Abortion pill to stay on the market until U.S. Supreme Court ruling after appeals court order

UPDATED 4:15 p.m. Central, 8/16/23

WASHINGTON —  A federal appeals court ruled Wednesday the abortion pill can stay on the market, but it agreed with a lower court that ultimately use should revert to prescribing and dosage instructions that were in place before 2016.

That appeals court ruling will immediately be put on hold until the U.S. Supreme Court decides whether to take the case, under a decision the high court released in April. The ruling from the 5th Circuit Court of Appeals is expected to quickly be appealed to the high court.

The ruling means mifepristone remains legal and on the market in states that haven’t banned it, and, due to the Supreme Court’s earlier order, can be used under modifications approved by the Food and Drug Administration.

Mifepristone was originally approved in 2000 and is the first of two drugs used in medication abortion. It is approved for use up to 10 weeks gestation and is also frequently used to treat miscarriage.

The Kaiser Family Foundation released a survey in June showing that 62% of the nearly 600 OB-GYNs surveyed said they use mifepristone with a second drug called misoprostol to treat a miscarriage.

“Miscarriages are very common and an important aspect of many OBGYNs’ scope of practice, and sometimes involve the same procedures and medications that are used for abortions,” KFF wrote. “In early pregnancy, medical management for miscarriage with misoprostol and mifepristone allows a shorter time course than waiting for nonviable pregnancy tissue to pass on its own (expectant management) in patients without complications.”

Many questions in oral arguments

The three-judge panel from the New Orleans-based appeals court that issued the ruling Wednesday heard oral arguments in the case in May after the federal government appealed a district judge’s ruling.

The judges had dozens of questions for the federal government’s attorney, the lawyer representing a manufacturer and the attorney for Alliance Defending Freedom, the anti-abortion legal organization that originally filed the case.

Wednesday’s ruling comes from that same panel, made up of Jennifer Walker Elrod, who was nominated by former President George W. Bush, as well as James C. Ho and Cory T. Wilson, who were both nominated by former President Donald Trump.

The appeals court on Wednesday disagreed with the district court judge’s ruling that the 2000 approval of mifepristone should be overturned and that the generic version of the pharmaceutical should no longer be available.

The appeals judges agreed with the lower court’s opinion that several changes the FDA made in 2016 and 2021 regarding dosing and use of the prescription should no longer be in effect.

“In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it,” the appeals court’s ruling states.

“It failed to consider the cumulative effect of removing several important safeguards at the same time. It failed to consider whether those ‘major’ and ‘interrelated’ changes might alter the risk profile, such that the agency should continue to mandate reporting of non-fatal adverse events,” the appeals judges wrote. “And it failed to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person.”

The appeals court acknowledged in its ruling that several medical organizations filed briefs expressing concern that eliminating access to mifepristone for miscarriage management “even temporarily, may pose health risks to certain women.”

“These concerns are not insignificant,” the appeals court wrote. “But they apply primarily (if not wholly) to the challenge to the 2000 Approval — a claim that we have concluded is not likely to succeed.”

Arguments about reducing access to mifepristone by reverting to the more limited use instructions in place before 2016 “are lessened by the fact that mifepristone would remain available… as would options for surgical abortion,” the appeals court wrote.

Ho wrote his own opinion, saying that unlike his colleagues on the appeals court, he believed the anti-abortion organizations that filed the lawsuit likely would succeed with their challenge to the 2000 approval of mifepristone.

Limits prior to 2016

Reverting to the pre-2016 instructions would lower when the medication can be prescribed from 10 weeks gestation to seven weeks and change dosage and timing.

It would mean only doctors, not qualified health care providers, could prescribe mifepristone. Patients would need to attend three in-person doctor’s office visits, eliminating the ability for the medication to be prescribed via telehealth and shipped through the mail.

The generic version of mifepristone could be at risk of no longer being approved, though the appeals court rejected that option in its Wednesday ruling.

The manufacturer of the brand name version, Mifeprex, would need to relabel the product to comply with the court’s ruling, if the Supreme Court ultimately agrees with the appeals court’s ruling. Lawyers for the company that manufactures the brand-name version have said this could take months.

