WASHINGTON, DC – Energy and Commerce Committee Chairman Greg Walden (R-OR) and Health Subcommittee Chairman Michael C. Burgess, M.D. (R-TX) issued the following statement after legislation was introduced in the House of Representatives to improve access to experimental treatments for patients.
“This updated ‘Right to Try’ bill is the direct result of conversations with our colleagues, the administration, and stakeholders on all sides of the issue,” said Chairmen Walden and Burgess. “This is a complicated issue with passionate advocates on both sides and it was imperative we got the policy right. After months of thoughtful discussions, we believe this legislation is ready for a vote in the House.”
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.
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
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.