WASHINGTON, DC - Energy and Commerce Committee leaders, along with key proponents of “Right to Try" legislation today announced an updated proposal will be considered by the House of Representatives on Tuesday. The bill, to be formally introduced tomorrow, will improve access to experimental treatments for patients with terminal diseases or conditions.
“This bill has been a long-time coming, but in striking the right balance for patients and their safety, the House is on track to deliver hopeful news for patients desperately seeking the right to try investigational treatments and therapies," said Energy and Commerce Committee Chairman Greg Walden (R-OR) and Health Subcommittee Chairman Michael C. Burgess, M.D. (R-TX). “We encourage our colleagues on both sides of the aisle to support this important measure on Tuesday, and look forward to swift action by our Senate colleagues."
“Each day, families across the country receive the devastating news of a terminal diagnosis. Even with the amazing work done in American medical research and development, for too many, access to these potentially lifesaving treatments will come too late, or not at all. Right to Try opens the opportunity to trial-stage care and establishes the freedom for patients and their doctors to try therapies where the benefits far outweigh the risks," said Rep. Brian Fitzpatrick (R-PA). “Americans - our constituents - should have every opportunity to fight for their life, or the life of their loved one. Whether it’s a father courageously battling ALS or a brave child living with Duchene Muscular Dystrophy, they deserve the right to try."
“All Americans deserve the right and freedom to try to save their lives. I am pleased that, after years in the making, this policy is being considered on the House Floor," said Rep. Andy Biggs (R-AZ). “Right to Try legislation would not be possible without the dedicated efforts of Senator Ron Johnson, Congressman Brian Fitzpatrick, the Goldwater Institute, Laura and Jordan McLinn, and my predecessor, Congressman Matt Salmon. I am hopeful that President Trump will soon sign this act into law."
Specifically the bill will:
* Create a new alternative pathway for patients who do not qualify for a clinical trial
* 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 to the FDA
* Provide certainty to manufacturers regarding how the FDA will use patient outcomes when evaluating new drug applications
Background:
Patient access to investigational drugs was the subject of an October 2017 #SubHealth hearing. The subcommittee reviewed multiple pieces of legislation and heard directly from FDA Commissioner Scott Gottlieb about concerns within those existing bills.
In the time since that hearing, Chairmen Walden and Burgess have continued working toward legislation that would strike the right balance of allowing patients to have greater access to these unapproved therapies and treatments, while also ensuring proper patient protections are in place.
Advancing this policy has been a long-time priority for Vice President Pence, who signed Indiana’s Right to Try law while serving as governor of the Hoosier State. It has also been a priority for President Trump, who called for the bill’s passage in his State of the Union Address earlier this year.
