FDA advisors recommend that new Covid vaccines target an omicron XBB variant this fall

A woman receives a booster dose of the Moderna coronavirus disease (COVID-19) vaccine at a vaccination centre in Antwerp, Belgium, February 1, 2022.

Johanna Geron | Reuters

The U.S. Food and Drug Administration‘s independent panel of advisors on Thursday recommended that updated Covid shots for the fall and winter target one of the XBB variants, which are now the dominant strains of the virus nationwide. 

The committee unanimously voted that the new jabs should be monovalent — meaning they are designed to protect against one variant of Covid — and target a member of the XBB family.

Those strains of Covid are descendants of the omicron variant, which caused cases to surge to record levels early last year. They are some of the most immune-evasive strains to date.

Advisors also generally agreed that the new shots should specifically target a variant called XBB.1.5. The panel only discussed that specific strain selection and did not vote on the matter.

XBB.1.5 accounted for nearly 40% of all Covid cases in the U.S. as of early June, according to data from the Centers for Disease Control and Prevention. That proportion is slowly declining, and cases of the related XBB.1.16 and XBB.2.3 variants are on the rise. 

Advisors noted that XBB.1.5 appears most ideal for the fall since vaccine manufacturers Pfizer, Moderna and Novavax have already started to develop jabs targeting the strain.

“The 1.5 looks good. It seems like it’s the most feasible to get across the finish line early without resulting in delays and availability,” said Dr. Melinda Wharton, a senior official at the National Center for Immunization and Respiratory Diseases. “The vaccine we can use is the vaccine that we can get. And so it feels like this would be a good choice.”

The FDA typically follows the advice of its advisory committees, but is not required to do so. It’s unclear when the agency will make a final decision on strain selection.

There is also uncertainty about which age groups the FDA and CDC will advise to receive the updated shots this fall.

But the panel’s recommendation is already a win for Pfizer, Moderna and Novavax — all of which have been conducting early trials on their respective XBB.1.5 shots ahead of the meeting.

“Novavax expects to be ready for the commercial delivery of a protein-based monovalent XBB COVID vaccine this fall in line with today’s [advisory committee] recommendation,” said John Jacobs, the company’s president and CEO.

The U.S. is expected to shift vaccine distribution to the private sector this fall. That means the vaccine makers will start selling their new Covid products directly to health-care providers and vie for commercial market share. 

The panel’s recommendation coincides with a broader shift in how the pandemic impacts the country and the world at large. 

Covid cases and deaths have dropped to new lows, governments have rolled back stringent health mandates like masking and social distancing and many people believe the pandemic is over altogether.  

But Dr. Peter Marks, head of the FDA’s vaccine division, said the agency is concerned that the U.S. will have another Covid wave “during a time when the virus has further evolved, immunity of the population has waned further and we move indoors for wintertime.”

Updated Covid vaccines that are periodically updated to target a high circulating variant will restore protective immunity against the virus, said Dr. David Kaslow, a senior official in the FDA’s vaccine division. 

It’s a similar approach to how the strains are selected for the annual flu shot. Researchers assess strains of the virus in circulation and estimate which will be the most prevalent during the upcoming fall and winter.

But it’s unclear how many Americans will roll up their sleeves to take the updated shots later this year. 

Only about 17% of the U.S. population — around 56 million people —have received Pfizer and Moderna’s boosters since they were approved in September, according to the CDC.

More than 40% of adults 65 and older have been boosted with those shots, while the rate among younger adults and children ranges between 18% and 20%.

Those boosters were bivalent, meaning they targeted the original strain of Covid and the omicron subvariants BA.4 and BA.5. 

Pfizer, Moderna and Novavax shot data

During the meeting, Pfizer, Moderna and Novavax presented preliminary data on updated versions of their shots designed to target XBB variants. 

Moderna has been evaluating shots targeting XBB.1.5 and XBB.1.16 — another transmissible omicron descendant, according to Rituparna Das, the company’s vice president of Covid vaccines. 

