Regulatory Focus™ > News Articles > Texas Approves New Stem Cell Therapies, Setting up Possible FDA Showdown

Texas Approves New Stem Cell Therapies, Setting up Possible FDA Showdown

Posted 16 April 2012 | By Alexander Gaffney, RAC 

The state of Texas approved new-and controversial-rules to allow doctors to use adult stem cells to conduct institutional review board (IRB)-approved procedures on patients, reports The New York Times.

The changes, instituted 13 April by the Texas Medical Board, were reportedly spearheaded by Texas Governor and former Republican presidential nominee Rick Perry, who has said he experienced relief from the procedures, reports The Times.

Some researchers, however, are skeptical about the procedure's benefits and say the use of stem cells on patients before clinical trials are conducts is exposing patients to unnecessary risk, reports The Times.

"Researchers said the evidence of success of stem cell injections is anecdotal, and they advocate waiting for clinical trial results before allowing doctors to charge patients for the procedures, which typically cost tens of thousands of dollars," wrote The Times.

The new rules also raise the prospect of a showdown with the US Food and Drug Administration (FDA), which has in the past determined that adult stem cells require agency approval.

"Stem cells, like other medical products that are intended to treat, cure or prevent disease, generally require FDA approval before they can be marketed," writes FDA on its website. "At this time, there are no licensed stem cell treatments."

Texas' rules seek to circumvent this by requiring IRB approval and treating the procedure like a clinical trial instead of a normal procedure.

"The proposed Texas rules would allow doctors to bypass the FDA so long as they satisfy other conditions before offering certain experimental adult stem-cell treatments, including obtaining patient consent and securing approval from an independent review board," reports Fox News.

It's a "clever way around the FDA's appropriate role overseeing clinical trials," said Dr. Irving Weissman of Stanford University's Institute for Stem Cell Biology and Regenerative Medicine to The Houston Chronicle.

For now, at least, the FDA is only reasserting it's authority in written statements-not actions.

"The FDA has regulatory authority over human cells, tissues and/or cellular and tissue-based products," the agency said in a statement to Fox News.

Read more:

The New York Times - Texas Board Approves Rules on Use of Stem Cells

FDA - What are stem cells? How are they regulated?

Fox News - Texas considers change to stem cell regulations

The Houston Chronicle - Texas accused of ignoring FDA on stem cell rules

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