LOS ANGELES (CN) — A Ninth Circuit panel agreed Friday that the U.S. Food and Drug Administration has the authority to regulate a California provider of stem cell treatments that have been likened to “liquid magic.”
In a unanimous opinion, the three-judge panel reversed the decision by a federal judge who two years ago concluded that the procedure, which involves extracting body fat from a patient, isolating stomal vascular fraction, or SVF, cells from the tissue and injecting these back into the patient, doesn’t amount to creating a drug and falls under the so-called same surgical procedure exemption to FDA oversight.
“SVF fits comfortably within the Food, Drug, and Cosmetic Act because it is sold and administered to patients for therapeutic purposes, and there is no reason to think that Congress intended it to be outside the FDCA’s scope,” U.S. Circuit Judge Michelle Friedland, a Barack Obama appointee, said in finding that SVF is indeed a drug. “In fact, recent legislation suggests that Congress presupposes that the FDA regulates stem cell therapies.”
The panel was divided as to why the treatment doesn’t fall under same surgical procedure exception.
U.S. Circuit Judge Jennifer Sung, a Joe Biden appointee, and U.S. Circuit Judge Kim McLane Wardlaw, a Bill Clinton appointee, agreed with the FDA that, unlike skin or vein grafts, the human cells, tissues, and cellular and tissue-based products, or HCT/Ps, that are extracted in stem cell treatments aren’t the same as the processed HCT/Ps that are injected back.
The same surgical procedure exemption, Sung wrote, applies to procedures that involve relatively low risk — risk no greater than that typically associated with conventional surgery. This, she said, conflicts with the California Stem Cell Treatment Center’s interpretation of the exception that would exempt surgical procedures that subject HCT/Ps to substantial processing, even if such processing introduces risk far greater than that associated with conventional surgery.
“The FDA’s interpretation is more consistent with the [same surgical procedure] exception’s plain meaning,” Sung wrote. “And it is the only interpretation that makes sense in light of the HCT/P regulations’ tiered, risk-based framework, and its purpose and history.”
Friedland concurred that the stem cell procedure doesn’t fall under the exemption from FDA oversight but didn’t think that the regulatory language resolved the argument.
“I believe that the [same surgical procedure] exception provision is ambiguous, and that we owe deference to the FDA’s interpretation of it,” she wrote.
Nathaniel Garrett, an attorney for the California Stem Cell Treatment Center, didn’t immediately respond to a request for comment on the ruling.
At the February hearing on the FDA’s appeal in Pasadena, California, Garrett argued that the agency was trying to rewrite the same surgical procedure exemption to get around the uncontested fact that the cells that are injected into the patients are the same as those that were removed, minus any superfluous tissue.
According to Garrett, the FDA was trying to smuggle in processing and handling restrictions on the same surgical procedure exemption that weren’t part of it when the rule was formulated 25 years ago.
“When they do care about processing and handling, they put it in the regulation,” Garrett said at the hearing. But when the FDA enacted the exemption for same surgery procedures, they said “processing controls are not going to apply. We are not going to impose processing limitations on the SSP exemption.”
The agency sued the Southern California clinic together with a Florida-based one in 2018, claiming they were disregarding patients’ safety by peddling “unproven products that exploit the hope of patients and their loved ones.”
But while the FDA won an injunction against the Florida clinic that was upheld by the 11th Circuit, the California case went to trial before U.S. District Judge Jesus Bernal in Riverside, who sided with the defendants. The Ninth Circuit ruling with the FDA avoids a circuit split that might have gotten the U.S. Supreme Court’s attention.
Clinics offering newfangled and unapproved stem cell therapies have sprung up all over the country in recent years, promising treatment for a host of chronic diseases and ailments, from multiple sclerosis and Parkinson’s disease to dementia and erectile dysfunction.
Stem cells have the ability to self-renew and to regenerate specialized cells in tissues. Given these unique regenerative abilities, they have been used as therapies to generate tissues but only a limited number of medical conditions can be safely and effectively treated with stem cell therapies, according to an amicus curiae brief by the International Society for Stem Cell Research and the International Society for Cell and Gene Therapy in the Ninth Circuit case.
One such treatment is the transplantation of blood-forming stem cells derived from bone marrow or umbilical cord blood for the reconstitution of the blood-forming and immune systems after chemotherapy or systemic radiation therapy.
“Unproven stem cell therapies marketed directly to consumers by clinics have resulted in patients being blinded, paralyzed, and infected with dangerous pathogens,” the two organizations said in support of the FDA’s appeal. “A lack of FDA oversight, caused by reduced federal regulation or by companies that evade FDA regulation, undermines adverse event reporting requirements and makes it harder to identify unapproved stem cell therapies that cause serious illness in patients.”