ISCT Responds to Signing of Right to Try Legislation
Tuesday, June 26, 2018
The mission of ISCT is to promote access to innovative, evidence-supported cell and gene therapies to patients. In this context, the ISCT opposes the recent enactment of the Right to Try Law and sees the legislation as a potential risk to patients, particularly those in the fragile situation of dealing with desperate medical conditions. It is understandable that patients in those situations and their families would look for new innovative treatment options, but the opportunity for that access to experimental treatments is already regulated and supported by expanded access programs by the FDA. In contrast, this new legislation represents an additional incentive for the increasing number of individuals and clinics offering unproven, unregulated, and potentially dangerous supposed treatments to patients.
“Enhancing the power of cells to introduce new treatments to the market is still a pioneering field with tremendous implications, especially for those conditions with few current approved effective treatments. However, this has led some clinics to offer treatments with, at best, questionable data, and at worst, terrible consequences for patients,” said Massimo Dominici, Chair of the ISCT Presidential Task Force (PTF) on the Use of Unproven Cellular Therapies.
The ISCT, for the sake of patient safety, has fought unproven cell and gene therapies via the ISCT PTF on the Use of Unproven Cellular Therapies and has been joined by many organizations in the field in supporting the recent actions by the FDA and its Commissioner, Scott Gottlieb, to fight unproven cell therapies. ISCT continues to support the legitimate uses of new therapies in a safe, regulated manner, such as the FDA’s existing expanded access compassionate use program.