FOX NEWS | Last year 47,000 Americans had their blindness reversed through the transplantation of cells from a corneal donor’s final selfless act. It is safe, it is effective, and because it is curative, it is a relatively cost effective procedure. It is medicine at its most beautiful.
And according to FDA regulations, the distribution of this cell therapy is in violation of federal law.
That’s right. The regulation says that no matter how competent the surgeon, the FDA must first approve cells from donated corneas as if they were a drug—a process that takes over a decade and can costs billions of dollars — all for a practice that has been successfully restoring sight for more than 50 years.
The good news: the FDA doesn’t always adhere to its regulations and has not in this case.
The bad news: inconsistent enforcement creates uncertainty, deterring innovation for other unmet medical needs such as arthritis, back pain, and diabetic ulcers.
Read more at Fox News.