Press Releases

Today, Congressman Bill Huizenga (MI-02) released the following statement after voting in support of the Right to Try Act. This legislation allows terminally ill patients who have exhausted all other options to try medications that have passed basic Food and Drug Administration safety protocols but not completed the full multi-year approval process.

“While medical breakthroughs continue to improve the quality of life and save lives across the globe, more must be done to help those suffering from terminal conditions. This important legislation affords patients the right to try experimental drugs that have passed the FDA’s basic safety testing. The current FDA approval process, while improving, often remains a slow-moving multi-year process. This legislation cuts through the red tape and gives patients and their families a fighting chance.”

Specifically the Right to Try Act:

• Establishes a robust informed consent to access unapproved drugs

• Specifies that any unapproved drug used in the new alternative pathway must have an active application and is not the subject of a clinical hold

• Includes a sponsor and manufacturer notification to the FDA after they make an unapproved drug available to an eligible patient

• Guards patients from manufacturers purposefully misbranding or mislabeling drugs

• Provides 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

• Obligates 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

• Affords certainty to manufacturers regarding how the FDA will use patient outcomes when evaluating new drug applications