House File 2122 - Introduced HOUSE FILE 2122 BY STOLTENBERG , OSMUNDSON , DETERMANN , SHERMAN , HAYES , and HENDERSON A BILL FOR An Act relating to certification requirements for the provision 1 of abortion-inducing drugs, providing penalties, and 2 providing effective date provisions. 3 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 4 TLSB 5639YH (3) 90 pf/ko
H.F. 2122 Section 1. NEW SECTION . 146F.1 Definitions. 1 As used in this chapter, unless the context otherwise 2 requires: 3 1. a. Abortion means the act of using or prescribing 4 any instrument, medicine, drug, or any other substance, 5 device, or means with the intent to terminate a clinically 6 diagnosable pregnancy with knowledge that the termination by 7 those means will with reasonable likelihood cause the death of 8 the unborn child. Abortion includes the act of prescribing an 9 abortion-inducing drug with reasonable certainty that the drug 10 will prevent the growth or implantation, or otherwise cause the 11 death of the unborn child, if the drug is ingested prior to 12 confirmation of a clinically diagnosed pregnancy. 13 b. Abortion does not include any use, prescribing, 14 or means if done with the intent described in any of the 15 following: 16 (1) To save the life or preserve the health of the unborn 17 child. 18 (2) To remove a dead unborn child resulting from a 19 spontaneous abortion commonly known as a miscarriage. 20 (3) To remove an ectopic pregnancy. 21 (4) To treat a maternal disease or illness for which the 22 prescribed drug is medically indicated. 23 2. Abortion complication or complication means only the 24 following physical or psychological conditions which, in the 25 reasonable medical judgment of a licensed health care provider, 26 arise as a primary or secondary result of an induced abortion: 27 uterine perforation, cervical laceration, infection, bleeding, 28 vaginal bleeding that qualifies as a grade 2 or higher adverse 29 event according to the common terminology criteria for 30 adverse events produced by the United States national cancer 31 institute, pulmonary embolism, deep vein thrombosis, failure 32 to actually terminate the pregnancy, incomplete abortion or 33 retained tissue, pelvic inflammatory disease, endometritis, 34 missed ectopic pregnancy, cardiac arrest, respiratory arrest, 35 -1- LSB 5639YH (3) 90 pf/ko 1/ 20
H.F. 2122 renal failure, shock, amniotic fluid embolism, coma, free 1 fluid in the abdomen, allergic reactions to anesthesia and 2 abortion-inducing drugs, psychological complications as 3 diagnosed that are listed in the current diagnostic and 4 statistical manual and any termination of pregnancy with 5 complications or abortion with complications diagnosis as 6 specified in current international classification of diseases 7 (ICD) ICD-10 codes. 8 3. a. Abortion-inducing drug means mifepristone, 9 misoprostol, and any other medicine, drug, or other substance 10 that is prescribed or dispensed with the intent of terminating 11 a clinically diagnosable pregnancy with knowledge that the 12 termination will with reasonable likelihood cause the death of 13 the unborn child. 14 b. Abortion-inducing drug includes all of the following: 15 (1) The off-label use of drugs known to have 16 abortion-inducing properties which are prescribed or dispensed 17 specifically with the intent of terminating a clinically 18 diagnosable pregnancy. 19 (2) The off-label use of drugs known to have 20 abortion-inducing properties that are prescribed without a 21 diagnosed pregnancy for the purpose of causing an abortion at 22 a future time rather than contemporaneously with a clinically 23 diagnosed pregnancy. 24 c. Abortion-inducing drug does not include drugs that may 25 be known to cause an abortion but that are prescribed for other 26 medical indications. 27 4. Adverse event means the same as defined in 21 C.F.R. 28 312.32. 29 5. Associated physician means a physician who has entered 30 into an associated physician contract with another physician 31 under this chapter to provide for hospital admitting privileges 32 as required under this chapter. 33 6. Department means the department of inspections, 34 appeals, and licensing. 35 -2- LSB 5639YH (3) 90 pf/ko 2/ 20
