FDA oversight gap: new 'personalized medicine' pathway bypasses clinical trials
S. 4698 — Right to Try for Individualized Treatments Act · Filed by Ron Johnson (R-WI) · 1 cosponsor · Introduced Jun 8, 2026 · Referred to committee
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What it does
This bill expands the 'Right to Try' law to allow terminally ill or severely debilitated patients to use experimental drugs and personalized genetic treatments that have not yet been approved by the FDA, provided they have exhausted approved options and a licensed physician certifies their condition. The bill adds a new category of 'investigational individualized medical treatments' based on a patient's genomic profile, alongside existing Right to Try access to experimental drugs.
Why we flagged it
The bill's core function is to expand compassionate-use access to experimental drugs and add a new category of personalized genomic treatments for terminally ill patients. It is not primarily a deregulation or liability shield, though those mechanisms are embedded in the operative text.
What the text implies
- The bill defines 'investigational individualized medical treatment' to include any drug or biological product based on genomic analysis, potentially capturing a broad range of personalized therapies with minimal pre-market safety data, creating a parallel pathway to FDA approval that bypasses standard clinical trial requirements.
- Physician certification that a patient has 'considered' (not 'exhausted') approved treatment options for individualized treatments is a lower bar than the 'exhausted' standard for traditional Right to Try drugs, potentially enabling access to unproven genomic treatments before conventional options are truly depleted.
The full analysis lists 5 implications of this text.
Who stands to gain
pharmaceutical manufacturers (reduced regulatory burden for personalized/genomic drugs); biotechnology companies (expanded market access for investigational treatments); genomic testing and sequencing companies (increased demand for patient genomic profiling)