Preclinical trial data on mice suggests that a monovalent vaccine targeting XBB.1.5 produces a more robust immune response against the currently circulating XBB variants than the authorized bivalent shot targeting BA.4 and BA.5, according to Das. 

She added that clinical trial data on more than 100 people similarly demonstrates that the monovalent XBB.1.5 vaccine produces protective antibodies against all XBB variants. All trial participants had previously received four Covid vaccine doses.

Das said that comprehensive protection against XBB strains is likely due to the fewer unique mutations between the variants, which means their composition is similar.

There are only three unique mutations between the variants XBB.1.5 and XBB.1.16, according to Darin Edwards, Moderna’s Covid vaccine program leader. By comparison, there are 28 mutations between omicron BA.4 and BA.5.

That means the immune response an updated shot produces against XBB variants will likely be similar, regardless of which specific variant it targets, Edwards said.

Pfizer also presented early trial data indicating that a monovalent vaccine targeting an XBB variant offers improved immune responses against the XBB family. 

The company provided specific timelines for delivering an updated vaccine, depending on the strain the FDA selects. 

Pfizer will be able to deliver a monovalent shot targeting XBB.1.5 by July and a jab targeting XBB.1.16 by August, according to Kena Swanson, the company’s senior principal scientist.

Pfizer won’t be able to distribute a new shot until October if the FDA chooses a completely different strain, Swanson said.

Novavax did not provide a specific timeline for delivering a shot targeting XBB.1.5, but noted that an XBB.1.16 shot would take eight weeks longer.

Novavax unveiled preclinical trial data indicating that monovalent vaccines targeting XBB.1.5 and XBB.1.16 induce higher immune responses to XBB subvariants than bivalent vaccines do. 

Data also demonstrates that an XBB.1.5 shot produces antibodies that block XBB.2.3 from binding to and infecting human cells, according to Dr. Filip Dubovsky, Novavax’s chief medical officer.

Dubovsky said the trial results support the use of a monovalent XBB.1.5 shot in the fall.

Novavax’s jab uses protein-based technology, a decades-old method for fighting viruses used in routine vaccinations against hepatitis B and shingles.

The vaccine works differently than Pfizer’s and Moderna’s messenger RNA vaccines but achieves the same outcome: teaching your body how to fight Covid.

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You Got Your Abortion Bill In My Trans Ban!

There was a hell of a lot of news just yesterday about the ongoing effort to make sure women, children, and some men too don’t get any silly ideas about having bodily autonomy, so let’s dig right in, with the reminder that the GOP’s drive to ban abortion everywhere is hugely unpopular with everyone except the hardcore anti-abortion folks who now dominate the Gruesome Orc Party.

North Carolina: GOP Lege Overrides Veto, Passes 12-Week Ban


The Republican supermajority in both houses of the North Carolina Legislature voted Tuesday to override Democratic Gov. Roy Cooper’s recent veto, passing a ban on abortions after 12 weeks of pregnancy. The veto override wouldn’t have been possible in the state House without the party switch by state Rep. Tricia Cotham, who suddenly announced in April that she had decided to become a Republican. That move cemented a two-thirds GOP majority in the House, and now we’re sure Cotham is very happy with her 30 pieces of flair from GOP donors. Back in ancient times — i.e., January of this year — Cotham cosponsored a bill that would have codified abortion rights into state law, but honestly, who remembers January any more? We have a feeling that voters may remember Cotham’s switcheroo in 2024.

