When the Food and Drug Administration (FDA) approved the chemical abortion drug regimen mifepristone and misoprostol in 2000, it recognized the dangers surrounding mifepristone. It placed a “black box warning” on mifepristone’s drug label—which is only used on the most dangerous drugs—about the risks of “serious and sometimes fatal infections of bleeding” that may occur. Thus, while the chemical abortion regimen was allowed to go to market, it was highly regulated, with heightened patient safeguards. These safeguards were later codified as the “Risk Evaluation and Mitigation Strategy,” or “REMS” program, to ensure patient safety.
A drug is placed on a REMS program when it deemed “is necessary to ensure that the benefits of the drug outweigh the risks of the drug,” and REMS are designed to mitigate drug risks while still allowing patients to have access to them. The program generally includes provider and dispensing requirements, as well as warnings and restrictions. The first REMS the FDA placed on mifepristone strictly limited its use to a few, highly monitored circumstances. Originally, only a physician could dispense mifepristone at an in-office setting. Further, a woman had to have three visits to the provider and could only take mifepristone on the second visit. This was to ensure that she was not medically ineligible for mifepristone and was not experiencing coercion. The third visit was a follow-up to make sure the abortion was complete. Additionally, doctors had to monitor patients for all side effects and report adverse events. Even at this stage, ultrasounds were not strictly required—the prescriber was only required to have the ability to confirm gestational age. Thus, there was no reliable way to confirm the baby’s gestational age to ensure the woman was not past seven weeks pregnant or rule out an ectopic pregnancy, which is a contraindication for chemical abortion.
In the twenty-six years since mifepristone’s approval, however, the FDA has consistently stripped away most of the REMS requirements. In 2016, the FDA expanded mifepristone to 10 weeks gestation, without doing additional studies to guarantee the safety of the expansion. They allowed non-physicians to dispense the drugs and reduced the in-person visit requirement to just one visit. The FDA also loosened reporting requirements over the years; contrary to mifepristone’s original reporting safeguards, medical professionals now only need to report fatal adverse events but not “serious adverse events”, leaving women with less information about the numerous risks of mifepristone and affecting their ability to have true informed consent.
With the latest REMS removal in 2023, in-person dispensing requirements have been dropped completely. Now, most medical professionals and even some pharmacies can dispense mifepristone to women during a single visit. Further, this visit does not need to be in-office but can be done through a telehealth appointment or even a website chat. Without in-person dispensing, prescribers or pharmacists may send abortion pills to a woman through the mail. Mailing abortifacients, however, has been illegal in the United States since the Comstock Act was passed in 1873. It was most recently recodified in the late 1990s, under the Clinton Administration, when Roe v. Wade was still enforced. It has never been repealed, and thus still carries the weight of good law.
Removing the in-person dispensing requirement raises numerous risks for women. Without in-person visits, women cannot be adequately screened, both to ensure that they are the one who will be taking the pills and that they are not victims of intimate partner violence or other abuse. The farther along a woman is in her pregnancy the more likely she is to have major complications from a chemical abortion. Additionally, the symptoms of an ectopic pregnancy mirror the symptoms of a chemical abortion. This means that, if a woman has not been screened for an ectopic pregnancy, she may have one and not seek urgent medical attention since her symptoms may appear to simply be the side effects of a chemical abortion. Finally, a woman may suffer rhesus immunization, where her Rh-negative blood interacts with Rh-positive blood from her unborn child, causing an immune system response that produces antibodies. These antibodies may attack a future pregnancy, making her lose a wanted child. Without an in-person blood test, and, if indicated, preventative RhoGAM shot, there is no way to guarantee that her future children will be safe.
Even with these safety concerns for women taking the drugs, some citizen petitions have asked the FDA to remove the remaining Elements to Assure Safe Use (ETASU). ETASU are specific safeguards within the REMS programs. Although the FDA establishes which elements are placed on a REMS drug, Congress, by statute, lists what types of elements can be placed on a drug. Currently, there are only three ETASU placed on mifepristone; these require a prescriber agreement form, a patient agreement form, and a pharmacy agreement form.
First, the prescriber agreement form seeks to ensure the medical professional has adequate experience and the ability to treat a woman for complications or otherwise provide her with care through another medical professional. This is a basic standard of care required for all practitioners of any medicine. Since chemical abortions are often prescribed through telemedicine, women are being treated by medical providers who have not physically met them. Thus, they are already at a disadvantage which should not be increased by removing a treatment requirement.
Second, the patient agreement form has patients sign their agreement that they have given their full informed consent and are getting an abortion without any coercion. Again, this is a basic medical principle. All women should be given the information necessary to make an informed decision about a medical intervention. However, removing the requirement for a patient agreement form only threatens women’s ability to make an authentic choice and incentivizes abusers and profiteers.
Finally, the pharmacy agreement form mandates pharmacies to certify that they will comply with the REMS program and verify that prescribers are certified to prescribe mifepristone. As with the others, this is a commonsense rule to ensure patient health and safety with mifepristone’s heightened safeguards.
Recently, two Supreme Court cases have attempted to reinstate at least some of mifepristone’s REMS. In FDA v. Alliance for Hippocratic Medicine, a group of doctors sought to reinstate the drug’s original REMS to enable them to treat their patients more effectively. Although the Supreme Court ultimately ruled that the doctors did not have standing, the case showcased the extensive array of conscience protections in federal statutes and regulations that ensure doctors may conscientiously object to performing abortions. In Louisiana v. FDA and related cases, states are challenging the 2023 REMS changes, highlighting a Louisiana woman’s forced abortion to show the dangers of mail-order abortion drugs.
Americans United for Life (AUL) is committed to protecting women and children by restricting dangerous telemedical practices and limiting the harmful effects of chemical abortions. AUL’s Abortion Pills Kill initiative works to do this by spreading awareness of the harms of chemical abortion drugs and partnering with federal and state lawmakers to protect women and preborn children by passing pro-life laws and enforcing the Comstock Act. Through this work, AUL will continue to fight for a world where all life is valued and protected, from conception to natural death.
