California now has a first-of-its-kind stem cell law that requires clinics pitching non-FDA approved stem cell offerings to be upfront with patients. It’s a bill that will help to protect patients. How?
With Jerry Brown’s signature yesterday, the new California law mandates that stem cell clinics in our state take some steps to inform patients of various facts regarding what the clinics are marketing.
The bill, SB 512, was sponsored by Senator Dr. Ed Hernandez and now as a law adds Section 684 to the Business and Professions Code, relating to healing arts.
In the press release, Hernandez described the new law:
“I authored SB 512 to establish protections for consumers seeking early-stage, unproven experimental therapies,” said Senator Hernandez. “There are currently over 100 medical offices in California providing non-FDA approved stem cell treatments. Patients spend thousands of dollars on these treatments, but are totally unaware of potential risks and dangerous side effects. Thank you to Governor Brown for understanding the need for this law.”
The digest of the bill (now law) begins this way:
“This bill would require a licensed health care practitioner who performs a stem cell therapy that is not approved by the United States Food and Drug Administration (FDA) to communicate to his or her patient seeking stem cell therapy specified information regarding the provision of stem cell therapies on a specified notice in a prominent display in an area visible to patients in his or her office, posted conspicuously in the entrance of his or her office, and provided in writing to the patient prior to providing the initial stem cell therapy.”
The law requires this specific notification by the clinics:
“THIS NOTICE MUST BE PROVIDED TO YOU UNDER CALIFORNIA LAW. This health care practitioner performs one or more stem cell therapies that have not yet been approved by the United States Food and Drug Administration. You are encouraged to consult with your primary care physician prior to undergoing a stem cell therapy.”
This notice must be posted in the clinic and given in writing to the patients. The law also has some teeth to promote compliance. After the first violation, each subsequent violation results in a $1,000 fine.
Big kudos to Senator Hernandez and CCST Senate Fellow, Bao-Ngoc Nguyen, who made this possible through a lot of hard work. I was happy to have some tiny role in helping, including testifying at the Capitol here in Sacramento in support.
One of the most important sections gets the California State Medical Board involved:
“(e) The Medical Board of California shall indicate in its annual report, commencing with the 2018–19 annual report, all of the following with regard to licensees who provide stem cell therapies:(1) The number of complaints received.(2) Any disciplinary actions taken.(3) Any administrative actions taken.”
FDA should have reviewed, revised and updated rules and regulations per current advanced sciences and technology, and common sense in a timely manner.
Stem cells is excellent let’s PROVE a point to FDA. This is legal in every country except the U.S. let’s get this legal by proving it works starting off with non FDA approved to becoming FDA approved.
This is AWESOME! LETS PROVE STEM CELL WORKS.
NO surgery or procedure has FDA approval
The procedure amounts to extracting cells from your own body, concentrating them, and then injecting them back into you. Where is the danger in that? What we really need is a way to determine if a stem cell clinic knows what they are doing and are getting successful results. That would be helpful and might be called “groundbreaking”. But this law shouldn’t be called that. Surgeons, Hospitals and Pharma are all threatened by stem cell therapies and I suspect that is who is behind this law: basically scare patients away from trying it.
FDA IN BED WITH BIG PHARMA UNTIL BIG PHARMA CAN PATENT THE WHOLE FIELD AND SOCK IT TO US.
If their cost for the stem cells are $1000, they are socking it to us already. We do not have to wait for Big Pharma.
My Dr told me it was not FDA approved and he would not violate FDA regulations, but it might work. I should have been told that if he didn’t violate FDA regulations it would not work. The injection did not work and I learned later that if he had used an enzyme to clean up the fat, it had a better chance of working. That injection was costly.
Kind of strange that the state is saying just put up a sign and feel free to violate FDA regulations!
Violating and/or ignoring federal regulations is nothing new in California.
So they can offer a random experiment but they have to state that their treatment is not FDA approved? Useless law.
How about forcing them to apply for an IND to run their experiment? Or state that they are offering unapproved stem cell treatments following an FDA approved IND application?
It’s a step in the right direction and the California State Medical Board will now monitor situation with stem cell clinics. Yes, even more is needed, but passing a law isn’t easy.