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 TrumpSenate GOP budget ignores Trump, cuts defense Trump says he'll nominate Stephen Moore to Fed White House: ISIS territory in Syria has been 100 percent eliminated 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 HoyerOvernight Defense: Top Marine warns border deployment could hurt readiness | McSally aims for sexual assault reforms in defense bill | House to vote on measure opposing transgender ban | New warning over F-35 sale to Turkey House Dems unveil measure to reject anti-Israel boycotts House to vote on measure opposing transgender military ban 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 PalloneHillicon Valley: EU hits Google with .7 billion antitrust fine | GOP steps up attack over tech bias claims | Dems ask FTC for budget wishlist | Justices punt on Google privacy settlement Dems ask FTC if it needs more money to protect privacy Trump officials take bold steps on Medicaid 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 BurgessDivisions emerge over House drug price bills Overnight Health Care — Presented by PCMA — Dems push Pelosi on bill allowing federal funding of abortion | Key Republican says Dems left him out of drug pricing talks | Court upholds Ohio law to defund Planned Parenthood | Trump taps acting FDA chief Key Republican says Dems left him out of process on drug pricing bills MORE (R-Texas), the House Energy and Commerce health subcommittee chairman, said during the debate. 

Last week, House Majority Leader Kevin McCarthyKevin Owen McCarthyHouse leaders need to modernize Congress for the sake of America Overnight Energy: McConnell tees up vote on Green New Deal | Centrist Dems pitch alternative to plan | House Republican likens Green New Deal to genocide | Coca-Cola reveals it uses 3M tons of plastic every year House GOP lawmaker says Green New Deal is like genocide 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 JohnsonScott Walker considering running for Wisconsin governor or Senate: report GOP moves to rein in president's emergency powers The Hill's 12:30 Report: O'Rourke jumps into 2020 fray MORE (R-Wis.) and Joe DonnellyJoseph (Joe) Simon DonnellyLobbying World Lobbying World Overnight Energy: Trump taps ex-oil lobbyist Bernhardt to lead Interior | Bernhardt slams Obama officials for agency's ethics issues | Head of major green group steps down 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 WaldenThe 25 Republicans who defied Trump on emergency declaration House GOP lawmaker says Green New Deal is like genocide Overnight Health Care — Presented by PCMA — FDA issues proposal to limit sales of flavored e-cigs | Trump health chief gets grilling | Divisions emerge over House drug pricing bills | Dems launch investigation into short-term health plans 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 Schumer4 in 5 Americans say they support net neutrality: poll GOP senator: Trump's criticism of McCain 'deplorable' Schumer to introduce bill naming Senate office building after McCain amid Trump uproar 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.”