H.F. 2122 7. Distributor means the same as wholesale distributor as 1 defined in section 155A.3. 2 8. Facility means a public or private hospital, clinic, 3 center, medical school, medical training institution, health 4 care business, physician office, infirmary, dispensary, 5 ambulatory surgical center, or other institution or location or 6 business wherein medical care or pharmaceuticals are provided 7 to any person. 8 9. Gestational age means the time that has elapsed since 9 the first day of the pregnant womans last menstrual period. 10 10. Health care provider means a person who is licensed, 11 certified, or otherwise authorized or permitted by law of this 12 state to administer health care in the ordinary course of 13 business or in the practice of a profession. 14 11. Hospital means the same as defined in section 135B.1. 15 12. Manufacturer means the same as defined in section 16 155A.3. 17 13. Pharmacy means a pharmacy as defined in section 18 155A.3 located in that state that is also certified by the 19 manufacturers of abortion-inducing drugs to dispense the drugs 20 via prescription. 21 14. Physician means a person licensed to practice pursuant 22 to chapter 148. 23 15. Pregnant or pregnancy means the female reproductive 24 condition of having an unborn child in the females uterus. 25 16. Provide , provided , or providing means, when used 26 regarding abortion-inducing drugs, any act of giving, selling, 27 dispensing, administering, transferring possession to, or 28 otherwise providing or prescribing an abortion-inducing drug. 29 Sec. 2. NEW SECTION . 146F.2 Applicability. 30 This chapter applies to any physician, health care provider, 31 manufacturer, distributor, pharmacy, or other person providing 32 abortion-inducing drugs within the state. 33 Sec. 3. NEW SECTION . 146F.3 Abortion-inducing drug 34 certification program creation. 35 -3- LSB 5639YH (3) 90 pf/ko 3/ 20
H.F. 2122 1. The board of pharmacy shall create an abortion-inducing 1 drug certification program to provide oversight and to regulate 2 the provision of abortion-inducing drugs in the state. 3 2. Abortion-inducing drugs shall be transported and 4 provided in the state at wholesale only by manufacturers or 5 distributors certified under the program. 6 3. Abortion-inducing drugs shall only be provided to 7 patients by physicians certified to prescribe and dispense the 8 drugs under the program. 9 4. Abortion-inducing drugs shall not be provided directly 10 to a patient outside of the program, including through the 11 mail. 12 Sec. 4. NEW SECTION . 146F.4 Board of pharmacy 13 abortion-inducing drug certification program duties. 14 1. The board of pharmacy shall require all of the following 15 at a minimum from manufacturers, distributors, and pharmacies 16 in the state that provide abortion-inducing drugs: 17 a. Completion of the certification process for 18 manufacturers, distributors, physicians, and pharmacies as 19 described under this chapter. 20 b. Notification by manufacturers, distributors, and 21 pharmacies of the physicians certified under the program. 22 c. Compliance with reporting requirements as specified under 23 this chapter. 24 d. Prohibited shipment of abortion-inducing drugs to 25 physicians who are not certified under the program. 26 e. Auditing of newly certified manufacturers, distributors, 27 and pharmacies within ninety calendar days following initial 28 certification and annually thereafter, to ensure compliance 29 with the processes and procedures required under the program. 30 f. Suspension of the certification of a manufacturer, 31 distributor, or pharmacy found to be noncompliant until the 32 manufacturer, distributor, or pharmacy demonstrates full 33 compliance. 34 g. Enforcement of certification compliance in accordance 35 -4- LSB 5639YH (3) 90 pf/ko 4/ 20
H.F. 2122 with this chapter. 1 2. The board of pharmacy shall require all of the following 2 at a minimum from physicians in the state who provide 3 abortion-inducing drugs: 4 a. Completion of the certification process. 5 b. Auditing of newly certified physicians within ninety 6 calendar days following initial certification and annually 7 thereafter, to ensure compliance with the processes and 8 procedures required under the program. 9 c. Suspension of the certification of a physician found 10 to be noncompliant until the physician demonstrates full 11 compliance. 12 d. Enforcement of certification compliance in accordance 13 with this chapter. 14 3. The board of pharmacy shall require that all 15 manufacturers of abortion-inducing drugs submit a list of any 16 manufacturers, distributors, pharmacies, and physicians that 17 are certified or otherwise approved by the manufacturer of 18 abortion-inducing drugs to dispense the drugs in the state. 19 Sec. 5. NEW SECTION . 146F.5 Certification program 20 requirements for manufacturers, distributors, and pharmacies. 21 1. The board of pharmacy shall create a certification 22 program for manufacturers, distributors, and pharmacies 23 intending to provide abortion-inducing drugs in the state. 24 2. To be eligible for certification under this section, 25 a manufacturer, distributor, or pharmacy shall do all of the 26 following, as applicable: 27 a. Be licensed by the board of pharmacy. 28 b. Only distribute abortion-inducing drugs to physicians 29 certified under this chapter. 30 c. Record each national drug code, serial number, lot 31 number, and expiration date from the pharmaceutical packages 32 of abortion-inducing drugs distributed to each certified 33 physician. 34 d. Only dispense abortion-inducing drugs to patients based 35 -5- LSB 5639YH (3) 90 pf/ko 5/ 20
