| AI Summary |
This bill expands access to individualized investigational treatments for patients with life-threatening or severely debilitating illnesses by allowing, but not requiring, manufacturers to provide customized drugs, biological products, or medical devices based on a patient’s genetic profile.
Key Provisions of the Bill
1. Patient Eligibility Criteria
To request an individualized investigational drug, biological product, or device, a patient must:
- Have a life-threatening or severely debilitating illness, as confirmed by their treating physician.
- Have considered all FDA-approved treatment options.
- Have received a recommendation from their treating physician.
- Provide written, informed consent for using the investigational treatment.
- Have documentation from their physician confirming they meet these criteria.
2. Manufacturer Participation (Optional)
- A manufacturer may, but is not required to, provide the individualized investigational treatment.
- The manufacturer must operate within an institution that complies with federal human subject protection regulations.
- Manufacturers can provide the treatment for free or charge to cover costs.
3. Legal Protections for Manufacturers & Health-Care Providers
- No liability: If the treatment harms the patient, the patient cannot sue the manufacturer or any health-care provider involved—so long as they follow the law and act with reasonable care.
- No license penalties: Health-care providers cannot be penalized or lose their medical license for recommending or overseeing the use of these treatments.
4. Health Insurance Considerations
- Does not affect insurers' existing obligations: The bill does not change a health insurer’s responsibilities regarding coverage for clinical trial participation.
Summary
- Eligible patients (with severe or life-threatening illnesses) may request a customized, investigational treatment based on their genetic profile.
- Manufacturers can provide the treatment voluntarily and may charge to cover costs.
- Legal protections prevent lawsuits against manufacturers and protect doctors' licenses.
- Health insurers' obligations remain unchanged regarding coverage for clinical trials.
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| Summary |
The bill allows, but does not require, an eligible patient to request
from a manufacturer the manufacturer's individualized investigational
drug, biological product, or device, which is a drug, biological product,
or device that is unique and produced exclusively for use by an individual
patient based on the patient's own genetic profile. The manufacturer must
be operating within an institution that operates under federal rules for the
protection of human subjects. An eligible patient is an individual who
has:
•
A life-threatening or severely debilitating illness, as
attested to by the patient's treating physician;
•
Considered all other treatment options currently approved
by the United States food and drug administration;
•
Received a recommendation from the patient's treating
physician;
•
Given written, informed consent for the use of the
individualized investigational drug, biological product, or
device; and
•
Documentation from the treating physician that the
individual meets the definition of eligible patient.
The bill authorizes, but does not require, a manufacturer to make
the individualized investigational drug, biological product, or device
available to an eligible patient at no charge, but the manufacturer may
require payment to cover the cost.
If any harm is caused to the eligible patient resulting from the use
of the individualized investigational drug, biological product, or device,
a private right of action cannot be brought against the manufacturer or
against any other individual or entity involved in the care of the eligible
patient with regard to the eligible patient's use of the individualized
investigational drug, biological product, or device, so long as the
manufacturer, individual, or entity complied with the law and exercised
reasonable care.
The bill prohibits any action against a health-care provider's
license based on the health-care provider's recommendations regarding
the use of the individualized investigational drug, biological product, or
device.
Nothing in the bill affects a health-care insurer's obligation under
current law relating to coverage for an insured's participation in a clinical
trial.
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