The Biden Administration is continuing to push for the loosening of safety standards placed on the abortion pill, mifepristone. The Justice Department (DOJ) and Danco Laboratories, the manufacturer of mifepristone, have submitted filings to the Supreme Court urging a reversal of the U.S. Court of Appeals for the Fifth Circuit’s ruling to reinstate safety measures on the abortion pill. Those safety standards prohibited telemedicine abortions and mail-order shipments of the abortion pill.
In a written brief submitted to the Supreme Court, the DOJ said the 5th Circuit’s decision “threatens to destabilize the pharmaceutical industry, which relies both on the FDA’s ability to make predictive judgments and on courts not second-guessing those scientific judgments.”
In addition, Solicitor General Elizabeth Prelogar claimed in the brief, “The loss of access to mifepristone would be damaging for women and healthcare providers around the nation. For many patients, mifepristone is the best method to lawfully terminate their early pregnancies.”
However, the abortion pill has long proven dangerous for women, though most women are unaware, since only about half of all states are required to even report abortion-related complications. The chemical abortion pill process involves the use of mifepristone to block the naturally occurring pregnancy hormone progesterone, which ensures the child is nourished and sustains the pregnancy, and a second drug, misoprostol, which induces contractions. Abortion activists often assert that mifepristone is as ‘safe as Tylenol,’ but this claim is misleading.
A study by the abortion industry itself disclosed an ER and urgent care visit rate of six percent following administration of the abortion pill, 107 times higher than that of acetaminophen/Tylenol. In addition, the abortion pill has been found to be four times more dangerous for women than first-trimester surgical abortions. One risk is that women may unknowingly be experiencing an undiagnosed ectopic pregnancy, risking fatal hemorrhage when they take the abortion pill. Without pre-abortion ultrasound or blood testing (known as “no-test” abortions), miscalculations of pregnancy duration can lead to incomplete abortion and life-threatening infection.
The FDA first approved mifepristone in 2000 for use up to seven weeks. In 2011, the FDA placed the drug under its REMS safety system, but not before multiple women had died* in association with the use of the abortion pill regimen. The FDA then removed several safety requirements in 2016, prompting the Alliance for Hippocratic Medicine, a group of medical doctors and organizations that claim the 2000 approval of the drug was illegal, to file a lawsuit against the FDA in November 2022. Many doctors testified that women are going to the emergency room with complications after taking the abortion pill.
READ: The FDA and the abortion pill: A timeline of key events
In recent years, the FDA has progressively expanded the use of the abortion pill — reducing the required in-person doctor’s visits, extending the gestational timeframe for abortion pill administration, and allowing mail delivery of the drug.
Randall K. O’Bannon, Ph.D., NRL Director of Education and Research, highlighted the true danger of the abortion pill, stating, “Of course, any discussion of this sort ignores the most obvious and serious safety issue with mifepristone – that someone dies every time the abortion drug is used successfully – the innocent unborn child who is the target of this ‘medication.’”
Sadly, the shift to telehealth during the COVID-19 pandemic has dangerously popularized at-home abortions, with medication abortions now accounting for over half of all abortions in the U.S. in 2020, according to the Centers for Disease Control and Prevention.
The Biden Administration’s push to curb abortion pill restrictions aligns with the 51st anniversary of the now-overturned Roe v. Wade decision. President Biden, advocating for the restoration of Roe, pledged to protect access to the abortion pill. Since the 2022 Supreme Court decision Dobbs v. Jackson Women’s Health Organization that overturned Roe, 14 U.S. states have implemented laws protecting most preborn children from abortion, while others enacted laws that protect certain preborn children after a specific duration of pregnancy.
“The Biden-Harris Administration supports a policy of unlimited abortion, meaning abortion anytime, anywhere, and under any circumstances,” said Carol Tobias, president of National Right to Life. “Both Joe Biden and Kamala Harris see the lives of precious preborn babies as expendable.”
Oral arguments for the appeal are scheduled to be heard by the Supreme Court on March 26. In the meantime, mifepristone will remain on the market for the duration of the legal proceedings. A decision is expected in the timeframe of late June 2024.
*The FDA has received reports of serious adverse events in patients who took mifepristone. As of December 31, 2022, there were 32 reports of deaths in patients associated with mifepristone since the product was approved in September 2000, including two cases of ectopic pregnancy (a pregnancy located outside the womb, such as in the fallopian tubes) resulting in death; and several fatal cases of severe systemic infection (also called sepsis). 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, 2022, is here. The FDA has reviewed this information and did not identify any new safety signals. The FDA intends to update this summary report as appropriate.
Editor’s Note 1/30/24: This article was updated with the date for oral arguments in the case.
