Citations Affected: IC 16-18-2; IC 16-34-3; IC 35-51-16-1.
Synopsis: Abortion inducing drugs. Amends the definition of
"abortion clinic" to include facilities that provide 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 related to abortion inducing drugs and
maintained by the medical licensing board are public records. Makes
a violation concerning distribution of an abortion inducing drug and
failure to report an adverse event a Class A misdemeanor.
Effective: July 1, 2013.
January 8, 2013, read first time and referred to Committee on Health and Provider
A BILL FOR AN ACT to amend the Indiana Code concerning
AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY
1, 2013]: Sec. 1.6. "Abortion inducing drug", for purposes of
IC 16-34-3, has the meaning set forth in IC 16-34-3-1.
inducing drug to a pregnant woman for the purpose of inducing an
abortion or enabling a person 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 satisfies the protocol outlined in the final print labeling as approved by the federal Food and Drug Administration.
(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) Conduct ultrasound imaging or oversee fetal ultrasound imaging by an individual who is licensed or certified in Indiana and whose scope of practice within the licensure or certification includes conducting ultrasound imaging.
(3) 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.
(4) Provide the following information to the pregnant woman:
(A) A copy of the final printed drug label.
(B) The name and telephone number for the physician in which the treating physician has entered into an agreement under IC 16-34-2-4.5(a)(2) concerning the management of possible complications for the pregnant woman.
(C) The information required in IC 16-34-2-1.1.
(5) Comply with the admitting privilege requirements set forth in IC 16-34-2-4.5.
(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 at 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 the woman's
return, and the name of the individual who performed the efforts.
Sec. 5. A physician licensed under IC 25-22.5 that gives, sells, dispenses, administers, prescribes, or otherwise provides an abortion inducing drug to a pregnant woman shall comply with the hospital admitting privilege requirements under IC 16-34-2-4.5.
Sec. 6. (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 do the following:
(1) Compile and retain the reports received under subsection (a).
(2) Make the reports available as public records and open to inspection. However, the medical licensing board of Indiana shall ensure that personally identifiable information contained in the reports concerning a patient are redacted before the reports are made available to the public under this section.
Sec. 7. (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.