(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. ยง 314.520, also referred to as "Subpart H", which is the only United States 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 that 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-milligram tablets of mifepristone taken orally, followed by two (2) two-hundred-microgram 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 milligrams (200 mg) of mifepristone, followed by a single vaginal or buccal dose of eight-tenths milligram (.8 mg) of 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, fatigue, uterine hemorrhage, viral infections, and pelvic inflammatory disease;
(15) Abortion-inducing drugs are associated with an increased risk of complications relative to surgical abortion, and 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;
(16) (A) In July 2011, the United States Food and Drug Administration reported two thousand two hundred seven (2,207) adverse events in the United States of America after women used the Mifeprex regimen for the termination of pregnancy.
(B) Among those were fourteen (14) deaths, six hundred twelve (612) hospitalizations, three hundred thirty-nine (339) blood transfusions, and two hundred fifty-six (256) infections, including forty-eight (48) severe infections;
(17) (A) Off-label or so-called evidence-based use of the Mifeprex regimen may be deadly.
(B) To date, fourteen (14) women have reportedly died after administration of the Mifeprex regimen, with eight (8) deaths attributed to severe bacterial infection.
(C) All eight (8) of those women administered the regimen in an off-label or evidence-based manner advocated by abortion providers.
(D) The United States Food and Drug Administration has not been able to conclude whether off-label use led to the eight (8) deaths; and
(18) Medical evidence demonstrates that women who use abortion-inducing drugs incur more complications than those who have surgical abortions.
(b) Based on the findings in subsection (a) of this section, it is the purpose of this subchapter to:
(1) 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
(2) Ensure that physicians abide by the protocol tested and approved by the United States Food and Drug Administration for such abortion-inducing drugs, as outlined in the drug labels.
Section: 20-16-1502 20-16-1503 20-16-1504 20-16-1505 20-16-1506 20-16-1507 20-16-1508 20-16-1509 20-16-1510 NextLast modified: November 15, 2016