I think this is the right decision. A federal judge has ruled that stem cell treatments that manipulate the cells into another form are drugs for purposes of FDA oversight. From the New Scientist story:
It’s official: stem cells are drugs. At least, that’s the opinion of the US district court in Washington DC, which has ruled that the Food and Drug Administration (FDA) has the authority to regulate clinics offering controversial stem cell therapies. Treatments in which stem cells are harvested from bone marrow and injected straight back into the same patient are deemed part of routine medical practice – not regulated by the US government. But if the cells are subjected to more than “minimal manipulation”, the FDA maintains that the therapy becomes a “drug”, which must be specifically approved for use.
It was on this basis that in 2008 the FDA began moves to shut down Regenerative Sciences, a clinic in Broomfield, Colorado, that treats orthopaedic problems using a stem cell therapy called Regenexx. Regenerative Sciences challenged the FDA’s authority to regulate its activities, setting the stage for a legal fight. In 2010, the FDA sought an injunction to take Regenexx off the market. This has now been granted in the court’s ruling.
There has been too much hype around stem cells and too many people potentially susceptible to quackery. This ruling could help in that regard.
The Ninth Circuit does not control Texas. But I hope this gives that state’s new desperate human subjects pay-for-it-yourself stem cell clinics great pause.
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