Right to Try for Individualized Treatments Act
Sponsored By: Representative Harshbarger, Diana [R-TN-1]
Introduced
Summary
This bill would create a new pathway that lets patients with life-threatening or severely debilitating conditions request access to investigational individualized medical treatments outside clinical trials. It centers patient requests and physician oversight while leaving supply decisions to manufacturers.
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- Patients and families: Eligible patients could request treatments through two pathways with rules on disease severity, prior treatments, physician certification, and extra informed consent. Requests are tied to the patient’s clinical status and must come from an eligible health care facility or the manufacturer.
- Physicians and health care facilities: The treating physician must be in good standing, certify eligibility, and obtain additional informed consent. Eligible facilities must comply with federal human subjects protections referenced in the Public Health Service Act.
- Manufacturers and regulatory guardrails: Manufacturers may provide investigational individualized medical treatments but are not required to supply any patient. They must meet federal assurances, avoid improper payments to certifying physicians, and benefit from expanded investigational exemptions under the Federal Food, Drug, and Cosmetic Act.
This bill would expand access options for seriously ill patients while keeping ethical and regulatory safeguards in place.
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Bill Overview
Analyzed Economic Effects
1 provisions identified: 0 benefits, 0 costs, 1 mixed.
Access to individualized experimental treatments
If enacted, you would be able to ask for experimental drugs or individualized treatments if you have a life‑threatening or severely debilitating condition. A licensed doctor must certify you meet the rules and you must give written informed consent. Individualized treatments would be based on your unique genomic profile and may need extra written disclosures about the plan and possible outcomes. Manufacturers would be allowed to offer these treatments but would not be required to supply them, and the bill would not create new federal funding or guarantee insurance payments.
Sponsors & CoSponsors
Sponsor
Harshbarger, Diana [R-TN-1]
TN • R
Cosponsors
Rep. Biggs, Andy [R-AZ-5]
AZ • R
Sponsored 6/8/2026
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov