I appreciate your opinion, and I think Texas would make a good plan A except there are some unknowns with this. The question I have is: will the feds go along with the Texas law, or will they try to spend tax dollars shutting down clinics. Certain Stem Cell therapies are currently regulated and some that are sold - are not regulated. I think Gottlieb has to deal with this right away. And I think that a national law reform will have to come through and it will open up the doors for us.
The texas law taking effect means that no state law enforcement will interfere with clinic operations.
But does the FDA have the man power, or do they even care to go to texas and stop stem cell clinics from selling therapies that go against FDA protocol ?
"And though the Texas law says that it applies to stem cell treatments currently under investigation in clinical trials, it also blocks the Texas Medical Board from revoking, failing to renew or suspending a physician’s license “based solely on the physician’s recommendations to an eligible patient regarding access to or use of an investigational stem cell treatment.”
FDA Inaction
FDA has so far let these direct-to-consumer stem cell clinics flourish and has only issued a limited number of warning letters to companies like Cell Vitals in 2014, Irvine Stem Cell Treatment Center in 2015 and Lavian in 2016.
Former FDA Commissioner Robert Califf, Center for Biologics Evaluation and Research Director Peter Marks and CBER Deputy Director Celia Witten in December 2016 made the case in the New England Journal of Medicine that the hype over such treatments outpaces the evidence that they are safe and effective, though the agency has not cracked down on the direct-to-consumer stem cell market.
“FDA could’ve done something since 2009, this is a marketplace that’s been around a while,” Turner said.
And because many of the clinics engage in interstate commerce, Turner said they do clearly fall within FDA’s jurisdiction. But it’s not just FDA, he added, the Federal Trade Commission could also act, as could state consumer protection agencies or state medical boards.
So why isn’t FDA taking action? The agency did not respond to a request for comment and Turner said he has not received a straight answer from the agency.
“Will they knock out these businesses? Talking with FDA, I didn’t hear that,” he said, adding that he did not get the impression that there’s a comprehensive, organized plan to deal with the emergence of such a large and growing marketplace.
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