US appeals court allows abortion pills mifepristone to remain on market but blocks delivery by mail

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In this 2018 photo, mifepristone and misoprostol pills are available at the Carafem medical abortion clinic in Skokie, Illinois.

Erin Hooley | News Tribune | Getty Images

A federal appeals court has allowed the abortion pill mifepristone to remain on the US market for now, but imposed major restrictions on the drug that will severely limit access.

The 5th U.S. Circuit Court of Appeals late Wednesday blocked U.S. District Judge Matthew Kacsmaryk’s order suspending the Food and Drug Administration’s approval of mifepristone. The court said federal statutes of limitations prevent the anti-abortion groups that filed the lawsuit from challenging the agency’s more than two-decade-old approval of the drug.

But the court temporarily overturned major changes the FDA had made over the years to make mifepristone easier to use and obtain. The order prohibits delivery of the abortion pill by mail. Patients will now have to obtain a prescription from a doctor, and they will have to undergo several personal examinations while taking the medication.

The court changed the deadline when mifepristone can be given up to 49 days of pregnancy, which is less than before 70 days.

Three justices voted 2 to 1 to reinstate restrictions on mifepristone. Justices Kurt Engelhardt and Andrew Oldham, appointed by former President Donald Trump, voted in favor. Judge Catharina Haynes, an appointee of former President George Bush, upheld blocking Kacsmaryk’s entire order for a short time.

The court referred the case for oral arguments on the next available date.

The Justice Department is sure to challenge the 5th Circuit’s decision. Government lawyers and Danco Laboratories, the distributor of mifepristone, have vowed to take the case to the Supreme Court if necessary.

Mifepristone, used in combination with another drug called misoprostol, is the most common method of terminating a pregnancy in the United States. The order does not affect misoprostol, which is commonly used as a stand-alone abortion drug in other parts of the world.

The outcome of the legal battle over the pill could change access to abortion even in states where it remains legal after the Supreme Court overturned Roe v. Wade last year.

Complaints the court said the FDA’s decision to eliminate the requirement that patients obtain the abortion pill in person resulted in “a major change in the legal framework governing the dispensing of mifepristone.” That requirement was the FDA’s main tool to ensure the drug’s safe distribution or use, the court said.

The court cited a warning the FDA issued with its 2000 approval that surgery may be necessary if mifepristone causes an incomplete abortion, along with a form the agency asks patients to sign stating that the drug may not work in 2 to 7 out of every 100 women taking mifepristone. This form instructs patients to contact a health care provider immediately if they have a fever of 100.4 degrees or higher for more than four hours, heavy bleeding, or severe abdominal discomfort.

“FDA therefore cannot deny that serious complications from mifepristone are certainly at risk,” the judges wrote in their decision. “These complications are there on the patient agreement form that the FDA itself has approved and that Danco requires every user of mifepristone to sign.”

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The court cited testimony from doctors in the case who said they had treated women who had experienced adverse effects from mifepristone.

The appeals court only ruled on Kacsmaryk’s order, which was for mifepristone.

In a separate ruling on Friday, U.S. Judge Thomas Rice of the Eastern District of Washington barred the FDA from “altering the status quo and rights regarding the availability of mifepristone” in 17 states and the District of Columbia that had sought to keep the drug on the market there.

The 5th Circuit did not mention the Washington state case. It was not immediately clear whether the restrictions in the court’s ruling apply to those 17 states and D.C

The court also said it was possible that Alliance Defending Freedom, the group that filed the lawsuit, could succeed in challenging the underlying approval of mifepristone later in the court process. The Alliance to Defend Freedom represents a coalition of anti-abortion doctors called the Alliance for Hippocratic Medicine.

“There is no way women using this drug can go back to their prescribing doctors for a surgical abortion, so again, as the patient agreement form itself says, they must instead seek emergency care from a qualified doctor,” they said. judges.

The FDA, hundreds of members of Congress, leading medical associations, and drug law experts have strongly disputed the claims against mifepristone. They argue that the scientific evidence has shown conclusively that the drug is a safe and effective way to terminate an early pregnancy, and that the FDA’s regulatory actions were thorough and legal.

The FDA first approved mifepristone in 2000. The agency imposed restrictions on the pill’s use and distribution to ensure patient safety. Medical associations such as the American College of Obstetricians and Gynecologists have long criticized these restrictions and have faced lawsuits.

In 2016, the FDA reduced the number of required in-person office visits to one. It also allowed non-physicians to prescribe mifepristone and extended the time frame in which patients can take the pill up to 70 days into pregnancy.

In January, the agency permanently eliminated requirements for in-person visits and allowed delivery of pills by mail. It also allowed retail pharmacies to dispense mifepristone if they become certified under a federal monitoring program.

Walgreens and CVS announced in January that they would be certified under the program and dispense mifepristone in states where the law allows it.

The 5th Circuit judges also discussed at length the Comstock Act, a 19th-century law that prohibits sending anything that would cause an abortion through the mail. The Justice Department argued that the Comstock Act does not prohibit the shipment of abortion drugs if the sender has no intent to violate any law, citing court cases from the early 20th century that narrowed the scope of the law.

The court said it had not had time to definitively explore the scope of the Comstock Act, but said the uncertainty surrounding its application weighed in favor of anti-abortion groups.

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