Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA’s new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine
However, with all of the medical potential, also comes novelty and uncertainty as this field matures. 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. These dishonest actors exploit the sincere reports of the significant clinical potential of properly developed products as a way of deceiving patients and preying on the optimism of patients facing bad illnesses. This puts the entire field at risk. Products that are reliably and carefully developed will be harder to advance if bad actors are able to make hollow claims and market unsafe science. In such an environment a select few, often motivated by greed without regard to responsible patient care, are able to promote unproven, clearly illegal, and often expensive treatments that offer little hope, and, even worse, may pose significant risks to the health and safety of vulnerable patients. These so-called treatments run afoul of the
At the same time, it's incumbent upon the
For example, sometimes when cells or tissues are taken from and given back to the same individual or when the cells or tissues do not undergo significant manufacturing, are intended to perform the same basic functions, and are not combined with another drug or device, among other factors; their benefits and risks are well understood. In these circumstances, the products may not require premarket review under current law. However, when significant manufacturing is performed on the cells or tissues, or when the cells or tissues are not intended to perform the same basic functions, far greater uncertainty exists as to the benefits and risks involved. In these cases, it's necessary to understand the benefits and risks in clinical trials prior to widespread use of the products. Therefore, premarket review is required.
At the same time that we take steps to prevent unscrupulous actors from being able to deceive patients and potentially harm their health, we also need to make sure that the vast majority of responsible product developers know where the regulatory lines governing this new field are drawn. The
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
Stepped Up Enforcement
In terms of compliance, and with regard to our increased oversight and enforcement: In the last few days alone, the
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
Efficient Regulation
With regard to our regulation of these products, I want to expand on the need for bright lines and appropriate oversight to accommodate the good actors working on genuine science.
As we work to protect Americans from the bad actors, I'm equally committed to doing all we can to help bring to patients more quickly innovative, scientifically proven regenerative cell therapies. For this reason, we're developing a comprehensive and efficient, science-based policy with the aim of accelerating the proper development of these products.
The
At the same time, we will also issue a compliance policy that, with the exception of outliers potentially harming public health in a significant way right now, will give current product developers a very reasonable period of time to interact with the
In addition, the
Ultimately, the agency's goal is to make sure that the potential of regenerative medicine can continue to advance to benefit the patients who need new and innovative options for their medical problems. These technologies hold out the potential to significantly alter the course of a broad range of diseases. We are committed to taking steps to make sure these opportunities advance as quickly as possible. To do so, we must put in place the framework to separate the promising treatments from those products that pose significant risks or offer patients little to no chance of benefit. We will also continue to take steps to keep those who would exploit this promising area from harming patients and abusing the public's trust. We can't let a small number of unscrupulous actors poison the well for the good science that holds the promise of changing the contours of human illness and altering the trajectory of medicine and science.
For more information:
The
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