Citations Affected: IC 16-18-2; IC 16-34-3; IC 35-51-16-1.
Synopsis: Abortion inducing drugs. Specifies that only a physician
who meets certain conditions may administer to a pregnant woman an
abortion inducing drug, and sets forth the procedure the physician must
follow. Requires a physician who learns of an adverse event following
the use of an abortion inducing drug to report the adverse event to the
Food and Drug Administration and the medical licensing board.
Specifies that the reports of adverse events maintained by the medical
licensing board are public records. Establishes a Class A misdemeanor
for a violation concerning distribution of an abortion inducing drug and
for failure to report an adverse event.
Effective: July 1, 2013.
January 22, 2013, read first time and referred to Committee on Public Policy.
A BILL FOR AN ACT to amend the Indiana Code concerning
means a medicine, drug, or substance prescribed or dispensed with
the intent of terminating a clinically diagnosable pregnancy with
the knowledge that the termination will, with reasonable likelihood,
cause the death of the fetus. The term includes the off-label use of
a drug known to have abortion inducing properties if the drug is
prescribed with the intent of causing an abortion.
(b) The term does not include a drug or substance that may be known to cause an abortion when the drug is being prescribed for another medical indication.
Sec. 2. As used in this chapter, "adverse event" means an undesirable experience associated with the use of an abortion inducing drug. The term includes the following incidents:
(2) Life threatening occurrence.
(4) Disability or permanent damage.
(5) Congenital anomaly or birth defect of the fetus.
(6) Medical intervention required to prevent permanent impairment or damage.
Sec. 3. As used in this chapter, "drug label" means the pamphlet or document accompanying an abortion inducing drug that:
(1) outlines the protocol tested and authorized by the federal Food and Drug Administration;
(2) sets forth how the drug is to be used; and
(3) has been agreed upon by the drug manufacturer applying for authorization of the drug by the federal Food and Drug Administration.
Sec. 4. (a) It is unlawful for an individual to knowingly give, sell, dispense, administer, prescribe, or otherwise provide an abortion inducing drug to a pregnant woman for the purpose of inducing an abortion or enabling an individual to induce an abortion unless the individual meets the following requirements:
(1) The individual is a physician licensed under IC 25-22.5.
(2) The individual follows the drug label protocol for the abortion inducing drug.
(b) Before giving, selling, dispensing, administering, prescribing, or otherwise providing an abortion inducing drug to a pregnant woman, a physician licensed under IC 25-22.5 shall do the following:
(1) Examine in person the pregnant woman.
(2) Document the following information on the pregnant woman's medical chart:
(A) The gestational age of the fetus.
(B) The intrauterine location of the fetus.
(3) Provide the following information to the pregnant woman:
(A) A copy of the drug label.
(B) The physician's telephone number and the name of the hospital where the physician has admitting privileges as required in IC 16-34-2-4.5.
(C) The information required in IC 16-34-2-1.1.
(c) A physician licensed under IC 25-22.5 who gives, sells, dispenses, administers, prescribes, or otherwise provides an abortion inducing drug to a pregnant woman shall schedule a follow-up appointment with the woman approximately fourteen (14) days after administration of the abortion inducing drug to:
(1) confirm that the pregnancy is terminated by conducting ultrasound imaging; and
(2) assess the degree of bleeding experienced by the pregnant woman.
(d) The physician described in subsection (c) shall make a reasonable effort to ensure that the pregnant woman returns for the follow-up appointment described in subsection (c), including recording in the pregnant woman's medical records the date and time of the follow-up appointment, a brief description of the efforts by the physician and the physician's staff to ensure that the pregnant woman returns for the follow-up appointment, and the name of the individuals who made those efforts.
Sec. 5. (a) A physician licensed under IC 25-22.5 who gives, sells, dispenses, administers, prescribes, or otherwise provides an abortion inducing drug to a pregnant woman and who is aware of a subsequent adverse event from the abortion inducing drug shall report the adverse event not later than three (3) days following the physician's knowledge of the adverse event to the following:
(1) The federal Food and Drug Administration through the federal Medwatch reporting system.
(2) The medical licensing board of Indiana.
(b) The medical licensing board of Indiana shall maintain and compile a report of each adverse event reported to the board under subsection (a). A report compiled under this subsection is a public record and is open to inspection. The report may not contain information that personally identifies a pregnant woman who experienced the adverse event described in subsection (a).
Sec. 6. (a) A person who intentionally, knowingly, or recklessly violates this chapter commits an unlawful activity related to an
abortion inducing drug, a Class A misdemeanor. A pregnant
woman upon whom the drug induced abortion is performed may
not be assessed a penalty under this section.
(b) In addition to the criminal penalty under subsection (a), a person who violates this chapter may be subject to disciplinary sanctions under IC 25-1-9 and civil liability for wrongful death and medical malpractice.