FDA Launches Safety Review of Mifepristone Under Trump Administration
FDA launches safety review of mifepristone, approved since 2000 and used in majority of U.S. abortions.
Event / Politics
Mifepristone Abortion Pill Legal Battle
Ongoing legal disputes over access to mifepristone, including Supreme Court stays and lower court rulings affecting FDA regulations on mail-order distribution and remote prescription of the medication.
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2026-08-17 to 2026-11-14 · UTC publication dates
Coverage begins 2 May, 00:37 UTC
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What happened
FDA established permanent rule in 2023 permitting telehealth mifepristone distribution
The Food and Drug Administration permanently adopted in 2023 a rule allowing mifepristone to be dispensed via telehealth and mail. This rule had been temporarily implemented during the COVID-19 pandemic and was made permanent as several states began restricting abortion access following the 2022 Supreme Court decision overturning Roe v. Wade.
Supreme Court rejected 2024 challenge to mifepristone access based on standing
In 2024, the U.S. Supreme Court rejected an effort to revoke access to mifepristone, ruling that the anti-abortion doctors and groups who filed the lawsuit did not have legal standing to bring the case.
5th Circuit Court of Appeals rules to block telehealth and mail distribution of mifepristone
The 5th U.S. Circuit Court of Appeals issued a ruling on Friday that reinstated a requirement for the abortion pill mifepristone to be dispensed only in person, blocking doctors from prescribing it via telehealth or mail. The three-judge panel ruled unanimously in favor of Louisiana's challenge to FDA guidelines that had permitted telehealth and mail distribution of the drug.
Danco Laboratories requests Supreme Court stay of 5th Circuit mifepristone ruling
Danco Laboratories, the primary manufacturer of mifepristone, filed an emergency application with the U.S. Supreme Court on Saturday requesting an immediate stay of the 5th Circuit ruling that blocks telehealth and mail distribution of the drug. The company argued the ruling creates immediate confusion and harm to patients, providers, pharmacies, and the drug-regulatory system, and that mifepristone is its only product.
GenBioPro also planning to appeal 5th Circuit mifepristone ruling
GenBioPro, another manufacturer of mifepristone, has indicated it will file an appeal of the 5th Circuit ruling blocking telehealth and mail distribution of the drug.
Louisiana challenges FDA mifepristone telehealth guidelines in court
Louisiana filed a legal challenge against FDA guidelines permitting telehealth and mail distribution of mifepristone. Louisiana Attorney General Liz Murrill stated the state was defending against abortion pill access, having been among the first states to ban abortion after Roe v. Wade was overturned.
FDA approved mifepristone for medical abortion in 2000
The Food and Drug Administration approved mifepristone in 2000 for medical termination of pregnancy. Prior to the COVID-19 pandemic, the drug could only be prescribed during in-person appointments.
Medication abortion accounts for over half of US abortions
Medication abortions, using drugs like mifepristone, account for more than half of all abortions performed in the United States. Mifepristone is used as part of a two-drug regimen to terminate pregnancies.
Danco Laboratories announces emergency appeal to Supreme Court
Danco Laboratories, one of the two companies distributing mifepristone in the United States, announced its intention to petition the US Supreme Court with an emergency request to overturn the appeals court decision suspending postal delivery of the medication.
Supreme Court rejected similar mifepristone challenge in June 2024
The US Supreme Court rejected a similar legal challenge to mifepristone access in June 2024 on procedural grounds, ruling that the plaintiffs—medical associations and practitioners opposed to abortion who neither prescribe nor use the medication—lacked legal standing to bring the lawsuit.
Trump Health Secretary Kennedy initiates mifepristone safety review
Robert Kennedy Jr, Health Secretary in the Trump administration, initiated a safety re-evaluation of mifepristone in 2025 that has not yet concluded. This review was undertaken amid ongoing legal challenges to the medication's availability.
Lower court paused mifepristone restriction case in April 2025
A trial court issued a decision in April 2025 that paused the mifepristone restriction case, setting a six-month deadline for the FDA to provide the court with conclusions from its ongoing safety analysis of the product.
FDA lifted in-person requirement for mifepristone in 2023
The US Food and Drug Administration lifted the requirement for patients to obtain mifepristone in person in 2023, allowing telemedicine distribution of the medication. This change expanded access to abortion medication, though Louisiana and other states have contested this policy.
