A federal court has denied a request by Whole Woman’s Health Alliance (WWHA) for a preliminary injunction in a lawsuit the abortion chain filed against the U.S. Food and Drug Administration (FDA). The suit asked the District Court for the Western District of Virginia to order the FDA to remove the abortion pill from under its Risk Evaluation and Mitigation Strategy (REMS) safety requirements due to “chaos surrounding mifepristone.”
The lawsuit asked the court to enjoin the government agency from “altering the availability of mifepristone under the January 2023 REMS, to ensure some modicum of certainty and continued patient access to a safe, effective medication that has been repeatedly targeted simply because of its association with abortion.” In addition, the lawsuit petitioned the Court to “[e]njoin Defendants… from taking any action under the REMS against any providers in Virginia, Montana, or Kansas.”
Whole Woman’s Health Alliance (WWHA) v FDA mifepristone abortion pill lawsuit
The abortion pill mifepristone was approved by the FDA in 2000 in a regimen along with a second drug, misoprostol. In 2011, the FDA made the decision to place mifepristone under its REMS safety system, but not before multiple women had died in association with use of the abortion pill regimen.
Background Cases
This lawsuit comes on the heels of additional abortion pill lawsuits challenging the drug’s approval or requesting protections for its continued dispensing nationwide, including a case out of West Virginia which was filed by GenBioPro, the generic maker of the abortion pill.
In that case (GenBioPro, Inc. v. Mark Sorsaia), a decision by U.S. District Court Judge Robert C. Chambers partially dismissed GenBioPro’s challenge to West Virginia’s Unborn Child Protection Act and limitations the state passed regarding the dispensing of the drug.
In his decision, Judge Chambers rejected most of GenBioPro’s arguments, except for the “law ensuring women see a physician in person before receiving chemical abortion drugs,” according to the Alliance Defending Freedom (ADF) which also wrote that “West Virginia had amended its law to prohibit telehealth practitioners from ‘prescribing or dispensing an abortifacient,’ so now the lawsuit will proceed only as it regards that prohibition.”
In the more recent Whole Woman’s Health decision, the court mentioned two pending cases, summarized below.
Alliance for Hippocratic Medicine (AHM) v. FDA: On April 7, 2023, U.S. District Court Judge Matthew J. Kacsmaryk ruled in favor of the Plaintiffs in the AHM lawsuit to immediately suspend the 2000 approval and subsequent FDA changes to the abortion pill. But the case was appealed to the U.S. Court of Appeals for the Fifth Circuit, which issued a partial stay followed by a separate order from the U.S. Supreme Court, which allowed mifepristone to remain on the market while legal proceedings continued.
AHM’s case went back to the Fifth Circuit on August 16, 2023, where the Appeals Court ruled to allow the abortion pill mifepristone to remain “available to the public under the conditions for use that existed” prior to 2016. The decision would therefore remove mail order and pharmacy dispensing of the drug while leaving in place the FDA’s 2000 approval as well as its 2019 approval of the generic version (GenBioPro). The pill remains available under that April order from the U.S. Supreme Court and will stay in effect until the high court rules again on the matter or refuses to hear the case on appeal.
State of Washington v. FDA: This competing lawsuit involves a petition filed by a number of pro-abortion politicians in February, requesting that the judge enjoin the FDA from (1) enforcing or applying the 2023 REMS, and (2) taking any action to remove mifepristone from the market or otherwise cause the drug to become less available…” In April of 2023, U.S. District Judge Thomas O. Rice granted that preliminary injunction to bar the FDA from “altering the status quo and rights as it relates to the availability of Mifepristone under the current operative January 2023 Risk Evaluation and Mitigation Strategy under 21 U.S.C. § 355-1 in Plaintiff States.”
WWHA Preliminary Injunction Denied
In the most recent case involving Whole Woman’s Health (WWHA), the pro-abortion Center for Reproductive Rights, which represented WWHA, alleged in their release about the decision that the preliminary injunction – if granted by the court – would have “protected access to the abortion pill mifepristone in Virginia, Montana, and Kansas.” Expansion of the abortion pill over the past years has followed clinical trials and published studies authored by some with potential conflicts of interest and close ties to abortion pill manufacturers and their investors.
But in his decision regarding the WWHA lawsuit, United States District Judge Robert S. Ballou was unwilling to grant the preliminary injunction since the FDA had repeatedly decided to keep the drug under the REMS.
In his ruling, Judge Ballou pointed to the previously mentioned AHM case, writing, “The Fifth Circuit maintained that mifepristone will remain available under the pre-2016 REMS in both its name brand and generic form but recognized that ‘all of this relief is subject to the Supreme Court’s prior order, which stays the district court’s order until the disposition of any petition for certiorari.’ To be clear, the Supreme Court stay keeps mifepristone available in whatever states it can be legally prescribed subject to the 2023 REMS at least through the final determination of the litigation in the Alliance case.”
Judge Ballou also pointed out that “While FDA has changed the mifepristone REMS since its approval in 2000 and it has considered whether to retain or change the REMS repeatedly throughout the last 23 years, it continues to find that the REMS remain necessary. Plaintiffs seek removal of mifepristone’s REMS, just as several other organizations have before them,” he wrote.
But the judge added that “Plaintiffs [WWHA] seek a preliminary injunction during the pendency of this litigation to enjoin FDA ‘from deviating from the status quo in the states in which [Plaintiffs] provide care.’”
“Plaintiffs argue that the preliminary injunction is necessary because of the pending Alliance and Washington cases to which Plaintiffs are not parties and because of a new citizen petition to FDA seeking to have mifepristone’s approval revoked,” Judge Ballou wrote. “Here, I find that Plaintiffs have not adequately established irreparable harm in the absence of preliminary relief.”
In addition, the judge claimed that “Plaintiffs have offered no evidence that FDA intends to take action to change any of mifepristone’s REMS or to restrict the access of the drug in Virginia, Kansas, or Montana.”
“Indeed, FDA has been enjoined from changing the REMS at this time in 17 states and the District of Columbia by the Washington court. The record contains no evidence that FDA can promulgate regulations that would apply in certain states and not others, that it has ever done so, or that it intends to take such action. Thus, much of Plaintiffs’ allegations of irreparable harm are not rooted in actual and imminent events or actions taken by FDA,” the court wrote.
And while the court agreed that “the outcome of the Alliance case could have an impact on Plaintiffs,” Judge Ballou was clear that it “is neither necessary nor appropriate to issue a preliminary injunction in anticipation of or because of a ruling from another court.”
According to Judge Ballou “… Plaintiffs have failed to show irreparable harm caused by FDA. Because Plaintiffs cannot show that they will suffer irreparable harm, they cannot establish the necessary factors for preliminary injunctive relief.”
Live Action News’ “Bad Actors” series details how the abortion industry has repeatedly flouted FDA’s REMS by prescribing the drug past the approved gestational limit as well as to women who are not even pregnant, leaving women to deal with potentially dangerous ectopic pregnancies on their own, and encouraging emergency staff to conceal complications.
Removal from the REMS could allow the deadly pill to eventually be placed over the counter, something ‘Big Abortion’ would like to ultimately accomplish.
