Advocates of “right to try” legislation have been given a jolt of momentum by President TrumpDonald TrumpUN meeting with US, France canceled over scheduling issue Trump sues NYT, Mary Trump over story on tax history McConnell, Shelby offer government funding bill without debt ceiling MORE’s decision to tout the bill during his State of the Union address.
The legislation would allow patients with a serious illness to request access to experimental medicines that the Food and Drug Administration (FDA) hasn’t yet approved.
Trump called on Congress to send the measure to his desk, saying he believes “patients with terminal conditions, terminal illness, should have access to experimental treatment immediately that could potentially save their lives.”
Supporters of the bill were elated by Trump’s endorsement of the Right to Try Act to a national audience and are now hopeful that the bill, which has already passed the Senate, can quickly pass the House.
“That’s an incredibly strong endorsement and demonstrates how much of a priority this is for the administration,” 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. “We certainly think that that puts pressure on the House to take action on the bill that’s been sitting with them for several months now.”
Right to try legislation has passed in nearly 40 states, and a federal version has garnered powerful allies. Groups backed by conservative mega-donors Charles and David Koch launched a new right to try campaign in early January to push the House to pass the bill, and Vice President Pence — who signed a similar bill when he was governor of Indiana — has been a staunch advocate of the
Specifically, the bill would allow seriously ill patients to use medication that has completed the FDA’s phase one of testing — a small-scale clinical trial — but is still undergoing clinical trials at the agency.
Proponents of the bill note that the drug approval process can be lengthy and say terminally ill patients should be permitted to try medicine that could potentially save their lives. But others have raised concerns that the legislation could
undermine patient safety and drug development efforts.
In August, the Senate passed the legislation by unanimous consent. Right to try advocates are pushing for the House to pass the bill without changes, which would prevent it from being pingponged between the two chambers.
Trump’s push in the State of the Union “puts tremendous pressure” on the House to get the bill through committee and onto the floor, said David Barnes, the policy director for Generation Opportunity, which is funded in part by the Koch brothers.
The House Energy and Commerce Committee held a hearing on the issue in early October. A GOP committee spokesperson wrote in an email that “Chairman [Greg] Walden is dedicated to ensuring patients have access to potentially lifesaving treatment while also preserving FDA’s vital oversight authority.”
“Having held a hearing last year, the committee continues to engage with patients, members, and advocates to advance fair policy that helps patients understand the full benefit of access to investigational drugs and therapies,” the committee spokesperson wrote, adding Walden (R-Ore.) “looks forward to continuing to work with the administration to get these reforms over the finish line for patients.”
A different GOP aide wrote in an email that the committee is working to bring the measure to a vote before the full House “as quickly as possible.”
Some lawmakers have raised red flags with the legislation.
“I am concerned that the legislation being considered could expose seriously ill patients to greater harm instead of the greater access that they are looking for,” Rep. Frank Pallone Jr.Frank Joseph PalloneHouse Democrats ramp up probe of FDA approval of Alzheimer's drug Intercept bureau chief: Democrats dropping support of Medicare for All could threaten bill's momentum House Democrats reintroduce road map to carbon neutrality by 2050 MORE (N.J.), the top Democrat on the House Energy and Commerce Committee, said at the October hearing.
He said he worries the legislation “erodes important patient safeguards” and noted that, even if the bill passes, it doesn’t mean patients will receive the experimental therapies because companies aren’t required to comply with the request.
Opponents of the legislation note that the FDA already has a compassionate use program, allowing physicians to submit an application for a terminally ill patient to access an unapproved drug. Those who support right to try laws say that process is onerous.
Trump’s strong support of right to try laws Tuesday came as a pleasant to surprise to some urging its passage.
Rep. Andy Biggs (R-Ariz.), who sponsored the legislation in the House, found out when the text of the speech was released just before delivery. The congressman is optimistic the House will pass the bill soon, according to his spokesman, Daniel Stefanski.
Former Rep. Tim HuelskampTimothy (Tim) Alan HuelskampManchin may be the only one who can save the Hyde Amendment Democratic-linked group runs ads in Kansas GOP Senate primary Cure for cancer would become more likely if FDA streamlined the drug approval process MORE (R-Kan.) now serves as the president of the conservative Heartland Institute and has been closely watching the right to try issue.
“We’d been requested by the White House if we had any suggested things that we’d like to hear in the State of the Union address, and we requested right to try, and hoped the president would step in and help out,” Huelskamp said. “We’re excited to see that he did.”