Yesterday’s vote means that there are now no states south of Virginia and east of New Mexico where abortion remains legal and relatively easy to obtain. Even inside the 12-week limit, abortions in North Carolina will require a 72-hour waiting period between an initial visit and the actual provision of abortion services, even for medical abortions using mifepristone, if it remains legal. Doctors must be present when patients take the pill as well. [Politico]

National: Appeals Court Hears Abortion Pill Ban Today

The federal appeals court in New Orleans is hearing oral arguments today in the unspeakably shoddy lawsuit to reverse the FDA’s 2000 approval of the abortion drug mifepristone. The lawsuit, custom made for Matthew Kacsmaryk, a Trump-appointed federal judge in Texas, should have been laughed out of court from the start because the plaintiffs have no plausible standing in the case, and because the alleged “scientific” evidence that the FDA wrongly approved the drug is crap, but then, that’s the Trump judiciary we have. The case is being heard in the notoriously rightwing Fifth Circuit Court of Appeals by a three-judge panel consisting of two Trump appointees and a GW Bush appointee, all of whom have histories of supporting abortion restrictions. One of the judges, Trump appointee James Ho, called abortion a “moral tragedy” in a 2018 opinion, and you just ignore the research showing that 99 percent of women who’ve had abortions continue to believe it was the right choice even several years later. They’ve all been brainwashed to rationalize their decision, you see.

In addition to the bullshit Texas case, the appeals court will also hear the case from Washington state that ruled the FDA can’t reverse its approval of mifepristone. That case has been combined with the one from Texas. In April, the Supreme Court issued a stay on enforcement of Kacsmaryk’s ruling, meaning that mifepristone will remain available at least until the Fifth Circuit rules in the case at some point following today’s arguments. Whatever the outcome, get ready for the entire shitshow of legal uncertainty to start all over again until the case eventually gets to the Supreme Court. [NBC News / AP]

Montana: Greg Gianforte Signs Abortion Restrictions Days After State Supreme Court Upholds Abortion Rights

In Montana Tuesday, Republican Gov. Greg Gianforte body-slammed reproductive freedom by signing four anti-abortion bills, which included a 12-week ban on all dilation and evacuation abortions after 15 weeks. Other restrictions signed by Gianforte will add new regulations on clinics and restrict Medicaid coverage for abortions.

As the Montana Free Press reports, Gianforte’s approval of the abortion restrictions came just days after the Montana Supreme Court

upheld a nearly 25-year-old legal precedent allowing abortion access under the state Constitution’s right to privacy. That case, Weems v. State, found that advanced practice nurse practitioners with proper training can provide abortions in Montana and reaffirmed that women have a fundamental right “to seek abortion care from a qualified health care provider of her choosing, absent a clear demonstration of a medically acknowledged, bona fide health risk.”

But then, what does the state supreme court know about state law anyway? Gianforte issued a statement saying he was “proud to round out our legislative session with another suite of pro-life, pro-family bills that protect the lives of unborn babies in Montana,” and if your family includes anyone who thinks they need an abortion, then clearly it’s not a real family.

The legislation is likely to face a legal challenge, what with the earlier state supreme court ruling. Also, as the Montana Free Press notes, the legislation

bars “dismemberment abortion,” a nonmedical term that the legislation defines in part as “the use or prescription of any instrument, medicine, drug, or other substance or device” to intentionally terminate pregnancies and the “insertion of grasping instruments” to remove a fetus.

The law includes exceptions for the treatment of ectopic pregnancies, and for “medical emergencies,” which of course can be a dicey determination that leads to delays of any treatment until a patient is close to death. Planned Parenthood of Montana immediately filed a motion in state court Tuesday to prevent the new law from being enforced. [Montana Free Press]

Nebraska: GOP Breaks Filibuster Of Anti-Trans Bill By Adding Abortion Ban, Because Why Not Oppress Everyone?

Finally, the GOP’s two most repulsive movements to restrict human freedom merged in Nebraska yesterday, as Republicans in the state’s unicameral Legislature sought to use a ban on abortion to break the three-month filibuster against the Republicans’ attempts to ban gender-affirming care for transgender minors. Democratic state Sens. Machaela Cavanaugh and Megan Hunt (who has a trans son, aged 12) have been absolute BOSSES in their ongoing efforts to kill the anti-trans bill, refusing to allow any legislation at all to move forward until Republicans dropped it. And it worked for months, until yesterday.

