FDA approval of generic abortion pill sparks criticism

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LOUISVILLE, Ky. (KT) – The Federal Drug Administration approved last month another generic version of mifepristone, the first pill used in a two-drug regimen to abort pregnancies through 10 weeks' gestation. 

 Southern Baptists are among the voices speaking out against another mifepristone pill hitting the market.

Gary Hollingsworth, interim president of the Ethics and Religious Liberty Commission, sent a letter to the FDA and Department of Health and Human Services on Friday, expressing deep concern and noting "grave moral implications for the drug's approval."

"The FDA's approval of a new, generic abortion pill should weigh heavy on the hearts of Southern Baptists, who boldly and bravely speak the truth of God as the Creator and giver of life. We affirm that life is a sacred gift, not a commodity to be regulated or discarded," Hollingsworth said in a press release.

 The new pill is produced by Evita Solutions. Mifeprex, brand-name mifepristone, was originally approved by the FDA in September 2000; a generic pill manufactured by GenBioPro was approved in 2019.

 "Evita Solutions believes that all people should have access to safe, affordable, high-quality, effective, and compassionate abortion care," according to its website. The company also said it seeks "to normalize abortion care."

"There will never be anything normal about abortion, and there is nothing compassionate about ending the life of an unborn child," said Addia Wuchner, executive director of Kentucky Right to Life.

Wuchner called the FDA's approval "an assault on women's health" that diminishes maternal care.

 "The product's own published risks and black box warnings are clear. This medication carries multiple and serious health risks, including hemorrhage and infection…To expand its use is reckless, dangerous, and morally indefensible," she said.

 A spring report by the Ethics & Public Policy Center examined insurance claims related to adverse events associated with mifepristone. The EPCC said it found approximately 10% of women who used the drug to end a pregnancy experienced serious side effects, including sepsis, infection, and hemorrhage. Clinical trials for the drug showed that less than 0.5% of women who used mifepristone reported a serious adverse event.

In June, messengers at the Southern Baptist Convention Annual Meeting approved a resolution standing against the moral evils and medical dangers of abortion pills. 

The ERLC's executive vice president and chief of staff, Miles Mullin, said the FDA's decision was tragic.

"The outcomes of the FDA’s approval of a new generic form of mifepristone are clear: more women will suffer and more preborn children will die,” Mullin said. “As we made clear in a resolution on this very topic at our last Annual Meeting in Dallas, Southern Baptists want this dangerous drug taken off the market altogether. Unfortunately, this decision by the FDA moves in the other direction, expanding its availability and fanning the flames of the culture of death that still persists in our country over three years since the Dobbs decision.”

Chemical abortions account for a majority of elective pregnancy terminations in the U.S. since the Supreme Court overturned Roe v. Wade in 2022. Since the FDA permanently lifted its in-person dispensing requirement in 2023, organizations such as Aid Access and The MAP have provided mifepristone via telehealth, shipping abortion pills nationwide despite legal challenges and efforts by some states to ban chemical abortions or block telehealth abortion services.

According to the Associated Press, new drug applications are typically approved by the FDA within 10 months, as generic drugmakers usually just need to prove their drug matches the ingredients and formula used in the original medication. Evita Solutions requested approval for their version of mifepristone back in October 2021.

Last week, Secretary of Health Robert F. Kennedy Jr. commented on X that federal law requires FDA approval “when an application proves the generic is identical to the brand-name drug.”

He pledged to “review all the evidence – including real-world outcomes – on the safety of this drug.” Kennedy added that recent studies have indicated “serious risks when mifepristone is used without proper medical oversight.”

The company told the AP that it expects to send the drug to market in January 2026.

 Hollingsworth encouraged Southern Baptists to pray.

 "Let's continue to pray—for our leaders, for our nation, for mothers and fathers facing unexpected pregnancies, and for a renewed culture of life that cherishes every person as made in the image of God."

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This article appeared in Kentucky Today.

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