WASHINGTON — The decision by the U.S. Food and Drug Administration’s acting commissioner to suspend enforcement of the agency’s in-person prescribing requirement for the abortion drug endangers women’s health and possibly their lives, pro-life leaders said.
On April 12, Dr. Janet Woodcock said the FDA will “exercise enforcement discretion” regarding its own requirement that is part of the risk management program for mifepristone as long as President Joe Biden’s declaration of a public health emergency for COVID-19 remains in place.
The brand name for mifepristone is Mifeprex. Also called RU-486, it is used to end pregnancies during the first 10 weeks.
Archbishop Joseph F. Naumann of Kansas City, Kansas, chairman of the U.S. bishops’ Committee on Pro-Life Activities, said April 16 it was difficult to see the FDA’s decision “as anything other than callous capitulation to the requests of abortion activists without regard for the health and safety of the women involved.”
“With this decision, not only are women being sold the lie that abortion will solve their problems, but also that chemical abortion is a safe and easy way to go about it,” he said in a statement. “By pushing women away from medical oversight, abortion advocates are luring women into isolated, unsafe and medically unwise decisions.”
“The inalienable dignity of women and their unborn children deserves so much more,” he added.
Woodcock said making women pick up the drug may increase their risk of contracting COVID-19, FDA said, so it will temporarily allow clinics to distribute the drug via telemedicine, directly by mail or through a mail-order pharmacy.
FDA regulations also required patients to sign a form acknowledging risks associated with the drug before they could receive it in person.
“An in-person evaluation by a medical professional is necessary to accurately determine the age of the baby” because abortion pills are only approved for use in the first 70 days, Archbishop Naumann said.
This evaluation also is needed “to determine whether the pregnancy is ectopic,” which the woman has no way of knowing on her own, he continued, and as well as “to test and treat for Rh-incompatibility between mother and baby.”
“Without this information and proper treatment, a woman’s health, future fertility and life are placed in serious jeopardy,” he said.
Rh incompatibility occurs when a woman who has Rh-negative blood becomes pregnant with a baby with Rh-positive blood. These antibodies help drive an immune system attack against the baby, which the mother’s body views as a foreign object. Rh immune globulin must be administered during the woman’s pregnancy to prevent this incompatibility.
In an April 13 statement, Dr. Christina Francis, chair of the American Association of Pro-Life OB/GYNs, said “an in-person visit is medically necessary and sound medical practice because it ensures that every woman receives a full evaluation for any contraindications to a medication abortion.”
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