Courtroom holds it available in the market, blocks mail supply

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

Erin Hooley | Tribune News Service | Getty Images

A federal appeals court has allowed the abortion pill mifepristone to stay on the US market for now, but it has placed significant restrictions on the drug that will severely limit access.

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

However, the court temporarily reversed important changes the FDA has made over the years to make mifepristone easier to use and obtain. The order prohibits mail delivery of the abortion pill. Patients must now obtain the prescription drug from a doctor and undergo multiple in-person exams while taking the drug.

The court changed the time frame if mifepristone can be administered up to 49 days after the onset of pregnancy, less than before 70 days.

The three-judge panel voted 2-1 to reintroduce restrictions on mifepristone. Justices Kurt Engelhardt and Andrew Oldham, appointed by ex-President Donald Trump, voted in favour. Judge Catharina Haynes, appointed by former President George Bush, advocated briefly blocking Kacsmaryk’s entire order.

The court has brought the case forward for hearing at the next possible date.

The Justice Department will certainly appeal the 5th Circuit’s decision. Government lawyers and mifepristone distributor Danco Laboratories have vowed to take the case to the Supreme Court if necessary.

The Planned Parenthood Federation of America condemned the 5th Circuit’s decision as a rejection of science and law, endangering the health of millions by restricting access to medical abortions and undermining the drug licensing system.

“The federal judiciary — for the second time this week — rejected the science and the law, and this time the court ruled that they had the authority to rewrite the label on mifepristone,” said Alexis McGill Johnson, president of Planned Parenthood. “If approved, the consequences of this decision will be catastrophic, not just for access to medical abortion, but for the entire drug approval system.”

Alliance Defending Freedom, the anti-abortion group that is suing the FDA, said the appeals court’s decision restores critical safeguards as the litigation continues.

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

The outcome of the pill court battle could alter access to abortion even in states where it remains legal after the Supreme Court ruled Roe v. Wade lifted.

the appeals The court said the FDA’s decision to remove the requirement that patients receive the abortion pill in person created “a fundamental change in the legal framework for the distribution of mifepristone.” This requirement is FDA’s primary tool to ensure safe distribution or use of the drug, the court said.

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

“Therefore, the FDA cannot deny that serious complications from mifepristone are certain to be imminent,” the judges wrote in their order. “These complications are written directly on the patient agreement form that the FDA has self-approved and that Danco requires every mifepristone user to sign.”

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The court cited statements by doctors in the case who said they had treated women suffering from side effects of mifepristone.

In a separate decision Friday, U.S. District Judge Thomas Rice in the Eastern District of Washington barred the FDA from changing “the status quo and rights regarding the availability of mifepristone” in the 17 states and the District of Columbia based on The drugs on the market there had complained about keeping them.

The 5th Circuit did not mention Washington State’s case. It wasn’t immediately clear if the limitations in the court’s ruling apply to those 17 states and DC

The court also noted that it is possible that Alliance Defending Freedom, the group that filed the lawsuit, could succeed in its challenge to the underlying approval of mifepristone at a later stage in the litigation. The Alliance Defending Freedom represents an anti-abortion coalition of doctors called the Alliance for Hippocratic Medicine.

“The women using this drug cannot possibly return to their non-prescribing physicians for surgical abortions, so, as stated in the patient agreement itself, they must seek emergency care from a qualified physician instead,” the judges said.

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

The FDA first approved mifepristone in 2000. The agency imposed restrictions on how the pill is used and distributed to ensure patient safety. These limitations have long been criticized and faced with litigation by medical organizations such as the American College of Obstetricians and Gynecologists.

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

In January, the agency permanently lifted the in-person requirements and allowed the pill to be delivered by mail. It also allowed retail pharmacies to dispense mifepristone if certified under a federal oversight program.

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

The 5th Circuit Justices also discussed at length the Comstock Act, a 19th-century statute that forbids mailing anything that would lead to an abortion. The Department of Justice has argued that the Comstock Act does not prohibit the mailing of abortion drugs if the sender does not intend to break any laws, citing court cases from the early 20th century that narrowed the scope of the law.

The court said it did not have time to finally examine the Comstock Act’s scope but said uncertainty surrounding its application weighed in favor of anti-abortion groups.

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