This Tuesday, the House will vote on a revised version of the “Right to Try” Act that gives critically ill patients access to experimental medications.
Last summer the Senate, via a unanimous consent motion, passed a right to try bill in August of 2017. The legislation has been championed by President Trump who called on Congress to pass the act in his January State of the Union address. Other supporters include conservative donors Charles and David Koch.
The Senate version of the legislation has been criticized by approximately 40 patient advocacy groups who believe the bill exposes patients to unnecessary harm. One letter with more than 300 signatures from ethicists and physicians argues that the Senate legislation “...sells vulnerable patients and families false hope at the expense of weakening the FDA’s critical role in making sure that all Americans can have confidence in the safety and effectiveness of our medical products.”
Critics have also argued that the FDA currently has a system in place for allowing access to unapproved drugs for patients who are out of options. The system, Emergency Investigational New Drug (EIND) application, allows physicians to request that an unapproved drug be made available to patients with no other options for treatment. The Senate legislation would remove the FDA from this process.
The House version seeks to address some of the critics' concerns. The bill requires that the patient must have a condition or disease that will cause death in a matter of months and requires that the FDA be notified when a patient receives an experimental drug.
The text of the House version can be found here: http://docs.house.gov/billsthisweek/20180312/HR____.pdf
If approved, the legislation will go back to the Senate for another vote.