H.F. 2122 on prescriptions by physicians certified under this chapter. 1 e. Only dispense a prescription for abortion-inducing drugs 2 to a patient if the prescription is accompanied by a patient 3 agreement form signed by the patient. 4 f. Have available for examination the certification required 5 by the manufacturer of abortion-inducing drugs. 6 g. Comply with all applicable standards of the utilization 7 review accreditation commission and the national association of 8 the boards of pharmacy. 9 h. For online sales or orders, hold a current pharmacy or 10 pharma domain and comply with all standards required by the 11 national association of the boards of pharmacy to maintain the 12 domain. 13 i. Comply with all other applicable state and federal 14 laws related to the distribution or delivery of legend drugs, 15 including abortion-inducing drugs. 16 j. Comply with all acceptable processes and procedures to 17 maintain a distribution or delivery system that is secure, 18 confidential, and follows all processes and procedures, 19 including those for storage, handling, shipping, tracking of 20 national drug codes, serial numbers, lot numbers and expiration 21 dates on products, proof of delivery, and controlled returns of 22 abortion-inducing drugs. 23 Sec. 6. NEW SECTION . 146F.6 Certification program 24 requirements for physicians. 25 1. The board of pharmacy shall create a certification 26 program for physicians intending to provide abortion-inducing 27 drugs to pregnant women in the state. Physicians providing 28 abortion-inducing drugs in other states shall not be 29 automatically certified in Iowa but shall be fully certified 30 under this chapter prior to providing any abortion-inducing 31 drugs to any pregnant women in this state. To be eligible to be 32 certified under this section, a physician shall comply with all 33 of the following: 34 a. Hold a license to practice medicine in good standing in 35 -6- LSB 5639YH (3) 90 pf/ko 6/ 20
H.F. 2122 the state. 1 b. Examine any pregnant woman in person prior to prescribing 2 or dispensing an abortion-inducing drug. 3 c. Present and continually hold a current prescriber 4 agreement form with the manufacturer of each abortion-inducing 5 drug prescribed by the physician in accordance with guidelines 6 of the United States food and drug administration. 7 d. Sign an annual dispensing agreement form developed 8 and provided by the board of pharmacy before providing 9 abortion-inducing drugs. 10 e. Obtain the signature of the pregnant woman to whom an 11 abortion-inducing drug is dispensed on the patient agreement 12 form required by the manufacturer of each abortion-inducing 13 drug used in accordance with the guidelines of the United 14 States food and drug administration. 15 f. Attach the signed patient agreement form to any 16 prescription for an abortion-inducing drug issued to a 17 certified pharmacy. 18 g. Inform the pregnant woman to whom the abortion-inducing 19 drug is to be dispensed of gestational age-specific risks of 20 using abortion-inducing drugs. 21 h. Screen the pregnant woman to whom the abortion-inducing 22 drug is to be dispensed for coercion, abuse, and anxiety, 23 and refer the pregnant woman to the appropriate health care 24 provider for treatment consistent with the screening results. 25 i. Inform the pregnant woman to whom an abortion-inducing 26 drug is to be dispensed that the pregnant woman may see the 27 remains of the unborn child in the process of completing the 28 abortion, that it may be possible to reverse the effects of 29 the drug-induced abortion if the pregnant woman changes her 30 mind but that time is of the essence, that studies show that 31 babies born following the abortion reversal process do not have 32 a higher rate of birth defects than the general population, 33 and that studies show that following the reversal process or 34 otherwise treating a pregnant woman with progesterone during 35 -7- LSB 5639YH (3) 90 pf/ko 7/ 20
