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What the Supreme Court’s Decision Means for Abortion Pills

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The high court blocked an order by the Fifth U.S. Circuit Court of Appeals that would have significantly affected the way mifepristone is used and dispensed for abortions. The Biden administration and Danco Laboratories LLC, which sells the drug under the brand name Mifeprex, had filed an emergency appeal to the Supreme Court, asking it to suspend the lower-court order while litigation continues.

The fight over mifepristone is the biggest abortion-related case since the Supreme Court voted to overturn Roe v. Wade last summer. More than a dozen states have passed near-total abortion bans in the aftermath of the Supreme Court decision. Several states remain in legal battles over abortion access.

More patients have sought abortion-inducing drugs from channels outside the formal medical system, including websites selling unapproved medication, since the overturning of Roe v. Wade, reproductive-health experts said.

What happens to access to abortion pills now?

Access to mifepristone is unchanged for now in states where abortion is allowed. The Fifth Circuit is scheduled to hear arguments in the case in mid-May. The case could return to the Supreme Court later in the year.

U.S. District Judge Matthew Kacsmaryk in Amarillo, Texas, ruled on April 7 to temporarily suspend the Food and Drug Administration’s approval of mifepristone. The Fifth Circuit later blocked part of Judge Kacsmaryk’s order and voted to retain FDA approval of mifepristone for abortions up to about seven weeks of pregnancy. The drug had previously been approved for use up to about 10 weeks of pregnancy.

The appellate court also rolled back other earlier efforts by the government to loosen access to mifepristone. Under the court’s ruling, mifepristone couldn’t be sent to patients through the mail and required three in-person doctor’s visits.

Reproductive-health experts said the restrictions would significantly affect access to abortions. The Supreme Court suspended the Fifth Circuit’s order, preserving the status quo of how mifepristone can be used and dispensed.

Amid the earlier uncertainty over mifepristone, abortion providers and clinics said they were considering the best options for patients, including alternative medication-abortion regimens.

What is medication abortion?

Medication abortion, also known as medical abortion or plan C, involves the administration of so-called abortion pills to terminate a pregnancy. Patients obtain the pills from a prescribing clinician or from online pharmacies and can take the medications in a clinical setting or at home.

In the U.S., medication abortion is approved by the FDA for up to 10 weeks of pregnancy. Though their efficacy decreases as gestational age increases, abortion pills can be safe and effective beyond the 10-week mark, according to the American College of Obstetricians and Gynecologists. In some countries, including the U.K., abortion pills are used to terminate pregnancies of up to 24 weeks. For later-term abortions, the pills are administered in clinical settings.

A two-drug regimen of mifepristone and misoprostol is the gold standard for safe and effective medication abortions, according to ACOG. Misoprostol alone can be used to terminate pregnancies and is an acceptable option if mifepristone is unavailable, ACOG said. The misoprostol-only regimen is less effective than the two-drug option, research shows.

In 2020, about 98% of medication abortions in the U.S. used the two-medication regimen of mifepristone and misoprostol, according to the Guttmacher Institute, a policy group that supports abortion rights and tracks abortion statistics.

In the combination regimen, a single dose of mifepristone is followed by a course or several courses—depending on the number of weeks of pregnancy—of misoprostol pills. The regimen is safe and highly effective, reproductive health experts say, with efficacy rates of 95% if administered at 10 weeks of pregnancy or earlier.

In the U.S., mifepristone is sold under the brand name Mifeprex, manufactured by Danco Laboratories, a pharmaceutical distributor based in New York, and Korlym, made by Silicon Valley-based Corcept Therapeutics. Korlym isn’t prescribed or marketed for abortion in the U.S. and is approved by the FDA only for the treatment of Cushing’s syndrome, a hormonal disorder. A generic version of the drug, also known as RU-486, was approved by the FDA in 2019 and is distributed by GenBioPro Inc., a Nevada-based pharmaceutical company.

Costs for a medication abortion vary by state and aren’t always covered by insurance. The combination regimen can cost up to $750, according to Planned Parenthood. U.S. telehealth providers including Hey Jane, Just the Pill and Choix charge $350 or less for a medication abortion, including pills and a medical consultation.

In the U.S., medication abortion had been approved by the FDA for up to 10 weeks of pregnancy. Photo: Taylor Glascock for The Wall Street Journal

What is a one-pill abortion?

A misoprostol-only regimen has been used internationally for decades and is considered safe and effective, though it has a lower rate of efficacy compared with the combination regimen, reproductive-health experts said.

The misoprostol-only regimen has an efficacy rate of upward of 80% when administered during the first trimester of pregnancy, studies have shown.

About 0.7% of people using misoprostol alone to induce abortions were hospitalized or received blood transfusions related to the procedures, according to a 2019 meta-analysis.

