The Supreme Court once again has an abortion case on its docket. At issue are the FDA’s safety regulations for the RU-486 abortion pill, also known as Mifeprex. A federal district court in Maryland enjoined the regulations, and the federal government is asking the U.S. Supreme Court to stay – temporarily lift – that injunction to allow the safety rules to remain in place while the case works its way through litigation.
At issue, the Trump Administration explains in its application, is“the FDA’s longstanding, minimally burdensome requirement that patients obtain Mifeprex at a hospital, clinic, or doctor’s office after being counseled about the drug’s risks.” In other words, under current FDA regulations, pregnant women seeking abortion pills must meet with the health care provider in person to get the pills and to be informed of possible risks. The challengers – the pro-abortion American College of Obstetricians and Gynecologists (ACOG) and others – instead want expectant mothers to be able to get abortion pills by mail, after a “telehealth” encounter, using the COVID-19 pandemic as a pretext to expand abortion. The FDA, however, has long determined that there are “serious health risks associated with the drug” RU-486, and that the challenged regulations protect maternal health.
Recently, the Attorney General of California, Xavier Becerra, and twenty other state Attorneys General sent you a letter (hereinafter “the letter”) requesting increased access to the abortion pill, through mitigation of the FDA’s Risk Evaluation and Mitigation Strategy (“REMS”) and the use of telehealth for the prescribing of RU-486 (“Mifepristone.”) The letter claims, “The REMS create unnecessary delays for women who need access to time-sensitive healthcare and force them to travel unnecessarily.” For the reasons set forth below, it is both unwise and unsafe to exploit crisis-period-approval during the COVID-19 outbreak to enhance access to abortion for which Attorney General Becerra and others advocate. . . .
Further, General Becerra and the Attorneys General of the concurring states have routinely opposed REMS precautions and now seek to exploit a national health emergency to further their political interests to the detriment of the greater public at large.
Subsequent to our letter, the ACOG and others filed their lawsuit against the FDA and obtained an injunction. In its application for stay to the Supreme Court, the Trump Administration reiterates the safety concerns:
[T]he agency identified at least two reasons for keeping the safety requirements. First, the FDA concluded that requiring in-person dispensing permits contemporaneous counseling that could inform patients about possible serious complications and help them know what to do if they experience certain adverse events. . . . Second, the FDA explained, in-person dispensing avoids the possibility of delay that could arise if the drug were dispensed by a party other than the healthcare provider, such as in cases where patients had difficulty finding a pharmacy that stocks the drug. . . . That concern was particularly important because delay in initiating the abortion could increase the risks of serious complications.
Ironically, the abortion pill regulations were put in place by the pro-abortion administrations of Presidents Clinton and Obama. The federal district court therefore did not claim that this was some attempt to deny abortions as such. Instead, the trial court held that the COVID-19 pandemic made it too burdensome for a pregnant woman to visit a pill-dispensing clinic. As the federal government’s application explains:
[T]he district court’s finding of a substantial obstacle reduces to the observation that COVID-19 has made going anywhere riskier or more difficult than in normal times. . . . Yet that undifferentiated difficulty arising from an unforeseen global pandemic is an “incidental effect” not traceable to the safety requirements. . . . In barring enforcement of the requirements because of such incidental effects, the court inappropriately created an affirmative duty for the FDA to “remove [obstacles] not of its own creation.”
As the Trump Administration points out, limits on abortion pills do not at all affect the availability of surgical abortions, which remain an available alternative. Moreover, abortion pills are a relatively recent option, first approved in 2000, 27 years after Roe v. Wade invented a right to abortion. To say that a limit on such pills is unconstitutional, the government notes, “would imply that the FDA was constitutionally required to approve Mifeprex in 2000” when President Clinton’s administration first approved the drug (emphasis added).
When the federal district court nevertheless granted ACOG’s request to enjoin the FDA’s safety regulations for the duration of the COVID-19 emergency, the FDA requested a stay from that trial court and from the federal appeals court (the Fourth Circuit). Both requests were denied. The FDA is now asking the Supreme Court to lift the injunction. An order could issue anytime in the next few weeks.
Chief Justice John Roberts has ordered the ACOG and others who brought the lawsuit to provide a response to the Administration’s application for stay by Tuesday, September 8th, at noon.
The abortion industry is relentless in its opposition to anything that might delay or in any way inconvenience access to abortion. The COVID-19 pandemic has given abortion activists a handy excuse to attack the safety regulations for abortion pills, and a district court bought their argument. Let’s hope the Supreme Court sees through this ruse and lets the safety regulations go back into place.
It’s horrible that millions of innocent children die in abortions every year. Must the mothers also pay the price of a ravenous abortion lobby’s desire to cut corners?
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