Okla. Stat. tit. 63, § 63-1-729a

A. The Legislature finds that:

1. The U.S. Food and Drug Administration (FDA) approved the

drug mifepristone (brand name "Mifeprex"), a first-generation

[selective] progesterone receptor modulator ([S]PRM), as an

abortion-inducing drug with a specific gestation, dosage, and

administration protocol;

2. The FDA approved mifepristone (brand name Mifeprex) under

the rubric of 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";

3. The FDA does not treat Subpart H drugs in the same manner as

drugs which undergo the typical approval process;

4. As approved by the FDA, and as outlined in the Mifeprex

final printed labeling (FPL), an abortion by mifepristone consists

of three two-hundred-milligram tablets of mifepristone taken orally,

followed by two two-hundred-microgram tablets of misoprostol taken

orally, through forty-nine (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 the abortion has been completed. This FDA-approved

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protocol is referred to as the "Mifeprex regimen" or the "RU-486

regimen";

5. The aforementioned procedure requires three 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;

6. The Mifeprex final printed labeling (FPL) outlines the FDA-

approved dosage and administration of both drugs in the Mifeprex

regimen, namely mifepristone and misoprostol;

7. 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);

8. 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

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 two days (Day 3) to check if my pregnancy

has ended. My provider will give me misoprostol if I

am still pregnant";

9. 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 final printed labeling (FPL) on

self-administering misoprostol at home;

10. The use of abortion-inducing drugs 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;

11. 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;

12. In July 2011, the FDA reported 2,207 adverse events in the

United States after women used abortion-inducing drugs. Among those

were 14 deaths, 612 hospitalizations, 339 blood transfusions, and

256 infections (including 48 "severe infections");
ons increases with advancing gestational age, and, in the

instance of the Mifeprex regimen, with failure to complete the two-

step dosage process;

12. In July 2011, the FDA reported 2,207 adverse events in the

United States after women used abortion-inducing drugs. Among those

were 14 deaths, 612 hospitalizations, 339 blood transfusions, and

256 infections (including 48 "severe infections");

13. "Off-label" or so-called "evidence-based" use of abortion-

inducing drugs may be deadly. To date, fourteen women have

Oklahoma Statutes - Title 63. Public Health and Safety Page 302

reportedly died after administering abortion-inducing drugs, with

eight deaths attributed to severe bacterial infection. All eight of

those women administered the drugs in an "off-label" or "evidence-

based" manner advocated by many abortion providers. The FDA has

received no reports of women dying from bacterial infection

following administration according to the FDA-approved protocol for

the Mifeprex regimen. The FDA has not been able to conclude one way

or another whether off-label use led to the eight deaths;

14. Medical evidence demonstrates that women who utilize

abortion-inducing drugs incur more complications than those who have

surgical abortions;

15. Based on the foregoing findings, it is the purpose of this

act to:

a. protect women from the dangerous and potentially

deadly off-label use of abortion-inducing drugs, and

b. ensure that physicians abide by the protocol approved

by the FDA for the administration of abortion-inducing

drugs, as outlined in the drugs' final printed

labeling (FPL); and

16. In response to the Oklahoma Supreme Court's decision in

Cline v. Oklahoma Coalition for Reproductive Justice (No. 111,939),

in which the Oklahoma Supreme Court determined, in contravention of

this Legislature's intent, that this act prohibits all uses of

misoprostol for chemical abortion and prohibits the use of

methotrexate in treating ectopic pregnancies, it is also the purpose

of this act to legislatively overrule the decision of the Oklahoma

Supreme Court and ensure that should such questions be presented

before that Court in the future it will reach the proper result that

this act does not ban use of misoprostol in chemical abortion (and

allows it as part of the FDA-approved Mifeprex regimen) nor prevent

the off-label use of drugs for the treatment of ectopic pregnancy.

