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Fifth Circuit upholds protections in abortion pill appeal

U.S. Fifth Circuit Court of Appeals. BP file photo

NEW ORLEANS (BP) – A federal appeals court has blocked a nationwide injunction suspending the two-decade-old approval of the abortion pill but restored protective requirements weakened in recent years by the U.S. Food and Drug Administration.

In an opinion issued late Wednesday (April 12), a three-judge panel of the Fifth Circuit Court of Appeals in New Orleans halted a federal judge’s April 7 stay of the FDA’s 2000 approval of mifepristone, the first drug in a two-step process commonly referred to as medical or chemical abortion. The panel, however, upheld for now the lower court’s prohibition of a series of FDA actions beginning in 2016 that pro-life advocates said reduced safeguards for women’s health.

U.S. Attorney General Merrick Garland announced Thursday morning (April 13) the Department of Justice (DOJ) would appeal the ruling to the Supreme Court.

Pro-life leaders expressed gratitude for the appeals court’s decision to restore previous protections.

The ruling, said Southern Baptist public policy specialist Hannah Daniel, “puts important safety precautions back in place for vulnerable women and saves more preborn lives.”

“Chemical abortion drugs not only end the life of a precious child but also put the health, safety and welfare of women at serious risk,” said Daniel, policy manager for the Ethics & Religious Liberty Commission (ERLC), in written comments for Baptist Press. “Though this case is far from over, this is a moment worth celebrating as women will be better protected from the predatory abortion industry and more lives will be saved.

“The ERLC will be closely monitoring this case as it continues to develop rapidly and remains committed to building a culture of life that cares for both women and their children.”

Erin Hawley, senior counsel for Alliance Defending Freedom (ADF), said the FDA “put politics ahead of the health of women and girls when it impermissibly failed to study how dangerous the chemical abortion drug regimen is and when it unlawfully removed every meaningful safeguard that it previously implemented.”

In a written statement, she described the Fifth Circuit ruling as “a significant victory for the doctors we represent, women’s health, and every American who deserves an accountable federal government acting within the bounds of the law.”

ADF represents the pro-life doctors and medical associations that brought the lawsuit.

Planned Parenthood Federation of America (PPFA), the country’s No. 1 abortion provider, was “furious” with the decision. “This baseless case is a politically motivated attack to further restrict access to abortion that will place care out of reach for patients — and we will not stand for it,” PPFA President Alexis McGill Johnson said in written remarks.

In granting a stay April 7, Federal Judge Matthew Kacsmaryk of Amarillo, Texas, said the FDA failed to address mifepristone’s safety issues “based on plainly unsound reasoning and studies that did not support its conclusions.” He delayed his stay’s implementation for seven days to permit the Biden administration time to pursue “emergency relief” from the Fifth Circuit Court. On April 10, the DOJ urged the court to block the federal judge’s order while the lawsuit is under consideration.

The Fifth Circuit panel found the statute of limitations had expired regarding the pro-life challenge to the FDA’s approval of mifepristone in 2000. Yet, it rejected the request by the FDA and Danco Laboratories, which manufactures and distributes mifepristone in the United States, to block Kacsmaryk’s prohibition on actions taken by the federal agency in 2016 and thereafter.

As a result, the Fifth Circuit decision includes the following effects for now:

  • Mifepristone’s use is returned to the first seven weeks of a preborn child’s gestation instead of the 10-week limit the FDA instituted in 2016.
  • In-person visits required with a physician are restored to three after they were decreased to one in 2016.
  • Only doctors may prescribe and administer the abortion pill in contrast to a 2016 change.
  • Women must appear in person to receive mifepristone, ending a 2021 FDA decision permanently allowing the drug to be dispensed by mail.

In January of this year, the FDA announced retail pharmacies would be able to carry and dispense mifepristone for the first time. The decision was another in a series of actions taken by President Biden and his administration in an effort to minimize the effect of the Supreme Court’s reversal of the 1973 Roe v. Wade ruling. In June 2022, the high court returned abortion policy to the states by overturning Roe, which legalized abortion throughout the country.

About 32,000 fewer abortions were reported in the six months after the Supreme Court’s June opinion in contrast to the period before the decision, according to a study issued April 11 by the Society of Family Planning.

Pro-life medical associations challenged approval of mifepristone in a 2002 citizen petition, but the FDA waited until 2016 before denying it. When pro-life organizations submitted another petition in 2019 to contest changes made in 2016 that weakened requirements for the drug’s use, the FDA failed to respond until it again issued a denial more than two years later.

The FDA “stonewalled judicial review – until now,” Kacsmaryk wrote.

On the same day as Kacsmaryk’s ruling, a federal judge in Washington state issued a conflicting decision. Thomas Rice of  Spokane ordered the “status quo” should remain in effect regarding mifepristone’s availability.

Rice’s ruling applied to the District of Columbia and 17 states: Arizona; Colorado; Connecticut; Delaware; Hawaii; Illinois; Maine; Maryland; Michigan; Minnesota; Nevada; New Mexico; Oregon; Pennsylvania; Rhode Island; Vermont; and Washington.

Mifepristone, often known as RU 486 and authorized by the FDA under President Clinton, causes the lining of the uterus to release the embryonic child, resulting in his or her death. Misoprostol, a drug approved by the FDA to treat ulcers, is typically taken one to two days later and causes the uterus to contract, expelling the body.

Medical/chemical procedures as a percentage of all abortions have increased dramatically the last two decades. They rose between 2001 and 2020 from 5 percent of all abortions to 53 percent, the Guttmacher Institute reported in December.

The FDA spent four years considering the application for mifepristone’s distribution in this country and says the drug is safe for women to use.

The Charlotte Lozier Institute (CLI), however, reported in 2021 a new study it conducted found “chemical abortion is consistently and progressively associated with more postabortion [emergency room] visit morbidity than surgical abortion.” An analysis of Medicaid claims information from 17 states that pay for abortions showed the “rate of abortion related ER visits following a chemical abortion increased 507%” between 2002 and 2015, according to CLI, a pro-life, research organization.

The case is Alliance for Hippocratic Medicine v. FDA.

Brandon Porter, associate vice president for convention news at the SBC Executive Committee, contributed to this report.