FDA Announces Crackdown On ‘Unscrupulous’ Stem Cell Clinics
Earlier this week, the US Food and Drug Administration indicated that crackdown on dangerous stem cell clinics, while at the same time pledging to ease the path to approval for companies and doctors with legitimate treatments in the growing field.
FDA Commissioner Scott Gottlieb, in a statement said the agency “will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work.”
Stem cells, which can be extracted from bone marrow, blood or fat, can develop into many different types of cells, and are thought to have the potential to repair or replace tissue damaged by disease, injury or aging. But so far, the F.D.A. has approved only a few stem-cell products.
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 raid came after the F.D.A. learned that the vaccine was being used to create an unapproved stem cell product, a combination of excess amounts of vaccine and stem cells derived from body fat, which was then
administered to cancer patients with potentially compromised immune systems.The F.D.A. also issued a warning letter to U.S. Stem Cell, a private clinic in Sunrise, Fla. The company was the subject of a March report in The New England Journal of Medicine, describing how one woman went blind and two others suffered severe, permanent eye damage after being given shots of stem cells, extracted from fat, into their eyes.
The warning letter accused the company of impairing the F.D.A.’s ability to conduct its inspection by refusing to allow inspectors in, and denying them access to employees.
Gottlieb, in the statement about the regulation of stem-cell therapies, said that the emerging field of cell-based and so-called regenerative medicine holds “significant promise for transformative and potentially curative treatments” for serious illnesses but that “a small number of unscrupulous actors” is putting the field at risk. He said he is launching a new working group at the FDA “to pursue unscrupulous clinics through whatever legally enforceable means are necessary to protect the public health.”
At the same time, he said, the agency will develop a framework to more clearly describe the “rules of the road” for the field and to allow responsible developers of stem-cell treatments to more easily win FDA approval. “The FDA must advance an efficient and least burdensome framework as a way to help new products remain compliant with the law through a regulatory structure that does not become a barrier to beneficial new innovation,” he said.
Public health advocates praised the F.D.A. for moving against the companies, but said it should have happened sooner, given the widespread knowledge of public harm.
“The F.D.A.’s proposal is clear evidence of the fact that the regenerative medicine sector has matured and has moved from just a research sector to a development of market ready products,” said Michael Werner, a partner in the law firm of Holland & Knight and the executive director of the Alliance for Regenerative Medicine. “He’s clearly distinguishing unscrupulous actors who are playing upon hype and taking advantage of patients and product developers who are actually going to treat diseases.”
‘He is trying to balance patient safety and a regulatory pathway that is as least burdensome as possible,” Mr. Werner said.
