Plans for new stringent enforcement and regulation strategies concerning stem cell therapies were announced today by the Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD.
In a statement Dr. Gottlieb announced the creation of a dedicated FDA working group tasked with pursuing unscrupulous clinics, ‘through whatever legally enforceable means are necessary to protect the public health.’ Additionally, the agency plans to roll out a comprehensive policy this fall that establishes when a stem cell therapy falls under the FDA’s authority, allowing for the formation of a definitive process for evaluating the safety and effectiveness of these therapies.
“We want to facilitate innovation,” said Dr. Gottlieb. “We seek a regulatory process that accommodates the complexity of developing these therapies, and takes measure of their tremendous and near-term potential.”
The FDA announcement come simultaneously with news of crackdowns on two stem cell clinics. Five vials of Vaccinia Virus Vaccine (Live) were seized by US Marshals at Californian stem cell treatment centers in Rancho Mirage and Beverly Hills, at the behest of the FDA.
The vaccine is not commercially available and is viewed as potentially dangerous and unproven. In a statement the FDA said they have ‘serious concerns about how StemImmune obtained the product for use as part of an unapproved and potentially dangerous treatment.’ The vaccine is reserved only for those at high risk for smallpox.
Meanwhile a separate clinic, the US Stem Cell Clinic of Sunrise (Florida), was issued an FDA warning letter for significant deviations from current “good manufacturing practice requirements.” An FDA inspection of the clinic found that adipose tissue was being processed into stromal vascular fraction (stem cells derived from body fat) which was then administered intravenously or directly into the spinal cord of patients.
“The FDA has not reviewed or approved any biological products manufactured by US Stem Cell Clinic for any use,” read the FDA statement. Over 256 lots of stem cell products were deemed to deviate significantly from current good manufacturing practices, including a disregard for following procedures to prevent microbiological contamination.
Addressing the wider issue of emerging stem cell therapies, Dr. Gottlieb said, “It’s incumbent upon the FDA to make sure that this existing [regulatory] framework is properly defined.” In his detailed statement he signaled out a small number of ‘unscrupulous actors’, who make deceptive assurances to patients founded upon unproven products.
Dr. Gottlieb made assurances that the comprehensive policy will offer responsible product developers “a way to more efficiently gain FDA approval for their products through a process that is minimally burdensome and less costly.”
For more information visit FDA.gov.