Tuesday, 18 March 2014

Stem cells must be regulated as a drug product

A US federal appeals court maintains that stem cells proliferated in a lab must be regulated as a drug. The D.C. Circuit Court of Appeals has ruled that culturing a patient’s stem cells for therapeutic use falls under the aegis of the US Food and Drug Administration (FDA). FDA has said therapeutic stem cells should be regulated as drugs.

In relation to this topic, Leigh Turner, a bioethicist at the University of Minnesota, told Nature News that: "It is much too simplistic to think that stem cells are removed from the body and then returned to the body without a ‘manufacturing process’ that includes risk of transmission of communicable diseases. Maintaining the FDA’s role as watchdog and regulatory authority is imperative."

Posted by Tim Sandle