New FDA Drug Designation: “Regenerative Medicine Advanced Therapy”
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Last month (November 2019), we came across a promising report (see below) of a new drug designation created by the FDA: the “Regenerative Medicine Advanced Therapy” (RMAT). This designation was actually announced back in early 2017, but we suspect many readers may not know about it yet, so we’d like to share it here!
We call this development “promising” because some people in our growing community have expressed concern that excessive regulation may be a significant burden in the rapid development of rejuvenation biotechnologies for aging humans. While that may be true, this relatively new FDA drug designation illustrates that the FDA has indeed been mindful of the advancements of biotechnology, and the complexities of multi-modal interventions, that they have responded with the creation of this new drug designation.
In a description of this designation, the FDA highlights the nature of the drugs it’s trying to classify with the RMAT designation:
…a drug is eligible for regenerative medicine advanced therapy (RMAT) designation if:
The drug is a regenerative medicine therapy, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products;
The drug is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and
Preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition
…certain human gene therapies and xenogeneic cell products may also meet the definition of a regenerative medicine therapy.
We would like to see something stated about prevention being considered, given that about 50% of people in the United States die of cardiovascular diseases or cancer. If a life-ending disease process is so prevalent, perhaps it would be easier to slow the human massacre if we had less damage to address by starting earlier in the disease process (atherosclerosis in heart disease, for example). We hope the FDA has mechanisms for testing preventatives that we’re not aware of.
In any case, we’re happy to see this new drug designation from the FDA.