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IN HB1065
Bill
Status
3/24/2015
Primary Sponsor
Wes Culver
Click for details
AI Summary
HEA 1065 Summary
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Establishes a new chapter (IC 16-42-26) allowing manufacturers to make investigational drugs, biological products, and devices available to qualified patients who have completed Phase I of FDA clinical trials but lack FDA approval for general use.
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Defines "qualified patient" as an individual meeting requirements under IC 25-22.5-1-2.1(a), including those with terminal diseases lacking comparable FDA-approved treatment options where a licensed physician determines the experimental treatment risk is not greater than the disease risk.
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Permits manufacturers to provide investigational treatments either without compensation or by requiring patients to pay manufacturing costs.
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Requires treating physicians to provide written and oral informed consent disclosures explaining the experimental nature of treatment, lack of FDA approval, material risks, and treatment details.
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Prohibits creation of liability claims against manufacturers and healthcare providers for harm resulting from investigational drugs, biological products, or devices used by patients.
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Declares an emergency for immediate enactment.
Legislative Description
Use of investigational drugs, biological products, and devices. Provides that a manufacturer of an investigational drug, biological product, or device may make the drug, biological product, or device available to a patient who meets certain requirements. Adds to the requirements concerning experimental or nonconventional medical treatment and the authority to allow a patient to receive an experimental or nonconventional medical treatment if a physician determines that the patient: (1) has been diagnosed with a terminal disease or condition; and (2) does not have comparable or satisfactory treatment options. Specifies that a new cause of action is not created. Makes a
Last Action
Public Law 2
3/24/2015