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In a surprising rebuff to President Trump and Republican leaders, the House derailed a bill on Tuesday that would have given patients with terminal illnesses a right to try unproven experimental treatments. The bill was considered under special fast-track procedures that required a two-thirds majority for passage, and it fell short. When the roll was called, 259 House members supported the bill, and 140 opposed it. (Pear, 3/13)

The vote for the measure was 259-140, but that fell seven votes short of the two-thirds majority the GOP needed to prevail under special procedures. Since the Senate approved similar legislation last August, Republicans could well revisit the legislation under rules that would require only a simple majority for passage, perhaps after reworking the measure. (Fram, 3/13)

“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." (Karlin-Smith, 3/13)

The Republicans pushing the legislation, Commerce Committee Chairman Greg Walden (R-Ore.) and Health Subcommittee Chairman Michael C. Burgess (R-Tex.), expressed disappointment at the outcome. “For months we sought to strike the right balance by allowing patients greater access to these unapproved treatments and therapies while also ensuring proper patient protections,” they said in a joint statement. “This bill does just that.” The vote capped an emotionally charged debate that kicked into high gear over the weekend after Walden and Burgess released their bill and said they planned a quick floor vote. The Senate passed a similar measure last summer that was pushed by Sen. Ron Johnson (R-Wis.). (McGinley, 3/13)

The vote was an embarrassing defeat not only for House Republicans but for President Trump, who had called on Congress to quickly pass right-to-try legislation, and Vice President Mike Pence, a longtime supporter of the effort. It was also a rare misstep from Speaker Paul Ryan, who like most congressional leaders almost never schedules votes on legislation without some certainty that the given measure has the support to pass. (Mershon, 3/13)

House Democratic leaders opposed the bill (HR 5247), mostly over the process Republicans used. Republicans released the so-called “Right to Try” bill at about 12:30 a.m. early Saturday morning, and on Sunday, leaders said it would get a vote on Tuesday under suspension of the rules, which does not allow amendments and requires approval from two-thirds of those present to pass. But only about 32 House Democrats joined Republicans in supporting the bill, and two GOP lawmakers broke with their party. (Siddons, 3/13)

On Monday, more than 70 patient advocacy groups signed a letter to the leaders of both parties in the House expressing their concerns that the bill would not improve access to experimental therapies, while making it riskier for patients by eliminating federal oversight from the process. "The FDA has never been the problem in terms of the time for approval nor whether or not to approve unless there is evidence that expanded access would be problematic," said Dr. Barbara Bierer, professor of pediatric medicine at Harvard Medical School and program director of the Regulatory Foundations, Ethics and Law Program at the Harvard Clinical and Translational Science Center. (Johnson, 3/13)