By Matthew Holloway |
Rep. Andy Biggs (R-AZ5) has introduced legislation that would establish a federal pathway for patients with life-threatening or severely debilitating diseases to access individualized investigational treatments when no approved treatment options remain.
According to a press release from Biggs’ office, the Right to Try for Individualized Treatments Act was introduced this week by Biggs and Rep. Diana Harshbarger (R-TN), with companion legislation introduced in the U.S. Senate by Sen. Ron Johnson (R-WI).
The legislation builds on the original federal Right to Try Act, which was signed into law by President Donald Trump and provides terminally ill patients access to certain investigational treatments that had not yet received full approval from the U.S. Food and Drug Administration (FDA).
“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,” Biggs said. “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.”
Biggs said supporters of the original legislation sought to provide patients with additional treatment options when facing terminal illnesses and that the new proposal would build upon that framework.
“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,” Biggs said. “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.”
According to the bill sponsors, the legislation is intended to address advances in precision medicine and genomics that have enabled treatments tailored to individual patients. The lawmakers argue that existing regulatory pathways were designed for therapies intended for broader patient populations and do not adequately accommodate patient-specific treatments.
“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,” Harshbarger said. “This legislation makes sure patients have a clear, durable path to pursue individualized treatments when all other options have failed.”
Under the proposal, patients diagnosed with life-threatening or severely debilitating diseases could access investigational individualized therapies under physician supervision when no approved treatment options remain. Patients would need a physician’s recommendation before receiving treatment, which would be administered in qualified healthcare facilities that meet federal safety and quality standards and are subject to Institutional Review Board oversight and informed consent requirements.
Johnson said the measure would expand upon the original Right to Try framework by addressing therapies developed for individual patients and rare diseases.
“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,” Johnson said. “This is about medical freedom and putting doctors and patients at the top of the treatment pyramid.”
The legislation would also establish a statutory framework for individualized treatments rather than relying solely on administrative guidance. According to Biggs’ office, the FDA released draft guidance in February outlining a framework to support the development of individualized therapies, but the sponsors argue congressional action is needed to create durable patient protections and access pathways.
The Goldwater Institute, which helped pioneer the original Right to Try movement that was enacted into federal law in 2018, also advocated for the introduction of the Right to Try for Individualized Treatments Act.
In a statement, Goldwater Institute President and CEO Victor Riches said, “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.”
The proposal also has roots in Arizona. According to the release, Right to Try legislation received nearly 80 percent support in the Arizona Legislature in 2014 during Biggs’ tenure as a state lawmaker. The release states that Right to Try policies have since been adopted in 41 states, while “Right to Try 2.0” laws addressing individualized treatments have been enacted in 17 states, including Arizona.
Matthew Holloway is a senior reporter for AZ Free News. Follow him on X for his latest stories, or email tips to Matthew@azfreenews.com.
