WASHINGTON – Congressman French Hill (AR-02) issued the following statement after supporting the Right to Try Act, which passed by a vote of 267-149:
“Tonight, we voted to remove unnecessary bureaucratic red tape for terminally ill patients and their families. These patients deserve the option to receive investigational drugs that have passed the Food and Drug Administration’s (FDA) basic safety testing without having to ask the agency for permission first. This common-sense measure will facilitate a potentially life-saving chance for dying Americans.”
Background:
The Right to Try Act, H.R. 5247, allows terminally ill patients who have exhausted all other options to try medications that have passed basic FDA safety protocols but not completed the full, multiyear approval process. This bill safeguards any pharmaceutical company that may wish to participate in Right to Try, but it in no way requires participation, nor does it impose a mandate on anyone. Instead, this legislation gives patients who have no other options a chance.
Specifically, the bill will:
· 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 in real time, through notification to the FDA – both within the existing expanded access program and through the new alternative pathway.
· Provide certainty to manufacturers regarding how the FDA will use patient outcomes when evaluating new drug applications.
