Abortion pill case

On Tuesday, the US Supreme Court heard oral arguments in FDA v. Alliance for Hippocratic Medicine, which centers around the availability of abortion pill mifepristone in the US. The case stems from a lawsuit filed in Nov 2022 against the Food and Drug Administration (FDA) by anti-abortion group Alliance Defending Freedom, which seeks to reinstate tighter rules on access to the drug. Medical abortions, the vast majority of which incorporate mifepristone, accounted for an estimated 63% of abortions in the US in 2023.

Details: The lawsuit by Alliance Defending Freedom – representing groups of doctors and medical associations opposed to abortion – contends the FDA unlawfully loosened restrictions on mifepristone’s use in 2016 and 2021. The FDA rule adjustments in question:

• 2016: FDA expanded the approved maximum gestational age for mifepristone from 7 weeks of pregnancy to 10 weeks; reduced the number of required in-person doctor visits from 3 to one; and allowed the drug to be prescribed by nurse practitioners and certified midwives in addition to doctors.
• 2021: FDA removed the requirement for at least one in-person doctor visit and enabled prescriptions to be filled through the mail or at a pharmacy.

A key consideration in the case is whether the doctors and doctor associations have standing (i.e., the legal right to sue in federal court) under Article III of the constitution to challenge the FDA rule changes. Alliance Defending Freedom argues the loosened FDA rules have put doctors opposed to abortion at substantial risk of performing abortion-related treatments on patients with emergency complications from mifepristone, and doctors that have already done so have suffered harm.

For context: In a lower court proceeding, the Fifth US Circuit Court of Appeals in New Orleans ruled the FDA erred in its previous loosening of the rules and that the rule changes should be rolled back. The federal government and mifepristone manufacturer Danco Laboratories appealed that ruling, which landed the case in the Supreme Court.

A Supreme Court ruling is expected in June. Observers note the Supreme Court’s tone during Tuesday’s hearing suggests it is unlikely to curb the drug’s availability based on the case.

Recent debate focuses on the extent to which access to mifepristone should be restricted and the merits of the lawsuit. Read on to learn more and form a viewpoint of your own.

Notable viewpoints

SUPPORTIVE OF TIGHTENING MIFEPRISTONE RESTRICTIONS

The FDA’s loosening of mifepristone rules heightens risks for women using the drug.

• Not requiring oversight through an in-person doctor visit increases the chance a woman will mistake an ectopic pregnancy – which can be fatal if untreated – for normal side effects from mifepristone.
• Without physician oversight and an ultrasound, a woman could miscalculate the gestational age of her pregnancy and improperly elect for a medical abortion at serious health risk; one study found 39% of women receiving medical abortion after 84 weeks required a follow-up surgery and 4% suffered infection.
• Not requiring in-person doctor visits makes it harder to determine if a woman is being forced to get an abortion against her will in situations such as sex trafficking or abusive male partners.
• The FDA’s 2016 expansion of the approved maximum gestational age for mifepristone from 7 weeks to 10 weeks increases the risk to pregnant women because the risk of adverse side effects increases with gestational age.

The FDA’s justifications for loosening mifepristone rules are based on incomplete data.

• The FDA’s data collection policies on mifepristone – which, as of 2016, no longer require providers to report complications other than death – are inadequate and result in significant underreporting of adverse effects; from 2020-2022, 6 states reported a total of 1,004 complications from medical abortions while the FDA system captured only 17.
• The FDA’s conclusion that removal of the in-person visit requirement did not result in an increase in adverse events for patients is based on incomplete data from its own Adverse Event Reporting System (FAERS) that the agency itself has suggested should not be used as a basis for evaluating the likelihood of side effects.

Mifepristone is dangerous for women to use.

• According to one study in Finland, roughly 10% of women attempting a medical abortion require follow-up medical care for incomplete abortions.
• According to one study in Finland, 20% of women experience adverse effects such as hemorrhaging or infections compared to 6% of women with surgical abortions.
• The 32 deaths reported among women taking mifepristone from Sep 2000 – Dec 2022 highlight the dangers of the drug.
• The realities and risks of medical abortion are underreported and mothers are uneducated on its effects, which can result in unexpected medical emergencies and psychological damage.

The doctors have standing for the lawsuit and the case should proceed.

• The argument that the doctors represented in the case have standing (i.e., a legal right to sue) under Article III of the constitution is valid and is not “probabilistic;" there is tangible evidence doctors represented in the case had to participate in abortion-related treatments that harmed their conscience; one doctor performed a procedure removing tissue from a medical abortion patient’s uterus in order to save a life. (Summarized from hearing argument by Erin Hawley, lawyer representing Alliance Defending Freedom.)
• The FDA has itself acknowledged that 2.9%-4.6% of women who take mifepristone will go to the ER and hundreds of doctors represented in the case work in positions that may encounter such patients in the ER; dozens of these doctors have already provided some form of abortion-related treatment. (Summarized from hearing argument by Erin Hawley, lawyer representing Alliance Defending Freedom.)

