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 TrumpLincoln Project ad dubs Jared Kushner the 'Secretary of Failure' Pence: Chief Justice Roberts 'has been a disappointment to conservatives' Twitter bans Trump campaign until it deletes tweet with COVID-19 misinformation 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 HoyerGOP expects Senate to be in session next week without coronavirus deal This week: Negotiators hunt for coronavirus deal as August break looms The Hill's 12:30 Report - Presented by Facebook - Fauci gives his COVID-19 vaccine estimate 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 PallonePharma execs say FDA will not lower standards for coronavirus vaccine Dem chairmen urge CMS to prevent nursing homes from seizing stimulus payments Federal watchdog finds cybersecurity vulnerabilities in FCC systems 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 BurgessTechnical difficulties mar several remote House hearings The Hill's Coronavirus Report: Moniz says U.S. needs energy jobs coalition and Manchin says Congress is pushing Wall Street solutions that don't work for Main Street; Burr to step aside The Hill's 12:30 Report: House returns to DC for coronavirus relief MORE (R-Texas), the House Energy and Commerce health subcommittee chairman, said during the debate. 

Last week, House Majority Leader Kevin McCarthyKevin Owen McCarthyGaetz set to endorse primary opponent of fellow Florida GOP lawmaker Bass honored US Communist Party leader in unsurfaced remarks Don't let Trump distract us from the real threat of his presidency 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 JohnsonGOP chairmen hit back at accusation they are spreading disinformation with Biden probe Unemployment debate sparks GOP divisions Tensions flare as GOP's Biden probe ramps up  MORE (R-Wis.) and Joe DonnellyJoseph (Joe) Simon DonnellyEx-Sen. Joe Donnelly endorses Biden Lobbying world 70 former senators propose bipartisan caucus for incumbents 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 WaldenHillicon Valley: Trump backs potential Microsoft, TikTok deal, sets September deadline | House Republicans request classified TikTok briefing | Facebook labels manipulated Pelosi video Top House Republicans request classified TikTok briefing Pelosi huddles with chairmen on surprise billing but deal elusive 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 SchumerGroup of GOP senators back more money for airlines to pay workers GOP super PAC launching August ad blitz Schiff, Khanna call for free masks for all Americans in coronavirus aid package 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.”