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Explainer: Pro-life leaders ask FDA to remove abortion pill from the market

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July 31, 2020

On Tuesday, July 28, a group of 22 pro-life leaders—including ERLC President Russell Moore—sent a letter to the Food and Drug Administration (FDA) urging the agency to categorize the abortion pill mifepristone, sold under the brand name Mifeprex, as an “imminent hazard to the public health.”

The letter is in response to the a ruling earlier this month by a federal judge that suspended a rule requiring women during the COVID-19 pandemic to visit a hospital, clinic, or medical office to obtain the abortion pill.

U.S. District Judge Theodore Chuang in Maryland concluded that the “in-person requirements” for patients seeking medication abortion care impose a “substantial obstacle” to abortion patients and are likely unconstitutional under current laws pertaining to abortion.

Moore said the FDA has “a responsibility to protect the American people from the marketing of dangerous drugs and products. This pill is lethal to preborn children and also potentially perilous for their mothers too. The FDA should reject this drug, and we should all work to support children and their mothers in ways that affirm life, not violence.”

What is Mifeprex?

Mifeprex is the brand name for mifepristone, a drug that was formerly known as RU-486. The drug was developed in France in the 1980s and banned by President George H.W. Bush administration’s FDA in 1989. In 1993, President Bill Clinton asked the FDA to review the ban, which was lifted in 2000. Since then it has become the most common drug used for chemical abortions. 

Currently, the drug is approved by the FDA provided it is “dispensed in certain healthcare settings, specifically, clinics, medical offices and hospitals, by or under the supervision of a certified prescriber.” In 2016, the FDA extended the time the abortion pill could be taken to 70 days into a pregnancy. 

How does Mifeprex cause abortion?

The two broad methods for legal abortions in the U.S. are medical and surgical. A medical abortion (sometimes referred to as a medication abortion, chemical abortion, or pharmaceutical abortion) is a method that uses an abortifacient to stimulate uterine contractions and end the pregnancy in a process similar to miscarriage.

The FDA approved method for chemical abortions is a two-step process involving the drugs mifepristone and misoprostol. Mifepristone (brand name Mifeprex) ends a pregnancy by blocking the hormone progesterone, which is needed to maintain a pregnancy. Because this hormone is blocked, the uterine lining begins to shed, removing the child (in the embryonic state) that was attached. The second step, which occurs 24 to 48 hours later, requires taking misoprostol which causes the woman to expel the child and the uterine lining in a matter similar to a miscarriage.

Are chemical abortions dangerous to women?

As Americans United for Life notes, numerous, well-documented studies in peer-reviewed medical journals have demonstrated that chemical abortions pose significant medical risks for women. A review of nearly 7,000 abortions performed in Australia in 2009 and 2010 found that 3.3 percent of patients who used mifepristone in the first trimester required emergency hospital treatment, in contrast to 2.2% of patients who underwent surgical abortions.

Women receiving chemical abortions were also admitted to hospitals at a rate of 5.7% following the abortion, as compared with 0.4% for patients undergoing surgical abortion. The letter to the FDA also cites the warning by the Association of Pro-Life Obstetricians and Gynecologists (APLOG) that “the abortion pill poses a four-times higher risk of complication than surgical abortion in the first trimester.” 

Which pro-life groups/leaders signed the letter?

In addition to ERLC President Russell Moore, the letter was signed by: