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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 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)

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)

U.S. marshals on Friday seized five vials of smallpox vaccine, including one that was partially used. The agency is investigating how the company obtained the vaccine, which has been stockpiled by the government in case of a bioterrorist attack. The vaccine is made with live vaccinia virus, a poxvirus similar to but less harmful than smallpox. The vaccine could cause life-threatening problems in immune-compromised cancer patients, and also in certain unvaccinated people who might be accidentally infected by the patients, the FDA explained. (McCullough, 8/28)

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)

"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)

Over the next several months, the FDA plans to clarify which treatments will fall under its oversight, and tell providers of the therapies what they need to do to get regulators’ approval. For example, some individualized treatments where doctors at a clinic remove a patient’s stem cells and put them back in with minimal manipulation likely won’t be subject to FDA review, Gottlieb said. However, when the cells are manufactured on a larger scale, the FDA would police the product, he said. (Edney, 8/28)