The FDA announced May 9 that it is seeking permanent injunctions against a stem cell clinic in Florida and one in California to stop marketing stem cell products that lack FDA approval. The clinics also have deviated from “good manufacturing practice requirements,” putting patients’ health at risk, according to the FDA.
The actions are part of a comprehensive approach to the government’s oversight of regenerative medicine products — products promoted in many medical specialties, including aesthetic medicine. In fact, one of the physicians named in the FDA’s May 9 press release is cosmetic surgeon Mark Berman, M.D.
“The FDA is also seeking a permanent injunction to stop California Stem Cell Treatment Center Inc., with locations in Rancho Mirage and Beverly Hills, California; Cell Surgical Network Corporation of Rancho Mirage, California; and Elliot B. Lander, M.D. and Mark Berman, M.D., from marketing to patients stem cell products without FDA approval. Berman and Lander control the operations of approximately 100 for-profit affiliate clinics, including the California Stem Cell Treatment Center. The FDA is seeking an order of permanent injunction requiring California Stem Cell Treatment Center Inc. and Cell Surgical Network Corporation and the individual defendants to cease marketing their stem cell products until, among other things, they obtain necessary FDA approvals and correct their violations of current good manufacturing practice requirements,” according to the FDA.
Stem cell clinic openings have been on the rise in the U.S. in recent years, according to Bradford E. Adatto, an attorney and partner at the ByrdAdatto law firm, which specializes in legal issues impacting healthcare and aesthetic providers.
“The growth of the stem cell market has brought more businesses into the medical market attempting to offer quick, alternative ways of improving an individual’s health,” according to Adatto. “According to the FDA’s website, it has not approved any stem cell-based products for use other than cord blood-derived cells.”
While the FDA does not have control over a physician’s ability to prescribe “off-label” or conduct “experimental use” of a drug, physicians taking such actions are subjected to the oversight of their medical boards, according to Adatto. For example, he says, the Texas Medical Board allows limited use of stem cells that are not FDA approved if certain conditions are met, which include: (1) institutional review board approval for stem cell use; and, (2) special informed consents from the patients on the use of unapproved investigational therapy.
“Physicians that are interested in providing stem cells need to also confirm they are meeting the supervision required of those healthcare practitioners providing the medical services,” Adatto says. “What the medical community is witnessing is the growing trend of patients attempting to find other methods, including nonsurgical methods, to alleviate pain and discomfort. For those physicians that determine that stem cell-based therapy is a viable alternative method of treatment for their patients, they need to make sure they are compliant with their state medical boards and laws.
