Supreme Court, Through Stays While Appeals Continue, Allows Continued Mail-Order Delivery of Mifepristone

The Supreme Court today, in a 7-2 decision in Danco Laboratories, LLC v.  Louisiana, (Sup. Ct., May 14, 2026), granted a stay while appeals continue of the 5th Circuit's decision that had barred telehealth prescribing and mail order delivery of the abortion drug mifepristone. The majority granted the stay in a one-paragraph order.

Justice Thomas filed a dissenting opinion, saying in part:

... [I]t is a criminal offense to ship mifepristone for use in abortions. The Comstock Act bans using “the mails” to ship any “drug . . . for producing abortion.” 18 U. S. C. §1461.  A neighboring provision makes it a felony to use “any express company or other common carrier or interactive computer service” to ship “any drug . . . designed, adapted, or intended for producing abortion.” §1462(c)....

... Applicants are not entitled to a stay of an adverse court order based on lost profits from their criminal enterprise. They cannot, in any legally relevant sense, be irreparably harmed by a court order that makes it more difficult for them to commit crimes.

Justice Alito also filed a dissenting opinion, saying in part:

...  What is at stake is the perpetration of a scheme to undermine our decision in Dobbs v. Jackson Women’s Health Organization ... which restored the right of each State to decide how to regulate abortions within its borders. 

... [W]ithout any current indication that the FDA plans to resume enforcing the in-person-dispensing requirement, there is no reason to believe that the manufacturers could not continue their current distribution practices....

If the FDA were to execute an abrupt about-face and commence enforcement of the in-person-dispensing requirement, the manufacturers could promptly reapply for stays at that time.  But even were that to happen, the manufacturers have not shown that they would suffer irreparable injury....

NBC reports on the decision. 

Mifepristone Makers Ask Supreme Court to Stay 5th Circuit's Ruling Ending Mail-Order Delivery of Abortion Drug

As previously reported, last Friday the U.S. 5th Circuit Court of Appeals granted a stay pending appeal of the FDA's 2023 ruling that removed the requirement that the abortion drug mifepristone be prescribed only after an in-person visit with a doctor. The FDA ruling permitted out-of-state doctors to prescribe mifepristone which then could be delivered by mail. Within one day of the 5th Circuit's ruling, two pharmaceutical manufacturers that had intervened as defendants in the case in the lower courts filed an emergency petition with the U.S. Supreme Court asking it to stay the 5th Circuit's ruling while appeals continue. Alternatively, they seek immediate Supreme Court review. They also ask for an immediate administrative stay of the 5th Circuit's judgement while the Supreme Court is considering their petition. 

The 56-page petition (full text) in Danco Laboratories, L.L.C. v. State of Louisiana, Ct. filed 5/2/2026) contends in part that Louisiana lacks standing to challenge the FDA ruling and that the 5th Circuit's judgment "injects immediate confusion and upheaval into highly time-sensitive medical decisions."

SCOTUSblog reports on the case and traces much of the background to the present filing.

5th Circuit Stays FDA Ruling That Allows Mail Order Delivery of Mifepristone

In State of Louisiana v. Food and Drug Administration, (5th Cir., May 1, 2026), the U.S. 5th Circuit Court of Appeals granted a stay pending appeal of the FDA's 2023 ruling that removed the requirement that the abortion drug mifepristone be prescribed only after an in-person visit with a doctor. The FDA ruling permitted out-of-state doctors to prescribe mifepristone which could be delivered by mail. The district court refused to stay the FDA action because the FDA was conducting its own review of its 2023 action. The 5th Circuit disagreed. First, it held that Louisiana has standing to challenge the FDA's action, saying in part:

... [T]he agency’s 2023 REMS causes “federal interference with the enforcement of [Louisiana] law,” which gives Louisiana standing to challenge it...

Louisiana provided hard evidence linking thousands of dollars in Medicaid costs to care stemming from out-of-state mifepristone. As the district court correctly held, that “alone [is] sufficient to establish Louisiana’s standing.”...

Every abortion facilitated by FDA’s action cancels Louisiana’s ban on medical abortions and undermines its policy that “every unborn child is human being from the moment of conception and is, therefore, a legal person.” La. Stat. Ann. § 40:1061.1(A)(1) (2022). Once lost, that sovereign prerogative of protecting unborn life cannot be regained by legal remedy. And because FDA “is entitled to sovereign immunity,”... Louisiana’s financial harms are also irremediable.

... [T]he agency “essentially acknowledged APA procedural deficits with respect to mifepristone” by “stating that [its] intention to review the mifepristone regulatory framework was precipitated by ‘the lack of adequate consideration underlying the prior REMS approvals.’” 

Based on the same defects, our court has previously concluded that FDA’s actions here were likely unlawful....

ADF issued a press release announcing the decision. [Thanks to Thomas Rutledge for the lead.]

FDA Restrictions on Abortion Drug Held to Be Arbitrary and Capricious

 In Purcell v. Kennedy, (D HI, Oct. 30, 2025), a Hawaii federal district court, in a 79-page opinion, held that the FDA must re-evaluate the "Risk Evaluation and Mitigation Strategy" which it has imposed for the use of mifepristone. The court said in part:

... [T]he court concludes that the Agency violated the APA by failing to provide a reasoned explanation for its restrictive treatment of the drug, which was compounded by its decision to limit the scope of information it considered when evaluating the REMS. More specifically, the Agency neglected to consider certain required statutory factors and generally failed to sufficiently explain the logic behind any reasoning it did provide, rendering the 2023 REMS Decision arbitrary and capricious.

The court ordered the FDA to reconsider its restrictions. ACLU issued a press release announcing the decision.  [Thanks to Thomas Rutledge for the lead.]

FDA Approves Generic Mifepristone

The pharmaceutical company Evita Solutions announced that last month the FDA approved its generic version of the abortion pill mifepristone. NBC News reporting on the FDA action said in part:

The FDA often issues a press release after new or significant drug approvals, but did not in this case....

Sen. Bill Cassidy, R-La., the chair of the Health, Education, Labor and Pensions Committee, which oversees the FDA chimed in on X: “I fully support President Trump’s Pro-Life, Pro-Family agenda, but the FDA approving one more tool to kill babies is a betrayal. This is not what Commissioner Makary and Secretary Kennedy indicated they would do in their confirmation hearings.”

4th Circuit: FDA Regulation of Mifepristone Does Not Pre-Empt West Virginia's Abortion Ban

In GenBioPro, Inc. v. Raynes, (4th Cir., July 15, 2025), the U.S. 4th Circuit Court of appeals in a 2-1 decision, held that federal law regulating the abortion drug mifepristone does not pre-empt West Virginia's Unborn Child Protection Act which bans almost all abortions. The suit was brought by a manufacturer of generic mifepristone. The majority said in part:

We begin by addressing GenBioPro’s field preemption theory. GenBioPro argues that the FDAAA “occupied the field of regulating access to REMS drugs with safe-use elements.”... In its view, West Virginia’s abortion law intrudes into this field by restricting access to mifepristone.  

We disagree. West Virginia’s abortion law and the FDAAA operate in different fields. West Virginia’s law regulates the incidence of abortion. It determines whether an abortion may be performed at all, prohibiting the procedure in all but a few specific circumstances. In contrast, the FDAAA permits the FDA to regulate how mifepristone must be prescribed and dispensed if and when a medication abortion is performed....

And even were we to assume the state and federal laws regulate the same field, that field is not one that Congress has occupied....

We last address GenBioPro’s contention that the West Virginia law conflicts with the FDAAA....

The company claims that it cannot comply with both federal and state law because the FDA has authorized the sale of mifepristone while the state has banned its use. It likewise argues that the West Virginia law poses an obstacle to the FDAAA’s goal of ensuring drug access. In its view, Congress struck a careful balance between drug safety and access, and West Virginia’s abortion law disrupts this balance by burdening access to mifepristone. 

Both of these theories rely on the same flawed premise: that Congress intended to guarantee nationwide access to mifepristone when it enacted the FDAAA. We see no indication that it did....

Judge Benjamin dissented, saying in part:

By criminalizing medical providers and prohibiting medication abortions, then, West Virginia has exceeded the ability to regulate abortion as established in Dobbs and has trespassed on the FDA’s authority to regulate the safe use of and unburdened access to mifepristone.  

Stated simply, the majority’s conclusion on this point focuses on regulation of abortion generally, despite the issue here being the state regulation of an otherwise federally approved drug—a much narrower focus.  The federal government has clearly occupied the drugs with REMS and elements to assure safe use field, and West Virginia overreaches by seeking to add additional regulations to the same.  Accordingly, field preemption applies....

Because the UCPA burdens patients and healthcare systems and imposes inconsistent regulation of mifepristone in ways not intended by Congress, conflict preemption also precludes the state law.

Metro News reports on the decision.

