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Mifepristone in the US Courts: Chemical abortion on trial

Despite substantial evidence of real risks to the life and health of women from chemical abortion using the drug mifepristone (formerly known as RU486) the US Food and Drug Administration (FDA) has been increasingly reckless in its progressively looser protocols for its distribution and use since first approving it in 2000 under an accelerated drugs program under the claim that pregnancy is a life-threatening illness and culminating in the January 2023 approval of mail-order distribution with no requirement for any in-person assessment of the pregnant woman.

A group of claimants headed by the Alliance for Hippocratic Medicine has achieved some initial success in holding the FDA to account for this recklessness.

US District Court Judge Matthew Kacsmaryk, in his ruling on their  initial application delivered on 7 April 2023, slammed the FDA's reckless, unjustifiable and unlawful 2000 initial approval of mifepristone as well as subsequent removals of safeguards in 2016, 2019 and 2023.1 He granted an injunction against the operation of the 2000 approval but suspended the operation of that injunction for seven days to allow an appeal to the US Fifth Circuit Court of Appeals.

Judge Kacsmaryk noted that two women had died in 2022 after taking mifepristone. One woman was 7 weeks pregnant, but the other woman was 21 weeks pregnant which is 11 weeks over the 10-week FDA protocol limit. By not requiring an in-person visit and an ultrasound the FDA has facilitated such tragedies.

The judge also remarked that an "individual justice” and “irreparable injury” analysis also arguably applied to the “unborn humans” whose lives are extinguished by mifepristone, although he mainly focused on the evidence of harm to women.

In addressing the original 2000 approval under Subpart H which, by law, "extends only to drugs and biological products that target ‘serious or life-threatening illnesses’ and offer a ‘meaningful’ benefit over existing treatments”, he noted that even the Population Council acknowledged that “the imposition of Subpart H is unlawful” because “the plain meaning of these terms does not comprehend normal, everyday occurrences such as pregnancy and unwanted pregnancy.” 

He further noted that “this reading is also consistent with the fact that aside from mifepristone, FDA had approved fewer than forty NDAs under Subpart H by early 2002. And of those other approvals, twenty were for the treatment of HIV and HIV-related diseases, nine were for the treatment of various cancers and their symptoms, four were for severe bacterial infections, one was for chronic hypertension, and one was for leprosy.

The learned judge illustrated this obvious discrepancy in FDA’s practice by citing Sesame Street: “One of these things is not like the others, one of these things just doesn’t belong.”

The judge scathingly dismissed the defendants argument that unaborted children of the women “who seek but are unable to obtain an abortion” are “expected to do worse in school,” “to have more behavioral and social issues, and ultimately to attain lower levels of completed education”; and “are also expected to have lower earnings as adults, poorer health, and an increased likelihood of criminal involvement” as relying on an intolerable use of “abortion to promote eugenic goals”. He noted that “Abortion has proved to be a disturbingly effective tool for implementing the discriminatory preferences that undergird eugenic” but that though “eugenics were once fashionable in the Commanding Heights and High Court, they hold less purchase after the conflict, carnage, and casualties of the last century revealed the bloody consequences of Social Darwinism practiced by would-be Übermenschen.”

The US Court of Appeals for the Fifth Circuit in its decision upheld the District Court’s injunction against the FDA’s 2016, 2019 and 2023 protocols but overturned the injunction  against the original 2000 approval.2

Justices Engelhardt and Oldham ruled that "Defendants have not shown that plaintiffs are unlikely to succeed on the merits of their timely challenges."

Mifepristone was approved in 2000 under an accelerated drugs program under the claim that pregnancy is a life-threatening illness. The approval was subject to a set of ““risk evaluation and mitigation strategies” (REMS), including:

  1. limiting the drug to pregnant women and girls for use through 49 days gestation;
  2. requiring three in-person office visits, the first to administer mifepristone, the second to administer misoprostol, and the third to assess any complications and ensure there were no fetal remains in the womb;
  3. requiring the supervision of a qualified physician; and
  4. requiring the reporting of all adverse events from the drugs.

The challenge to this 2000 decision by the FDA was, the Court of Appeals found, not sufficiently certain to succeed (The Court called it "admittedly a close question" on which "plaintiffs might very well prevail ... later in this litigation") because it may be barred by the statute of limitations so the Court of Appeal granted a stay on the comprehensive ban on mifepristone.

