Marshall: Supports "Right to Try" Bill for Terminally Ill Patients

Press Release

On Wednesday, Congressman Marshall voted in support of the Right to Try Act of 2018. This legislation gives people with a terminally ill diagnosis the option to try medications that are in the clinical trial phase.

"We are talking about patients that are faced with terminal diagnoses and have exhausted all of their conventional treatment options," Rep. Marshall said. There are experimental drugs that have passed phase one safety trials by the FDA that could potentially provide a cure. I believe we should at least give our patients and their families a fighting chance, and the option to try these drugs while the FDA makes their final determination of the medications."

"Some have said that providing access to these drugs will do 'more harm than good.' Why don't they tell that to the patients that are fighting for their lives? By offering no solution, we are not doing what's best for these families. Despite the terminally ill diagnoses, they are not giving up hope, and members of Congress should not try to steal that from them."

This bill gives those patients suffering from a terminal illness a fighting chance to try medical cures that are waiting for approval by the Food and Drug Association. This law has already passed in 38 states. In Kansas, it has been introduced but has not passed.

This legislation would :

- 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

Source