The Supreme Court will decide this term whether to limit access to a key abortion drug, returning the polarizing issue of reproductive rights to the high court for the first time since the conservative majority overturned Roe v. Wade last year.
The justices announced Wednesday that they will review a decision from the conservative U.S. Court of Appeals for the 5th Circuit that said the Food and Drug Administration did not follow proper procedures when it began loosening regulations for obtaining mifepristone, which was first approved more than 20 years ago.
The changes made over the last few years included allowing the drug to be taken later in pregnancy, mailed directly to patients and prescribed by a medical professional other than a doctor.
Medications to terminate pregnancy, which can be taken at home, have increased in importance over the last 18 months, as more than a dozen states severely limited or banned abortions following the Supreme Court’s ruling in Dobbs v. Jackson Women’s Health Organization.
The justices agreed to review the mifepristone case as the broader issue of abortion access remains divisive politically and legally. A pregnant woman in Texas this week lost her legal battle for permission to end her pregnancy, after she had left the state to obtain an abortion. Last week, a Kentucky woman went to court asserting the state’s abortion restrictions violate her constitutional right to privacy.
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Democrats have tried to capitalize on the backlash to stringent limits, and abortion rights initiatives have played a role in Republican defeats in recent elections in Ohio, Kentucky and Virginia.
The Supreme Court’s much-anticipated decision to overturn Roe after nearly 50 years was a long-sought win for conservatives that cleared the way for states to quickly restrict or ban abortion. The court majority included three nominees of President Donald Trump. The former president, now the leading GOP candidate for the 2024 election, has touted his role in overturning Roe, but more recently has tried to appear more moderate, attracting criticism from some conservatives.
The court’s decision to review the mifepristone case is not surprising. In April, after a district-court ruling to suspend FDA approval of the drug, the justices said existing rules for prescribing and distributing mifepristone would remain in place nationwide while the litigation continues.
In that order, only Justices Clarence Thomas and Samuel A. Alito Jr. said they would not have granted the Biden administration’s request for a stay of the district-court decision. Critics say the lower court’s ruling undermines the role of federal regulatory agencies.
The justices said Wednesday they would not consider a separate challenge to FDA’s initial approval of mifepristone in 2000. That means that whatever the Supreme Court decides will not remove the medication from the market but could make it more difficult to obtain.
If access to mifepristone was restricted, abortion providers and advocates say, pregnancies could still be terminated using only the second drug in the regimen, misoprostol. But using that drug alone causes more cramping and bleeding, and abortion opponents could move to restrict its use as well if they win limits on the use of mifepristone from the high court.
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End of carouselWhat is mifepristone?
Mifepristone is one of two drugs that work together to terminate a pregnancy, and is approved by the U.S. Food and Drug Administration through 10 weeks gestation. Mifepristone was first approved for use in France in 1988, and approved in the U.S. in 2000.
How a medication abortion works
A patient first takes mifepristone as a single pill, which blocks the hormone progesterone, preventing a pregnancy from progressing. About 24 hours later, the patient typically takes a four-pill dose of misoprostol to prompt contractions that expel the embryo or fetus.
Safety
A large body of research shows mifepristone is safe and effective. The American College of Obstetricians and Gynecologists analyzed hundreds of published studies, and found "serious side effects occur in less than 1% of patients, and major adverse events — significant infection, blood loss, or hospitalization — occur in less than 0.3%.”
Mifepristone and abortion access
Mifepristone is used in more than half of U.S. abortions, according to the Guttmacher Institute, a group that supports abortion rights. If mifepristone is taken off the market, abortion providers will have to provide only surgical abortions, or use a medication abortion regimen that includes only misoprostol.
Misoprostol-only medication abortion
A misoprostol-only abortion requires three doses of four pills each. While misoprostol is widely used on its own to perform abortions around the world, studies show it is less effective than the two-step regimen, and usually causes more cramping and potential side effects, including diarrhea, fever and chills.
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White House press secretary Karine Jean Pierre said in a statement that the Supreme Court must ensure full access to mifepristone. The lower-court ruling, she said, “threatens to undermine the FDA’s scientific, independent judgment and would reimpose outdated restrictions on access to safe and effective medication abortion.”
“States have imposed extreme and dangerous abortion bans that put the health of women in jeopardy and that threaten to criminalize doctors for providing the health care that their patients need and that they are trained to provide,” Pierre said.
In urging the court to take the case, Solicitor General Elizabeth B. Prelogar emphasized in court filings that mifepristone has been safely used by millions of people over more than two decades and warned that allowing the lower court’s decision to stand would have “damaging consequences for women seeking lawful abortions and a healthcare system that relies on the availability of the drug under the current conditions of use.”
The challenge to mifepristone was initiated by the Alliance for Hippocratic Medicine, an association of antiabortion doctors and others. The group asserted that the FDA did not sufficiently consider safety concerns when it approved the drug in 2000 or when it removed some restrictions years later — allowing the use of mifepristone through 10 weeks of pregnancy, for instance, instead of seven.
The group filed its lawsuit in Amarillo, Tex., where U.S. District Judge Matthew J. Kacsmaryk — a Trump nominee with long-held antiabortion views — is the sole sitting judge. He sided with the challengers and suspended FDA approval of the medication.
The 5th Circuit reversed that part of Kacsmaryk’s order, but agreed with him in blocking the changes starting in 2016 for how the drug was prescribed and distributed, and at what point in a pregnancy it could be used.
Erin Hawley, an Alliance Defending Freedom attorney who represents the challengers, urged the Supreme Court to reinstate restrictions on the medication.
“Like any federal agency, the FDA must rationally explain its decisions. Yet its removal of common-sense safeguards — like a doctor’s visit before women are prescribed chemical abortion drugs — does not reflect scientific judgment but rather a politically driven decision to push a dangerous drug regimen,” Hawley said in a statement.
The case is FDA v. Alliance for Hippocratic Medicine.
