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House File 2122 - IntroducedA Bill ForAn Act 1relating to certification requirements for the provision
2of abortion-inducing drugs, providing penalties, and
3providing effective date provisions.
4BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
1 Section 1. NEW SECTION. 146F.1 Definitions.
2As used in this chapter, unless the context otherwise
3requires:
41. a. “Abortion” means the act of using or prescribing
5any instrument, medicine, drug, or any other substance,
6device, or means with the intent to terminate a clinically
7diagnosable pregnancy with knowledge that the termination by
8those means will with reasonable likelihood cause the death of
9the unborn child. “Abortion” includes the act of prescribing an
10abortion-inducing drug with reasonable certainty that the drug
11will prevent the growth or implantation, or otherwise cause the
12death of the unborn child, if the drug is ingested prior to
13confirmation of a clinically diagnosed pregnancy.
14b. “Abortion” does not include any use, prescribing,
15or means if done with the intent described in any of the
16following:
17(1) To save the life or preserve the health of the unborn
18child.
19(2) To remove a dead unborn child resulting from a
20spontaneous abortion commonly known as a miscarriage.
21(3) To remove an ectopic pregnancy.
22(4) To treat a maternal disease or illness for which the
23prescribed drug is medically indicated.
242. “Abortion complication” or “complication” means only the
25following physical or psychological conditions which, in the
26reasonable medical judgment of a licensed health care provider,
27arise as a primary or secondary result of an induced abortion:
28uterine perforation, cervical laceration, infection, bleeding,
29vaginal bleeding that qualifies as a grade 2 or higher adverse
30event according to the common terminology criteria for
31adverse events produced by the United States national cancer
32institute, pulmonary embolism, deep vein thrombosis, failure
33to actually terminate the pregnancy, incomplete abortion or
34retained tissue, pelvic inflammatory disease, endometritis,
35missed ectopic pregnancy, cardiac arrest, respiratory arrest,
-1-1renal failure, shock, amniotic fluid embolism, coma, free
2fluid in the abdomen, allergic reactions to anesthesia and
3abortion-inducing drugs, psychological complications as
4diagnosed that are listed in the current diagnostic and
5statistical manual and any termination of pregnancy with
6complications or abortion with complications diagnosis as
7specified in current international classification of diseases
8(ICD) ICD-10 codes.
93. a. “Abortion-inducing drug” means mifepristone,
10misoprostol, and any other medicine, drug, or other substance
11that is prescribed or dispensed with the intent of terminating
12a clinically diagnosable pregnancy with knowledge that the
13termination will with reasonable likelihood cause the death of
14the unborn child.
15b. “Abortion-inducing drug” includes all of the following:
16(1) The off-label use of drugs known to have
17abortion-inducing properties which are prescribed or dispensed
18specifically with the intent of terminating a clinically
19diagnosable pregnancy.
20(2) The off-label use of drugs known to have
21abortion-inducing properties that are prescribed without a
22diagnosed pregnancy for the purpose of causing an abortion at
23a future time rather than contemporaneously with a clinically
24diagnosed pregnancy.
25c. “Abortion-inducing drug” does not include drugs that may
26be known to cause an abortion but that are prescribed for other
27medical indications.
284. “Adverse event” means the same as defined in 21 C.F.R.
29§312.32.
305. “Associated physician” means a physician who has entered
31into an associated physician contract with another physician
32under this chapter to provide for hospital admitting privileges
33as required under this chapter.
346. “Department” means the department of inspections,
35appeals, and licensing.
-2- 17. “Distributor” means the same as wholesale distributor as
2defined in section 155A.3.
38. “Facility” means a public or private hospital, clinic,
4center, medical school, medical training institution, health
5care business, physician office, infirmary, dispensary,
6ambulatory surgical center, or other institution or location or
7business wherein medical care or pharmaceuticals are provided
8to any person.
99. “Gestational age” means the time that has elapsed since
10the first day of the pregnant woman’s last menstrual period.
1110. “Health care provider” means a person who is licensed,
12certified, or otherwise authorized or permitted by law of this
13state to administer health care in the ordinary course of
14business or in the practice of a profession.
1511. “Hospital” means the same as defined in section 135B.1.
1612. “Manufacturer” means the same as defined in section
17155A.3.
1813. “Pharmacy” means a pharmacy as defined in section
19155A.3 located in that state that is also certified by the
20manufacturers of abortion-inducing drugs to dispense the drugs
21via prescription.
2214. “Physician” means a person licensed to practice pursuant
23to chapter 148.
2415. “Pregnant” or “pregnancy” means the female reproductive
25condition of having an unborn child in the female’s uterus.
2616. “Provide”, “provided”, or “providing” means, when used
27regarding abortion-inducing drugs, any act of giving, selling,
28dispensing, administering, transferring possession to, or
29otherwise providing or prescribing an abortion-inducing drug.
30 Sec. 2. NEW SECTION. 146F.2 Applicability.
31This chapter applies to any physician, health care provider,
32manufacturer, distributor, pharmacy, or other person providing
33abortion-inducing drugs within the state.
34 Sec. 3. NEW SECTION. 146F.3 Abortion-inducing drug
35certification program — creation.
-3- 11. The board of pharmacy shall create an abortion-inducing
2drug certification program to provide oversight and to regulate
3the provision of abortion-inducing drugs in the state.
42. Abortion-inducing drugs shall be transported and
5provided in the state at wholesale only by manufacturers or
6distributors certified under the program.
73. Abortion-inducing drugs shall only be provided to
8patients by physicians certified to prescribe and dispense the
9drugs under the program.
104. Abortion-inducing drugs shall not be provided directly
11to a patient outside of the program, including through the
12mail.
13 Sec. 4. NEW SECTION. 146F.4 Board of pharmacy —
14abortion-inducing drug certification program duties.
151. The board of pharmacy shall require all of the following
16at a minimum from manufacturers, distributors, and pharmacies
17in the state that provide abortion-inducing drugs:
18a. Completion of the certification process for
19manufacturers, distributors, physicians, and pharmacies as
20described under this chapter.
21b. Notification by manufacturers, distributors, and
22pharmacies of the physicians certified under the program.
23c. Compliance with reporting requirements as specified under
24this chapter.
25d. Prohibited shipment of abortion-inducing drugs to
26physicians who are not certified under the program.
27e. Auditing of newly certified manufacturers, distributors,
28and pharmacies within ninety calendar days following initial
29certification and annually thereafter, to ensure compliance
30with the processes and procedures required under the program.
31f. Suspension of the certification of a manufacturer,
32distributor, or pharmacy found to be noncompliant until the
33manufacturer, distributor, or pharmacy demonstrates full
34compliance.
35g. Enforcement of certification compliance in accordance
-4-1with this chapter.
22. The board of pharmacy shall require all of the following
3at a minimum from physicians in the state who provide
4abortion-inducing drugs:
5a. Completion of the certification process.
6b. Auditing of newly certified physicians within ninety
7calendar days following initial certification and annually
8thereafter, to ensure compliance with the processes and
9procedures required under the program.
10c. Suspension of the certification of a physician found
11to be noncompliant until the physician demonstrates full
12compliance.
13d. Enforcement of certification compliance in accordance
14with this chapter.
153. The board of pharmacy shall require that all
16manufacturers of abortion-inducing drugs submit a list of any
17manufacturers, distributors, pharmacies, and physicians that
18are certified or otherwise approved by the manufacturer of
19abortion-inducing drugs to dispense the drugs in the state.
20 Sec. 5. NEW SECTION. 146F.5 Certification program
21requirements for manufacturers, distributors, and pharmacies.
