H.R. 9190: Right to Try for Individualized Treatments Act

The Right to Try for Individualized Treatments Act aims to amend existing laws related to the access of investigational medical treatments for patients diagnosed with life-threatening or severely debilitating conditions. Here’s a breakdown of what the bill entails:

Definitions and Key Terms

The bill introduces new definitions and clarifies key terms, including:

• Eligible Patient: A patient diagnosed with a life-threatening disease who has exhausted all approved treatment options and cannot participate in clinical trials, or someone who has a severely debilitating illness and has considered approved treatment options.
• Investigational Individualized Medical Treatment: This refers to drugs or biological products tailored for patients based on their unique genomic profiles.
• Eligible Health Care Facility: A facility that complies with federal regulations concerning human subject protections.

Eligibility for Treatments

The bill specifies that eligible patients may access investigational individualized medical treatments that are compliant with all federal regulations. However, manufacturers are not mandated to provide these treatments to all patients, meaning availability can vary.

Informed Consent Requirements

Patients must give written informed consent before receiving an investigational individualized medical treatment. This process includes:

• Understanding the currently approved treatments for their condition.
• Agreeing with their physician that the existing treatments are unlikely to extend or improve their life.
• Being informed about the specific investigational treatment recommended by their physician.
• Receiving a description of potential outcomes associated with the treatment.

Regulatory Framework

The bill necessitates that all investigational individualized medical treatments be offered in compliance with applicable federal laws, aiming to ensure safety and ethical standards are upheld during their use.

Exemptions and Amendments

It expands existing legal frameworks to incorporate investigational individualized medical treatments alongside investigational drugs and grants the Secretary of Health and Human Services authority to modify regulations to adapt to this new category of treatment.

Relevant Companies

None found.