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Microsoft word - abortion-inducing drugs safety act - 2011 lg _2_.docABORTION-INDUCING DRUGS
(RU-486 & RESPONSE TO
Model Legislation & Policy Guide
For the 2011 Legislative Year
Medical abortion,1 such as that caused by mifepristone (RU-486), has become a veritable “pot of
gold” for Planned Parenthood and other abortion providers. Because RU-486 is virtually unregulated in the majority of states, abortion providers have been misusing it for years in order For example, the Food and Drug Administration (FDA) tested and approved the RU-486 regimen to be used only in the first 49 days following a woman’s last menstrual period (LMP), at a clinic or medical facility and under the supervision of a physician, and in the following manner: Day One: Mifeprex Administration: Three 200 mg tablets of Mifeprex are taken in a Day Three: Misoprostol Administration: Two 200 mcg tablets of misoprostol are taken Day 14: Post-Treatment Examination: The patient must return to confirm that a complete termination has occurred. If not, surgical termination is recommended to manage However, Planned Parenthood readily admits3 that it provides RU-486 to women up to 63 days LMP and provides women with just a single oral dose of mifepristone, followed by a single dose of misoprostol, which it directs women to administer vaginally instead of orally. Planned Parenthood even allows and directs women to take the drugs at home and in the absence physician oversight. Finally, no follow-up care is ensured. Why the blatant misuse? Certainly not because it is safer for women. Abortion providers misuse RU-486 because it is more convenient—and more profitable. By providing it to women through 63 days LMP and sending them home to ingest the drugs alone, abortion providers cancharge more women for abortions, increasing their profit exponentially. . 1 Medical abortion involves the ingestion of drugs in order to terminate pregnancy. It is contrasted with surgical abortion procedures, such as dilation & curettage, where the abortion provider physically removes the unborn child. 2 See Mifeprex Label, available at http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20687lbl.htm (last visited August 23, 2010); Food and Drug Administration, Mifeprex (mifepristone) Information (Feb. 24, 2010), available at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111323.htm (last visited Aug ust 23, 2010). 3 Planned Parenthood has documented this misuse in court records in both the Sixth Circuit Court of Appeals and a state court in Arizona. Abortion-Inducing Drugs Safety Act 2 Americans That abortion providers’ agenda is dominated by financial priorities rather than concern for women’s health has been seen recently in the state of Iowa, where abortion providers have begun using “telemed” services to provide RU-486 (i.e. a “telemed” abortion). Rather than meet with the woman personally, abortion provider Susan Haskell and Planned Parenthood of the Heartland have been consulting with patients over Skype or other teleconferencing systems. Under this scheme, Haskell briefly addresses abortion patients from a teleconferencing hook-up from her office in Des Moines. After explaining the medical abortion process, a button is pushed and an electronic drawer opens that contains the drugs. There is no examination, no physician-patient relationship, and no patient follow-up; but it does allow Haskell the opportunity to provide abortions to more women without ever having to meet with the women in person. In other words, medical abortion is the new profit-boosting frontier for abortion providers. Yet women are not routinely told of the non-approved (or “off-label”) use of the RU-486 regimen, nor are they informed that “[n]early all of the women who receive Mifeprex and misoprostol will report adverse reactions, and many can be expected to report more than one such reaction.”4 These adverse reactions include bleeding more heavily than during a heavy menstrual period; abdominal pain and uterine cramping; nausea; vomiting; diarrhea; pelvic pain; fainting; headaches; dizziness; and asthenia (weakness or lack of energy).5 In fact, by May of 2006, the FDA acknowledged a total of 1070 adverse event reports related to the use of RU-486.6 These adverse events included 6 deaths, 9 life-threatening incidents, 232 hospitalizations, 116 blood transfusions, and 88 cases of infection.7 Since that time, there have been hundreds of additional adverse events reported, as well as additional deaths in the United States.8 A European drug manufacturer has publicly stated that 29 women have died worldwide Even when administered according to the approved FDA protocol, RU-486 can have devastating consequences for women. No ultrasound is required under this protocol, despite the fact that an ultrasound is necessary to determine the gestational age of the pregnancy and whether the 4 See Mifeprex Label, supra (emphasis added). 