Wednesday, April 24, 2019

California's Intial Moves on Regulation of Dubious, Unregulated Stem Cell Clinics

Legislation targeting unregulated,"snake-oil," stem cell clinics easily cleared its first hurdle yesterday and was put on track for speedy approval by the  California legislature.

The measure was amended by its author, Assemblyman Kevin Mullin, D-San Mateo, to set deadlines for moving forward next year with new regulation of the clinics, which have proliferated in California and elsewhere.

The proposal is supported by the state's $3 billion stem cell agency. Jonathan Thomas, chairman of the agency, has called the treatments "snake oil."

The clinics peddle ostensible stem cell therapies for which they charge thousands of dollars. The treatments are not approved by the federal Food and Drug Administration. Some have resulted in injury, including blindness.

An analysis of the measure (AB617) by legislative staff said,
"According to the Centers for Disease Control and Prevention in the past year, at least 17 individuals across five states were hospitalized after being injected with therapeutic products made from umbilical cord blood. These particular illnesses have been identified as bacterial infections that have caused swollen spinal disc, infected bones and joints, and abscesses on their backs. Of the 17 infections, 15 have been linked to a single California based company that sells vials of a solution containing umbilical cord blood that they market to ‘stimulate regenerative healing.'" 
Mullin's  bill would charge the state Department of Public Health with creating a body by February 2020 that could enact "emergency" regulations, with 90-day  notice, to deal with clinics not in compliance with federal regulations. The panel would also be charged with making recommendations to the legislature by July of next year for new laws concerning the clinics.

The 2020 deadlines were added to the bill on Monday. However, it is unlikely to mean creation of emergency regulations any sooner than the middle of next year, given state's normal processes.

Mullin's bill won unanimous approval yesterday and was sent to the Assembly Appropriations Committee and was recommended for the consent calendar, which means that it will receive routine approval unless other issues come up. The bill also requires full Assembly and Senate approval and a signature from the governor.

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