H.F. 2122 pregnancy does not lead to increased mortality rates. 1 j. Refrain from knowingly supplying abortion-inducing drugs 2 to persons who present with any of the following: 3 (1) Absence of a pregnancy. 4 (2) Being post-seventy days gestation or post-ten weeks of 5 pregnancy. 6 (3) Having risk factors medically contraindicated for 7 taking abortion-inducing drugs, including but not limited to 8 any of the following: 9 (a) An ectopic pregnancy. 10 (b) Problems with the adrenal glands near the kidneys. 11 (c) Being treated with long-term corticosteroid therapy. 12 (d) Allergic reactions to abortion-inducing drugs, 13 mifepristone, misoprostol, or similar drugs. 14 (e) Bleeding problems, anemia, or taking anticoagulant drug 15 products. 16 (f) Having inherited porphyria. 17 (g) Having an intrauterine device in place. 18 (h) Being Rh negative and requiring the administration of 19 Rhogam before providing abortion-inducing drugs. 20 k. Provide or refer the pregnant woman for emergency 21 surgical intervention in cases of an incomplete abortion, 22 severe bleeding, or other medical complications, through 23 maintenance of hospital admitting privileges or through a 24 written agreement with an associated physician as specified in 25 this chapter. 26 l. Ensure the pregnant woman access to medical facilities 27 equipped to provide blood transfusions and resuscitation or 28 other necessary treatments, if necessary. 29 m. Sign and ensure that the pregnant woman signs all 30 required informed consent materials, provide the pregnant 31 woman with a copy of the signed consent materials showing both 32 signatures, and place the original signed consent materials in 33 the pregnant womans medical record. 34 n. Record the national drug code, serial number, lot number, 35 -8- LSB 5639YH (3) 90 pf/ko 8/ 20
H.F. 2122 and expiration date from the package of each abortion-inducing 1 drug provided to the pregnant woman in the pregnant womans 2 medical record. 3 o. Submit a written protocol of efforts that will be made 4 to schedule the follow-up appointment with the pregnant woman 5 within fourteen days to assure a completed abortion. 6 p. Report to the board of pharmacy and the United States 7 food and drug administration any death associated with the 8 physicians provision of abortion-inducing drugs to a pregnant 9 woman with the following guidelines: 10 (1) The pregnant woman shall be referenced in the report 11 by a nonidentifiable reference and the national drug code, 12 lot number, and expiration date from the package of the 13 abortion-inducing drug given, whether or not considered drug 14 related. 15 (2) The report shall be submitted as soon as possible but no 16 later than fifteen calendar days from the initial receipt of 17 the information by the physician. 18 q. Submit a written protocol of how complications will be 19 handled by the physician and a copy of any signed contract 20 with an associated physician credentialed to handle certain 21 complications specified in this chapter to the board of 22 pharmacy. 23 r. Comply with all applicable state and federal laws 24 regarding medical records retention, confidentiality, and 25 privacy. 26 s. Agree to follow and document compliance with all other 27 required conditions for performing abortions in the state. 28 2. The requirements under this subsection do not affect 29 the other reporting requirements for a physician under the 30 abortion-inducing drugs certification program or any other 31 applicable law. 32 Sec. 7. NEW SECTION . 146F.7 Hospital admitting privileges 33 associated physician agreements requirements. 34 The board of pharmacy shall require all of the following of 35 -9- LSB 5639YH (3) 90 pf/ko 9/ 20
H.F. 2122 physicians certified under this chapter: 1 1. Maintain hospital admitting privileges at one or more 2 hospitals in the county or a contiguous county where the 3 abortion-inducing drug is provided by the physician, and inform 4 the pregnant woman of any hospital where the physician holds 5 admitting privileges. 6 2. a. In lieu of subsection 1, enter into a written 7 agreement with an associated physician in the county or a 8 contiguous county where the abortion-inducing drug is provided 9 to comply with the requirements for maintenance of hospital 10 admitting privileges. A physician who enters into such written 11 agreement shall ensure compliance with all of the following: 12 (1) The physician who provides an abortion-inducing drug 13 shall notify the pregnant woman of the location of any hospital 14 at which the associated physician has admitting privileges. 15 (2) The physician shall keep a copy of the written agreement 16 at the physicians practice location. 17 (3) The physician shall submit a copy of the written 18 agreement to the department as part of any required facility 19 licensure. 20 (4) The written agreement shall be renewed annually. 21 (5) The written agreement shall include a requirement 22 that the associated physician present and continually 23 hold any certifications required by the manufacturers of 24 abortion-inducing drugs. 25 (6) The written agreement shall include a requirement 26 that the associated physician provide to the pregnant woman 27 and require the pregnant woman to sign all informed consent 28 materials required by the state. 29 (7) The written agreement shall require the compliance by 30 the associated physician with all reporting requirements and 31 any other required conditions for performing abortions in the 32 state. 33 b. (1) The board of pharmacy shall verify the validity of 34 the written agreement and shall provide a copy of each written 35 -10- LSB 5639YH (3) 90 pf/ko 10/ 20
