Senate File 14 - Introduced SENATE FILE 14 BY ANDERSON A BILL FOR An Act relating to abortion-inducing drug safety and providing 1 penalties. 2 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 3 TLSB 1071XS (3) 85 pf/nh
S.F. 14 Section 1. NEW SECTION . 146A.1 Definitions. 1 As used in this chapter, unless the context otherwise 2 requires: 3 1. “Abortion” means abortion as defined in section 146.1, 4 and includes a medical abortion. 5 2. “Abortion-inducing drug” means a medicine, drug, or any 6 other substance prescribed or dispensed with the intent of 7 terminating the clinically diagnosable pregnancy of a woman, 8 with knowledge that the drug will with reasonable likelihood 9 cause the termination of the pregnancy. “Abortion-inducing 10 drug” includes the off-label use of drugs known to have 11 abortion-inducing properties, which are prescribed specifically 12 with the intent of causing an abortion, but does not include 13 drugs that may be known to cause an abortion, but which are 14 prescribed for other medical indications. 15 3. “Adverse event” means adverse event as defined by the 16 United States food and drug administration for the voluntary 17 Medwatch reporting system form FDA 3500. 18 4. “Department” means the department of public health. 19 5. “Drug label” means the document published by the United 20 States food and drug administration which accompanies an 21 abortion-inducing drug and specifies the protocol tested and 22 authorized by the United States food and drug administration 23 and agreed upon by the drug company applying for authorization 24 of that drug. 25 6. “Gestational age” means the time that has elapsed since 26 the first day of the woman’s last menstrual period. 27 7. “Medical abortion” means the use of an abortion-inducing 28 drug to induce an abortion. 29 8. “Physician” means any person licensed to practice 30 medicine and surgery or osteopathic medicine and surgery 31 pursuant to chapter 148. 32 9. “Pregnant” means the female reproductive condition of 33 having a developing human offspring in the woman’s uterus from 34 conception until birth. 35 -1- LSB 1071XS (3) 85 pf/nh 1/ 7
S.F. 14 Sec. 2. NEW SECTION . 146A.2 Abortion-inducing drugs —— 1 requirements. 2 1. An individual shall not knowingly give, sell, 3 dispense, administer, or otherwise provide or prescribe an 4 abortion-inducing drug to a pregnant woman for the purpose 5 of inducing an abortion in that pregnant woman, or for the 6 purpose of enabling another person to induce an abortion in 7 the pregnant woman, unless the individual who gives, sells, 8 dispenses, administers, or otherwise provides or prescribes 9 the abortion-inducing drug is a physician, and the provision 10 or prescription of the abortion-inducing drug satisfies the 11 protocol tested and authorized by the United States food and 12 drug administration and as specified in the drug label for the 13 abortion-inducing drug. 14 2. The physician giving, selling, dispensing, 15 administering, or otherwise providing or prescribing the 16 abortion-inducing drug shall first examine the pregnant woman 17 and document, in the woman’s medical chart, the gestational age 18 and intrauterine location of the pregnancy prior to giving, 19 selling, dispensing, administering, or otherwise providing or 20 prescribing the abortion-inducing drug. 21 3. Each pregnant woman to whom a physician gives, sells, 22 dispenses, administers, or otherwise provides or prescribes any 23 abortion-inducing drug shall be provided with a copy of the 24 drug’s label. 25 4. The physician giving, selling, dispensing, 26 administering, or otherwise providing or prescribing the 27 abortion-inducing drug shall have a signed contract with a 28 physician who agrees to handle complications and shall be 29 able to produce that signed contract upon request of the 30 pregnant woman or the department. The physician giving, 31 selling, dispensing, administering, or otherwise providing 32 or prescribing an abortion-inducing drug shall provide the 33 pregnant woman with the name and telephone number of the 34 physician who will be handling emergencies, and the hospital 35 -2- LSB 1071XS (3) 85 pf/nh 2/ 7
