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2015 SESSION

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HB 1750 Investigational drugs; expanded access.

Introduced by: Margaret B. Ransone | all patrons    ...    notes | add to my profiles | history

SUMMARY AS PASSED:

Expanded access to investigational drugs, biological products, and devices. Provides that a manufacturer of an investigational drug, biological product, or device may make such drug, product, or device available to a person who has a terminal condition when (i) the person has, in consultation with his treating physician, considered all other treatment options currently approved by the U.S. Food and Drug Administration and the treating physician has determined that no reasonable opportunity exists for him to participate in an ongoing clinical trial; (ii) the potential benefits of use of the investigational drug, biological product, or device to treat his terminal condition are greater than the potential risks; (iii) the person has received a recommendation from his treating physician for use of such drug, product, or device for treatment of his terminal condition; and (iv) the person has provided written informed consent. The bill provides that a manufacturer that provides such drug, product, or device may provide the drug, product, or device free of charge or may require the person to pay costs associated with its manufacture and provides that health insurance providers may, but are not required to, provide coverage for costs associated with use of such drug, product, or device. For a health care provider who recommends an investigational drug, biological product, or device and for a manufacturer, distributor, administrator, health care provider, sponsor, or physician who manufactures, supplies, distributes, administers, prescribes, or recommends such drug, product, or device, the bill provides immunity from civil liability and provides that no claim or cause of action shall exist in any state court for claims of property, personal injury, or death caused by, arising out of, or relating to the design, development, clinical testing and investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescription, recommendation, administration, efficacy, or use of such drug, product, or device to a person who meets eligibility under the law. The bill provides that no health care provider who recommends, prescribes, administers, distributes, or supplies an investigational drug, biological product, or device shall be deemed to have engaged in unprofessional conduct or shall be adversely affected in any decision relating to licensure on such grounds and provides that nothing shall require any person to violate or act in contravention of any federal or state law as such law relates to the prescribing, dispensing, administration, or use of an investigational drug, biological product, or device. This bill is identical to SB 732.

SUMMARY AS PASSED HOUSE:

Expanded access to investigational drugs, biological products, and devices. Provides that a person who has a terminal condition shall be eligible for expanded access to an investigational drug, biological product, or device when (i) no comparable or satisfactory alternative treatment options approved by the U.S. Food and Drug Administration are available to treat his terminal condition; (ii) the potential benefits of the use of the investigational drug, biological product, or device outweigh the risks of use of the investigational drug, biological product, or device; (iii) his treating physician has recommended use of the investigational drug, biological product, or device; and (iv) the person or his legally authorized representative or his parent or legal guardian has provided informed written consent to use of the investigational drug, biological product, or device. The bill also provides that a manufacturer may provide an investigational drug, biological product, or device for treatment of such eligible person's terminal condition and may do so free of charge or may require the person to pay costs associated with manufacture of the investigational drug, biological product, or device and that health insurance providers may, but are not required to, provide coverage for costs associated with use of the investigational drug, biological product, or device. The bill provides immunity from civil liability for health care providers who recommend an investigational drug, biological product, or device and for manufacturers of investigational drugs, biological products, or devices that make such drugs, products, or devices available to a person who meets the criteria set forth in the bill.

SUMMARY AS INTRODUCED:

Expanded access to investigational drugs, biological products, and devices. Provides that a person who has a terminal condition shall be eligible for expanded access to an investigational drug, biological product, or device when (i) no comparable or satisfactory alternative treatment options approved by the U.S. Food and Drug Administration are available to treat his terminal condition; (ii) the potential benefits of the use of the investigational drug, biological product, or device outweigh the risks of use of the investigational drug, biological product, or device; (iii) his treating physician has recommended use of the investigational drug, biological product, or device; and (iv) the person has provided informed written consent to use of the investigational drug, biological product, or device. The bill also provides that a manufacturer may provide an investigational drug, biological product, or device for treatment of such eligible person's terminal condition and may do so free of charge or may require the person to pay costs associated with manufacture of the investigational drug, biological product, or device. The bill also provides that health insurance providers may, but are not required to, provide coverage for costs associated with use of the investigational drug, biological product, or device.