The U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, has been curtailed following dueling federal court decisions in Texas and Washington. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S. Department of Justice (the “DOJ”) asked the Fifth Circuit to grant an emergency or administrative stay of that decision. Although the Fifth Circuit did grant temporary, albeit limited, relief, the court maintained that Mifepristone could only be prescribed in the first seven weeks of pregnancy, under a physician’s supervision, and the drug cannot be sent by mail.
The Fifth Circuit’s decision directly conflicts with a recent decision out of the Eastern District of Washington enjoining the FDA from altering the status quo as it relates to the availability of Mifepristone in seventeen states and Washington, D.C. Due to the “regulatory chaos” that has ensued since the issuance of the Fifth Circuit order, Danco Laboratories, LLC (“Danco”), distributor of the drug, Mifepristone, sought emergency relief from the U.S. Supreme Court to either stay the Texas District Court’s preliminary injunction in full pending appeal or grant certiorari in the case. The DOJ followed suit immediately thereafter, filing its own emergency request with the U.S. Supreme Court to restore access to the drug nationwide. Hours before the restrictions were set to go into effect, Supreme Court Justice Samuel Alito placed a five day administrative stay on the Fifth Circuit’s order, giving the high court until Wednesday, April 19th at 11:59 pm ET to fully consider the issue.
This article provides an in-depth analysis of the dueling decisions, with a deep dive into the implications of the Texas case, including the availability and use of the Mifepristone drug going forward, and the potential impact to the FDA’s broader authority, if the Texas plaintiffs ultimately prevail.
The Lifecycle of Mifepristone
How did we get here? A Timeline
In the landmark decision, Dobbs v. Jackson Women’s Health Organization, the Supreme Court overruled Roe v. Wade and Planned Parenthood v. Casey, holding that there is no constitutional right to abortion, and granting individual states the authority to regulate abortion as they deem appropriate.
In addition to a flurry of other lawsuits, legislative activity, and agency guidance, two federal cases playing out in the states of Washington and Texas are receiving national attention for the potential impact to the availability of the commonly used abortion medication, Mifepristone. These cases have been proceeding on roughly parallel tracks, with disparate outcomes:
| Washington Lawsuit[1] | Texas Lawsuit[2] |
| February 2023: A dozen democratic attorneys general file suit against the FDA in the Eastern District of Washington, challenging the FDA’s current restrictions on Mifepristone, including distribution and certification requirements, as burdensome and unnecessary. The lawsuit seeks declaratory relief that Mifepristone is safe and effective, and that the FDA’s approval of the drug is lawful. In its motion for preliminary injunction to enjoin the FDA from removing Mifepristone from the market, the plaintiffs note that “FDA’s restrictions also single Mifepristone out for paper-trail requirements that create Orwellian dangers for patients and providers, potentially subjecting them to harassment, lawsuits, or even criminal prosecution.” Mot. at 2. | November 2022: Alliance for Hippocratic Medicine, American Association of ProLife Obstetricians and Gynecologists, American College of Pediatricians, Christian Medical & Dental Associations, and individual providers (collectively, the “Texas Plaintiffs”) filed suit in the Northern District of Texas, challenging the FDA’s decades old approval of Mifepristone under the Administrative Procedure Act (5 U.S.C. § 706). In their motion for preliminary injunction to withdraw or suspend the FDA approvals of chemical abortion drugs, the Texas Plaintiffs claim that the FDA is “running roughshod over the laws and regulations that govern the agency and, more importantly, protect the public from harmful drugs.” Mot. at 2. |
| April 7, 2023: Judge Thomas Rice rules that the FDA is prohibited from “altering the status quo and rights as it relates to the availability of Mifepristone” in seventeen states and the District of Columbia. | April 7, 2023: Judge Matthew Kacsmaryk rules in favor of Plaintiffs, halting FDA’s approval of Mifepristone, but stays the ruling for seven days in order to allow the Biden Administration time to seek an emergency appeal. |
| April 10, 2023: DOJ seeks clarification from court regarding the FDA’s obligations in light of the Texas ruling. | April 12, 2023: Fifth Circuit grants DOJ’s request for a stay in part, allowing partial access to the abortion drug pending the appeal. The Fifth Circuit noted that while “the statute of limitations bars plaintiffs’ challenges to the Food and Drug Administration’s approval of Mifepristone in 2000,” challenges to FDA’s 2016 REMS changes to expand access and limit restrictions are in fact timely. Fifth Circuit Order, at 2. |
| April 13, 2023: In response to the request for clarification, Judge Rice issued an order affirming that for the 17 states and D.C., access to Mifepristone should remain unchanged, Texas ruling notwithstanding. | April 14, 2023: Distributor of Mifepristone, Danco, Laboratories, LLC (“Danco”) filed an application to the U.S. Supreme Court for emergency relief, following the Fifth Circuit’s order to reinstate restrictions on Mifepristone during the appeal. Danco requested either a full stay of the Texas District Court ruling pending appeal or for the court to grant certiorari in the case. April 14, 2023: Immediately after Danco filed its application,DOJ also sought emergency relief from the U.S. Supreme Court with the same basis as Danco. April 14, 2023: Supreme Court Justice Samuel Alito issued a five day hold on the restrictions imposed under the Fifth Circuit order, giving the court until 11:59 pm ET on April 19th to fully consider the issue. |
As a result of the Fifth Circuit ruling, and, if the U.S. Supreme Court allows the stay on the ruling to expire after April 19th, Mifepristone will continue to be available for use while the Texas case is on appeal, but only for the first seven weeks of pregnancy and under physician supervision (as required under the pre-2016 REMS). Mifepristone will no longer be available via mail order while the Texas decision is being appealed.
