§ 144E.3 — Manufacturer and eligible facility rights

Iowa § 144E.3

• Jurisdiction: Iowa
• Title IV: PUBLIC HEALTH
• Ch. 144E: EXPERIMENTAL TREATMENTS FOR TERMINALLY ILL PERSONS

Text

1. A manufacturer of an investigational drug, biological product, or device or a
manufacturer operating within, and in compliance with all requirements applicable to, an
eligible facility may make available, and an eligible patient, as applicable under section
144E.2, subsection 2, paragraph “a” or “b”, may request from a manufacturer of an
investigational drug, biological product, or device, or a manufacturer operating within, and
in compliance with all requirements applicable to, an eligible facility, the manufacturer’s
investigational drug, biological product, or device, or the manufacturer’s individualized
investigationaltreatmentunderthischapter. Thischapterdoesnotrequireamanufacturerof
an investigational drug, biological product, or device, or of an individualized investigational
treatment to provide or otherwise make available the investigational drug, biological
product, or device, or the individualized investigational treatment to an eligible patient.
2. An eligible facility, or a manufacturer described in subsection 1, that is in compliance
with all applicable requirements, may do any of the following:
a. Provide an investigational drug, biological product, or device, or an individualized
investigational treatment to an eligible patient, as applicable under section 144E.2,
subsection 2, paragraph “a” or “b”, without receiving compensation.
b. Require an eligible patient, as applicable under section 144E.2, subsection 2,
paragraph “a” or “b”, to pay the costs of, or the costs associated with, the manufacture of
the investigational drug, biological product, or device, or the individualized investigational
treatment.