HARRISBURG, Pa., Nov. 17 /PRNewswire/ --  Robert S. Zimmerman Jr. today announced the department is issuing guidelines to all registered abortion providers and licensed physicians in Pennsylvania to affirm that the state's Abortion Control Act will apply to the use of the abortion pill RU-486.

In September, the Food and Drug Administration (FDA) approved the use of RU-486 -- also known as mifespristone or the brand name Mifeprex -- with restrictions, to induce an abortion.

"Pennsylvania's Abortion Control Act applies to all abortions, whether surgical or drug induced," Zimmerman said. "The Act is clear."

"Gov. Ridge has shared publicly his view that abortion by pill should be subject to the same restrictions that a conventional abortion is subject to in Pennsylvania. These guidelines are consistent with that view."

The Department of Health and the Department of State enforce several provisions of the Abortion Control Act. Both agencies will apply the provisions of the Act for which they are responsible to drug-induced abortions.

Major provisions in the Act that must be met for drug-induced abortions include:

-- Parental consent for minors;

-- Informed consent. A woman must be given information about alternatives to, and risks of, the proposed procedure, as well as information about health and other services available at least 24 hours before the abortion is provided;

-- Only a physician may provide mifepristone to induce an abortion, and that must take place in a facility registered with the Department of Health to provide abortions;

-- A report on each abortion must be filed with the Department of Health by the facility and signed by the physician responsible for the abortion; and

-- A report of complications arising from an abortion or attempted abortion must be filed with the Department of Health by a physician who provides medical care to the woman due to the complication.

Today, the Department of Health began notifying Pennsylvania's registered abortion providers about the application of the Act to the use of mifepristone to induce an abortion. Within the next several days, all Pennsylvania licensed physicians will receive a letter notifying them of the Act-compliance requirements in case they intend to provide this drug to patients.

Additional information is available by visiting the Department of Health's website through the PA PowerPort at http://www.state.pa.us/ or directly at http://www.health.state.pa.us/ (click on "What's New"). Public notice will be published in the Pennsylvania Bulletin. Information on Mifeprex also can be accessed through the FDA website at http://www.fda.gov/.

NOTE: Copies of the Pennsylvania Bulletin notice and the letter the Department of Health is sending to physicians are below.

Dear Physician:

The Food and Drug Administration (FDA) recently announced that it had approved the use of mifepristone (trade name Mifeprex; also known as RU486), with certain restrictions, for the purpose of inducing an abortion. This federal approval raised questions with respect to the application of Pennsylvania's Abortion Control Act (ACA) to abortions induced by drugs.

The Departments of State and Health have enforcement authority for several provisions of the ACA in the Commonwealth. This letter is intended to inform licensed physicians regarding applicability of the ACA to drug-induced abortions.

The ACA, in its entirety, applies to abortions induced by drugs. Among other requirements, the following apply:

-- Only a physician may provide a drug to induce an abortion, and it must occur in a facility registered with the Department of Health to provide abortions.

-- Under the ACA's "informed consent" provision, a woman must be given information about alternatives to, and risks of, a proposed procedure or treatment to cause an abortion that a reasonable person would consider material to the decision of whether or not to undergo an abortion, as well as information about health and other services available before an abortion is provided.

-- Informed consent requires that certain information be provided 24 hours before a drug is provided to induce an abortion.

-- The consent of a parent, or another adult as directed by the ACA, is required for an unemancipated woman under 18 years of age.

-- A report of each abortion must be filed by the facility and signed by the physician responsible for the abortion.

-- A report of complications arising from an abortion or attempted abortion must be filed by a physician who provides medical care to the woman due to the complication.

The ACA provides exceptions to some of these requirements. More comprehensive information on the ACA's application to drug-induced abortions is available on the internet at the following address: http://www.health.state.pa.us/mifepristone.htm. In the near future, the notice that can be found on the website will also be published in the Pennsylvania Bulletin. Additional information on mifepristone and the FDA's decision can be accessed on the internet at the following address: http://www.fda.gov/.

Abortion providers already registered with the Department of Health are receiving a copy of the notice and information published by the FDA. Please keep in mind that the requirements in the Pennsylvania ACA apply in addition to the restrictions imposed by the federal FDA on mifepristone.

Sincerely,

Richard H. Lee
Deputy Secretary for Quality Assurance
Department of Health

C. Michael Weaver, Esquire
Deputy Secretary for Regulatory Programs
Department of State

Notice of Application of Abortion Control Act
To Abortions Induced by Drugs

Notice is hereby given that Commonwealth agencies under the Governor that have responsibility under the Abortion Control Act (ACA) (18 Pa.C.S. Sections 3201-3220) interpret those provisions of the ACA that pertain to abortions, for which they are responsible to satisfy or implement, to apply to abortions induced by drugs.