B. As used in this section:

1. "Abortion-inducing drug" means a medicine, drug, or any

other substance prescribed or dispensed with the intent of inducing

an abortion. 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, such as chemotherapeutic agents or diagnostic

drugs, or for treatment of an ectopic pregnancy;

2. "Abortion" means the use or prescription of any instrument,

medicine, drug, or any other substance or device intentionally to

terminate the pregnancy of a female known to be pregnant with an

intention other than to increase the probability of a live birth, to

preserve the life or health of the child after live birth, to remove

an ectopic pregnancy, or to remove a dead unborn child who died as

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the result of a spontaneous miscarriage, accidental trauma, or a

criminal assault on the pregnant female or her unborn child;

3. "Drug label" or "drug's label" means the pamphlet

accompanying an abortion-inducing drug which outlines the protocol

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 printed labeling (FPL)" or referred to
l trauma, or a

criminal assault on the pregnant female or her unborn child;

3. "Drug label" or "drug's label" means the pamphlet

accompanying an abortion-inducing drug which outlines the protocol

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 printed labeling (FPL)" or referred to

as the "FDA-approved label", it is the FDA-approved document which

delineates how a drug is to be used according to the FDA approval;

4. "Mifeprex regimen" means the abortion-inducing drug regimen

that is described in the FDA-approved Mifeprex final printed

labeling, and which involves administration of mifepristone (brand

name "Mifeprex") and misoprostol. It is the only abortion-inducing

drug regimen approved by the FDA, and it does not include any dosage

or administration not explicitly approved in Mifeprex final printed

labeling. It is also commonly referred to as the "RU-486 regimen"

or simply "RU-486";

5. "Mifepristone" means the first drug used in the Mifeprex

regimen;

6. "Misoprostol" means the second drug used in the Mifeprex

regimen;

7. "Personal identifying information" means any information

designed to identify a person and any information commonly used or

capable of being used alone or in conjunction with any other

information to identify a person; and

8. "Physician" means a doctor of medicine or osteopathy legally

authorized to practice medicine in the state.

C. No person shall knowingly or recklessly give, sell,

dispense, administer, prescribe, or otherwise provide an abortion-

inducing drug, including the Mifeprex regimen, unless the person who

gives, sells, dispenses, administers, prescribes, or otherwise

provides the abortion-inducing drug is a physician who:

1. Has the ability to assess the duration of the pregnancy

accurately;

2. Has the ability to diagnose ectopic pregnancies;

3. Has the ability to provide surgical intervention in cases of

incomplete abortion or severe bleeding, or has made and documented

in the patient's medical record plans to provide such care through

other qualified physicians; and

4. Is able to assure patient access to medical facilities

equipped to provide blood transfusions and resuscitation, if

necessary.

D. No physician who provides an abortion-inducing drug,

including the Mifeprex regimen, shall knowingly or recklessly fail

to provide or prescribe the drug according to the protocol

authorized by the U.S. Food and Drug Administration and as outlined

in the FDA-approved label. In the specific case of the Mifeprex

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regimen, the Mifeprex label includes the FDA-approved dosage and

administration instructions for both mifepristone (brand name

Mifeprex) and misoprostol, and any provision accomplished according

to that labeling is not prohibited.

E. No physician who provides an abortion-inducing drug,

including the Mifeprex regimen, shall knowingly or recklessly fail

to:

1. Provide each patient with a copy of the drug manufacturer's

medication guide and drug label for the drug(s) being used; when the

Mifeprex regimen is being utilized, this requirement is satisfied so

long as the patient is provided the FDA-approved Mifeprex medication

guide and final printed labeling;

2. Fully explain the procedure to the patient, including, but

not limited to, explaining that the drug is being used in accordance

with the protocol authorized by the U.S. Food and Drug

Administration and as outlined in the drug label for the abortion-

inducing drug;

3. Provide the female with a copy of the drug manufacturer's

patient agreement and obtain the patient's signature on the patient

agreement;

4. Sign the patient agreement; and

5. Record the drug manufacturer's package serial number in the

patient's medical record.

F. Because the failure and complications rates from abortion-
and as outlined in the drug label for the abortion-

inducing drug;

3. Provide the female with a copy of the drug manufacturer's

patient agreement and obtain the patient's signature on the patient

agreement;

4. Sign the patient agreement; and

5. Record the drug manufacturer's package serial number in the

patient's medical record.