Patients take several doses of misoprostol to terminate a pregnancy. Side effects such as nausea, diarrhea and cramping can be more severe with the misoprostol-only regimen, compared with the two-medication regimen, physicians said.

Misoprostol is available as a generic drug and under the brand name Cytotec, which is manufactured by Pfizer Inc.

How common is the use of abortion pills, or medication abortion?

Medication abortion accounted for 54% of abortions in the U.S. in 2020, according to the Guttmacher Institute. Since 2000, when the FDA approved mifepristone, a steadily increasing proportion of patients have chosen medication abortions. Some 37% of U.S. abortions were medication abortions in 2017, up from 14% in 2005.

How do abortion pills work? How long do they take to work?

Mifepristone blocks the hormone progesterone, which is needed to sustain a pregnancy. Misoprostol causes uterine contractions and bleeding. Physicians say the experience is similar to a miscarriage, and typically involves several hours of heavy bleeding and cramping.

In rare cases where an abortion isn’t completed, an additional dose of misoprostol can be taken. While unlikely, an in-clinic procedure might be necessary if multiple rounds of misoprostol are ineffective.

How is medication abortion different from the morning-after pill?

While medication abortion terminates pregnancy, the morning-after pill, or emergency contraception, helps to prevent pregnancy by suppressing ovulation and curbing implantation. There are three types of emergency contraception pills: progestin-only pills such as levonorgestrel (sold under the brand name Plan B, among others), ulipristal (brand named Ella) and combined emergency contraception pills that consist of ethinyl estradiol and levonorgestrel.

Are abortion pills safe and effective?

Yes. Studies have shown the two-medication abortion regimen to be safer than widely used drugs including acetaminophen, penicillin and Viagra. Less than 0.4% of patients using mifepristone and misoprostol to terminate their pregnancies were hospitalized or required blood transfusions, according to a 2013 scientific review of the efficacy and safety of the two-medication regimen.

Research has shown the misoprostol-only regimen to be similarly safe.

Common side effects of medication abortions include bleeding, cramping, nausea, vomiting, diarrhea, headache and dizziness. The symptoms are typically short-lived and usually abate after a day or two.

The additional risk to patients taking abortion pills at home is minimal, so long as the medication is acquired from reliable sources, said Nisha Verma, an obstetrician-gynecologist and ACOG fellow.

“However, it is important that people taking medications at home have access to safe, nonjudgmental, and supportive care within the formal medical system if they need it at any point,” Dr. Verma said. “People who do have questions or concerns before, during or after a self-managed abortion should be able to safely and confidently get the care that they need.”

Following a medication abortion, patients experiencing prolonged fever and severe cramping—that doesn’t resolve with over-the-counter painkillers—or have continued symptoms of pregnancy should seek medical care.

According to ACOG, there are a small minority of patients for whom medication abortion isn’t recommended, including those with ectopic pregnancies and chronic adrenal failure. In cases of ectopic pregnancy, a medical emergency in which a fertilized egg implants outside the uterus, patients can either be treated with a medication called methotrexate or undergo surgery. For other at-risk patients, in-clinic procedures would be the only abortion option available.

Do you need a prescription? Where can I get an abortion pill?

In the U.S., abortion pills require a prescription from a healthcare provider. The FDA had previously required patients to pick up mifepristone in person from a clinical setting. The agency lifted that restriction in April 2021 and allowed abortion pills to be sent by mail. In January, the FDA passed a measure allowing bricks-and-mortar pharmacies to also dispense mifepristone.

The Fifth Circuit’s order sought to temporarily reinstate some earlier restrictions, including requiring in-person doctor visits to obtain the drug. The Supreme Court has lifted those restrictions for now.

Patients can buy mifepristone and misoprostol without a prescription from online pharmacies based overseas. International health providers, including Aid Access, connect U.S. patients to physicians in Europe and mail them abortion pills from outside the country. The FDA has said that the online sale of abortion pills that aren’t regulated by the agency is a violation of U.S. law.

“Healthcare providers based internationally may feel more insulated” from potential legal ramifications in the U.S., said Julia Kaye, a lawyer with the American Civil Liberties Union Reproductive Freedom Project.

The safety of these imported medications is also not guaranteed. Plan C, an abortion-pill advocacy group, has a pill-finding guide on its website, organized by state. For each provider listed, Plan C highlights any potential legal or safety risks.

Are states that support abortion rights thinking of expanding access to abortion pills?

Lawmakers in several states, including New York, California and Connecticut, have enacted legislation aimed at strengthening abortion protections.

In November, California, Michigan and Vermont became the first states to enshrine protections for reproductive rights in their constitutions after voters approved the changes.

Washington Gov. Jay Inslee said on April 4 that the state had purchased a three-year supply of mifepristone—about 30,000 doses—in anticipation of a potential disruption to access.

Sarah Toy and Laura Kusisto contributed to this article.

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Source: What the Supreme Court’s Decision Means for Abortion Pills – WSJ