(The Washington Stand) With a new study confirming the high hazard rate for women and girls taking the abortion pill regimen, Senator Josh Hawley (R-Mo.) has reintroduced a bill that will direct the Food and Drug Administration (FDA) to restore safety measures on the mifepristone-misoprostol drug cocktail. The proposal comes in the midst of renewed controversy for a drug now responsible for two-thirds or more of U.S. abortions. It comes as well in the midst of mixed signals from the Trump administration, whose recent appointees have faced strict scrutiny from the Missouri Republican who has consistently led efforts in Congress to limit the harms of abortion.
Mifepristone is the key component of the abortion cocktail. Approved under emergency use policies in the waning days of the Clinton administration in 2000, it functions by blocking progesterone and glucocorticosteroid receptors key to nurturing a healthy pregnancy. The impact is to induce the death of the developing embryo, and the follow-up drug, misoprostol, then causes contractions to expel the child. The process has been shown to be associated with infections, multiple days of cramping, bleeding, and other complications that lead many women to the emergency room. Ever since its approval, abortion drug sellers have benefited from successively lax policies that were enacted under Democratic presidents and remained under their Republican counterparts.
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Pro-life researcher Carole Novielli has summarized the policies adopted by the FDA to expand use of the drug:
2016 (Obama administration):
- The original requirement that mifepristone be taken in the presence of the medical provider is rescinded;
- The original requirement that the drug be administered solely by a certified prescriber who meets tests of capability to treat certain complications is rescinded;
- The requirement that non-fatal complications from use of the drug be reported to FDA is rescinded and now only deaths must be reported;
- The requirement that the drug be used before seven weeks of pregnancy is rescinded and a new, 10-week gestational limit is installed.
2019 (Trump administration):
- GenBioPro’s application to manufacture a generic version of the drug is approved, supplementing the original manufacturer, Danco Laboratories, specially created by the Population Council, an activist group that obtained the U.S. manufacturing rights from the French company, Roussel-Calf, that invented the drug.
2020 (Trump administration):
- The abortion industry champions a new “no-test” protocol designed to facilitate pharmacy and mail order distribution of the drug, eliminating standard tests for women and girls to rule out ectopic pregnancy, Rh sensitivity, and other potential contraindications to the drug.
2021 (Biden administration):
- Citing the COVID epidemic, the Biden administration approves limited mail-order distribution of the drug;
- Later in the year, Biden eliminates any in-person dispensing requirement and permanently enables shipping the drug by mail (irrespective of the existence of existing federal law, which criminalizes the mailing of abortion pills in the United States).
2023 (Biden administration):
- Biden makes it clear that retail pharmacies can offer the drug whenever prescribed, minimizing further any medical supervision or contact with the women or whoever is purchasing the drug.
The net result of these policy changes has been to make the drug commonly available for do-it-yourself abortion. Online sales of the drug have proliferated, including from domestic and international sources. At the time of the 2023 changes, the FDA revealed that, as of June 2022, mifepristone had been associated with 28 reports of deaths. In the waning days of the Biden administration, the FDA released an update on abortion drug use that mentioned 36 total deaths from various causes as of December 31, 2024, remarking that the deaths “cannot with certainty be causally attributed” to mifepristone because of potentially confounding conditions and gaps in information.
What about injuries short of death? Here is where the trail turns away from the FDA’s broken process, and where Hawley has led efforts to restore strong policy and accountability at the agency. In short, to a significant degree, the gaps in information and the lack of certainty about the drug’s dangers are a direct result of the policy choices mentioned above and the ending of required reporting of the non-lethal events that have been identified in overseas and U.S. literature over the course of several decades. The Trump administration’s original efforts regarding the pill regimen have not been encouraging in this regard, but it is possible the tide may now be turning in the wake of the newest study, a review of a massive amount of claims data published by scholars at the Ethics and Public Policy Center (EPPC) detailed here.
Last August, in response to a media question, then-candidate Trump replied about the burgeoning use of abortion pills by inferring that, if elected, he would look into the question of drug safety. “You can do things that will supplement [state policy]. Absolutely …[things] that were pretty open and humane.” A week later, his running mate, J.D. Vance, who had previously espoused opposition to the pill, seemed to suggest no action on the drug was likely, but he left the door slightly ajar. “What the president has said very clear[ly] 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 noted that Trump had “consistently” said the party needs “to get out of the culture war side of the abortion issue.” The election won, Trump affirmed the Vance stance, telling Time magazine in his “Person of the Year” interview in early December that he was “100% unlikely” to limit access to mifepristone. “That would be my commitment,” he concluded.
