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5th circuit panel rules to keep in place portion of district court’s order requiring FDA to restore previous safeguards for chemical abortion drugs

by | Apr 13, 2023

DOJ to appeal to the Supreme Court

By Dave Andrusko

Near midnight on Wednesday evening, a three judge panel of the 5th Circuit Court of Appeals in New Orleans ruled that the FDA’s initial approval of mifepristone in 2000 could remain in effect for now but reinstated crucial safeguards for women. Since 2016, the FDA had made a series of changes removing protections for women, and those protections will go back into effect. 

The Justice Department has announced they will be seeking emergency relief from the Supreme Court. “The Justice Department strongly disagrees with the Fifth Circuit’s decision in Alliance for Hippocratic Medicine v. FDA to deny in part our request for a stay pending appeal,” Attorney General Merrick Garland said in a statement. “We will be seeking emergency relief from the Supreme Court to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care.”

The decision temporarily narrowed last Friday’s ruling by U.S. District Judge Matthew Kacsmaryk that had completely blocked the FDA’s approval.

Judge Kacsmaryk issued a one week temporary stay to allow the government to appeal. The administration asked the 5th Circuit to extend that pause, and to do so by Thursday at noon “to enable the government to seek relief in the Supreme Court if necessary.”

The plaintiffs in the lawsuit, the Alliance for Hippocratic Medicine, included four medical associations and four doctors experienced in caring for pregnant and post-abortive women. They were represented by the Alliance Defending Freedom. According to the ADF

In its decision, the 5th Circuit ruled that abortionists are no longer allowed to send chemical abortion drugs through the mail, which the FDA had been allowing since 2021, in direct violation of longstanding federal law. Additionally, in 2016, the FDA extended the permissible gestational age of the baby for which a girl or woman may take chemical abortion drugs—from seven weeks’ gestation to 10 weeks’ gestation. The 5th Circuit’s order moved that back to seven weeks’ gestation, protecting the mother from adverse complications that increase with gestational age, reinstated necessary doctor visits, and brought back the requirement that abortionists must check women for complications after their chemical abortions. The 5th Circuit also agreed with Alliance Defending Freedom attorneys that the FDA’s approval of generic mifepristone was unlawful, and that manufacturer must cease production by Friday.

More than half of all abortions in the U.S. are now performed using chemical abortion pills.

The appeals court panel emphasized that it was issuing its decision in a rush as opposed to the glacial pace of the FDA. For example, the judges looked at the long gap between the submission of a 2002  citizen petition challenging the 2000 Approval and the FDA’s denial in 2016 of the petition and as much as accused the agency of slow-walking its decision.

In his opinion, Judge Kacsmaryk wrote that the FDA “postponed and procrastinated for nearly 6,000 days” [emphasis in the original]. “Simply put, FDA stonewalled judicial review — until now. Before Plaintiffs filed this case, FDA ignored their petitions for over sixteen years, even though the law requires an agency response within ‘180 days of receipt of the petition.’”  

The 5th circuit panel deciding not to reopen the 2000 approval was a “close call” and that “plaintiffs could very well prevail on this reopening claim.”

 The 42 page opinion delved into complications which defenders essentially deny occur. But the FDA “cannot deny that serious complications from mifepristone are certainly impending. Those complications are right there on the Patient Agreement Form that FDA itself approved and that Danco requires every mifepristone user to sign.”

The judges also cited real-life examples of “adverse events” including “torrential bleeding”:

Several doctors testified that they have seen an increasing number of women coming to the emergency room with complications from chemical abortions due to FDA’s virtual elimination of controls on the dispensing and administration of the drugs. …

[W]e hold that on the record before us applicants know that hundreds of thousands of women will with applicants own statistical certainty need emergency care on account of applicants actions. And because applicants chose to cut out doctors from the prescription and administration of mifepristone, plaintiff doctors and their associations will necessarily be injured by the consequences.

 “The 5th Circuit’s decision is 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,” said Erin Hawley, an attorney for ADF.

On April 5, National Right to Life released a white paper about the myths involving the Food and Drug Administration’s (FDA) approval and management of mifepristone (generic for Mifeprex).

Addressing Many of the Myths the Media is Repeating about the FDA’s Approval and Management of Mifeprex (Mifepristone) can be accessed here.

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