Peter Aldhous from New Scientist reports today that the U.S. District Court in Washington, DC, has ruled that a person's own cultured stem cells are drugs subject to regulation by the Food and Drug Administration.
This is a big deal, as it's the cornerstone of an ongoing argument between the agency and Colorado-based Regenerative Sciences (The FDA Law Blog summarized the legal tussles nicely last October). It's also germane to the issues surrounding Texas-based Celltex, which I've blogged about before.
According to Aldhous:
It's official: stem cells are drugs. At least, that's the opinion of the [court]... 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.
Aldhous also quotes Regenerative Sciences' medical director Christopher Centeno, MD, vowing to appeal the ruling, as well as Stanford's own Christopher Scott:
"I think it's a good ruling, and I'm glad to see that that the FDA has exercised its muscle on the case," says Christopher Scott, who heads the Program on Stem Cells in Society at Stanford University in California.
Scott hopes that the FDA will now step up its efforts to regulate other clinics offering unproven stem cell therapies. These include Celltex of Sugar Land, Texas, which rose to prominence after Texas governor Rick Perry was injected with stem cells supplied by the company to aid his recovery from back surgery.
Previously: FDA audit of Texas stem cell clinic revealed by Houston Chronicle and Stanford's Irving Weissman on the (lost?) promise of stem cells
Photo by sideonecincy
