Stem Cell Clinic Raid Is Part Of FDA’s Crackdown On Industry’s ‘Unscrupulous Actors’
The California clinic has been using smallpox vaccine on seriously ill cancer patients. Food and Drug Administration Commissioner Scott Gottlieb says he is launching a new working group at the agency “to pursue unscrupulous clinics through whatever legally enforceable means are necessary to protect the public health."
The New York Times:
F.D.A. Cracks Down On ‘Unscrupulous’ Stem Cell Clinics
The Food and Drug Administration announced a crackdown on dangerous stem cell clinics on Monday, while at the same time pledging to ease the path to approval for companies and doctors with legitimate treatments in the growing field. The agency reported actions against two large stem cell clinics and a biotech company, saying that it was critical to shut down “unscrupulous actors” in regenerative medicine, a broad umbrella that includes stem cell and gene therapies and immunotherapies. (Kaplan and Grady, 8/28)
The Washington Post:
FDA Cracks Down On Stem-Cell Clinics, Including One Using Smallpox Vaccine In Cancer Patients
The Food and Drug Administration on Monday announced a crackdown on stem-cell clinics offering on “unapproved and potentially dangerous" treatments, including an outfit in California that has been using the smallpox vaccine on seriously ill cancer patients. U.S. marshals on Friday raided San Diego-based StemImmune Inc. and seized the vaccine, which the FDA said had been combined with stem cells derived from fat to create an unapproved product. The concoction was injected intravenously and directly into patients' tumors at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, the agency said. (McGinley, 8/28)
Stat:
Unauthorized Smallpox Vaccine Used By Stem Cell Clinic Seized
Federal authorities raided a California stem cell clinic and seized a smallpox vaccine that is reserved only for the military and high-risk populations, as the Food and Drug Administration expressed “serious concerns” about how the clinic obtained access to the vaccine at all. The U.S. Marshals Service seized five vials of the smallpox vaccine, which is not commercially available, the FDA announced Monday. Four of the vials — which each hold 100 vaccine doses — were unused, but a portion of the fifth vial had been used. (Joseph, 8/28)
The Wall Street Journal:
FDA To Expand Its Authority Over Stem-Cell Treatment Facilities
The FDA announced it was crafting rules to govern the development of treatments based on the cells. The FDA also said it was cracking down on a company and three clinics that sold stem-cell treatments the agency said were potentially dangerous. The moves signaled the FDA planned to extend its authority regulating drugs and medical devices to the field known as regenerative medicine, after spending years effectively watching it emerge. (Rockoff, 8/28)
NPR:
FDA Takes Aim At Clinics Selling Unapproved Stem-Cell Treatments
"There are a small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt assurances to patients based on unproven and, in some cases, dangerously dubious products," FDA Commissioner Scott Gottlieb said in a statement Monday. (Stein, 8/28)
KPBS:
FDA Seizes Risky Smallpox Vaccine From San Diego Stem Cell Company
A San Diego company has been using a risky smallpox vaccine as part of "unapproved and potentially dangerous" stem cell treatments, according to the U.S. Food and Drug Administration. The FDA said on Monday it has seized five vials of the vaccine belonging to San Diego-based StemImmune Inc. (Wagner, 8/28)