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 John TrumpSunday Shows preview: Lawmakers, Trump allies discuss Russia probe, migrant family separation Seth McFarlane: Fox News makes me 'embarrassed' to work for this company  'Art of the Deal' co-author: Trump would act like Kim Jong Un if he had the same powers 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 HoyerPelosi, Dems hammer GOP for ‘derailing’ DACA debate Hoyer warns GOP: Don’t dabble with DACA compromise bill Dem House candidate gets pepper sprayed in the face in campaign ad 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 PalloneOvernight Health Care — Sponsored by PCMA — Showdown in court over Medicaid overhaul Hillicon Valley: Fallout from bombshell DOJ report on Clinton probe | AT&T win could see new wave of mergers | World Cup cyber warning | Facebook comms chief stepping down Top Dem blasts Facebook for failing to answer questions from April hearing 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 BurgessTrump signs 'right to try' drug bill House approves 'right to try,' sends bill to Trump's desk Overnight Health Care: New allegations against VA nominee | Dems worry House moving too fast on opioid bills | HHS chief back in DC | FDA reexamines safety of controversial Parkinson's drug MORE (R-Texas), the House Energy and Commerce health subcommittee chairman, said during the debate. 

Last week, House Majority Leader Kevin McCarthyKevin Owen McCarthyHillicon Valley: Trump hits China with massive tech tariffs | Facebook meets with GOP leaders over bias allegations | Judge sends Manafort to jail ahead of trial | AT&T completes Time Warner purchase McCarthy: 'The Mueller investigation has got to stop' McConnell: Mueller 'ought to wrap it up' 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 JohnsonSenate probes FBI's heavy-handed use of redactions to obstruct congressional investigators Hillicon Valley: DHS gets new cyber chief | White House warns lawmakers not to block ZTE deal | White nationalists find home on Google Plus | Comcast outbids Disney for Fox | Anticipation builds for report on FBI Clinton probe Graham jokes about Corker: GOP would have to be organized to be a cult MORE (R-Wis.) and Joe DonnellyJoseph (Joe) Simon DonnellyDems seek to leverage ObamaCare fight for midterms Todd Young in talks about chairing Senate GOP campaign arm The Hill's Morning Report — Sponsored by PhRMA — Primary results give both parties hopes for November 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 WaldenFacebook faces new data firestorm What the net neutrality repeal means Unending Pruitt controversies leave Republicans frustrated 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 SchumerCharles (Chuck) Ellis SchumerOvernight Health Care — Sponsored by PCMA — Dems want answers on DOJ ObamaCare decision The Hill's 12:30 Report — Trump, Kim make history with summit Schumer blames congressional GOP for net neutrality repeal 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.”