I’m here at the World Stem Cell Summit in Florida. I just was in the audience for a great panel discussion on The Role of States in Regulating Stem Cell Therapies. It was contentious but raised almost all of the key questions in this area.
There was particularly interesting and vigorous debate between two participants, bioethicist Leah Turner and Mitchell Fuerst, a counsel involved in the U.S. vs Regenerative Sciences case.
One interesting question was the legitimacy of a state’s rights argument for the FDA not regulating autologous stem cell therapies.
I wonder who at the state level would be qualified to evaluate if a stem cell therapy is safe or effective?
Frankly after studying stem cells for what seems like forever they still have many things to teach me and they constantly surprise me. Can a physician or state medical board have the expertise needed to make judgments about stem cell safety and efficacy?
I think not.
It was also argued that the FDA regulating stem cells stymies innovation.
The innovation argument is clouded by the MDs charging for the patient huge sums of money. Innovation is great but innovation without appropriate regulation is a recipe for patient harm.
It will probably come as no surprise to you that I agreed with Dr. Turner’s arguments in these discussions.