Abortion Pill

Under Biden administration, FDA faces pressure to remove safety protocols on abortion pill

abortion pill

The U.S. Food and Drug Administration (FDA) under the Biden administration is under intense pressure from abortion advocates to approve DIY at-home abortions by pill, removing the FDA’s long-held safety requirements for obtaining the abortion pill. As POLITICO noted, pressure is mounting from multiple sources, including “activists, lawmakers, and medical groups.”

Predictably, abortion advocates have framed the debate over mail-order or online access to the abortion pill as an issue of safety during the ongoing global pandemic, particularly for underserved populations. For example, an abortion advocate with All* Above All claimed, “We are working towards a future where abortion care is there when we need it, where it’s affordable, accessible and on our own terms, without barriers. Medication abortion gets us closer to that world — where it doesn’t matter who we are, how much we earn, or where we live.”

Additionally, Planned Parenthood supporter and abortion provider Dr. Jennifer Villavicencio of Michigan told POLITICO that last spring she distributed abortion pills to patients in their cars in her office’s parking lot. “We were trying to avoid interactions with other people to try to quell the rising numbers of Covid-19 cases,” she said, insisting, “Many medications that have much higher risk profiles were allowed to remove the in-person requirement because of the pandemic. But that courtesy and safety measure was not offered to people who were seeking abortion care or miscarriage management.”

READ: An OB/GYN speaks: The ‘no-test’ abortion pill protocol experiments with women’s health

Unfortunately, POLITICO failed to discuss the real safety concerns that come with at-home abortions, which have already played out in countries where DIY abortions were legalized during the pandemic. Earlier this month, Live Action News shared a piece from Right to Life UK which noted that ambulance calls due to DIY abortion complications in Wales have increased 100% since the pills were approved for temporary use last year. That piece highlighted the complete lack of oversight in multiple European countries that puts women at risk for serious complications from telemedicine abortion and provided evidence of the massive underreporting of complications leading to an inability to accurately gauge the true complication rate. In addition, a recent poll points out that many UK doctors have ‘serious concerns’ about the at-home abortion pill regimen.

When the woman takes the first pill in-office, she has already had a pregnancy test in the clinic and usually confirmation of her preborn child’s gestational age via ultrasound, as the abortion pill regimen is only approved through 10 weeks by the FDA. Bloodwork is also done to check for Rh incompatibility, which would require a shot to prevent problems in future pregnancies. With a remote “no-test” abortion pill protocol, no medical professional will confirm the child’s gestational age, nor will anyone confirm that the pregnancy is intrauterine, nor will anyone do bloodwork. One potentially serious problem with this is that a pregnancy could be ectopic. A rupture of the Fallopian tube can be life-threatening for the woman, and the abortion pill regimen will not work on an ectopic pregnancy, meaning that the pregnancy could continue without the woman’s knowledge until the point of rupture.

A September 2020 letter from Republican lawmakers to the FDA commissioner noted, “According to FDA reporting, the abortion pill has taken more than 3.7 million preborn lives, caused 24 maternal deaths, and resulted in at least 4,195 adverse maternal reactions including hemorrhage, excruciating abdominal pain, and severe life-threatening infections. Of course, adverse events are notoriously underreported, which makes the true number impossible to assess.”

Certainly, the American College of Obstetricians and Gynecologists is one of the foremost medical groups lobbying for telemedicine/”no-test” abortions. Yet, the ACOG routinely fails to disclose its own financial conflict of interest, including its receipt of monies from an organization directly funded by the abortion pill manufacturer, Danco. ACOG further sees no problem with the fact that a change in recent years to Danco’s complication reporting requirements made it so that only fatal adverse events from the abortion pill regimen are required to be reported to the federal government. Live Action News previously reported that the abortion pill regimen has been found to be four times more dangerous than a first-trimester surgical abortion.

For now, a stay from the United States Supreme Court prohibiting the lifting of FDA safety guidelines on abortion pill administration remains in place.

Editor’s Note, 4/18/21: The FDA has received reports of serious adverse events in women who took Mifeprex. As of December 31, 2018, there were reports of 24 deaths of women associated with Mifeprex since the product was approved in September 2000, including two cases of ectopic pregnancy resulting in death; and several cases of severe systemic infection (also called sepsis), including some that were fatal. 

The adverse events cannot with certainty be causally attributed to mifepristone because of concurrent use of other drugs, other medical or surgical treatments, co-existing medical conditions, and information gaps about patient health status and clinical management of the patient. A summary report of adverse events that reflects data through December 31, 2018 is here.

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