Utah flouts FDA with law greenlighting placental stem cell therapies

The state of Utah is challenging the authority of the U.S. Food and Drug Administration (FDA) 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. The new statute , passed almost unanimously by both houses of the Utah legislature in February and signed by Governor Spencer Cox (R) last month, declares that Utah health care providers “may perform a [placental] stem cell therapy that is not approved by [FDA]” so long as they prominently note it is unapproved and obtain signed patient consent forms. Providers are defined as anyone in a long list that includes, in addition to physicians, naturopaths, chiropractors, podiatrists, pharmacists, nurses, and midwives—as long as their “scope of practice includes stem cell therapy.” “Utah empowers patients, not bureaucrats, and this legislation focuses on the plentiful, safe, and ethically acceptable stem cell source that … potentially provides relief for patients [with] damaged or diseased organs and tissues,” says state Senator Curtis Bramble (R), the legislation’s lead sponsor. Mac Haddow, a lobbyist with the Washington, D.C., firm Upstream Consulting who urged Bramble to develop the bill, calls it “a very, very small step forward” that will be “a model for other states....
Source: Science of Aging Knowledge Environment - Category: Geriatrics Source Type: research