F. Because the failure and complications rates from abortion-

inducing drugs increase with increasing gestational age, and because

the physical symptoms of an abortion induced by drugs can be

identical to the symptoms of ectopic pregnancy, thereby increasing

the risk of ruptured ectopic pregnancy, the physician giving,

selling, dispensing, administering, or otherwise providing or

prescribing the abortion-inducing drug shall 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.

G. An abortion-inducing drug must be administered in the same

room and in the physical presence of the physician who prescribed,

dispensed, or otherwise provided the drug to the patient. The

physician inducing the abortion, or a person acting on behalf of the

physician inducing the abortion, shall schedule the patient for a

follow-up appointment and make all reasonable efforts to ensure that

the patient returns twelve (12) to eighteen (18) days after the

administration or use of the abortion-inducing drug for a follow-up

visit so that the physician can confirm that the pregnancy has been

terminated and assess the patient's medical condition. A brief

description of the efforts made to comply with this subsection,

including the date, time, and identification by name of the person

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making such efforts, shall be included in the patient's medical

record.

H. 1. If a physician provides an abortion-inducing drug and

knows that the female who uses the abortion-inducing drug

experiences within one (1) year after the use of the abortion-

inducing drug an incomplete abortion, severe bleeding, or an adverse

reaction to the abortion-inducing drug or is hospitalized, receives

a transfusion, or experiences any other serious event, the physician

shall, as soon as is practicable, but in no case more than sixty

(60) days after the physician learns of the adverse reaction or

serious event, provide a written report of the incomplete abortion,

severe bleeding, adverse reaction, hospitalization, transfusion, or

serious event to the drug manufacturer. If the physician is a

doctor of medicine, the physician shall simultaneously provide a

copy of the report to the State Board of Medical Licensure and

Supervision. If the physician is a doctor of osteopathy, the

physician shall simultaneously provide a copy of the report to the

State Board of Osteopathic Examiners. The relevant Board shall

compile and retain all reports it receives pursuant to this

subsection. All reports the relevant Board receives under this

subsection are public records open to inspection pursuant to the

Oklahoma Open Records Act; however, absent an order by a court of

competent jurisdiction, neither the drug manufacturer nor the

relevant Board shall release the name or any other personal

identifying information regarding a person who uses or provides the

abortion-inducing drug for the purpose of inducing an abortion and

who is the subject of a report the drug manufacturer or the relevant

Board receives under this subsection.

2. No physician who provides an abortion-inducing drug to a

pregnant female shall knowingly or recklessly fail to file a report

required under paragraph 1 of this subsection. Knowing or reckless

failure to comply with this subsection shall subject the physician

to sanctioning by the licensing board having administrative

authority over such physician.
nt

Board receives under this subsection.

2. No physician who provides an abortion-inducing drug to a

pregnant female shall knowingly or recklessly fail to file a report

required under paragraph 1 of this subsection. Knowing or reckless

failure to comply with this subsection shall subject the physician

to sanctioning by the licensing board having administrative

authority over such physician.

I. Any female upon whom an abortion has been performed, the

father of the unborn child who was the subject of the abortion if

the father was married to the woman who received the abortion at the

time the abortion was performed, or a maternal grandparent of the

unborn child may maintain an action against the person who performed

the abortion in knowing or reckless violation of this section for

actual and punitive damages. Any female upon whom an abortion has

been attempted in knowing or reckless violation of this section may

maintain an action against the person who attempted to perform the

abortion for actual and punitive damages.

J. If a judgment is rendered in favor of the plaintiff in any

action described in this section, the court shall also render

judgment for a reasonable attorney fee in favor of the plaintiff

Oklahoma Statutes - Title 63. Public Health and Safety Page 306

against the defendant. If a 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 a reasonable attorney fee in favor of the defendant

against the plaintiff.

K. No pregnant female who obtains or possesses an abortion-

inducing drug to terminate her own pregnancy shall be subject to any

action brought under subsection I of this section.

L. If some or all of the language in this section is ever

temporarily or permanently restrained or enjoined by judicial order,

then this section shall be enforced as though such restrained or

enjoined provisions had not been adopted; provided, however, that

whenever such temporary or permanent restraining order or injunction

is stayed or dissolved, or otherwise ceases to have effect, such

provisions shall have full force and effect.