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FDA Cannot Regulate Stem Cell Treatments, DC Circ. Hears
By Erica Teichert
Law360, Washington (October 21, 2013, 5:28 PM ET) —
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 patient’s stem cells mixed with other components to treat joint, muscle, tendon and bone pain — is a medical practice rather than a drug, according to Ittleman, and is governed by state law rather than federal drug regulations.
“The Regenexx procedure constitutes a practice of medicine,” Ittleman said. “The procedure involves the patient’s own cells.”
Although Regenerative Sciences does use an FDA-regulated antibiotic when it injects the stem cells into patients, the company maintained their use of that drug shouldn’t open the entire procedure to agency scrutiny, claiming that such is similar to a doctor using a hospital bed or surgical tool to aid in a patient examination.
“All of those procedures are going to use some sort of an FDA-regulated medical device or drug that comes in from another state,” Ittleman said. “It doesn’t give FDA the authority to regulate that doctor’s office.”
But Judges Thomas B. Griffith and Harry T. Edwards voiced skepticism at Ittleman’s claims, as drugs like the antibiotic clearly fall within the FDA’s regulatory authority.
“Can’t it be that the practice of medicine uses a drug?” Judge Griffith said. “If it’s a practice of medicine that uses a drug, there’s nothing that keeps it from being regulated by federal authorities.”
In July 2012, U.S. District Judge Rosemary M. Collyer granted the FDA’s motion for summary judgment and permanently barred Regenerative Sciences from making Regenexx in a suit challenging the agency’s regulation of the stem cell product, finding that Regenexx was a drug subject to FDA enforcement.
Judge Collyer found the company’s statements that the procedure is intended to treat orthopedic, musculoskeletal and spinal injuries, and arthritis through stem cells that “repair the patient’s degenerated or injured area” fully satisfied the FFDCA’s definition of a drug.
The FDA supported Judge Collyer’s decision, noting that Regenerative Sciences doesn’t qualify for limited regulation as a human cell or tissue product under the Public Health Service Act. To qualify under that framework, a product must be “minimally manipulated,” whereas Regenexx is highly processed.
“Defendants here have admitted they’re trying to manipulate the characteristics of these cells,” FDA counsel Abby C. Wright said.
Judges Thomas B. Griffith, Sri Srinivasan and Harry T. Edwards sat on the panel for the D.C. Circuit.
Regenerative Sciences is represented by Mitchell S. Fuerst and Andrew S. Ittleman of Fuerst Ittleman David & Joseph PL and William Francis Coffield IV of Coffield Law Group LLP.
The case is United States of America v. Regenerative Sciences, LLC, case number 12-5254, in the U.S. Court of Appeals for the District of Columbia Circuit.
–Additional reporting by Helen Christophi. Editing by Philip Shea.
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