The plaintiffs in a federal lawsuit pending against the Food and Drug Administration want to make the abortion pill as accessible as penicillin.
A Hawaiian physician and three organizations are contesting FDA safeguards for mifepristone, marketed as Mifeprex, the only FDA-approved abortion drug. They argue that the standards pose an unconstitutional impediment to obtaining an abortion.
However, the greatest obstacle to Mifeprex sales is not the FDA, but the scruples of doctors themselves. Quite simply, Mifeprex is limited because health care providers are not stocking and prescribing a drug they regard as dangerous or unethical.
The risks associated with Mifeprex, which blocks the progesterone necessary for a continued pregnancy, occur frequently, are significant and increase as the pregnancy progresses: hemorrhage, incomplete abortion and infection. An additional risk for any pregnancies that continue despite the abortion attempt is that misoprostol — a potent drug used in combination with Mifeprex under the FDA-approved regimen — is associated with birth defects.
The need for an exact determination of gestational age, as well as for ongoing physician involvement to manage complications, makes easy pharmacy access to Mifeprex very dangerous for women.
The alleged “burdens” imposed by the Mifeprex regulations are a simple certification to demonstrate a provider’s competence and a requirement that providers prescribe and dispense Mifeprex in a qualified health care setting (rather than outsource this to retail pharmacies). Abortion advocates view the doctor’s appointment as an unnecessary impediment to the use of telemedicine, particularly in rural areas where abortion facilities are sparse.
Let that sink in. The goal is self-administered abortion at home, with a prescriber-patient relationship limited to a video chat. An abortionist would bear no responsibility for a thorough examination that might detect a life-threatening condition like ectopic pregnancy, or an in-person interview capable of revealing abuse or coercion in the patient’s abortion decision. Instead, after receiving the patient’s blood test and ultrasound and conducting a videoconference, the health care provider could fax a prescription for Mifeprex to a retail pharmacy virtually anywhere.
In fact, some abortion advocates view these standard prenatal tests as unnecessary.
Abortion advocates also claim the FDA’s requirements deter many health care practitioners. One plaintiff in the lawsuit, Dr. Graham T. Chelius, never attempted to become a certified provider of Mifeprex. He does not wish to stock Mifeprex in his office, because he believes that some of his colleagues “would be upset, angry, and/or uncomfortable” if they were “asked” to be involved in chemical abortion. Instead, he wants to write prescriptions for Mifeprex for his patients to fill at a local or mail-order pharmacy.
Dr. Chelius’ argument is specious. Most medical professionals who abstain from dispensing Mifeprex do not want to prescribe it at all. As the plaintiffs admit, a recent survey of more than 1,100 practicing board-certified OB-GYNs found that fewer than one in five of the doctors not currently prescribing Mifeprex would begin prescribing the drug if the safety protocols were removed — hardly a dramatic shift in Mifeprex availability.
The plaintiffs in the lawsuit fail to acknowledge serious, legitimate concerns about the safety of prescribing Mifeprex by teleconference. It would be unacceptably hazardous to remove a protocol, deemed necessary by the FDA for mitigating risks from a dangerous drug, simply because health care providers want to distance themselves from abortion.
Courts and the FDA should consider whether they are effectively swapping the proverbial coat hanger for a pill if they capitulate. Is it truly a move toward reproductive freedom for a woman to receive Mifeprex from a prescriber she has met only over the Internet, who may be hundreds of miles away or unqualified to handle abortion complications, leaving her with the emergency room as her only recourse in a potentially life-threatening situation?
It is not the FDA’s job to normalize chemical abortion as part of family medicine or obstetric practice. It is not the FDA’s job to encourage abortionists to locate in rural areas. It is not the FDA’s job to challenge public discomfort with or opposition to abortion that results in a real or perceived stigma against abortionists. It is not the FDA’s job to bypass their own conclusion that a drug needs a stringent protocol that is incompatible with telemedicine. It is the FDA’s job to protect patient safety.
Perhaps the practitioners and administrators who do not want to dispense Mifeprex have their own concerns about the drug’s risks, the push to expand “convenient” abortion into people’s homes, or abortion in general.
We should listen to them.
Mary E. Harned served as an Investigative Counsel with the Select Investigative Panel of the U.S. House Energy and Commerce Committee, where she coauthored reports examining the fetal tissue industry. She also crafted original model legislation and supporting materials to aid state and federal legislators in advancing policy objectives within her expertise.
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