HB 1662-FN - AS INTRODUCED
2016 SESSION
\t16-2115
\t01/10
HOUSE BILL\t1662-FN
AN ACT\trelative to abortion-inducing drugs.
SPONSORS:\tRep. Wuelper, Straf. 3; Rep. Murotake, Hills. 32; Rep. Itse, Rock. 10; Rep. Prudhomme-O'Brien, Rock. 6; Rep. Souza, Hills. 43; Rep. Gould, Hills. 7; Rep. Notter, Hills. 21; Sen. Cataldo, Dist 6
COMMITTEE:\tHealth, Human Services and Elderly Affairs
-----------------------------------------------------------------
ANALYSIS
\tThis bill establishes the abortion-inducing drugs safety act.
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Explanation:\tMatter added to current law appears in bold italics.
\t\tMatter removed from current law appears [in brackets and struckthrough.]
\t\tMatter which is either (a) all new or (b) repealed and reenacted appears in regular type.
\t16-2115
\t01/10
STATE OF NEW HAMPSHIRE
In the Year of Our Lord Two Thousand Sixteen
AN ACT\trelative to abortion-inducing drugs.
Be it Enacted by the Senate and House of Representatives in General Court convened:
\t\tI. The general court hereby finds that:
\t\t\t(a) The Food and Drug Administration (FDA) approved the drug mifepristone (brand name "Mifeprex"), a first-generation progesterone receptor modulator ([S]PRM), as an abortion-inducing drug with a specific gestation, dosage, and administration protocol.
\t\t\t(b) The FDA approved mifepristone under 21 C.F.R. section 314.520, also referred to as "Subpart H," which is the only FDA approval process that allows for postmarketing restrictions. Specifically, the Code of Federal Regulations (CFR) provides for accelerated approval of certain drugs that are shown to be effective but "can be safely used only if distribution or use is restricted."
\t\t\t(c) The FDA does not treat Subpart H drugs in the same manner as drugs which undergo the typical approval process.
\t\t\t(d) As approved by the FDA and as outlined in the Mifeprex final printed labeling (FPL), an abortion by mifepristone consists of 3 (200) mg tablets of mifepristone taken orally, followed by 2 (200) mcg tablets of misoprostol 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. This FDA-approved protocol is referred to as the "Mifeprex regimen."
\t\t\t(e) The treatment requires 3 office visits by the patient, and the dosages may only be administered in a clinic, medical office, or hospital and under supervision of a physician.
\t\t\t(f) The Mifeprex FPL outlines the FDA-approved dosage and administration of both drugs in the Mifeprex regimen, namely mifepristone and misoprostol.
\t\t\t(g) When the FDA approved the Mifeprex regimen under Subpart H, it did so with certain restrictions. For example, the distribution and use of the Mifeprex regimen must be under the supervision of a physician who has the ability to assess the duration of pregnancy, diagnose ectopic pregnancies, and provide surgical intervention (or has made plans to provide surgical intervention through other qualified physicians).
\t\t\t(h) One of the restrictions imposed by the FDA as part of its Subpart H approval is a written agreement that must be signed by both the physician and patient. In that agreement, the woman, along with the physician, attests to the following, among other statements:
\t\t\t\t(1) "I believe I am no more, than, 49 days (7 weeks) pregnant;"
\t\t\t\t(2) "I understand that I will take misoprostol in my provider's office 2 days after I take Mifeprex (Day 3);" and
\t\t\t\t(3) "I will do the following... return to my provider's office in 2 days (Day 3) to check if my pregnancy has ended. My provider will give me misoprostol if I am still pregnant."
\t\t\t(i) The FDA concluded that available medical data did not support the safety of home use of misoprostol, and it specifically rejected information in the Mifeprex FPL on self-administering misoprostol at home.
\t\t\t(j) Court testimony by Planned Parenthood and other abortion providers demonstrates that providers routinely fail to follow the FDA-approved protocol for the Mifeprex regimen, as it is outlined in the Mifeprex FPL. See, e.g., Planned Parenthood Cincinnati Region v. Taft, 459 F. Supp. 2d 626 (S.D. Oh. 2006).
