Last year, the FDA announced a regulatory framework for stem cell clinics, and hopes were raised that it would finally crack down on the hundreds of quack stem cell clinics in the US. Yesterday, the FDA dropped the hammer on two clinics, seeking injunctions in federal court to stop them. Is this the beginning of a real (and long overdue) crackdown on these clinics?
More and more, alternative medicine practitioners are offering unproven, almost certainly ineffective, and potentially dangerous stem cell therapies. How are they doing it?
Many are the stem cell clinics that hype their product as basically a magical cure for whatever ails you like so many used car salesmen deploying the hard sell. Florida seems to be the paradise where these poorly regulated clinics ply their unethical trade.
Last week, the FDA released final regulatory guidance regarding freestanding stem cell clinics. The new regulatory framework appears custom-made to allow the FDA to crack down on quack stem cell clinics. But will it?
Well, it’s done. Today, the Senate passed the 21st Century Cures Act, a bill designed to weaken the FDA and empower pharmaceutical companies, sending it to President Obama’s desk. There’s no way Obama won’t sign it, as it contains provisions funding his Precision Medicine Initiative, and he supported it all along. For all its flaws, […]