Washington, DC - Congresswoman Elise Stefanik (R-NY-21) and her House colleagues have passed the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018. This bipartisan bill would give terminally ill patients access to potentially life-saving medicine. This bill passed the House by a vote of 267-149.
“This bill moves us in a direction of more compassionate, patient-centered care for those suffering from incurable disease,” said Congresswoman Stefanik. “Medication needs to be subjected to rigorous approval processes to ensure the public is kept safe; however, there is a delicate balance that must be met to ensure regulatory approval processes aren’t standing in between terminally ill patients and potentially lifesaving treatments. This bipartisan bill aims to give those suffering another chance.”
Specifically, the bill will:
- Create a new alternative pathway for patients who do not qualify for a clinical trial
- Establish a robust informed consent process to access unapproved drugs
- Specify that any unapproved drug used in the new alternative pathway must have an active application and is not the subject of a clinical hold
- Include a sponsor and manufacturer notification to the FDA after they make an unapproved drug available to an eligible patient
- Guard patients from manufacturers purposefully misbranding or mislabeling drugs
- Provide liability protections for manufacturers, sponsors, physicians, clinical investigators, and hospitals that participate in the existing expanded access program and the new alternative pathway; unless there is reckless or willful misconduct, gross negligence, or an intentional tort
- Obligate sponsors and manufacturers to report adverse events to the FDA
- Provide certainty to manufacturers regarding how the FDA will use patient outcomes when evaluating new drug application
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