Right to Try for Individualized Treatments Act
- Sponsor
- Rep. Harshbarger, Diana [R-TN-1]
- Committees
- Energy and Commerce Committee (primary)
- Last action
- Jun 8, 2026
Bottom line
This bill broadens access to experimental, personalized genomic treatments for seriously ill patients under the existing "Right to Try" framework, aiming to provide options when approved treatments are exhausted.
What it actually does
This bill amends the Federal Food, Drug, and Cosmetic Act to expand the existing "Right to Try" law, allowing patients with life-threatening diseases or severely debilitating illnesses to access "investigational individualized medical treatments." These treatments are defined as drugs or biological products tailored to a patient's unique genomic profile. The bill establishes specific eligibility criteria for patients and manufacturers, including a detailed "additional informed consent" process.
Proponents argue
Supporters argue this bill provides a crucial lifeline for patients with no other options, allowing them to access cutting-edge, personalized treatments that could save or significantly improve their lives. They contend it upholds patient autonomy and accelerates access to innovative therapies for those with rare or unique genetic conditions.
Opponents contend
Critics might contend that expanding "Right to Try" to highly experimental, individualized genomic treatments could expose vulnerable patients to unproven therapies without sufficient oversight. They may argue it risks offering false hope, diverting resources from rigorous clinical trials, and potentially leading to unforeseen adverse effects due to the lack of comprehensive safety and efficacy data.
The bill is concise, making it accessible for a quick review, but its implications for medical ethics and regulatory oversight warrant deeper consideration.
Section 2(a)
Expansion of Eligible Patient Criteria and New Treatment Definitions
This section amends the Federal Food, Drug, and Cosmetic Act to expand who qualifies for experimental treatments. It creates a new category of "eligible patient" for "investigational individualized medical treatments" (IIMT), which are drugs or biological products tailored to a patient's unique genomic profile. For these IIMTs, patients must have a life-threatening disease or condition or a severely debilitating illness, have considered approved treatment options, and provide a new, more detailed "additional informed consent" than for standard investigational drugs.
Supporters argue
Supporters argue this is crucial for patients with rare diseases or unique genetic profiles for whom standard treatments or clinical trials are not suitable. It empowers patients and their doctors to pursue innovative, tailored therapies when all other options have been exhausted.
Critics contend
Critics might argue that broadly defining "severely debilitating illness" could open the door to less critical cases, and that even "additional informed consent" might not fully mitigate the risks of unproven, highly complex genomic treatments for vulnerable patients.
Tradeoffs
This provision balances patient autonomy and the desire for innovative treatments against the need for regulatory oversight and patient safety, especially with highly experimental and personalized therapies that lack extensive clinical data.
Section 2(b) and 2(c)
Authorization for Individualized Treatments and Regulatory Exemptions
This section explicitly authorizes manufacturers operating within eligible health care facilities to make investigational individualized medical treatments (IIMTs) available to eligible patients. It also allows eligible patients to request these treatments. Crucially, it extends the existing exemptions from certain FDA requirements (like those for clinical trials) to these new IIMTs, meaning they can be used without undergoing the full FDA approval processes typically required for new drugs.
This section defines "additional informed consent" for individualized medical treatments, requiring written attestation by the physician and a witness. It mandates explanations of currently approved treatments, patient concurrence that approved treatments are unlikely to prolong or improve their life, clear identification of the specific proposed IIMT, and a description of potential outcomes based on the physician's knowledge.
Section 2(a)(6)
Why it matters:This level of detail is standard for legislative definitions, but its specific requirements are crucial for patient protection in this expanded "Right to Try" context, acting as a key safeguard for highly experimental treatments.
Case for: Supporters argue these detailed consent requirements are essential safeguards, ensuring patients fully understand the risks, benefits, and alternatives before pursuing highly experimental treatments, thereby protecting patient autonomy.
Case against: Critics might argue that even with detailed consent, the inherent vulnerability of patients facing dire prognoses makes true "informed" consent difficult, especially for treatments with unknown efficacy and safety profiles, potentially offering false hope.
Estimated impact: Enhances patient protection and physician responsibility in the context of IIMT access, potentially reducing instances of patients pursuing treatments without full understanding of the implications.