No More Abortion Pills Through the Mail?
The court’s 7-2 ruling blocks a lower court order that would have taken the drug mifepristone off the market as the court considers a lawsuit over whether the drug was validly approved.
In a Nutshell
- Chemical abortion pills account for more than half the abortions in the United States now, and the percentage is growing.
- Many are sent to pregnant women through the mail, but pro-lifers say that violates federal law.
- While supporters of abortion pills say they’re safe, pro-lifers say under current federal protocols they’re not.
- Two lower federal courts have recently criticized the Food and Drug Administration’s loosening of the rules while issuing stays that would suspend at least some of them.
- The U.S. Supreme Court is expected to decide on Friday, April 21, if a lower-court ruling restricting but not banning abortion pills will stand.
Today’s expected U.S. Supreme Court decision may help determine whether women can get abortion pills through the mail, including in states that outlaw abortion.
While most of the national discussion of the case focuses on whether abortion pills are safe for the women who take them and whether the federal agency that approved them acted properly, the mailing question will determine how effective state anti-abortion laws can be if abortion pills retain federal approval.
“Abortion pills are a way to get around state pro-life laws,” said Walter Weber, senior counsel of the American Center for Law and Justice, which filed a friend-of-the-court brief this week arguing that federal law prohibits sending abortion pills by mail, in a telephone interview with the Register. “It’s much easier if you’re going to try to smuggle abortion into a state where it’s illegal to do it by pills.”
The U.S. Supreme Court case is called Danco Laboratories v. Alliance for Hippocratic Medicine et alia.
Is It Legal?
The Comstock Act of 1873 makes it illegal to mail “[e]very article, instrument, drug, medicine, or thing … for producing abortion …” The prohibition in current federal law also applies to “any express company or other common carrier.”
In December 2021, the U.S. Food and Drug Administration announced that mifepristone could be sent by mail, on a permanent basis.
In December 2022, the U.S. Department of Justice’s Office of Legal Counsel issued an opinion arguing that mailing abortion pills does not violate the Comstock Act “where the sender lacks the intent that the recipient of the drugs will use them unlawfully.”
But a federal judge in Texas rejected that reasoning earlier this month in a case brought by pro-life physicians challenging the U.S. Food and Drug Administration’s approvals of mifepristone for chemical abortions during the past two decades.
Concerning the Comstock Act, Judge Matthew Kacsmaryk found that the “plain text” of the federal statute prohibits sending abortion drugs through the mail, whether the seller intends those drugs to be used unlawfully or not, and that the pro-life plaintiffs in the case “have a substantial likelihood of prevailing on their claim” that sending abortion drugs through the mail “violates unambiguous federal criminal law.”
The Trump-appointed judge, in the U.S. District Court for the Northern District of Texas, also granted a preliminary injunction that would have suspended the current federal approval of mifepristone for chemical abortions pending a trial to determine if the FDA acted properly. While the drug was first approved in 2000, the judge found the pro-lifers’ court challenge timely, noting that it took the federal agency almost 14 years to deny a 2002 challenge of its initial approval of the drug.
Five days later, the 5th Circuit Court of Appeals on April 12 found that the statute of limitations has likely already run out for the pro-lifers’ original challenge in 2000, although the court called it a “close question.” But the appeals court also found a subsequent challenge to be timely. In that challenge, pro-lifers opposed the agency’s 2016 loosening of the rules governing mifepristone — including increasing the gestational age for using the drug from 49 days to 70 days, reducing the number of required in-person office visits from three to one, allowing non-doctors to prescribe and administer the abortion pills, and eliminating a requirement to report non-fatal adverse events to the agency.
That last point drew the ire of the three-judge appeals-court panel, which said that the Food and Drug Administration stopped requiring reports of non-fatal adverse events in 2016 and then “turned around in 2021 and declared the absence of non-fatal adverse-event reports means mifepristone is ‘safe.’”
“This ostrich’s-head-in-the-sand approach is deeply troubling,” the appeals court said in its decision.
As for mailing abortion pills, the appeals court expressed doubt that it’s legal, but opted not to explore the topic more fully in the interests of time, saying the pro-life doctors already had enough of a case to win a stay of the FDA’s loosening of the rules in 2016.
U.S. Supreme Court Justice Samuel Alito during the past seven days has issued two stays of the appeals court ruling, allowing time for the full court to decide whether to uphold it, overturn it, modify it, or let it stand. The high court’s current deadline is late Friday night, April 21.
What Is a Chemical Abortion?
Chemical abortion ends a pregnancy through pills rather than through surgery or machines.
The most common form of chemical abortion involves taking mifepristone to block the hormone progesterone, which is essential for a pregnancy to continue, followed a day or two later by misoprostol, which helps the body expel the remains of the embryo (the term for an unborn child through eight weeks of pregnancy) or fetus (the term for the unborn child after eight weeks) through contractions, leading to cramping and bleeding.