States Lack Standing to Challenge FDA's Rules on Dispensing of Abortion Pill

In State of Washington v. U.S. Food and Drug Administration, (9th Cir., July 24, 2024), the U.S. 9th Circuit Court of Appeals refused to permit the state of Idaho (and 6 other states) to intervene in a lawsuit brought by a group of states led by the state of Washington challenging the FDA's restrictions on pharmacies' dispensing of the abortion pill mifepristone. FDA regulations adopted in 2021 allow mifepristone to be dispensed by pharmacies in retail locations or by mail, but only if the pharmacy is specially certified to do so. Washington's lawsuit contends that the certification and documentation requirements are unnecessary.  Idaho, on the other hand, wants the court to order the FDA to go back to earlier requirements that only allowed mifepristone to be dispensed in person by a physician and did not allow it to be obtained directly from pharmacies. The court concluded that because Idaho seeks fundamentally different relief that does Washington, it must establish its own standing in order to intervene. The court concluded that Idaho did not have separate standing, saying in part:

Idaho first alleges that elimination of the in-person dispensing requirement will cause the state economic injury in the form of increased costs to the state’s Medicaid system.  At oral argument, Idaho stated that this is its “strongest basis” for standing.  Even taking Idaho’s highly speculative allegations as true, the complaint does not demonstrate an injury-in-fact because it depends on an attenuated chain of healthcare decisions by independent actors that will have only indirect effects on state revenue....

Idaho next alleges that elimination of the in-person dispensing requirement will harm its sovereign interest in law enforcement by making illegal mifepristone use harder to detect.  This allegation is insufficient to convey standing because nothing in the 2023 REMS impairs Idaho’s sovereign authority to enact or enforce its own laws regulating chemical abortion....

Finally, Idaho alleges that elimination of the in-person dispensing requirement will harm its “quasi-sovereign interest” in maternal health and fetal life.  Idaho cannot sue FDA on this basis because the allegations concern the interests of individual citizens—not the separate interests of the state itself....

Courthouse News Service reports on the decision. [Thanks to Thomas Rutledge for the lead.]

Supreme Court Says Plaintiffs Lack Standing To Challenge FDA's Rules on Abortion Drugs

In Food and Drug Administration v. Alliance for Hippocratic Medicine, (Sup. Ct., June 13, 2024), the U.S. Supreme court today held unanimously that plaintiffs who are challenging the FDA’s rules on prescribing and distributing the abortion drug mifepristone lack standing to bring the lawsuit.  The Court said in part:

Here, the plaintiff doctors and medical associations are unregulated parties who seek to challenge FDA’s regulation of others. Specifically, FDA’s regulations apply to doctors prescribing mifepristone and to pregnant women taking mifepristone. But the plaintiff doctors and medical associations do not prescribe or use mifepristone. And FDA has not required the plaintiffs to do anything or to refrain from doing anything….

The plaintiffs have sincere legal, moral, ideological, and policy objections to elective abortion and to FDA’s relaxed regulation of mifepristone. But under Article III of the Constitution, those kinds of objections alone do not establish a justiciable case or controversy in federal court. Here, the plaintiffs have failed to demonstrate that FDA’s relaxed regulatory requirements likely would cause them to suffer an injury in fact. For that reason, the federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions. The plaintiffs may present their concerns and objections to the President and FDA in the regulatory process, or to Congress and the President in the legislative process. And they may also express their views about abortion and mifepristone to fellow citizens, including in the political and electoral processes. 

“No principle is more fundamental to the judiciary’s proper role in our system of government than the constitutional limitation of federal-court jurisdiction to actual cases or controversies.”

Justice Kavanaugh wrote the Court’s opinion, and Justice Thomas filed a concurring opinion.

AP reports on the decision.

Catholic Bishops Mobilize Special Prayer Efforts for Supreme Court's Decision on Abortion Pill Availability

On March 26, the U.S. Supreme Court will hear oral arguments in Food and Drug Administration v. Alliance for Hippocratic Medicine and a companion case Danco Laboratories, LLC v. Alliance for Hippocratic Medicine. (SCOTUSblog case page.) At issue are challenges to the Food and Drug Administration's relaxation of restrictions on the administration and use of the abortion drug mifepristone. (See prior posting.) On March 14, the U.S. Conference of Catholic Bishops issued a letter (full text) calling for the recitation of a special prayer beginning the day before oral arguments and daily until the date in June when the case is decided.  The letter reads in part:

The USCCB Committee on Pro-Life Activities is inviting Catholics to join a focused effort of prayer for the end of abortion and the protection of women and preborn children, beginning on March 25, the eve of the oral arguments, and the anniversary of St. John Paul II’s landmark, pro-life encyclical, The Gospel of Life (Evangelium vitae). In particular, we will invoke the intercession of St. Joseph, Defender of Life....

