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The FDA’s Unforgivable Deceptions on Chemical-Abortion Drugs

By the FDA’s own admission, its actions sent more women and girls to the emergency room.
Erin Morrow Hawley
When the FDA allowed abortion-by-mail, it enabled sex trafficking. Trafficked women can now be more easily kept away from doctors and coerced into abortion

When the federal agency responsible for ensuring the safety of the food we eat, medication we take, and products we use decided to remove critical safeguards that it originally deemed necessary for abortion drugs, it knew there’d be a problem.

Yet the Food and Drug Administration recklessly plowed ahead anyway and disregarded the harms it would cause when it eliminated the few, crucial safety measures that had been in place for years.

The federal government knew it would cause more women to need emergency care, and therefore planned on emergency-room doctors and OB-GYN hospitalists stepping in to treat the women it abandoned. My colleagues and I at Alliance Defending Freedom are representing physicians like these in our lawsuit currently before the U.S. Supreme Court. As we explained in our latest brief filed with the court on February 22, we’re challenging the Biden administration because it betrayed Americans — particularly pregnant women and girls — when it removed its safety standards that had protected their health.

As the U.S. Court of Appeals for the Fifth Circuit agreed, these doctors have suffered concrete and specific injuries, including forced participation in elective abortion, because of the FDA’s deregulation of abortion drugs. Emergency-room physicians and OB-GYN hospitalists are now called upon to treat abortion-drug complications, and that is not a bug in the system but part of its very design. The FDA has always known that those doctors would be needed to respond to harms caused by abortion drugs — many of which could have been avoided had they kept the original safety and protocol standards in place.

When the FDA first approved abortion drugs in 2000, it required doctors to provide ongoing care to women using the drugs, including an initial in-person visit to screen for dangerous contraindications, such as an ectopic pregnancy, and follow-up visits to check for serious complications such as severe bleeding and infections. The agency’s inexplicable decision to remove that ongoing care endangered the health of vulnerable female patients.

Our clients are physicians who have witnessed the harm caused by the FDA to women and to doctors called on to help. When the FDA eliminated the initial in-person doctor visit in 2021 — the mechanism to diagnose a life-threatening ectopic pregnancy and confirm gestational age — it relied on emergency rooms to manage the consequences, which were already overwhelmed.

When the FDA eliminated the last remaining in-office visit requirement, it confirmed that “there may be more frequent ED/urgent care visits related to the use of mifepristone when dispensed by mail.” That’s why the safety of removing the in-person visit depended on the “common practice” of healthcare providers “provid[ing] emergency care coverage for other healthcare providers’ patients.” Moreover, the FDA’s own label for mifepristone and misoprostol says that roughly one in 25 women who take the drug will end up in the emergency room. In other words, the FDA knew that eliminating the in-office visit and only opportunity to screen for ectopic pregnancy (as well as other contraindications) would burden hospitalists who serve in the emergency room.

FDA’s decision to allow the mailing of abortion drugs without an in-person doctor’s visit relied on studies that concluded such policy results in more pregnant women sent to the emergency room. The one study, which compared outcomes of women who were mailed abortion drugs after an in-person examination with outcomes of women who were never seen in person, found a more than 50 percent increase in the incidence of women needing unplanned medical care — even though the study included a mandatory follow-up visit. The FDA concluded that this study “suggests a pre-abortion examination may decrease the occurrence of procedural intervention and decrease the number of unplanned visits for post-abortion care.” Yet the agency inexplicably removed the requirement that doctors provide that examination.

By the FDA’s own admission, its actions sent more women and girls to the emergency room. As we explain in a previous brief filed with the Supreme Court in this case, “FDA’s data and the doctors’ testimony show that women will continue to present to the emergency room after taking mifepristone, requiring urgent treatment. That trend is not speculative — it is ‘predictable’ and ‘consistent.’”

The pro-women OB-GYNs, hospitalists, and emergency-room doctors we represent have personally witnessed the harm to women and girls caused by the FDA’s reckless actions. When the FDA callously eliminated the requirement for doctors to provide ongoing care to women using abortion drugs, it replaced one-on-one physician care with traumatizing emergency-room visits. As a result, our clients have treated significantly more women suffering injuries and complications from taking these drugs alone and without ever having seen a medical professional. The complications can be very serious; for example, one doctor cared for a woman who arrived unconscious in the emergency room after taking these drugs.

Our clients are on the front lines witnessing the harms the FDA has caused and are working to care for the many women who are facing crises because of the FDA’s shameful actions. Doctors take an oath to do no harm, and Americans expect the FDA to promote that oath. That is why our clients are holding the FDA accountable for failing to protect the health and safety of women and girls.

Regardless of Americans’ beliefs about abortion, no one should be okay with the FDA leaving pregnant women to take these high-risk drugs all alone. Thankfully, the doctors we represent in this case are challenging the federal government. We urge the Supreme Court to require the FDA to do its job: Put the health and well-being of pregnant women first by reinstating necessary safeguards for abortion drugs.

Erin Hawley, Senior Counsel, Vice President of Center for Life & Regulatory Practice
Erin Morrow Hawley
Senior Counsel, Vice President of Center for Life & Regulatory Practice
Erin Morrow Hawley serves as senior counsel and vice president of the Center for Life and regulatory practice at Alliance Defending Freedom.