82R13672 NAJ-F By: Laubenberg H.B. No. 3408 A BILL TO BE ENTITLED AN ACT relating to distributing or prescribing abortion-inducing drugs; providing penalties. BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: SECTION 1. Chapter 171, Health and Safety Code, is amended by adding Subchapter D to read as follows: SUBCHAPTER D. ABORTION-INDUCING DRUGS Sec. 171.081. DEFINITIONS. In this subchapter: (1) "Abortion" means the act of using or prescribing an instrument, a medicine, a drug, or any other substance, device, or means with the intent to terminate a clinically diagnosable pregnancy of a woman and with knowledge that the termination by those means will, with reasonable likelihood, cause the death of the woman's unborn child. An act is not an abortion if the act is done with the intent to: (A) save the life or preserve the health of an unborn child; (B) remove a dead, unborn child whose death was caused by spontaneous abortion; (C) remove an ectopic pregnancy; or (D) treat a maternal disease or illness for which the prescribed drug is indicated. (2) "Abortion-inducing drug" means a medicine, a drug, or any other substance prescribed or dispensed with the intent of terminating a clinically diagnosable pregnancy of a woman and with knowledge that the termination will, with reasonable likelihood, cause the death of the woman's unborn child. The term includes off-label use of drugs known to have abortion-inducing properties that are prescribed with the intent of causing an abortion, including misoprostol and methotrexate. The term does not include a drug that may be known to cause an abortion but is prescribed for other medical reasons. (3) "Drug label" means a pamphlet accompanying an abortion-inducing drug that: (A) outlines the protocol tested and authorized by the United States Food and Drug Administration and agreed to by the drug company applying for authorization of the drug by that agency; and (B) delineates how a drug is to be used according to approval by that agency. (4) "Gestational age" means the amount of time that has elapsed since the first day of a woman's last menstrual period. (5) "Medical abortion" means the use of abortion-inducing drugs to induce an abortion. (6) "Physician" means an individual who is licensed to practice medicine in this state, including a medical doctor and a doctor of osteopathic medicine. (7) "Pregnant" means the female reproductive condition of having an unborn child in a woman's uterus. (8) "Unborn child" means an offspring of human beings from conception until birth. Sec. 171.082. DISTRIBUTION OF ABORTION-INDUCING DRUG. (a) Unless the person 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 as outlined in the drug's drug label, a person may not knowingly give, sell, dispense, administer, provide, or prescribe an abortion-inducing drug to a pregnant woman for the purpose of: (1) inducing an abortion in the pregnant woman; or (2) enabling another person to induce an abortion in a pregnant woman. (b) The physician must examine the pregnant woman and document, in the woman's medical record, the gestational age and intrauterine location of the pregnancy before giving, selling, dispensing, administering, providing, or prescribing the abortion-inducing drug. (c) The physician shall provide a copy of the abortion-inducing drug's drug label to the pregnant woman. (d) The physician must: (1) have a signed contract with another physician who agrees to treat emergencies arising from the drug; and (2) produce the signed contract on demand by the pregnant woman or the department. (e) The physician shall provide the pregnant woman with the name and phone number of: (1) the physician who would treat an emergency arising from the drug; and (2) the hospital at which an emergency arising from the drug would be treated. (f) A physician who contracts to treat an emergency arising from an abortion-inducing drug must have active admitting, gynecological, and surgical privileges at the hospital designated to treat the emergency. (g) The physician who gives, sells, dispenses, administers, provides, or prescribes an abortion-inducing drug or the physician's agent must schedule a follow-up visit for the woman to occur not more than 14 days after the administration of the abortion-inducing drug. At the follow-up visit, the physician must: (1) confirm that the pregnancy is completely terminated; and (2) assess the degree of bleeding. (h) The physician or the physician's agent shall make a reasonable effort to ensure that the woman returns for the scheduled appointment. The physician or the physician's agent shall 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) 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 a person who uses the drug experiences a serious adverse event, as defined by the MedWatch Reporting System, during or after using the drug, the physician shall report the event to the United States Food and Drug Administration through the MedWatch Reporting System within three days of the event. Sec. 171.083. CRIMINAL PENALTY. (a) A person commits an offense if the person violates Section 171.082. (b) An offense under this section is a Class A misdemeanor. (c) Each violation constitutes a separate offense. (d) A penalty may not be assessed under this section against a pregnant woman who receives a medical abortion. Sec. 171.084. CIVIL PENALTY. (a) A person who knowingly violates Section 171.082 is liable for a civil penalty of not less than $100 or more than $500 for each violation if the department determines that the violation threatens the health and safety of a woman. (b) Each violation constitutes a separate ground for recovery. (c) A penalty may not be assessed under this section against a pregnant woman who receives a medical abortion. Sec. 171.085. ADMINISTRATIVE PENALTY. (a) The department may assess an administrative penalty against a person who violates Section 171.082. (b) The penalty may not exceed $1,000 for each violation. (c) Each violation constitutes a separate violation. (d) In determining the amount of an administrative penalty assessed under this section, the department shall consider: (1) the seriousness of the violation; (2) the history of previous violations; (3) the amount necessary to deter future violations; (4) efforts made to correct the violation; and (5) any other matters that justice may require. (e) All proceedings for the assessment of an administrative penalty under this section are subject to Chapter 2001, Government Code. (f) A penalty may not be assessed under this section against a pregnant woman who receives a medical abortion. SECTION 2. This Act takes effect immediately if it receives a vote of two-thirds of all the members elected to each house, as provided by Section 39, Article III, Texas Constitution. If this Act does not receive the vote necessary for immediate effect, this Act takes effect September 1, 2011.