A three-judge panel of the U.S. Court of Appeals for the District of Columbia has unanimously upheld a July 2012 district court decision to place an injunction on a stem cell procedure performed by Regenerative Sciences known as Regenexx.
The lower court had ordered the Colorado medical practice to cease marketing its cultured cell therapy that regenerates bone and cartilage, saying such therapies are drugs subject to FDA enforcement.
The appellate court’s decision ultimately turned on the fact that not only was the doxycycline that Regenerative Sciences used to protect against microbial contamination in patients’ stem cell samples obtained via interstate commerce, placing it squarely within federal jurisdiction, but that “the facilities, methods and controls for processing the Mixture violated federal manufacturing standards in numerous respects.”
Additionally, the court said, the mixture was misbranded, as Regenerative Sciences failed to provide “adequate directions for use,” as well as “Rx only” on the mixture’s labeling, as required by the 1938 FD&C Act.
Read the appellate court’s decision at www.fdanews.com/ext/resources/files/02/02-10-14-StemCells.pdf. — Lena Freund
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