AUTHOR'S / SPONSOR'S STATEMENT OF INTENT
Mifeprex (RU-486) was approved by the United States Food and Drug Administration (FDA) for use by pregnant women wishing to terminate their pregnancy for up to 49 days gestation only. The drug has no other approved indication for use during pregnancy. The Mifeprex (RU-486) label instructs that the tablets are intended for oral administration only, and should be administered only in a clinic, medical office, or hospital, and by or under the supervision of a physician able to assess the gestational age of an embryo and to diagnose ectopic pregnancies. Abortion-inducing drugs pose substantial risks to women, and these risks are magnified when the drugs are misused.
The purpose of C.S.S.B. 1790 is to protect the health and welfare of women considering a drug-induced abortion. It ensures that physicians providing drug-induced abortions are only doing so in the way in which the FDA tested and approved the abortion-inducing drug.
C.S.S.B. 1790 amends current law relating to distributing or prescribing abortion-inducing drugs and providing an administrative penalty.
RULEMAKING AUTHORITY
SECTION BY SECTION ANALYSIS
SECTION 1. Amends Chapter 171, Health and Safety Code, by adding Subchapter D, as follows:
SUBCHAPTER D. ABORTION-INDUCING DRUGS
Sec. 171.081. DEFINITIONS. Defines, in this subchapter, "abortion," "abortion-inducing drug," "drug label," "gestational age," "medical abortion," "physician," "pregnant," and "unborn child."
Sec. 171.082. ENFORCEMENT BY THE TEXAS MEDICAL BOARD. Requires the Texas Medical Board (TMB), notwithstanding Section 171.005 (Department to Enforce), to enforce this subchapter.
Sec. 171.083. DISTRIBUTION OF ABORTION-INDUCING DRUG. (a) Prohibits a person, from knowingly giving, selling, dispensing, administering, providing, or prescribing an abortion-inducing drug to a pregnant woman for the purpose of inducing an abortion in the pregnant woman, or enabling another person to induce an abortion in a pregnant woman unless the person who gives, sells, dispenses, administers, 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 United States Food and Drug Administration (FDA) as outlined in the abortion-inducing drug's drug label.
(b) Requires the physician, before the physician gives, sells, dispenses, administers, provides, or prescribes the abortion-inducing drug, to examine the pregnant woman and document, in the woman's medical record, the gestational age and intrauterine location of the pregnancy.
(c) Requires the physician who gives, sells, dispenses, administers, provides or prescribes the abortion-inducing drug to provide a copy of the abortion-inducing drug's drug label to the pregnant woman.
(d) Requires the physician who gives, sells, dispenses, administers, provides or prescribes the abortion-inducing drug to have a signed contract with another physician who agrees to treat emergencies arising from the drug, and produce the signed contract on demand by the pregnant woman or TMB.
(e) Requires the physician who gives, sells, dispenses, administers, provides or prescribes the abortion-inducing drug to provide the pregnant woman with the name and phone number of the physician who would treat an emergency arising from the drug, and the hospital at which an emergency arising from the drug would be treated.
(f) Requires a physician who contracts to treat an emergency arising from an abortion-inducing drug to have active admitting, gynecological, and surgical privileges at the hospital designated to treat the emergency.
(g) Requires the physician who gives, sells, dispenses, administers, provides, or prescribes an abortion-inducing drug, or the physician's agent, to schedule a follow-up visit for the woman to occur not more than 14 days after the administration of the drug. Requires the physician, at the follow-up visit, to confirm that the pregnancy is completely terminated, and assess the degree of bleeding.
(h) Requires the physician who gives, sells, dispenses, administers, provides or prescribes the abortion-inducing drug, or the physician's agent, to make a reasonable effort to ensure that the woman returns for the scheduled appointment. Requires the physician or the physician's agent to include a brief description of any effort made to comply with this subsection, including the date, time, and name of the person making the effort, in the woman's medical record.
(i) Requires the physician, if a physician provides an abortion-inducing drug to a pregnant woman for the purpose of inducing an abortion as authorized by this section and the physician knows that the woman experiences a serious adverse event, as defined by the MedWatch Reporting System, during or after using the drug, to report the event to the FDA through the MedWatch Reporting System within three days of the event.
Sec. 171.084. ADMINISTRATIVE PENALTY. (a) Authorizes TMB to take disciplinary action under Chapter 164 (Disciplinary Actions and Procedures), Occupations Code, against a person who violates Section 171.083, or assess an administrative penalty under Subchapter A (Administrative Penalties), Chapter 165 (Penalties), Occupations Code, against a person who violates Section 171.083.
(b) Prohibits a penalty from being assessed under this section against a pregnant woman who receives a medical abortion.
SECTION 2. Effective date: upon passage or September 1, 2011.