The Fifth Circuit order remains in conflict with the Washington state district court order, which creates a paradoxical situation.
As an initial matter, a federal district court decision (e.g., the Eastern District of Washington) is not binding on other district courts, including district courts in the same jurisdiction. A circuit court decision (e.g., the Fifth Circuit) is only binding on federal district courts (not state courts) within that circuit, and does not bind courts outside of the circuit in which it is located. This means that the Fifth Circuit order restricting the use of Mifepristone is binding on all district courts within the Fifth Circuit. Where, as here, courts in different circuits have adopted conflicting interpretations of federal law, the U.S. Supreme Court is often called upon to intervene and settle the conflict.
In the interim, the FDA exists in all jurisdictions. Following the U.S. Supreme Court’s stay, the FDA narrowly (and temporarily) avoided facing the impossible task of complying with both the Washington state district court order requiring it to maintain the status quo in seventeen states and Washington, D.C., while simultaneously complying with the Fifth Circuit’s order reinstating pre-2016 REMS restrictions on Mifepristone nationwide. For this reason, Danco and DOJ sought emergency relief from the U.S. Supreme Court to provide direction in the face of these dueling injunctions, and the critical question is whether the high court will do so before April 19th.
A Deep Dive into the Texas Case and its Implications if the Plaintiffs Prevail on their Claims
Implications of the Texas Ruling
In the aftermath of Dobbs, the withdrawal of Mifepristone not only impacts (and further restricts) access to abortion medication, but also creates uncertainty for providers and the FDA regulatory framework.
Accessibility: Medication abortions currently account for more than 50% of all abortions in the United States. If Mifepristone is no longer on the market or access is more limited, in states where abortion is legal, women may look to other forms of abortion, including surgical abortion, as an alternative, potentially increasing demands on already overburdened healthcare systems. Women who are at risk for complications from anesthesia or sedation may be compelled to use Misoprostol off-label, which may accelerate the termination timeline, compared to a Mifepristone/Misoprostol regimen. Although this off-label use may cause an abortion to occur faster, it carries the potential for complications.
Provider Uncertainty: In states where abortion is legal, adoption of this Misoprostol-only protocol may pose challenges. Some states adopt the position that medication abortions take place at the time the provider prescribes the medication, while other states claim that the medication abortion occurs when the pregnancy is terminated. This creates legal uncertainty for patients traveling between states where abortion is banned and states where abortion is legal and may impact how a provider instructs a patient to complete the misoprostol regimen.
FDA Regulatory Framework: The Texas District Court’s decision to withdraw Mifepristone relied heavily on the conclusion that abortion medication does not fall under the scope of the Accelerated Approval framework. Even though the FDA conducted a comprehensive scientific analysis of Mifepristone, and the Government Accountability Office published a 2008 report finding that FDA operated within their authority under Subpart H to approve the drug, the District Court chose not to defer to the FDA’s expertise. The Texas ruling, if upheld, may undermine the FDA’s statutory authority to evaluate and determine the safety and efficacy of drugs and medical devices through its longstanding regulatory approval pathways. This unprecedented ruling to withdraw an FDA approved drug may lead to future challenges to other previously approved drugs, and may also cause uncertainty regarding the FDA’s approval of new treatments. Finally, this decision could have significant impacts on agency deference more generally, far beyond the FDA and its authority to regulate drug safety and efficacy.
What’s Next?
Following the U.S. Supreme Court’s stay of the Fifth Circuit order, the high court still does not have much time to rule on the underlying issue. The Fifth Circuit order goes into effect at 11:59 pm ET on April 19, 2023, and, without further intervention from the highest court, the FDA will face the impossible task of complying with two directly conflicting court orders.
Sheppard Mullin’s Women in Healthcare Leadership Collaborative (“WHLC”) continues to closely monitor both dockets and will provide updates as the cases progress.
FOOTNOTES
[1] State of Washington v. U.S. Food and Drug Administration, No. 1:23-cv-032026 (E.D. Wa. Apr. 7, 2023).
[2] See Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, No. 2:22-CBV-223-Z (N.D. Tex. Apr. 7, 2023).