Trump Signs 'Right-to-Try' Into Law

'I never understood why it was hard,' the president said during a signing ceremony Wednesday at the White House.

Patients with life-threatening illnesses will have more leeway to undergo treatments that have not yet received final approval from the Food & Drug Administration, thanks to a signature Wednesday by President Donald Trump.

As expected, Trump signed the "Right-to-Try" bill, which Congress approved last week, despite concerns raised by critics who argued bypassing the FDA could make it easier for fraudsters peddling unproven remedies to take advantage of vulnerable patients.

"We worked hard on this. I never understood why it was hard. They've been trying to have it passed for years," Trump said during a signing ceremony at the White House.

Related: House Sends 'Right-to-Try' Bill to Trump's Desk

Proponents of the measure have argued the slow-moving bureaucracy of the FDA approval processes can inappropriately impede an individual patient's ability to access potentially life-saving experimental treatment.

• A great name: "In my State of the Union address four months ago, I called on Congress to pass 'Right-to-Try.' It's such a great name," Trump said. "Some bills, they don't have a good name, OK? They really don't. But this is such a great name. From the first day I heard it, it's so perfect: Right. To. Try. And a lot of that trying is going to be successful. I really believe that. I really believe it."
   
• Bipartisan backing: Vice President Mike Pence, who introduced Trump for Wednesday's ceremony, praised members from both major political parties for backing the measure. "This is how Congress should work to advance the interests of the American people," Pence said. When the House voted 250-169 in favor of the bill last week, 22 Democrats voted with the majority. All 169 who opposed it were Democrats.
   
• Commitment from FDA: "This new law amends the Federal Food, Drug, and Cosmetic Act to establish a new pathway aimed at increasing access to unapproved, investigational treatments for patients diagnosed with life-threatening diseases or conditions who have exhausted approved treatment options and who are unable to participate in a clinical trial," FDA Commissioner Scott Gottlieb, MD, said in a statement. "Our implementation of the Right to Try Act will build on our long-standing efforts to help patients and families who are facing life-threatening diseases or conditions, in a way that seeks to protect their autonomy, their safety, and the safety of others following in their paths.

Although some proposals had applied only to "terminally ill" patients, this version applies to those who have been "diagnosed with a life-threatening disease or condition."

Editor's note: This story was updated to include a statement from FDA Commissioner Scott Gottlieb.