May 6, 2024

Utah’s new stem cell law undermines FDA’s authority

The state of Utah has just enacted a law permitting patients to receive medical treatments using placental stem cells without formal approval by the United States’ federal regulatory body, the Food and Drug Administration (FDA). 

Some experts are worried that this will undermine the FDA’s authority to regulate drugs and other medical treatments. Furthermore, what is also concerning is that other states may follow suit. 

The bill, “Placental Tissue Amendment Bill “, part of SB 0199, passed in both houses of the Utah State Legislature in February and was signed into law in March by Governor Spencer Cox. It will take effect on 1 May 2024. 

Placental stem cells have demonstrated experimental clinical promise in studies as placentas have a rich source of stem cells. However, no therapy has undergone a randomised human trial, which would require the FDA to approve its market entry. While some stem cell products are within the same surgical exception and minimally manipulated cellular products used in a homologous manner that do not require pre-marketing review and licensure by the FDA, several of them are classified as biologics, drugs or medical devices that need safety and efficacy testing in clinical trials and FDA pre-marketing authorisation. 

The Utah legislation introduces specific requirements for healthcare providers administering placental stem cell treatments. Its primary focus is to ensure that patients receive sufficient disclosures regarding the nature of the treatment, mainly if it involves stem cell therapy that the FDA has not been approved. 

The statute provides that Utah healthcare providers may perform a placental stem cell therapy that is not approved by the FDA so long as the healthcare provider explicitly states that the treatment is unapproved federally and gets a signed informed consent, as elaborated below. 

Under the legislation, medical professionals administering treatments using placental stem cells, including those involving therapies not approved by the FDA, must provide patients with certain disclosures. A healthcare provider whose scope of practice includes the use of stem cell therapy may perform a stem cell therapy that the FDA does not approve if they provide the patient with the following written notice before performing the treatment:

‘THIS NOTICE MUST BE PROVIDED TO YOU UNDER UTAH 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 provider before undergoing a stem cell therapy.'” 

The written notice must be prominently displayed in the provider’s office.

Moreover, the provider must obtain a signed consent form before performing the therapy, signed by the patient or their representative if they are not legally competent. This form needs to explain the various matters in a language the patient could reasonably be expected to understand, including the treatment’s FDA approval status (or lack thereof), the anticipated results of the treatment, the alternative types of treatment, the risks, complications and anticipated benefits involved in the treatment. Moreover, in print advertisement, the notice should be clearly legible.

While these are essential safeguards, they are insufficient to protect the vulnerable patient. 

Criticizing Utah’s new state law, Leigh Turner, a bioethics professor at the University of California, Irvine stated:

“Businesses in Utah that market to patients placental stem cell interventions will be able to sell such products without first obtaining premarketing authorization from the US FDA. It also appears that they will be free to market such products without having convincing safety and efficacy data to support whatever advertising claims they make about such interventions serving as treatments for various diseases and injuries.

“Clinics will apparently be able to market placental stem cell interventions without first conducting randomized controlled trials, earlier phase studies, or even having to conduct pre-clinical research. Placental stem cell interventions unsupported by convincing evidence will be marketed and administered to patients without FDA oversight and without first administering them to research participants in FDA-cleared and institutional review board approved clinical trials. Furthermore, the law does not contain any legal requirements concerning the processing, manufacturing, and distribution of such products. 

“There’s a great deal of information patients will not be able to access and consider when they sign informed consent forms that will then be weaponized and used against them if any patients suffer serious complications and later seek legal redress for any harms they are alleged to have suffered as a result of being administered such unapproved stem cell products.” 

What is also disturbing is that besides doctors, the new law allows several others, such as naturopaths, chiropractors, podiatrists, pharmacists, nurses and midwives, to provide procedures that use placental stem cells.  

The FDA must challenge Utah’s new law by sending a warning letter to any clinic administering a federally unapproved therapy. It has issued warning letters and untitled letters in the past. The FDA could also escalate the matter by seeking an injunction to stop a clinic from offering placental stem cell-based treatments. The agency has successfully sued errant stem cell clinics in Florida and California. But the recent California case, U.S.A. v. California Stem Cell Treatment Center, Inc., et al.,, is still unresolved (the FDA lost the case and its appeal to the Court of Appeals for the 9th Circuit is pending). This case may eventually end up in the U.S. Supreme Court. 

According to Turner, “the new law is meant to make it difficult for the FDA to enforce federal laws and regulations in Utah. While federal law pre-empts state law, state laws such as SB 199 are intended to undercut the FDA’s authority and make it more difficult to enforce the application of federal laws and regulations that are applicable to placental stem cell-based products marketed in Utah. There are obvious parallels here with the passage of state ‘right-to-try’ laws and the role they played in contesting the regulatory authority of the FDA.” 

These events demonstrate the ongoing complexities and challenges of stem cell regulation. 

The passage of the bills could lead to a state versus federal court case. And this new Utah law may influence other states to adopt similar bold legislation. “I’m guessing we will see more such laws,” Turner stated. “This one is focused on placental stem cell interventions. Other state bills might take a similar approach but refer to autologous stem cell products or perhaps try to smooth the way for the sale of a range of non-FDA-approved birth tissue-derived allogeneic stem cell products.” 

Patrick Foong