221. The board of pharmacy shall create a certification
23program for manufacturers, distributors, and pharmacies
24intending to provide abortion-inducing drugs in the state.
252. To be eligible for certification under this section,
26a manufacturer, distributor, or pharmacy shall do all of the
27following, as applicable:
28a. Be licensed by the board of pharmacy.
29b. Only distribute abortion-inducing drugs to physicians
30certified under this chapter.
31c. Record each national drug code, serial number, lot
32number, and expiration date from the pharmaceutical packages
33of abortion-inducing drugs distributed to each certified
34physician.
35d. Only dispense abortion-inducing drugs to patients based
-5-1on prescriptions by physicians certified under this chapter.
2e. Only dispense a prescription for abortion-inducing drugs
3to a patient if the prescription is accompanied by a patient
4agreement form signed by the patient.
5f. Have available for examination the certification required
6by the manufacturer of abortion-inducing drugs.
7g. Comply with all applicable standards of the utilization
8review accreditation commission and the national association of
9the boards of pharmacy.
10h. For online sales or orders, hold a current pharmacy or
11pharma domain and comply with all standards required by the
12national association of the boards of pharmacy to maintain the
13domain.
14i. Comply with all other applicable state and federal
15laws related to the distribution or delivery of legend drugs,
16including abortion-inducing drugs.
17j. Comply with all acceptable processes and procedures to
18maintain a distribution or delivery system that is secure,
19confidential, and follows all processes and procedures,
20including those for storage, handling, shipping, tracking of
21national drug codes, serial numbers, lot numbers and expiration
22dates on products, proof of delivery, and controlled returns of
23abortion-inducing drugs.
24 Sec. 6. NEW SECTION. 146F.6 Certification program
25requirements for physicians.
261. The board of pharmacy shall create a certification
27program for physicians intending to provide abortion-inducing
28drugs to pregnant women in the state. Physicians providing
29abortion-inducing drugs in other states shall not be
30automatically certified in Iowa but shall be fully certified
31under this chapter prior to providing any abortion-inducing
32drugs to any pregnant women in this state. To be eligible to be
33certified under this section, a physician shall comply with all
34of the following:
35a. Hold a license to practice medicine in good standing in
-6-1the state.
2b. Examine any pregnant woman in person prior to prescribing
3or dispensing an abortion-inducing drug.
4c. Present and continually hold a current prescriber
5agreement form with the manufacturer of each abortion-inducing
6drug prescribed by the physician in accordance with guidelines
7of the United States food and drug administration.
8d. Sign an annual dispensing agreement form developed
9and provided by the board of pharmacy before providing
10abortion-inducing drugs.
11e. Obtain the signature of the pregnant woman to whom an
12abortion-inducing drug is dispensed on the patient agreement
13form required by the manufacturer of each abortion-inducing
14drug used in accordance with the guidelines of the United
15States food and drug administration.
16f. Attach the signed patient agreement form to any
17prescription for an abortion-inducing drug issued to a
18certified pharmacy.
19g. Inform the pregnant woman to whom the abortion-inducing
20drug is to be dispensed of gestational age-specific risks of
21using abortion-inducing drugs.
22h. Screen the pregnant woman to whom the abortion-inducing
23drug is to be dispensed for coercion, abuse, and anxiety,
24and refer the pregnant woman to the appropriate health care
25provider for treatment consistent with the screening results.
26i. Inform the pregnant woman to whom an abortion-inducing
27drug is to be dispensed that the pregnant woman may see the
28remains of the unborn child in the process of completing the
29abortion, that it may be possible to reverse the effects of
30the drug-induced abortion if the pregnant woman changes her
31mind but that time is of the essence, that studies show that
32babies born following the abortion reversal process do not have
33a higher rate of birth defects than the general population,
34and that studies show that following the reversal process or
35otherwise treating a pregnant woman with progesterone during
-7-1pregnancy does not lead to increased mortality rates.
2j. Refrain from knowingly supplying abortion-inducing drugs
3to persons who present with any of the following:
4(1) Absence of a pregnancy.
5(2) Being post-seventy days gestation or post-ten weeks of
6pregnancy.
7(3) Having risk factors medically contraindicated for
8taking abortion-inducing drugs, including but not limited to
9any of the following:
10(a) An ectopic pregnancy.
11(b) Problems with the adrenal glands near the kidneys.
12(c) Being treated with long-term corticosteroid therapy.
13(d) Allergic reactions to abortion-inducing drugs,
14mifepristone, misoprostol, or similar drugs.
15(e) Bleeding problems, anemia, or taking anticoagulant drug
16products.
17(f) Having inherited porphyria.
18(g) Having an intrauterine device in place.
19(h) Being Rh negative and requiring the administration of
20Rhogam before providing abortion-inducing drugs.
21k. Provide or refer the pregnant woman for emergency
22surgical intervention in cases of an incomplete abortion,
23severe bleeding, or other medical complications, through
24maintenance of hospital admitting privileges or through a
25written agreement with an associated physician as specified in
26this chapter.
27l. Ensure the pregnant woman access to medical facilities
28equipped to provide blood transfusions and resuscitation or
29other necessary treatments, if necessary.
30m. Sign and ensure that the pregnant woman signs all
31required informed consent materials, provide the pregnant
32woman with a copy of the signed consent materials showing both
33signatures, and place the original signed consent materials in
34the pregnant woman’s medical record.
35n. Record the national drug code, serial number, lot number,
-8-1and expiration date from the package of each abortion-inducing
2drug provided to the pregnant woman in the pregnant woman’s
3medical record.
4o. Submit a written protocol of efforts that will be made
5to schedule the follow-up appointment with the pregnant woman
6within fourteen days to assure a completed abortion.
7p. Report to the board of pharmacy and the United States
8food and drug administration any death associated with the
9physician’s provision of abortion-inducing drugs to a pregnant
10woman with the following guidelines:
11(1) The pregnant woman shall be referenced in the report
12by a nonidentifiable reference and the national drug code,
13lot number, and expiration date from the package of the
14abortion-inducing drug given, whether or not considered drug
15related.
16(2) The report shall be submitted as soon as possible but no
17later than fifteen calendar days from the initial receipt of
18the information by the physician.
19q. Submit a written protocol of how complications will be
20handled by the physician and a copy of any signed contract
21with an associated physician credentialed to handle certain
22complications specified in this chapter to the board of
23pharmacy.
24r. Comply with all applicable state and federal laws
25regarding medical records retention, confidentiality, and
26privacy.
27s. Agree to follow and document compliance with all other
28required conditions for performing abortions in the state.
292. The requirements under this subsection do not affect
30the other reporting requirements for a physician under the
31abortion-inducing drugs certification program or any other
32applicable law.
33 Sec. 7. NEW SECTION. 146F.7 Hospital admitting privileges
34— associated physician agreements — requirements.
35The board of pharmacy shall require all of the following of
-9-1physicians certified under this chapter:
21. Maintain hospital admitting privileges at one or more
3hospitals in the county or a contiguous county where the
4abortion-inducing drug is provided by the physician, and inform
5the pregnant woman of any hospital where the physician holds
6admitting privileges.
72. a. In lieu of subsection 1, enter into a written
8agreement with an associated physician in the county or a
9contiguous county where the abortion-inducing drug is provided
10to comply with the requirements for maintenance of hospital
11admitting privileges. A physician who enters into such written
12agreement shall ensure compliance with all of the following:
13(1) The physician who provides an abortion-inducing drug
14shall notify the pregnant woman of the location of any hospital
15at which the associated physician has admitting privileges.
16(2) The physician shall keep a copy of the written agreement
17at the physician’s practice location.