S.F. 14 at which any emergencies will be handled. The physician who 1 contracts to handle emergencies must have active admitting 2 privileges and gynecological and surgical privileges at the 3 hospital designated to handle any emergencies associated with 4 the use or ingestion of the abortion-inducing drug. 5 5. The physician giving, selling, dispensing, 6 administering, or otherwise providing or prescribing an 7 abortion-inducing drug, or an agent of the physician, shall 8 schedule a follow-up visit for the woman within fourteen days 9 after administration of the abortion-inducing drug to confirm 10 that the pregnancy is completely terminated and to assess the 11 degree of bleeding. The physician, or agent of the physician, 12 shall make all reasonable efforts to ensure that the woman 13 returns for the scheduled appointment. A brief description of 14 the efforts made to comply with this subsection, including the 15 date, time, and identification by name of the person making 16 such efforts, shall be included in the woman’s medical record. 17 Sec. 3. NEW SECTION . 146A.3 Reporting —— adverse event. 18 1. If a physician administers an abortion-inducing drug to 19 a pregnant woman for the purpose of inducing an abortion and if 20 the physician knows that the pregnant woman experiences, during 21 or after the administration of the drug, an adverse event, the 22 physician shall provide a written report of the adverse event 23 within three days of the event to the United States food and 24 drug administration under the Medwatch voluntary reporting 25 system using form FDA 3500, and to the department. 26 2. The department shall compile and retain all reports 27 received under this section. All reports received are public 28 records. However, the department shall not release to any 29 person the name or any other personal identifying information 30 regarding a person who was administered an abortion-inducing 31 drug for the purpose of inducing an abortion and who is the 32 subject of a report received under this section. 33 Sec. 4. NEW SECTION . 146A.4 Criminal penalties. 34 1. A person who intentionally, knowingly, or recklessly 35 -3- LSB 1071XS (3) 85 pf/nh 3/ 7
S.F. 14 violates any provision of this chapter is guilty of a class “D” 1 felony. 2 2. A criminal penalty shall not be assessed against a 3 pregnant woman upon whom a medical abortion is performed. 4 Sec. 5. NEW SECTION . 146A.5 Civil penalties. 5 1. In addition to any other remedies available under the 6 common or statutory law of the state, failure to comply with 7 the requirements of this chapter provides a basis for all of 8 the following: 9 a. A civil malpractice action for actual and punitive 10 damages. 11 b. A professional disciplinary action under chapter 148. 12 c. Recovery by the woman’s survivors for the wrongful death 13 of a woman upon whom a medical abortion was performed. 14 2. Civil liability shall not be assessed against a pregnant 15 woman upon whom a medical abortion was performed. 16 3. When requested, the court shall allow a woman to proceed 17 in any action using solely her initials or a pseudonym and may 18 close any proceedings in the case and enter other protective 19 orders to preserve the privacy of the woman upon whom a medical 20 abortion was performed. 21 4. If judgment is rendered in favor of the plaintiff, the 22 court shall also render judgment for reasonable attorney fees 23 in favor of the plaintiff against the defendant. 24 Sec. 6. NEW SECTION . 146A.6 Construction. 25 1. This chapter shall not be construed as creating or 26 recognizing a right to abortion. 27 2. This chapter shall not be construed to legalize an 28 abortion that is not authorized by state or federal law. 29 Sec. 7. NEW SECTION . 146A.7 Right to intervene. 30 A member of the general assembly may intervene in any case in 31 which the constitutionality of this chapter is challenged as 32 a matter of right. 33 Sec. 8. NEW SECTION . 146A.8 Severability. 34 If any provision of this chapter or its application to any 35 -4- LSB 1071XS (3) 85 pf/nh 4/ 7
S.F. 14 person or circumstance is held invalid, the invalidity does 1 not affect other provisions or application of this chapter 2 which can be given effect without the invalid provision or 3 application, and to this end the provisions of this chapter are 4 severable. 5 EXPLANATION 6 This bill relates to the protocol relating to medical 7 abortions. 