5 Id. 6 Staff Report, The FDA and RU-486: Lowering the Standard for Women’s Health, prepared for the Chairman of the House Subcommittee on Criminal Justice, Drug Policy and Human Resources, at page 25 (Oct. 2006), available at http://www.usccb.org/prolife/issues/ru486/SouderStaffReportonRU-486.pdf (last visited August 23, 2010). 7 Id. 8 Id. at 32. 9 See, e.g., APM Health Europe, Italy questions safety of Exelgyn's abortion pill, approval still not granted (June 23, 2009), available at http://www.apmhe.com/story.php?mots=MIFEPRISTONE&searchScope=1&searchType=0&numero=L15579 (last visited August 23, 2010). Abortion-Inducing Drugs Safety Act 3 Americans pregnancy is ectopic. In fact, RU-486 is particularly dangerous because its side effects are confusingly similar to the symptoms of an ectopic pregnancy. Failing to properly diagnose an ectopic pregnancy can lead to a rupture of the fallopian tube, causing bleeding, severe pain, and even death. By failing to follow the FDA protocol, Planned Parenthood is clearly placing women’s health and lives even more at risk. In order to protect women against the risks and misuse of RU-486, AUL has drafted the “Abortion-Inducing Drugs Safety Act.” Importantly, this model has been updated to include a requirement that a physician actually examine a woman before providing RU-486 (See Section 4(b)), effectively precluding the use of so-called “telemed” abortions. For more information and drafting assistance, please contact AUL’s Legislative Coordinator at DENISE M. BURKE, ESQ.
Vice President of Legal Affairs
Americans United for Life
Abortion-Inducing Drugs Safety Act 4 Americans ABORTION-INDUCING DRUGS SAFETY ACT
HOUSE/SENATE BILL No. ______
By Representatives/Senators ____________
Section 1. Title.
This Act may be known and cited as the “Abortion-Inducing Drugs Safety Act.” Section 2. Legislative Findings and Purposes.
[Legislature] of the State of [Insert State] finds that: The Food and Drug Administration (FDA) approved the drug mifepristone, a first-generation [selective] progesterone receptor modulator ([S]PRM), as an abortion-inducing drug with a specific gestation, dosage, and administration As tested and approved by the FDA, and as outlined in the drug label, an abortion by mifepristone consists of three 200 mg tablets of mifepristone taken orally, followed by two 200 mcg tablets of misopristol taken orally, through 49 days LMP (a gestational measurement using the first day of the woman’s “last menstrual period” as a marker). The patient is to return for a follow-up visit in order to confirm that a complete termination of pregnancy has occurred The aforementioned treatment requires three office visits by the patient, and the dosages may only be administered in a clinic, medical office, or hospital and Court testimony by Planned Parenthood and other physicians demonstrates that physicians routinely fail to follow the mifepristone protocol as tested and approved by the FDA, and as outlined in the drug label. See e.g. Planned Parenthood Cincinnati Region v. Taft, 459 F. Supp. 2d 626 (S.D. Oh. 2006). Specifically, Planned Parenthood and other physicians are administering a single oral dose of 200 mg of mifepristone, followed by a single vaginal dose of .8 mg misopristol, through 63 days LMP, without medical supervision, and without Abortion-Inducing Drugs Safety Act 5 Americans follow-up care. See e.g. Planned Parenthood Cincinnati Region, 459 F. Supp. 2d The use of mifepristone presents significant medical risks to women, including but not limited to C. sordellii bacterial infection, septic shock, toxic shock syndrome, adult respiratory distress syndrome from sepsis, Escheria coli sepsis, group B Streptococcus septicemia, disseminated intravascular coagulopathy (DIC) with heptic and renal failure, severe pelvic infection, and massive Abortion-inducing drugs are associated with an increased risk of complications relative to surgical abortion. The risk of complications increases with increasing gestational age, and, in the instance of mifepristone, with failure to complete the “Off-label” use of mifepristone can be deadly. As of August 2010, a European drug manufacturer acknowledged at least 29 deaths worldwide. Medical studies have indicated that 1 to 2 out of every 1,000 women who undergo mifepristone abortions will require emergency blood transfusion for massive hemorrhage. By May 2006, the FDA reported that at least 116 women required blood transfusions for massive bleeding after mifepristone abortions, with at least 54 losing more than half of their blood volume. The absence of proper follow-up care after mifepristone abortions has resulted in at least 17 women having undetected ectopic pregnancies, eleven of which Based on the findings in Subsection (a) of this Section, it is the purpose of this Act to: Protect women from the dangerous and potentially deadly off-label use of abortion-inducing drugs, such as, but not limited to, mifepristone. Ensure that physicians abide by the protocol tested and approved by the FDA for such abortion-inducing drugs, as outlined in the drug labels. Abortion-Inducing Drugs Safety Act 6 Americans Section 3. Definitions.