\t\t\t(k) Specifically, Planned Parenthood and other abortion providers are administering a single oral dose of 200 mg of mifepristone, followed by a single vaginal or buccal dose of .8 mg misoprostol, through 63 days LMP, without medical supervision and without follow-up care. See, e.g., Planned Parenthood Cincinnati Region, 459 F. Supp. 2d at 630n.7.
\t\t\t(l) The use of mifepristone presents significant medical risks to women, including, but not limited to, abdominal pain, cramping, vomiting, headache, fatigue, uterine hemorrhage, viral infections, and pelvic inflammatory disease.
\t\t\t(m) Abortion-inducing drugs are associated with an increased risk of complications relative to surgical abortion. The risk of complications increases with advancing gestational age, and, in the instance of the Mifeprex regimen, with failure to complete the two-step dosage process.
\t\t\t(n) In July 2011, the FDA reported 2,207 adverse events in the U.S. after women used the Mifeprex regimen for the termination of pregnancy. Among those were 14 deaths, 612 hospitalizations, 339 blood transfusions, and 256 infections (including 48 "severe infections").
\t\t\t(o) "Off-label" or so-called "evidence-based" use of the Mifeprex regimen may be deadly. To date, 14 women have reportedly died after administration of the Mifeprex regimen, with 8 deaths attributed to severe bacterial infection. All 8 of those women administered the regimen in an "off-label" or "evidence-based" manner advocated by abortion providers. The FDA has not been able to determine whether off-label use led to the 8 deaths.
\t\t\t(p) Medical evidence demonstrates that women who use abortion-inducing drugs incur more complications than those who have surgical abortions.
\t\tII. Based on the findings in paragraph I, it is the purpose of this act to:
\t\t\t(a) Protect women from the dangerous and potentially deadly off-label use of abortion-inducing drugs, such as, but not limited to the Mifeprex regimen; and
\t\t\t(b) Ensure that physicians abide by the protocol tested and approved by the FDA for such abortion-inducing drugs, as outlined in the drug labels.
\t2 New Chapter; Abortion Inducing Drugs Safety. Amend RSA by inserting after chapter 132-A the following new chapter:
CHAPTER 132-B
ABORTION INDUCING DRUGS SAFETY ACT
\t132-B:1 Name of Act. This chapter may be known and cited as the abortion-inducing drugs safety act.
\t132-B:2 Definitions. In this chapter:
\t\tI. "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 abortion if done with the intent to:
\t\t\t\t(a) Save the life or preserve the health of the unborn child;
\t\t\t\t(b) Remove a dead unborn child caused by spontaneous abortion;
\t\t\t\t(c) Remove an ectopic pregnancy; or
\t\t\t\t(d) Treat a maternal disease or illness for which the prescribed drug is indicated.
\t\tII. "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. Abortion-inducing drug 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, diagnostic drugs, etc.). Use of such drugs to induce abortion is also know as "medical, drug-induced or chemical abortion."
\t\tIII. "Department" means the department of health and human services.
\t\tIV. "Final printed labeling (FPL)" means the FDA-approved informational document for an abortion-inducing drug which outlines the protocol authorized by the FDA and agreed upon by the drug company applying for FDA authorization of that drug.
\t\tV. "LMP" or "gestational age" means the time that has elapsed since the first day of the woman's last menstrual period.
\t\tVI. "Mifeprex regimen" means the abortion-inducing drug regimen that involves administration of mifepristone (brand name "Mifeprex") and misoprostol. It is the only abortion-inducing drug regimen approved by the FDA. It is also known as the "RU-486 regimen" or simply "RU-486."
\t\tVII. "Mifepristone" means the first drug used in the Mifeprex regimen.
\t\tVIII. "Misoprostol" means the second drug used in the Mifeprex regimen.