More than half of abortions in the United States now occur through pills taken at home rather than through physical interventions at an abortion facility or hospital, according to the federal Centers for Disease Control and Prevention. The percentage appears to be increasing.
Mifepristone, a drug also known as RU-486, was developed in France in the 1980s.
In 1996, the Population Council, a nonprofit organization headquartered in New York City, filed an application with the federal Food and Drug Administration to make and use mifepristone to provide chemical abortions in the United States, eventually getting approval in September 2000 to administer them through seven weeks of gestation.
The Population Council was founded in 1952 by John D. Rockefeller III (1906-1978), a grandson of the co-founder of Standard Oil and a supporter of limiting population growth. The organization supports abortion as a means of promoting what it calls “sexual and reproductive health, rights, and choices.”
The organization at some point during the 1990s (court documents don’t say when) formed a company called Danco Laboratories, which its lawyers described in a court filing Jan. 13, 2023, as “a small pharmaceutical company” that “sells one drug” — Mifeprix, the brand name of mifepristone.
Danco keeps its place of business and the names of its chief executive and board members secret for fear of violence from abortion opponents, according to a story published by Bloomberg on April 13. The company’s pills are made in Europe, a company spokesman told The Wall Street Journal, according to a story published in July 2022.
In April 2019, the agency approved a generic version of mifepristone, which a Las Vegas-based company called GenBioPro Inc. makes and sells — more than 850,000 units of the drug since 2019, the company said in a court filing this week.
On Wednesday, GenBioPro filed a lawsuit in federal court in Maryland asking a judge to prevent the FDA from declaring its drug “mislabeled” in response to recent court decisions, which the company says would prevent it from selling it.
GenBioPro supplies about two-thirds of the mifepristone used for the approximately 500,000 chemical abortions a year in the United States, the company said in a friend-of-the-court brief filed April 14 with the U.S. Supreme Court.
Has the FDA Acted Properly?
The Food and Drug Administration says using mifepristone for chemical abortions is safe for pregnant women, noting that the agency approved it more than 20 years ago and that “periodic reviews of postmarketing data … have not identified any new safety concerns” since the agency approved lengthening the gestation period for usage to 70 days in 2016, according to a statement published in January 2023.
Danco Laboratories, the company that has made and marketed brand-name abortion pills since 2000, called mifepristone “a safe and effective drug that is approved for use in 82 countries” in a filing with the U.S. Supreme Court on Tuesday, April 18, and called the lower-courts’ rulings “first-in-a-century judicial second-guessing of FDA’s scientific judgment” that is causing “immediate chaos and nationwide confusion.”
President Joe Biden’s press secretary, Karine Jean-Pierre, said during a White House press conference Wednesday that the abortion-pills case “is a high priority” for the administration, which supports both legal abortion and abortion pills, and said administration officials “are prepared for a long legal fight.” The U.S. solicitor general, Elizabeth Prelogar, a Biden appointee, in a filing with the U.S. Supreme Court last week, said the abortion drug has a “well-documented safety record” based on a “mountain of evidence and experience.”
Opponents say the abortion drug isn’t safe, particularly under the current rules. They include Dr. Donna Harrison, an obstetrician-gynecologist and director of research for the American Association of Pro-Life Obstetricians and Gynecologists, one of the plaintiffs in the case.
The current system, she told the Register, allows for a woman to have a single online telehealth visit with a doctor, get a prescription for chemical abortion drugs, receive them in the mail, take them at home, and wait for the abortion to occur.
But the only reliable way to establish gestational age of a pregnancy is by an ultrasound, which must be done in person, she said. Without it, a pregnant woman may be farther along than she thinks, even past the 10-week cutoff the FDA currently sets for administering the drug.
In addition, Harrison said, an ectopic pregnancy, which means a fertilized egg has implanted outside the uterus, is a potentially life-threatening condition for a woman if it goes untreated, and yet without an in-person visit with a competent physician, such a condition may go undetected.
She told the Register she has reviewed adverse-event reports describing how women have died after taking the drug, and that the first the pill’s prescriber heard about it was in news stories.
“So this is not a trivial problem, to not have an examination for women. This is a serious problem,” Harrison told the Register.
Erica Steinmiller-Perdomo, a lawyer for Alliance Defending Freedom, which is representing the pro-life organizations in the federal case (including Dr. Harrison’s), told the Register that allowing abortion pills to be sent through the mail undermines both state pro-life laws and the safety of pregnant women.
“What the abortion industry is intending to do is to flout state laws in order to put these drugs in the hands of women, where state law would otherwise protect women from these dangerous chemical abortions,” Steinmiller-Perdomo said.
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