The Trump Administration’s Mifepristone Mess

By: Chuck Donovan, originally published October 9, 2025, The Washington Stand

In the past decade, the mass distribution of the prescription drug mifepristone has changed the landscape of abortion in the United States and around the world. In 2016, using the incomplete data from the dilatory U.S. Centers for Disease Control, an estimated 27.9% of federally reported abortions were carried out using a pharmaceutical. Only six years later, the percentage of abortions reportedly executed by drug was 53.3%. CDC noted last November, “Use of early medication abortion increased 4% from 2021 to 2022 and 129% from 2013 to 2022.” The percentage of abortions conducted by this means is almost certainly larger still in 2025. The Trump administration is nearly flatfooted in response to this relentless trend.

For the moment, that observation may be an understatement. In another busy week of executive policymaking at the federal level, the Trump Food and Drug Administration (FDA) announced that it had granted approval for the distribution of yet another generic version of the primary abortion “medication,” mifepristone. The manufacturer in this instance is a company called Evita Solutions, whose license was okayed by the FDA hours before the onset of the government shutdown on October 1. Evita Solutions is ideologically committed to advancing abortion at a global level and uses politically correct language that refers to users of the pills as “people” and not as women. “Evita Solutions believes that all people should have access to safe, affordable, high-quality, effective, and compassionate abortion care, regardless of their race, sex, gender, age, sexuality, income, or where they live,” reads the company website.

A Dun & Bradstreet website offers scant information about Evita, which is located in Virginia. The site states that the company has revenue of less than $250,000, which suggests that, like the primary manufacturer of mifepristone, Danco Laboratories, it has no product line that might be used to evaluate the company’s soundness and assure its sensitivity to public and buyer concerns. The various sites offer no information about the price of the generic (though these alternatives cost an average of 80 to 85% less than brand-name drugs from the company that has borne the cost of research and development) or any measures the company will take to ensure that the drug is not obtained by third parties for potential criminal use. Incidents of such serious crimes continue to be reported around the country.

Pro-life leaders and legislators in Washington and around the country responded to the FDA decision with varying degrees of outrage. Senator Josh Hawley (R-Mo.) scorned the approval, saying, “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.” Hawley has closely followed actions by the Trump administration on abortion generally and noted that the Evita approval came in the midst of “a top-to-bottom safety review of the chemical abortion drug.”

The administration claimed in turn that it has little or no discretion when it reviews a generic drug application, but critics note that the original Evita application came to the FDA four years ago during the Biden administration. The reasons for that delay are unclear, but they suggest that a pro-choice administration had some grounds for slow-walking the process with Evita Solutions and that the Trump administration, already engaged in a fresh and urgently needed analysis of the pills’ safety, could likewise have deferred securing a marketplace for a much cheaper version of a drug that is known to kill human embryos and cause elevated harm to the women who take it.

One thing is clear, however. The action on Evita, while a surprise as to timing, has been foreshadowed by a range of statements and actions by leading figures in the Trump campaign and cabinet. The story begins last year on the campaign trail when now-Vice President J.D. Vance indicated in an interview on “Meet the Press” that a Trump administration would not ban the sale of abortion pills. “What the president has said very clearly is that abortion policy should be made by the states, right? You of course want to make sure that any medicine is safe and it’s prescribed in the right way, and so forth.” Vance added that Trump had “consistently” said that the GOP needed “to get out of the culture war side of the abortion issue.” Vance was responding to a report from NBC News quoting candidate Trump to the effect that he would consider directing the FDA to block the pill. Vance’s remarks were widely seen as walking back the implication of Trump’s remarks and reaffirming the stance, enunciated in the 2024 Republican national platform, that abortion policy should be made by the states and respected no matter what the outcome.

The result has been the present collision course — given the reality that the FDA’s Clinton-era decision on abortion pills has now, with accelerated relaxation of safety rules imposed on a drug that was and is demonstrably more hazardous than surgical abortion — between a federally approved drug and the states-only Trump creed. The appointment of Robert F. Kennedy Jr., who embraces legal abortion, kept the administration on that course. Hawley has led the way in 2025 through his consistent pressuring of Secretary Kennedy and FDA Commissioner Marty Makary to conduct a thorough safety review of mifepristone. The Department of Health and Human Services and the FDA agreed to such a review in testimony and described their intentions in a September 19 letter to 22 state attorneys general who wrote the administration expressing concern about their inability to stem the tide of abortion drugs into their states.

The September 19 letter appears to be carefully worded. “This administration will ensure that women’s health is properly protected by thoroughly investigating the circumstances under which mifepristone can be safely dispensed,” Kennedy and Makary wrote. Naturally, this should go without saying for any drug approval. But it skirts the primary issue, which remains that mifepristone is designed to ensure the demise of the unborn child, and its action, in combination with misoprostol, is designed to dislodge the now-dead child from its haven in the womb.

The letter is consistent with Vance’s words from last August, with President Trump’s 2024 platform clauses all but eliminating a federal role in protecting the unborn, and the position of Secretary Kennedy as a member of a family long associated with leading the antagonism to the pro-life cause. It is this record that likely prompted former Vice President Mike Pence to declare on X after the Evita debacle that it was “a complete betrayal of the pro-life movement” and to call for Kennedy’s replacement with a pro-life secretary of HHS.

Such an action seems unlikely given the administration’s consistently maintained states-right stance on abortion. In the meantime, the FDA can and should do now what it should have done from day one if safety for women was truly a high priority. It could lower the gestational age at which the deadly drug can be used because maternal risks increase as pregnancy proceeds. It could reinstate mandatory reporting of abortion injuries, reversing the very limited mandate that exists now only to report fatal events for the mother. It could reinstate the policy that women can obtain the medication only from a physician who has personally examined her and ruled out ectopic pregnancy and determined her Rh status. It can instruct the Department of Justice to pursue remedies against the mailing of the pills, anonymously or otherwise, and to compile a report on abuse of the drug to inflict abortion on an unsuspecting woman. It can support legislation to give parents a private right of action against an abortion pill supplier who surreptitiously mails pills across state lines to a minor.

Finally, it can state clearly its support for the existing and new studies that can document the elevated rates of injury and emergency room visits that have been caused by mifepristone. It can ensure that researchers have access to public and private databases capable of documenting these harms so that our nation’s policies once again support the well-being of vulnerable mothers and babies. The alternative is to continue to see more women injured and more than one million abortions a year in a nation founded on the endowment of a right to life.

Chuck Donovan served in the Reagan White House as a senior writer and as Deputy Director of Presidential Correspondence until early 1989. He was executive vice president of Family Research Council, a senior fellow at The Heritage Foundation, and founder/president of Charlotte Lozier Institute from 2011 to 2024. He has written and spoken extensively on issues in life and family policy.