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Abortion-Inducing Drugs Safety Act

Abortion-Inducing Drugs Safety Act

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Published by jecarter4
Americans United for Life Model Legislation
Americans United for Life Model Legislation

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Published by: jecarter4 on Jul 07, 2013
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11/09/2013

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Americans United for Life | Defending Life245
[Drafer’s Note: AUL has drafed detailed talking points to assist those interested in introducing this model in preparing or and countering arguments typically raised by abortion providers. Tose talking points are aailable upon request by contacting AUL’s Legislatie Coordinator at (202) 741-4907 or Legislation@AUL.org 
.
]
Section 1. Title.
Tis Act may be known and cited as the “Abortion-Inducing Drugs Saety Act.”
Section 2. Legislative Findings and Purposes.
A. Te [
 Legislature
] o the State o [
 Insert name o State
] fnds that:1. Te Food and Drug Administration (FDA) approved the drug miepristone (brand name“Mieprex”), a frst-generation [selective] progesterone receptor modulator ([S]PRM), as an abortion-inducing drug with a specifc gestation, dosage, and administration protocol.2. As approved by the FDA, and as outlined in the Mieprex drug label, an abortion by miepristoneconsists o three 200 mg tablets o miepristone taken orally, ollowed by two 200 mcg tablets o misoprostol taken orally, through 49 days LMP (a gestational measurement using the frst day o the woman’s “last menstrual period” as a marker). Te patient is to return or a ollow-up visit in orderto confrm that a complete termination o pregnancy has occurred. Tis FDA-approved protocol isreerred to as the “Mieprex regimen.”3. Te aorementioned treatment requires three oce visits by the patient, and the dosages may only be administered in a clinic, medical oce, or hospital and under supervision o a physician.
 
4. Te Mieprex fnal printed labeling (FPL) outlines the FDA-approved dosage and administrationo both drugs in the Mieprex regimen, namely miepristone and misoprostol.5. Court testimony by Planned Parenthood and other abortion providers demonstrates that providersroutinely ail to ollow the FDA-approved protocol or the Mieprex regimen, as it is outlined in theMieprex FPL.
See, e.g 
.,
 Planned Parenthood Cincinnati Region . af 
, 459 F. Supp. 2d 626(S.D. Oh. 2006).6. Specifcally, Planned Parenthood and other abortion providers are administering a single oral doseo 200 mg o miepristone, ollowed by a single vaginal or buccal dose o .8 mg misoprostol, through63 days LMP, without medical supervision, and without ollow-up care.
See, e.g.
,
 Planned Parenthood Cincinnati Region
, 459 F. Supp. 2d at 630n.7.7. Te use o miepristone presents signifcant medical risks to women, including but not limited toabdominal pain, cramping, vomiting, headache, atigue, uterine hemorrhage, viral inections, pelvicinammatory disease, severe bacterial inection, and death.8. Abortion-inducing drugs are associated with an increased risk o complications relative to surgicalabortion. Te risk o complications increases with advancing gestational age, and, in the instance o miepristone, with ailure to complete the two-step dosage process.
Abortion-Inducing Drugs Safety Act
HOUSE/SENATE BILL NO.
 By Representatives/Senators
 
 
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Americans United for Life | Defending Life246
9. In July 2011, the FDA reported 2,207 adverse events in the U.S. aer women used the Mieprexregimen or the termination o pregnancy. Among those were 14 deaths, 612 hospitalizations, 339blood transusions, and 256 inections (including 48 “severe inections”).10. “O-label” or so-called “evidence-based” use o the Mieprex regimen can be deadly. o date,14 women have reportedly died aer administration o the Mieprex regimen, with eight deathsattributed to severe bacterial inection. All eight o those women administered the regimen inan “o-label” or “evidence-based” manner advocated by abortion providers.11. Medical evidence demonstrates that women who utilize abortion-inducing drugs incur morecomplications than those who have surgical abortions.B. Based on the fndings in Subsection (a) o this Section, it is the purpose o this Act to:1. Protect women rom the dangerous and potentially deadly o-label use o abortion-inducing drugs,such as, but not limited to, the Mieprex regimen; and2. Ensure that physicians abide by the protocol tested and approved by the FDA or such abortion-inducing drugs, as outlined in the drug labels.
Section 3. Defnitions.
A. Abortion-inducing drug” means a medicine, drug, or any other substance prescribed or dispensed withthe intent o terminating the clinically diagnosable pregnancy o a woman, with knowledge that thetermination will with reasonable likelihood cause the death o the unborn child. Tis includes o-label useo drugs known to have abortion-inducing properties, which are prescribed specifcally with the intent o causing an abortion, such as misoprostol (Cytotec), and methotrexate. Tis defnition does not apply todrugs that may be known to cause an abortion, but which are prescribed or other medical indications (e.g.,chemotherapeutic agents, diagnostic drugs, etc.).Use o such drugs to induce abortion is also known as “medical abortion.”B. Abortion” means the act o using or prescribing any instrument, medicine, drug, or any other substance,device, or means with the intent to terminate the clinically diagnosable pregnancy o a woman, withknowledge that the termination by those means will with reasonable likelihood cause the death o theunborn child. Such use, prescription, or means is not an abortion i done with the intent to:1. Save the lie or preserve the health o the unborn child;2. Remove a dead unborn child caused by spontaneous abortion;3. Remove an ectopic pregnancy; or4. reat a maternal disease or illness or which the prescribed drug is indicated.C. “Department” means the Department o [Insert appropriate title] o the State o [
 Insert name o State
].D. “Final printed labeling (FPL)” means the FDA-approved inormational document or an abortion-inducing drug which outlines the protocol authorized by the FDA and agreed upon by the drug company applying or FDA authorization o that drug.E. “LMP” or “gestational age” means the time that has elapsed since the frst day o the woman’s lastmenstrual period.
 