18(3) The physician shall submit a copy of the written
19agreement to the department as part of any required facility
20licensure.
21(4) The written agreement shall be renewed annually.
22(5) The written agreement shall include a requirement
23that the associated physician present and continually
24hold any certifications required by the manufacturers of
25abortion-inducing drugs.
26(6) The written agreement shall include a requirement
27that the associated physician provide to the pregnant woman
28and require the pregnant woman to sign all informed consent
29materials required by the state.
30(7) The written agreement shall require the compliance by
31the associated physician with all reporting requirements and
32any other required conditions for performing abortions in the
33state.
34b. (1) The board of pharmacy shall verify the validity of
35the written agreement and shall provide a copy of each written
-10-1agreement to the department.
2(2) The department shall annually submit a copy of each
3written agreement to each hospital located in the county or a
4county that is contiguous to the county where an abortion was
5performed.
6(3) The department shall confirm to a member of the public,
7upon request, that the written agreement required under this
8section has been received by the department.
9 Sec. 8. NEW SECTION. 146F.8 Reporting system — annual
10reports — reports of abortion complications or adverse events —
11requirements for certified physicians and others.
121. The board of pharmacy shall adopt an electronically based
13reporting system for physicians certified under this chapter to
14report annually all of the following regarding the provision of
15abortion-inducing drugs:
16a. The number of pregnant women provided abortion-inducing
17drugs.
18b. The age of each pregnant woman provided abortion-inducing
19drugs.
20c. The race of each pregnant woman provided
21abortion-inducing drugs.
22d. The county and state of residence of each pregnant woman
23provided abortion-inducing drugs.
24e. If a pregnant woman resides outside of the United States,
25the city and country of residence of each such pregnant woman
26provided abortion-inducing drugs.
27f. The county and state in which each pregnant woman was
28provided abortion-inducing drugs.
29g. A list of the staff attending the pregnant woman provided
30abortion-inducing drugs, including licensing numbers and
31evidence of other qualifications.
32h. The abortion-inducing drug provided for each pregnant
33woman, by date.
34i. Any known abortion complications or adverse events
35experienced by a pregnant woman following provision of the
-11-1abortion-inducing drug, and how the abortion complications or
2adverse events were addressed, by date.
3j. Any unresolved cases.
42. Emergency department physicians and other physicians
5who treat abortion complications or adverse events shall also
6report these instances to the reporting system.
73. A physician reporting under this section shall protect
8from disclosure any personally identifiable information of the
9pregnant woman in accordance with applicable federal and state
10law.
114. A certified physician shall also report to the board
12of pharmacy, as well as the MedWatch reporting system of
13the United States food and drug administration any abortion
14complication or adverse event as defined by the United States
15food and drug administration in the MedWatch reporting system.
165. A certified physician shall also report to the board
17of pharmacy any death of a pregnant woman associated with
18abortion-inducing drugs in accordance with the following
19guidelines:
20a. The pregnant woman shall be identified by a
21nonidentifiable reference and the national drug code, serial
22number, lot number, and expiration date from each package of
23the abortion-inducing drug provided, whether or not the death
24is considered drug related.
25b. The report shall be submitted as soon as possible but no
26later than fifteen calendar days from the initial receipt of
27the information by the physician.
286. The reporting requirements under this section are in
29addition to any other reporting requirements applicable to a
30physician under this chapter or any other required conditions
31for performing an abortion in the state.
327. The board of pharmacy shall develop a system of reporting
33abortion complications and adverse events resulting from the
34use of abortion-inducing drugs in the state.
35a. The system shall require reporting of abortion
-12-1complications and adverse events, including but not limited to
2death, blood loss including hemorrhage, infection including
3sepsis, blood transfusions, administration of drugs for
4an ectopic pregnancy, and other adverse effects requiring
5hospitalization or additional medical care.
6b. All of the following persons shall report abortion
7complications and adverse events in writing to the system:
8(1) Physicians certified to provide abortion-inducing
9drugs.
10(2) Emergency department physicians.
11(3) Any physician licensed in the state who treats women
12with adverse abortion complications or adverse effects.
13(4) Other persons as determined by the board of pharmacy.
14c. A person required report so shall also report adverse
15events and patient deaths to the United States food and drug
16administration.
17 Sec. 9. NEW SECTION. 146F.9 Violations — penalties —
18remedies.
191. A manufacturer, distributor, physician, or pharmacist
20shall not provide abortion-inducing drugs without being
21certified as required by this chapter.
222. A manufacturer, distributor, physician, or pharmacist
23who knowingly, intentionally, or recklessly violates this
24chapter is guilty of a class “D” felony.
253. A manufacturer, distributor, physician, or pharmacist
26who knowingly, intentionally, or recklessly violates this
27chapter by fraudulent use of an abortion-inducing drug, with or
28without the knowledge of the pregnant woman, is guilty of an
29aggravated misdemeanor.
304. a. In addition to any other remedies available under
31common or state law, failure to comply with the requirements of
32this chapter shall result in all of the following:
33(1) A basis for a civil malpractice action for actual and
34punitive damages.
35(2) A basis for a professional disciplinary action by the
-13-1appropriate licensing board or other entity.
2(3) A basis for recovery following a pregnant woman’s death
3for the woman’s survivors pursuant to a wrongful death action.
4b. When requested, the court shall allow a pregnant woman
5to proceed using solely the woman’s initials or a pseudonym
6and may close any proceedings in the case and enter other
7protective orders to preserve the privacy of the pregnant woman
8upon whom the drug-induced abortion was attempted, induced, or
9performed.
10c. (1) If judgment is rendered in favor of the plaintiff,
11the court shall also award reasonable attorney fees in favor
12of the plaintiff.
13(2) If judgment is rendered in favor of the defendant and
14the court finds that the plaintiff’s suit was frivolous and
15brought in bad faith, the court may award reasonable attorney
16fees in favor of the defendant.
175. A civil or criminal penalty shall not be assessed
18against a pregnant woman upon whom a drug-induced abortion is
19attempted, induced, or performed.
20 Sec. 10. NEW SECTION. 146F.10 Enforcement by the board of
21pharmacy.
221. The board of pharmacy shall enforce this chapter by any
23of the following means:
24a. When a manufacturer, distributor, physician,
25or pharmacist intentionally or knowingly provides
26abortion-inducing drugs without first seeking certification
27under this chapter in violation of this chapter, the board of
28pharmacy shall do all of the following:
29(1) Immediately report the illegal act to local law
30enforcement or other applicable state and local agencies for
31investigation and other appropriate action, where appropriate.
32(2) Impose a fine of no less than five million dollars for
33manufacturers, distributors, or pharmacies and two hundred
34fifty thousand dollars for physicians.
35b. When a certified manufacturer, distributor, pharmacy,
-14-1or physician is determined to be in noncompliance, suspend
2certification until full compliance is demonstrated to the
3satisfaction of the board of pharmacy.
4c. When a current or previously certified manufacturer,
5distributor, or pharmacy is found to have intentionally
6or knowingly violated this chapter or refuses to be fully
7compliant within ninety calendar days, suspend certification
8and prohibit continued provision of abortion-inducing drugs
9by the manufacturer, distributor, or pharmacy until full
10compliance is demonstrated to the satisfaction of the board of
11pharmacy.
12d. When a certified manufacturer, distributor, pharmacy,
13or physician is in noncompliance, suspend all annual
14recertifications until compliance is demonstrated to the
15satisfaction of the board of pharmacy.
16e. When a current or previously certified manufacturer,
17distributor, pharmacy, or physician is found to have
18intentionally or knowingly violated this chapter or refuses to
19be fully compliant:
20(1) Immediately suspend the manufacturer’s, distributor’s,
21pharmacy’s, or physician’s certification until full compliance
22is demonstrated.
