New Texas Law on Stem Cell Treatments: Showdown With FDA Coming? – Regulatory Focus

Posted 28 June 2017 By Zachary Brennan

With a new Texas law now in the books to allow companies to sell unproven stem cell treatments without US Food and Drug Administration (FDA) approval, some experts wonder when FDA will step in to shut down companies and clinics exposing people to unapproved medical products.

Similar to the Right to Try laws spreading across the US and attempting to undercut FDAs regulation of investigational products, the Texas law, which had been brewing in some form since 2012, applies to certain investigational stem cell treatments for patients with certain severe chronic diseases or terminal illnesses.

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 physicians license based solely on the physicians recommendations to an eligible patient regarding access to or use of an investigational stem cell treatment.

An investigation by Nature in 2012 uncovered unproven and costly stem cell treatments being sold in Texas.

Leigh Turner, anassociate professorat the University of Minnesotas Center for Bioethics and School of Public Health and co-author of a paper in Cell on the selling of stem cell therapies directly to US consumers, explained to Focus the unpredictable nature of Texas law, as the state already has one of the highest concentrations of unregulated stem cell clinics (California and Florida also have high concentrations of such clinics, he said, noting his investigation found more than 500 such clinics in the US).

There are lots of credible stem cell researchers in Texas, but theyre not the ones pushing for this bill, Turner said, noting that the greatest concern should be focused on clinics offering unproven stem cell treatments for a range of diseases with few or no treatment options, like ALS, autism, spinal cord injuries and others.

And though there are provisions in the bill that, according to Turner, could knock some businesses out of the marketplace in Texas, he said its hard to know which way itll break, though it seems clearly based on the fantasy that Texans have to go elsewhere to receive these investigational stem cell therapies.

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 couldve done something since 2009, this is a marketplace thats been around a while, Turner said.

And because many of the clinics engage in interstate commerce, Turner said they do clearly fall within FDAs jurisdiction. But its not just FDA, he added, the Federal Trade Commission could also act, as could state consumer protection agencies or state medical boards.

So why isnt 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 didnt hear that, he said, adding that he did not get the impression that theres a comprehensive, organized plan to deal with the emergence of such a large and growing marketplace.

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New Texas Law on Stem Cell Treatments: Showdown With FDA Coming? - Regulatory Focus