American Elephants

U.S District Court Has Ruled that Stem Cells Are Drugs. by The Elephant's Child

The U.S. District Court in Washington DC has ruled, last Wednesday,  that a person’s own cultured stem cells are drugs subject to regulation by the Food and Drug Administration.

Peter Aldhous from New Scientist, reported:

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.

The argument, of course, is that the FDA should have no jurisdiction over one’s own cells, versus the argument that the FDA is needed to make sure that everything is pure, sterile,  and to the standards of the FDA. The companies argue that the FDA is trying to tell them how to practice medicine, the FDA claims that stem cells fall within FDA’s jurisdiction as they affect interstate commerce, and the cultured stem cells are drugs.

This interpretation of the interstate commerce clause shows how stretched that one clause has become. The results from regenerative medicine and adult stem cells have been enormously encouraging, and one would like to see it move much faster.

The FDA has a reputation for extreme slowness in approvals for new drugs, unnecessary regulation and too many costly barriers. I am only a bystander and my opinions of no matter, but I distrust government regulation and government bureaucracy, and the current administration.

%d bloggers like this: