Sen. Ron Johnson said he is frustrated that the House has not passed his bill to give terminally ill children the ability to try experimental treatments, even though the Senate passed it unanimously in August.
“It is frustrating that we hit this logjam for months,” said the Wisconsin Republican, lead sponsor of the Senate bill.
However, Johnson said President Trump’s support for "right to try" legislation during his State of the Union address and at a separate speech at the GOP retreat last week could help break that logjam. Vice President Mike Pence is also a major supporter, having signed a state law for right-to-try when he was Indiana's governor.
“I am hoping we can get this resolved in the next couple of weeks,” Johnson said of a potential timing on a vote.
Johnson and House supporters of the bill met with House GOP leadership on Monday night, but no timetable was confirmed.
House Energy and Commerce Committee Chairman Greg Walden, R-Ore., is mulling changes to the legislation to ensure bipartisan support in the House.
Johnson disagreed with changes the committee is pursuing.
“I am concerned they want to narrow it to a very, very tight definition of the terminally ill,” Johnson said. “The bill has already been compromised. We worked with pharma, and we worked with Democrats. I think we came up with compromise language that worked for everybody.”
A House aide told the Washington Examiner that Walden is engaged in a bipartisan discussion on how to balance individual rights with patient safety.
"Throughout this process, Walden has valued how the champions of this issue not only want to help vulnerable patients, but also make sure folks have proper safeguards in place to protect them from unintended harm," the aide said. "While we don’t have a scheduling announcement at this time, Walden looks forward to continuing to work with the administration to get these reforms over the finish line for patients."
The bill would let a terminally ill person who has tried all other treatments try an experimental drug. The product must have passed the first of three clinical trials the FDA requires a drug to go through to prove safety and effectiveness.
However, some patient safety groups charge the bill instills false hope since the effectiveness of the drug hasn’t been tested enough. Some groups also worry about whether the products are safe enough for patients.
The Food and Drug Administration already has a program called “compassionate use” that provides access to an experimental treatment for people that qualify. The agency and an expert on a review board studying the drug must approve any “compassionate use” request for the product.
The bill would bypass this program.
But it would not require the drugmaker to provide the product. The “compassionate use” program also does not require drugmaker participation.
Sometimes, drugmakers do not provide their products for experimental use because they are scared results such as an injury or death could imperil FDA approval. People who seek a drug through “compassionate use” are typically sicker than people in a clinical trial.
The FDA sought to give some leniency in reporting to the agency if someone outside of a clinical trial dies while on the drug. The goal is to entice drugmakers to be more comfortable with offering a drug under “compassionate use.”