Independent reporter Erin Reed reports that in the latest attempt to move the anti-trans bill, LB 574, Republican state Sen. Ben Hansen amended the bill with a ban on abortions after 12 weeks. (Really 10 weeks, since pregnancy by statute “begins” with the the patient’s last missed period.) In addition, his amendment hands all authority on rules related to healthcare for trans youth to the state’s Chief Medical Officer, who of course was appointed by the Republican Gov. Jim Pillen. Says Reed,

While some may label this as a compromise, it feels like a more radical turn. It underlines the unsettling truth that the battles over gender-affirming care and abortion rights are not separate, but rather two faces of the same coin, driven by the same factions, using the same justifications to limit access to vital care.

The amendment technically drops the part of LB 574 that forbids puberty blockers and hormone therapy, instead only banning gender-affirming surgical procedures for anyone under the age of 19. That seems like a compromise, since the vast majority of trans people don’t seek surgery until after they’re adults anyway.

Oh, but then there’s the catch: By transferring all authority to set rules on gender affirming care to the state’s Chief Medical Officer, the amendment simply shifts the banning of puberty blockers and hormone treatment from the Lege to that appointed bureaucrat, Dr. Timothy Tesmer, who will almost certainly eliminate the treatments — and would also be free to add other restrictions that weren’t in the original version of LB 574. Sneaky, huh?

The amended bill moved forward last night in a procedural vote that broke the filibuster by a single vote.

Sen. Cavanaugh this morning gave a powerful speech evoking the words of Montana state Rep. Zooey Zephyr, condemning the dishonest tactics used by Republicans in forcing an end to the filibuster by combining two Republican obsessions, punishing women for having sex, and punishing trans people for existing:

“You literally have to cheat at every moment of this debate. In every possible way, you are cheating. […]

“Women will die. Children are dying. It is your fault. It is your fault! And you are allowing it to happen. You DO literally have blood on your hands, and if you vote for this you will have buckets and buckets of blood on your hands.”

After a final round of debate today, the combined measure is likely to pass — and then the fight to protect trans young people’s lives will shift to the courts. Sen. Hunt noted minutes ago on Twitter that she’s already getting death threats, but she’s not afraid. The more the bastards attack people’s rights to be themselves and to have autonomy over their own bodies, the more they will lose. She also eloquently pointed out that the Nebraska case makes clear once and for all that these are not separate issues (and for that matter, neither are the attacks on schools and libraries).

“Trans rights are directly tied to the greater fight for reproductive rights and bodily autonomy – we are all in this fight together, no one is siloed away from being impacted by the rollback of our collective rights.

“What’s happening in Nebraska is proof.”

Americans are not going to stand for this, and we all need to come together to protect our rights. Get ready for a long fight, and organize, organize, organize. We’ll close with a prayer from Rev. Molly Ivins, from her final column. She was talking about the Iraq War and George W. Bush, but it applies here, today, just as well; just substitute “women and trans kids” for “troops” and it’s right on target:

We are the people who run this country. We are the deciders. And every single day, every single one of us needs to step outside and take some action to help stop this war. Raise hell. Think of something to make the ridiculous look ridiculous. Make our troops know we’re for them. […] We need people in the streets, banging pots and pans and demanding, “Stop it, now!”

Amen.

[Erin in the Morning / Omaha World-Herald / Photo: Ted Eytan, Creative Commons License 2.0]

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Jay Inslee: Send Me Your Trans Kids And Women Needing Abortions, But Not Your AR-15s

Sometimes it’s easy to forget that Jay Inslee is still the governor of Washington, what with all the competence and the just generally not making a lot of waves. But damn, he and Democrats in the state Lege have done some good governing lately. This week, the state Senate passed a “shield law” to protect transgender people in Washington, including people fleeing the increasingly awful anti-trans laws in other states. It now goes to Inslee for his signature. That will make Washington the 10th state with a law or an executive order protecting people — especially trans minors and their families — who cross state lines to receive gender- affirming medical care.