An "abortion" is defined in the ACA as follows:

"Abortion." The use of any means to terminate the clinically diagnosable pregnancy of a woman with knowledge that the termination by those means will, with reasonable likelihood, cause the death of the unborn child except that, for the purpose of the [ACA], abortion shall not mean the use of an intrauterine device or birth control pill to inhibit or prevent ovulation, fertilization or the implantation of a fertilized ovum within the  uterus. 18 Pa.C.S. Section 3203.

This definition must be read to implicitly include an intent requirement pursuant to American College of Obstetricians and Gynecologists, Pennsylvania Section v. Thornburgh, 737 F.2d 283 (1984), aff'd, 476 U.S. 747 (1986).

With respect to abortions induced by drugs, the Department of Health (DOH) and the Department of State (DOS) interpret provisions of the ACA that pertain to abortions, for which they are responsible  o implement, as follows:

DEPARTMENT OF HEALTH

18 Pa.C.S. Section 3207. Abortion facilities.
This section gives DOH the authority to adopt regulations with respect to the performance of abortions and with respect to facilities in which abortions are performed. A physician who intends to perform an abortion by providing or prescribing drugs must do so only in a facility that is registered with DOH to perform abortions. This section also requires any entity that chooses to operate a facility at which abortions will be performed to first file a report with DOH as described in that section. DOH has labeled the report form the "Abortion Facility Registration Form."

18 Pa.C.S. Section 3208. Printed information.
This section requires DOH to prepare and distribute printed materials that, except in the case of a medical emergency, in the course of securing informed consent to an abortion must be made available to a woman and, unless judicial bypass procedures are followed, must also be made available to other persons such as a parent or guardian when the woman is adjudicated to be incapacitated or is under 18 years of age and not emancipated.

The United States Food and Drug Administration (FDA) recently approved the use of mifepristone to induce an abortion. The FDA approval is  accompanied by several restrictions. One of the restrictions is that mifepristone may not be provided pursuant to a prescription; it may only be dispensed. DOH will supplement the printed material it has already developed with materials developed by the FDA pertaining to the use of mifepristone to induce an abortion and the medical risks commonly associated with that use. DOH will distribute those materials to all facilities registered with DOH to perform abortions and any other person who requests those materials from DOH. These and other materials developed by the FDA which are pertinent to the use of mifepristone to induce abortions may be accessed at http://www.fda.gov/cder/drug/infopage/mifepristone/.

18 Pa.C.S. Section 3213. Prohibited acts.
Subsection (c) of this section provides that DOH is to adopt regulations to assure that prior to the performance of an abortion the maternal Rh status shall be determined and that anti-Rh sensitization prophylaxis shall be provided to a woman at risk of sensitization unless she refuses. DOH has adopted 28 Pa. Code Section 29.33(6) and (7) to address these matters. These provisions are to be satisfied before a drug is provided to or prescribed for a woman for the purpose of inducing an abortion, except as otherwise permitted under subsection (c).

18 Pa.C.S. Section 3214. Reports.
This section requires the filing of various reports with DOH. They include:

Report of Induced Termination of Pregnancy
(18 Pa.C.S. Section 3214(a) and (b))

A facility is required to file a report with DOH for every abortion performed. This applies to an abortion that is performed as the result of a physician providing or prescribing a drug for a woman at the facility. As needed, DOH will update the form and instructions for completing the form and will send the updates to all hospitals and all freestanding facilities registered with DOH to perform abortions.

Abortions: Pathological Examinations
(18 Pa.C.S. Section 3214(c) and (d))

Tissue that is removed when an abortion is performed or induced is to be subjected to a pathological examination and a report to DOH may be required. Pathological examination and reporting requirements differ based upon whether the abortion is performed during or after the first trimester of pregnancy. When a drug is used to induce an abortion fetal and other tissue may be expelled by the woman at a place other than the abortion facility. If no tissue is removed by the physician there is no duty to file a report. However, the reporting requirement does apply if tissue is removed by the physician following an abortion or attempted abortion induced by mifepristone or any other drug.

Abortions: Quarterly Facility Reports
(18 Pa.C.S. Section 3214(f))

A facility is required to file a quarterly report with DOH of all abortions performed in the facility. This applies to an abortion that is performed as the result of a physician providing or prescribing a drug for a woman at the facility.

Report of Maternal Death
(18 Pa.C.S. Section 3214(g))

This report is to be filed with DOH for all maternal deaths that occur in this Commonwealth arising out of pregnancy, childbirth or abortion. The reporting requirement applies when a drug induces the abortion as well s to a maternal death arising from continued pregnancy or childbirth and occurring after an induced abortion has been attempted but not completed.

Abortions: Report of Complications
(18 Pa.C.S. Section 3214(h))

A physician is to file this report with DOH if the physician provides medical treatment or care to a woman due to a complication resulting, in the good faith judgment of the physician, from the woman having undergone an abortion or attempted abortion. The reporting requirement applies when the abortion or attempted abortion was induced by a drug.

DEPARTMENT OF STATE

The following provisions apply to licensed health care professionals. Violations of these provisions constitute unprofessional conduct and may lead to the imposition of disciplinary sanctions by the appropriate licensing board in the Department of State.