So far in 2024, in his choice of health care leadership, Trump has appeared to hew to that commitment, from his nomination of the pro-choice Robert F. Kennedy Jr. to the decision of the Trump Justice Department in early May to argue for the dismissal of the lawsuit by three states challenging the approval of mifepristone for distribution in their states, which have acted to protect the unborn. On April 24, new FDA Commissioner Dr. Martin Makary told an audience at the Semafor World Economic Forum that the FDA had no plans to limit access to the drug, but Makary went on to crack the same door, “There is an ongoing set of data coming into the FDA on mifepristone. So if the data suggests something or tells us there’s a real signal, we can’t promise we’re not going to act on that data.”
If Dr. Makary is referring to the data FDA now obtains from pill providers, users, and emergency rooms, where the vast majority of complications are treated, the problem is precisely that the data is not coming into the FDA by its own decree. On Wednesday of last week, Hawley pointed out this problem again and cited the findings of the EPPC study that document for a large group of women serious adverse events may range as high as 11% of cases. Facing the Senate Committee on Health, Education, Labor and Pensions, Kennedy responded to a question about the study from Hawley, saying, “It’s alarming. Clearly, it indicates that, at very least, the label should be changed.”
Despite the rather weak endorsement of a potential label change on a drug that has no medicinal purpose in its primary use to abort the unborn, the liberal media are up in arms about the EPPC study and the FDA review. The Guardian, for example, ran a news story asserting that the EPPC study described ectopic pregnancy as a complication of mifepristone. The assertion is spurious, as the question rather is the danger of ectopic pregnancy when it goes undiagnosed as a result of the FDA-approved “no-test” protocol, a life-endangering scenario that has indeed already been associated with two deaths after mifepristone use. The lack of balanced and curious media reporting is itself a danger to women.
The same concern pertains to the impact of the no-test protocol on the dating of the gestational age of the pregnancy. In addition to failing to identify and locate an ectopic pregnancy, the omission of an ultrasound will endanger women by misidentifying the stage of the pregnancy. The risks of abortion drugs increase with increasing length of pregnancy. If a woman doesn’t know how far along she is, there is no way she can know what her risks are for taking the drug. At seven weeks of pregnancy, the drug is known to fail in at least one in 20 women. But at 11 weeks of pregnancy, the drug is known to fail one in three women with massive hemorrhaging. Women have a right to know this information before deciding to take the drug. Every human being has a right to informed consent before taking any drug.
The FDA has, in summary, not collected adverse events data on mifepristone since 2016. Women are acknowledged to experience severe cramping and bleeding for nine to 16 days after taking the two-drug regimen. Retained parts of the baby and pregnancy tissue are a problem that can necessitate a second, surgical abortion or cause infection. Obtaining the drugs through the mail, at a retail pharmacy, or from a physician or other source who is thousands of miles away, not available for consult, or otherwise engaged is a formula for injuries to be treated by urgent care or emergency room providers who may be unaware, or misled, about the occurrence of a medication-induced abortion. For these reasons, even if studies based on such related materials as claims data do not permit ideal comprehensive analysis, they are far superior to (and now more numerous than) any other source for data on what mifepristone is inflicting on women in the extremely lax environment now prevailing around use of the drug.
The FDA can and should take every step possible to address this chronic and aggravated data dearth immediately. The mandatory reporting of all adverse events should be reinstated now, and the requirement to do so should be applied not just to the pill manufacturers and providers but to any health care personnel who are called upon to treat one of the many different conditions mifepristone is known to cause. The FDA likewise should reassert its policy advising women to accurately communicate use of mifepristone when they seek health care follow-up, and it should make access to its adverse event reporting system easy to navigate in this advanced world of online communication.
Tweet This: The FDA can and should take every step possible to address the chronic and aggravated data dearth on mifepristone immediately.
Finally, the scrutiny of mifepristone should not be limited to any pre-defined outcome. The Supreme Court ruling in the Dobbs case did not limit either federal or state policymaking to the safety issues, as vital as they are. Mifepristone and misoprostol are potentially the future of abortion worldwide, and state efforts to protect their citizens from the depredations of drug vendors will be extremely challenging, if not impossible, if the FDA sides with Danco, GenBioPro, and drug manufacturers around the world. Hawley has, as noted, introduced legislation that would codify elements of the safety protections for women and correct the kind of inbred policymaking that has prevailed at the FDA on drugs and devices from oxycontin to Essure to Mifeprex. Hawley deserves strong praise from all Americans for his “show me” efforts to champion life and the well-being of American women.
Editor's note: 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. He served on the board for Heartbeat International which manages Pregnancy Help News. This article was published by The Washington Stand and is reprinted with permission.
