WASHINGTON, DC - The House of Representatives today passed H.R. 5247, the Tricket Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018, by a vote of 267-149. H.R. 5247 will improve access to experimental treatments for patients with terminal diseases or conditions.
“With the House’s passage, we’re one step closer in delivering for patients with no other treatment options who are 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’d like to thank everyone who helped us coalesce around this revised legislation - Reps. Brian Fitzpatrick (R-PA) and Andy Biggs (R-AZ) in the House, Sen. Ron Johnson (R-WI), Vice President Pence, and key stakeholders - it is through your dedication to this issue that we are able to advance this bill today."
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:
Access to investigational drugs for patients with terminal diseases or conditions 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.