H.F. 2122 agreement to the department. 1 (2) The department shall annually submit a copy of each 2 written agreement to each hospital located in the county or a 3 county that is contiguous to the county where an abortion was 4 performed. 5 (3) The department shall confirm to a member of the public, 6 upon request, that the written agreement required under this 7 section has been received by the department. 8 Sec. 8. NEW SECTION . 146F.8 Reporting system annual 9 reports reports of abortion complications or adverse events 10 requirements for certified physicians and others. 11 1. The board of pharmacy shall adopt an electronically based 12 reporting system for physicians certified under this chapter to 13 report annually all of the following regarding the provision of 14 abortion-inducing drugs: 15 a. The number of pregnant women provided abortion-inducing 16 drugs. 17 b. The age of each pregnant woman provided abortion-inducing 18 drugs. 19 c. The race of each pregnant woman provided 20 abortion-inducing drugs. 21 d. The county and state of residence of each pregnant woman 22 provided abortion-inducing drugs. 23 e. If a pregnant woman resides outside of the United States, 24 the city and country of residence of each such pregnant woman 25 provided abortion-inducing drugs. 26 f. The county and state in which each pregnant woman was 27 provided abortion-inducing drugs. 28 g. A list of the staff attending the pregnant woman provided 29 abortion-inducing drugs, including licensing numbers and 30 evidence of other qualifications. 31 h. The abortion-inducing drug provided for each pregnant 32 woman, by date. 33 i. Any known abortion complications or adverse events 34 experienced by a pregnant woman following provision of the 35 -11- LSB 5639YH (3) 90 pf/ko 11/ 20
H.F. 2122 abortion-inducing drug, and how the abortion complications or 1 adverse events were addressed, by date. 2 j. Any unresolved cases. 3 2. Emergency department physicians and other physicians 4 who treat abortion complications or adverse events shall also 5 report these instances to the reporting system. 6 3. A physician reporting under this section shall protect 7 from disclosure any personally identifiable information of the 8 pregnant woman in accordance with applicable federal and state 9 law. 10 4. A certified physician shall also report to the board 11 of pharmacy, as well as the MedWatch reporting system of 12 the United States food and drug administration any abortion 13 complication or adverse event as defined by the United States 14 food and drug administration in the MedWatch reporting system. 15 5. A certified physician shall also report to the board 16 of pharmacy any death of a pregnant woman associated with 17 abortion-inducing drugs in accordance with the following 18 guidelines: 19 a. The pregnant woman shall be identified by a 20 nonidentifiable reference and the national drug code, serial 21 number, lot number, and expiration date from each package of 22 the abortion-inducing drug provided, whether or not the death 23 is considered drug related. 24 b. The report shall be submitted as soon as possible but no 25 later than fifteen calendar days from the initial receipt of 26 the information by the physician. 27 6. The reporting requirements under this section are in 28 addition to any other reporting requirements applicable to a 29 physician under this chapter or any other required conditions 30 for performing an abortion in the state. 31 7. The board of pharmacy shall develop a system of reporting 32 abortion complications and adverse events resulting from the 33 use of abortion-inducing drugs in the state. 34 a. The system shall require reporting of abortion 35 -12- LSB 5639YH (3) 90 pf/ko 12/ 20
