GOP eyes changes to ‘right to try’ bill

The “right to try” bill on experimental medications will likely see changes before the lower chamber passes it, House Energy and Commerce Committee Chairman Greg Walden (R-Ore.) said Monday, meaning it would need to be sent back to the Senate before the measure could go to President Trump’s desk.

Some advocates have been pushing for the House to pass the Senate’s version of the bill to prevent it from being ping-ponged between the two chambers. Sen. Ron Johnson (R-Wis.), who championed the bill in the Senate, expressed concern Monday that it would be tough to get the measure back through the Senate, even though it passed the upper chamber by unanimous consent in August.

The right to try bill would let patients with a serious illness request access to experimental medicines that the Food and Drug Administration (FDA) hasn’t yet approved. The legislation received a jolt of energy last week when Trump urged Congress to pass it in his State of the Union address.

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Walden told reporters Monday evening that “I think there’s some improvements that we could make to the good work that Sen. Johnson did that will improve upon the concept.”

“As you know, some of the advocacy groups have actually been concerned about the language that came over from the Senate and are not full throated in support of it, and so we want to make sure that we listen to them, and that we get this in a way that works for everybody.”

On Monday, six academics who work at the intersection of medical ethics and drug development sent a letter against the bill to House Energy and Commerce leaders. They gathered more than 330 signatures from other scholars, patient advocates and individuals on the letter that expressed “strong opposition” to the bill.

“This legislation sells vulnerable patients and families false hope at the expense of weakening the FDA’s critical role in making sure that all Americans can have confidence in the safety and effectiveness of our medical products,” the letter states.

Walden said “we’re working to make sure that the program will work for the patients who need access to these medicines.”

“We want to make sure it’s safe, we want to make sure it works, and they can take advantage of it,” Walden said. He noted that he met with Vice President Pence and FDA Commissioner Scott Gottlieb roughly two weeks ago on the bill, saying, “We’ve been socializing language, and we’re very, very close.”

Pence is a staunch supporter of right to try laws, and signed such a bill into law when he was governor of Indiana. Groups backed by conservative mega-donors Charles and David Koch have also been pushing for passage of the bill.

After a meeting with GOP leadership and House backers of the bill Monday afternoon, Johnson said, “My concern is if they change it in any way, shape or form in the House, we’re going to have to bring it back up in the Senate. It’s a relatively heavy lift to get anything passed in the Senate, even something that previously passed by unanimous consent — 100 to 0.”

The main sponsors of the bill in the House — GOP Reps. Andy Biggs (Ariz.) and Brian Fitzpatrick (Pa.) — sent a letter Monday to House GOP leaders calling for them to bring the Senate bill to a vote on the House floor “as soon as possible.” About 40 lawmakers signed onto the letter.

“Moving forward, placing S. 204 on the suspension calendar would be the best and most expedient way to proceed, and we have no doubt that such an effort would be successful,” the two wrote.  

Supporters of the bill argue terminally ill patients should have every tool at their disposal to try and counteract a disease. They say the drug approval process is lengthy, and that an FDA compassionate-use program, which allows physicians to submit an application for a terminally ill patient to access an unapproved drug, is cumbersome.

Opponents of the measure say it undermines patient safety and drug development. They note it doesn’t necessarily mean patients will actually get the medicines, as drug companies aren’t required to grant requests for the unapproved drugs.