House Republicans failed Tuesday evening to pass a “right-to-try” bill that would give terminally ill patients access to experimental drugs without FDA authorization after failing to muster enough votes to approve it through an expedited process.
The 259-140 vote fell short of the necessary two-thirds support from the House chamber. The failed vote is a setback for President Donald Trump, who called on Congress to approve the bill in his State of the Union address six weeks ago, and a small libertarian think tank that has been the driving force behind the effort.
House Democrats who largely opposed the measure had questioned whether the bill would help patients, and they criticized GOP leaders for bringing the bill to a floor vote without going through committee first.
“This legislation delivers the false hope to patients and their families that they will receive a cure to their underlying disease or condition,” House Energy and Commerce ranking member Frank Pallone said. The bill is also “based on false premise that patients are not receiving access to investigational treatments as a result of the Food and Drug Administration.”
Republicans strongly disagreed that the bill would provide dying patients with unreasonable expectations about their chance at a cure.
“There is no false hope. They know it’s a Hail Mary pass,” Rep. Morgan Griffith said. “They know it’s unlikely to succeed, but they are willing to make the decision and choice to take that chance.”
Republicans tried to pass the bill under a suspension of House rules, which requires support from two-thirds of voting House members instead of a simple majority. The legislative maneuver is usually reserved for noncontroversial items that can easily pass on a voice vote. Two Republicans crossed party lines to vote against the bill, and 32 Democrats voted for it.
After the vote, House Majority Leader Kevin McCarthy said the chamber will try again to pass the bill. A GOP aide said House Republicans are likely to bring a Senate version of the bill to the floor or try to attach the bill to a bigger legislative package.
But Tuesday’s defeat is a big symbolic loss for Republicans, and it’s also an unusual defeat for the libertarian Goldwater Institute, which crafted the right-to-try idea. The Arizona-based think tank since 2014 has successfully pushed bills through 38 state legislatures with large bipartisan support and counts Vice President Mike Pence among its top allies.
The Senate unanimously passed right-try-to legislation last summer, but efforts to pass similar legislation in the House stalled for months.
Despite the universal appeal of right-to-try – few politician wants to say no to dying patients – possible drawbacks to the idea started to emerge in recent months. Goldwater could point to very few patients who have benefited from the state right-to-try laws. After the Senate passed its bill, dozens of prominent patient and doctors groups came out against the idea, arguing it could put jeopardize patient safety. The powerful pharmaceutical industry has also quietly pushed against the measure, warning it could make it harder for companies to conduct clinical trials to determine whether a new drug is safe and effective.
Trump’s FDA commissioner, Scott Gottlieb, gave a lukewarm review of right-to-try at a House Energy and Commerce Committee hearing in the fall. Gottlieb told lawmakers that the bill was unlikely to give patients access to drugs they couldn’tget under an existing FDA program known as compassionate use, which already helps sick patients receive experimental treatments.
Gottlieb explained that companies face barriers to providing experimental medicines, and he emphasized that the vast majority of drugs given to patients through the FDA’s compassionate use program turn out to be ineffective.
“We know that 70 percent of all drugs that are offered under an expanded access setting are never approved by FDA,” Gottlieb said.
After initially trying to work with Democrats to come up with a bipartisan alternative, House Republicans — facing pressure from the White House — released an updated version of right-to-try early Saturday morning. They added a number of tweaks aimed at improving safety protections for patients.
Many health policy experts and bioethicists applauded the changes, but they still said they couldn’t support the bill. Their concerns were echoed by House Democratic leaders on Tuesday morning.
“On the process side we are not for this and on the substance side we also think there are substantial issues that have been raised by companies, by a number of health care groups who believe this will pose real risks to people,” Democratic Minority Whip Steny Hoyer said.
Jennifer Haberkorn contributed to this report.