First things first, that lawless ruling from the wingnut Texas judge has been appealed.
The U.S. Justice Department on Monday asked a federal appeals court to keep the abortion pill mifepristone on the U.S. market as litigation plays out, days after a federal judge suspended the Food and Drug Administration’s approval of the medication nationwide.
The DOJ asked the U.S. 5th Circuit Court of Appeals to block U.S. Judge Matthew Kacsmaryk’s unprecedented decision from taking effect. The U.S. government’s lawyers said “there is no basis for extraordinary nationwide relief that would upend a decades-long status quo.”
“If allowed to take effect, that order will irreparably harm patients, healthcare systems, and businesses,” the Justice Department lawyers wrote in a court filing.
Kacsmaryk of the U.S. Northern District of Texas said Friday that his decision to suspend the FDA approval of mifepristone would not go into effect for seven days so mifepristone distributor Danco Laboratories and the Biden administration had time to appeal.
“The Court should immediately extend the administrative stay and then stay the district court’s order pending appeal,” the Justice Department lawyers told the 5th Circuit.
Danco will likely ask the Supreme Court to intervene if the 5th Circuit does not grant the request to halt Kacsmaryk’s decision from taking effect, the company’s attorney Jessica Ellsworth said.
“I anticipate that if the Fifth Circuit does not grant a stay or at least an administrative stay, which is sort of a short term stay so it has time to consider the stay request in an orderly fashion, either Danco and or the United States will ask the U.S. Supreme Court for a stay,” Ellsworth said during a call with reporters on Monday.
When asked whether Danco will stop distributing mifepristone if Kacsmaryk’s decision takes effect this Friday, Ellsworth said the company will consult with the FDA about how to proceed.
“I think there will be some difficult questions that Danco needs to address and some conversations that it will need to have with FDA around what happens next,” Ellsworth said.
See here and here for the background. In theory, there should be an answer soon on this. In the meantime, the Justice Department has also asked for a clarification from the judge who issued the other ruling.
Eastern District of Washington Judge Thomas Rice ruled Friday that the Food and Drug Administration (FDA) has to maintain the “status quo” in keeping the drug available for the states involved in the case. A coalition of Democratic attorneys general had filed suit to lift some of the long-time restrictions that make mifepristone singularly hard to access, and which the medical community has long opposed as political and not medical in nature.
Minutes before, Judge Matthew Kacsmaryk out of the northern district of Texas stayed the FDA’s approval of the drug nationwide (a ruling that will go into effect after a seven-day delay). The two decisions were forced into conflict, and the issue will likely reach the Supreme Court.
On Monday, the government lawyers involved in the Washington case — where they oppose the bid to get the FDA to lift all of mifepristone’s restrictions — asked the judge for clarification.
“The result of that order appears to be in significant tension with this Court’s order prohibiting FDA from ‘altering the status quo and rights as it relates to the availability of Mifepristone’ in Plaintiff States,” the lawyers write of Kacsmaryk’s decision. “The Court did not address the interaction between the two orders, presumably because they were issued less than 20 minutes apart. To ensure that Defendants comply with all court orders in these unusual circumstances, Defendants respectfully request that this Court clarify their obligations under its preliminary injunction in the event that the Alliance order takes effect and stays the approval of mifepristone.”
The technical legal term for this situation is “clusterfuck”. Don’t ask me how I know these things, I just do. As for what the administration may do if the Fifth Circuit does its usual Fifth Circuit bullshit, they say they will not ignore the wingnut ruling despite some calls for them to do so.
“I believe the Food and Drug Administration has the authority to ignore this ruling, which is why I’m again calling on President Biden and the FDA to do just that,” Sen. Ron Wyden (D-OR) said Friday. “The FDA, doctors, and pharmacies can and must go about their jobs like nothing has changed and keep mifepristone accessible to women across America. If they don’t, the consequences of banning the most common method of abortion in every single state will be devastating.”
Sens. Elizabeth Warren (D-MA) and Mazie Hirono (D-HI) recently appealed to the White House to use any tools at its disposal to keep the drug available, including its enforcement discretion. Rep. Alexandria Ocasio-Cortez (D-NY) also called on the administration to “ignore” the Friday decision.