23(2) For certified manufacturers, distributors, or
24pharmacies, impose fines of not less than one million dollars
25per offense.
26(3) For certified physicians, impose fines of not less than
27one hundred thousand dollars per offense.
28(4) Permanently revoke the certification of the offender if
29the offender fails to demonstrate full compliance within ninety
30calendar days.
31(5) Impose remedial actions, which may include additional
32education, additional reporting, or other actions as required
33by the board of pharmacy.
34(6) In the case of a licensed manufacturer, distributor, or
35pharmacy, recommend sanctioning to the appropriate licensing
-15-1board or other entity.
2(7) In the case of a physician, report the violation and
3recommend appropriate sanctioning to the board of medicine.
4(8) Publicly report any disciplinary actions consistent
5with the practices of the appropriate licensing board or other
6entity.
7(9) Permanently revoke the certification of the offender.
8(10) In the case of a licensed manufacturer, distributor, or
9pharmacy, recommend permanent revocation of licensure.
10(11) In the case of a licensed physician, recommend
11appropriate sanctioning to the board of medicine.
122. A person shall have a private right of action to seek
13restitution in any court of law with appropriate jurisdiction
14for any damages suffered due to a violation of this chapter.
15 Sec. 11. NEW SECTION. 146F.11 Online public portal.
161. The board of pharmacy shall develop on its internet
17site a complaint portal for patients, pharmacies, health care
18providers, and the public to submit information about potential
19violations at no cost.
202. The portal shall list the names of manufacturers,
21distributors, pharmacies, and physicians certified under the
22program.
233. The portal shall allow a person to make a complaint
24anonymously.
254. The board of pharmacy shall review each complaint and
26determine a disposition, including a referral to another
27appropriate entity, within thirty days of receipt of the
28complaint.
295. Confidentiality of the originator of the complaint shall
30be protected at all times except for intrastate referrals for
31investigation.
32 Sec. 12. NEW SECTION. 146F.12 Construction.
331. This chapter shall not be construed as creating or
34recognizing a right to abortion.
352. It is not the intention of this chapter to make lawful an
-16-1abortion that is otherwise unlawful.
23. This chapter does not repeal, replace, or otherwise
3invalidate existing federal or state laws, regulations, or
4policies.
5 Sec. 13. NEW SECTION. 146F.13 Right to enforce or intervene
6by attorney general.
7The attorney general may bring an action to enforce
8compliance with this chapter or intervene as a matter of right
9in any case in which the constitutionality of this chapter is
10challenged.
11 Sec. 14. NEW SECTION. 146F.14 Severability.
12If any provision of this chapter or its application to any
13person or circumstance is held invalid, the invalidity does
14not affect other provisions or applications of this chapter
15which can be given effect without the invalid provision or
16application, and to this end the provisions of this chapter are
17severable.
18 Sec. 15. EFFECTIVE DATE. This Act, being deemed of
19immediate importance, takes effect upon enactment.
20EXPLANATION
21The inclusion of this explanation does not constitute agreement with
22the explanation’s substance by the members of the general assembly.
23This bill relates to certification requirements relating to
24the provision of abortion-inducing drugs.
25The bill provides definitions used in the bill and creates
26a new Code chapter that applies to any physician, health care
27provider, manufacturer, distributor, pharmacy, or other person
28providing abortion-inducing drugs within the state.
29The bill provides that the board of pharmacy shall create
30an abortion-inducing drug certification program to provide
31oversight and to regulate the provision of abortion-inducing
32drugs in the state. Abortion-inducing drugs shall be
33transported and provided in the state at wholesale only by
34certified manufacturers or distributors; abortion-inducing
35drugs shall only be provided to patients by certified
-17-1physicians; and abortion-inducing drugs shall not be provided
2directly to a patient outside of the program including through
3the mail.
4The bill directs the board of pharmacy to establish a
5certification system with certain minimum measures relating
6to manufacturers, distributors, pharmacies, and physicians
7who provide abortion-inducing drugs in the state. The bill
8specifies requirements of manufacturers, distributors,
9physicians, and pharmacists who provide abortion-inducing drugs
10in the state under the state certification program.
11The bill requires that a physician certified under the bill
12either shall maintain hospital admitting privileges at one or
13more hospitals in the county or a contiguous county where the
14abortion-inducing drug is provided by the physician or enter
15into a written agreement with an associated physician who has
16such privileges. The bill specifies the requirements for such
17written agreement.
18The bill requires the board of pharmacy to create an
19electronically based reporting system for physicians certified
20under the bill to report annually certain information regarding
21the provision of abortion-inducing drugs. The bill also
22requires emergency department physicians and other physicians
23who treat abortion complications or adverse events to report
24these instances to the reporting system.
25The bill requires certified physicians to report to the
26board of pharmacy, as well as the MedWatch reporting system of
27the United States food and drug administration, any abortion
28complication or adverse event as defined by the United States
29food and drug administration in the MedWatch reporting system.
30The bill requires certified physicians to report to the board
31of pharmacy any death of a pregnant woman associated with
32abortion-inducing drugs. The reporting requirements under
33the bill are in addition to any other reporting requirements
34applicable to a physician under the bill or any other required
35conditions for performing abortions in the state.
-18- 1The bill requires the board of pharmacy to develop a
2system of reporting abortion complications and adverse events
3resulting from the use of abortion-inducing drugs in the state.
4Physicians certified to provide abortion-inducing drugs,
5emergency department physicians, and any physicians licensed in
6the state who treat women with adverse abortion complications
7or adverse effects, and other persons as determined by the
8board of pharmacy shall report abortion complications and
9adverse events to the system. A person required to do so shall
10also report adverse events and patient deaths to the United
11States food and drug administration.
12The bill provides penalties and remedies for violations
13of the bill. A manufacturer, distributor, physician, or
14pharmacist who intentionally, knowingly, or recklessly violates
15the bill is guilty of a class “D” felony. A class “D” felony
16is punishable by confinement for no more than five years and a
17fine of at least $1,025 but not more than $10,245.
18A manufacturer, distributor, physician, or pharmacist who
19intentionally, knowingly, or recklessly violates the bill by
20fraudulent use of an abortion-inducing drug, with or without
21the knowledge of the pregnant woman, is guilty of an aggravated
22misdemeanor. An aggravated misdemeanor is punishable by
23confinement for no more than two years and a fine of at least
24$855 but not more than $8,540.
25In addition to any other remedies available under common
26or state law, failure to comply with the requirements of the
27bill provides a basis for a civil malpractice action for actual
28and punitive damages; a basis for a professional disciplinary
29action by the appropriate licensing board or other entity; and
30a basis for recovery following a pregnant woman’s death for the
31woman’s survivors pursuant to a wrongful death action. A civil
32or criminal penalty shall not be assessed against a pregnant
33woman upon whom a drug-induced abortion is attempted, induced,
34or performed.
35The bill requires the board of pharmacy to enforce the
-19-1provisions of the bill by specified means.
2The bill directs the board of pharmacy to develop a complaint
3portal on its internet site for patients, pharmacies, health
4care providers, and the public to submit information about
5potential violations of the bill at no cost.
6The bill is not to be construed as creating or recognizing
7a right to abortion or to make lawful an abortion that is
8otherwise unlawful, and does not repeal, replace, or otherwise
9invalidate existing federal or state laws, regulations, or
10policies.
11The bill provides that the attorney general may bring an
12action to enforce compliance with the bill or intervene as a
13matter of right in any case in which the constitutionality of
14the bill is challenged.
