Representative Andy Biggs (R-AZ) has introduced legislation affirming patients' right to receive individualized investigational treatment for life-threatening or severely debilitating illnesses.
What the Bill Does
Rep. Biggs's Right to Try for Individualized Treatments Act builds upon the 2017 Right to Try Act, which originally allowed patients with terminal illnesses to access investigational drugs not yet fully approved by the U.S. Food and Drug Administration (FDA), by allowing patients to access individualized therapies and treatments tailored to the patient's genetic profile, a policy that has never been enacted.
While the bill requires that this can only be enacted if a patient has no approved options left, other provisions include a requirement for treatment to occur under physician supervision in qualified healthcare facilities meeting established federal safety and quality standards, Institutional Review Board (IRB) oversight and robust informed consent protections for participating patients, and deems that manufacturers are not obligated to provide treatments, and physicians are not required to recommend treatments they deem inappropriate for a patient.
What Lawmakers are Saying
"One of my first efforts upon taking office in January 2017 was to partner with Senator Ron Johnson to champion Right to Try, which we passed through both the U.S. House and Senate," said Rep. Biggs in a press release. "Many of us know people who are terminally ill and desperately seeking to extend their lives. Right to Try gives these individuals hope, freedom, and power to try potentially life-saving drug therapies.
The Arizona congressman further emphasized, "Our coalition was unwilling to let one more American die without this chance, and we are motivated to build on this original bill with the Right to Try for Individualized Treatments Act."
Representative Diana Harshbarger (R-TN), the bill's cosponsor, commented, "When someone is fighting for their life, the last thing they need is the government standing in their way."
"We are entering a new era of medicine where breakthroughs in genomics and precision therapies can create treatments designed specifically for an individual patient, but our regulatory system was built for a different time and simply hasn't kept up," Rep. Harshbarger further commented. "This legislation makes sure patients have a clear, durable path to pursue individualized treatments when all other options have failed."
