Less than two years after the Supreme Court overturned Roe v. Wade, the issue of reproductive rights is returning to the high court Tuesday as the justices consider whether to limit access to a medication used in more than 60% of U.S. abortions.

The Biden administration and the manufacturer of mifepristone are seeking to reverse a lower court ruling that would make it more difficult to obtain the medication, first approved nearly 25 years ago and shown in multiple studies to be overwhelmingly safe.

The conservative U.S. Court of Appeals for the 5th Circuit said the Food and Drug Administration failed to follow proper procedures and thoroughly explain its reasoning when it began loosening regulations. The changes made in 2016 and again in 2021 allowed mifepristone to be taken up to 10 weeks into pregnancy, instead of seven weeks, prescribed by a medical professional other than a doctor, and mailed directly to patients without an in-person medical consultation.

The pharmaceutical industry has warned that second-guessing the FDA’s determinations in this case will more broadly disrupt the nation’s drug approval process and stymie private investment in research.

A decision should come by the end of June or early July, putting abortion front and center as Democrats campaign on the issue in the November election.

Here’s a look at what’s at stake.

ABORTION ACCESS

The case could make it harder to get medication abortions even in states where abortion is legal. Allowing medication abortions to proceed without an ultrasound or in-person medical visit has increased access, particularly for women in rural areas and others who struggle to go to a clinic in person, by allowing them to complete the entire process from home.

The Supreme Court could also further impede abortion access for those living in one of the more than a dozen states with strict abortion bans in place. A few telemedicine clinics have started allowing U.S.-based doctors to prescribe and mail pills into restricted states, relying on new “shield laws” passed in several blue states to protect them from prosecution. The largest of these clinics, Aid Access, now mails approximately 6,000 doses of medication abortion into anti-abortion states every month, according to founder Rebecca Gomperts.

Many abortion rights advocates say they will continue to send abortion pills through the mail no matter how the Supreme Court rules. Some are ready to switch to a misoprostol-only protocol, a method of medication abortion that uses only the second drug in the current two-step regimen. That option is also highly effective but causes significantly more cramping and bleeding.

A narrowed time window for accessing abortion pills would have major implications nationwide. In 2021, 56% of all abortions occurred beyond seven weeks of pregnancy. Just 20% occurred after 10 weeks, the FDA’s current mifepristone limit.

THE DRUG APPROVAL PROCESS

For the FDA and the pharmaceutical industry, the legal battle over mifepristone casts a shadow over all drugs, medical devices and diagnostics that the agency approves. If the 5th Circuit’s decision is upheld, industry and former government officials say, it would undercut the FDA’s stature as the global gold standard of regulating medicine – as well as the ability of drugmakers to raise money from investors. That, in turn, could deprive patients of innovative therapies.

Pharmaceutical companies denied approval for a drug could use the courts to reverse the agency’s scientific judgments – or challenge the approval of a competitor’s drug, former FDA commissioners said in a brief to the high court. Advocates for patients who suffer side effects from a drug could ask judges to bar other patients from taking an otherwise safe and effective medication.

A brief signed by hundreds of biotech executives said allowing a court to override the FDA’s process for approving drugs “will create intolerable risks and undermine the incentives for investment regardless of the drug at issue.”

A group of former Trump-era Department of Health and Human Services officials, however, sided with the challengers in a separate brief that says the FDA failed to properly assess the broader effects of lifting restrictions on mifepristone. James R. Lawrence III, an FDA chief counsel under President Donald Trump, said a ruling in favor of the agency could embolden other drugmakers to demand fewer restrictions.

A ruling against the FDA also could broaden who can sue the agency. In the mifepristone case, the four doctors suing the FDA claimed they had legal standing not because their patients were directly harmed by the drug, but because women suffering adverse effects crowding into emergency rooms would take away resources needed to treat other patients.

“Basically, any physician could sue the agency over any drug approval they disagree with,” said Holly Fernandez Lynch, an attorney and assistant professor of health policy at the Perelman School of Medicine at the University of Pennsylvania.