(a) “Abortion-inducing drug” means a medicine, drug, or any other substance prescribed or
dispensed with the intent of terminating the clinically diagnosable pregnancy of a woman, with knowledge that the termination will with reasonable likelihood cause the death of the unborn child. This includes off-label use of drugs known to have abortion-inducing properties, which are prescribed specifically with the intent of causing an abortion, such as misoprostol (Cytotec), and methotrexate. This definition does not apply to drugs that may be known to cause an abortion, but which are prescribed for other medical indications (e.g., chemotherapeutic agents, Use of such drugs to induce abortion is also known as “medical abortion.”
“Abortion” means the act of using or prescribing any instrument, medicine, drug, or any
other substance, device, or means with the intent to terminate the clinically diagnosable pregnancy of a woman, with knowledge that the termination by those means will with reasonable likelihood cause the death of the unborn child. Such use, prescription, or means is not an Save the life or preserve the health of an unborn child; Remove a dead unborn child caused by spontaneous abortion; Treat a maternal disease or illness for which the prescribed drug is indicated. (c) “Department” means the Department of [Insert appropriate title] of the State of [Insert
“Drug label” or “drug’s label” means the pamphlet accompanying an abortion-inducing
drug which outlines the protocol tested and authorized by the U.S. Food and Drug Administration (FDA) and agreed upon by the drug company applying for FDA authorization of that drug. Also known as “final printing labeling instructions,” it is the FDA document which
delineates how a drug is to be used according to the FDA approval. (e) “LMP” or “gestational age” means the time that has elapsed since the first day of the
Abortion-Inducing Drugs Safety Act 7 Americans “Mifepristone” means the specific abortion-inducing drug regimen also known as “RU-
“Physician” means any person licensed to practice medicine in this State. The term
includes medical doctors and doctors of osteopathy. “Pregnant” or “pregnancy” means that female reproductive condition of having an
unborn child in the mother’s [woman’s] uterus. “Unborn child” means the offspring of human beings from conception until birth.
Section 4. Unlawful Distribution of Abortion-Inducing Drug
It shall be unlawful to knowingly give, sell, dispense, administer, otherwise provide, or prescribe any abortion-inducing drug to a pregnant woman for the purpose of inducing an abortion in that pregnant woman, or enabling another person to induce an abortion in a pregnant woman, unless the person who gives, sells, dispenses, administers, or otherwise provides or prescribes the abortion-inducing drug is a physician, and the provision or prescription of the abortion-inducing drug satisfies the protocol tested and authorized by the FDA and as outlined in the drug label for the abortion-inducing drug. Because the failure and complications from medical abortion increase with increasing gestational age, because the physical symptoms of medical abortion can be identical to the symptoms of ectopic pregnancy, and because abortion-inducing drugs do not treat ectopic pregnancies but rather are contraindicated in ectopic pregnancies, the physician giving, selling, dispensing, administering, or otherwise providing or prescribing the abortion-inducing drug must first examine the woman and document, in the woman’s medical chart, gestational age and intrauterine location of the pregnancy prior to giving, selling, dispensing, administering, or otherwise providing or prescribing the abortion-inducing drug. 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 of The 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 able to produce that signed contract on demand by the patient or by the Department. Every pregnant woman to whom a physician gives, sells, dispenses, Abortion-Inducing Drugs Safety Act 8 Americans administers otherwise provides, or prescribes any abortion-inducing drug shall receive the name and phone number of the physician who will be handling emergencies, and the hospital at which any emergencies will be handled. The physician who contracts to handle emergencies must have active admitting privileges and gynecological/surgical privileges at the hospital designated to handle any emergencies associated with the use or ingestion of the abortion-inducing drug. Section 5. Reporting.
