By Sarah Holliday

The Food and Drug Administration (FDA) quietly approved a new generic version of the abortion drug mifepristone on Tuesday — produced by Evita Solutions LLC, a company that’s mission is to make abortion “normal” and “accessible to all.” The new drug will most likely be sold at a lower price.

When the news broke on Thursday afternoon, pro-lifers immediately sounded the alarm. “This reckless decision by the FDA to expand the availability of abortion drugs is unconscionable,” said Marjorie Dannenfelser, president of Susan B. Anthony Pro-Life America (SBA). “These dangerous drugs take the lives of unborn children, place women and underage girls at serious risk, empower abusers, and trample the pro-life laws enacted by states across the nation.”

According to the Guttmacher Institute, Planned Parenthood’s research arm, chemical abortions accounted for 63% of all U.S. abortions in 2023. Additionally, wrote SBA, “the drugs are responsible for the deaths of millions of Americans.” Despite these concerns, the FDA has progressively relaxed safety regulations for the abortion pill, leaving many women unaware of its risks. Pro-life groups highlight the severe physical and emotional toll — intense pain and trauma — that often catches women off guard. In some cases, the effects are deadly. Just last month, Health and Human Services Secretary Robert F. Kennedy Jr. cited Foundation for the Restoration of America and the Ethics & Public Policy Center data that found nearly 11% of women experience severe adverse events like hemorrhaging, infection, and sepsis.

Another alarming trend involves those who use the drug as a form of manipulation, with numerous reports of abusive partners stockpiling it to poison or coerce women. In addition to SBA, several pro-life leaders have spoken out. “UNACCEPTABLE,” wrote Lila Rose of Live Action. “This drug starves babies and harms mothers! The FDA just said it would do a new serious safety study — so why approve another generic now? [Secretary Kennedy] must reverse this decision!” Kristan Hawkins, president of Students for Life of America, also posted, stating this decision “represents a true failure” on behalf of the Trump administration.

She continued, “The Pro-Life Generation asked during the campaign and from day one in this new administration for one Republican President to undo the political manipulations of three Democratic Party Presidents who prioritized the business model of Chemical Abortion Pill pushers.” Hawkins stressed, “More babies will die; More women will be harmed; and More Americans exposed to Abortion Water Pollution as a direct result of this unfathomable decision. This is a stain on the Trump Presidency and another sign that the deep state at the FDA must go.”

Reacting to the FDA’s announcement, Senator Josh Hawley (R-Mo.) wrote on X, “This is shocking. FDA has just approved ANOTHER chemical abortion drug, when the evidence shows chemical abortion drugs are dangerous and even deadly for the mother. And of course 100% lethal to the child.” He dug deeper on Thursday’s “Washington Watch” with Family Research Council President Tony Perkins.

“I don’t understand at all what the FDA is doing here — at all,” Hawley stated. He explained that the “application for this new drug has been pending for four years. Joe Biden’s FDA didn’t approve it. The FDA is supposed to be doing a safety study of the chemical abortion drug. And rather than that, they just approved a new one.” Hawley shook his head. “I’m incredibly disheartened by this. I just can’t imagine what the rationale is.” He called on the agency “to reverse course immediately and put back into place all of the safety guardrails that were in place when President Trump was in office before,” which he described as “terrific guardrails.” The FDA, he asserted, “needs to get with the program. I can only assume that these are bureaucrats completely run amok here. But whatever the explanation is, it needs to be reversed. This is really outrageous.”

Perkins addressed the timing of this decision, noting that the FDA did it “right before government shut down,” right “when all this stuff stops, they get this across the line. … [I]t’s been in the process for four years. They approve it at the 11th hour before a government shutdown.” On top of this, they make this decision in “the midst of what’s supposed to be a study looking at the harms of this … drug to women. It doesn’t add up. It really doesn’t.”

Hawley agreed, stating how there have been at least “two major independent studies just in the last few months that show that one in 10 women who take the chemical abortion drug develop major, serious health risks — like trips to the emergency room, hemorrhaging, Really serious stuff.” According to Hawley, the FDA had promised him, other senators, and the public that “they would do a top to bottom review of this drug. But to now not do that, but instead … [put] another abortion drug … on the market. It’s inexplicable to me.”

“Have you reached out to the FDA?” Perkins asked. “I have,” Hawley responded, “and believe me, they know what my position is on this. I’ve communicated with them about this review multiple times. … I don’t understand that at all. I don’t understand why now, and I don’t understand why this review is not the top priority. People are literally dying of this” — women and their babies.

In an official statement, Perkins and FRC’s Director for the Center for Human Dignity Mary Szoch further condemned the decision. Perkins called on the White House to act, stating, “The Trump administration must change the Biden-era policy that is undermining the pro-life laws that dozens of states have enacted since Dobbs recognized their right to do so.”

Echoing this, Szoch underscored, “The approval of another generic form of mifepristone should never have been granted.” In fact, she added, “The FDA’s expansion of the availability of mifepristone demonstrates the immediate need for the results of an unbiased, transparent review. As the FDA waits for that review to take place, we call on them to courageously reinstate the original safety measures for mifepristone strengthened with a requirement for an ultrasound.” This, she concluded, “will at least mitigate the danger to women and the unborn as we wait for this dangerous drug’s approval to ideally be revoked.”

Sarah Holliday is a reporter at The Washington Stand.