Chief Deputy Whip Patrick McHenry released the following statement on yesterday's passage of H.R. 5247, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018:

“Terminally ill patients deserve the right to try every possible treatment option to cure their illness. Yet bureaucratic hurdles prevent many patients from trying new and experimental treatments. With today’s passage of the bipartisan Right to Try Act of 2018, this has changed. I’m proud to join the Trump Administration in supporting this important legislation that can help improve the lives of countless Americans.”

Background on H.R. 5247 provided courtesy of the House Energy and Commerce Committee:

• Create a new alternative pathway for patients who do not qualify for a clinical trial
• Establish a robust informed consent 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 applications