WASHINGTON — A new “right-to-try” bill hurtling toward a House vote this week would give the Food and Drug Administration some oversight of experimental treatments permitted under a new process, but critics warn that it would still undermine the agency’s role in protecting patients.
The new legislation, from House Energy and Commerce Committee Chairman Greg Walden (R-Ore.), is the latest salvo in the effort to create a new pathway for patients with terminal illness to access experimental therapies. The House of Representatives is set to vote on the measure Tuesday, after which it will head back to the Senate for further consideration.
Walden’s bill, hammered out after weeks of negotiations with advocates, critics, and the FDA itself, largely mirrors earlier legislation from Sen. Ron Johnson (R-Wis.) that passed the Senate last fall. But it adds new limits on exactly who can access the new pathway — to patients who may die “within a matter of months” or who have a disease that will “result in significant irreversible morbidity.”