By Randall K. O’Bannon, Ph.D., NRL Director of Education & Research
Editor’s note. The issues raised here in this series are part of a larger more detailed defense and analysis of the FDA’s regulations on mifepristone offered in National Right to Life’s “Special Report” found at nrlc.org/uploads/reports/RUREMSDefenseReport.pdf.
Because of known risks with the drug, the U.S. Food and Drug Administration (FDA) has had restrictions on the distribution of mifepristone from the time it first approved marketing in September of 2000. Over the years it has modified its label, issued warnings and reinforced and extended these restrictions in light of issues and injuries which have come to light
With that 2000 approval, the FDA used the authority it had under a regulatory framework known as “Subpart H” to impose limits on its distribution. It required, among other things, that mifepristone (the first of the two drugs) only be distributed under the supervision of physician who could certify that he or she understood how the chemical abortion process worked and knew the risks associated with the drug.
In 2007 the Subpart H framework was replaced by a new FDA regulatory system called the Risk Evaluation and Mitigation Strategy (REMS). The FDA applies REMS to drugs it feels need special safety management.
Current REMS for mifepristone were issued in March of 2016. Despite legal challenges and calls for their rescission, they remain on the books, reflecting the FDA’s considered medical opinion and ongoing concerns about the drug based on nearly two decades of experience with the drug.
The REMS regulations imposed on mifepristone were a reasonable response by the FDA to concerns it had about the drug’s safety.
According to the FDA
A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication.
In light of the “serious safety concerns,” some detailed below, the FDA imposed the following conditions on prescribers ordering mifepristone, the drug used in most chemical abortions in the U.S. They required that they have the ability to:
• assess the duration of pregnancy accurately
• diagnose ectopic pregnancies
• provide surgical intervention in cases of incomplete abortion or severe bleeding or have made plans to provide such care through others.
• assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.
Healthcare providers prescribing the drugs must also review the FDA’s Patient Agreement Form with the patient. This describes the procedure, major risks, and symptoms that should prompt the woman to seek emergency help. Both the woman and prescriber are to sign the agreement. One copy goes in the patient’s medical record and the other is given to the patient along with a more detailed Medication Guide.
The pills are only to be distributed to clinics, medical offices, or hospitals “by or under the supervision of a certified prescriber” (i.e., ones who have completed the certification process).
The distributor is to keep records and ensure that appropriate processes are being followed. Pills are not to be shipped to prescribers who become decertified.
Any deaths are to be reported to the pill’s authorized distributor. The distributor is to report any deaths of mifepristone patients to the FDA within 15 days of receiving such information.
Abortion pill advocates resist these common sense safety measures.
The abortion industry has fought against virtually every limit that the FDA has placed on mifepristone. Though they complain that such regulations are unnecessary and burdensome, their clear objective has been to broaden the potential customer base and to widen the pool of prescribers or “providers.”
It fought to ensure there was no ultrasound requirement. This would have helped doctors more accurately date and locate the pregnancy, insured that the mother was not too far along for the abortion pill to work, and that she did not have an ectopic pregnancy for which the pills would not work.
The abortion industry fought any requirement that the prescribing clinician would have had to have surgical training to handle bleeding issues or failed or incomplete abortions, conditions likely for a significant portion of patients. The industry went further. They pushed the FDA to allow not just doctors to prescribe these pills, but also any generic “certified healthcare provider” who may not only lack any surgical skill but may have only a modicum of medical training.
It fought against any protocol calling for women to visit or return to the clinic or doctor’s office for screening, counseling, an examination, or to receive or be administered the pills. They argued these could be done virtually or by phone or even by a computer questionnaire.
This, of course, ignores the gravity of this encounter, the importance of examining the woman, dating and locating her pregnancy, and impressing on her the importance of following instructions, making sure she is clear about warning or danger signs. Critically, that encounter also provides her with a face, a name, an address close enough for her to contact if and when problems arise.
Watering down or getting rid of any of these restrictions do nothing to address or reduce the risk associated with these abortions. But they do make it easier, cheaper for would be “providers.”
If pills don’t have to be delivered on site, if prescribers don’t have to be doctors trained to handle complications, then doctors, offices, expensive ultrasound and resuscitation equipment, surgical facilities and instruments, etc., aren’t needed. Pills can be sold by entrepreneurs over the internet with minimal medical training.
Potentially more profitable for certain members of the abortion industry, obviously, but clearly not safer for the patients involved.
The active supervision of healthcare professionals is critical to the safety of medication abortion patients.
The chemical abortion process is inherently bloody, painful, and complicated. It doesn’t work a significant percentage of the time. There are several common conditions for which health care professionals must screen potential chemical abortion patients, given that they could result in the drugs being ineffective or render their use more dangerous.
The FDA knows of multiple cases where women who appeared to be in prime physical condition took the drugs and died or experienced serious complications or “adverse events.”
Some organizations, including National Right Life, feel this is sufficient to merit the removal of this drug from market altogether. At the very least, it clearly justifies as much control over the drug’s distribution and utilization as possible in order to minimize the inevitable deaths and injuries.
Tomorrow, in Part IV, we’ll look at the critical role that medically trained healthcare professionals play in screening unsuitable candidates from chemical abortion and monitoring the progress of those who have taken the pills.
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