Thursday, May 02, 2019

New Effort to Require California Medical Board to Act on Snake Oil Stem Cell Clinics

A California measure aimed at regulating "snake oil," stem cell clinics sometime next year has taken a major turn as it wends its way through the legislative process in Sacramento. 

The bill, AB617, was amended this week to require California's Medical Board to move on the clinics, which have proliferated across the country in recent years. California has more than 100, according to the latest estimates.  An earlier version of  the measure placed responsibility with the state Department of Public Health. 

The clinics charge thousands of dollars for treatments using substances that they describe as stem cells. However, in virtually all cases, the treatments have not been tested scientifically. Some have led to serious injuries. 

According to the latest version of the measure, the state Medical board would be required to create a stem cell advisory group by February 2020 that would make recommendations by July 2020 for regulation of the dubious clinics.

The group could also recommend emergency regulations that could be adopted by the state Medical Board with a 90 day notice. 

The new group would have nine members. Three would be appointed by the California stem cell agency, three by state Medical Board, two by the state osteopathic medical board and one by the state nursing board. 

The changes in the bill mean that it will require a 70 percent vote by both houses of the legislature. The previous version would have required only a majority vote. The increase is dictated by the fact that it changes Proposition 71 of 2004, which created the state stem cell agency, formally known as the California Institute for Regenerative Medicine (CIRM). 

A spokesman for CIRM said today,
"CIRM is working with legislators to help them pass a bill that will regulate clinics offering unproven and unapproved stem cell therapies."
The California Stem Cell Report has asked Mullin's office for comment on the rationale for the latest amendments. We will carry his comments verbatim when they are received. 

(Following the posting of this item, Mullin released a statement that said: 
(“An important part of the legislative process is working with stakeholders to make sure legislation is as effective as it can be. Our amendments to move the requirements of AB 617 to the California Medical Board's jurisdiction will have a positive outcome. I look forward to continuing to work with MBC, CDPH, CIRM and others to address the serious issues related to potentially fraudulent stem cell clinics.")
The bill has cleared its first Assembly committee and is now before the Assembly Appropriations Committee. 

(An early version of this item said that a staff analysis of the bill said it was supported by CIRM. That phrasing was replaced in this version by the quote from CIRM.)
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