The appeals court can rule on the dispute at any time

The Justice Department and a manufacturer of abortion pills asked for an appeals court to freeze a federal judge’s decision to suspend the approval of mifepristone

The Justice Department and a manufacturer of abortion pills have submitted the final round of court briefs in the emergency dispute over whether an appeals court should freeze a judge’s ruling that would suspend the Food and Drug Administration’s approval of medication abortion drugs.

Kacsmaryk on Friday night said he was halting the FDA’s approval of the drug mifepristone but that he was delaying the order by seven days to give the pill’s defenders time to appeal the case. The Justice Department has asked the appeals court to act by 12 p.m. CT Thursday on its request that Kacsmaryk’s ruling be paused, to give the government time to seek a Supreme Court intervention if need be. The 5th Circuit is not obligated to meet that deadline.

The anti-abortion doctors defended Kacsmaryk’s ruling called it a “meticulously considered” ruling that “paints an alarming picture of decades-long agency lawlessness – all to the detriment of the women and girls FDA is charged to protect.”

Mifepristone has been approved by the FDA for terminating pregnancies for nearly 23 years. Leading medical associations rebuked the claims by the legal challengers and judge that the drug is unsafe.

“Specifically, this NPRM proposes to strengthen privacy protections by prohibiting the use or disclosure of protected health information by regulated entities, such as health insurance plans, providers and others, specifically for a criminal, civil or administrative investigation into proceeding against a person in connection with seeking, obtaining, providing or facilitating reproductive health care where such health care is lawful under the circumstances in which it was provided,” a senior administration official said.

The new rule proposal comes as Vice President Kamala Harris is set to convene an interagency taskforce meeting on reproductive rights at the White House. The Attorney General and the Secretary of Health and Human Services will attend.

In a call with reporters, senior administration officials previewed the notice of proposed rulemaking from the Biden administration, issued in response to a Texas federal judge’s ruling late last week to suspend the US Food and Drug Administration’s approval of medication abortion drug mifepristone.

The senior administration official said that it was a step further from the guidance they had given in the wake of the Supreme Court ruling. The current guidance, still in effect, protects HIPAA privacy rights by not requiring the disclosure of patient information under certain circumstances. Some providers would still be afraid of being subpoenaed because of the guidance they were told to follow.

This proposed rule, they said, providers further cover “to not provide that information, if it’s not for the specific purpose articulated in the role.”

The US Department of Education gave guidance to over 20,000 school officials to remind them about their obligations to student privacy, according to a statement from the White House.

White House Dialogue with Abortion: Implications of the Texas High Court Decision on Medication Absorption and the Supreme Court of Appeals

A separate and conflicting abortion pill ruling in Washington on the same day, created arguably the most contentious and chaotic legal flashpoint over abortion access since last summer.

The Texas ruling sparked a new scramble from administration officials, who were bracing for it to come down and convened behind closed doors to make a response. After the decision dropped Friday, a senior administration official said the White House immediately began engaging allies on the next steps.

“We’ve had very close contact with the Hill with members both in the House and the Senate, and staff, with groups who are focused on abortion, women’s groups, health care providers,” a second senior official told CNN. We have been in close contact with allies on the state level. And we will continue to do all of that.”

“The vice president will also point out that this unprecedented decision is not only an attack on women’s freedom to make decisions about her own body, but it also threatens our nation’s system of drug approvals and the rights of Americans across the country who expect that a medication approved by the FDA and prescribed by their doctor will be available to them when they need it,” the official continued.

Harris has led the administration’s response on abortion rights. Since the Supreme Court legalized abortion, she has hosted dozens of Roundtable discussions on reproductive rights, including contraception and medication abortion, and met with legislators across the country.

A federal appeals court late Wednesday night froze parts of a Texas judge’s order that would have suspended the US Food and Drug Administration’s approval of a medication abortion drug.

However, the US 5th Circuit Court of Appeals is leaving in place parts of the ruling that halted changes the FDA made to the rules around the drug that expanded access to medication abortion pills. Those changes include the FDA’s end of the requirement that mifepristone be picked up in person, the agency’s approval of a generic version of the drug, and adjustments the FDA made to the label instructions for the drug’s use.

The Supreme Court last year overturned the previous precedent that protected abortion rights nationwide, prompting a renewed debate about the legality of medication abortion.

It is unclear if the Justice Department or the drug manufacturer, Danco Laboratories, will ask the Supreme Court to intervene at this point. The DOJ said it would go to the high court if the 5th Circuit did not act by Thursday.

Two Donald Trump nominees handed down the appellate order, as did a George W. Bush nominee. Haynes, however, did not sign on to some aspects of the order.

Part of the 5th Circuit order was dedicated to analyzing procedural issues in bringing a case. The appeals court was sympathetic to part of the plaintiffs’ allegations that the drug has serious safety issues.