Right to Try for Individualized Treatments Act
Sponsored By: Senator Johnson, Ron [R-WI]
Introduced
Summary
This bill would create two new pathways letting seriously ill patients access investigational drugs and genomic‑tailored therapies outside clinical trials. It centers on expanded patient access to investigational individualized medical treatments while keeping physician certification and written informed consent as guardrails.
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- Patients and families: Patients with life‑threatening or severely debilitating conditions who have exhausted or considered approved options could receive eligible investigational drugs or individualized treatments based on their unique genomic profile. Patients must give written informed consent or have a legally authorized representative consent for them.
- Treating physicians and facilities: Physicians must certify they are in good standing and must not accept direct payment from manufacturers for that certification. Eligible health care facilities must operate under federal human subject protections and physicians must provide an "additional informed consent" document with specific elements about current care, life expectancy, and risks.
- Manufacturers and access rules: The bill lets manufacturers make investigational individualized medical treatments available to eligible patients but does not require them to do so. It also amends the Federal Food, Drug, and Cosmetic Act to add and align definitions and cross‑references for these treatments.
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Bill Overview
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
Access to experimental genetic treatments
If enacted, this bill would let patients with life‑threatening or severely debilitating illnesses ask drug makers for experimental treatments. It creates two access paths: one for investigational drugs after you exhaust approved options and cannot join a trial. The other path covers individualized treatments based on your unique genomic profile when approved options are unlikely to help. A licensed physician in good standing must certify eligibility and cannot be paid directly by the manufacturer for that certification. You (or a legal representative) must give written informed consent. For genomic treatments, an extra consent must be signed by the physician and a witness. That consent must explain approved options, the specific proposed treatment, and possible outcomes. Treatments must be provided in facilities that follow federal human subject protections. Manufacturers could make these treatments available but would not be required to do so.
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