Be it enacted by the general assembly of the state of iowa



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SF 14 (LSB 1071XS (3) 85)

SENATE FILE 14
BY  ANDERSON


A BILL FOR

An Act relating to abortion-inducing drug safety and providing penalties.



BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
   Section 1.  NEW SECTION.  146A.1  Definitions.

   As used in this chapter, unless the context otherwise requires:

   1.  “Abortion” means abortion as defined in section 146.1, and includes a medical abortion.

   2.  “Abortion-inducing drug” means a medicine, drug, or any other substance prescribed or dispensed with the intent of terminating the clinically diagnosable pregnancy of a woman, with knowledge that the drug will with reasonable likelihood cause the termination of the pregnancy. “Abortion-inducing drug” includes the off-label use of drugs known to have abortion-inducing properties, which are prescribed specifically with the intent of causing an abortion, but does not include drugs that may be known to cause an abortion, but which are prescribed for other medical indications.

   3.  “Adverse event” means adverse event as defined by the United States food and drug administration for the voluntary Medwatch reporting system form FDA 3500.

   4.  “Department” means the department of public health.

   5.  “Drug label” means the document published by the United States food and drug administration which accompanies an abortion-inducing drug and specifies the protocol tested and authorized by the United States food and drug administration and agreed upon by the drug company applying for authorization of that drug.

   6.  “Gestational age” means the time that has elapsed since the first day of the woman’s last menstrual period.

   7.  “Medical abortion” means the use of an abortion-inducing drug to induce an abortion.

   8.  “Physician” means any person licensed to practice medicine and surgery or osteopathic medicine and surgery pursuant to chapter 148.

   9.  “Pregnant” means the female reproductive condition of having a developing human offspring in the woman’s uterus from conception until birth.

   Sec. 2.  NEW SECTION.  146A.2  Abortion-inducing drugs —— requirements.

   1.  An individual shall not knowingly give, sell, dispense, administer, or otherwise provide or prescribe an abortion-inducing drug to a pregnant woman for the purpose of inducing an abortion in that pregnant woman, or for the purpose of enabling another person to induce an abortion in the pregnant woman, unless the individual who gives, sells, dispenses, administers, or otherwise provides or prescribes the abortion-inducing drug is a physician, and the provision or prescription of the abortion-inducing drug satisfies the protocol tested and authorized by the United States food and drug administration and as specified in the drug label for the abortion-inducing drug.

   2.  The physician giving, selling, dispensing, administering, or otherwise providing or prescribing the abortion-inducing drug shall first examine the pregnant woman and document, in the woman’s medical chart, the gestational age and intrauterine location of the pregnancy prior to giving, selling, dispensing, administering, or otherwise providing or prescribing the abortion-inducing drug.

   3.  Each pregnant woman to whom a physician gives, sells, dispenses, administers, or otherwise provides or prescribes any abortion-inducing drug shall be provided with a copy of the drug’s label.

   4.  The physician giving, selling, dispensing, administering, or otherwise providing or prescribing the abortion-inducing drug shall have a signed contract with a physician who agrees to handle complications and shall be able to produce that signed contract upon request of the pregnant woman or the department. The physician giving, selling, dispensing, administering, or otherwise providing or prescribing an abortion-inducing drug shall provide the pregnant woman with the name and telephone number of the physician who will be handling emergencies, and the hospital at which any emergencies will be handled. The physician who contracts to handle emergencies must have active admitting privileges and gynecological and surgical privileges at the hospital designated to handle any emergencies associated with the use or ingestion of the abortion-inducing drug.

   5.  The physician giving, selling, dispensing, administering, or otherwise providing or prescribing an abortion-inducing drug, or an agent of the physician, shall schedule a follow-up visit for the woman within fourteen days after administration of the abortion-inducing drug to confirm that the pregnancy is completely terminated and to assess the degree of bleeding. The physician, or agent of the physician, shall make all reasonable efforts to ensure that the woman returns for the scheduled appointment. A brief description of the efforts made to comply with this subsection, including the date, time, and identification by name of the person making such efforts, shall be included in the woman’s medical record.

   Sec. 3.  NEW SECTION.  146A.3  Reporting —— adverse event.

   1.  If a physician administers an abortion-inducing drug to a pregnant woman for the purpose of inducing an abortion and if the physician knows that the pregnant woman experiences, during or after the administration of the drug, an adverse event, the physician shall provide a written report of the adverse event within three days of the event to the United States food and drug administration under the Medwatch voluntary reporting system using form FDA 3500, and to the department.

   2.  The department shall compile and retain all reports received under this section. All reports received are public records. However, the department shall not release to any person the name or any other personal identifying information regarding a person who was administered an abortion-inducing drug for the purpose of inducing an abortion and who is the subject of a report received under this section.

   Sec. 4.  NEW SECTION.  146A.4  Criminal penalties.

   1.  A person who intentionally, knowingly, or recklessly violates any provision of this chapter is guilty of a class “D” felony.

