By Tre Critelli
In September of 2000, the Food and Drug Administration (FDA) approved the marketing and use of mifepristone (brand name Mifeprex, but commonly known as RU-486) for the termination of early intrauterine pregnancy, which is defined as a pregnancy of 49 days or less counting from the last menstrual period. The FDA conditioned the distribution of the drug, however, on the performance of specified medical requirements to ensure its safe use. This is known in the legal/medical industry as a ”Subpart H” approval. See 21 CFR 314.520.
On May 17, 2006, Dr. Jane Woodcock, Deputy Commissioner for Operations at the Food and Drug Administration, testified to a subcommittee of the U.S. House of Representative’s Committee on Government Reform about the FDA’s approval of Mifeprex. It was during her tenure as the Director of the FDA’s Center for Drug Evaluation and Research that the FDA approved Mifeprex for use. As noted by Dr. Woodcock:
Some complications of medical abortion are similar to those of surgical abortion, and some of these require a surgical intervention. Comprehensive risk management of abortion therefore requires that the managing physician be able to diagnose an ectopic pregnancy, manage the risks of abortion, including bleeding and infection, and be able to conduct a surgical abortion if necessary or quickly refer a patient to a provider who is trained, qualified, and readily available to do so.Woodcock, p.2.
According to Dr. Woodcock, as part of the Subpart H approval for Mifeprex, distribution of the drug was restricted in several ways, including that it must be provided by or under the supervision of a physician who meets certain qualifications. These restrictions were designed to ensure the safe use of the drug. They include specific requirements concerning diagnosis, treatment, patient information and reporting:
Diagnostic requirements: Physician must be able to accurately assess the duration of the pregnancy and whether or not the patient has an ectopic pregnancy.
Treatment requirements: Physician must have the ability to provide either directly or through another qualified physician, surgical intervention in cases of incomplete abortion or severe bleeding, and the ability to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.
Informational requirements: Physician must understand the prescribing information about Mifeprex; must explain and discuss with the patient the procedure that will be performed, provide the patient with a Medication Guide and Patient Agreement, and obtain the patient’s signature on the Patient Agreement.
Reporting requirements: Physician must record the Mifeprex package serial number in the patient’s medical record, notify the drug’s sponsor in the event the pregnancy is not completely terminated by the procedure or if the patient needed any hospitalization, transfusion or other serious complication.
Further, the approving label for Mifeprex includes a Prescriber’s Agreement that each provider must sign before being able to receive the drug for distribution. This includes agreement with the following statement: “Under Federal law, Mifeprex must be provided by or under the supervision of a physician.”
Ordinarily, the FDA requirements are complied with and a physician is physically in attendance during the consultation, diagnosis and procedure. Under a plan pioneered and currently in practice here in Iowa by Planned Parenthood of the Heartland, however, the attending physician is no longer physically present with the patient, but is instead there virtually, by what is known as telemedicine.
What is telemedicine?
According to the American Telemedicine Association, the term telemedicine refers to “the use of medical information exchanged from one site to another via electronic communications to improve patients’ health status.” It is often used to describe the rendering of clinical services remotely through some form of electronic medium, be it a phone, fax, video or email. As noted by the ATA website:
Telemedicine is not a separate medical specialty. Products and services related to telemedicine are often part of a larger investment by health care institutions in either information technology or the delivery of clinical care. Even in the reimbursement fee structure, there is usually no distinction made between services provided on site and those provided through telemedicine and often no separate coding required for billing of remote services.
Given the ubiquity of the internet these days, telemedicine certainly offers a great benefit to both the provider and the recipient of medical services. The use of telemedicine to perform abortions, however, goes beyond electronic medical records, remote viewing of records by radiologists and online medical prescriptions. It is aimed at creating a new method of administering an abortion, the telabortion.
What is a telabortion?
Telabortion is the remote performance of an abortion, perhaps best described as an “internet abortion.” Unlike other forms of telemedicine where medical information is exchanged, conditions diagnosed and prescriptions written, telabortion stands out because the physician is actually performing a medical procedure without being physically present with the patient. During a telabortion, the patient is seated at a computer in one location while the attending physician is located off-premises. There is a nurse or aid present with the patient. The doctor and patient are able to see and speak to each other. After consultation, the doctor can then remotely open a drawer at the patient?s location. Inside the drawer is a dose of Mifeprex, which is then taken by the patient.
Are telabortions in compliance with the law?
The question of the legality of telabortion will ultimately turn on whether or not a physician who is virtually present can comply with the necessary requirements of Iowa law pertaining to abortions as well as the specific federal regulations concerning Mifeprex.
Iowa Code section 707.7 is quite specific that only those “licensed to practice medicine and surgery under the provisions of Chapter 148, or an osteopathic physician and surgeon licensed to practice osteopathic medicine and surgery under the provisions of Chapter 150A can terminate a human pregnancy.” If anyone else performs an abortion, it is a felony (emphasis Quiner’s Diner). Thus, in order to be in compliance with the law, proponents of telabortions must take the position that it is the physician who is performing the medical procedure. To argue that another individual is actually performing the procedure is a clear violation of the law.
The matter is further complicated when it is a minor seeking an abortion. While the State of Iowa allows abortions to be performed upon minors, there are specific requirements set forth in Iowa Code section 135L which must be fulfilled by the physician who will be performing the abortion, ranging from the obtaining a completed certificate concerning the offering of a statutorily required video to the minor to the requirement that “the licensed physician who will perform the abortion shall provide notification in person or by mailing the notification by restricted certified mail to a parent of the minor.” Such a notification has to be served at least 48 hours before the abortion is performed, except in certain circumstances. See Iowa Code section 135L.3(3)(m). At least one of the listed exceptions (grandparent notification) requires the physician and minor to exchange written documentation. It is difficult to see how these documentation and notification requirements can be complied with during a single telabortion session. It should be noted that failure to comply with the requirements is punishable by up to a year in prison.
Practically speaking, it will be Planned Parenthood of the Heartland’s ability to comply with the FDA regulations concerning Mifeprex that will determine whether or not a telabortion can be performed. Can a virtual physician fulfill the requirements as set forth in Dr. Woodcock’s testimony? Can such a physician “diagnose an ectopic pregnancy, manage the risks of abortion, including bleeding and infection, and be able to conduct a surgical abortion if necessary or quickly refer a patient to a provider who is trained, qualified, and readily available to do so.”
The answer will ultimately have to be decided by the Courts. Until such time, however, the default answer should be ‘no’ and all telabortions in the State of Iowa halted. The burden should be upon Planned Parenthood of the Heartland to prove that their virtually present physician can perform as ethically and legally required, not upon opponents of the procedure to prove otherwise. The cost to Planned Parenthood of the Heartland for stopping telabortions is minimal, merely one of convenience: a woman may have to drive a bit farther to receive an abortion. The cost of not stopping telabortions, however, could potentially result in the loss of her life. Given the choice, there is little doubt that she would choose a little more time in her car over the risk of suffering a life-threatening complication while her attending physician watches, helpless, over the internet.
[Telabortions will have a profound long term effect on Iowa, and eventually the entire U.S. if the practice is allowed to continue. Guest columnist, Tre Critelli, presents a concise legal background on this issue. Mr. Critelli is an Iowa Trial Lawyer/English Barrister/Certified Fraud Examiner. Quiner’s Diner thanks him for the legal background on this abominable practice. Check out additional posts on this critical subject here. Encourage your friends to read the above article to be informed.]