\t\tIX. "Physician" means any person licensed pursuant to RSA 329.
\t\tX. "Pregnant" or "pregnancy" means that female reproductive condition of having an unborn child in the mother's uterus.
\t\tXI. "Unborn child" means the offspring of human beings from conception until birth.
\t132-B:3 Unlawful Distribution of Abortion-Inducing Drug.
\t\tI. It shall be unlawful to knowingly give, sell, dispense, administer, or 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 authorized by the FDA, as outlined in the printed FPL for the drug or drug regimen. In the case of the Mifeprex regimen, the Mifeprex label includes the FDA-approved dosage; and administration instructions for both mifepristone (Mifeprex) and misoprostol.
\t\tII. Because the failure and complication rates from medical abortion increase with advancing 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.
\t\tIII. Every pregnant woman to whom a physician gives, sells, dispenses, administers, or otherwise provides or prescribes any abortion-inducing drug shall be provided with a copy of the drug's label.
\t\tIV. The physician giving, selling, dispensing, administering, or 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. The physician who contracts to handle emergencies must have active admitting privileges and gynecological/surgical privileges at a hospital designated to handle any emergencies associated with the use or ingestion of the abortion-inducing drug. Every pregnant woman to whom a physician gives, sells, dispenses, administers, or otherwise provides or prescribes any abortion-inducing drug shall receive the name and phone number of the contracted physician and the hospital at which that physician maintains admitting privileges can handle any emergencies.
\t\tV. The physician giving, selling, dispensing, administering, or otherwise providing or prescribing any abortion-inducing drug, or an agent of said physician, must schedule a follow-up visit for the woman at approximately 14 days after administration of the abortion-inducing drug to confirm that the pregnancy is completely terminated and to assess the degree of bleeding. Said physician or agent of physician shall make all reasonable efforts to ensure that the woman returns for the scheduled appointment. A brief description of the efforts made to comply with this subsection, including the date, time, and identification by name of the person making such efforts, shall be included in the woman's medical record.
\t132-B:4 Reporting.
\t\tI. If a physician provides an abortion-inducing drug to another for the purpose of inducing an abortion as authorized in RSA 132-B:3, and if the physician knows that the woman 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 adverse event within 3 days of the event to the FDA via the Medwatch Reporting System and to the board of medicine established in RSA 329:2.
\t\tII. The board of medicine shall compile and retain all reports it receives under this section. All reports the board receives are public records open to inspection under RSA 91-A. In no case shall the board of medicine 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 received by the board of medicine under this section.
\t\tIII. An "adverse event" shall be defined for purposes of this section according to the FDA criteria given in the Medwatch Reporting System.
\t132-B:5 Criminal Penalties.
\t\tI. A person who intentionally, knowingly, or recklessly violates any provision of this chapter shall be guilty of a class A felony.
\t\tII. No criminal penalty shall be assessed against the pregnant woman upon whom the drug-induced abortion is performed.
\t132-B:6 Civil Remedies and Professional Sanctions.
\t\tI. In addition to whatever remedies are available under the common or statutory law of this state, failure to comply with the requirements of this chapter shall:
\t\t\t(a) Provide a basis for a civil malpractice action for actual and punitive damages.
\t\t\t(b) Provide a basis for a professional disciplinary action under RSA 329.
\t\t\t(c) Provide a basis for recovery for the woman's survivors for the wrongful death of the woman.
\t\tII. No civil liability may be assessed against the pregnant woman upon whom the drug-induced abortion is performed.
\t\tIII. 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.
\t\tIV. 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.
\t\tV. If judgment is rendered in favor of the defendant and the court finds that the plaintiff's suit was frivolous and brought in bad faith, the court shall also render judgment for reasonable attorney's fee in favor of the defendant against the plaintiff.
\t132-B:7 Construction. Nothing in this chapter shall be construed as creating or recognizing a right to abortion. It is not the intention of this chapter to make lawful an abortion that is currently unlawful.
