The Biden administration appealed to the US supreme court on Friday asking it to halt an appellate ruling that adds onerous restrictions to a key abortion drug. The restrictions were slated to go into effect at 12.01am on Saturday morning.
The ruling at the center of the emergency application to the high court was issued on Wednesday night by the fifth circuit court of appeals. The US Department of Justice had asked the appeals court to block a lower court order revoking the Food and Drug Administration’s (FDA) approval of mifepristone in 2000.
The Louisiana-based appellate court – considered one of the most conservative in the US – blocked part of that order, but allowed other parts to stand, and temporarily reimposed restrictions on the drug that the FDA had lifted starting in 2016.
“If allowed to take effect, the lower courts’ orders would thwart FDA’s scientific judgment and undermine widespread reliance in a healthcare system that assumes the availability of mifepristone as an alternative to more burdensome and invasive surgical abortions,” wrote the solicitor general, Elizabeth Prelogar, in the filing.
According to the restrictions reinstated by the fifth circuit, the drug can only be taken up to seven weeks of pregnancy, rather than the current 10-week limit. It also cannot be delivered through the mail and must be dispensed in-person. These limitations roll back a number of FDA actions taken in recent years that have significantly widened access to medication abortion, the most common method of abortion care in the US. The judges who signed the order point to safety concerns raised by anti-abortion groups, despite numerous agency and academic studies that have found mifepristone to be extremely safe.
The justice department urged the high court to swiftly and fully block ruling while the case proceeds. Given the “profound disruption and grave harm” the mifepristone orders would create, writes the justice department, the supreme court should ultimately stay the ruling after a full review of the case’s merits.
“If allowed to take effect, the lower courts’ orders would upend the regulatory regime for mifepristone, with sweeping consequences for the pharmaceutical industry, women who need access to the drug, and FDA’s ability to implement its statutory authority,” wrote Prelogar.
The Department of Justice has appealed to Justice Samuel Alito, who is in charge of hearing emergency appeals from the fifth Circuit, and who authored last year’s decision overturning the constitutional right to abortion in the US, which has ushered in full or partial abortion bans in more than a dozen states.
The supreme court is widely expected to take up the case, in part because of a ruling from a Washington state district court that conflicts with the decisions out of Texas and Louisiana. The Washington ruling orders the FDA to maintain the status quo for the drug in 17 states and the District of Columbia. The FDA faces an “obvious threat of irreparable harm” from conflicting court orders, the justice department writes.
The mifepristone drug manufacturer, Danco, also appealed to the supreme court for intervention on Friday, pointing to the “regulatory chaos” that would be unleashed if limitations on the drug went into effect. The result of dueling federal court orders creates an “untenable limbo, for Danco, for providers, for women, and for healthcare systems all trying to navigate these uncharted waters”, the drug company writes, arguing that casting doubt on the FDA approvals process would create a dangerous precedent for the drug market broadly.
“This is a dark day for public health, especially for reproductive rights and the reliance on science and medical expertise to guide decisions about what drugs are safe and effective and should be available to patients,” said Abby Long, Danco’s director of public affairs, in a statement.
If the supreme court does not act, write justice department lawyers, the “resulting disruption would deny women lawful access to a drug FDA deemed a safe and effective alternative to invasive surgical abortion”.
