A Summary of a Recent Amicus Brief Filed by 102 Members of Congress
Twenty-four U.S. senators and 78 members of the House of Representatives have filed a bicameral amicus curiae (friend of the court) brief in the case of American College of Obstetricians and Gynecologists v. United States Food and Drug Administration (ACOG v. FDA). The case is currently on appeal from the District of Maryland to the 4th U.S. Circuit Court of Appeals.
This case comes to the 4th Circuit as a result of the lower court’s issuance of a preliminary injunction in ACOG v. FDA, which blocked the FDA’s enforcement of the “Elements to Assure Safe Use” (ETASU) in the Risk Evaluation and Mitigation Strategy (REMS) for dispensing the chemical abortion pill mifepristone. Due to this injunction, mifepristone may now be distributed by clinics, medical offices, and hospitals through the mail or delivery service, whereas under previously enforced ETASU and REMS, it was generally limited to be dispensed in person by a certified provider in an approved facility. This dispute over abortion “access” arose amidst the COVID-19 pandemic, and the preliminary injunction will apply 30 days beyond the end of the public health crisis.
As members of Congress, the amici have a special interest in this case since they are constitutionally required to oversee the FDA and ensure the agency approves drugs and devices that are “safe and effective” for use by the American public. The amici argue that the district court relied on the medical evidence presented by plaintiff ACOG, rather than the scientific judgement of the FDA, and erroneously “imposed a nationwide injunction against the enforcement of certain” REMS.
The amici present three arguments why the lower court’s decision should be reversed by the 4th Circuit. First, they argue the district court’s decision misapplied Planned Parenthood v. Casey’s undue burden standard and runs afoul of the “Supreme Court’s recent directions to overturn an abortion regulation only if it operates as a substantial obstacle for a large fraction of women seeking an abortion.” Second, the amici argue that the court’s decision runs contrary to the “well-established safety concerns the FDA relied upon in adopting the REMS.” Finally, they argue that the lower court “failed to take into account the important public interest in ensuring that women are not subject to intimidation and coercion in seeking abortion.”
We now take each of the amici’s arguments in turn.
At the district court level, amici argue that the court applied the wrong standard in ruling on ACOG v. FDA. The amici discuss how the court erroneously used the cost-benefit test from Whole Woman’s Health v. Hellerstedt, rather than the undue burden standard as first set forth in Planned Parenthood v. Casey and reestablished in the recent decision of June Medical Services v. Russo. Under Casey, if there is a substantial obstacle to abortion, that is an “undue burden,” and this infringes on a woman’s fundamental right of privacy. In contrast, Hellerstedt mentions a cost-benefit analysis by which “courts consider the burdens a law imposes in abortion access together with the benefits those laws confer.” However, with the recent plurality decision in June Medical Services, amici argue that the part of the Court’s decision, in which Chief Justice Roberts agreed with the plurality on the substantial obstacle test of Casey, is controlling, rather than the plurality’s use of the benefits-burdens analysis of Hellerstedt. The district court instead applied the June Medical Services plurality benefits-burdens analysis, which Amici take issue with, as it’s not the standard of the Supreme Court. Moreover, there’s currently another abortion case at the 8th Circuit in which the court found Roberts’ concurrence controlling; amici urge the 4th Circuit to avoid any conflict with another circuit and reverse and remand the case.
Next, amici argue that the “preliminary injunction permits an untested form of telemedicine in chemical abortions and puts at risk women’s health and safety.” The district court rejected the sound science and FDA requirements in order to allow women to undergo a chemical abortion entirely remotely. When it comes to duration of pregnancy and ectopic pregnancy—both significant factors when considering medication abortion—amici argue that the district court’s decision is “contrary to established medicine.” Amici then mention further concerns surrounding the standard of care in testing for Rh negative blood, which can impact future pregnancies, and which the district court disregarded in its decision to allow use of telemedicine for prescribing Mifeprex. Additionally, amici found that the district court “put little weight on the FDA’s scientific judgement that the in-person requirements are necessary for women’s health and safety.” Rather than trusting the experts, the district court presumed the safety of Mifeprex while ignoring the underlying issues of informed consent and whether a chemical abortion is “medically appropriate” and by disregarding the REMS safeguards.
Finally, amici express concerns that the district court failed to look at the issue of domestic violence, and in doing so it “erroneously analyzed the balance of equities and public interest” in the case, which must be done when a court considers issuing a preliminary injunction. Amici argue that there are two public policy concerns in plaintiff ACOG’s claim: using telemedicine appointments in the time of COVID-19 as an attempt to prevent the spread of the disease, and requirements for medical professionals to see patients in person and assess for domestic violence. Although the lower court addressed the issue of COVID-19, it failed to identify and analyze concerns over domestic violence and abortion, which the amici go on to discuss in detail.
Given the application of the wrong standard by the lower court, combined with the risks to women and the public interest, the amici members of Congress present three sound arguments for the 4th Circuit to reverse the district court’s decision in ACOG v. FDA.
Katey Price, J.D. is a CLI associate scholar. She’s an attorney and manages political digital campaigns.