THE SUPREME COURT

When the court’s conservative majority overturned Roe in June 2022, Justice Samuel Alito wrote that it was time to “return the issue of abortion to the people’s elected representatives.” Justice Brett Kavanaugh wrote separately, saying questions about the basic legality of abortion “will be resolved by the people and their representatives in the democratic process in the states or Congress” – not by the nine members of the Supreme Court.

Instead, the court has two abortion-related cases before it this term, the mifepristone case and one involving whether emergency room physicians must terminate pregnancies in some cases even in states where abortion is banned.

This is not the first time the court has considered the FDA’s regulation of mifepristone. During the pandemic, doctors and abortion providers sued the FDA, trying to remove the requirement that patients obtain the drug in person. A lower court judge agreed, saying in-person visits imposed unnecessary health risks due to COVID-19.

But the Trump administration appealed, and the Supreme Court’s conservative majority reversed the lower-court decision, reinstating the in-person pickup requirement even though most patients take the medication at home.

The majority has generally been skeptical of the power of federal agencies and is reviewing several other challenges this term to the so-called administrative state, long a target of conservative criticism. But back in 2021, Chief Justice John Roberts sided with the Trump administration because, he said, courts should defer to public health experts.

Roberts’ position will be tested now that the court is being asked by the FDA and the Biden administration to retain full access to mifepristone, including to allow the medication to be sent to patients by mail.

THE ELECTION

Whatever the Supreme Court decides will further inflame the election-year debate over abortion rights, with Democrats eager to campaign on the issue and Republicans struggling to craft a winning message since the fall of Roe.

President Biden has repeatedly vowed to defend access to mifepristone, part of his broader pledge to protect access to abortion. If the justices side with the White House and allow current regulations for mifepristone to stand, Biden and his allies can claim a legal victory; if the court limits access, Democrats will inevitably use the decision to mobilize voters.

Abortion rights arguably have been Democrats’ strongest advantage this political cycle, with voters repeatedly siding with the party on ballot measures and candidates in states such as Kansas, Kentucky and Ohio. Voters also say they trust Democrats to handle abortion more than Republicans by a 14-point margin, according to a February poll by KFF, a nonpartisan health care research organization.

Voters also favor access to abortion medication. Two-thirds of Americans said that mifepristone should remain on the market, according to a Washington Post-ABC News poll in May 2023.

GOP leaders, meanwhile, have continued to stake out opposition to the medication. A proposal released last week by the Republican Study Committee, an influential congressional caucus that represents most House Republicans, called for rolling back access to mifepristone. Conservative policy groups such as the Heritage Foundation have also said that Trump should use executive authority to crack down on the drug if he is elected again.

AT STAKE FOR THE ANTI-ABORTION MOVEMENT

The abortion pill has in many ways thwarted the anti-abortion movement’s vision for a post-Dobbs America, allowing tens of thousands of abortions to continue in states where abortion is illegal. And while anti-abortion advocates have scrambled to imagine new laws that might crack down on the flow of pills through the mail system, any legislation of that kind would be very difficult to get through Congress and hard to enforce at the state level.

Many anti-abortion advocates have instead pinned their hopes on changing the culture around abortion pills – hoping to make women skeptical of obtaining the pills through the mail without an ultrasound or a doctor’s visit, even though studies show it is overwhelmingly safe to do so. Anti-abortion arguments about the risks of abortion pills are based largely on studies that have recently been retracted by the journal that published them.

A Supreme Court ruling that compels the FDA to reinstate old restrictions would be an important step toward changing how the pills are perceived, anti-abortion advocates said.

“Many women … are taking these drugs in unsafe ways because they’re hearing from the FDA that they’re safe to take in this way,” said Christina Francis, chief executive of the American Association of Pro-Life Obstetricians and Gynecologists. “The (FDA’s) stamp of approval still carries a lot of weight.”

A large body of research shows mifepristone is safe and effective. The FDA points to published studies of tens of thousands of women showing that serious adverse events after mifepristone use occur in fewer than 1% of cases.

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