The White House told TPM Monday that it will not heed those calls.
“No,” a White House spokesperson said, when asked whether it plans to ignore Kacsmaryk’s ruling, and any future decisions upholding it, and have the FDA use its enforcement discretion to leave mifepristone on the market.
“We stand by FDA’s approval of mifepristone, and we are prepared for a long legal fight, if needed,” the spokesperson continued. “The focus of the Administration is on ensuring that we prevail in the courts. There is a process in place for appealing this decision and we will pursue that process vigorously and do everything we can to prevail in the courts.”
It’s in keeping with how members of the administration have talked publicly about the case — emphasizing the judicial procedure, though not talking about what it’ll do if its attempts to go through a series of right-wing courts to retain FDA approval are unsuccessful.
[…]
Major abortion providers made it clear that at least for the duration of Kacsmaryk’s delay, nothing has changed.
“Like we said before — we follow directives from the FDA, and not anti-abortion judges in Texas who lack any formal medical training,” Whole Woman’s Health said in a tweet. “Whole Woman’s Health will continue to dispense Mife in our clinics and our Pills by Mail Program for the next week as we monitor both decisions.”
“Nothing has changed yet: medication abortions with mifepristone are still available,” Trust Women tweeted. “Now, as ever, it’s critically important to support your local abortion funds and clinics, and contact your legislators and demand that mife remains legal health care.”
It should be noted that “not ignoring the wingnut decision” does not mean pulling mifepristone off the shelves:
If the FDA uses its enforcement discretion, what it is doing is recognizing that approval is stayed, not ignoring it. In the face of a drug with stayed approval, the FDA is saying we are assessing what drugs are unsafe and risky, and going after those, not mifepristone. /2
— David S. Cohen (@dsc250) 9:39 AM – 10 April 2023
To be clear, we may get to the point of needing to ignore the court. I’m not against that if extreme situations dictate. But Kacsmaryk did NOT order FDA or Danco to do anything. Making his order into something it isn’t gives him too much power and us, Biden, & FDA too little. /4
— David S. Cohen (@dsc250) 9:42 AM – 10 April 2023
PS. Think of it this way: which is the Biden FDA more likely to do? Ignore a court or use a long-recognized legal option supported by unanimous Supreme Court authority? Language matters here!
— David S. Cohen (@dsc250) 10:00 AM – 10 April 2023
Something to think about. Finally, while it’s highly unlikely to get anywhere, there is a legislative solution out there.
Democratic lawmakers are mobilizing in the wake of the decision in Texas that threw access to the so-called abortion pill into flux Friday, introducing legislation Monday to protect access to the most widely used form of abortion in the U.S.
Reps. Pat Ryan of New York and Lizzie Fletcher of Texas will introduce the Protecting Reproductive Freedom Act on Monday during a pro forma session of the House, seeking to reaffirm the Food and Drug Administration’s final approval authority on medication abortion and continue to allow providers to prescribe the abortion pill via telehealth, which was widely expanded during the coronavirus pandemic.
“The Texas decision has nothing to do with science or medicine and everything to do with radical groups whose only goal is a national abortion ban,” said Ryan, who credits wins in his swing district in New York state in part to his stance on abortion rights. “My priority is protecting abortion access for women in New York and across the country.”
Fletcher, who called her state, Texas, “the epicenter of attacks on the health and freedom of Americans,” said “the unprecedented district court decision, which, if enforced, would be devastating to women and families across our country and to our established drug-approval system.”
It’s yet another move from congressional Democrats to send a message about the issue of reproductive access, despite the unlikelihood that the legislation will ever pass the GOP-controlled House. Nevertheless, Democrats will continue to keep the focus on abortion access — especially after having seen its power across the country in the 2022 midterms.
There’s basically no chance that this bill will see the light of day in the Republican-controlled House. As a messaging effort, it can be effective. Everyone has to make it clear what is being voted on next year. Daily Kos and The 19th have more.
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