But wait! There’s more! Like some other shield laws, Washington HB 1469 will also protect people who travel to Washington seeking abortion services, since it’s written to include both gender-affirming care and “reproductive health care services that are lawful in the state of Washington” under the umbrella of “protected healthcare services.” So it’s a twofer of protection against the most extreme laws being passed in other states.


As the indispensable indy journalist Erin Reed reports, the bill even goes a little further than some other states’ already good safe haven laws and EOs. Where some, like Minnesota’s executive order, authorize the governor to refuse extradition to other states that want to punish healthcare providers or parents for “aiding and abetting” the provision of gender-affirming care, HB 1469 actually prohibits Washington’s governor from cooperating with such requests. (That’s why a law is better than an EO — Minnesota Gov. Tim Walz can’t prevent future governors from acting against trans folks.) Here’s that bit from the Washington law:

The governor of this state shall not surrender any person described in subsection (1) of this section where the charge against the person is based on the provision, receipt, attempted provision or receipt, assistance in the provision or receipt, or attempted assistance in the provision or receipt of protected health care services as defined in section 2 of this act that are lawful in the state of Washington.

For instance, if someone is charged under Idaho’s stupid new “abortion trafficking” law, which prohibits anyone but parents from assisting a minor in getting abortion services, Washington will refuse to extradite Aunt Nora or her Subaru Outback.

Further, the law prohibits state agencies from cooperating with data requests from states investigating people for providing or using protected health services — even under subpoena from another state.

The day before Idaho Gov. Brad Little signed that “abortion trafficking” bill, Inslee sent Little a letter to very politely tell him what a shitty idea the law was. Inslee wrote,

I question the constitutionality of this law and I know you are aware of the costly legal challenges that await should you choose to sign this bill, but, as the governor of a neighboring state, I am also deeply concerned about the impacts that (Engrossed House Bill) 242 will have on Washington residents traveling to and from Idaho.

Inslee also warned Little against any attempt to punish Washington healthcare providers under the new Idaho law, which includes a bizarre provision allowing lawsuits for no less than $20,000 to be brought against medical providers on the behalf of an aborted fetus by a relative of said nonbaby. Inslee wrote,

But, make no mistake, Governor Little, the laws of another state that seek to punish anyone in Washington for lawful actions taken in Washington will not stand. We will protect our providers, and we will harbor and comfort your residents who seek health care services that are denied to them in Idaho.

Even before a federal judge in Texas cancel-cultured the decades-old FDA authorization of the abortion pill mifepristone, Inslee took steps to stockpile a four-year supply, a total of 40,000 doses. Inslee managed that with One Weird Trick, as the Seattle Times explains:

Inslee ordered the Department of Corrections, which has a pharmacy license, to buy 30,000 doses of mifepristone last month. UW Medicine also obtained 10,000 doses of the drug. Between the two entities, Inslee said, the state now has about a four-year supply. […]

State lawmakers introduced Senate Bill 5768 to authorize the Department of Corrections to sell or distribute the drug to licensed providers in Washington.

In a statement last week, Inslee called the Texas lawsuit “a clear and present danger to patients and providers” not only in Washington, but all across the US, saying that Washington is “a pro-choice state and no Texas judge will order us otherwise.”

Finally, over the weekend, the state Senate passed a ban on assault weapons that Inslee had pushed for; the bill had already been passed by the state House, but since the Senate added some amendments, it has to get final passage in the House before it goes to Inslee to be signed. The bill will ban the sale, manufacture, and import of assault weapons, but doesn’t ban their possession because that would be a whole ‘nother pile of lawsuits.