The Tablet and Catholic World Report both report on the Bishops' Nationwide Invitation to Prayer.

Supreme Court Grants Review of FDA's Rules on Prescribing and Distributing Abortion Pill

The U.S. Supreme Court today granted certiorari in two related cases, FDA v. Alliance for Hippocratic Medicine, (Docket No. 23-235, cert. granted 12/13/2023) and Danco Laboratories, LLC v. Alliance for Hippocratic Medicine, (Docket No. 23-236, cert. granted, 12/13/2023). (Order List.) (SCOTUSblog case pages 23-235, 23-236) In the single opinion applying to both cases, the U.S. 5th Circuit Court of Appeals upheld portions of a Texas federal district court's orders that stayed actions taken by the FDA in 2016 and 2021 regarding the administration and distribution of the abortion pill mifepristone. The 2016 action increased the gestational age when the drug can be used and lightened certain other dosage and prescribing restrictions. In 2021, in connection with the Covid epidemic, the FDA removed the in-person prescribing requirement for mifepristone, allowing it to be sent by mail. The court found that doctors have standing to challenge these actions, among other things citing conscience injuries to objecting doctors.  Challenges to two other FDA actions on mifepristone were rejected on standing and statute of limitations grounds. (See prior posting.) 

The Supreme Court denied review in Alliance for Hippocratic Medicine v. FDA, (Docket No. 23-395, cert. denied, 12/13/2023) which sought review of the FDA's original approval of mifepristone in 2000. (SCOTUSblog case page.)

The district court's orders are not currently in effect because in April, the U.S. Supreme Court stayed the orders while appeals work their way through the courts. (See prior posting.) 

SCOTUSblog reports on the Supreme Court's grants of review.

West Virginia's Ban on Prescribing Mifepristone By Telemedicine Is Pre-Empted By FDA Rules

In GenBioPro, Inc. v. Sorsaia,, (D WV, Aug. 24, 2023), a West Virginia federal district court dismissed a challenge to West Virginia abortion restrictions that are no longer in effect. The restrictions will go back into effect only if provisions of the more recent Unborn Child Protection Act (UCPA) are held unconstitutional. The court held that neither federal statutes nor FDA rules pre-empt state restrictions on when abortions may be performed. However, the court refused to rule further on the UCPA provisions, saying in part:

[T]he Court has not found that the UCPA is unconstitutional. As none of these prior restrictions are currently in effect, this Court may not issue an advisory opinion as to the constitutionality of a law not presently operative.

The court also rejected arguments that state restrictions on the sale of mifepristone violate the Commerce Clause, saying in part:

[T]he Supreme Court and Courts of Appeals have repeatedly affirmed that morality-based product bans do not intrinsically offend the dormant Commerce Clause. 

However the court did find that West Virginia's ban on prescribing mifepristone by telemedicine, which is still in effect, is pre-empted by FDA rules allowing telemedicine prescriptions for the drug. The Hill reports on the decision.

5th Circuit Says FDA Improperly Reduced Abortion Pill Restrictions, But Prior Supreme Court Order Keeps FDA Rules In Effect During Appeals

In Alliance for Hippocratic Medicine v. U.S. Food & Drug Administration, (5th Cir., Aug. 16, 2023), the U.S. 5th circuit Court of Appeals upheld the portions of a Texas federal district court's orders that stayed actions taken by the FDA in 2016 and 2021 regarding the administration and distribution of the abortion pill mifepristone. The 2016 action increased the gestational age when the drug can be used from 49 to 70 days. It also lightened certain other dosage and prescribing restrictions. In 2021, in connection with the Covid epidemic, the FDA removed the in-person prescribing requirement for mifepristone, allowing it to be sent by mail. The court found that doctors have standing to challenge these actions, among other things citing conscience injuries to objecting doctors.  Challenges to two other FDA actions on mifepristone were rejected on standing and statute of limitations grounds.

The court concluded that plaintiffs are likely to succeed on their Administrative Procedure Act challenges that the FDA's actions were arbitrary, capricious, an abuse of discretion or otherwise not in accordance with law. This was the case as to the 2016 action because the FDA did not consider the cumulative effect of the changes it was proposing. They were likely to succeed on their challenge to the 2021 action because the FDA did not adequately study adverse event data.

