FDA Cannot Regulate Stem Cell Treatments, DC Circ. Hears

Law360, Washington (October 21, 2013, 5:28 PM EDT) -- Regenerative Sciences LLC on Monday blasted the U.S. Food and Drug Administration's attempt to regulate its stem cell treatments as a drug, telling a D.C. Circuit panel that the agency doesn't have the authority to oversee its medical practices.

Regenerative Sciences' counsel Andrew S. Ittleman accused the agency of trying to gain “limitless authority” over the medical practice by claiming its Regenexx procedure had violated the Federal Food, Drug and Cosmetic Act by shipping its components across state lines.

The Regenexx procedure — which uses a...
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