"The 'Right to Try' bill gives terminally ill patients the freedom to try experimental drugs that might extend their life in a safe and dignified way. We worked very closely with President Trump and Vice President Pence to pass this bill out of the House with a strong bipartisan vote, and we encourage the Senate to take this bill up quickly so we can get it signed into law. This bill has been years in the making and is the result of deliberate negotiations and careful consideration for patients' safety and freedom. I applaud the hard work of my colleagues Brian Fitzpatrick and Andy Biggs, as well as the Energy and Commerce Committee, who led this legislation to successful passage."
Specifically, the bill will:
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
Background information is courtesy of the Energy and Commerce Committee.