8 The bill provides that an individual shall not knowingly 9 give, sell, dispense, administer, or otherwise provide or 10 prescribe any abortion-inducing drug to a pregnant woman 11 for the purpose of inducing an abortion in that pregnant 12 woman, or enabling another person to induce an abortion in 13 a pregnant woman, unless the individual is a physician, and 14 the provision or prescription of the abortion-inducing drug 15 satisfies the protocol tested and authorized by the United 16 States food and drug administration (FDA) and as specified 17 in the drug label for the abortion-inducing drug. The bill 18 requires that the physician, prior to providing or prescribing 19 the abortion-inducing drug, first examine the pregnant woman, 20 and document in the woman’s medical chart, the gestational age 21 and intrauterine location of the pregnancy prior to providing 22 or prescribing the abortion-inducing drug. The physician is 23 required to provide the pregnant woman with the drug’s label; 24 to have a signed contract with a physician who agrees to handle 25 complications and to have this contract available upon request 26 by the pregnant woman or department of public health (DPH); and 27 to provide the pregnant woman with the name and the telephone 28 number of the physician who will be handling emergencies, and 29 the hospital at which any emergencies will be handled. The 30 physician who contracts to handle emergencies must have active 31 admitting privileges and gynecological and surgical privileges 32 at the hospital designated to handle any emergencies associated 33 with the use or ingestion of the abortion-inducing drug. 34 The bill requires the physician providing or prescribing 35 -5- LSB 1071XS (3) 85 pf/nh 5/ 7
S.F. 14 an abortion-inducing drug, or an agent of the physician, to 1 schedule a follow-up visit for the woman within 14 days after 2 administration of the abortion-inducing drug to confirm that 3 the pregnancy is completely terminated and to assess the degree 4 of bleeding, and to make all reasonable efforts to ensure that 5 the woman returns for the scheduled appointment. The physician 6 is directed to include a brief description of the follow-up 7 efforts made, including the date, time, and identification by 8 name of the person making such efforts, in the woman’s medical 9 record. 10 The bill requires a physician to report adverse events 11 that the physician knows the woman experienced during or 12 after the use of the drug within three days of the event to 13 the FDA and to DPH. DPH is directed to compile and retain 14 all reports received. The reports are public records, but 15 DPH is not to release to any person the name or any other 16 personal identifying information regarding a person who used an 17 abortion-inducing drug for the purpose of inducing an abortion 18 and who is the subject of a report received. 19 A person who intentionally, knowingly, or recklessly 20 violates any provision of the bill is guilty of a class “D” 21 felony. A class “D” felony is punishable by confinement for no 22 more than five years and a fine of at least $750 but not more 23 than $7,500. However, a criminal penalty is not to be assessed 24 against the pregnant woman upon whom the drug-induced abortion 25 is performed. The bill also provides that in addition to any 26 other remedies available under the common or statutory law of 27 the state, failure to comply with the requirements of the bill 28 provides the basis for a civil malpractice action for actual 29 and punitive damages, a professional disciplinary action, or 30 recovery by the woman’s survivors for the wrongful death of the 31 woman. However, civil liability is not to be assessed against 32 the pregnant woman upon whom the drug-induced abortion is 33 performed. The bill provides that in any action the court may 34 allow a woman to use solely her initials or a pseudonym and may 35 -6- LSB 1071XS (3) 85 pf/nh 6/ 7
S.F. 14 close any proceedings in the case and enter other protective 1 orders to preserve the privacy of the woman upon whom the 2 drug-induced abortion was performed. If judgment is rendered 3 in favor of the plaintiff, the bill provides for the awarding 4 of reasonable attorney fees. 5 The bill is not to be construed as creating or recognizing 6 a right to abortion or to legalize an abortion that is not 7 authorized under state or federal law. 8 The bill provides that a member of the general assembly 9 may intervene in any case in which the constitutionality of 10 the bill is challenged as a matter of right. The bill also 11 provides for severability of any provision of the bill or its 12 application if held invalid so that the invalidity does not 13 affect other provisions or application of the bill which can be 14 given effect without the invalid provision or application. 15 -7- LSB 1071XS (3) 85 pf/nh 7/ 7