“Passing an assault weapon ban will be a momentous step forward for Washington state,” Inslee said. “Time and again, we’ve seen the carnage these weapons allow people to unleash on communities. Time and again, we’ve watched the NRA and politicians defend, normalize, and even celebrate these weapons. But now the time is here when the majority’s will prevails, and we put the lives of our children first.”

Inslee appeared on MSNBC’s “All In With Chris Hayes” last night to take several victory laps on abortion, trans rights, and guns, and to invite people to move to Washington. Enjoy the video!

youtu.be

Guest host Ali Velshi, who’s Canadian, had to get his two cents in and make a pitch for people moving to Canada, and honestly that sounds good too, especially to those of us watching from godforsaken Idaho.

[Erin in the Morning / Washington HB 1469 / Idaho Reports / Seattle Times / Jay Inslee on Substack / KIRO-TV]

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The Abortion Wars Are Back On, Thanks To Hacks Parked On The Court By Trump And McConnell

The important thing to know about a Texas court’s nationwide ban of the drug mifepristone is that it’s based on a lie. Well, to be more precise, it’s based on a whole series of lies, but one lie in particular stands out from the others … a Big Lie, if you will. That lie is about the approval process for the drug, which has been on the market since 1988 and is offered for sale in more than 80 countries.

The plaintiffs, a consortium of anti-choice groups that incorporated in Amarillo, Texas after anti-choice activist Matthew Kacsmaryk was confirmed to the only federal court in the district, stake their claims on the fact that the FDA approved mifepristone in 2000 under an emergency protocol known as Subpart H. This protocol allows lifesaving drugs to reach the market sooner and has mostly been used to fast-track AIDS drugs. In reality, mifepristone went through four years of rigorous examination before its approval. But in response to political pressure, the FDA used Subpart H to impose additional dispensing protocols known as Risk Evaluation and Mitigation Strategies or REMS.


Back in March, when the parties made their case to Judge Kacsmaryk for injunctive relief, Slate legal writer Mark Joseph Stern observed that, not only were the plaintiffs lying about the approval process, but that Kacsmaryk seemed to accept their false version of events:

This entire argument is built upon a lie. The FDA did not fast-track mifepristone in 2000. Rather, the agency took more than four years to greenlight the drug, doing so only after extensive (and arguably superfluous) examination of its (very minor) risks. When the FDA did finally approve the use of mifepristone, after an unusually thorough review, however, it imposed heightened restrictions on its distribution. It was theseextra barriers to mifepristone access that were set up through a process known as accelerated approval. The plaintiffs here exploit confusion about these procedural details to peddle the false narrative that the agency recklessly hastened review of mifepristone. It is an extremely ominous sign that Kacsmaryk appeared to agree with their false history.

And that turned out to be exactly what happened when Kacsmaryk dropped his ruling on Good Friday, a love letter to the anti-choice loons that put him on the federal bench to do just what he did. Reasoning that Subpart H is reserved for “serious or life-threatening ‘conditions,’” he ruled that it was inappropriate to use for a drug that ends pregnancy, since “Pregnancy is a normal physiological state most women experience one or more times during their childbearing years — a natural process essential to perpetuating human life.”

It’s an offensively stupid argument, in an opinion chock full of offensively stupid arguments and outright lies about the dangerousness of the drug, which has almost no risk of side effects. For instance, Kacsmaryk presents a bevy of reasons that the six-year statute of limitations on FDA challenges does not apply. Perhaps the government ignored the plaintiff’s administrative challenges (it did not); perhaps the REMS modification in 2016 or the approval of a generic version of the drug in 2021 restarted the clock; perhaps any administrative challenge would have been futile; or maybe you can ignore the plain meaning of the law under the doctrine of equitable tolling, AKA “vibes, man.” In any case, Kacsmaryk deems it wholly appropriate for him to “stay” the FDA’s 23-year-old approval of the drug, making it a dicey proposition for manufacturers to keep selling it.