18 Pa.C.S. Section 3204.
Medical consultation and judgment. This section provides that an abortion shall be performed only by a physician, and only after the physician has either determined in the physician's best clinical judgment that the abortion is necessary, or receives what the physician reasonably believes to be a written statement signed by another physician (hereinafter called the "referring physician") certifying that in that physician's best clinical judgment the abortion is necessary.

Except in a medical emergency where there is insufficient time before the abortion is to be performed, the physician who is considering performing the abortion or the referring physician is to have a private medical consultation with the woman upon whom the abortion may be performed, in a place and at a time and or a duration reasonably sufficient to determine whether, based upon the physician's best clinical judgment, the abortion is necessary.

In complying with the aforementioned requirements, in determining whether an abortion is necessary the physician's best clinical judgment may be exercised in light of all factors relevant to the well-being of the woman, but an abortion sought solely because of the sex of the unborn child shall not be considered a necessary abortion.

The provisions of this section apply to a physician providing or prescribing for a woman a drug to induce an abortion. This section prohibits the physician who is considering performing the abortion or the referring physician from delegating to another person the performance of any of the requirements of this section.

A physician who violates this section is guilty of unprofessional conduct and is subject to discipline under the Medical Practice Act of 1985 or the Osteopathic Medical Practice Act, depending upon the act under which the physician is licensed. For a first offense the State Board of Medicine or the State Board of Osteopathic Medicine may prescribe such penalty as it deems appropriate. For a second offense the board shall suspend the physician's license for at least 90 days. For a third offense the board shall revoke the physician's license.

A physician who violates this section is guilty of unprofessional conduct and is subject to discipline under the Medical Practice Act of 1985 or the Osteopathic Medical Practice Act, depending upon the act under which the physician is licensed. For a first offense the State Board of Medicine or the State Board of Osteopathic Medicine may prescribe such penalty as it deems appropriate. For a second offense the board shall suspend the physician's license for at least 90 days. For a third offense the board shall revoke the physician's license. No physician shall be guilty of violating this section for failing to furnish the information required to secure the informed consent of the woman to an abortion if the physician can demonstrate, by a preponderance of the evidence, that the physician reasonably believed that the furnishing of the information would have resulted in a severely adverse effect on the physical or mental health of the patient.

18 Pa.C.S. Section 3206. Parental consent.
This section provides that in addition to the informed consent requirements of 18 Pa.C.S. Section 3205 (relating to informed consent), when a woman is adjudged to be an incapacitated person under 20 Pa.C.S. Section 5511, or is less than 18 years of age and unemancipated, a physician may be required to secure the informed consent of an additional person. The duty to secure that additional informed consent does not apply in the case of a medical emergency and under other circumstances explained in this section. Also, if judicial bypass procedures afforded by this section are pursued, neither the informed consent of the woman who is adjudged to be an incapacitated person or is less than 18 years of age and unemancipated, nor of any other person, will be required if the court determines that the woman is not mature and capable of giving informed consent or if the woman does not claim to be mature and capable of giving informed consent, and the court determines that the performance of the abortion would be in the best interests of the woman.

The provisions of this section apply to a physician providing or prescribing for a woman a drug to induce an abortion. This section prohibits the physician who is considering performing the abortion or the referring physician from delegating to another person the performance of any of the informed consent requirements of this section, except as expressly stated in this section or 18 Pa.C.S. Section 3205.

A physician who performs an abortion upon an unemancipated woman less than 18 years of age or a woman adjudged to be incapacitated, either with knowledge or reckless disregard that she is an unemancipated woman less than 18 years of age or a woman adjudged to be incapacitated, and who intentionally, knowingly or recklessly fails to perform any of the requirements of this section imposed upon the physician is guilty of unprofessional conduct and the license of the physician shall be suspended for at least three months under the Medical Practice Act of 1985 or the Osteopathic Medical Practice Act, depending upon the act under which the physician is licensed. For a second offense the State Board of Medicine or the State Board of Osteopathic Medicine shall also suspend the physician's license for at least 90 days. For a third offense the board shall revoke the physician's license.

18 Pa.C.S. Section 3210. Determination of gestational age.
This section provides that except in a case of a medical emergency that prevents compliance with the section, no abortion is to be performed or induced unless the physician who is considering performing or inducing the abortion or the referring physician has first made a determination of probable gestational age of the unborn child. In making that determination, the physician is required to make such inquiries of the patient and perform or cause to be performed such medical examination and tests as a prudent physician would consider necessary to make or perform in making an accurate diagnosis of gestational age.

If an abortion occurs, the physician who performs or induces the abortion is to report on forms provided by DOH the type of inquiries made and the type of examinations and tests utilized to determine the gestational age of the unborn child and the basis for the diagnosis or gestational age. The form DOH provides for this purpose is the Report of Induced Termination of Pregnancy form.

ST: Pennsylvania

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