House eyes changes for ‘right to try’ bill

Lawmakers in the House appear likely to make changes to the “right to try” bill on experimental drugs, something supporters worry could make it harder to get the bill to President Trump’s desk.

Advocates of the measure — which would let terminally ill patients request access to treatments the Food and Drug Administration (FDA) hasn’t approved — want the House to take up the Senate-passed bill as is. But that’s unlikely, House Energy and Commerce Committee Chairman Greg Walden (R-Ore.) said Monday.

Proponents of the bill are worried about the changes and fear they could cause the legislation to get jammed up in the Senate, which passed the original version with unanimous consent.

{mosads}“We don’t want to see changes that water this down,” said Rep. Andy Biggs (R-Ariz.), who introduced the measure in the House along with Rep. Brian Fitzpatrick (R-Pa.). He added that he hasn’t been involved in discussions to change the bill, but that he’s concerned the legislation could become narrower. 

Last week, Trump gave the legislation a jolt of momentum when he endorsed the bill during his State of the Union address. The legislation has other major backers who are working to get it over the finish line, including groups backed by conservative mega-donors Charles and David Koch. Vice President Pence, who signed a version of right to try legislation when he was governor of Indiana, is also a supporter.

On Monday afternoon, Biggs, Fitzpatrick and Sen. Ron Johnson (R-Wis.) met with House GOP leadership about the bill, a conversation Biggs characterized as “positive.”

“They committed to us that they’re supportive of getting a bill out, and they understood our concerns,” Biggs said in a phone interview Tuesday.  

Those involved in tweaking the legislation say they’re trying to strike a balance. 

“We’re working to make sure that the program will work for the patients who need access to these medicines,” Walden said Monday evening. “We want to make sure it’s safe, we want to make sure it works, and they can take advantage of it.”

Though it’s unclear exactly what the potential changes to the bill might be, proponents want to ensure they don’t detract from what they are trying to accomplish.

“We are worried and concerned that what is being contemplated is really just reforming an existing program,” said Starlee Coleman, a senior policy adviser for the Goldwater Institute, a libertarian think tank that wrote the model legislation for right to try laws.

Potential changes to the bill have not been made public, and Walden’s committee office declined to discuss the revisions under consideration. 

A House Energy and Commerce spokesperson wrote in an email that “our shared goal — with patients, advocates, lawmakers, and the Trump administration — is to put a bill on the president’s desk as soon as possible that increases access to investigational drugs without causing any unintended harm. This is a top priority for the committee, and we are working tirelessly to help patients who are out of options.”

“The whole point of right to try is that it’s people and their doctors making these decisions without an FDA bureaucrat having to step in the way. As long as that’s still moving forward, than it’s still right to try,” said David Barnes, policy director for Generation Opportunity, which is funded in part by the Koch brothers.

Walden noted on Monday that patient advocacy groups have had concerns, and “so we want to make sure that we listen to them, and that we get this in a way that works for everybody.” 

Indeed, the legislation has received pushback from some patient advocacy groups, nearly 40 of which sent a letter in opposition to the bill to House leaders Tuesday. They warned the measure would “likely do more harm than good.”

The groups argued that the current regulatory framework is meant to protect patients, adding that an FDA expanded-use program approves 99.7 percent of requests for patients to try an experimental drug. They also noted patient access to unapproved drugs might not actually increase if the bill becomes law, since drug companies aren’t required to provide the medicines.

Supporters counter that terminally ill patients should have every tool at their disposal to try a drug that could help them. They say the decision to try an unapproved drug is personal — and one between a doctor and a patient — and note that right to try requires that a drug has passed the FDA’s phase one testing, a small-scale clinical trial, and is still undergoing clinical trials at the agency.

In August, the Senate approved the right to try bill Johnson championed by unanimous consent, which requires every senator to sign off on it. 

Supporters of the measure are pushing the House to take up the Senate version of the legislation so that it doesn’t have to be passed back and forth between the chambers. They worry sending the bill back to the Senate could impede its passage, with supporters voicing concerns it could be difficult to get right to try passed again in the Senate.

“I respect that,” Walden said. “[Johnson] expressed that directly to me. I understand that, I respect that, but I think where it had unanimous support in the Senate before, I think if we make it even better, we’ll find a way to get it passed.”

Tags Brian Fitzpatrick Donald Trump experimental drugs FDA Greg Walden Right to Try Ron Johnson

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