What’s at stake in the Supreme Court’s abortion pill case

Less than two years after the Supreme Court handed down Roe v. Wade overturned, the issue of reproductive rights returns to the Supreme Court on Tuesday as the justices consider whether to restrict access to a drug used in more than 60% of abortions in the United States.

The Biden administration and the maker of mifepristone are seeking to overturn a lower court ruling that would make it harder to obtain the drug, which was first approved nearly 25 years ago and has been shown to be exceedingly safe in multiple studies.

A patient prepares to take the first of two combination pills, mifepristone, for a medication abortion during a visit to a clinic in Kansas City, Kansas, in 2022.
Related press file photo

The conservative U.S. Court of Appeals for the 5th Circuit said the Food and Drug Administration failed to follow due process and fully explain its reasoning when it began relaxing regulations. The changes made in 2016 and again in 2021 allowed mifepristone to be taken up to ten weeks of pregnancy instead of seven weeks, prescribed by a healthcare professional other than a doctor and sent directly to patients without personal medical advice.

The pharmaceutical industry has warned that questioning the FDA’s decisions in this case would further disrupt the country’s drug approval process and hinder private investment in research.

A decision should come by late June or early July, putting abortion at the center of Democrats’ campaign on the issue in the 2024 election.

Here you can see what it’s all about.

Access to abortions

The case could make it more difficult to obtain medication abortions, even in states where abortions are legal. The ability to perform medication abortions without an ultrasound or in-person doctor’s visit has increased access, particularly for women in rural areas and others who have difficulty going to a clinic in person, as they can complete the entire process from home.

The Supreme Court could also further complicate access to abortions for those who live in one of the more than a dozen states that have strict abortion bans. Some telemedicine clinics have begun allowing U.S.-based doctors to prescribe and ship pills to restricted states, relying on new “shield laws” passed in several blue states to protect them from prosecution. The largest of these clinics, Aid Access, ships about 6,000 doses of abortion drugs each month to anti-abortion states, according to founder Rebecca Gomperts.

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

A narrower window for access to abortion pills would have a significant impact nationwide. In 2021, 56% of all abortions occurred after the seventh week of pregnancy. Only 20% occurred after 10 weeks, the current FDA 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 approved by the agency. If the 5th Circuit’s decision is upheld, industry and former government officials say it would undermine the FDA’s status as the global gold standard for regulating medicine – and also the ability of drugmakers to raise money from investors. This in turn could lead to patients no longer receiving innovative therapies.

Drug companies denied approval of a drug could use the courts to overturn the agency’s scientific rulings – or challenge the approval of a competitor’s drug, former FDA commissioners said in a brief to the Supreme Court. Advocates for patients suffering side effects from a medication could ask judges to ban other patients from taking an otherwise safe and effective medication.

A brief signed by hundreds of biotech executives says allowing a court to override the FDA drug approval process “will create intolerable risks and undermine investment incentives regardless of the drug in question.”

But a group of former Trump-era Department of Health and Human Services officials sided with the challengers in a separate letter, saying the FDA failed to properly assess the broader impact of lifting restrictions on mifepristone. James R. Lawrence III, the FDA’s chief adviser under President Donald Trump, said a decision in the agency’s favor could encourage other drugmakers to seek fewer restrictions.

A ruling against the FDA could also expand the ability to sue the agency. In the mifepristone case, the four doctors who sued the FDA argued that they had standing to sue not because their patients were directly harmed by the drug, but because women suffering side effects and rushing to the emergency room were doing so to them would take away resources they need to treat other patients.

“In principle, any doctor could sue the agency over any drug approval they disagree with,” said Holly Fernandez Lynch, a lawyer and assistant professor of health policy at the University of Pennsylvania’s Perelman School of Medicine.

The Supreme Court

When the court’s conservative majority overturned Roe in June 2022, Justice Samuel A. Alito Jr. wrote that it was time to “leave the question of abortion back to the people’s elected representatives.” Writing separately, Justice Brett M. Kavanaugh said questions about the fundamental legality of abortion “will be resolved by the people and their representatives in the democratic process in the states or in 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 doctors must terminate pregnancies in some cases, even in states where abortion is banned.

This is not the first time the court has addressed the FDA’s regulation of mifepristone. During the pandemic, doctors and abortion providers sued the FDA, seeking to overturn the requirement that patients receive the drug in person. A lower court judge agreed, saying in-person visits posed unnecessary health risks due to Covid-19.

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

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

Roberts’ position is now being tested as the court is asked by the FDA and the Biden administration to maintain full access to mifepristone, including the ability to ship the drug to patients by mail.

The choice

Whatever the Supreme Court decides will further inflame the debate over abortion rights in an election year, as Democrats are eager to campaign on the issue and Republicans have struggled to craft a winning message since the overturn of Roe.

President Biden has repeatedly vowed to defend access to mifepristone, part of his broader promise to protect abortion access. If the justices side with the White House and allow the current regulations for mifepristone to remain in place, Biden and his allies can score a legal victory; If the court restricts access, Democrats will inevitably use the decision to mobilize voters.

Abortion rights were arguably Democrats’ strongest advantage this political cycle, with voters in states like Kansas, Kentucky and Ohio consistently siding with the party on ballot measures and candidates. Voters also say they trust Democrats more than Republicans by a 14 percent margin, according to a February poll by KFF, a nonpartisan health research organization.

Voters also support access to abortion drugs. According to a May 2023 Washington Post-ABC News poll, two-thirds of Americans said mifepristone should remain on the market. GOP leaders, meanwhile, have continued to voice opposition to the drug. A proposal released last week by the Republican Study Committee, an influential congressional group that represents most Republicans in the House of Representatives, called for restricting access to mifepristone. Conservative political groups such as the Heritage Foundation have also said former president and current GOP nominee Donald Trump should use executive power to crack down on the drug if he is re-elected.

At stake for the anti-abortion movement

The abortion pill has in many ways destroyed the anti-abortion movement’s vision for a post-Dobbs America and enabled tens of thousands of abortions in states where abortion is illegal. And while anti-abortion advocates have wrestled with drafting new laws that could crack down on sending pills through the mail, a law of this kind would be very difficult to get through Congress and difficult to enforce at the state level.

Many abortion advocates are instead pinning their hopes on changing the culture around abortion pills — hoping to make women wary of receiving the pills in the mail without an ultrasound or a doctor’s visit, even though studies show it is overwhelmingly safe. Anti-abortion arguments about the risks of abortion pills are based largely on studies recently retracted by the journal that published them.

A Supreme Court ruling forcing the FDA to reinstate old restrictions would be an important step toward changing perceptions of the pills, abortion opponents said.

“Many women … take these medications in unsafe ways because they hear from the FDA that it is safe to take them that way,” said Christina Francis, executive director of the American Association of Pro-Life Obstetricians and Gynecologists. “The [FDA’s] The seal of quality still carries great weight.”

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

• Daniel Gilbert, David Ovalle and Dan Diamond contributed to this report.

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