H.F. 2122 complications and adverse events, including but not limited to 1 death, blood loss including hemorrhage, infection including 2 sepsis, blood transfusions, administration of drugs for 3 an ectopic pregnancy, and other adverse effects requiring 4 hospitalization or additional medical care. 5 b. All of the following persons shall report abortion 6 complications and adverse events in writing to the system: 7 (1) Physicians certified to provide abortion-inducing 8 drugs. 9 (2) Emergency department physicians. 10 (3) Any physician licensed in the state who treats women 11 with adverse abortion complications or adverse effects. 12 (4) Other persons as determined by the board of pharmacy. 13 c. A person required report so shall also report adverse 14 events and patient deaths to the United States food and drug 15 administration. 16 Sec. 9. NEW SECTION . 146F.9 Violations penalties 17 remedies. 18 1. A manufacturer, distributor, physician, or pharmacist 19 shall not provide abortion-inducing drugs without being 20 certified as required by this chapter. 21 2. A manufacturer, distributor, physician, or pharmacist 22 who knowingly, intentionally, or recklessly violates this 23 chapter is guilty of a class D felony. 24 3. A manufacturer, distributor, physician, or pharmacist 25 who knowingly, intentionally, or recklessly violates this 26 chapter by fraudulent use of an abortion-inducing drug, with or 27 without the knowledge of the pregnant woman, is guilty of an 28 aggravated misdemeanor. 29 4. a. In addition to any other remedies available under 30 common or state law, failure to comply with the requirements of 31 this chapter shall result in all of the following: 32 (1) A basis for a civil malpractice action for actual and 33 punitive damages. 34 (2) A basis for a professional disciplinary action by the 35 -13- LSB 5639YH (3) 90 pf/ko 13/ 20
H.F. 2122 appropriate licensing board or other entity. 1 (3) A basis for recovery following a pregnant womans death 2 for the womans survivors pursuant to a wrongful death action. 3 b. When requested, the court shall allow a pregnant woman 4 to proceed using solely the womans initials or a pseudonym 5 and may close any proceedings in the case and enter other 6 protective orders to preserve the privacy of the pregnant woman 7 upon whom the drug-induced abortion was attempted, induced, or 8 performed. 9 c. (1) If judgment is rendered in favor of the plaintiff, 10 the court shall also award reasonable attorney fees in favor 11 of the plaintiff. 12 (2) If judgment is rendered in favor of the defendant and 13 the court finds that the plaintiffs suit was frivolous and 14 brought in bad faith, the court may award reasonable attorney 15 fees in favor of the defendant. 16 5. A civil or criminal penalty shall not be assessed 17 against a pregnant woman upon whom a drug-induced abortion is 18 attempted, induced, or performed. 19 Sec. 10. NEW SECTION . 146F.10 Enforcement by the board of 20 pharmacy. 21 1. The board of pharmacy shall enforce this chapter by any 22 of the following means: 23 a. When a manufacturer, distributor, physician, 24 or pharmacist intentionally or knowingly provides 25 abortion-inducing drugs without first seeking certification 26 under this chapter in violation of this chapter, the board of 27 pharmacy shall do all of the following: 28 (1) Immediately report the illegal act to local law 29 enforcement or other applicable state and local agencies for 30 investigation and other appropriate action, where appropriate. 31 (2) Impose a fine of no less than five million dollars for 32 manufacturers, distributors, or pharmacies and two hundred 33 fifty thousand dollars for physicians. 34 b. When a certified manufacturer, distributor, pharmacy, 35 -14- LSB 5639YH (3) 90 pf/ko 14/ 20
H.F. 2122 or physician is determined to be in noncompliance, suspend 1 certification until full compliance is demonstrated to the 2 satisfaction of the board of pharmacy. 3 c. When a current or previously certified manufacturer, 4 distributor, or pharmacy is found to have intentionally 5 or knowingly violated this chapter or refuses to be fully 6 compliant within ninety calendar days, suspend certification 7 and prohibit continued provision of abortion-inducing drugs 8 by the manufacturer, distributor, or pharmacy until full 9 compliance is demonstrated to the satisfaction of the board of 10 pharmacy. 11 d. When a certified manufacturer, distributor, pharmacy, 12 or physician is in noncompliance, suspend all annual 13 recertifications until compliance is demonstrated to the 14 satisfaction of the board of pharmacy. 15 e. When a current or previously certified manufacturer, 16 distributor, pharmacy, or physician is found to have 17 intentionally or knowingly violated this chapter or refuses to 18 be fully compliant: 19 (1) Immediately suspend the manufacturers, distributors, 20 pharmacys, or physicians certification until full compliance 21 is demonstrated. 22 (2) For certified manufacturers, distributors, or 23 pharmacies, impose fines of not less than one million dollars 24 per offense. 25 (3) For certified physicians, impose fines of not less than 26 one hundred thousand dollars per offense. 27 (4) Permanently revoke the certification of the offender if 28 the offender fails to demonstrate full compliance within ninety 29 calendar days. 30 (5) Impose remedial actions, which may include additional 31 education, additional reporting, or other actions as required 32 by the board of pharmacy. 33 (6) In the case of a licensed manufacturer, distributor, or 34 pharmacy, recommend sanctioning to the appropriate licensing 35 -15- LSB 5639YH (3) 90 pf/ko 15/ 20
