DemDaily: The New Abortion Battleground

April 12, 2023

Last Friday, judges in Texas and Washington issued conflicting decisions on the fate of the abortion pill -- the new battleground in the war over reproductive rights that has raged since the US Supreme Court overturned the landmark 1973 Roe v. Wade decision.

The high court's June 2022 reversal of a woman's right to choose abortion, which had been the constitutional rule of law for almost 50 years, turned the authority to implement abortion laws over to individual states.

It sparked a wave of restrictions across the country, with more than 13 states enacting near-total bans on abortions and another five outlawing them after six to 20 weeks..

While most of the new laws focus on the abortion procedure, "medical abortion," or the abortion pill, actually accounts for more than 55% of pregnancy terminations nationwide.

Medical Abortion: The two-pill abortion regimen was first approved by the US Food and Drug Administration (FDA) in 2000, for use up to the tenth week of pregnancy. The first drug, mifepristone, ends a pregnancy and the second, misoprostol, empties the uterus. Mifepristone is also used to treat women who have suffered miscarriages and Cushing syndrome, a hormone-related condition. Misoprostol has been available by prescription for decades as a treatment for stomach ulcers and to manage postpartum hemorrhaging.

In December 2021, the FDA provisionally lifted the in-person dispensing requirement for mifepristone for the duration of the COVID-19 pandemic. In January 2023, it permanently lifted that requirement, allowing the medication to be sent by mail.

The decision was lauded at the time by pro-choice advocates and mainstream medical organizations as providing a lifeline to women in states where access to abortion is now prohibited -- most particularly for those unable to travel to a clinic, often people of color, low-income individuals and those in rural areas.

In last week's Texas decision, US District Judge Matthew Kacsmaryk, a conservative Trump appointee with longstanding ties to the anti-abortion movement, issued a decision suspending the FDA's 23-year approval of the medication, while providing seven days -- through this Friday, April 14 -- for implementation of his order.

In his 67-page ruling siding with the conservative Alliance Defending Freedom, which brought the suit, Kacsmaryk called abortion providers “abortionists” and described the use of mifepristone's intent “to kill the unborn human.” He also described the “intense psychological trauma” of people who use the pills and then see “the remains of their aborted children.”

“FDA acquiesced on its legitimate safety concerns -- in violation of its statutory duty" when it approved mifepristone more than 20 years ago, said Kacsmaryk, falsely asserted that “the lack of restrictions resulted in many deaths and many more severe or life-threatening adverse reactions.”

It is the first time in history that a court has suspended longtime FDA approval of a medication despite opposition from the agency and the drug’s manufacturer.

In truth, Mifepristone, when taken alongside misoprostol, has been proven to be extremely safe and effective and is recommended by the American Medical Association, the American College of Obstetricians and Gynecologists and the World Health Organization. The rate of serious complications requiring hospitalization or blood transfusion is less than 0.4%, and the mortality rate for medical abortion is 14 times lower than the mortality rate for childbirth. In fact, rates of patient deaths due to the drug are lower for mifepristone than they are for Tylenol, penicillin, or Viagra.

Legal experts have questioned several issues in Kacsmaryk's decision, including the question of standing by the plantiffs to file the suit -- which requires demonstration of harm.

The plaintiffs claim that the doctors in their suit have been harmed by “being forced, contrary to their most deeply held ethical, medical and religious convictions, to participate and finish elective abortions.”

Kacsmaryk agreed, writing in his ruling that the “adverse events from chemical abortion drugs can overwhelm the medical system,” and thus, they have associational and organizational standing to bring this suit.

Within an hour of the Texas decision, Washington state US District Judge Thomas O. Rice issued a decision in a separate case, ruling ordering the FDA to maintain "the status quo" for access to mifepristone in the 17 states, along with D.C., that filed the lawsuit.

The Justice Department on Monday appealed the Texas decision to 5th Circuit Court, arguing that the challengers had no standing to file the lawsuit since they were not personally harmed by the abortion pill. DOJ lawyers, representing the FDA, also asked the judges to keep the order on hold until the appeal is decided.

If the 5th Circuit does not temporarily stay Kacsmaryk’s order, the DOJ could go directly to the US Supreme Court in an effort to keep the medication available for women seeking to terminate pregnancies.

DOJ has also asked Judge Rice in the Washington state case for clarification on how to reconcile the contradictory opinions between the two jurisdictions -- issued 20 minutes apart -- "in the event that the [Texas] order takes effect and stays the approval of mifepristone.”

Drug company Danco, which manufactures mifepristone and joined in the DOJ appeal, called Kacsmaryk’s ruling an “unprecedented judicial assault” on the nation’s regulatory process which could undercut FDA's authority and spark challenges to other approved drugs.

The White House on Monday said, “We stand by the FDA’s approval of mifepristone, and we are prepared for a long legal fight.”

A decision on Judge Kacsmaryk’s order to halt distribution of mifepristone while the case is being decided is anticipated by Thursday. Regardless, it is ultimately expected to go to the US Supreme Court.

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Kimberly Scott

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Sources: BBC, New York Times, Texas Tribune, Politico, Vox, Washington Post

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