House approves 'right to try,' sends bill to Trump's desk

House approves 'right to try,' sends bill to Trump's desk
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The House sent “right to try” legislation on experimental drugs to President TrumpDonald TrumpTrump PACs brought in over M for the first half of 2021 Chicago owes Trump M tax refund, state's attorney mounts legal challenge Biden hits resistance from unions on vaccine requirement MORE’s desk Tuesday — a measure Trump, Vice President Pence and groups backed by mega-donors Charles and David Koch have repeatedly urged Congress to pass.

The House passed the bill largely along party lines by a 250-169 vote. 

Twenty-two Democrats broke ranks to join Republicans in supporting the bill which lets patients bypass the Food and Drug Administration (FDA) when they request access to drugs the agency hasn’t yet approved.

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Passage of the bill is a victory for Trump, who has personally called on lawmakers to send the measure to his desk, including an unexpected endorsement in his State of the Union speech.

Right to try has drawn backlash from House Democrats and patient safety organizations, who worry sidelining the FDA puts patients in danger. 

More than 100 advocacy groups — such as the American Cancer Society Cancer Action Network and Friends of Cancer Research — sent a letter Monday to House Republican and Democratic leadership expressing their “strong opposition” to the bill. Guidance from House Minority Whip Steny HoyerSteny Hamilton HoyerProgressives camp outside Capitol to protest evictions House adjourns for recess without passing bill to extend federal eviction ban Top Democrat: 'A lot of spin' coming from White House on infrastructure MORE (D-Md.) on the day’s schedule urged Democrats to vote against the legislation.

“FDA oversight of access to experimental treatments exists for a reason — it protects patients from potential snake oil salesmen or from experimental treatments that might do more harm than good,” 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 (D-N.J.), the House Energy and Commerce Committee’s ranking member, said Tuesday during debate on the bill.

“By removing FDA oversight, you are counting on physicians and manufacturers to serve as the gatekeeper and protector of patients,” he said. “I simply don’t buy that that’s going to work.” 

Opponents argue it gives “false hope” to patients since drugmakers aren’t required to give unapproved medicines to patients who ask for them. They also contend that the FDA already has a program that helps patients access investigational drugs and approves 99 percent of those requests.

But proponents counter that program is onerous. They argue that very sick patients should have every tool at their disposal to try to extend their lives.

“It’s about patients. It’s about having more time with their loved ones,” 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), the House Energy and Commerce health subcommittee chairman, said during the debate. 

Last week, House Majority Leader Kevin McCarthyKevin McCarthySunday shows preview: Delta concerns prompt CDC mask update; bipartisan infrastructure bill to face challenges in Senate After police rip Trump for Jan. 6, McCarthy again blames Pelosi Capitol Police asked to arrest the maskless MORE (R-Calif.) announced the House would take up the Senate’s bill. Over the next few days, bipartisan, bicameral talks ensued in an attempt to make changes to the bill, but, according to a Senate Democratic aide, they failed to produce anything.

“The Senate passed a bill, so now it’s incumbent upon the House to act,” the aide wrote Monday in an email.

The legislation has had a winding path to passage.

In August, the Senate passed a right to try bill by unanimous consent. Sens. Ron JohnsonRonald (Ron) Harold JohnsonBiden's bipartisan deal faces Senate gauntlet Trump urged DOJ officials to call election corrupt 'and leave the rest to me' Chuck Todd is dead wrong: Liberal bias defines modern journalism MORE (R-Wis.) and Joe DonnellyJoseph (Joe) Simon DonnellySupreme Court battle could wreak havoc with Biden's 2020 agenda Republicans fret over divisive candidates Everybody wants Joe Manchin MORE (D-Ind.) championed the measure.

The bill remained largely stagnant in the House but gained new life when Trump urged Congress to pass right to try in his State of the Union speech in late January.

House Energy and Commerce Committee Chairman Greg WaldenGregory (Greg) Paul WaldenEx-Sen. Cory Gardner joins lobbying firm Ex-Rep. John Shimkus joins lobbying firm Lobbying world MORE (R-Ore.) expressed concerns with the bill and hammered out a different version in the House. It further defined who would be allowed to get the experimental drugs, making the criteria more restrictive, while also including some additional patient protections.

In late March, the House passed its bill largely along party lines, in a 267-149 vote.

But it appeared stalled in the Senate.

Since the opposition from House Democrats, Senate Minority Leader Charles SchumerChuck SchumerSenate infrastructure talks spill over into rare Sunday session Senate holds sleepy Saturday session as negotiators finalize infrastructure deal An August ultimatum: No recess until redistricting reform is done MORE (D-N.Y.) has brought up concerns about taking the FDA out of the process. He blocked a unanimous consent request to take up the House bill.

Though the Senate’s bill —  and not Walden’s — will be sent to President Trump’s desk, he told reporters Monday that he had talked to FDA Commissioner Scott Gottlieb and that Gottlieb “believes he can provide the safety through regulation that might otherwise be missing” in the Senate bill, Walden said.

Earlier in the day, Gottlieb tweeted on the issue saying he was “ready to implement it in a way that achieves Congress' intent to promote access and protect patients.”

This year, groups backed by Charles and David Koch have been exerting pressure on Congress to act on the legislation.

As recently as late last month, Americans for Prosperity launched a six-figure national television and targeted digital ad campaign calling on Congress to pass right to try. The group announced this week it would key vote the measure, meaning they’ll use this vote for their congressional scorecard of members votes.

And Trump has continued to push for passage.

In the Rose Garden earlier this month, Trump was readying to unveil his drug pricing blueprint. But before turning to that plan, he said, “And right to try is happening, right? … Right to try. So important.”