Federal appeals court suspends mifepristone postal delivery nationwide
A conservative federal appeals court suspended on Friday the postal delivery of mifepristone, the pill used in the majority of abortion procedures in the United States. The decision applies to the entire country and restricts access to abortion medication, with more than one quarter of abortions in the US being performed via telemedicine according to specialized organizations.
Supreme Court overturned federal abortion protection in June 2022
The conservative-majority Supreme Court issued a landmark decision in June 2022 that eliminated the federal constitutional guarantee of abortion rights, returning full authority to individual states to regulate abortion. Following this decision, approximately twenty states have banned abortion entirely or imposed strict regulations, regardless of whether the procedure is performed medically or surgically.
Louisiana requests court restriction on mifepristone access
Louisiana, a state with one of the country's most restrictive abortion laws, requested the appeals court decision restricting mifepristone access. The state challenged the FDA's 2023 decision lifting the requirement for patients to obtain the medication in person, citing potential risks that scientific consensus has rejected.
Appeals court overturned previous restrictions lifting in 2023
In 2023, the same conservative appeals court that issued the current suspension had previously restored multiple restrictions on mifepristone access that the FDA had lifted since 2016, including reducing the gestational age limit from ten weeks to seven weeks and banning postal delivery.
Trump credited with appointments enabling 2022 abortion ruling reversal
Donald Trump stated that his appointments of three conservative judges to the Supreme Court enabled the 2022 decision overturning the federal abortion protection guarantee.
Louisiana state challenge blocks mifepristone mail distribution pending further litigation
Louisiana brought a legal challenge against a 2023 FDA rule allowing mifepristone distribution by mail. The appeals court ruling in response to Louisiana's challenge blocks the mail-order distribution of the drug, restoring requirements that women must see a medical professional in person to obtain a mifepristone prescription. The decision remains in effect while the court considers the full challenge, which could take months to resolve.
FDA reviewing mifepristone safety with review expected after November elections
The Food and Drug Administration is conducting a review of mifepristone's safety as it decides whether to repeal current regulations. District Judge David Joseph paused the lawsuit on April 7 pending the FDA review, which is expected to be completed after the November midterm elections. The Biden administration previously determined the drug is safe and effective, citing studies showing major adverse effects occurred in fewer than 1 percent of patients.
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2 alternative perspectives
Appeals court temporarily suspends telemedicine mifepristone access nationwide
Appeals court suspends telemedicine mifepristone access; Supreme Court to decide on extending restrictions.
Democratic states pass laws protecting abortion pill prescribers
Democratic states enact protective laws for abortion pill prescribers amid federal restrictions.
Supreme Court precedent anchors mifepristone's FDA approval despite ongoing restrictions
FDA approval from 2000 remains the baseline precedent constraining lower court restrictions on mifepristone.
Supreme Court blocks Fifth Circuit restrictions on mifepristone access
Supreme Court blocks lower court restrictions on mifepristone mail delivery and telehealth access.
Mifepristone: FDA approval, usage patterns, and regulatory foundations
FDA approved mifepristone in 2000; it now represents the majority method for abortion in America.
Louisiana challenges FDA's telehealth mifepristone rule in court
Louisiana sues to overturn FDA's 2023 telehealth mifepristone distribution rule.
Mifepristone manufacturers escalate legal challenges to Fifth Circuit restrictions
Two mifepristone manufacturers are appealing the Fifth Circuit's block on mail and telehealth distribution to higher courts.
Medication abortions surge to 60 percent as access restrictions tighten
Medication abortions now dominate U.S. abortion practice, yet court restrictions are blocking primary access pathways.
Mifepristone manufacturer escalates legal fight with Supreme Court emergency appeal
Mifepristone manufacturer escalates legal fight with emergency Supreme Court appeal against mailing restrictions.
Four-year legal battle over mifepristone traces shifting judicial landscape
Four years of legal battles show shifting judicial treatment of mifepristone access despite Supreme Court precedent.
Trump administration intensifies mifepristone enforcement through cabinet appointments
Trump administration shifts mifepristone enforcement through cabinet appointments and new safety reviews.