Florida has the second highest number of for-profit stem cell clinics in the United States, and a new proposal by a Tampa lawmaker would crack down on those that prey on elderly and vulnerable Floridians.
These procedures take stem cells harvested from patients’ belly fat, bone marrow or blood and re-inject them into the body to try to cure a range of diseases.
Senator Dana Young said stem cell treatments are already heavily regulated by the Food & Drug Administration, but the rules allow less scrupulous procedures to fall through the cracks.
“There’s some loopholes that have allowed these clinics to proliferate,” Young said. “We are legislating in a way that we can control these clinics to an extent without infringing on the FDA's regulatory authority."
Young said her proposal would not implicate hospitals, medical schools or clinics that are owned and operated by physicians using stem cell treatments.
"It really is focused on clinics where you might have a doctor affiliated with it but the doctor is not actually working there, or perhaps the clinic is owned by a corporation rather than a physician,” Young said.
The proposal comes after three patients at a South Florida clinic went blind last year after receiving stem cell injections to treat macular degeneration.
If the bill passes and becomes law, stem-cell clinics will have to register with the Department of Health, have a designated physician on staff responsible for complying with all requirements related to registration and operation of the clinic, and comply with annual DOH inspections.
It would also dictate the Florida Board of Medicine to adopt rules governing advertising by stem-cell clinics and informed consent guidelines, and allow DOH to impose an administrative fine up to $5,000 per violation.