15The bill includes a severability clause. The bill takes
16effect upon enactment.
-20-pf/ko
2of abortion-inducing drugs, providing penalties, and
3providing effective date provisions.
4BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
1 Section 1. NEW SECTION. 146F.1 Definitions.
2As used in this chapter, unless the context otherwise
3requires:
41. a. “Abortion” means the act of using or prescribing
5any instrument, medicine, drug, or any other substance,
6device, or means with the intent to terminate a clinically
7diagnosable pregnancy with knowledge that the termination by
8those means will with reasonable likelihood cause the death of
9the unborn child. “Abortion” includes the act of prescribing an
10abortion-inducing drug with reasonable certainty that the drug
11will prevent the growth or implantation, or otherwise cause the
12death of the unborn child, if the drug is ingested prior to
13confirmation of a clinically diagnosed pregnancy.
14b. “Abortion” does not include any use, prescribing,
15or means if done with the intent described in any of the
16following:
17(1) To save the life or preserve the health of the unborn
18child.
19(2) To remove a dead unborn child resulting from a
20spontaneous abortion commonly known as a miscarriage.
21(3) To remove an ectopic pregnancy.
22(4) To treat a maternal disease or illness for which the
23prescribed drug is medically indicated.
242. “Abortion complication” or “complication” means only the
25following physical or psychological conditions which, in the
26reasonable medical judgment of a licensed health care provider,
27arise as a primary or secondary result of an induced abortion:
28uterine perforation, cervical laceration, infection, bleeding,
29vaginal bleeding that qualifies as a grade 2 or higher adverse
30event according to the common terminology criteria for
31adverse events produced by the United States national cancer
32institute, pulmonary embolism, deep vein thrombosis, failure
33to actually terminate the pregnancy, incomplete abortion or
34retained tissue, pelvic inflammatory disease, endometritis,
35missed ectopic pregnancy, cardiac arrest, respiratory arrest,
-1-1renal failure, shock, amniotic fluid embolism, coma, free
2fluid in the abdomen, allergic reactions to anesthesia and
3abortion-inducing drugs, psychological complications as
4diagnosed that are listed in the current diagnostic and
5statistical manual and any termination of pregnancy with
6complications or abortion with complications diagnosis as
7specified in current international classification of diseases
8(ICD) ICD-10 codes.
93. a. “Abortion-inducing drug” means mifepristone,
10misoprostol, and any other medicine, drug, or other substance
11that is prescribed or dispensed with the intent of terminating
12a clinically diagnosable pregnancy with knowledge that the
13termination will with reasonable likelihood cause the death of
14the unborn child.
15b. “Abortion-inducing drug” includes all of the following:
16(1) The off-label use of drugs known to have
17abortion-inducing properties which are prescribed or dispensed
18specifically with the intent of terminating a clinically
19diagnosable pregnancy.
20(2) The off-label use of drugs known to have
21abortion-inducing properties that are prescribed without a
22diagnosed pregnancy for the purpose of causing an abortion at
23a future time rather than contemporaneously with a clinically
24diagnosed pregnancy.
25c. “Abortion-inducing drug” does not include drugs that may
26be known to cause an abortion but that are prescribed for other
27medical indications.
284. “Adverse event” means the same as defined in 21 C.F.R.
29§312.32.
305. “Associated physician” means a physician who has entered
31into an associated physician contract with another physician
32under this chapter to provide for hospital admitting privileges
33as required under this chapter.
346. “Department” means the department of inspections,
35appeals, and licensing.
-2- 17. “Distributor” means the same as wholesale distributor as
2defined in section 155A.3.
38. “Facility” means a public or private hospital, clinic,
4center, medical school, medical training institution, health
5care business, physician office, infirmary, dispensary,
6ambulatory surgical center, or other institution or location or
7business wherein medical care or pharmaceuticals are provided
8to any person.
99. “Gestational age” means the time that has elapsed since
10the first day of the pregnant woman’s last menstrual period.
1110. “Health care provider” means a person who is licensed,
12certified, or otherwise authorized or permitted by law of this
13state to administer health care in the ordinary course of
14business or in the practice of a profession.
1511. “Hospital” means the same as defined in section 135B.1.
1612. “Manufacturer” means the same as defined in section
17155A.3.
1813. “Pharmacy” means a pharmacy as defined in section
19155A.3 located in that state that is also certified by the
20manufacturers of abortion-inducing drugs to dispense the drugs
21via prescription.
2214. “Physician” means a person licensed to practice pursuant
23to chapter 148.
2415. “Pregnant” or “pregnancy” means the female reproductive
25condition of having an unborn child in the female’s uterus.
2616. “Provide”, “provided”, or “providing” means, when used
27regarding abortion-inducing drugs, any act of giving, selling,
28dispensing, administering, transferring possession to, or
29otherwise providing or prescribing an abortion-inducing drug.
30 Sec. 2. NEW SECTION. 146F.2 Applicability.
31This chapter applies to any physician, health care provider,
32manufacturer, distributor, pharmacy, or other person providing
33abortion-inducing drugs within the state.
34 Sec. 3. NEW SECTION. 146F.3 Abortion-inducing drug
35certification program — creation.
-3- 11. The board of pharmacy shall create an abortion-inducing
2drug certification program to provide oversight and to regulate
3the provision of abortion-inducing drugs in the state.
42. Abortion-inducing drugs shall be transported and
5provided in the state at wholesale only by manufacturers or
6distributors certified under the program.
73. Abortion-inducing drugs shall only be provided to
8patients by physicians certified to prescribe and dispense the
9drugs under the program.
104. Abortion-inducing drugs shall not be provided directly
11to a patient outside of the program, including through the
12mail.
13 Sec. 4. NEW SECTION. 146F.4 Board of pharmacy —
14abortion-inducing drug certification program duties.
151. The board of pharmacy shall require all of the following
16at a minimum from manufacturers, distributors, and pharmacies
17in the state that provide abortion-inducing drugs:
18a. Completion of the certification process for
19manufacturers, distributors, physicians, and pharmacies as
20described under this chapter.
21b. Notification by manufacturers, distributors, and
22pharmacies of the physicians certified under the program.
23c. Compliance with reporting requirements as specified under
24this chapter.
25d. Prohibited shipment of abortion-inducing drugs to
26physicians who are not certified under the program.
27e. Auditing of newly certified manufacturers, distributors,
28and pharmacies within ninety calendar days following initial
29certification and annually thereafter, to ensure compliance
30with the processes and procedures required under the program.
31f. Suspension of the certification of a manufacturer,
32distributor, or pharmacy found to be noncompliant until the
33manufacturer, distributor, or pharmacy demonstrates full
34compliance.
35g. Enforcement of certification compliance in accordance
-4-1with this chapter.
22. The board of pharmacy shall require all of the following
3at a minimum from physicians in the state who provide
4abortion-inducing drugs:
5a. Completion of the certification process.
6b. Auditing of newly certified physicians within ninety
7calendar days following initial certification and annually
8thereafter, to ensure compliance with the processes and
9procedures required under the program.
10c. Suspension of the certification of a physician found
11to be noncompliant until the physician demonstrates full
12compliance.
13d. Enforcement of certification compliance in accordance
14with this chapter.
153. The board of pharmacy shall require that all
16manufacturers of abortion-inducing drugs submit a list of any
17manufacturers, distributors, pharmacies, and physicians that
18are certified or otherwise approved by the manufacturer of
19abortion-inducing drugs to dispense the drugs in the state.
20 Sec. 5. NEW SECTION. 146F.5 Certification program
21requirements for manufacturers, distributors, and pharmacies.
221. The board of pharmacy shall create a certification
23program for manufacturers, distributors, and pharmacies
24intending to provide abortion-inducing drugs in the state.
