill’s introducer or the Florida Senate.