   2.  A criminal penalty shall not be assessed against a pregnant woman upon whom a medical abortion is performed.

   Sec. 5.  NEW SECTION.  146A.5  Civil penalties.

   1.  In addition to any other remedies available under the common or statutory law of the state, failure to comply with the requirements of this chapter provides a basis for all of the following:

   a.  A civil malpractice action for actual and punitive damages.

   b.  A professional disciplinary action under chapter 148.

   c.  Recovery by the woman’s survivors for the wrongful death of a woman upon whom a medical abortion was performed.

   2.  Civil liability shall not be assessed against a pregnant woman upon whom a medical abortion was performed.

   3.  When requested, the court shall allow a woman to proceed in any action using solely her initials or a pseudonym and may close any proceedings in the case and enter other protective orders to preserve the privacy of the woman upon whom a medical abortion was performed.

   4.  If judgment is rendered in favor of the plaintiff, the court shall also render judgment for reasonable attorney fees in favor of the plaintiff against the defendant.

   Sec. 6.  NEW SECTION.  146A.6  Construction.

   1.  This chapter shall not be construed as creating or recognizing a right to abortion.

   2.  This chapter shall not be construed to legalize an abortion that is not authorized by state or federal law.

   Sec. 7.  NEW SECTION.  146A.7  Right to intervene.

   A member of the general assembly may intervene in any case in which the constitutionality of this chapter is challenged as a matter of right.

   Sec. 8.  NEW SECTION.  146A.8  Severability.

   If any provision of this chapter or its application to any person or circumstance is held invalid, the invalidity does not affect other provisions or application of this chapter which can be given effect without the invalid provision or application, and to this end the provisions of this chapter are severable.

EXPLANATION



   This bill relates to the protocol relating to medical abortions.

   The bill provides that an individual shall not knowingly give, sell, dispense, administer, or otherwise provide or prescribe any abortion-inducing drug to a pregnant woman for the purpose of inducing an abortion in that pregnant woman, or enabling another person to induce an abortion in a pregnant woman, unless the individual is a physician, and the provision or prescription of the abortion-inducing drug satisfies the protocol tested and authorized by the United States food and drug administration (FDA) and as specified in the drug label for the abortion-inducing drug. The bill requires that the physician, prior to providing or prescribing the abortion-inducing drug, first examine the pregnant woman, and document in the woman’s medical chart, the gestational age and intrauterine location of the pregnancy prior to providing or prescribing the abortion-inducing drug. The physician is required to provide the pregnant woman with the drug’s label; to have a signed contract with a physician who agrees to handle complications and to have this contract available upon request by the pregnant woman or department of public health (DPH); and to provide the pregnant woman with the name and the telephone number of the physician who will be handling emergencies, and the hospital at which any emergencies will be handled. The physician who contracts to handle emergencies must have active admitting privileges and gynecological and surgical privileges at the hospital designated to handle any emergencies associated with the use or ingestion of the abortion-inducing drug.

   The bill requires the physician providing or prescribing an abortion-inducing drug, or an agent of the physician, to schedule a follow-up visit for the woman within 14 days after administration of the abortion-inducing drug to confirm that the pregnancy is completely terminated and to assess the degree of bleeding, and to make all reasonable efforts to ensure that the woman returns for the scheduled appointment. The physician is directed to include a brief description of the follow-up efforts made, including the date, time, and identification by name of the person making such efforts, in the woman’s medical record.

   The bill requires a physician to report adverse events that the physician knows the woman experienced during or after the use of the drug within three days of the event to the FDA and to DPH. DPH is directed to compile and retain all reports received. The reports are public records, but DPH is not to release to any person the name or any other personal identifying information regarding a person who used an abortion-inducing drug for the purpose of inducing an abortion and who is the subject of a report received.

   A person who intentionally, knowingly, or recklessly violates any provision of the bill is guilty of a class “D” felony. A class “D” felony is punishable by confinement for no more than five years and a fine of at least $750 but not more than $7,500. However, a criminal penalty is not to be assessed against the pregnant woman upon whom the drug-induced abortion is performed. The bill also provides that in addition to any other remedies available under the common or statutory law of the state, failure to comply with the requirements of the bill provides the basis for a civil malpractice action for actual and punitive damages, a professional disciplinary action, or recovery by the woman’s survivors for the wrongful death of the woman. However, civil liability is not to be assessed against the pregnant woman upon whom the drug-induced abortion is performed. The bill provides that in any action the court may allow a woman to use solely her initials or a pseudonym and may close any proceedings in the case and enter other protective orders to preserve the privacy of the woman upon whom the drug-induced abortion was performed. If judgment is rendered in favor of the plaintiff, the bill provides for the awarding of reasonable attorney fees.

   The bill is not to be construed as creating or recognizing a right to abortion or to legalize an abortion that is not authorized under state or federal law.

   The bill provides that a member of the general assembly may intervene in any case in which the constitutionality of the bill is challenged as a matter of right. The bill also provides for severability of any provision of the bill or its application if held invalid so that the invalidity does not affect other provisions or application of the bill which can be given effect without the invalid provision or application.



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