Right to Try for Individualized Treatments Act
- Bill Number
- H.R. 9190
- Origin Chamber
- House
- Congress
- 119th Congress, Session 2
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2026-06-08: Referred to the House Committee on Energy and Commerce.
- Last Updated
- 2026-07-01T21:33:25Z
AI-Generated Summary
Purpose This legislation amends the Federal Food, Drug, and Cosmetic Act to expand access to investigational individualized medical treatments for patients diagnosed with life-threatening diseases, conditions, or severely debilitating illnesses. It builds on existing "Right to Try" provisions by authorizing personalized treatments derived from a patient's genomic profile.
Key Provisions
- Definitions: Updates terms in Section 561B, including "eligible patient" (distinguishing between standard investigational drugs and individualized treatments), "eligible health care facility" (those operating under federal human subjects protections), "investigational individualized medical treatment" (a drug or biological product based on analysis of the patient's genomic sequence, chromosomes, DNA, genes, or metabolites), and "additional informed consent" (written attestation covering approved treatments, physician assessment, proposed treatment, and potential outcomes).
- Eligibility: Allows manufacturers of such treatments, operating in compliant facilities, to make them available; patients may request access if they have considered approved options (certified by an uncompensated physician in good standing) and provided informed consent. Manufacturers are not required to provide treatments.
- Exemptions: Extends regulatory exemptions from the Federal Food, Drug, and Cosmetic Act to these treatments, similar to existing investigational drugs.
- Consent Requirements: Mandates written informed consent, with additional details for individualized treatments.
Significant Changes to Existing Law
- Extends the Right to Try framework (previously limited to eligible investigational drugs) to genomic-based personalized treatments.
- Modifies patient eligibility by replacing "exhausted" approved treatments with "considered" them for individualized treatments and adding coverage for "severely debilitating illness."
- Introduces requirements for health care facilities to follow federal human subjects protections and adds specific "additional informed consent" elements.
- Updates section headings and cross-references for conformity.
Potential Impacts
- Government Agencies: The Food and Drug Administration (FDA) would have reduced pre-approval oversight for qualifying treatments, shifting focus to post-access monitoring.
- Citizens: Patients with serious conditions gain earlier access to personalized options outside clinical trials, potentially improving outcomes but with limited safety data.
- International Relations: Minimal direct effects, though it could influence global standards for personalized medicine access.
- Other: Healthcare facilities and manufacturers may face increased demand and liability considerations.
Main Stakeholders Affected
- Patients with life-threatening or severely debilitating conditions and their families.
- Physicians certifying eligibility and providing consent.
- Manufacturers of investigational treatments.
- Eligible health care facilities.
- The FDA and other federal health regulators.
Notable Legal, Constitutional, or Political Implications
- Reinforces patient autonomy in medical decisions by limiting certain FDA restrictions, consistent with prior Right to Try laws.
- Raises questions about balancing individual access against public safety standards under the Commerce Clause and FDA's regulatory authority.
- No major constitutional challenges are evident in the text, but it could prompt debates on informed consent standards and manufacturer protections.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Rep. Harshbarger, Diana [R-TN-1]
Cosponsors (1)
Recent Actions
- 2026-06-08: Referred to the House Committee on Energy and Commerce.
- 2026-06-08: Introduced in House
- 2026-06-08: Introduced in House
Bill Versions
- Right to Try for Individualized Treatments Act — issued 2026-06-08 — PDF (8 pages)