House fails to pass 'right to try' bill amid Dem objections

House fails to pass 'right to try' bill amid Dem objections
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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 McCarthyKevin McCarthyHouse to resume mask mandate after new CDC guidance McCarthy pulls GOP picks off House economic panel GOP up in arms over Cheney, Kinzinger MORE (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 RyanPaul Davis RyanRealClearPolitics reporter says Freedom Caucus shows how much GOP changed under Trump Juan Williams: Biden's child tax credit is a game-changer Trump clash ahead: Ron DeSantis positions himself as GOP's future in a direct-mail piece MORE’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 WaldenGregory (Greg) Paul WaldenEx-Sen. Cory Gardner joins lobbying firm Ex-Rep. John Shimkus joins lobbying firm Lobbying world MORE (R-Ore.) and health subcommittee chairman Rep. Michael BurgessMichael Clifton BurgessOVERNIGHT ENERGY: Supreme Court rules that pipeline can seize land from New Jersey | Study: EPA underestimated methane emissions from oil and gas development | Kevin McCarthy sets up task forces on climate, other issues Texas Republicans condemn state Democrats for response to official calling Scott an 'Oreo' Americans have decided to give professionals a chance MORE (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.Frank Joseph PalloneIntercept bureau chief: Democrats dropping support of Medicare for All could threaten bill's momentum House Democrats reintroduce road map to carbon neutrality by 2050 House Democrats criticize Texas's 'shortcomings in preparations' on winter storms MORE (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 PelosiNancy PelosiHouse to resume mask mandate after new CDC guidance McCarthy pulls GOP picks off House economic panel GOP up in arms over Cheney, Kinzinger MORE (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 GriffithHoward (Morgan) Morgan GriffithGOP lawmakers press social media giants for data on impacts on children's mental health Lawmakers press federal agencies on scope of SolarWinds attack House Republicans urge Democrats to call hearing with tech CEOs MORE (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 TrumpDonald TrumpRealClearPolitics reporter says Freedom Caucus shows how much GOP changed under Trump Jake Ellzey defeats Trump-backed candidate in Texas House runoff DOJ declines to back Mo Brooks's defense against Swalwell's Capitol riot lawsuit MORE 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 HoyerSteny Hamilton HoyerHoyer urges conference talks on bipartisan infrastructure bill Hoyer suggests COVID-19 rules will stay — and might get tougher Senators reach billion deal on emergency Capitol security bill MORE (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.