However, as the court recognized, the U.S. Supreme Court has already ordered a stay of all the district court's orders until federal appeals are completed. Thus the 5th Circuit's action does not reinstate the district court's bans. 

Judge Ho concurred in part and dissented in part, saying tht he would also hold that the initial approval of mifepristone in 2000 should be set aside.

NPR reports on the decision.

Supreme Court Stays District Court's Order That Invalidated FDA's Approval of Abortion Pill

The U.S. Supreme Court yesterday evening in Danco Laboratories, LLC v. Alliance for Hippocratic Medicine, (Sup. Ct., April 21, 2023), and in a companion case in which the FDA was a party, granted stays of a Texas federal district court's order that had found the FDA's approval of the abortion drug mifepristone to be invalid. The stays will remain in effect while appeals work their way through the courts. Justice Thomas indicated that he would have denied the applications for stays.  Justice Alito filed an opinion dissenting from the grant of the stays, saying that the applicants have not shown that they would suffer irreparable harm if the stays were not granted. SCOTUSblog has additional reporting on the Supreme Court's action.

Supreme Court Grants 5-Day Administrative Stay of Texas District Court's Abortion Pill Order

U.S. Supreme Court Justice Samuel Alito this afternoon in Food & Drug Administration v. Alliance for Hippocratic Medicine, (Docket No. 22A902, April 14, 2023), granted a 5-day administrative stay of a Texas federal district court's order invalidating the FDA's approval of the abortion drug mifepristone. Any response to the application for a lengthier stay must be filed by 11:59 pm April 18. Any response to that filing must be submitted by noon the next day. CNN reports on developments.

UPDATE: Here is the White House's reaction to the Court's stay.

Supreme Court Asked to Stay Abortion Pill Rulings

Today both the FDA and the manufacturer of the abortion drug mifepristone filed with the U.S. Supreme Court applications for a stay of the Texas federal district court's Order invalidating the FDA's approval of the drug. The 5th Circuit Court of Appeals allowed part of the district court's order to remain in effect. Today's Applications for a Stay were filed with Justice Alito, the Justice assigned by the Court to receive emergency applications from the 5th Circuit.  Here is the filing by Danco Laboratories, and here is the Solicitor General's filing on behalf of the FDA.  Axios reports on the filings.

5th Circuit Allows Part of Stay on Abortion Pills To Remain; U.S. Will Appeal to Supreme Court

 In Alliance for Hippocratic Medicine v. Food & Drug Administration,(5th Cir., April 12, 2023), the U.S. 5th Circuit Court of Appeals granted a partial stay of a Texas federal district court's decision invalidating the FDA's approval of the abortion drug mifepristone. The appeals court held that the statute of limitations barred a challenge to the FDA's initial approval of the drug in 2000. However, the court refused to stay the district court's disapproval of changes the FDA made in 2016.  Those changes significantly reduced prior restrictions on the administration and use of the drug. The court said in part:

Here, applicants have failed to carry their burden at this preliminary stage to show that FDA’s actions were not arbitrary and capricious. We have two principal concerns in that regard. First, FDA failed to “examine the relevant data” when it made the 2016 ... changes.... That’s because FDA eliminated ... safeguards based on studies that included those very safeguards....

Second, the 2016 ... Changes eliminated the requirement that non-fatal adverse events must be reported to FDA. After eliminating that adverse-event reporting requirement, FDA turned around in 2021 and declared the absence of non-fatal adverse-event reports means mifepristone is “safe.”... This ostrich’s-head-in-the-sand approach is deeply troubling.... It’s unreasonable for an agency to eliminate a reporting requirement for a thing and then use the resulting absence of data to support its decision.

Reuters reports on the decision. 

Earlier today, the Justice Department announced that it would seek emergency relief from the U.S. Supreme Court.

FDA Seeks Stay Pending Appeal of Order Ending Approval of Mifepristone

The Justice Department on behalf of the U.S. Food and Drug Administration yesterday filed an Emergency Motion for a Stay Pending Appeal (full text of motion) in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, (5th Cir., filed 4/10/2023). The motion seeks a stay while an appeal is heard by the 5th Circuit of a Texas federal district court decision setting aside the 2000 FDA order approving doctors prescribing mifepristone for medical abortions. The FDA argues in part:

The [district] court repeatedly characterizes mifepristone as unsafe. But over the last two decades, the available evidence conclusively demonstrates that mifepristone is safe under the approved conditions of use. More than five million women have used mifepristone to terminate their pregnancies in the United States.... Mifepristone is also approved in dozens of other countries..... The literature reflects “exceedingly rare” rates of serious adverse events.

