The House failed to pass “right to try” legislation on experimental drugs Tuesday evening after Democrats expressed safety concerns over how the measure would let patients bypass the Food and Drug Administration (FDA).
In a vote of 259-140, the bill fell short of the necessary two-thirds support to send it to the Senate. The House had voted for the measure under suspension of the rules.
Despite the bill’s failure Tuesday, House Majority Leader Kevin McCarthy (R-Calif) said in a statement that “the House will not let this be the end.”
“We will try again, pass legislation, and bring hope to those whose only desire is the right to try to live,” he said.
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“Right to try” is a priority for the White House, and Republican leaders on the House Energy and Commerce Committee unveiled a revised version of the bill over the weekend.
Before the vote, Speaker Paul Ryan’s (R-Wis.) spokeswoman tweeted: “Are Democrats really going to deny critically ill patients every opportunity to find treatment?”
Democrats have countered that the measure provides “false hope” given no requirement in the bill that drugmakers provide the medicines to those who ask.
Specifically, the “right to try” bill would have let terminally ill patients request access to drugs the FDA hasn’t yet approved — and to do so without going through the agency.
The revised version of the bill struck “the right balance for patients and their safety,” House Energy and Commerce Chairman Greg Walden (R-Ore.) and health subcommittee chairman Rep. Michael Burgess (R-Texas) said in a statement Sunday.
But Democrats and patient advocacy groups quickly vocalized their concerns. More than 75 patient organizations sent a letter Monday to leadership in both parties saying they opposed the measure.
Rep. Frank Pallone Jr. (N.J.), the the top Democrat on the House Energy and Commerce Committee, announced his opposition to the measure on Monday.
Pallone and other opponents expressed concern that the bill could harm patient safety by bypassing the FDA. They also pointed to the agency’s compassionate use program, saying the FDA approves 99 percent of requests it receives to let a patient use an experimental drug.
“The review process is working well, but this legislation would completely take FDA out of the review process. This is dangerous, and could put patients at serious risk,” Pallone said during the House’s debate on the bill Tuesday.
“FDA is part of the process for a reason: it protects patients from potentially bad actors or from experimental treatments that might do more harm than good.”
Democratic leadership had signaled their concerns. A spokesman for House Minority Leader Nancy Pelosi (D-Calif.) wrote in an email Tuesday that the Democratic leader “will follow the lead of numerous patient and disease groups in opposing this legislation.”
But the legislation’s supporters say terminally ill patients should have every tool at their disposal to try drugs that could potentially help them. They argue the bill is safe, as it requires a drug to have passed a phase 1 clinical trial and still be under FDA’s consideration. And they say applying to the FDA’s compassionate use program is onerous.
“I’ve heard that patients will be at risk, that they lose their safeguards,” Rep. Morgan Griffith (R-Va.), a member of the House Energy and Commerce Committee, said during the bill’s debate.
“They’ve received a terminal diagnosis. They know they are at risk. They don’t care about safeguards. They want to fight for life.”
President Trump called on Congress to pass the measure in his State of the Union speech in late January. The Senate passed the bill by unanimous consent over the summer, so that put the onus on the House to act.
Vice President Pence and groups backed by conservative mega-donors Charles and David Koch have also been staunch supporters of the measure.
On Tuesday, Democrats decried the process of putting the bill on the floor.
The House held a hearing on “right to try” in October, but the specific bill released over the weekend did not have a hearing or a mark-up.
On the floor, Pallone expressed frustration that the House was voting on the bill Tuesday under suspension of the rules, a move typically reserved for noncontroversial, bipartisan bills — a concern Democratic leadership shared.
“This should have gone through the committee. This is a serious bill, an important bill, and we should consider it as such,” House Minority Whip Steny Hoyer (D-Md.) told reporters.
“They put this on the suspension calendar on Saturday. We responded, after talking to — as we do our process, is we talk to the ranking member, ‘What is your view on this?’ The ranking member asked that we not vote for this because he believed and believes that it should be considered in committee and maybe make changes that will make it more acceptable.”
Updated: 7:23 p.m.