Press Releases

WASHINGTON – Congressman French Hill (AR-02) issued the following statement after supporting the Right to Try Act:

“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 Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act, S. 204, 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.

• 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.

• Require manufacturers to publish annual reports on the use of unapproved drugs.

• Product must have completed a Phase 1 (safety) clinical trial.