The three-year grace period for not enforcing premarket approval requirements for human cells, tissues, and cellular and tissue-based products (HCT/Ps) is more than half over, and the US Food and Drug Administration (FDA) said Wednesday that it has not received the responses from manufacturers that it expected.
To combat this lackluster response rate from HCT/P manufacturers, including stem cell clinics, the agency is launching a temporary program (ending at the end of the year) to help companies obtain a rapid, preliminary, informal and non-binding assessment from FDA regarding how the HCT/Ps will be regulated. The agency said it intends to respond to inquiries that contain enough detail for evaluation within three days of receipt, as resources permit.
Acting FDA Commissioner Ned Sharpless said in a statement: “The pace of progress of those offering these human cells, tissues, and cellular and tissue-based products, including stem cell treatments, to come into compliance with the requirements has been slower than expected. It’s possible some stakeholders have questions about the requirements or length of the process.”
But some believe that because FDA already has several other ways
for industry to obtain information on the regulatory status of their HCT/Ps, the new temporary program, called the TRG Rapid Inquiry Program (TRIP), may not be useful.
Leigh Turner, an associate professor at the University of Minnesota Center for Bioethics, told Focus
: “I understand why the FDA is making this option available, but I doubt many companies will take advantage of it. Most businesses advertising purported stem cell treatments or trying to bring cellular therapies to market likely already know how their cell-based products are regulated. While there are some regulatory grey zones and some businesses might not be familiar with federal regulations, my sense is that most businesses market unlicensed stem cell products not because they are clueless but because it is very profitable to violate the law.”
An FDA spokesperson declined to offer more specifics on how many stem cell clinics or other HCT/P manufacturers have yet to reach out during the grace period. And Turner said he thinks the grace period has allowed more of these businesses to proliferate.
“What the FDA will not want to acknowledge when that time arrives is the extent to which the three-year period of enforcement discretion has provided time for many more businesses to begin selling unlicensed and unproven stem cell products. If the FDA doesn’t like playing stem cell clinic whack-a-mole, they shouldn’t have given these businesses years to keep pouring into the marketplace,” Turner said.
TRG Rapid Inquiry Program (TRIP)