Tag: unchanged

The appeals court ruling — if it takes effect — would suspend several policies the FDA has approved since 2016 to make mifepristone more accessible, including telemedicine prescription, mail delivery and retail pharmacy dispensing. The ruling also would suspend approval of the generic version of the drug and would narrow the window of time the drug can be prescribed from 10 to seven weeks of pregnancy — though off-label prescription after seven weeks would still be possible. The Biden administration warned the court in its Friday petition that letting these changes move forward would wreak “regulatory chaos” nationwide and harm patients.

The ruling had been scheduled to take effect on Saturday. But it is now temporarily frozen by Alito’s interim orders — known as administrative stays — keeping everything on hold until next Wednesday night while the justices receive further briefing and decide whether to issue a longer stay.

The anti-abortion medical groups challenging the pill’s approval have until noon on Tuesday to file responses. In a statement Friday, their attorney, Alliance Defending Freedom Senior Counsel Erin Hawley, called Alito’s stay orders “standard operating procedure” that would give justices “sufficient time to consider the parties’ arguments before ruling.”

Alito’s move maintains for now the current national patchwork of abortion access, with near-total bans on all forms of abortion in many red states and broad access to both medication abortion and surgical abortion in blue states.

Alito, a George W. Bush appointee who wrote the court’s decision last year overturning Roe v. Wade and allowing a wave of GOP-led states to impose abortion bans, single-handedly issued the administrative stays on Friday because all emergency appeals from the 5th Circuit are initially directed to him. As is customary with interim orders, he did not elaborate on why he granted the temporary relief. But administrative stays are typically intended only to buy the court time in fast-moving litigation and do not foreshadow the justices’ substantive views.

The FDA did not immediately comment on the stay orders or how the agency plans to enforce the restrictions if the high court allows them to go into effect.

Abortion rights groups cheered the stay orders and vowed to keep pressing the court to permanently halt the looming restrictions on the drug. Anti-abortion groups called them disappointing, with one group, Students for Life, accusing the Supreme Court of “playing politics.”

The legal battle over mifepristone escalated last week when a federal district judge in Texas, Matthew Kacsmaryk, issued an order suspending the approval of mifepristone nationwide and halting the various moves FDA has made since 2016 to broaden access to the drug.

On Wednesday, a panel of the New Orleans-based 5th Circuit issued a 2-1 ruling putting a hold on the portion of the lower judge’s order that suspended the drug’s approval but allowing the rest of his decision to kick in on Saturday.

That prompted the Justice Department and Danco, which makes the brand-name version of mifepristone, to turn to the high court for relief. They said that even the 5th Circuit panel’s approach – leaving the drug approved but rolling back expanded access in recent years – would be highly disruptive and could force the company to stop selling and distributing the drug for months.

Adding to the turmoil is a separate ruling from a federal judge in Washington state, who last week ordered the FDA not to permit any new restrictions on access to mifepristone in 17 states and the District of Columbia.