Smucker Statement Following House Passage of Right to Try Act
Washington, D.C. – U.S. Rep. Lloyd Smucker issued the following statement after the U.S. House of Representatives passed the Right to Try Act last night:
“Terminally-ill patients are some of the toughest, most resilient individuals I have ever met,” said Rep. Smucker. “They and their families never give up hope for a lifesaving treatment or cure. This legislation isn’t just common sense – it sends the powerful message that Washington won’t give up hope either.
“This legislation also has broad bipartisan support. Not only did it pass the U.S. House, it passed the Pennsylvania House and Senate unanimously and was signed into law by Governor Wolf. When it comes to empowering patients and doctors to make decisions on the best course of treatment, Congress is getting on the same page as the 38 states that have passed Right to Try laws. I urge my colleagues in the Senate to take up this bill in short order and send it to the president for his signature.”
Rep. Smucker spoke in support of Right to Try legislation last November on the House floor. You can watch his speech here.
The Right to Try Act allows terminally-ill patients who have exhausted all other options to try medications that have passed basic Food and Drug Administration (FDA) safety protocols but have not yet completed the full, multiyear approval process.
During his first State of the Union address on January 30th, 2018, President Donald Trump said “people who are terminally-ill should not have to go from country to country to seek a cure. It is time for Congress to give these wonderful Americans the ‘right to try.’”
Specifically, this legislation:
- Establishes a robust informed-consent process to access FDA-unapproved drugs
- Specifies that any FDA-unapproved drug used must have an active application and is not the subject of a clinical hold
- Includes a sponsor and manufacturer notification to the FDA when an FDA-unapproved drug is made available to an eligible patient
- Protects 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
- Provides certainty to manufacturers regarding how the FDA will use patient outcomes when evaluating new drug applications