Congressman Biggs Introduces Right to Try for Individualized Treatments Act

WASHINGTON, D.C. - This week, Congressman Andy Biggs (AZ-05) and Congresswoman Diana Harshbarger (TN-01) introduced the Right to Try for Individualized Treatments Act, legislation to create a pathway for patients with life-threatening or severely debilitating diseases to access individualized investigational treatments when no approved options remain. A companion bill was introduced by Sen. Ron Johnson (R-WI) in the U.S. Senate.

"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 Congressman Biggs."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. 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. I am honored to again help lead this bill in the U.S. House, and I pray we can quickly send it to President Trump's desk to be enacted into law."

"When someone is fighting for their life, the last thing they need is the government standing in their way," said Congresswoman Harshbarger. "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. This legislation makes sure patients have a clear, durable path to pursue individualized treatments when all other options have failed."

"I championed Right to Try to provide hope and freedom to those with terminal illnesses by giving them access to experimental treatments without waiting for full FDA approval. The original Right to Try Act was about giving terminal patients a fighting chance by cutting through red tape," said Sen. Johnson. "Right to Try 2.0 builds on that success and would provide access to individualized, rare disease and one-patient therapies that the current regulatory environment has yet to accommodate. This is about medical freedom and putting doctors and patients at the top of the treatment pyramid."

"Patients battling serious and life-threatening diseases too often reach a devastating dead end: no approved treatments left, and nowhere else to turn. The Right to Try for Individualized Treatments Act changes that by giving these patients and their doctors the ability to pursue promising, individualized therapies while preserving strong transparency and safety guardrails. This legislation is a critical breakthrough that ensures medical innovation doesn't stop at the FDA's door-it reaches the patients who need it most after conventional options have failed. We are deeply grateful to Reps. Harshbarger and Biggs and Senator Johnson for championing this patient-first approach. They are helping restore hope, agency, and dignity to families facing the hardest moments of their lives by putting them back in the driver's seat of their own care," said Terry Wilcox, Co-Founder & CEO of Patients Rising.

"No American should be forced to beg the government for permission to try to save their own life, and no bureaucrat should prevent a patient from accessing cutting-edge therapies. The Right to Try for Individualized Treatments opens the door to the latest advances in medical treatment and brings the federal government into the 21st century," said Victor Riches, President and CEO of the Goldwater Institute.

Right to Try is a bipartisan policy that has passed in 41 states, including Arizona, during Congressman Biggs's time there in the State Legislature, where it received nearly 80 percent of the vote in 2014. Right to Try 2.0 has been enacted in 17 states - also including Arizona.

BACKGROUND:

The bill builds on the original Right to Try Act of 2017 signed into law by President Trump, which gave terminally ill patients the right to access investigational drugs not yet fully approved by the U.S. Food and Drug Administration (FDA). This legislation adapts that same patient-first framework for a new era of precision medicine, where therapies can be tailored to a single patient's unique genetic profile-something existing regulatory pathways designed for broad patient populations were never built to accommodate.

The bill complements recent FDA efforts related to individualized therapies while establishing long-term patient protections through federal law. On February 23, 2026, the FDA released draft guidance outlining a "plausible mechanism" framework to support development of individualized therapies. However, agency guidance alone can be revised or withdrawn and does not create enforceable rights for patients. Establishing a durable statutory pathway requires congressional action.

KEY PROVISIONS:

• Allows patients diagnosed with a life-threatening or severely debilitating disease to access investigational individualized therapies when no approved treatments remain.
  
• Requires treatment to occur under physician supervision in qualified healthcare facilities meeting established federal safety and quality standards.
  
• Ensures Institutional Review Board (IRB) oversight and robust informed consent protections for participating patients.
  
• Supports the generation of real-world clinical data that can inform future regulatory decisions and therapeutic development.
  
• Provides a durable statutory framework that does not depend on changing regulatory guidance or administrative priorities.
  
• A patient must have a physician's recommendation for an investigational individualized treatment.
  
• Manufacturers are not obligated to provide treatments, and physicians are not required to recommend treatments they deem inappropriate for a patient. The Right to Try for Individualized Treatments Act is voluntary for all parties involved.

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