H.F. 2122 board or other entity. 1 (7) In the case of a physician, report the violation and 2 recommend appropriate sanctioning to the board of medicine. 3 (8) Publicly report any disciplinary actions consistent 4 with the practices of the appropriate licensing board or other 5 entity. 6 (9) Permanently revoke the certification of the offender. 7 (10) In the case of a licensed manufacturer, distributor, or 8 pharmacy, recommend permanent revocation of licensure. 9 (11) In the case of a licensed physician, recommend 10 appropriate sanctioning to the board of medicine. 11 2. A person shall have a private right of action to seek 12 restitution in any court of law with appropriate jurisdiction 13 for any damages suffered due to a violation of this chapter. 14 Sec. 11. NEW SECTION . 146F.11 Online public portal. 15 1. The board of pharmacy shall develop on its internet 16 site a complaint portal for patients, pharmacies, health care 17 providers, and the public to submit information about potential 18 violations at no cost. 19 2. The portal shall list the names of manufacturers, 20 distributors, pharmacies, and physicians certified under the 21 program. 22 3. The portal shall allow a person to make a complaint 23 anonymously. 24 4. The board of pharmacy shall review each complaint and 25 determine a disposition, including a referral to another 26 appropriate entity, within thirty days of receipt of the 27 complaint. 28 5. Confidentiality of the originator of the complaint shall 29 be protected at all times except for intrastate referrals for 30 investigation. 31 Sec. 12. NEW SECTION . 146F.12 Construction. 32 1. This chapter shall not be construed as creating or 33 recognizing a right to abortion. 34 2. It is not the intention of this chapter to make lawful an 35 -16- LSB 5639YH (3) 90 pf/ko 16/ 20
H.F. 2122 abortion that is otherwise unlawful. 1 3. This chapter does not repeal, replace, or otherwise 2 invalidate existing federal or state laws, regulations, or 3 policies. 4 Sec. 13. NEW SECTION . 146F.13 Right to enforce or intervene 5 by attorney general. 6 The attorney general may bring an action to enforce 7 compliance with this chapter or intervene as a matter of right 8 in any case in which the constitutionality of this chapter is 9 challenged. 10 Sec. 14. NEW SECTION . 146F.14 Severability. 11 If any provision of this chapter or its application to any 12 person or circumstance is held invalid, the invalidity does 13 not affect other provisions or applications of this chapter 14 which can be given effect without the invalid provision or 15 application, and to this end the provisions of this chapter are 16 severable. 17 Sec. 15. EFFECTIVE DATE. This Act, being deemed of 18 immediate importance, takes effect upon enactment. 19 EXPLANATION 20 The inclusion of this explanation does not constitute agreement with 21 the explanations substance by the members of the general assembly. 22 This bill relates to certification requirements relating to 23 the provision of abortion-inducing drugs. 24 The bill provides definitions used in the bill and creates 25 a new Code chapter that applies to any physician, health care 26 provider, manufacturer, distributor, pharmacy, or other person 27 providing abortion-inducing drugs within the state. 28 The bill provides that the board of pharmacy shall create 29 an abortion-inducing drug certification program to provide 30 oversight and to regulate the provision of abortion-inducing 31 drugs in the state. Abortion-inducing drugs shall be 32 transported and provided in the state at wholesale only by 33 certified manufacturers or distributors; abortion-inducing 34 drugs shall only be provided to patients by certified 35 -17- LSB 5639YH (3) 90 pf/ko 17/ 20
