Barletta Votes to Provide Hope to Terminally Ill Patients
WASHINGTON – Yesterday, the U.S. House of Representatives passed H.R. 5247, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018, a bill that allows terminally ill patients, who have exhausted all other available options, to try medications that have passed basic Food and Drug Administration (FDA) safety protocols, but are still caught up in the full, multi-year approval process. Congressman Lou Barletta (PA-11), who is a cosponsor of similar legislation, voted in favor of the bill, which passed by a bipartisan vote of 267 to 149.
“The House gave millions of Americans facing life-threatening diseases hope,” Barletta said after the vote. “I’m pleased that my colleagues were able to come together and support this bipartisan measure. Patients suffering from fatal conditions, who have exhausted the traditional avenues of treatment, have a right to pursue alternative avenues. Government bureaucracy should not stand in the way of these patients and potentially life-saving medications.”
Currently, 38 states have their own Right to Try legislation, including Pennsylvania, which unanimously passed a Right to Try bill last year through the General Assembly. H.R. 5247 allows these state laws to have a meaningful impact on the lives of those suffering from terminal diseases by providing clarity for patients, manufacturers, doctors, and hospitals.
Furthermore, this legislation protects patients by establishing a robust informed consent program to access unapproved drugs, ensuring manufacturers cannot purposefully misbrand or mislabel those drugs, and requiring sponsors and manufacturers to report any adverse effects of these medications in real time to the FDA. This bill also allows patient outcomes to be considered during the full, multiyear approval process for these drugs and provides liability protections for manufacturers and sponsors.
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