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2015 SESSION

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SB 732 Investigational drugs; expanded access.

Introduced by: William M. Stanley, Jr. | 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 incorporates SB 1149 and SB 1222 and is identical to HB 1750.

SUMMARY AS PASSED SENATE:

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 illness 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) received a recommendation from his treating physician for use of an investigational drug, biological product, or device for treatment of his terminal illness; (iii)  the person has provided written informed consent. The bill provides that a manufacturer that provides such drug, product, or device may provide it free of charge or may require the person to pay costs associated with its manufacture.The bill also provides that health insurance providers may, but are not required to, provide coverage for costs associated with use of such drug, product, or device. This bill incorporates SB 1149 and SB 1222.
 

SUMMARY AS INTRODUCED:

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 illness 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; (ii) the person has been denied opportunity to participate in a clinical trial for the treatment of his terminal illness within one week of completion of the clinical trial application process or has been unable to participate in a clinical trial for the treatment of his terminal illness within 100 miles of his home address; (iii) the person's treating physician has recommended treatment with an investigational drug, biological product, or device; and (iv) the person has provided written informed consent. The bill provides that a manufacturer that provides such drug, product, or device may provide it free of charge or may require the person to pay costs associated with its manufacture. The bill also provides that health insurance providers may, but are not required to, provide coverage for costs associated with use of such drug, product, or device; that a health insurance provider may deny coverage other than coverage for preexisting conditions or benefits that commenced prior to the time treatment with the investigational drug, biological product, or device began to a person receiving treatment with an investigational drug, biological product, or device during the period of treatment; and that no health care provider who recommends such treatment shall be deemed to have engaged in unprofessional conduct solely on the grounds of such recommendation.