The supreme court is poised to decide whether to preserve access to a widely used abortion medication, after extending its deadline to act until at least Friday.
Less than a year after the court’s conservative majority overturned Roe v Wade and eliminated a constitutional right to an abortion, the justices are now reviewing new legal questions raised by an escalating case in Texas with potentially sweeping implications for women’s reproductive health and the federal drug approval process.
For now, the court is not weighing the merits of a legal challenge brought by abortion opponents seeking to suspend the Food and Drug Administration’s 23-year-old approval of mifepristone. At issue before the court is whether to allow restrictions on the drug imposed by a lower court that would sharply limit access to the drug, including in states where abortion remains legal.
The court had initially set a deadline of 11.59pm on Wednesday, but that afternoon, Justice Samuel Alito issued a brief order extending its stay by up to 48 hours. The one-sentence order provided no explanation for the delay but indicated the court expects to act before midnight on Friday.
The legal controversy erupted in Texas, where US district judge Matthew Kacsmaryk issued a ruling earlier this month that would revoke the FDA’s approval of mifepristone, a drug first approved more than two decades ago and used by more than 5 million women – in combination with a second pill, misoprostol – to terminate their pregnancies.
The Biden administration immediately appealed the order, which it assailed as an unprecedented attack on the the FDA’s decision-making. The US court of appeals for the fifth circuit then temporarily blocked the Texas decision, declining to suspend the FDA’s approval of mifepristone while the legal case plays out. But, in a partial victory for the challengers, it reinstated regulatory barriers taken by the FDA since 2016 that loosened restrictions on the pill.
The appeals court has scheduled oral arguments in the case on 17 May.
The Biden administration and drugmakers next asked the supreme court to pause the lower court’s ruling, arguing that reimposing the barriers would create chaos in the marketplace and cause confusion for providers and patients.
Alliance Defending Freedom, a coalition of anti-abortion doctors and organizations, has argued that the FDA failed to follow proper protocols and adequately assess safety concerns when it approved mifepristone for use in 2000 and in the regulatory actions it has taken since. Medical experts have said the claims are dubious and ignore decades of research and data from hundreds of medical studies showing mifepristone is both a safe and an effective way to end a pregnancy.
The challengers filed their lawsuit in Amarillo, where Kacsmaryk, a Trump appointee and a former attorney at Christian law group with long-held conservative views on gender and reproductive rights, is the only sitting judge.
Complicating the legal landscape, on the same day that Kacsmaryk ruled, a federal judge in Washington state, Thomas Rice, issued a contradictory order in a separate lawsuit brought by Democratic attorneys general in 17 states and the District of Columbia. The decision, which Rice reaffirmed after the appeals ruling in the Texas case, blocked the FDA from limiting the availability of mifepristone in those states.
Since the fall of Roe, more than a dozen US states have banned or severely restricted abortion. But many other states have moved in the opposite direction, passing legislation and approving ballot initiatives that protect abortion rights. Amid the patchwork legal landscape, attention has turned to medication abortion, which can be obtained by mail and administered at home.
Mifepristone is the first pill in a two-drug regimen that is the most common method of ending a pregnancy, accounting for more than half of all abortions in the US.
The drug first won FDA approval in 2000, and over the years the agency has loosened restrictions on its use. Those changes include allowing the drug’s use from seven to 10 weeks of pregnancy, lowering the dosage of mifepristone needed to safely end a pregnancy, allowing the pills to be delivered by mail, eliminating the in-person doctors visit requirement and approving a generic version.
Depending on how the justices rule, those changes could be reversed, at least while the case proceeds through the courts. On Wednesday, GenBioPro, the manufacturer of the generic form of mifepristone, sued the FDA to keep the drug on the market, setting up a new front in the legal battle over access to abortion medication.
