Watch Trump sign 'right-to-try,' allowing gravely ill patients to bypass FDA for experimental treatment
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President Donald Trump is slated to sign the controversial "right-to-try" bill on Wednesday, which would bypass drug regulators to give gravely ill patients access to experimental medicines.
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, people would need to ask the FDA for access to experimental treatments.
Trump and Vice President Mike Pence had been major supporters of passing the measure, which supporters say gives patients hope they would not otherwise have. The House of Representatives approved the bill last week, which is the same version the Senate passed in August.
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.
Critics say the legislation undermines the FDA's authority to regulate drugs and could leave patients vulnerable to medicines that might not work or even be harmful. The agency already runs an "expanded access" program where seriously ill patients can apply to access experimental treatments.
Commissioner Scott Gottlieb has said the agency has grants 99 percent of these requests.
Under the legislation, drugmakers aren't obligated to give patients the requested experimental medicines.