And that’s not the craziest part! The court relies on the Comstock Act of 1873, a law that prohibits using the mail to transport “Every obscene, lewd, lascivious, indecent, filthy or vile article, matter, thing, device, or substance.” Clearly this violates the First Amendment, which is why it’s never enforced, despite remaining on the books. The law has a provision that bans using the mail to send “every article or thing designed, adapted, or intended for producing abortion, or for any indecent or immoral use,” which birth control advocate Margaret Sanger successfully challenged in a 1936 case involving the importation of an early form of diaphragms.

Nevertheless, Kacsmaryk expresses astonishment that none of the parties in this case cite the Comstock Act as a reason to challenge the FDA’s approval of dispensing mifepristone by mail, and he cites a 1915 case as standing for the proposition that, in 2023, the US has “a national policy of discountenancing abortion as inimical to the national life.” This requires ignoring the Food and Drug Administration Amendments Act of 2007 (“FDAAA”), which Congress enacted expressly to permit the mail-order distribution of mifepristone. But ignoring inconvenient factual and legal realities is Matty K’s specialty!

He even sneaks in a passage about fetal personhood, musing that perhaps fetuses have standing to sue:

Parenthetically, said “individual justice” and “irreparable injury” analysis also arguably applies to the unborn humans extinguished by mifepristone — especially in the post-Dobbs era. [And then he cites to an amicus brief filed in Dobbs by anti-abortion activists saying] (“Nothing in the Constitution or in our Nation’s legal traditions authorizes the Court to adopt [the] theory of life” that States are required “to regard a fetus as lacking even the most basic human right — to live — at least until an arbitrary point in a pregnancy has passed.”)

There is so much that’s gross about this opinion — from excoriating the defendant for using the “unscientific” term “fetus” instead of “unborn child,” to speculating that women would be better off having to have surgical abortions than taking a pill and experiencing an afternoon of cramping. We couldn’t get it all in here if we tried, although Robyn did a great job over the weekend.

But let’s talk instead about the competing order from Judge Thomas Rice in the Eastern District of Washington which came out at roughly the same time last week. Because the FDA is still tinkering with that mifepristone REMS, and so 17 states plus DC sued to stop the government from enacting even more restrictions on distribution. So on Friday night, Judge Rice granted an injunction block the FDA from “altering the status quo and rights as it relates to the availability of Mifepristone under the current operative January 2023 Risk Evaluation and Mitigation Strategy under 21 U.S.C. § 355-1 in Plaintiff States.”

And that puts the FDA in a weird place, because WTF is even happening right now? Judge Kacsmaryk’s order, which goes into effect this Friday if it’s not blocked by a higher court, purports not to be a nationwide injunction, but rather a stay of the FDA’s 23-year-old approval under Section 705 of the Administrative Procedure Act (5 U.S.C. § 705). This law which allows courts to “postpone the effective date of an agency action or to preserve status or rights pending conclusion of the review proceedings.” But perhaps sensing the glaring defects of his ruling, Kacsmaryk wrote: “If the Fifth Circuit reverses this Court’s Section 705 analysis, the Court clarifies that it alternatively would have ordered Defendants to suspend the chemical abortion approval and all subsequent challenged actions related to that approval until the Court can render a decision on the merits.”

The government has appealed to the Fifth Circuit, which is a nightmare lineup, stacked with Trump appointees. It has not appealed the Washington decision, and, as we discussed in depth on the Opening Arguments podcast (shameless plug alert!), there is a universe in which both orders can coexist. The FDA could colorably argue that the Washington order blocks it from taking any enforcement action against mifepristone suppliers, but that’s not a longterm solution. And unfortunately, the Fifth Circuit and the Supreme Court have shown themselves remarkably willing to countenance the most vile, illegal arguments in an effort to ban abortion.

And Lemon, it’s only Monday.

[Slate / Alliance for Hippocratic Medicine v. FDA, docket via Court Listener / State of Washington v. FDA, docket via Court Listener]

Catch Liz Dye on Opening Arguments podcast.

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