However, the Court of Appeals declined to grant a stay on other aspects of the ban as follows:

In 2016 the FDA abolished or varied the 2000 REMS, by:

  1. increasing the maximum gestational age at which a woman can use the drug from 49 to 70 days;
  2. reducing the number of required in-person office visits from three to one;
  3. allowing non-doctors to prescribe and administer the chemical abortions drugs; and
  4. eliminating the requirement for prescribers to report non-fatal adverse events from chemical abortion

In January 2023, FDA approved a modified REMS for mifepristone lifting the in-person dispensing requirement (thereby allowing mail order delivery of mifepristone to women who may never have been examined in person with consequently greater risks of it being taken by women with a pregnancy beyond 70 days gestation, with an ectopic pregnancy or with other risk factors.

The Court of appeals held that the challenge to the 2016 FDA decision appears likely to succeed on its merits and so this part of the ban imposed by the District Court pending appeal remains in place, as does the ban on the generic versions of mifepristone approved by the FDA in 2019 and the ban on mail-order provision of mifepristone as approved by the FDA in January 2023.

This would have meant that mifepristone could only be supplied in accordance with the 2000 protocols – Danco product only; up to 49 days gestation; and qualified physician supervision with three in-person visits.

This would clearly be an illegal abortion in many States (post-Dobbs) so this decision, while not as far-reaching as the original District Court decision would have been if it had gone into effect fully, would still have prevented many chemical abortions and protected many women from harm.

The Biden administration sought emergency relief from the Supreme Court.
The US Supreme Court in a split 7-2 decision delivered on 21 April 2023 stayed all the bans imposed by the District Court until the “pending disposition of the appeal in the United States Court of Appeals for the Fifth Circuit and disposition of a petition for a writ of certiorari, if such a writ is timely sought.”1

Justice Clarence Thomas dissented without comment from the order.

Justice Samuel Alito explained his dissent from the order:

“As narrowed by the Court of Appeals, the stay that would apply if we failed to broaden it would not remove mifepristone from the market. It would simply restore the circumstances that existed (and that the Government defended) from 2000 to 2016 under three Presidential administrations. In addition, because the applicants’ Fifth Circuit appeal has been put on a fast track, with oral argument scheduled to take place in 26 days, there is reason to believe that they would get the relief they now seek—from either the Court of Appeals or this Court—in the near future if their arguments on the merits are persuasive.
“At present, the applicants are not entitled to a stay because they have not shown that they are likely to suffer irreparable harm in the interim.”

Addressing “the claim that Danco could not continue to market mifepristone because the drug would be mislabeled and that distribution could not resume until Danco jumped through a series of regulatory steps that would be largely perfunctory under present circumstances” Justice Alito noted “That would not take place, however, unless the FDA elected to use its enforcement discretion to stop Danco, and the applicants’ papers do not provide any reason to believe the FDA would make that choice. The FDA has previously invoked enforcement discretion to permit the distribution of mifepristone in a way that the regulations then in force prohibited, and here, the Government has not dispelled legitimate doubts that it would even obey an unfavorable order in these cases, much less that it would choose to take enforcement actions to which it has strong objections.”

In an entirely separate action, Life Legal Defense Foundation secured a victory against Danco for its failure to comply with basic labelling requirements under the US Tariff Act 1930 which required it to either identify China as the country of origin for the main ingredient in its product Mifeprix or to pay relevant marking duties to the US Government. In a deed of settlement Danco has agreed to pay a total of $774,269.08 with $116,140.35 of this going to Life Legal Defense Foundation for its role as relator in bringing the legal action on top of $46,220.28 for Life Legal’s expenses, attorneys’ fees, and costs.

These court actions have shed some much needed light on the dangers of chemical abortion and the lawless, reckless behaviour of both its distributor Danco and the FDA.

Here in Australia, mifepristone abortions are available by telehealth up to 63 days of pregnancy, with a Medicare rebate available for “tele-abortion” since 1 July 2021.

1 Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, No. 23-10362  USDC No. 2:22-CV-22 read more

2 No. 23-10362  USDC No. 2:22-CV-223 read more

3 Supreme Court article read more