Amy Dow, an Associate in the Health Care and Life Sciences practice, in the Chicago office, was quoted in an article titled “Court: FDA Regulation of Stem Cell Therapy Not Barred by Practice of Medicine Defense.”
Following is an excerpt:
Hospitals and physicians utilizing cutting edge treatment therapies should take note of a recent federal trial court decision that found a stem cell reinjection therapy developed and used by a physician practice qualifies as a drug subject to regulation by the Food and Drug Administration, attorneys told BNA (United States v. Regenerative Sciences LLC, D.D.C., No. 1:10-cv-1327, 7/23/12). ?…
Amy K. Dow, with Epstein Becker & Green PC, in Chicago, agreed that the case has important implications for providers that are increasingly using in-office stem cell therapies as part of a personalized medical treatment regime and who may not be aware of the limits to a practice-of-medicine defense to FDA’s assertion of jurisdiction over a specific procedure or therapy.
”As someone familiar with FDA’s regulation of cellular and tissue products, I was not at all surprised at FDA’s position that the product used in the Regenexx procedure is subject to regulation as a drug,” Dow said.
”That said, FDA’s authority over these products is unlikely to be common knowledge in the provider community, where I see similar therapies being used in plastic surgery, by cardiovascular surgeons, and by other providers in addition to orthopedic surgeons.”
”I think the key takeaway of the decision for providers is that they should be familiar with FDA regulations when performing novel procedures with human tissues—to enable them to comply with those requirements—or avoid activities that would subject them to FDA’s authority over these procedures.”