Injunction seeking to keep access to mifepristone denied

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Where abortion providers in Virginia, Kansas and Montana sought an injunction to maintain access to mifepristone in those states, but they offered no evidence that the Food and Drug Administration, or FDA, intends to restrict the access of the drug in those states, their motion was denied because they didn’t demonstrate irreparable harm.

Background

In 2000, the FDA approved mifepristone as a safe and effective drug used as part of a two-drug regimen to terminate early pregnancy. In every review of mifepristone since then, FDA has reached the same conclusions about the drug’s safety and effectiveness, but FDA has attached several restrictions, commonly known as REMS, which affect the prescribing and dispensing of the drug.

Plaintiffs are abortion providers in Virginia, Kansas and Montana where mifepristone remains an available FDA-approved drug for early termination of pregnancy. Plaintiffs challenge the need for the REMS in this lawsuit alleging that “[c]ontinued enforcement of the REMS perpetuates harmful and unnecessary barriers that make it more difficult to access essential healthcare and interferes with this decision-making.”

Of immediate interest, plaintiffs seek a preliminary injunction to prevent “defendants and any person in active concert or participation with them from altering the status quo as it relates to the availability of mifepristone under the 2023 REMS in Virginia, Montana, and Kansas, where Plaintiffs operate.”

Standing

Defendants argue that plaintiffs lack standing to seek the preliminary injunction. The court disagrees. Defendants conflate the constitutional requirements for standing and the requirements for a preliminary injunction and analyze whether plaintiffs have suffered irreparable harm and whether a preliminary injunction could redress their alleged injuries.

However, the standing inquiry looks only at “whether a plaintiff had the requisite stake in the outcome of a case ‘at the outset of the litigation.’” Here, plaintiffs have standing to bring this action asserting that FDA imposed REMS that have affected access to mifepristone which establishes a cognizable injury to their patients and business that may be remedied by removal of the REMS.

Exhaustion

The exhaustion requirement “provides an agency with an opportunity ‘to correct its own mistakes with respect to programs it administers before it is haled into federal court.’” Exhaustion, however, has its exceptions, including situations where resorting to administrative procedures would be futile.

Plaintiffs allege that “FDA reevaluated the provisions of the mifepristone REMS in 2016, and again in 2019, 2021, and 2023, but it has continually decided to reimpose the REMS despite longstanding objections from the medical community and its own review of the data showing mifepristone’s safety and efficacy.” Plaintiffs argue that “[t]here is no prospect that FDA would take a different view if Plaintiffs were required to submit a citizen petition now.”

I find that requiring administrative exhaustion is futile, as FDA has demonstrated by its past actions and prior findings that it will not grant the relief sought by plaintiffs. I agree with two other recent courts which found that yet another citizen petition to FDA asking that it reconsider the REMS would be futile.

Injunctive relief

Plaintiffs have not clearly established that they will suffer irreparable harm because of FDA’s actions in the absence of preliminary relief. Presently, mifepristone, whether in a generic or name brand form, can be marketed and prescribed by providers and used for the effective and safe termination of a pregnancy. 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 another 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.

Finally, while plaintiffs cite to Alliance for Hippocratic Med. v. U.S. Food and Drug Admin., where a Texas district court stayed “the effective date of FDA’s September 28, 2000, Approval of mifepristone and all subsequent challenged actions related to that approval,” because of subsequent Supreme Court stay, mifepristone remains 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. As such, the harm plaintiffs allege could result from the Alliance case is purely speculative.

Although I need not consider the balance of the equities and public interest because plaintiffs have failed to make a clear showing regarding irreparable harm, I note that plaintiffs have not shown that the equities weigh in their favor at this time.

Motion to stay

Defendants seek a stay in this case pending resolution of the Alliance case. I will take the motion to stay under advisement pending discussions with the parties about production of the administrative record.

Plaintiffs’ motion for preliminary injunction denied. Defendants’ motion to stay taken under advisement.

Whole Woman’s Health Alliance v. United States Food and Drug Administration, Case No. 3:23-cv-00019, Aug. 21, 2023. WDVA at Charlottesville (Ballou). VLW 023-3-509. 22 pp.