Appeals court keeps abortion pill on the market but sharply limits access
A federal appeals court ruled late Wednesday that an abortion pill can remain on the market but only under strict conditions that prohibit its use beyond seven weeks of pregnancy and bar its distribution by mail.
In a
42-page order, a three-judge panel of the 5th Circuit Court of Appeals agreed to temporarily block the central aspect of a Texas-based federal judge’s ruling that
suspended the FDA’s 2000 approval of the drug, mifepristone. But by a 2-1 vote, the panel permitted other aspects of that ruling to take effect that would block a seven-year effort by the FDA to widen access to the drug.
Among the policies temporarily blocked by the court’s order: the FDA’s decision to expand mifepristone’s availability until the 10th week of pregnancy; authorization for retail pharmacies to dispense the drug; eliminating the requirement for in-person office visits to obtain a mifepristone prescription and allowing physicians to prescribe the pills via telemedicine; allowing non-physicians to prescribe or administer the drug; and ending a requirement for prescribers to report “non-fatal adverse events” related to mifepristone.
Reining in the drug’s availability while keeping it on the market is likely to dramatically diminish its usefulness to patients seeking to terminate pregnancies in Republican-led states where severe restrictions on abortion kicked in or were passed after the Supreme Court overturned the federal constitutional right to abortion last June. The decision will also significantly hamper access in blue states that have sought to maintain broad access to the pills — both for their own residents and for the surge of patients traveling across state lines to terminate their pregnancies.
Mifepristone has been used for decades as part of a two-drug regimen to induce an abortion in the first trimester of pregnancy — in combination with the drug misoprostol. It now accounts for more than half of all abortions in the United States.
The Biden administration and abortion rights activists have sought to ease access to abortion medication by mail as an alternative to surgical abortion, which is easier for states to restrict as a practical matter.
Anti-abortion groups, aware that the drug is being used to circumvent state bans, sued to revoke the 23-year-old federal approval of the drug as well as the FDA’s more recent policies to expand its access. Last week, Judge Matthew Kacsmaryk, a Texas-based appointee of former President Donald Trump, suspended both the original approval and the expanded-access policies, setting up what is likely the most consequential legal battle over abortion since the high court’s 5-4 decision last June overturning
Roe v. Wade after nearly half a century.
The Biden administration is expected to ask the Supreme Court to intervene immediately. It can ask the justices to grant an emergency order putting all aspects of Kacsmaryk’s ruling on hold while the appeals process continues.
Justice Department spokespeople, representatives for the drug’s main manufacturer, Danco Laboratories, and for the anti-abortion groups seeking to block access to the medication, did not immediately respond to requests for comment early Thursday.
Without the high court’s intervention, the 5th Circuit’s ruling limiting access to the drug will take effect at the end of this week. The appeals court panel consisted of Judges Andrew Oldham and Kurt Engelhardt, who are both Trump appointees, and Judge Catharina Haynes, an appointee of former President George W. Bush. Haynes indicated she would have kept Kacsmaryk’s entire ruling on hold until a subsequent panel had a chance to consider the merits of the case.
Oldham and Engelhardt said suspending the original approval of mifepristone would have untenable consequences, but in a ruling issued shortly before midnight on Wednesday, they defended their decision to allow the other portions of Kacsmaryk’s ruling to stand.
“This is an exceedingly unusual regime,” the judges wrote, referring to the FDA’s relaxation of restrictions around the drug. They said the agency “chose to cut out doctors from the prescription and administration of mifepristone.” And they disputed the agency’s contention that the drug is just as safe as ibuprofen.
The Justice Department defended the drug’s safety record earlier this week in
court papers. “FDA made those changes after fifteen years of adverse event data that showed ‘known risks occurring rarely,’” the government’s lawyers wrote. “By that point, mifepristone’s ‘well-characterized safety profile’ was firmly established. Serious adverse events were ‘exceedingly rare,’ as demonstrated by eleven different studies and data from ‘well over 30,000 patients.’”
The appeals court opinion — like Kacsmaryk’s ruling last week — frequently deployed language more commonly associated with anti-abortion advocates, such as referring to the medication as “chemical abortion” and the follow-up procedure sometimes needed after a patient takes the pills in the first few weeks of pregnancy as “remov[ing] an unborn child.”
The court blocked the use of mifepristone beyond seven weeks of pregnancy and barred its distribution by mail.
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