Could the Stroke of a Pen Open Regen Medicine Floodgates?

Doug Oliver is the founder of a nonprofit organization known as Regenerative Outcomes. He helped push through the 21st Century Cures Act signed into law back in 2016. He believes that the act, combined with a simple executive order signed by the president, could open the floodgates of regenerative medicine. His proposal is at least worth considering.

In addition to being a proponent of regenerative medicine, Mr. Oliver is also a beneficiary of it. You see, Oliver was legally blind at one time as a result of macular degeneration. He underwent an adult stem cell treatment that is, to this day, still considered experimental. It worked. Read what Oliver wrote about his experience in an August 30 (2018) article published by The Hill:

“I went from legally blind, walking with a stick and prohibited from driving, to getting my driver’s license once again and ceremoniously gifting my now-unnecessary walking stick to U.S. Sen. Lamar Alexander.”

It should be obvious why Oliver is so excited about the potential of regenerative medicine to change the way we deal with sickness and disease. It is also easy to conclude that his executive order proposal is reasonable. Remember that Oliver knows a thing or two about the limits placed on regenerative medicine by bureaucracy and regulation.

Oliver’s Executive Order Proposal

Mr. Oliver proposes an executive order that would, with the stroke of a pen, designate any disease or condition that currently qualifies an American citizen to receive disability benefits as an unmet medical need. The value of this proposal can only be understood if you know what the FDA has done in response to the 21st Century Cures Act.

Among other things, the act resulted in the FDA creating two brand-new designations for products and medical devices being submitted for federal approval. One of those designations is known as the regenerative medicine advanced therapy (RMAT) designation. In order to receive this designation, a new regenerative medicine product or procedure would have to meet two conditions:

  • It would have to, in some measurable way, effectively address a serious or life-threatening disease or condition
  • It would have to address a medical need that remains unmet at the current time.

Macular degeneration certainly qualifies as a serious condition. So any regenerative medicine procedure designed to address it already meets the first qualification. But guess what? Macular degeneration is also a condition that is, at the current time, unmet by any available therapy. People made blind by macular degeneration are eligible for Social Security disability benefits. See the link?

A Flood of Regenerative Medicine

Utah-based Apex Biologix explains that, if nothing else, the new RMAT designation allows for the fast tracking of certain kinds of regenerative medicine products and procedures. That’s exactly what the designation is intended to do. Any product that receives the designation is automatically eligible for an expedited review process that saves both time and money.

That being the case, the executive order Oliver proposes could create a flood of regenerative medicine thanks to accelerated approval of dozens of procedures that might otherwise languish on the desks of FDA bureaucrats for more than a decade.

Oliver’s rationale is simple: current medical research focuses mainly on big-ticket areas pharmaceutical companies and device makers know will pay off sooner rather than later. Many conditions that would benefit from regenerative medicine research, like macular degeneration, are ignored because they are not considered big-ticket items. An executive order like the one Oliver proposes would change that. Fast tracking regenerative medicine would increase its profitability and encourage the industry to invest in it.

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