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Americans United for Life | Defending Life247
F. “Mieprex regimen” means the abortion-inducing drug regimen that involves administration o miepristone (brand name “Mieprex”) and misoprostol. It is the only abortion-inducing drug regimenapproved by the FDA. It is also known as the “RU-486 regimen” or simply “RU-486.G. “Miepristone” means the frst drug used in the Mieprex regimen.H. “Misoprostol” means the second drug used in the Mieprex regimen.I. “Physician” means any person licensed to practice medicine in this State. Te term includes medical doctorsand doctors o osteopathy. J. “Pregnant” or “pregnancy” means that emale reproductive condition o having an unborn child in themother’s [woman’s] uterus.K. “Unborn child” means the ospring o human beings rom conception until birth.
Section 4. Unlawul Distribution o Abortion-Inducing Drug.
A. It shall be unlawul to knowingly give, sell, dispense, administer, otherwise provide, or prescribe any abortion-inducing drug to a pregnant woman or the purpose o inducing an abortion in that pregnant woman, or enabling another person to induce an abortion in a pregnant woman, unless the person whogives, sells, dispenses, administers, or otherwise provides or prescribes the abortion-inducing drug is a physician, and the provision or prescription o the abortion-inducing drug satisfes the protocol authorizedby the FDA as outlined in the fnal printed labeling (FPL) or the drug or drug regimen. In the case o theMieprex regimen, the Mieprex label includes the FDA-approved dosage and administration instructionsor both miepristone (Mieprex) and misoprostol.B. Because the ailure and complications rates rom medical abortion increase with advancing gestational age,because the physical symptoms o medical abortion can be identical to the symptoms o ectopic pregnancy,and because abortion-inducing drugs do not treat ectopic pregnancies but rather are contraindicated inectopic pregnancies, the physician giving, selling, dispensing, administering, or otherwise providing or prescribing the abortion-inducing drug must frst examine the woman and document, in the woman’smedical chart, gestational age and intrauterine location o the pregnancy prior to giving, selling, dispensing,administering, or otherwise providing or prescribing the abortion-inducing drug.C. Every pregnant woman to whom a physician gives, sells, dispenses, administers, otherwise provides, or prescribes any abortion-inducing drug shall be provided with a copy o the drug’s label.D. Te physician giving, selling, dispensing, administering, otherwise providing, or prescribing the abortion-inducing drug must have a signed contract with a physician who agrees to handle complications and be ableto produce that signed contract on demand by the patient or by the Department. Every pregnant womanto whom a physician gives, sells, dispenses, administers, otherwise provides, or prescribes any abortion-inducing drug shall receive the name and phone number o the physician who will be handling emergencies,and the hospital at which any emergencies will be handled. Te physician who contracts to handleemergencies must have active admitting privileges and gynecological/surgical privileges at the hospitaldesignated to handle any emergencies associated with the use or ingestion o the abortion-inducing drug.E. Te physician giving, selling, dispensing, administering, otherwise providing, or prescribing any abortion-inducing drug, or an agent o said physician, must schedule a ollow-up visit or the woman atapproximately 14 days aer administration o the abortion-inducing drug to confrm that the pregnancy iscompletely terminated and to assess the degree o bleeding. Said physician or agent o physician shall make

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