Organ Ordinance
Scientists are making great strides toward more realistically using stem cells to grow replacement organs. Now, the US Food and Drug Administration is looking to fast-track a new regulatory framework that will encourage the development of legitimate treatments.
"In the last decade, we've seen improbable advances that hold out great hope for patients," said FDA commissioner Dr. Scott Gottlieb in a press release. "I believe that with the ability to facilitate the regeneration of parts of the human body, we're bearing witness to the beginning of a paradigm shift in the practice of medicine."
The advances made in this field have led to plenty of discussion about its potential as a game-changer for people in need of organ transplants. That level of hope and anticipation has prompted the emergence of certain unscrupulous entities, and so now the FDA is looking to crack down on the illegal side of this issue.
While there are plenty of instances where stem cells are being used to great effect, there are also clinics being set up that offer services to the public which don't yet have proven benefits. The FDA's new regulations should help to ensure that customers aren't taken advantage of, and don't have their health compromised.
"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," explained Gottlieb.
Safe Progress
The FDA wants to make sure that these regenerative treatments can continue to evolve. As such, the regulations that are set to be introduced will be the "least burdensome" that can be implemented while still maintaining the safety of patients. Within these regulations, both big and small companies will still be able to continue their research efforts.
Companies will be given access to FDA officials who will help them to determine whether they need to gain authorization to market their product and give guidance on how to carry out their application. The goal is to make the process of offering an effective treatment as efficient as possible so that worthwhile programs can be made available to the public in an expedient manner.
This kind of development can't come soon enough. Statistics from the US Department of Health & Human Services suggest that 116,000 men, women, and children were waiting for organ transplants as of August 2017, and on average 20 people die every day as they wait for a transplant.
Replacement organs grown using stem cells could cut these figures down significantly, so it's easy to see why the FDA would want to implement a framework that allows approved treatments to be made available as quickly and safely as possible.
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