Right to Try for Individualized Treatments Act
Sponsored By: Senator Johnson, Ron [R-WI]
Introduced
Summary
Creates a formal pathway for patient access to investigational individualized medical treatments. This bill would let patients with life‑threatening diseases or severely debilitating illnesses get treatments tailored to their unique genomic profile under defined safety and consent rules.
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- Patients: Eligible patients could request tailored investigational treatments based on their genomic data when a physician certifies available options and the illness meets the bill's severity tests. Access would require institutional assurances and detailed informed consent.
- Health care facilities and physicians: Facilities would need Federal assurances for human subjects protection and must use an expanded "additional informed consent" form that lists comparable treatments, likelihood of benefit, the proposed product, and possible outcomes. Physicians must attest to those disclosures and a witness must sign.
- Manufacturers: Companies could offer these individualized products but would not be forced to provide them. The bill adds new definitions and updates existing drug rules so these patient‑specific products fit into the regulatory framework.
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Bill Overview
Analyzed Economic Effects
2 provisions identified: 1 benefits, 0 costs, 1 mixed.
Access to individualized genomic treatments
If enacted, this bill would let eligible patients request investigational individualized medical treatments (IIIMTs) made from their own genomic profile. Manufacturers and eligible health care facilities could make these treatments available, but manufacturers would not have to provide them. Only facilities operating under the Federal assurance for protecting human research participants could host or provide the treatments. The bill would also make certain legal exemptions that apply to investigational drugs apply to IIIMTs.
Extra consent for individualized treatments
If enacted, this bill would require an additional written consent for investigational individualized medical treatments. A physician and a witness would have to sign the consent. The consent would have to list approved treatments, say the patient agrees standard care is unlikely to help, name the exact proposed treatment, and describe possible outcomes. The requirement would take effect upon enactment.
Sponsors & CoSponsors
Sponsor
Johnson, Ron [R-WI]
WI • R
Cosponsors
Sen. Tuberville, Tommy [R-AL]
AL • R
Sponsored 6/8/2026
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov