Lawmakers in Austin have approved a bill authorizing unapproved stem cell therapies, putting Texas on track to become the first state to explicitly recognize the experimental treatments.
The measure now heads to Governor Greg Abbott, who has signaled his support for it.
For years, clinics across the country have been offering experimental stem cell therapies for patients with chronic conditions or terminal illnesses, but no state has given them legal validation. Instead, clinics have largely operated under the radar of regulatory authorities, touting treatments for a range of injuries and diseases.
Many scientists, meantime, have warned that unapproved stem cell therapies can be not only ineffective but harmful outside limited and closely watched clinical trials.
The Texas measure was finalized Monday before the end of the Legislature’s session. Senators added amendments that would require the treatments to be delivered by a doctor at a hospital or ambulatory medical center and with the approval of an institutional review board, which reviews research that involves human participants. Another amendment would allow patients to sue should the treatment go awry.
Advocates who opposed the measure as it was introduced said they were still uneasy with aspects of it, but that they hoped the amendments would add protections for patients.
If the legislation becomes law, it will go into effect Sept. 1.
Meanwhile, two other measures focused on patient access to experimental therapies — often called “right-to-try” policies — failed in the Texas Senate after being approved by the House.
One would have aligned Texas’s right-to-try laws with similar statues in almost three dozen other states by allowing clinics to charge for unapproved treatments. Texas is the only state that bans patients from paying for investigational therapies, according to the Goldwater Institute, a libertarian think tank that supports many right-to-try laws.
A separate measure would have pushed Texas’s right-to-try law beyond the others. It would have expanded state law so that people with chronic conditions — not just patients with terminal conditions — could access experimental treatments. In Texas and every other state, the statutes limit access to patients with terminal illnesses, although the definition of those conditions varies from state to state.