ASCO recently joined nearly two dozen advocacy groups, representing millions of patients with serious and life-threatening diseases, in sending a letter to House Energy and Commerce Committee leadership strongly opposing “right-to-try” (RTT) legislation currently under consideration. The letter urges the committee to instead work on policies that would safely increase access to promising investigational therapies for patients.
The letter stresses that current clinical research subject protections are in place to ensure the safe and ethical treatment of clinical trials participants, and that patients seeking expanded access to unapproved therapies outside of clinical trials must be subject to the same ethical standards and protections. The letter also urges the committee explore ways to improve existing expanded access programs.
Earlier this year, ASCO issued a position statement on access to investigational drugs. The society supports FDA’s expanded access program, but ASCO does not support RTT legislation. As currently envisioned and enacted, these laws will interfere with already-streamlined and effective protocols, potentially putting patients at high risk for unclear benefit.