Judge mulls banning abortion pill in US, questions regulatory approval
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[March 16, 2023]
By Gabriella Borter and Brendan Pierson
AMARILLO, Texas (Reuters) -A U.S. judge on Wednesday questioned lawyers
for President Joe Biden's administration on whether the federal
regulatory approval given to the abortion pill mifepristone 22 years ago
was proper as he considered a request by anti-abortion groups to ban
sales of the drug nationwide.
U.S. District Judge Matthew Kacsmaryk during a hearing in Amarillo also
pressed the groups, led by the Texas-based Alliance for Hippocratic
Medicine, to explain how he could reverse approval of a long-established
drug.
The judge raised the possibility of a more limited ruling, keeping the
drug on the market but re-imposing some restrictions lifted by Biden's
administration, including requiring it to be dispensed in person rather
than by mail. Kacsmaryk, appointed to the bench by former President
Donald Trump, said he would rule "as soon as possible."
It is shaping up as the most consequential abortion case since the U.S.
Supreme Court, powered by its conservative majority, last year
overturned its landmark 1973 Roe v. Wade ruling that had recognized a
constitutional right to terminate a pregnancy.
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The anti-abortion groups sued the U.S. Food and Drug Administration in
November, contending the agency used an improper process when it
approved mifepristone in 2000 and did not adequately consider the drug's
safety when used by girls under age 18.
The plaintiffs are asking Kacsmaryk for a preliminary order halting
sales of mifepristone nationwide - even in states where abortion is
legal - while their lawsuit proceeds.
Twelve of the 50 states now ban abortion outright while many others
prohibit it after a certain length of pregnancy, according to the
Guttmacher Institute, a research organization that supports abortion
rights. A ruling against the FDA would hinder abortion access in every
state as medication abortion - with mifepristone part of a two-pill
regimen - accounts for more than half of U.S. abortions.
The judge heard arguments in a windowless courtroom in a small
courthouse in the northwest corner of Texas for more than four hours,
listening intently and asking questions.
Erik Baptist, a lawyer with the conservative legal group Alliance
Defending Freedom representing the plaintiffs, said the scope of the
judge's ruling should be "universal and nationwide."
The judge questioned lawyers for Biden's administration on how the FDA
accelerated its approval for mifepristone under a process typically used
for drugs to treat HIV infection and other life-threatening illnesses.
The administration has said that the drug's approval was well supported
by science, and that the challenge comes much too late.
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![](../images/031623PIX/health84.jpg)
Boxes of mifepristone, the first pill
given in a medical abortion, are prepared for patients at Women's
Reproductive Clinic of New Mexico in Santa Teresa, U.S., January 13,
2023. REUTERS/Evelyn Hockstein
![](http://archives.lincolndailynews.com/2023/Mar/16/images/ads/current/llm_lda_ANIMAL_2023.png) 'PUBLIC HARM'
Lawyers for the U.S. Justice Department and an attorney for
mifepristone's manufacturer, Danco Laboratories, argued that the
plaintiffs had no standing to bring the case, and said mifepristone
has an impressive safety and efficacy record.
"An injunction here would upend the status quo. An injunction would
cause significant public harm," Justice Department attorney Julie
Straus Harris told the judge.
Harris also argued that a ruling in favor of the plaintiffs would
undercut trust in the FDA, the agency charged with signing off on
the safety of food products and drugs in the United States. Harris
said such a ruling would also increase the burden on surgical
abortion clinics, already overcrowded as they admit patients from
states where clinics have closed in the wake of last year's Supreme
Court decision.
Mifepristone is available under the brand name Mifeprex and as a
generic. Used in conjunction with another drug called misoprostol,
it is approved to terminate a pregnancy within the first 10 weeks of
a pregnancy. The FDA in January said that the government for the
first time will allow mifepristone to be dispensed at retail
pharmacies.
Major medical organizations, including the American College of
Obstetricians and Gynecologists, have weighed in on the side of the
FDA, saying mifepristone "has been thoroughly studied and is
conclusively safe."
Abortion rights supporters, contending that the lawsuit is a
baseless attempt to slash abortion access, protested outside the
courthouse on Wednesday morning. One dressed as a kangaroo and
carried a gavel, suggesting that the hearing was a "kangaroo court."
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By suing in Amarillo, where the Alliance for Hippocratic Medicine
had been incorporated just three months earlier, the plaintiffs
ensured that the case would go before Kacsmaryk, a conservative
former Christian activist. His courthouse has become a favored
destination for Republicans seeking to challenge aspects of Democrat
Biden's agenda.
Kacsmaryk's eventual ruling is likely to be appealed immediately by
the losing side to the New Orleans-based 5th U.S. Circuit Court of
Appeals, with the U.S. Supreme Court a possible next step after
that.
The 5th Circuit has a conservative reputation, with more than
two-thirds of its judges appointed by Republican presidents. The
Supreme Court has a 6-3 conservative majority.
(Reporting Gabriella Borter in Amarillo, Texas and Brendan Pierson
in New York; Additional reporting by Liliana Salgado in Amarillo;
Editing by Will Dunham and Alexia Garamfalvi)
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