FDA Steps Up Enforcement on Unproven Stem Cell Therapies

FDA issues statement on enforcement and new policies for regenerative medicine

In a statement released on August 28, 2017, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, outlined the agency’s new policy goals and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine.

His statement reads in part:

“To make sure the agency is separating the promise from the unscrupulous hype, we are stepping up our enforcement activity in this area. At the same time, this fall the FDA will advance a comprehensive policy framework that will more clearly describe the rules of the road for this new field. This comprehensive policy is based on our existing authority. It will offer responsible product developers—including individual providers working in clinics and academic hospitals and advancing their own products as part of regenerative medicine procedures—a way to more efficiently gain FDA approval for their products through a process that is minimally burdensome and less costly….

“In terms of compliance, and with regard to our increased oversight and enforcement: In the last few days alone, the FDA has taken steps in Florida and California to address a number of especially troubling products being marketed. But unfortunately, these are examples of a larger pool of actors who claim that their unproven and unsafe products will address a serious disease, but instead put patients at significant risk. We will seek to take additional actions in the coming months as we address this field, and target those who are clearly stepping over the line, at the same time that they create a potential danger to patients. We have examples where some of these unproven treatments have clearly harmed patients.

“As the agency responsible for ensuring these therapies are safe and effective, I will not allow these activities to go unchecked. I’ve directed the FDA to launch a new working group to pursue unscrupulous clinics through whatever legally enforceable means are necessary to protect the public health. Late last week, FDA worked with the United States Attorney to ask a court to seize the components of a product that involved the use of vaccinia virus vaccine as part of a purported treatment for cancer that FDA believes created the potential for substantial risks to patients. The product posed significant public health concerns for the agency.”

Read the full statement here.

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