Bernard Siegel says new state laws show the federal government needs to ‘get its act together’ on patient access to innovative therapies.
This month, a new stem cell law took effect in Florida, marking a significant shift in the state’s approach to regenerative medicine. Under the new legislation, licensed physicians in Florida are now permitted to administer certain stem cell therapies that have not received approval from the US FDA, within specific medical contexts such as orthopedics, wound care and pain management.
The law is not a blanket authorization for all stem cell procedures; rather, it sets defined boundaries for who can provide these treatments and under what circumstances. The statute requires that stem cells be sourced from accredited facilities, prohibits the use of cells from aborted fetuses or embryos, and enforces strict informed consent and advertising transparency to safeguard patients.
The law change sparked a slew of announcements from companies in the stem cell field, including regenerative medicine firm Celularity, which inked a partnership with longevity clinic provider Fountain Health to supply its stem cell therapy products. Celularity CEO Dr Robert Hariri, applauded Florida’s “proactive, data-driven approach to advancing investigational stem cell therapies and improving patient outcomes.”
As America shifts into a new era for healthcare, is Florida’s move a sign of more to come for patient access to innovative therapies?
Longevity.Technology: Following recent law changes in Utah and Montana, Florida becomes the latest state to sidestep the FDA and offer unapproved therapies to its residents. Utah recently passed legislation permitting healthcare providers to administer stem cell therapies derived from placental tissue without FDA approval, while Montana went a step further, creating a licensing framework for experimental treatment centers, allowing clinics to offer and administer drugs and therapies that have only completed Phase I clinical trials.
Collectively, these states are at the forefront of expanding patient access to innovative but unproven therapies, seeking to balance innovation with new regulatory and ethical safeguards. But what can we really expect from these laws, and are they the catalyst for change at the federal level? To find out more, we sat down with Bernard Siegel, exec director of the nonprofit Regenerative Medicine Foundation and founder of Healthspan Action Coalition.
As a member of the Florida Bar Association for the past 50 years, and a full time advocate for regenerative medicine for more than 20 years, Siegel has some strong views on why these laws have started to appear.
“It’s important to realize that these bills are untested, and while each bill can be considered as progress, I think they also highlight the issue of the overall reforms that need to be made,” he says. “That is, to have all regulatory systems modified to keep up with the technologies that we have today. That’s the root of a lot of problems in the field.”
New regulation needed
To illustrate his point, Siegel refers to an article in Regenerative Medicine written in 2011 by UCL professor Chris Mason, which described cell therapy as a key “pillar” of healthcare.
“The other pillars of healthcare – pharmaceuticals, biologics and medical devices – already had infrastructure built-in, but cell therapies did not – no reimbursement, no special guide,” he says. “So, if you’re going to jam all cell therapies under the same rules as biologics, nothing could get through the rigorous clinical trials and massive expense. We needed laws to keep up with innovation, and we didn’t have them.”
Fast forward to today and Siegel feels the situation hasn’t changed much – certainly not at the federal level.
“The Healthspan Action Coalition has 275 member organizations cross sector, but there’s a huge frustration that our systems are broken down and have not taken advantage of the opportunities of innovation,” he says. “We are already overwhelmed with innovation, and emerging technologies like AI and data and analytics are going to explode things further. We need our regulatory systems to be able to keep up with it all.”
Laboratories of democracy
This is where individual states can have a real impact. Back in 1932, Supreme Court Justice Louis Brandeis referred to the American states as “laboratories of democracy” – a quote that Siegel believes has taken on an increasingly literal meaning in recent times.
“Think about the California Institute for Regenerative Medicine, which was passed by ballot measure and funded by taxpayers – a state literally funding laboratories,” he says. “That is a testament to the importance of American states of being able to enact laws that don’t conflict with the federal laws. These new laws in Florida, Utah and Montana are essentially laboratory experiments in law, and we should accept that and cheer that on, because that’s where innovation comes from – and that’s a benefit of the American state system.”
Of course, acknowledges Siegel, by their very nature, experiments have an element of uncertainty, and this translates into potential risks for patients and practitioners.
“For the practitioners that are going to take on and utilize these laws, they better make sure that they’ve talked to their own legal counsel as to the risk of medical malpractice,” he says, pointing out that each of the bills is completely different. For example, the Florida bill, which was subject to several rounds of lobbying and revisions, is generally considered to be more rational and conservative than the Utah bill.
“To really get into the differences between Utah and Montana and Florida, you almost need to have a team of lawyers,” adds Siegel. “But the states really need to try to mitigate the risks, because when that first lawsuit is filed and someone has been hurt by a therapy, even though it seemingly passes the criteria, if they are victims of malpractice, that’s going to damage the whole field. Because are they going to blame the malpractice on the physician, or are they going to blame the cells?”
‘We can’t wait 30 years for approved therapies’
However, despite the risks, Siegel feels that these laws are a necessary step to accelerating progress at a national level. Progress that he believes is inevitable.
“The changes in the Trump administration are very important – there will be different regulations and different levels of enforcement,” he says. “While some people are saying the sky is falling and this is turning into the Wild West, on the other hand, there’s going to be more patient autonomy as a result of this. Yes, these laws haven’t been tested in court yet, but from the general principle of patient autonomy, I support them – I support the movement.”
Siegel predicts “an explosion” of laws and changes to existing “right-to-try” laws in the years ahead.
“Perhaps more will even go down the road of the Montana model where you don’t necessarily have to have a life-threatening ailment in order to avail yourself of a therapy,” he says. “We are going to find more and more clinics offering cell therapies and other innovative therapies. I think we’re in the era of Future Shock times 10 – I sometimes feel like I’m living in an Arthur C Clarke novel.”
At the end of the day, Siegel says all of these initiatives will “put pressure on the federal government to get its act together and find a way to bring cell therapies level with pharmaceuticals and biologics, and understand they’re different and need different laws.”
“We can’t wait,” he adds. “We can’t cure a mouse of diabetes with stem cells, and expect to wait 20 or 30 years and billions of dollars to do it in humans. That’s not the answer.”
