Sponsors (3)
The bill creates a pathway for seriously ill patients to request individualized genomic investigational treatments—expanding access and adding clinician oversight—while raising substantial safety, cost, administrative, and oversight risks because these therapies are unproven and may lack coverage or standardized oversight.
Patients with life‑threatening or severely debilitating conditions can request individualized genomic investigational treatments that might otherwise be inaccessible, expanding potential therapeutic options.
Physicians must attest they considered approved treatment options before recommending individualized investigational therapies, which can strengthen clinical oversight and informed decision-making.
Manufacturers retain discretion to decline requests for individualized investigational products, protecting small developers from compelled production, supply strain, and additional liability burdens.
Patients may be exposed to unproven genomic treatments that lack established safety or efficacy, risking physical harm, adverse outcomes, or false hope.
Providing individualized investigational therapies outside clinical trials could impose substantial costs on patients, insurers, or taxpayers if coverage protections are absent, increasing financial burden.
Requiring physician certifications and enhanced consent procedures increases administrative and documentation burdens for clinicians and health systems, diverting time and resources.
Based on analysis of 2 sections of legislative text.
Adds an optional pathway allowing physicians and eligible facilities to request investigational individualized medical treatments, with new consent and eligibility rules; manufacturers may but need not provide them.
Expands the existing Right to Try framework to create a new, optional pathway allowing physicians and eligible health care facilities to request and receive investigational individualized medical treatments from manufacturers for seriously ill patients when other approved options have been considered. It adds definitions (including ‘‘investigational individualized medical treatment,’’ ‘‘eligible health care facility,’’ and ‘‘additional informed consent’’), clarifies who qualifies as an eligible patient for these individualized requests, and makes clear manufacturers may provide such treatments at their discretion but are not required to do so. The bill also updates cross-references in the FDA statute to accommodate the new pathway and specifies four required elements of additional informed consent that physicians must obtain and document before providing an investigational individualized medical treatment.
Official title: To amend the Federal Food, Drug, and Cosmetic Act to authorize the use of investigational individualized medical treatments by patients diagnosed with a life-threatening disease or condition or severely debilitating illness, and for other purposes.
Introduced June 8, 2026 by Diana Harshbarger · Last progress June 8, 2026