The case began in mid-November when Alliance Defending Freedom filed the lawsuit in the U.S. District Court for the Northern District of Texas.

ADF, on behalf of four anti-abortion medical organizations and four anti-abortion physicians, argued the U.S. Food and Drug Administration incorrectly approved mifepristone to terminate pregnancies in 2000.

The lawsuit asked the district court to overturn that approval, but in the event the judge didn’t agree to do that, ADF requested the court revert prescribing and use of the medication to instructions that were in place before 2016.

Judge Matthew Joseph Kacsmaryk ruled to end access to mifepristone in April when he issued a stay of the FDA’s original 2000 approval.

The U.S. Supreme Court placed that ruling on hold while the case works through the appeals process. That decision, which has kept mifepristone legal, would lift after the nine justices issue a ruling, or refuse to hear the case.

Reactions to ruling

​​Nancy Northup, president and CEO of the Center for Reproductive Rights, said in a written statement the “appeals court decision sets up a showdown at the Supreme Court over baseless attacks on medication abortion, which has been a lifeline since the high court reversed Roe last year.”

“This order, if allowed to take effect, could jeopardize the FDA’s entire scientific system of drug approvals and would leave patients panicked and confused about their health and safety,” Northup said.

Christopher M. Zahn, interim CEO of the American College of Obstetricians and Gynecologists, said in a statement the 5th Circuit Court of Appeals decision “is another example of judicial activism that reflects ideology, not science.”

“Mifepristone is demonstrably safe and effective for its FDA-approved use up to 10 weeks of gestation, it is demonstrably safe and effective when used as directed by telemedicine, and it is demonstrably safe and effective when prescribed by qualified advanced practice clinicians,” Zahn said. “The FDA made these changes to mifepristone’s regulation for medication abortion and miscarriage management based on robust scientific data and with the support of the medical community, including ACOG.”

The medical organization, Zahn said, looks “forward to sharing with the Supreme Court the overwhelming evidence and consensus of the medical community in support of mifepristone for medication abortion and miscarriage management.”

​​Alliance Defending Freedom Senior Counsel Erin Hawley said in a written statement that the 5th Circuit’s ruling was a “significant victory for the doctors and medical associations we represent and, more importantly, the health and safety of women.”

“The 5th Circuit rightly required the FDA to do its job and restore crucial safeguards for women and girls, including ending illegal mail-order abortions,” Hawley added. “The FDA will finally be made to account for the damage it has caused to the health of countless women and girls and the rule of law by unlawfully removing every meaningful safeguard from the chemical abortion drug regimen.”

Washington Democratic Sen. Patty Murray said in a statement that it’s “absolutely infuriating that we have judges overruling medical experts and patient and doctor experience to impose outdated restrictions on mifepristone that fly in the face of medical science.”

“This has nothing to do with facts or science — it’s about ideology and controlling women’s bodies, plain and simple,” Murray added. “This case has enormous implications for other safe and effective, FDA-approved medications Americans rely on — and while patients should know that current access to mifepristone will, for now, remain the same, it’s critical this decision is quickly appealed and that we win this case.”

Oregon Democratic Sen. Ron Wyden said in a written statement that any “effort to restrict access to safe and effective abortion medication is nothing more than a political ploy to control women’s bodies.”

“The science is clear and a wealth of evidence demonstrates the drug’s safety and efficacy, which is why the FDA approved it more than 20 years ago,” Wyden said. “In fact, mifepristone has fewer complications than Tylenol.”

New Jersey Democratic Sen. Bob Menendez said in a written statement that the 5th Circuit’s ruling “is yet another affront to basic reproductive rights in our country.”

“While access to mifepristone remains the law of the land for now, this misguided decision is setting up this case for the right-wing Supreme Court majority to further erode the freedom to choose for millions of women across the nation,” Menendez said. “This all-out assault on women’s reproductive health care is shameful and only proves one thing: Republican officials at virtually every level of government will stop at nothing to abolish the right to choose nationwide.”