Measure declares that regulatory agency can be ignored and patients given unapproved treatments
The Utah State Capitol in Salt Lake City. A new Utah law defies the Food and Drug Administration’s authority on stem cells.The state of Utah is challenging the authority of the U.S. Food and Drug Administration with a new, unusually bold law that allows patients to receive unapproved placental stem cell “therapies.” Observers predict that the law, which takes effect on 1 May, could significantly undermine FDA’s authority to regulate drugs and other treatments.
Other states have allowed unproven and unapproved stem cell treatments, which are claimed to restore tissues including joint, cartilage, andUtah “is basically saying : … ‘Our doctors can do it whether or not you approve of it,’” says Gail Javitt, an attorney who specializes in FDA law at the firm Hyman, Phelps & McNamara. “This seems like a pretty blatant broadbrush challenge to FDA’s authority.
“What’s disappointing to me is that this unregulated stuff really does give serious stem cell work, which could be lifesaving and life-changing to people, a bad name,” says Diana Farmer, a fetal surgeon at UC Davis who is runningUsing the placenta as source of stem cells “could be very promising.
The Utah law, by contrast, doesn’t require a physician to administer the cells, nor does it require any vetting for manufacturing standards, safety, cleanliness, or effectiveness. “I’m really disappointed,” says Kirstin Matthews, a science policy expert at Rice University. “I don’t think they truly realize the potential harms for the patient: financial, physical, emotional. … There are quite a few cases of people being hurt.
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