Arkansas Session Laws of the 2015 Regular Session (2015)
HB 1394, Act 577
For An Act To Be Entitled
AN ACT TO ESTABLISH THE ABORTION-INDUCING DRUGS SAFETY ACT; AND FOR OTHER PURPOSES.
Subtitle
TO ESTABLISH THE ABORTION-INDUCING DRUGS SAFETY ACT.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF ARKANSAS:
Subchapter 15 - Abortion-Inducing Drugs Safety Act
20-16-1501. Title.
This Act may be known and cited as the "Abortion-Inducing Drugs Safety Act."
20-16-1502. Legislative findings and purpose.
(a) The General Assembly finds that:
(1) The United States Food and Drug Administration approved the drug mifepristone, a first-generation progesterone receptor modulator, as an abortion-inducing drug with a specific gestation, dosage, and administration protocol;
(2) The United States Food and Drug Administration approved mifepristone under the rubric of 21 C.F.R. 314.520, also referred to as "Subpart H," which is the only Food and Drug Administration approval process that allows for postmarketing restrictions and 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";
(3) The United States Food and Drug Administration does not treat Subpart H drugs in the same manner as drugs which undergo the typical approval process;
(4) As approved by the United States Food and Drug Administration and as outlined in the final printed labeling of mifepristone, an abortion by mifepristone consists of three (3) two-hundred (200) mg tablets of mifepristone taken orally, followed by two (2) two-hundred (200) mcg tablets of misoprostol taken orally, through forty-nine (49) days from the first day of the woman's last menstrual period;
(5) The patient is to return for a follow-up visit in order to confirm that a complete termination of pregnancy has occurred;
(6) This United States Food and Drug Administration-approved protocol is referred to as the "Mifeprex regimen";
(7) This treatment requires three (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;
(8) The final printed labeling of Mifeprex outlines the United States Food and Drug Administration-approved dosage and administration of both drugs in the Mifeprex regimen, namely mifepristone and misoprostol;
(9) When the United States Food and Drug Administration approved the Mifeprex regimen under Subpart H, it did so with certain restrictions such as the requirement that 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;
(10) One (1) of the restrictions imposed by the United States Food and Drug Administration as part of its Subpart H approval is a written agreement that must be signed by both the physician and patient;
(11) In that agreement, the woman, along with the physician, attests to the following, among other statements:
(A) "I believe I am no more than 49 days (7 weeks) pregnant";
(B) "I understand that I will take misoprostol in my provider's office two days after I take Mifeprex (Day 3)"; and
(C) "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";
(12) The United States Food and Drug Administration concluded that available medical data did not support the safety of home use of misoprostol, and it specifically rejected information in the Mifeprex final printed labeling on self-administering misoprostol at home;
(13) Court testimony in Planned Parenthood Cincinnati Region v. Taft, 459 F. Supp. 2d 626 (S.D. Oh. 2006), by Planned Parenthood and other abortion providers demonstrates that providers routinely fail to follow the United States Food and Drug Administration-approved protocol for the Mifeprex regimen, as it is outlined in the Mifeprex final printed labeling and that providers are administering a single oral dose of two-hundred (200) mg of mifepristone, followed by a single vaginal or buccal dose of eight-tenths (.8) mg misoprostol, through sixty-three (63) days of the woman's last menstrual period, without medical supervision and without follow-up care;
(14) The use of mifepristone presents significant medical risks to women, including without limitation abdominal pain, cramping, vomiting, headache,...
