Right to Try for Individualized Treatments Act

Bill Number: S. 4698
Origin Chamber: Senate
Congress: 119th Congress, Session 2
Policy Area: Health
Status: Introduced
Latest Action: 2026-06-08: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Last Updated: 2026-07-01T17:02:28Z

AI-Generated Summary

The 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.

Definitions: Updates terms in Section 561B to include:
Investigational individualized medical treatment: A drug or biological product tailored to a patient's unique genomic profile, such as their DNA sequence, genes, or metabolites.
Eligible patient: Individuals who have considered approved treatments (certified by a licensed physician not compensated by the manufacturer) and provided written informed consent.
Eligible health care facility: Facilities operating under federal human subjects protection assurances.
Additional informed consent: A written process involving explanations of approved treatments, patient agreement that standard options are unlikely to help, identification of the proposed treatment, and potential outcomes.
Eligibility: Allows manufacturers of these treatments (in compliance with federal laws and operating in eligible facilities) to make them available; patients may request access, but manufacturers are not required to provide them.
Exemptions: Extends existing regulatory exemptions for investigational drugs to these individualized treatments.
Conforming changes: Updates section headings and cross-references for consistency.

Broadens the current Right to Try framework (previously focused on eligible investigational drugs) to cover personalized genomic-based treatments.
Introduces new consent and certification requirements specific to individualized treatments, including physician attestation of the patient's condition and consideration of approved options.
Adds facility eligibility criteria tied to federal human subjects protections.

On citizens: May increase options for patients with severe illnesses to pursue experimental personalized therapies outside standard clinical trials.
On government agencies: Could reduce FDA regulatory oversight for qualifying treatments due to exemptions, while maintaining requirements for informed consent and facility compliance.
On international relations: No direct effects identified in the legislation.

Patients diagnosed with life-threatening diseases, conditions, or severely debilitating illnesses.
Physicians and eligible health care facilities involved in certification and treatment provision.
Manufacturers of investigational individualized medical treatments.
Regulatory bodies such as the FDA responsible for drug oversight.

Reinforces patient access provisions similar to prior Right to Try laws by balancing expanded eligibility with consent safeguards and non-mandatory manufacturer participation.
Maintains physician licensing and non-compensation rules to support ethical implementation.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

2026-06-08: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
2026-06-08: Introduced in Senate

Right to Try for Individualized Treatments Act — issued 2026-06-08 — PDF (8 pages)