The Trump administration petitioned the U.S. Supreme Court Wednesday to reinstate FDA health and safety standards for chemical abortion pills while a lawsuit seeking a relaxing of the standards is ongoing.
The Food and Drug Administration’s rule that the abortion drug mifepristone be dispensed only in a clinic, medical office, or hospital, and that the patient be fully informed of the drug’s risks, has been in place to protect women’s health since 2000.
Pro-life advocates say that the FDA’s Risk Evaluation and Mitigation Strategy (REMS) is necessary to help protect women from dangerous abortion drugs, something the Trump administration acknowledged in its petition to the Supreme Court.
“The FDA has made, and continuously adhered to, the judgment that these requirements mitigate serious health risks associated with the drugs, which can increase if the patient delays taking the drug or fails to receive proper counseling about possible complications,” the petition said.
The America Civil Liberties Union (ACLU) representing the American College of Obstetricians and Gynecologists (ACOG) and other abortion-supporting groups, sued in May to have the safety restrictions relaxed during the coronavirus pandemic. The groups argued that the FDA REMS “mandates unnecessary travel and personal interactions, jeopardizing the health and lives of patients and clinicians” and thus should be waived.
DIY, "self-managed" and "at-home" abortion
Abortion advocates have pushed for more chemical abortion access for some time, calling it “do-it-yourself,” “self-managed” or “at-home” abortion. And they have used the coronavirus pandemic to step up efforts to promote chemical abortion along with general abortion access.
Federal District Court Judge Theodore Chuang sided with the pro-abortion groups in their lawsuit, singlehandedly stopping enforcement of the FDA REMS in a July 14 ruling.
Chuang allowed the abortion pills to be dispensed via webcam or mail, writing in his ruling that maintaining the REMS during the pandemic would “place a substantial obstacle in the path of women seeking a medication abortion and that may delay or preclude a medication abortion and thus may necessitate a more invasive procedure.”
The FDA appealed suspension of the safety requirements in late July.
Earlier this month in a modified court order Chuang also allowed the abortion drugs to be accessed by online and in pharmacies without an in-person doctor visit.
Trump’s Justice Department went straight to SCOTUS with its petition asking to stop the nationwide injunction on the safety rule for abortion drugs while the controversial case plays out in the U.S. Fourth Circuit Court of Appeals.
The DOJ noted how one judge blocked the FDA’s health and safety standards, with nationwide implications:
“The circumstance here – in which a single district court, presented with a suit by a single physician and a handful of organizations, displaced the FDA’s scientific judgment with respect to every medication provider in the country – illustrate the problems with allowing district courts to award relief untethered to the established injuries of the specific plaintiffs before them.”
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The administration’s petition for a stay of Chuang’s order was addressed to Chief Justice John Roberts, NBC News reports.
Roberts disappointed pro-life advocates earlier this summer in siding with the majority in June Medical Services v. Russo, striking down Louisiana’s Unsafe Abortion Protection Act and going against his own past opinion in support of upholding a similar Texas law in Whole Woman’s Health v. Hellerstedt.
A health hazard
Earlier this month 11 states filed an amicus brief in defense of the FDA REMS, and late in July more than 20 pro-life, Christian and conservative groups wrote to the FDA urging removal of the abortion pill from the U.S. market and declare it a health hazard.
The FDA has documented at least 4,000 cases of serious adverse events related to the abortion pill, including more than 1,000 women who required hospitalization. And as of December 31, 2018, there had been 24 reported deaths of women in the U. S. associated with abortion pills.
The chemical abortion process involves two drugs. The first, RU-486, or mifepristone/Mifeprex, drug blocks progesterone, the natural hormone in the mother’s body necessary for a pregnancy to thrive. The second abortion drug, misoprostol, is taken a day or so later, and causes the mother to then deliver her deceased child.
Possible complications of a chemical abortion include an incomplete abortion, possibly resulting in the need for a follow-up surgical abortion, heavy and prolonged bleeding, infection, fever and digestive system discomfort, according to the Mayo Clinic. Numerous other negative side effects have also been reported.
The DOJ said in its petition that enforcement of the FDA safety rules “does not constitute a substantial obstacle to abortion access,” even during the pandemic, “given that surgical abortion methods remain widely available.”
Citing Planned Parenthood v. Casey, the Justice Department said that regulating one method of abortion does not create a substantial obstacle when another abortion method remains available.
The petition also noted that women seeking abortion after 10 weeks (the legal cutoff point for chemical abortion in the U.S.) must see a doctor in person and that since this is not an undue burden neither does that apply to dispensing of chemical abortion pills.
“If requiring an in-person surgical abortion for women who seek abortions after ten weeks does not impose an undue burden, then requiring in-person interaction for a medication abortion is not an undue burden for earlier abortions simply because respondents would prefer another alternative.”
"Medically unnecessary" safety requirements
Aside from the issue of undue burden or substantial obstacle, the DOJ chided the lower court for overriding the FDA:
“And even on its own terms, the court erred in its balancing of benefits and burdens. This Court has made clear that judges are not to second-guess how officials address public-health concerns in areas of uncertainty, yet the district court dismissed the FDA’s expert judgment in favor of its own view that the safety requirements are medically unnecessary.”
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Abortion proponents criticized the petition.
ACLU Reproductive Freedom Project’s Julia Kay said in the NBC News report that the Trump administration “refuses to end its crusade to subject abortion patients and their families to entirely unnecessary exposure risks. Forcing patients to travel during a pandemic just to pick up a pill is irrational and dangerous.”
Conversely, pro-life groups welcomed the Trump administration’s petition.
“The Trump Administration’s proactive petition represents just what Pro-Life Americans expect from their government – a commitment to mothers and their children, born and preborn,” Students for Life of America President Kristan Hawkins said.
Susan B. Anthony List president Marjorie Dannenfelser said, “We are extremely grateful to the Trump Administration for taking another important step to uphold vitally important safety restrictions on dangerous chemical abortion pills. These proven safeguards are reasonable and necessary, and put the safety of women and young girls over the profits of the abortion industry.”