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MO HB1072
Bill
Status
2/26/2015
Primary Sponsor
James Neely
Click for details
AI Summary
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Allows manufacturers and physicians to market investigational drugs, biological products, or devices to eligible terminally ill patients who are considering informed consent for label-expansion, placebo-controlled trials
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Requires manufacturers or physicians seeking informed consent for placebo-controlled trials to either make the investigational treatment available outside the trial or provide contact information for physicians willing to prescribe it outside the trial
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Establishes a $100,000 fine per patient for manufacturers who violate the marketing and access requirements
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Creates the "Investigational Drug Fund" in the state treasury, funded by violation fines and lawsuit settlements related to off-label marketing, to cover costs for eligible patients whose insurance does not cover off-label use
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Defines eligible patients as those with terminal illness who have considered FDA-approved treatments and relevant clinical trials, received a physician recommendation, and provided written informed consent
Legislative Description
Changes the laws regarding investigational drug trials
Last Action
Public Hearing Scheduled, Bill not Heard (H)
5/6/2015