The bill’s proponents say there is no reason that terminally ill patients shouldn’t have access to experimental therapies if they are willing to accept the risks. | Getty House passes Trump-backed drug bill, letting sick patients bypass FDA

The House on Tuesday approved a right-to-try drug bill that would allow terminally ill patients nationwide to directly request experimental treatments from drugmakers, a libertarian-inspired effort that captured the personal interest of President Donald Trump and Vice President Mike Pence.

The bill, which would allow patients to bypass the Food and Drug Administration to make the request for drugs, now goes to the White House, where Trump is expected to sign it.


The bill passed 250-169, largely along party lines.

Critics fear there are not enough patient safeguards in the legislation. House Democrats on Tuesday warned that without FDA oversight, bad actors — such as drug-industry whipping boy Martin Shkreli — would peddle “snake oil” to extremely vulnerable patients with the promise of a cure.

Trump was a prominent supporter of the right-to-try effort, and his State of the Union call for the legislation propelled the once-stalled bill to his desk. In recent weeks, he personally called lawmakers to encourage them to move forward. Several lawmakers involved in the effort, including Sens. Ron Johnson (R-Wis.) and Lamar Alexander (R-Tenn.) and Rep. Greg Walden (R-Ore.), said the bill likely wouldn’t have passed without his involvement.

“I can’t tell you how many times I heard in private meetings, ‘Hey, where is right-to-try?’” said Johnson, one of the bill’s authors.

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The bill’s proponents say there is no reason that terminally ill patients shouldn’t have access to experimental therapies if they are willing to accept the risks. The drugs will have had to go through early-stage safety testing and can be sold at cost.

Trump heard from Pence — who had passed a similar bill while governor of Indiana — many anecdotes about terminally ill people and their families who wanted access to new drugs, according to an administration source.

The legislation took a winding path through Congress. The vote Tuesday was the third time the House attempted to pass a right-to-try measure, having failed once to get enough votes to fast-track the bill.

The effort also got caught up in a standoff between the House and Senate, which had competing versions of the bill. Patient advocacy groups that opposed the bill’s passage this week didn’t raise much opposition when the bill quietly passed the Senate unanimously last year. A last-ditch effort to get a new version through the Senate in recent days failed.

House Democrats on Tuesday largely opposed the measure.

“Without the FDA, there is no guarantee that what somebody gets as a form of treatment is going to be meaningful and not be harmful,” said Rep. Frank Pallone (D-N.J.). “Once the FDA is out of the picture, there is no way for the patient to know whether the doctor is unscrupulous or whether the manufacturer is unscrupulous.”

Early versions of right-to-try were drafted by the libertarian Goldwater Institute and enacted in more than three dozen states.