The Biden administration petitioned the Supreme Court on Tuesday to protect widespread access to the substance most widely used for medication abortions, claiming that decreasing its availability would hurt women throughout the country.
Both the government and the pharmaceutical Danco submitted papers defending key Food and Drug government actions, including making the mifepristone tablet available by mail. Danco manufactures the pill under the brand name Mifeprex.
“The loss of access to mifepristone would be detrimental to women and healthcare providers across the country,” Solicitor General Elizabeth Prelogar stated in the government’s brief.
“Mifepristone is the most effective way for many people to legally terminate their early pregnancies. They may select mifepristone over surgical abortion due to medical need, privacy concerns, or previous trauma,” she said.
Prelogar stated that the FDA approvals were based not just on scientific research, but also on “decades of safe use of mifepristone by millions of women in the United States and around the world.”
Oral arguments are not yet planned. They are scheduled to be held in early spring, with a decision likely by the end of June.
A group of doctors and other medical professionals represented by the conservative Christian legal organization Alliance Defending Freedom filed a challenge to the approval of mifepristone. They claim that the FDA’s 2000 approval, as well as subsequent decisions that made the medicine more accessible, were incorrect, in part because they failed to consider women’s safety concerns. According to the FDA and Danco, major side effects are “exceedingly rare.”
Lawyers for Danco argued in a separate brief that the questions posed in the case “are not hard under existing precedent” and “do not ask the court to wade into a politically charged debate around abortion.”
The appeals court decision under consideration “threatens to destabilize the pharmaceutical industry, which relies both on the FDA’s ability to make predictive judgments and on courts not second-guessing those scientific judgments,” the attorneys argued.
The challengers will submit their briefs in the coming weeks.
The justices already intervened in April, blocking in full a ruling by U.S. District Court Judge Matthew Kacsmaryk in Texas that overturned the FDA’s original clearance of the medicine more than 20 years ago. At the time, conservative justices Clarence Thomas and Samuel Alito stated that they would have permitted some of his rulings to take effect.
Kacsmaryk’s judgment endangered access to the medication, including postal delivery, but the Supreme Court injunction ensured that it remained available as usual while the dispute was ongoing.
Since the Supreme Court’s action in April, the case has progressed through the appeals process, and the scope has narrowed slightly to focus on later FDA decisions that relaxed limits rather than the original 2000 decision to authorize the pill.
When the court agreed last month to hear the Biden administration and Danco challenges, it denied a second petition to challenge the 2000 clearance.
The Supreme Court will focus on FDA moves from 2016 onward that made it easier to obtain the tablet, including the initial 2021 decision to make it available by mail, which was formalized last year.
The 2016 decision to expand the window in which mifepristone might be used to terminate pregnancies from seven to ten weeks gestation and to cut the number of in-person consultations for patients from three to one is also being reviewed. In another 2016 action, the FDA changed the dosage schedule, determining that a lower amount of mifepristone was enough.
In a related development in the case, three Republican state attorneys general attempted to intervene in support of the challenge. The state officials, who represent Missouri, Idaho, and Kansas, are attempting to calm fears that the initial plaintiffs had legal standing to suit, an argument Prelogar advanced in her brief.
The standing issue is essential because, in one possibility, the court may simply reject the case on those grounds, avoiding having to consider the substantial concerns of FDA clearance.
If the court allows the states to participate, the standing issue will be resolved, according to the state attorneys general’s court brief.
The FDA-approved pharmaceutical abortion regimen includes two drugs: mifepristone, which inhibits the hormone progesterone, and misoprostol, which causes contractions. The majority of abortions in the United States are performed with tablets.
The mifepristone case is one of two abortion cases before the court.
In the second case, the court will rule whether a section of Idaho law that might penalize doctors who perform abortions in emergency cases contradicts with a federal regulation governing medical care standards that applies to any hospital that gets federal financing through Medicare.