WASHINGTON — The Supreme Court said Friday it will temporarily keep in place federal rules for use of an abortion drug while it takes time to more fully consider the issues raised in a court challenge.
In an order signed by Justice Samuel Alito, the court put a five-day pause on the fast-moving case so the justices can decide whether lower court rulings restricting the Food and Drug Administration's approval of the drug, mifepristone, should be allowed to take effect in the short term.
The justices are asked at this point only to determine what parts of an April 7 ruling by U.S. District Judge Matthew Kacsmaryk in Texas, as modified by an appellate ruling Wednesday, can be in force while the case continues.
A 5th U.S. Circuit Court of Appeals ruling late Wednesday would prevent the pill, used in the most common abortion method, from being mailed or prescribed without an in-person visit to a doctor. It also would withdraw FDA approval of mifepristone for use beyond the seventh week of pregnancy. The FDA says it’s safe through 10 weeks.
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President Joe Biden’s administration and New York-based Danco Laboratories, the maker of the pill, asked the justices to intervene. The new limits would have taken effect Saturday if the court hadn't acted.
Doris Marlin, left, of Silver Spring, Md., and fellow activists demonstrate Friday in front of the Supreme Court on Capitol Hill in Washington.
The type of order issued by the court Friday, an administrative stay, ordinarily is not an indication of what the justices will do going forward. It was signed by Alito because he handles emergency filings from Texas.
Alito also is the author of last year’s opinion overturning Roe v. Wade. That allowed several states to restrict abortion and more than a dozen to effectively ban abortion outright. Late Thursday, Republican Gov. Ron DeSantis of Florida signed a bill that would ban abortion after six weeks.
Meanwhile, Kansas Gov. Laura Kelly vetoed a bill Friday that could have penalized doctors accused of not providing enough care to infants delivered during certain kinds of abortion procedures. The Democrat, who called the legislation “misleading and unnecessary,” vetoed a similar bill in 2019.
White House press secretary Karine Jean-Pierre said in a statement Friday evening that the Biden administration continues "to stand by FDA's evidence-based approval of mifepristone, and we will continue to support the FDA's independent, expert authority to review, approve, and regulate a wide range of prescription drugs."
"The stakes of this fight could not be higher in the face of ongoing attacks on women's health, and we will continue to fight to restore the protections of Roe v. Wade," she added.
The Supreme Court on Friday on Capitol Hill in Washington.
A lawyer for the anti-abortion doctors and medical organizations suing over mifepristone said the court's action Friday was "standard operating procedure" and urged the justices to allow the appeals court-ordered changes to take effect by the middle of next week.
The Justice Department and Danco both warned of "regulatory chaos" and harm to women if the high court doesn't block the lower-court rulings.
"This application concerns unprecedented lower court orders countermanding FDA's scientific judgment and unleashing regulatory chaos by suspending the existing FDA-approved conditions of use for mifepristone," Solicitor General Elizabeth Prelogar, the Biden administration's top Supreme Court lawyer, wrote Friday, less than two days after the appellate ruling.
The Biden administration and Danco now want a more lasting order that would keep the current rules in place as long as the legal fight over mifepristone continues. As a fallback, they asked the court to take up the issue, hear arguments and decide by early summer a legal challenge to mifepristone that anti-abortion doctors and medical organizations filed last year.
The court rarely acts so quickly to grant full review of cases before at least one appeals court has thoroughly examined the legal issues involved.
The 5th circuit narrowed an April 7 ruling by U.S. District Judge Matthew Kacsmaryk, whose far-reaching and virtually unprecedented order would have blocked FDA approval of the pill. He gave the administration a week to appeal.
"To the government's knowledge, this is the first time any court has abrogated FDA's conditions on a drug's approval based on a disagreement with the agency's judgment about safety — much less done so after those conditions have been in effect for years," Prelogar wrote.
Boxes of the drug mifepristone sit on a shelf March 16, 2022, at the West Alabama Women's Center in Tuscaloosa, Ala.
Erin Hawley, a lawyer for the challengers, said in a statement that the FDA put politics ahead of health concerns in its actions on medication abortion.
"The 5th Circuit rightly required the agency to prioritize women's health by restoring critical safeguards, and we'll urge the Supreme Court to keep that accountability in place," said Hawley, a senior counsel with Alliance Defending Freedom, a conservative legal group that also argued to overturn Roe v. Wade.
Mifepristone was approved by the FDA more than two decades ago and is used in combination with a second drug, misoprostol.
Adding to the uncertainty, a separate federal judge in Washington on Thursday clarified his own order from last week to make clear that the FDA is not to do anything that might block mifepristone's availability in 17 Democrat-led states suing to keep it on the market.
It's unclear how the FDA can comply with court orders in both cases, a situation that Prelogar described Friday as untenable.
Q&A: Abortion medication explained
Medication abortion explained
How the chemical combination of mifepristone and misoprostal acts to end a pregnancy. (AP Graphic)
How does medication abortion work?
Medication abortions became the preferred method for ending pregnancy in the U.S. even before the Supreme Court overturned Roe v. Wade. These involve taking two prescription medicines days apart — at home or in a clinic.
Abortion procedures are an invasive medical technique that empties the womb. They are sometimes called surgical abortions, although they don’t involve surgery.
