Experimental drugs bill runs aground despite Trump, Pence support

Advocates for White House–backed legislation intended to make it easier for sick patients to get access to experimental drugs are frustrated, believing that congressional momentum behind “right to try” has ground to a halt.   

Despite vocal support from President Trump and Vice President Pence, the House and Senate have made little if any progress on bridging differences with each other over separate bills that have passed each chamber.

“This obviously is a frustrating situation for us to be in when we are kind of waiting for somebody to blink,” said Starlee Coleman, a senior policy adviser for the Goldwater Institute, a libertarian think tank that wrote model legislation that has been turned into law in 40 states.

{mosads}“All sorts of good policy dies a quiet death in Washington, and we’re hoping that this isn’t one of them, but certainly if lawmakers decide that they’re not going to work together, then it could be.”

Groups backed by conservative mega-donors Charles and David Koch have thrown their weight behind right to try, coordinating a campaign earlier this year in an effort to get the measure passed.

Koch-backed Americans for Prosperity is announcing Thursday a new six-figure national television and targeted digital ad campaign calling on Congress to pass right to try.

“We’ve been frustrated at the fact that everyone agrees that right to try is important, and we need a bill, but they haven’t been actually able to get a law,” said David Barnes, the policy director of Generation Opportunity, another Koch-backed group.

Back in August, the Senate approved right to try legislation that Sen. Ron Johnson (R-Wis.) spearheaded by unanimous consent.

In the House, movement on a similar bill was stagnant, but gained new life when Trump called on Congress to pass right to try in his State of the Union address in late January.

A little more than a month later, the House passed its own bill, largely along party lines, in a 267-149 vote.

The legislation, hammered out by House Energy and Commerce Committee Chairman Greg Walden (R-Ore.), shifted from the Senate bill by further defining the criteria necessary for a patient to be able to receive experimental drugs. Walden effectively made who could receive experimental drugs more restrictive, while also including some additional patient protections.

House Democrats opposed Walden’s bill and don’t like the version that passed the Senate either.

They argue right to try bills put patients in danger by effectively sidelining the Food and Drug Administration (FDA). They also contend it isn’t needed, as they argue the FDA already has a process through which access to an unapproved drug can be requested.

Senate Democrats last year didn’t object to the bill Johnson introduced with Sen. Joe Donnelly (D-Ind.), which also sidesteps the FDA.

But since the opposition from House Democrats, Senate Minority Leader Charles Schumer (D-N.Y.) has voiced concerns about taking the FDA out of the equation.

In late March, when Johnson offered a request for unanimous consent to take up the House bill, Schumer rejected it.

“I believe we all support the goal of safely increasing access to investigational drugs for terminally ill people,” Schumer said at the time.

“But the key is we need to ensure there are safety mechanisms in place when we do this. A significant part of that is making sure the FDA is part of the process,” Schumer said, adding later, “I assure my colleagues that we will work together to get something done and done quickly.”

As Johnson sees it, there’s an easy path to send the bill to Trump’s desk: passing his version in the House. Donnelly agrees, according to his office.

But the plan still could face an uphill battle. 

Walden has expressed concerns with the Senate bill in the past. He’s pointed to comments from FDA Commissioner Scott Gottlieb saying the Senate bill’s definition of who could receive the drugs was too broad. He’s also noted critical comments from patient safety groups.

Walden said the Senate should take up the right to try bill he helped revise.

Senate Majority Leader Mitch McConnell (R-Ky.) has not committed to doing so. His office didn’t say if McConnell would bring the House bill up for a vote on the Senate floor, writing in an email that the office didn’t have any schedule announcements beyond this week’s nominations.

When asked if the House would consider Johnson and Donnelly’s bill, Walden said that’s a call the majority leader will make. Kevin McCarthy’s (R-Calif.) office did not respond to requests for comment.

The lack of progress has left advocates for the legislation exasperated.

“I think we’re incredibly frustrated because we don’t know what the future holds on this bill,” Jason Pye, the vice president of legislative affairs for FreedomWorks, said. “But we know there are families who could benefit potentially from what it provides.”