AP reports on the appeal.

Contradictory Orders From 2 District Court on FDA's Approval of Abortion Pill

In Alliance for Hippocratic Medicine v. U.S. Food & Drug Administration, (ND TX, April 7, 2023), a Texas federal district court held that plaintiffs have a substantial likelihood of success on their claim that the FDA's 2021 action allowing the abortion drug mifepristone to be distributed by mail violates the Comstock Act and thus was also in violation of the Administrative Procedure Act. The court also concluded that the FDA's approval in 2000 of doctors prescribing mifepristone violated the agency's rules for approval of new drugs. The FDA rules (Subpart H) relied upon to approve the drug apply to "new drug products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments...."  The court said in part:

[T]o satisfy Subpart H, FDA deemed pregnancy a “serious or life-threatening illness[]” and concluded that mifepristone “provide[d] [a] meaningful therapeutic benefit to patients over existing treatments.” See 21 C.F.R. §§ 314.500; 314.560. FDA was wrong on both counts....

Pregnancy is a normal physiological state most women experience one or more times during their childbearing years — a natural process essential to perpetuating human life. Defendants even admit pregnancy is not an “illness.”...

FDA also exceeded its authority under the second requirement of Subpart H. In addition to treating a serious or life-threatening illness, chemical abortion drugs must also provide a “meaningful therapeutic benefit” to patients over surgical abortion... [T]his cannot be the case because chemical abortion drugs do not treat “serious or life-threatening illnesses” — a prerequisite to reaching the second requirement.... Similarly, chemical abortion drugs cannot be “therapeutic” because the word relates to the treatment or curing of disease.

The court stayed the FDA's approval of mifepristone, but stayed the effectiveness of its order for 7 days so the government can appeal to the U.S. 5th Circuit Court of Appeals for emergency relief.  President Joe Biden issued a statement (full text) criticizing the court's decision and reporting that the Justice Department has already filed an appeal.  Vice President Kamala Harris also issued a statement (full text) criticizing the decision.

Meanwhile, in State of Washington v. U.S. Food & Drug Administration, (ED WA, April 7, 2023), a Washington federal district court issued a preliminary injunction barring the FDA from "altering the status quo and rights as it relates to the availability of Mifepristone" in the 17 states and District of Columbia that are plaintiffs in the case. Plaintiffs are challenging certain requirements for prescribing mifepristone added in 2023.

Seattle Times reports on the decisions.

Transcript of Hearing Released in Challenge to FDA Approval of Mifepristone

On March 15, Judge Matthew Kacsmaryk in the federal district court in the Northern District of Texas held a hearing on the preliminary injunction motion in the widely-watched case of Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration. The full transcript of the hearing has now been released. As previously reported, the case challenges the FDA's long-standing approval for use in the United States of the chemical abortion drug mifepristone. Axios reports on the hearing.

FDA Approves Label Change for Plan B Emergency Contraceptive: Not an Abortifacient

The U.S. Food and Drug Administration announced on Friday that it has approved a labeling change for the emergency contraceptive Plan B One-Step, sometimes known as the morning-after pill.  The labeling change states clearly that the medication is not an abortifacient.  The FDA says in part:

Plan B One-Step will not work if a person is already pregnant, meaning it will not affect an existing pregnancy. Plan B One-Step prevents pregnancy by acting on ovulation, which occurs well before implantation. Evidence does not support that the drug affects implantation or maintenance of a pregnancy after implantation, therefore it does not terminate a pregnancy.

The original label had been required to say in part: "this product works mainly by preventing ovulation (egg release). It may also prevent fertilization of a released egg (joining of sperm and egg) or attachment of a fertilized egg to the uterus (implantation)."

The FDA supports its conclusion that it does not affect implantation with a detailed Decisional Memorandum discussing more recent studies of the drug.

In the extensive litigation challenging rules under the Affordable Care Act that mandated health insurance policies cover contraceptive methods for women, religious objectors had pointed to Plan B as one of the medications that they considered an abortifacient because it could prevent implantation of a fertilized egg.  Also, since the Supreme Court's Dobbs case, abortion bans in some states might possibly be broad enough to cover medication that prevents implantation.

In a 2015 Memorandum, relying on research available at that time, the Catholic Medical Association rejected the use of Plan B even after a rape. AP reports on the FDA's approval of the labeling change.