Court Denies FDA Move Against California Stem Cell Clinics
A California federal judge has denied an FDA request for summary judgment in its case against a network of clinics that the government says is offering customers unauthorized stem cell treatments. FDA had wanted to shut down activities at the California Stem Cell Treatment Center and the Cell Surgical Network, saying the clinics were using unapproved drugs to treat patients suffering from conditions such as cancer, arthritis, multiple sclerosis, diabetes, Lou Gehrig’s disease, and Parkinson’s disease. The clinics have said their treatments involve substances that are exempt from FDA oversight, in part because they come from their patients’ bodies.
The Los Angeles Times reports that although FDA won summary judgment in a Florida federal court against U.S. Stem Cell Clinic, the California judge may have been influenced by a Supreme Court decision that came after the Florida ruling in which the high court narrowed the circumstances in which courts must defer to a federal agency’s interpretation of its own rules. Judge Jesus Bernal cited the Supreme Court decision in finding that FDA’s interpretation of its rules defining stem cell preparations as illegal drugs “is not entitled to deference,” the newspaper says. Florida federal judge Ursula Ungaro had ruled that the FDA interpretation must be given deference.
FDA declined to comment to the Times on the ruling because the case is still “pending litigation.” Through the Justice Department, the agency had said in the California case that the purportedly stem-cell-rich solution used by the clinics required FDA approval. “There have been no adequate and well-controlled studies performed on the … products demonstrating that they are safe or effective for any indication,” it said.
The Times says that providers targeted by FDA typically remove fat tissue from patients by liposuction, treat the fat to extract or concentrate stem cells in the tissue, and inject the concentrate back into the patients for supposedly therapeutic purposes. FDA has not approved any treatments using fat cells, it says.
The judge held that given the competing claims from the government and clinics about the procedure, “there is a triable issue of fact and summary judgment is not appropriate.”