\t132-B:8 Right of Intervention. The general court, by joint resolution, may appoint one or more of its members, who sponsored or cosponsored this chapter 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.
\t132-B:9 Severability. If any provision of this chapter or the application thereof to any person or circumstances is held invalid, such invalidity shall not affect other provisions or applications of the chapter which can be given effect without the invalid provision or application, and to this end the provisions of this chapter are declared to be severable.
\t3 Contingency. If HB 629-FN of the 2015 legislative session becomes law, then RSA 132-B:4, II shall not take effect.
\t4 Effective Date. This act shall take effect January 1, 2017.
\t\t\t\t\t\t\t\t\t\t\t16-2115
\t\t\t\t\t\t\t\t\t\t\t12/22/15
HB 1662-FN- FISCAL NOTE
AN ACT\trelative to abortion-inducing drugs.
FISCAL IMPACT:
The Office of Professional Licensure and Certification states this bill, as introduced, will increase state expenditures by an indeterminable amount in FY 2017 and each year thereafter. The Office of Legislative Budget Assistant states this bill may increase state and county expenditures by an indeterminable amount in FY 2017 and each year thereafter. There will be no fiscal impact on local expenditures or state, county, and local revenue.
METHODOLOGY:
The Office of Professional Licensure and Certification, Board of Medicine states this bill imposes several requirements on any physician responsible for providing a patient with Mifeprex, an FDA approved drug meant to induce abortion. One of the requirements is to file an adverse event report with the Medwatch Reporting System and the Board. The Board is required to compile and retain the reports which will be kept as public records open to inspection under RSA 91-A. The Board states Board staff would be responsible for redacting and personal identifying information when responding to such requests. The Board assumes, due to the nature of this topic, the requests will likely be numerous and time consuming. The Board indicates the bill also expands the regulatory authority of the Board by authorizing discipline for such omission as failure to document attempts to schedule a follow-up appointment. The Board assumes most of the cost to the Board would be related to the staff time needed to compile the reports and respond to right-to-know requests, but is not able to determine such cost.
The Office of Legislative Budget Assistant states this bill contains penalties that may have an impact on the New Hampshire judicial and correctional systems. There is no method to determine how many charges would be brought as a result of the changes contained in this bill to determine the fiscal impact on expenditures. However, the Judicial Branch, Department of Corrections, and New Hampshire Association of Counties have provided the Office with potential costs associated with the penalties contained in this bill. See table below for average cost information:
| FY 2017 | FY 2018 |
Judicial Branch |
|
|
Routine Criminal Felony Case | $449 | $470 |
Complex Civil Case | $724 | $756 |
Appeals | Varies | Varies |
It should be noted average case cost estimates for FY 2017 and FY 2018 are based on data that is more than ten years old and does not reflect changes to the courts over that same period of time or the impact these changes may have on processing the various case types. | ||
Department of Corrections |
|
|
FY 2015 Average Cost of Incarcerating an Individual | $34,336 | $34,336 |
FY 2015 Average Cost of Supervising an Individual on Parole/Probation | $520 | $520 |
NH Association of Counties |
|
|
County Prosecution Costs | Indeterminable | Indeterminable |
Estimated Average Daily Cost of Incarcerating an Individual | $85 to $110 | $85 to $110 |
Many offenses are prosecuted by local and county prosecutors. In those instances where the Department of Justice has prosecutorial responsibility or is involved with appeals for a conviction related to the offense contained in this bill, the Department would absorb the cost within its existing budget. If the bill results in the Department needing to prosecute significantly more cases or be involved in significantly more appeals, then there may be an indeterminable increase in costs to the Department.
The Judicial Council assumes, because the proposed legislation regulates the conduct of medical professionals acting within the scope of their professional responsibilities, anyone charged with an offense would be defended or indemnified by the medical provider’s insurance provider. The Council assumes it would not provide representation to the accused and there would be no impact on the expenditures of the Judicial Council.
The Department of Health and Human Services states the bill would have no fiscal impact on the Department.