This is pretty big and easily slipping under the radar.
President Trump has signed “right to try” legislation, which will essentially allow extremely ill patients to bypass drug regulators and try experimental drugs.
The legislation allows patients with life-threatening conditions to ask drugmakers for medicines that have cleared some testing but still haven’t been approved by the Food and Drug Administration. Previously, patients would need to ask the FDA for access to experimental treatments.
I’m really happy about this. It needed to happen. These people have absolutely nothing to lose. This gives them a glimmer of hope.
“Right to try. That’s such a great name,” Trump said. “Some bills, they don’t have a good name. Really. But this is such a great name, from the first day I heard it. Right to try. And a lot of the trying is going to be successful. I really believe that. I really believe it.”
It allows certain patients to ask drugmakers for medicines that have passed Phase 1 of the FDA approval process but haven’t been approved yet and are still undergoing testing. Patients must have exhausted other options and be unable to participate in a clinical trial. Drugmakers aren’t obligated to give patients the requested experimental medicines.
“The FDA is dedicated to achieving the goals that Congress set forth in this legislation, so that patients facing terminal conditions have an additional avenue to access promising investigational medicines,” Commissioner Scott Gottlieb said.
I think this is a good move that was long overdue. Everyone should be on board with this one, right?
h/t CNBC