If a physician provides an abortion-inducing drug to another for the purpose of inducing an abortion as authorized in Section 4 of this Act, and if the physician knows that the person who uses the abortion-inducing drug for the purpose of inducing an abortion experiences during or after the use an adverse event, the physician shall provide a written report of the serious event within three (3) of the event to the FDA via the Medwatch Reporting System [and to the State [The State Medical Board shall compile and retain all reports it receives under this Section. All reports the Board receives are public records open to inspection under [Insert citation(s) to or appropriate reference(s) to applicable State code section(s) regarding public records]. In no case shall the State Medical Board release to any person or entity the name or any other personal identifying information regarding a person who uses an abortion-inducing drug for the purpose of inducing an abortion and who is the subject of a report the State Medical Board receives under this provision.] An "adverse event" shall be defined for purposes of this Act according to the FDA criteria given
[Drafter’s note: Inclusion of the Reporting requirements is optional and may be removed
without diminishing the effect of the regulation itself.]
Section 6. Criminal Penalties.
A person who intentionally, knowingly, or recklessly violates any provision of this Act is guilty of a [Insert appropriate penalty/offense classification]. In this Section, “intentionally” is
defined by Section [Insert section number] of the [State Penal Code]. No criminal penalty may be assessed against the pregnant woman upon whom the drug-induced Abortion-Inducing Drugs Safety Act 9 Americans Section 7. Civil Penalties.
In addition to whatever remedies are available under the common or statutory law of this State, failure to comply with the requirements of this Act shall: Provide a basis for a civil malpractice action for actual and punitive damages. Provide a basis for a professional disciplinary action under [Medical Malpractice Provide a basis for recovery for the woman’s survivors for the wrongful death of the woman under the [Wrongful Death Act]. No civil liability may be assessed against the pregnant woman upon whom the drug- When requested, the court shall allow a woman to proceed using solely her initials or a pseudonym and may close any proceedings in the case and enter other protective orders to preserve the privacy of the woman upon whom the drug-induced abortion was performed. If judgment is rendered in favor of the plaintiff, the court shall also render judgment for a reasonable attorney’s fee in favor of the plaintiff against the defendant. Section 8. Construction.
Nothing in this Act shall be construed as creating or recognizing a right to abortion. It is not the intention of this Act to make lawful an abortion that is currently unlawful. Section 9. Right of Intervention.
The [Legislature], by joint resolution, may appoint one or more of its members, who sponsored or cosponsored this Act in his or her official capacity, to intervene as a matter of right in any case in which the constitutionality of this law is challenged. Abortion-Inducing Drugs Safety Act 10 Section 10. Severability.
Any provision of this Act held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, shall be construed so as give it the maximum effect permitted by law, unless such holding shall be one of utter invalidity or unenforceability, in which event such provision shall be deemed severable here from and shall not affect the remainder hereof or the application of such provision to other persons not similarly situated or to other, dissimilar Section 11. Effective Date.
This Act takes effect on [Insert date]. Abortion-Inducing Drugs Safety Act 11 STATE OF THE STATES:
WHERE ARE WE NOW?
One state requires that RU-486 be administered in compliance with the approved FDA protocol and the drug label: OH (in litigation). Five states specifically impose minimal administrative regulations on the dispensation of RU-486: CA, GA, NC, OK and RI. Abortion-Inducing Drugs Safety Act 12 More detailed information about the need and justification for laws regulating abortion-inducing drugs including RU-486 can be found in AUL’s annual publication Defending Life 2010: A State by State Legal Guide to Abortion, Bioethics, and the End of Life. Defending Life 2010 is available online at AUL.org or for purchase at Amazon.com. For further information regarding this or other AUL policy guides, please contact: 202.289.1478 | Fax 202.289.1473 | Legislation@AUL.org This policy guide may be copied and distributed freely as long as the content remains unchanged and Americans United for Life is referenced as the creator and owner this content.
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