Abortion by pills involves the drugs mifepristone and misoprostol. As more states seek abortion limits, demand for the pills is expected to grow.
Two pills work in combination
Mifepristone is taken first, swallowed by mouth. The drug dilates the cervix and blocks the effects of the hormone progesterone, which is needed to sustain a pregnancy.
Misoprostol, a drug also used to treat stomach ulcers, is taken 24 to 48 hours later. The pill is designed to dissolve when placed between the gums and teeth or in the vagina. It causes the uterus to cramp and contract, causing bleeding and expelling pregnancy tissue.
How late in pregnancy can the drugs be used?
Abortion medication is approved for use up to the 10th week of pregnancy.
The pills may be taken in a doctor’s office or clinic, where patients sometimes have an ultrasound or lab tests beforehand. Some providers also offer the pills through telehealth visits and then send patients the medication by mail.
Use of the pills has been increasing in recent years. As of 2020, they accounted for 54% of all U.S. abortions, according to preliminary data from the Guttmacher Institute. The group’s final estimate is due later this year.
Are the drugs safe? What are the risks?
Studies and real-use evidence show that when taken together, the pills are safe and up to 99% effective. Side effects may include nausea, vomiting and diarrhea.
Bleeding is normal. Very heavy bleeding — soaking more than two pads an hour for more than two hours — is uncommon but requires medical attention.
Dr. Stephanie Rand, a New York ob-gyn and abortion specialist with the advocacy group Physicians for Reproductive Health, says pregnancy tests should not be used right away to determine if a medication abortion was successful because the pregnancy hormone may linger in the body for several weeks. Bleeding, with blood clots that include lighter colored tissue, are signs of success, she said.
Serious complications are very rare. The Food and Drug Administration says more than 3.7 million U.S. women have used mifepristone since it was approved more than 20 years ago. The agency has received 26 reports of deaths in women using the medication, including two involving ectopic pregnancies, which grow outside the womb.
The medications are not recommended for certain patients, including those with suspected ectopic pregnancies or with implanted IUD birth control devices.
What are the costs and rules for use?
Costs vary by location but are similar to abortion procedures and may total more than $500. Health insurance coverage varies, with some plans making the pills free or low cost and others not covering them at all.
Mifepristone is sold under the brand name Mifeprex and misoprostol under the brand name Cytotec, but both pills are available as generics.
The FDA approved mifepristone to terminate pregnancy in 2000, when used with misoprostol. At the time, it imposed several limits on how the drug could be prescribed and dispensed.
In December, the agency dropped the biggest restriction: a requirement that patients pick up the medication in person. The FDA said a scientific review of the drug’s use — including during the COVID-19 pandemic — showed that women could safely receive the pills through the mail after an online consultation, without any increase in side effects or complications.
The decision allowed mail delivery of the pills nationwide, a change long-sought by medical professional groups and abortion-rights supporters.
Still, millions of women will have trouble accessing the pills due to a patchwork of state laws targeting abortion broadly and the pills specifically. About half of U.S. states are expected to ban or greatly restrict abortion.
Will the pills be covered by state abortion bans?
Legal experts foresee years of court battles over access to the pills, as abortion-rights proponents bring test cases to challenge state restrictions.
There are strong arguments and precedents on both sides, experts note, though little certainty about which side might prevail.
The Biden administration’s Justice Department has already signaled plans to challenge state restrictions on medication abortion. And federal lawyers are likely to be joined by outside parties, including abortion rights groups like Planned Parenthood and even the companies that make the pills.
The chief argument against pill restrictions is likely to be the longstanding principle that federal laws, including FDA decisions, preempts state laws. Indeed, few states have ever tried to fully ban an FDA-approved drug because of past rulings in the agency’s favor.
Still, states with blanket abortion bans are likely to interpret them as barring abortion pills. Many of the laws don't distinguish between abortion procedures and medication abortion.
“In the short term, those states that ban abortion are going to assume that their bans also include medication abortion and that will be prohibited,” said Greer Donley, a professor specializing in reproductive health care at the University of Pittsburgh Law School.
What is the current situation in the states?
Even if blanket bans are successfully challenged, more than 30 states have laws specifically restricting access to abortion pills. For example, 19 states require that clinicians be physically present when the drug is administered.
Those laws could withstand court challenges. States have long had authority over how physicians, pharmacists and other providers practice medicine.
States also set the rules for telemedicine consultations used to prescribe medications. Generally that means health providers in states with restrictions on abortion pills could face penalties, such as fines or license suspension, for trying to send pills through the mail.
Women have already been traveling across state lines to places where abortion pill access is easier. That trend is expected to increase.
Meanwhile, some women will still get the medication via online pharmacies in Canada and overseas, often with telehealth consultations from foreign doctors. The practice is technically illegal but essentially unenforced, and advocates believe women will increasingly choose this method as more states move to ban abortions.
“Anti-abortion states are going to do everything they can to restrict medication abortion, but practically speaking people have been and will continue to access it through the mail from international pharmacies,” Donley said.
Donley expects lawsuits based on various legal theories to play out for a few years before any clear decisions emerge.
One key question is how the nation’s top court might rule if and when it takes up those court cases. While the Supreme Court has rejected a constitutional right to abortion, conservative justices have also generally deferred to FDA's primacy over drug decisions.
