Florida is The latest states avoid the authority of the Food and Drug Administration by allowing patients to obtain certain stem cell therapies that have not yet been strictly evaluated and approved.
Under the new law that comes into effect on July 1, Florida doctors can manage unauthorized stem cell therapy for wound care, pain management, or orthopedics. There is growing support for medical freedom in the United States, a law supported by Secretary of Health and Human Services Robert F. Kennedy Jr., which may prompt other states to follow. Proponents say the law helps protect patients, while critics say it opens the door for physical and financial harm.
“There is interest in promoting the sale of stem cell products that the FDA has not yet approved,” said Leigh Turner, a professor of health, society and behavior at the University of California, Irving, who has been tracking the stem cell industry. “I think we’re going to see more.”
Last year, Utah passed a law that allows healthcare providers in the state to provide placental stem cell therapy, which is often used for the sale of wounds and injuries, as long as they clearly point out the unapproved status and obtain informed consent before the patient is treated. The 2017 law in Texas allows clinics and companies to provide unapproved stem cell therapy for patients with chronic or terminal illness when they deplete routine treatment options.
Stem cells have been experiencing great interest over the past 30 years as they are able to produce copies of themselves indefinitely and form more specialized cells in the body. Stem cells are the core of human development during pregnancy and can be found in embryos, placental tissues and cord blood, and are also naturally produced by adults, especially adults in the bone marrow, to allow the body to repair itself. Over the years, they have been studied as treatments for a variety of diseases, including arthritis, diabetes, heart failure, multiple sclerosis and Parkinson’s disease.
But despite decades of research, stem cells have not produced the treatment scientists hope. The only product approved by the FDA is blood-forming stem cells derived from umbilical cord blood. They are used in transplants to treat patients with certain cancers, blood and autoimmune diseases, who have their own blood-forming stem cells that are destroyed by high doses of chemotherapy or radiation.
Florida law prohibits embryonic stem cell therapy and classifies the use of embryonic stem cells as a third-degree felony. It also prohibits the use of cells obtained from the umbilical cord after abortion, although it allows cells to be sourced from discarded umbilical cord and placenta after live birth.
The FDA regulates stem cell therapy to drugs unless it is “minimum manipulated”, meaning that any treatment of the cell does not significantly alter its original relevant biological characteristics. The vulnerability allows clinics and companies to circumvent years of drug approval process and provide stem cell processing that has not been thoroughly tested for safety and effectiveness. Florida law does not specify whether stem cells provided in the state must be fine-tuned, which presumably allows manipulation of cells beyond that standard.
