Anti-abortion organizations urge U.S. Supreme Court to keep limits on abortion pill

WASHINGTON — Anti-abortion medical organizations on Tuesday urged the U.S. Supreme Court to maintain a lower court ruling that would push prescribing and administration of the abortion pill back to pre-2016 instructions, ending mail orders, while an ongoing legal case works through the appeals process. 

Meanwhile, more members of Congress lined up on either side of the ruling, with 23 Republican senators and 124 members of the House drafting a brief that supported anti-abortion organizations’ efforts. Among Democrats, 50 senators and 203 House members backed the U.S. Food and Drug Administration’s approval more than two decades ago. 

A decision is expected by midnight Wednesday by the high court.

Alliance Defending Freedom, leading the anti-abortion groups, argued in its 59-page brief against the federal government’s request for the Supreme Court to keep access to mifepristone exactly as it is now while the case works through the judicial process. 

ADF’s legal team wrote that the federal government’s request calls on the Supreme Court “to plunge prematurely into ongoing lower court proceedings that, at present, merely reinstate a status quo that governed without issue for 16 years.”

Alliance Defending Freedom wrote the Department of Justice’s request “comes with a heavy burden” and that “only ‘rarely’ is such extraordinary relief warranted.”

Earlier, the U.S. solicitor general wrote in the Department of Justice appeal to the Supreme Court that allowing lower courts’ rulings to take effect would “create significant chaos for patients, prescribers, and the health care delivery system.” 

The federal government, in its appeal, argued in support of the FDA’s medical and scientific authority in approving pharmaceuticals as well as on the safety and efficacy of mifepristone. 

Suit filed in 2022

ADF filed the lawsuit in mid-November on behalf of four anti-abortion medical organizations and four anti-abortion doctors.

The suit challenged mifepristone’s safety, a claim rejected by numerous medical organizations, as well as the way the FDA approved the medication. 

The case called on the judge to overturn the FDA’s 2000 approval of the medication.  

Judge Matthew Kacsmaryk in the U.S. District Court for the Northern District of Texas did just that earlier this month and the federal government quickly appealed that decision to the 5th Circuit Court of Appeals in New Orleans. 

The Department of Justice then asked the 5th Circuit to put the Texas judge’s ruling on hold while the case worked its way through the appeals process. 

The 5th Circuit did place the Texas ruling on hold to a degree, but the three-judge panel ruled that the prescribing and administration of mifepristone should revert to how it was used before changes were made in 2016 and 2021. 

The 2016 changes:

• Increased when mifepristone could be used during a pregnancy from seven weeks to 10 weeks. 
• Allowed health care professionals with the authority to prescribe medication the ability to do that instead of only doctors.
• Reduced the number of in-person visits from three to one.
• Eliminated the requirement for all adverse events to be reported to the FDA. 

The dosing and timing of the two-drug regimen that includes misoprostol as the second pharmaceutical also have changed since 2016.

The 2021 changes allowed for prescribing via telehealth and for mifepristone to be shipped through the mail. 

Appeal to Supreme Court

The U.S. Department of Justice and Danco Laboratories, the manufacturer of the name-brand version of mifepristone, both appealed the 5th Circuit’s partial stay of the Texas judge’s ruling to the Supreme Court. They urged the justices to keep access to mifepristone as it is now while the appeals process plays out. 

Justice Samuel Alito on Friday put a short-term stay in place, keeping access to mifepristone intact until Wednesday at midnight. Alito called for briefs in the case to be filed by noon Tuesday. 

In Alliance Defending Freedom’s brief to the Supreme Court, its legal team argued the 2016 and 2021 changes “removed critical safeguards on mifepristone’s use” and urged the justices to keep the 5th Circuit’s ruling intact throughout the appeals process. 

That would eliminate the generic version of mifepristone from the market and require Danco Laboratories to update its labeling to comply with what was in place before 2016, according to briefs filed with the Supreme Court by Danco and GenBioPro, Inc., the manufacturer of the generic version. 

Eastern District of Washington ruling

ADF’s attorneys rejected the argument from the federal government that a ruling from the U.S. District Court for the Eastern District of Washington state creates a conflict within the court system over access to mifepristone. 

That federal district court judge ruled the FDA could not alter access to mifepristone in 17 states and Washington, D.C., just minutes after the Texas federal district court judge issued his nationwide order staying the FDA’s 2000 approval of mifepristone. 

While the federal government has appealed the Texas judge’s ruling and asked the Supreme Court to intervene to alter the 5th Circuit’s stay, ADF attorneys wrote, “it has not lifted a finger to relieve itself of the purported ‘conflict’” from the Washington ruling. 

“The agency no doubt has political preferences that motivate that decision, but it is hardly this Court’s job to fix a conflict that has not yet manifested itself and before FDA has even tried to exhaust its lower-court remedies,” ADF lawyers wrote. 

ADF also rejected the federal government’s claim that women seeking to end pregnancies with medication abortion would be harmed by the 5th Circuit’s ruling, writing they were not applicants in the stay. 

“More important, as noted above and below, the harm runs the opposite way — removing safety protections like in-person doctor visits (including the possibility of an ultrasound) and mandatory reporting of adverse events causes greater harm to women than alternatives,” ADF wrote. 

Members of Congress heard from

As members of Congress weighed in with the Supreme Court, Democrats urged the justices to keep access to mifepristone intact and Republicans argued the FDA erred when it approved the medication more than two decades ago. 

The GOP brief, signed by 23 senators and 124 House members, included more than double the 69 lawmakers who backed the brief Republicans filed earlier with the 5th Circuit.

Top-ranking Republicans like Senate Republican Whip John Thune of South Dakota, Senate Republican Conference Chair John Barrasso of Wyoming, House Majority Leader Steve Scalise of Louisiana and House Republican Conference Chair Elise Stefanik of New York all joined in on the brief to the Supreme Court.

Senate Minority Leader Mitch McConnell of Kentucky and Speaker Kevin McCarthy of California were not included in the list of supporting lawmakers. 

The Democrats’ brief, supported by 50 senators and 203 House members, included 13 more supporters than the brief filed with the appeals court. 

Democrats wrote in their brief that the Texas judge’s ruling to stay the FDA’s 2000 approval of mifepristone “has no basis in law, threatens the Congressionally mandated drug approval process, and poses a serious health risk to pregnant individuals by making abortion more difficult to access — when access has already been seriously eroded in the aftermath of Dobbs v. Jackson Women’s Health Organization.

The GOP lawmakers argued, “FDA’s unlawful deregulation of chemical abortion drugs subverts Congress’ public policy considerations and safeguards for patient safety.”

Republicans expressed concern in their brief that “intimate partners, family members, and sex traffickers may be asserting reproductive control over the woman, which are ‘actions that interfere with a woman’s reproductive intentions.’”

“In the context of abortion, reproductive control not only produces coerced abortions or continued pregnancies, but it also affects whether the pregnancy was intended in the first place,” they wrote. “Reproductive control is a prevalent issue for women.”