252. To be eligible for certification under this section,
26a manufacturer, distributor, or pharmacy shall do all of the
27following, as applicable:
28a. Be licensed by the board of pharmacy.
29b. Only distribute abortion-inducing drugs to physicians
30certified under this chapter.
31c. Record each national drug code, serial number, lot
32number, and expiration date from the pharmaceutical packages
33of abortion-inducing drugs distributed to each certified
34physician.
35d. Only dispense abortion-inducing drugs to patients based
-5-1on prescriptions by physicians certified under this chapter.
2e. Only dispense a prescription for abortion-inducing drugs
3to a patient if the prescription is accompanied by a patient
4agreement form signed by the patient.
5f. Have available for examination the certification required
6by the manufacturer of abortion-inducing drugs.
7g. Comply with all applicable standards of the utilization
8review accreditation commission and the national association of
9the boards of pharmacy.
10h. For online sales or orders, hold a current pharmacy or
11pharma domain and comply with all standards required by the
12national association of the boards of pharmacy to maintain the
13domain.
14i. Comply with all other applicable state and federal
15laws related to the distribution or delivery of legend drugs,
16including abortion-inducing drugs.
17j. Comply with all acceptable processes and procedures to
18maintain a distribution or delivery system that is secure,
19confidential, and follows all processes and procedures,
20including those for storage, handling, shipping, tracking of
21national drug codes, serial numbers, lot numbers and expiration
22dates on products, proof of delivery, and controlled returns of
23abortion-inducing drugs.
24 Sec. 6. NEW SECTION. 146F.6 Certification program
25requirements for physicians.
261. The board of pharmacy shall create a certification
27program for physicians intending to provide abortion-inducing
28drugs to pregnant women in the state. Physicians providing
29abortion-inducing drugs in other states shall not be
30automatically certified in Iowa but shall be fully certified
31under this chapter prior to providing any abortion-inducing
32drugs to any pregnant women in this state. To be eligible to be
33certified under this section, a physician shall comply with all
34of the following:
35a. Hold a license to practice medicine in good standing in
-6-1the state.
2b. Examine any pregnant woman in person prior to prescribing
3or dispensing an abortion-inducing drug.
4c. Present and continually hold a current prescriber
5agreement form with the manufacturer of each abortion-inducing
6drug prescribed by the physician in accordance with guidelines
7of the United States food and drug administration.
8d. Sign an annual dispensing agreement form developed
9and provided by the board of pharmacy before providing
10abortion-inducing drugs.
11e. Obtain the signature of the pregnant woman to whom an
12abortion-inducing drug is dispensed on the patient agreement
13form required by the manufacturer of each abortion-inducing
14drug used in accordance with the guidelines of the United
15States food and drug administration.
16f. Attach the signed patient agreement form to any
17prescription for an abortion-inducing drug issued to a
18certified pharmacy.
19g. Inform the pregnant woman to whom the abortion-inducing
20drug is to be dispensed of gestational age-specific risks of
21using abortion-inducing drugs.
22h. Screen the pregnant woman to whom the abortion-inducing
23drug is to be dispensed for coercion, abuse, and anxiety,
24and refer the pregnant woman to the appropriate health care
25provider for treatment consistent with the screening results.
26i. Inform the pregnant woman to whom an abortion-inducing
27drug is to be dispensed that the pregnant woman may see the
28remains of the unborn child in the process of completing the
29abortion, that it may be possible to reverse the effects of
30the drug-induced abortion if the pregnant woman changes her
31mind but that time is of the essence, that studies show that
32babies born following the abortion reversal process do not have
33a higher rate of birth defects than the general population,
34and that studies show that following the reversal process or
35otherwise treating a pregnant woman with progesterone during
-7-1pregnancy does not lead to increased mortality rates.
2j. Refrain from knowingly supplying abortion-inducing drugs
3to persons who present with any of the following:
4(1) Absence of a pregnancy.
5(2) Being post-seventy days gestation or post-ten weeks of
6pregnancy.
7(3) Having risk factors medically contraindicated for
8taking abortion-inducing drugs, including but not limited to
9any of the following:
10(a) An ectopic pregnancy.
11(b) Problems with the adrenal glands near the kidneys.
12(c) Being treated with long-term corticosteroid therapy.
13(d) Allergic reactions to abortion-inducing drugs,
14mifepristone, misoprostol, or similar drugs.
15(e) Bleeding problems, anemia, or taking anticoagulant drug
16products.
17(f) Having inherited porphyria.
18(g) Having an intrauterine device in place.
19(h) Being Rh negative and requiring the administration of
20Rhogam before providing abortion-inducing drugs.
21k. Provide or refer the pregnant woman for emergency
22surgical intervention in cases of an incomplete abortion,
23severe bleeding, or other medical complications, through
24maintenance of hospital admitting privileges or through a
25written agreement with an associated physician as specified in
26this chapter.
27l. Ensure the pregnant woman access to medical facilities
28equipped to provide blood transfusions and resuscitation or
29other necessary treatments, if necessary.
30m. Sign and ensure that the pregnant woman signs all
31required informed consent materials, provide the pregnant
32woman with a copy of the signed consent materials showing both
33signatures, and place the original signed consent materials in
34the pregnant woman’s medical record.
35n. Record the national drug code, serial number, lot number,
-8-1and expiration date from the package of each abortion-inducing
2drug provided to the pregnant woman in the pregnant woman’s
3medical record.
4o. Submit a written protocol of efforts that will be made
5to schedule the follow-up appointment with the pregnant woman
6within fourteen days to assure a completed abortion.
7p. Report to the board of pharmacy and the United States
8food and drug administration any death associated with the
9physician’s provision of abortion-inducing drugs to a pregnant
10woman with the following guidelines:
11(1) The pregnant woman shall be referenced in the report
12by a nonidentifiable reference and the national drug code,
13lot number, and expiration date from the package of the
14abortion-inducing drug given, whether or not considered drug
15related.
16(2) The report shall be submitted as soon as possible but no
17later than fifteen calendar days from the initial receipt of
18the information by the physician.
19q. Submit a written protocol of how complications will be
20handled by the physician and a copy of any signed contract
21with an associated physician credentialed to handle certain
22complications specified in this chapter to the board of
23pharmacy.
24r. Comply with all applicable state and federal laws
25regarding medical records retention, confidentiality, and
26privacy.
27s. Agree to follow and document compliance with all other
28required conditions for performing abortions in the state.
292. The requirements under this subsection do not affect
30the other reporting requirements for a physician under the
31abortion-inducing drugs certification program or any other
32applicable law.
33 Sec. 7. NEW SECTION. 146F.7 Hospital admitting privileges
34— associated physician agreements — requirements.
35The board of pharmacy shall require all of the following of
-9-1physicians certified under this chapter:
21. Maintain hospital admitting privileges at one or more
3hospitals in the county or a contiguous county where the
4abortion-inducing drug is provided by the physician, and inform
5the pregnant woman of any hospital where the physician holds
6admitting privileges.
72. a. In lieu of subsection 1, enter into a written
8agreement with an associated physician in the county or a
9contiguous county where the abortion-inducing drug is provided
10to comply with the requirements for maintenance of hospital
11admitting privileges. A physician who enters into such written
12agreement shall ensure compliance with all of the following:
13(1) The physician who provides an abortion-inducing drug
14shall notify the pregnant woman of the location of any hospital
15at which the associated physician has admitting privileges.
16(2) The physician shall keep a copy of the written agreement
17at the physician’s practice location.
18(3) The physician shall submit a copy of the written
19agreement to the department as part of any required facility
20licensure.
