FDA & Abortion Pill — Pro-Life Leaders Ask FDA to Remove Drug Mifepristone from Market

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The headquarters of the U.S. Food and Drug Administration in Silver Spring, Md. (Jason Reed/Reuters)

In a letter this morning, more than 20 leaders from conservative and pro-life organizations are asking the Food and Drug Administration to remove the chemical-abortion drug mifepristone from the market, calling it “highly dangerous for women.”

“While we are encouraged by the FDA’s decision to shut down illegal websites trafficking unapproved abortion pills into the US, we futher insist you exercise your authority under 21 CFR § 2.5 to classify the abortion pill as an ‘imminent hazard to the public health’ that poses a ‘significant threat of danger,’” the letter says, according to a copy provided exclusively to National Review.

The letter follows a recent decision from a federal judge, who ruled that the FDA’s safety standards for mifepristone — which require that women obtain the drug in person from a physician or prescriber — are an unconstitutional “substantial obstacle” to women’s abortion rights during the COVID-19 pandemic.

“By causing certain patients to decide between forgoing or substantially delaying abortion care, or risking exposure to COVID-19 for themselves, their children, and family members, the In-Person Requirements present a serious burden to many abortion patients,” U.S. district judge Theodore Chuang wrote.

That ruling came after Democratic attorneys general and dozens of Democratic lawmakers demanded that the FDA remove its safety regulations so that women could more easily obtain chemical-abortion drugs for the duration of the pandemic.

“The constitutional merits of the right to abortion aside, the Supreme Court places no burden on the FDA to approve dangerous methods of abortion,” the letter from pro-life leaders states. It continued:

Yet, on July 13, 2020, a lone federal district judge circumvented the FDA’s considered judgement that this dangerous drug be dispensed in a healthcare setting, and enjoined the FDA from fully enforcing the REMS protocols. This rogue judicial activism is a gross breach of the separation of powers, undermining the FDA’s statutory authority to regulate drug safety, while recklessly endangering American women and preborn children.

While advocates of expanding legal abortion insist that chemical abortion is safe, mifepristone carries the risk of serious complications that often require follow-up care, a particular problem during the COVID-19 pandemic. Somewhere between 5 percent and 7 percent of women who ingest mifepristone abortion will require a follow-up surgical abortion. One survey found that more than 3 percent of women who underwent a medical abortion in the first trimester required emergency-room admission to manage complications.

The letter also points out that, since 2000, the FDA itself has documented more than 4,000 “adverse events” for women after taking mifepristone, including 24 maternal deaths. It notes that the FDA requires only abortion-pill manufacturers to report maternal deaths, while most women who experience severe side effects are likely to seek care at emergency rooms, which are not required to report adverse events.

The letter is signed by Jeanne Mancini of the March for Life, Jessica Anderson of Heritage Action, Marjorie Dannenfelser of the Susan B. Anthony List, Lila Rose of pro-life group Live Action, and more than a dozen other pro-life leaders and activists.





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