The House needs to decide its next move for legislation to give terminally ill patients access to experimental drugs, said Republican Sen. Ron Johnson, who spearheaded a Senate version that passed last year.
The Wisconsin Republican told reporters Wednesday that the House has two options to pass the bill, called “right to try,” after Democrats blocked it Tuesday. The first option is to attach the House bill to a must-pass spending bill, and the second is to take up the Senate version of the bill that passed the chamber last year.
“It is up to the House. The next action has to be the final action,” said Johnson, who led the Senate version. “My counsel has always been just bring up the Senate bill. It is the bill we crafted with Democrats, pharmaceutical industry and the [Food and Drug Administration]. It passed unanimously.”
The House voted 259-140 to approve the legislation Tuesday, but it fell seven votes shy of the two-thirds majority needed to pass it under the suspension of House rules. Suspending House rules is used to ensure fast passage of noncontroversial legislation and enables the House to bypass debate requirements.
Democrats objected to the legislation, arguing that it creates false hope for patients and could expose them to unsafe products.
The FDA already has a program called, “compassionate use,” that gives terminally ill patients access to experimental products. FDA Commissioner Scott Gottlieb has said the agency approves the vast majority of compassionate use requests it receives.
House Majority Leader Kevin McCarthy said Wednesday that the House will try again on the right-to-try legislation, but didn’t specify how.
Under both the Senate and House legislation, terminally ill patients can apply for access to a drug that has been through the first of three clinical trials the FDA requires for a drug to receive agency approval.
The first clinical trial determines whether a drug is safe but not if it works. The bill doesn’t require a manufacturer to provide the product to the patient.
The House and Senate bills differed on the definition for a patient who be allowed to try the drugs.
The Senate version said that someone has to be diagnosed with a life-threatening disease or medical condition. But the House version said the person must have a “reasonable likelihood of death” in a few months or would result in “significant irreversible morbidity that is likely to lead to severely premature death.”
Johnson had some qualms with the new definition.
“I thought our definition was just cleaner,” he said.
Right-to-try legislation has major support from the White House. President Trump mentioned the legislation in his State of the Union address in January, and Vice President Mike Pence signed a state right-to-try bill when he was governor of Indiana.