21(4) The written agreement shall be renewed annually.
22(5) The written agreement shall include a requirement
23that the associated physician present and continually
24hold any certifications required by the manufacturers of
25abortion-inducing drugs.
26(6) The written agreement shall include a requirement
27that the associated physician provide to the pregnant woman
28and require the pregnant woman to sign all informed consent
29materials required by the state.
30(7) The written agreement shall require the compliance by
31the associated physician with all reporting requirements and
32any other required conditions for performing abortions in the
33state.
34b. (1) The board of pharmacy shall verify the validity of
35the written agreement and shall provide a copy of each written
-10-1agreement to the department.
2(2) The department shall annually submit a copy of each
3written agreement to each hospital located in the county or a
4county that is contiguous to the county where an abortion was
5performed.
6(3) The department shall confirm to a member of the public,
7upon request, that the written agreement required under this
8section has been received by the department.
9 Sec. 8. NEW SECTION. 146F.8 Reporting system — annual
10reports — reports of abortion complications or adverse events —
11requirements for certified physicians and others.
121. The board of pharmacy shall adopt an electronically based
13reporting system for physicians certified under this chapter to
14report annually all of the following regarding the provision of
15abortion-inducing drugs:
16a. The number of pregnant women provided abortion-inducing
17drugs.
18b. The age of each pregnant woman provided abortion-inducing
19drugs.
20c. The race of each pregnant woman provided
21abortion-inducing drugs.
22d. The county and state of residence of each pregnant woman
23provided abortion-inducing drugs.
24e. If a pregnant woman resides outside of the United States,
25the city and country of residence of each such pregnant woman
26provided abortion-inducing drugs.
27f. The county and state in which each pregnant woman was
28provided abortion-inducing drugs.
29g. A list of the staff attending the pregnant woman provided
30abortion-inducing drugs, including licensing numbers and
31evidence of other qualifications.
32h. The abortion-inducing drug provided for each pregnant
33woman, by date.
34i. Any known abortion complications or adverse events
35experienced by a pregnant woman following provision of the
-11-1abortion-inducing drug, and how the abortion complications or
2adverse events were addressed, by date.
3j. Any unresolved cases.
42. Emergency department physicians and other physicians
5who treat abortion complications or adverse events shall also
6report these instances to the reporting system.
73. A physician reporting under this section shall protect
8from disclosure any personally identifiable information of the
9pregnant woman in accordance with applicable federal and state
10law.
114. A certified physician shall also report to the board
12of pharmacy, as well as the MedWatch reporting system of
13the United States food and drug administration any abortion
14complication or adverse event as defined by the United States
15food and drug administration in the MedWatch reporting system.
165. A certified physician shall also report to the board
17of pharmacy any death of a pregnant woman associated with
18abortion-inducing drugs in accordance with the following
19guidelines:
20a. The pregnant woman shall be identified by a
21nonidentifiable reference and the national drug code, serial
22number, lot number, and expiration date from each package of
23the abortion-inducing drug provided, whether or not the death
24is considered drug related.
25b. The report shall be submitted as soon as possible but no
26later than fifteen calendar days from the initial receipt of
27the information by the physician.
286. The reporting requirements under this section are in
29addition to any other reporting requirements applicable to a
30physician under this chapter or any other required conditions
31for performing an abortion in the state.
327. The board of pharmacy shall develop a system of reporting
33abortion complications and adverse events resulting from the
34use of abortion-inducing drugs in the state.
35a. The system shall require reporting of abortion
-12-1complications and adverse events, including but not limited to
2death, blood loss including hemorrhage, infection including
3sepsis, blood transfusions, administration of drugs for
4an ectopic pregnancy, and other adverse effects requiring
5hospitalization or additional medical care.
6b. All of the following persons shall report abortion
7complications and adverse events in writing to the system:
8(1) Physicians certified to provide abortion-inducing
9drugs.
10(2) Emergency department physicians.
11(3) Any physician licensed in the state who treats women
12with adverse abortion complications or adverse effects.
13(4) Other persons as determined by the board of pharmacy.
14c. A person required report so shall also report adverse
15events and patient deaths to the United States food and drug
16administration.
17 Sec. 9. NEW SECTION. 146F.9 Violations — penalties —
18remedies.
191. A manufacturer, distributor, physician, or pharmacist
20shall not provide abortion-inducing drugs without being
21certified as required by this chapter.
222. A manufacturer, distributor, physician, or pharmacist
23who knowingly, intentionally, or recklessly violates this
24chapter is guilty of a class “D” felony.
253. A manufacturer, distributor, physician, or pharmacist
26who knowingly, intentionally, or recklessly violates this
27chapter by fraudulent use of an abortion-inducing drug, with or
28without the knowledge of the pregnant woman, is guilty of an
29aggravated misdemeanor.
304. a. In addition to any other remedies available under
31common or state law, failure to comply with the requirements of
32this chapter shall result in all of the following:
33(1) A basis for a civil malpractice action for actual and
34punitive damages.
35(2) A basis for a professional disciplinary action by the
-13-1appropriate licensing board or other entity.
2(3) A basis for recovery following a pregnant woman’s death
3for the woman’s survivors pursuant to a wrongful death action.
4b. When requested, the court shall allow a pregnant woman
5to proceed using solely the woman’s initials or a pseudonym
6and may close any proceedings in the case and enter other
7protective orders to preserve the privacy of the pregnant woman
8upon whom the drug-induced abortion was attempted, induced, or
9performed.
10c. (1) If judgment is rendered in favor of the plaintiff,
11the court shall also award reasonable attorney fees in favor
12of the plaintiff.
13(2) If judgment is rendered in favor of the defendant and
14the court finds that the plaintiff’s suit was frivolous and
15brought in bad faith, the court may award reasonable attorney
16fees in favor of the defendant.
175. A civil or criminal penalty shall not be assessed
18against a pregnant woman upon whom a drug-induced abortion is
19attempted, induced, or performed.
20 Sec. 10. NEW SECTION. 146F.10 Enforcement by the board of
21pharmacy.
221. The board of pharmacy shall enforce this chapter by any
23of the following means:
24a. When a manufacturer, distributor, physician,
25or pharmacist intentionally or knowingly provides
26abortion-inducing drugs without first seeking certification
27under this chapter in violation of this chapter, the board of
28pharmacy shall do all of the following:
29(1) Immediately report the illegal act to local law
30enforcement or other applicable state and local agencies for
31investigation and other appropriate action, where appropriate.
32(2) Impose a fine of no less than five million dollars for
33manufacturers, distributors, or pharmacies and two hundred
34fifty thousand dollars for physicians.
35b. When a certified manufacturer, distributor, pharmacy,
-14-1or physician is determined to be in noncompliance, suspend
2certification until full compliance is demonstrated to the
3satisfaction of the board of pharmacy.
4c. When a current or previously certified manufacturer,
5distributor, or pharmacy is found to have intentionally
6or knowingly violated this chapter or refuses to be fully
7compliant within ninety calendar days, suspend certification
8and prohibit continued provision of abortion-inducing drugs
9by the manufacturer, distributor, or pharmacy until full
10compliance is demonstrated to the satisfaction of the board of
11pharmacy.
12d. When a certified manufacturer, distributor, pharmacy,
13or physician is in noncompliance, suspend all annual
14recertifications until compliance is demonstrated to the
15satisfaction of the board of pharmacy.
16e. When a current or previously certified manufacturer,
17distributor, pharmacy, or physician is found to have
18intentionally or knowingly violated this chapter or refuses to
19be fully compliant:
20(1) Immediately suspend the manufacturer’s, distributor’s,
21pharmacy’s, or physician’s certification until full compliance
22is demonstrated.
