Pharma

Mifepristone legal fight: What you need to know as the abortion pill case heads to the Supreme Court

The late-March oral arguments come as pharmacy giants prepare to sell mifepristone in some states.
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· 4 min read

The debate around abortion access—particularly medications commonly used in telehealth-assisted abortions—is expected to remain a hot topic in 2024.

This fall, voters will head to the polls for the first presidential election since the Supreme Court reversed its landmark Roe v. Wade decision, which triggered a series of state abortion restrictions as well as ballot fights to preserve access to the procedure. And those fights could heat up this summer, as the high court is set to weigh in on access to a medication that’s commonly used in abortions.

Mifepristone, one of two drugs used to help induce abortions in the US, gained newfound attention—and scrutiny—as telehealth abortions became more popular during the Covid-19 pandemic and as more states moved to restrict abortion access after the Supreme Court’s June 2022 Dobbs v. Jackson Women’s Health Organization ruling.

Here’s what you need to know about the current state of mifepristone access in the US.

Court consideration

A high-profile legal challenge centered around the federal government’s approval of mifepristone—including who can prescribe the drug and how long into a pregnancy it can be used—will go before the Supreme Court later this month.

On March 26, justices will hear oral arguments in a consolidated pair of cases that seek clarity on a US Court of Appeals for the 5th Circuit ruling, which maintained access to mifepristone with some restrictions. The court will also consider whether an association of doctors—like the conservative Alliance for Hippocratic Medicine, which filed a lawsuit in November 2022 against the FDA—has the right to challenge or block the federal government’s review and approval of medications, according to court records.

Executives from Danco Laboratories, which sells mifepristone under the name Mifeprex, asked the Supreme Court to review the appellate court’s decision, arguing in a December 2023 statement that the ruling was “inconsistent with established Supreme Court principles governing standing and administrative law challenges.”

The high court, in its December 2023 order announcing it would take up the mifepristone cases, declined to weigh in on a broader challenge that could have overturned the FDA’s 2000 approval of the abortion pill and ended access to mifepristone even in states that had not restricted abortion access.

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Mifepristone will remain available until the Supreme Court issues its decision—something that is not expected to happen until at least June, when the justices typically recess for the summer.

Pharmacy sales

In the meantime, Walgreens and CVS executives announced that the pharmacy giants will start dispensing mifepristone this month in some states where abortion remains legal. The retailers’ respective decisions to sell the abortion drug could play an important role in ensuring access to mifepristone if the Supreme Court upholds restrictions enacted by a lower court, which have been on hold since April 2023.

Patients seeking mifepristone have generally had to obtain the medication from providers or clinics with the help of mail-order pharmacies.

The FDA in January 2023 updated its policies to allow retail pharmacies to sell mifepristone upon meeting certain requirements and certifications, but the policy change doesn’t allow for over-the-counter sales.

More than 20 independent pharmacies have already gained approval from mifepristone manufacturers to distribute the drug, according to GenBioPro, which sells generic mifepristone in the US.

Walgreens spokesperson Fraser Engerman told Healthcare Brew that the pharmacy chain has completed the FDA certification process and expects to begin dispensing mifepristone “in select locations in New York, Pennsylvania, Massachusetts, California, and Illinois” by mid-March.

CVS also received certification to dispense the abortion pill, company spokesperson Amy Thibault confirmed.

“We’re working with manufacturers and suppliers to secure the medication and are not yet dispensing it in any of our pharmacies,” Thibault said in a March 5 email to Healthcare Brew. “We’ll begin filling prescriptions for the medication in Massachusetts and Rhode Island in the weeks ahead and will expand to additional states, where allowed by law, on a rolling basis.”

Maia Anderson contributed to this report.

Navigate the healthcare industry

Healthcare Brew covers pharmaceutical developments, health startups, the latest tech, and how it impacts hospitals and providers to keep administrators and providers informed.