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MO HB1072

Bill

Status

Introduced

2/26/2015

Primary Sponsor

James Neely

Click for details

Origin

House of Representatives

2015 Regular Session

AI Summary

  • 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

  • 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

  • Establishes a $100,000 fine per patient for manufacturers who violate the marketing and access requirements

  • 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

  • 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

Committee Referrals

Health and Mental Health3/11/2015

Full Bill Text

No bill text available