In this 2018 photo, mifepristone and misoprostol pills are provided at a Carafem medical abortion clinic in Skokie, Illinois.
Erin Holey | Tribune News Service | Getty Images
A federal appeals court has allowed the abortion pill mifepristone to remain on the US market for now, but has imposed major restrictions on the drug that will severely limit access.
The U.S. Court of Appeals for the 5th Circuit on Wednesday night 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 appear to prohibit 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 reversed major changes the FDA has implemented over the years to make mifepristone easier to use and get. The order prohibits mail delivery of the abortion pill. Patients will now have to obtain the drug by prescription from a doctor and will have to undergo several in-person examinations while taking the drug.
The court changed the deadline when mifepristone can be given up to 49 days after the onset of pregnancy, down from the previous 70 days.
The three-judge panel voted 2-1 in favor of reimposing restrictions on mifepristone. Judges Kurt Engelhardt and Andrew Oldham, appointed by former President Donald Trump, voted in favour. Judge Catharina Haynes, who was appointed by former President George Bush, supported blocking Kacsmaryk’s entire order for a brief period.
The court has expedited the case to oral argument on the next available date.
The Justice Department is certain to challenge the 5th Circuit’s decision. Government attorneys and Danco Laboratories, the distributor of mifepristone, have pledged 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 the law that jeopardizes the health of millions by limiting access to medical abortion and undermines the approval system medication.
“The federal judiciary has – for the second time this week – thrown out the science and the law, and this time the court has decided it has the power to rewrite the label for mifepristone,” said Alexis McGill Johnson , president of Planned Parenthood. “If she is allowed to run, the consequences of this decision will be catastrophic not only for access to medical abortion, but for the entire drug approval system.”
Alliance Defending Freedom, the anti-abortion group that sued the FDA, said the appeals court ruling restores key safeguards while litigation continues.
Mifepristone, used in combination with another drug, misoprostol, is the most commonly used method of terminating a pregnancy in the United States. The prescription does not affect misoprostol, which is commonly used as a stand-alone abortion medication 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.
The calls The court said the FDA’s decision to lift the requirement for patients to obtain the abortion pill in person created “a dramatic change in the legal framework governing the distribution of mifepristone.” This requirement was the FDA’s primary tool for ensuring safe distribution or use of the drug, the court said.
The court cited a warning issued by the FDA with its 2000 approval that surgery might be necessary if mifepristone causes an incomplete abortion, as well as a form the agency asks patients to sign stating that the drug may not work in 2-7 out of 100 cases. 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 stomach pain.
“The FDA therefore cannot deny that serious mifepristone-related complications are certainly imminent,” the judges wrote in their order. “These complications are listed on the patient consent form that the FDA itself has approved and that Danco requires every mifepristone user to sign.”
The court cited testimony from doctors in the case who said they had treated women with adverse effects from mifepristone.
In a separate ruling on Friday, U.S. District Judge Thomas Rice of the Eastern District of Washington barred the FDA from “altering the status quo and rights with respect to the availability of mifepristone” in the 17 states and the District of Washington. Columbia who sued to keep the drugs on the market there.
The 5th Circuit did not mention the Washington state case. It was not immediately clear if the court ruling’s restrictions applied to these 17 states and DC.
The court also said it is possible that Alliance Defending Freedom, the group that filed the lawsuit, will succeed in its challenge to the underlying approval of mifepristone at a later date in the litigation. The Alliance Defending Freedom represents a coalition of physicians, called the Hippocratic Medicine Alliance, who oppose abortion.
“Women using this drug cannot return to their non-prescribing physicians for surgical abortions, so again, as the patient consent form itself says, they must instead seek care from emergency to a qualified physician,” the judges said.
The FDA, hundreds of members of Congress, leading medical associations and drug law experts have strongly disputed the claims made against mifepristone. They argue that the scientific evidence has overwhelmingly shown 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 placed restrictions on how the pill is used and distributed to ensure patient safety. These restrictions have long been criticized by medical associations such as the American College of Obstetricians and Gynecologists, and have been the subject of litigation.
In 2016, the FDA reduced the number of required in-person office visits to one. It also allowed non-doctors to prescribe mifepristone and extended the time patients can take the pill up to 70 days after becoming pregnant.
In January, the agency permanently waived the in-person requirements and allowed delivery of the pill by mail. It also allowed retail pharmacies to dispense mifepristone if they become certified under a federal oversight program.
Walgreens and CVS announced in January that they would become certified under this program and distribute mifepristone in states where permitted by law.
The 5th Circuit judges also discussed at length the Comstock Act, a 19th-century law that prohibited the mailing of anything that would induce an abortion. The Justice Department has argued that the Comstock Act does not prohibit the sending of abortion drugs if the sender does not intend to break the laws, citing court cases dating back to the early 20th century that reduced the scope of the law.
The court said it had not had time to conclusively explore the scope of the Comstock Act, but said the uncertainty surrounding its application weighed in favor of anti-abortion groups.