Mifepristone should be prohibited from being mail-ordered under the Comstock Act.

• Mail-order abortion drugs violate the Comstock Act (1873), which prohibits mailing abortion instruments and contraceptives.
• “We don't think that there's any case of this Court that empowers FDA to ignore other federal law…the Comstock Act says that drugs should not be mailed…through the mail or through common carriers. So we think that the plain text of that, Your Honor, is pretty clear.” (Erin Hawley, lawyer representing Alliance Defending Freedom.)

OPPOSED TO TIGHTENING MIFEPRISTONE RESTRICTIONS

The FDA’s loosening of mifepristone rules has not caused an increase in adverse effects from the drug.

• Data gathered by the FDA after the removal of the in-person visit requirement in 2021 showed no increase in adverse effects among mifepristone patients compared to before the rule change.
• When evaluating the rule changes made in 2016 – including expanding the maximum approved gestational age to 10 weeks – the FDA evaluated data showing no increase in required follow-up care with the higher gestational age limit, and found incidences of follow-up care were lower compared to when the drug was first approved in 2000.

Mifepristone is safe for women to use.

• The vast majority of 100+ studies conducted across 124,000 medical abortions over 30 years indicate 99% of patients who had medical abortions reported no serious complications.
• While proponents of tightening restrictions on mifepristone point out that it has a higher incidence rate than surgical abortion, the majority of evidence suggests the risk is minimal and the technique safer than childbirth; for instance, one 2015 study found the “major complication rate” of medical abortions was 0.31%, higher than surgical abortion at 0.16% but lower than childbirth at 1.4%.
• While data suggests 3-5% of patients need a follow-up procedure to remove the pregnancy tissue or fully terminate the pregnancy, these follow-ups are no less safe than if the patient had a surgical abortion from the beginning.
• FDA data shows that there have been a total of 32 deaths and 97 ectopic pregnancies among the 5.9M women that have used mifepristone, and not all of those deaths are viewed as attributable to the drug.

Alliance Defending Freedom’s case is based on faulty data and misreadings of published findings.

• Alliance Defending Freedom’s argument is centered around a limited number of studies that don’t provide conclusive evidence against mifepristone’s safety; two of the 3 studies that note a higher incidence of serious complications from medical abortion examined pregnancies further along than the 12-week maximum typically used in the US; one of the studies that found 20% of medical abortion patients reported bleeding and clinician follow-up also stated that bleeding is expected and medical abortion is safe.
• One of the authors of a study referenced by Alliance Defending Freedom publicly commented that the organization was intentionally misreading the study and misinterpreting the full body of evidence.
• One of the studies cited in Alliance Defending Freedom’s original lawsuit was an analysis of anonymous blog posts on the anti-abortion blog “abortionchangesyou.com.”

The doctors do not have standing for the lawsuit and the case should not proceed.

• The doctors represented in the case don’t have standing (i.e., a legal right to sue) under Article III of the constitution because they are not in imminent harm or danger from the FDA rules; the potential sequence of events that may lead to a doctor assisting with an abortion against their conscience are “probabilistic.”
• Federal law protects doctors from being forced to assist in an abortion against their conscience, which gives any doctor the legal right to opt out of a procedure to avoid conscience injury; there is no evidence that doctors in the case who participated in abortion-related procedures participated against their vocal objection, which would be a more plausible claim to injury. (Summarized from Justice Elena Kagan's line of questioning in the hearing.)
• A victory for Alliance Defending Freedom in this case would set a precedent that enabled similar challenges to any drug already approved by the FDA and require an unnecessarily high bar for drug approval that would threaten thousands of other transformative drugs on the market.

Mail-order mifepristone should not be restricted under the Comstock Act.

• The Comstock Act (1873) is vague, and its potential application to limit the mailing or dispersal of medical abortion drugs is in dispute; the Justice Department has previously concluded the Comstock Act only outlaws mailing illegal abortion implements, not an approved drug.
• It was not the FDA’s responsibility to consider Comstock provisions and the FDA did not approve the mailing of mifepristone in a way that would violate them; therefore, the Comstock Act is not relevant to this case (Summarized from hearing argument by Solicitor General Elizabeth Prelogar, lawyer representing the FDA.)

From the source

Read more from select primary sources:

• Full transcript of Supreme Court hearing: FDA v. Alliance for Hippocratic Medicine (Mar 26, 2024)
• Full text of the initial lawsuit filed in Nov 2022: Alliance for Hippocratic Medicine v. US Food and Drug Administration
• FDA data on medical abortion outcomes: Mifepristone US Post-Marketing Adverse Events Summary through 12/31/2022
• Comstock Act (1873)

Be heard

We want to hear from you! Share your perspective on access to mifepristone and we may feature it in our socials or future newsletters. Reply to this email in the format of your choosing (text, audio, or video). Below are topic ideas to consider.

• Are you in favor of tightening, loosening, or maintaining current rules on access to mifepristone?
• What do you think of the legal arguments on either side of the case?

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