THE FEDERAL COURT in the US has this week ruled that the Food and Drug Administration (FDA) can classify stem cells which have been subjected to more than “minimal manipulation” as drugs.
The ruling was made in an attempt to put in place more stringent regulations regarding the use of stem cells which may have been insufficiently trialled in medical procedures.
The new ruling allows for the FDA to effectively ban clinics in the United States which offer procedures involving ‘cultured’ cells – the name typically given to cells grown under controlled conditions outside of their natural environment.
Responding to the news, Stephen Sullivan, who is the chief scientific officer of the Irish Stem Cell Foundation, said it was a positive step and hoped that similar steps would be taken in Ireland:
The recession has led to a rise in medical tourism scams and those involving stem cells are no different. The regulatory framework in the USA is now developing to better protect the public from such scams. The responsible agency, the FDA, has been given the legal authority to classify stem cells as “drugs” when used in medical treatment.
This means rogue clinics will be easier to shut down when unsubstantiated claims or dangerous treatments are offered to patients (including Irish patients solicited over the internet). The Irish Stem Cell Foundation hopes the Irish Government notes this development and works with the European Medicines Agency to take similar steps in Europe.