Texas expands patient access to unproven stem cell therapies
In defiance of federal regulations, Texan patients will now have access to experimental treatments that have not been approved by the FDA.
In a victory for ‘Right to Try’ advocates, Texas (USA) legislature has passed HB 810, which allows terminally ill patients to access experimental treatments that have not necessarily been tested and approved by the FDA. The bill, signed by Governor Greg Abbott, will allow clinics to offer these treatments, without the testing and approval usually required under federal law, provided they are prescribed and delivered by a physician, and performed at a hospital or medical center with oversight from an institutional review board.
Access to new treatments for patients in the USA was already expanded in 2016 with the signing of the 21st Century Cures Act. This Act allowed the FDA to be more flexible in how it assessed and approved regenerative medicine treatments that were designated to have met an unmet medical need. Utilizing the Regenerative Medicine Advanced Therapies (RMAT) designation, certain therapies will have more resources assigned to their FDA applications in order to expedite their review.
It is yet to be seen whether HB 810 actual does result in more patients being treated with these new therapies, whether it will maintain the status quo or whether more clinics will simply profit from vulnerable patients. Another worry is that access to unproven therapies that are less or not effective will negatively affect perception of regenerative medicine, making it harder to bring fully trialled and approved treatments to clinic.
Sources: Servick K. Texas signals support for unproven stem cell therapies. Science, 356 (6344), pp. 1219 (2017); http://www.prnewswire.com/news…