Right to Try for Individualized Treatments Act

119th Congress Introduced by Andy Biggs and 1 co-sponsor

Authorizes use of investigational, individualized treatments for life-threatening or severely debilitating conditions to expand rapid access while maintaining safety safeguards.

Introduced in House

Summary of HR 9190 (119th Congress)

Purpose and intent

HR 9190 seeks to amend the Federal Food, Drug, and Cosmetic Act to authorize the use of investigational individualized medical treatments by patients diagnosed with a life-threatening disease or condition or a severely debilitating illness. The bill aims to expand access to tailored or experimental therapies outside of traditional FDA-approved pathways, prioritizing rapid access for patients facing serious, progressive, or debilitating health situations.

Key provisions and changes (highlights)

Authorization of investigational individualized treatments: The bill would establish a framework allowing patients to receive therapies that are investigational and individualized, rather than requiring full FDA approval prior to use.

Criteria for eligibility: Patients must have a life-threatening disease or condition or a severely debilitating illness. The bill would specify conditions under which such treatments could be accessed, potentially including assessments of risk/benefit, lack of satisfactory alternatives, and other safeguards.

Physician and patient roles: Likely to involve medical professionals recommending and administering the investigational treatment, with patient consent and informed decision-making built into the process.

Oversight and safeguards: Provisions typically associated with investigational therapies may include requirements for monitoring, adverse event reporting, and criteria to ensure patient safety and informed consent. The bill could set up a process to review and approve access on a per-patient or per-treatment basis.

Regulatory alignment: The act would modify provisions in the Federal Food, Drug, and Cosmetic Act to accommodate individualized therapies while maintaining federal safety and efficacy standards.

Who would be affected

Patients: Individuals with life-threatening or severely debilitating diseases who lack effective approved treatments would gain potential access to investigational, individualized therapies.

Healthcare providers: Physicians and clinicians who evaluate eligibility, discuss risks and benefits, and administer treatments would play a central role.

Sponsors and developers: Researchers, biopharmaceuticals, and institutions developing investigational therapies could be impacted by new pathways for access and oversight.

Regulators and federal agencies: The FDA and related entities would implement and oversee the new authorization framework.

Procedural and timeline aspects

Referral: The bill was referred to the House Committee on Energy and Commerce on June 8, 2026.

Introduction: It was introduced in the House on June 8, 2026.

Next steps: If advanced, the committee may hold hearings, mark up the bill, and potentially move it to the House floor for a vote. Subsequent actions would depend on legislative priorities and negotiations.

Notes

The summary reflects the bill’s stated objective to broaden access to investigational, individualized medical treatments while maintaining safety considerations. Specific numerical thresholds, procedural steps, and detailed safeguards would be defined in the full text of the bill and any accompanying committee amendments.