23(2) For certified manufacturers, distributors, or
24pharmacies, impose fines of not less than one million dollars
25per offense.
26(3) For certified physicians, impose fines of not less than
27one hundred thousand dollars per offense.
28(4) Permanently revoke the certification of the offender if
29the offender fails to demonstrate full compliance within ninety
30calendar days.
31(5) Impose remedial actions, which may include additional
32education, additional reporting, or other actions as required
33by the board of pharmacy.
34(6) In the case of a licensed manufacturer, distributor, or
35pharmacy, recommend sanctioning to the appropriate licensing
-15-1board or other entity.
2(7) In the case of a physician, report the violation and
3recommend appropriate sanctioning to the board of medicine.
4(8) Publicly report any disciplinary actions consistent
5with the practices of the appropriate licensing board or other
6entity.
7(9) Permanently revoke the certification of the offender.
8(10) In the case of a licensed manufacturer, distributor, or
9pharmacy, recommend permanent revocation of licensure.
10(11) In the case of a licensed physician, recommend
11appropriate sanctioning to the board of medicine.
122. A person shall have a private right of action to seek
13restitution in any court of law with appropriate jurisdiction
14for any damages suffered due to a violation of this chapter.
15 Sec. 11. NEW SECTION. 146F.11 Online public portal.
161. The board of pharmacy shall develop on its internet
17site a complaint portal for patients, pharmacies, health care
18providers, and the public to submit information about potential
19violations at no cost.
202. The portal shall list the names of manufacturers,
21distributors, pharmacies, and physicians certified under the
22program.
233. The portal shall allow a person to make a complaint
24anonymously.
254. The board of pharmacy shall review each complaint and
26determine a disposition, including a referral to another
27appropriate entity, within thirty days of receipt of the
28complaint.
295. Confidentiality of the originator of the complaint shall
30be protected at all times except for intrastate referrals for
31investigation.
32 Sec. 12. NEW SECTION. 146F.12 Construction.
331. This chapter shall not be construed as creating or
34recognizing a right to abortion.
352. It is not the intention of this chapter to make lawful an
-16-1abortion that is otherwise unlawful.
23. This chapter does not repeal, replace, or otherwise
3invalidate existing federal or state laws, regulations, or
4policies.
5 Sec. 13. NEW SECTION. 146F.13 Right to enforce or intervene
6by attorney general.
7The attorney general may bring an action to enforce
8compliance with this chapter or intervene as a matter of right
9in any case in which the constitutionality of this chapter is
10challenged.
11 Sec. 14. NEW SECTION. 146F.14 Severability.
12If any provision of this chapter or its application to any
13person or circumstance is held invalid, the invalidity does
14not affect other provisions or applications of this chapter
15which can be given effect without the invalid provision or
16application, and to this end the provisions of this chapter are
17severable.
18 Sec. 15. EFFECTIVE DATE. This Act, being deemed of
19immediate importance, takes effect upon enactment.
20EXPLANATION
21The inclusion of this explanation does not constitute agreement with
22the explanation’s substance by the members of the general assembly.
23This bill relates to certification requirements relating to
24the provision of abortion-inducing drugs.
25The bill provides definitions used in the bill and creates
26a new Code chapter that applies to any physician, health care
27provider, manufacturer, distributor, pharmacy, or other person
28providing abortion-inducing drugs within the state.
29The bill provides that the board of pharmacy shall create
30an abortion-inducing drug certification program to provide
31oversight and to regulate the provision of abortion-inducing
32drugs in the state. Abortion-inducing drugs shall be
33transported and provided in the state at wholesale only by
34certified manufacturers or distributors; abortion-inducing
35drugs shall only be provided to patients by certified
-17-1physicians; and abortion-inducing drugs shall not be provided
2directly to a patient outside of the program including through
3the mail.
4The bill directs the board of pharmacy to establish a
5certification system with certain minimum measures relating
6to manufacturers, distributors, pharmacies, and physicians
7who provide abortion-inducing drugs in the state. The bill
8specifies requirements of manufacturers, distributors,
9physicians, and pharmacists who provide abortion-inducing drugs
10in the state under the state certification program.
11The bill requires that a physician certified under the bill
12either shall maintain hospital admitting privileges at one or
13more hospitals in the county or a contiguous county where the
14abortion-inducing drug is provided by the physician or enter
15into a written agreement with an associated physician who has
16such privileges. The bill specifies the requirements for such
17written agreement.
18The bill requires the board of pharmacy to create an
19electronically based reporting system for physicians certified
20under the bill to report annually certain information regarding
21the provision of abortion-inducing drugs. The bill also
22requires emergency department physicians and other physicians
23who treat abortion complications or adverse events to report
24these instances to the reporting system.
25The bill requires certified physicians to report to the
26board of pharmacy, as well as the MedWatch reporting system of
27the United States food and drug administration, any abortion
28complication or adverse event as defined by the United States
29food and drug administration in the MedWatch reporting system.
30The bill requires certified physicians to report to the board
31of pharmacy any death of a pregnant woman associated with
32abortion-inducing drugs. The reporting requirements under
33the bill are in addition to any other reporting requirements
34applicable to a physician under the bill or any other required
35conditions for performing abortions in the state.
-18- 1The bill requires the board of pharmacy to develop a
2system of reporting abortion complications and adverse events
3resulting from the use of abortion-inducing drugs in the state.
4Physicians certified to provide abortion-inducing drugs,
5emergency department physicians, and any physicians licensed in
6the state who treat women with adverse abortion complications
7or adverse effects, and other persons as determined by the
8board of pharmacy shall report abortion complications and
9adverse events to the system. A person required to do so shall
10also report adverse events and patient deaths to the United
11States food and drug administration.
12The bill provides penalties and remedies for violations
13of the bill. A manufacturer, distributor, physician, or
14pharmacist who intentionally, knowingly, or recklessly violates
15the bill is guilty of a class “D” felony. A class “D” felony
16is punishable by confinement for no more than five years and a
17fine of at least $1,025 but not more than $10,245.
18A manufacturer, distributor, physician, or pharmacist who
19intentionally, knowingly, or recklessly violates the bill by
20fraudulent use of an abortion-inducing drug, with or without
21the knowledge of the pregnant woman, is guilty of an aggravated
22misdemeanor. An aggravated misdemeanor is punishable by
23confinement for no more than two years and a fine of at least
24$855 but not more than $8,540.
25In addition to any other remedies available under common
26or state law, failure to comply with the requirements of the
27bill provides a basis for a civil malpractice action for actual
28and punitive damages; a basis for a professional disciplinary
29action by the appropriate licensing board or other entity; and
30a basis for recovery following a pregnant woman’s death for the
31woman’s survivors pursuant to a wrongful death action. A civil
32or criminal penalty shall not be assessed against a pregnant
33woman upon whom a drug-induced abortion is attempted, induced,
34or performed.
35The bill requires the board of pharmacy to enforce the
-19-1provisions of the bill by specified means.
2The bill directs the board of pharmacy to develop a complaint
3portal on its internet site for patients, pharmacies, health
4care providers, and the public to submit information about
5potential violations of the bill at no cost.
6The bill is not to be construed as creating or recognizing
7a right to abortion or to make lawful an abortion that is
8otherwise unlawful, and does not repeal, replace, or otherwise
9invalidate existing federal or state laws, regulations, or
10policies.
11The bill provides that the attorney general may bring an
12action to enforce compliance with the bill or intervene as a
13matter of right in any case in which the constitutionality of
14the bill is challenged.
15The bill includes a severability clause. The bill takes
16effect upon enactment.
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