H.F. 2122 physicians; and abortion-inducing drugs shall not be provided 1 directly to a patient outside of the program including through 2 the mail. 3 The bill directs the board of pharmacy to establish a 4 certification system with certain minimum measures relating 5 to manufacturers, distributors, pharmacies, and physicians 6 who provide abortion-inducing drugs in the state. The bill 7 specifies requirements of manufacturers, distributors, 8 physicians, and pharmacists who provide abortion-inducing drugs 9 in the state under the state certification program. 10 The bill requires that a physician certified under the bill 11 either shall maintain hospital admitting privileges at one or 12 more hospitals in the county or a contiguous county where the 13 abortion-inducing drug is provided by the physician or enter 14 into a written agreement with an associated physician who has 15 such privileges. The bill specifies the requirements for such 16 written agreement. 17 The bill requires the board of pharmacy to create an 18 electronically based reporting system for physicians certified 19 under the bill to report annually certain information regarding 20 the provision of abortion-inducing drugs. The bill also 21 requires emergency department physicians and other physicians 22 who treat abortion complications or adverse events to report 23 these instances to the reporting system. 24 The bill requires certified physicians to report to the 25 board of pharmacy, as well as the MedWatch reporting system of 26 the United States food and drug administration, any abortion 27 complication or adverse event as defined by the United States 28 food and drug administration in the MedWatch reporting system. 29 The bill requires certified physicians to report to the board 30 of pharmacy any death of a pregnant woman associated with 31 abortion-inducing drugs. The reporting requirements under 32 the bill are in addition to any other reporting requirements 33 applicable to a physician under the bill or any other required 34 conditions for performing abortions in the state. 35 -18- LSB 5639YH (3) 90 pf/ko 18/ 20
H.F. 2122 The bill requires the board of pharmacy to develop a 1 system of reporting abortion complications and adverse events 2 resulting from the use of abortion-inducing drugs in the state. 3 Physicians certified to provide abortion-inducing drugs, 4 emergency department physicians, and any physicians licensed in 5 the state who treat women with adverse abortion complications 6 or adverse effects, and other persons as determined by the 7 board of pharmacy shall report abortion complications and 8 adverse events to the system. A person required to do so shall 9 also report adverse events and patient deaths to the United 10 States food and drug administration. 11 The bill provides penalties and remedies for violations 12 of the bill. A manufacturer, distributor, physician, or 13 pharmacist who intentionally, knowingly, or recklessly violates 14 the bill is guilty of a class D felony. A class D felony 15 is punishable by confinement for no more than five years and a 16 fine of at least $1,025 but not more than $10,245. 17 A manufacturer, distributor, physician, or pharmacist who 18 intentionally, knowingly, or recklessly violates the bill by 19 fraudulent use of an abortion-inducing drug, with or without 20 the knowledge of the pregnant woman, is guilty of an aggravated 21 misdemeanor. An aggravated misdemeanor is punishable by 22 confinement for no more than two years and a fine of at least 23 $855 but not more than $8,540. 24 In addition to any other remedies available under common 25 or state law, failure to comply with the requirements of the 26 bill provides a basis for a civil malpractice action for actual 27 and punitive damages; a basis for a professional disciplinary 28 action by the appropriate licensing board or other entity; and 29 a basis for recovery following a pregnant womans death for the 30 womans survivors pursuant to a wrongful death action. A civil 31 or criminal penalty shall not be assessed against a pregnant 32 woman upon whom a drug-induced abortion is attempted, induced, 33 or performed. 34 The bill requires the board of pharmacy to enforce the 35 -19- LSB 5639YH (3) 90 pf/ko 19/ 20
H.F. 2122 provisions of the bill by specified means. 1 The bill directs the board of pharmacy to develop a complaint 2 portal on its internet site for patients, pharmacies, health 3 care providers, and the public to submit information about 4 potential violations of the bill at no cost. 5 The bill is not to be construed as creating or recognizing 6 a right to abortion or to make lawful an abortion that is 7 otherwise unlawful, and does not repeal, replace, or otherwise 8 invalidate existing federal or state laws, regulations, or 9 policies. 10 The bill provides that the attorney general may bring an 11 action to enforce compliance with the bill or intervene as a 12 matter of right in any case in which the constitutionality of 13 the bill is challenged. 14 The bill includes a severability clause. The bill takes 15 effect upon enactment. 16 -20- LSB 5639YH (3) 90 pf/ko 20/ 20