| 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.
|
