Abortion Pill Ruling: Read Annotated Excerpts From FDA Case

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Women who have aborted a child — especially through chemical abortion drugs that necessitate the woman seeing her aborted child once it passes — often experience shame, regret, anxiety, depression, drug abuse and suicidal thoughts because of the abortion.

Medication abortion is used in early pregnancies, typically before gestation at 12 weeks, and the tissue that passes out of a patient’s body is often in the form of blood clots. Patients cite varying reasons for having abortions, but several studies and surveys have suggested that patients often feel relief and experience fewer mental health symptoms like depression, anxiety and suicidal thoughts after terminating pregnancies they felt unprepared or unable to handle.

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Defendants contend that plaintiffs’ theories of standing “depend upon layer after layer of speculation.” But plaintiffs allege F.D.A.’s chemical abortion regimen “caused” intense side effects and significant complications for their patients requiring medical intervention and attention.

Judge Kacsmaryk’s opinion cites a handful of studies, several conducted by anti-abortion organizations, that the plaintiffs in the case submitted as evidence. The judge devotes little attention to the scores of studies that have shown medication abortion is very safe and that complications are rare, with patients needing hospitalization in less than 1 percent of cases.

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Considering F.D.A.’s 2021 decision to permit “mail-in” chemical abortion, many women and girls will consume mifepristone without physician supervision. And in maternity-care “deserts,” women may not have ready access to emergency care. In sum, there are fewer safety restrictions for women and girls today than ever before. Plaintiffs have good reasons to believe their alleged injuries will continue in the future, and possibly with greater frequency than in the past.

In 2021, the F.D.A. permanently lifted a requirement that patients obtain mifepristone in person from a provider, citing years of studies indicating this change would be safe. The drug still needs to be prescribed by a certified health provider, but not necessarily by a physician. For years before the rule was lifted, mifepristone was the only drug that the F.D.A. required to be obtained in person from a medical provider but that did not need to be taken in the presence of a provider — it could be taken at home or anywhere the patient chose. As a result, the F.D.A. and medical experts would dispute the judge’s contention that the 2021 rule change would create greater safety risks, especially since serious complications with mifepristone are rare.

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F.D.A.’s 2016 and 2021 changes thus significantly departed from the agency’s original approval of the abortion regimen. F.D.A. repeatedly altered its original decision by removing safeguards and changing the regulatory scheme for chemical abortion drugs.

Another point of contention in Judge Kacsmaryk’s order centers on the statute of limitations to file a lawsuit challenging the F.D.A.’s approval of a drug, which is six years. The F.D.A. approved mifepristone in 2000 and eased certain restrictions on the pill in 2016 before lifting the in-person requirement in 2021. The Justice Department argued that it is too late to file a lawsuit challenging the 2000 and 2016 decisions, and that only the most recent measure falls within the six-year limit. Judge Kacsmaryk interpreted each change as restarting the clock to challenge approval for the drug.

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The Comstock Act declares “nonmailable” every “article, instrument, substance, drug, medicine, or thing which is advertised or described in a manner calculated to lead another to use it or apply it for producing abortion.” 18 U.S.C. § 1461 (emphasis added). It is indisputable that chemical abortion drugs are both “drug[s]” and are “for producing abortion.” Therefore, federal criminal law declares they are “nonmailable.”

Judge Kacsmaryk relies in part upon the Comstock Act, an 1873 anti-vice law that barred the mailing of contraceptives and “lewd” materials, along with drugs that could be used in an abortion. His strict interpretation of that statute conflicts with a December 2022 opinion by the Justice Department’s Office of Legal Counsel, which concluded that abortion-causing drugs could be sent by mail if the sender does not intend for the recipient to use them unlawfully.