With the advent of modern technologies, the field of regenerative medicine has truly begun to approach its full potential.
Case in point: In recent months, the Food and Drug Administration has approved cutting edge treatments that genetically modify cells in order to treat devastating diseases. On Thursday, the agency announced a plan intended to speed up the approval process for what the agency is calling “regenerative medicine,” at the same time that it also plans to crack down on bad actors.
“These concepts are no longer the stuff of science fiction, but rather real-life science where cells and tissues can be engineered to grow healthy, functional organs to replace diseased ones; where new genes can be introduced into the body to combat disease; and where adult stem cells can generate replacements for cells that are lost to injury or illness,” FDA Commissioner Scott Gottlieb said in a statement. “The promise of this technology is why the FDA is so committed to encouraging and supporting innovation in this field.”
The new policy framework, outlined in four guidance documents, aims to clarify how modern therapies or products are regulated under policies that were created before many of today’s biomedical technologies even existed, in order to hopefully make the regulatory process smoother. It additionally outlines how the FDA plans to evaluate safety and effectiveness, as well as how it plans to crack down on products that trigger significant safety concerns (ahem, stem cell clinics).
“The rapid growth and promise of this field has increasingly sowed the ground for the entry of some unscrupulous actors, who have opportunistically seized on the clinical potential of regenerative medicine to make deceptive claims to patients about unproven and, in some cases, dangerous products,” Gottlieb said. “By exploiting the lack of consumer understanding of this area, as well as the fear and uncertainties posed by the diseases these bad actors claim to treat, they’re jeopardizing the legitimacy and advancement of the entire field.”
Those guidelines are final.
The second part of the framework aims to speed development and approval of new therapies. Two of the documents, submitted as drafts that must go through a public comment period before final approval, outline a plan intended to deliver on promises of the 21st Century Cures Act that would “simplify and streamline” regulatory requirements for regenerative medicine therapies and allow some to receive an expedited review.
“We must advance a modern, efficient and least burdensome framework that recognizes the breakneck speed of advancement in the products we’re being asked to evaluate, while ensuring patient safety,” Gottlieb said. “That is the goal of the policy we’re announcing today.”
This announcement may be an example of what the FDA commissioner recently called “deregulating by regulating.” Earlier this month, he announced a similar approach to genetic health tests and in September unveiled the “FDA Pre-Cert” pilot program to regulate digital health products.