A sign of what lies ahead
February 11, 2023 12:12 AM   Subscribe

The FDA's power to approve drugs faces sweeping challenge in lawsuit seeking to pull abortion pill from U.S. market - "Just how far the FDA's authority extends into states with abortion bans that conflict with the agency's decisions on mifepristone is a question which will be decided in federal courts in the months ahead, [ASU Center for Public Health Law and Policy's Jennifer] Piatt said."[1]

  • Anti-abortion physicians are suing to overturn the FDA’s approval of mifepristone, which dates back more than two decades.
  • Mifepristone used in combination with misoprostol is the most common way to terminate a pregnancy in the U.S.
  • If the lawsuit prevails, mifepristone would no longer be available in the U.S. market and the FDA’s drug approval powers would be weakened.
Republicans back lawsuit to overturn FDA approval of abortion pill and pull the medication from U.S. market - "The abortion rights group NARAL Pro-Choice America, in an analysis published Friday, said 40 million women would lose access to the abortion pill if the court overturns the FDA's approval. [Judge Matthew] Kacsmaryk on Thursday extended a key deadline in the case. He ordered one of the abortion pill makers, Danco Laboratories, to lay out its opposition to the lawsuit. The anti-abortion physicians who brought the case then have until Feb. 24 to respond."

How recent lawsuits could affect access to abortion pills - "Below is a guide to what is at stake."
WHAT WOULD HAPPEN IF THE TEXAS PLAINTIFFS WIN?

A plaintiffs' victory in Texas could completely remove mifepristone from the market nationwide, since federal judges have the power in some cases to issue injunctions that reach beyond their own districts to encompass the whole country. The FDA said in a recent court filing that pulling the drug off the market would dramatically harm patients, forcing them to have unnecessary, and sometimes riskier, surgical abortions and subjecting them to long wait times.

Abortion providers have raised the possibility of prescribing misoprostol alone for medication abortion, which is not a use approved by the FDA but is in some other countries. Such off-label prescribing is generally legal, but it is not clear how many providers would adopt it.

IS A WIN BY TEXAS PLAINTIFFS LIKELY?

Legal experts say that challenging FDA approval long after the fact on alleged safety grounds has no obvious precedent, and the plaintiffs will need to show a legal reason to overcome the normal six-year statute of limitations.

By filing in Amarillo, however, the plaintiffs have ensured that their case will go before U.S. District Judge Matthew Kacsmaryk, an outspoken conservative appointed to the federal bench by former Republican President Donald Trump, who has been friendly to conservative causes in past cases.

WHAT WOULD HAPPEN NEXT?

The FDA would seek an emergency stay of the injunction while it appeals to the 5th U.S. Circuit Court of Appeals. That court is also known as conservative, with a majority of judges appointed by Republicans. But some abortion rights advocates have said they believe it would be more cautious about pulling an FDA-approved drug. Whichever way the 5th Circuit rules, the case is likely to then be appealed to the U.S. Supreme Court.
An abortion public health emergency could protect access to a key drug nationwide, but it's a risky move. - "Inevitable legal challenges to such a move would risk constraining how the federal government responds to future public health emergencies."

Factbox-Abortion Battles in U.S. State Capitols to Watch in 2023 - "Here is a snapshot of state legislation seeking to ban or protect abortion access in 2023."

also btw...
DeSantis seeks wins on guns, abortion before facing Trump in 2024 - "[With a Republican supermajority] DeSantis has said he would sign a bill to ban abortions as early as six weeks if passed by lawmakers... DeSantis' hard-right stance on issues such as guns and abortion risks alienating the suburban voters he eventually would need to win the presidency in 2024. For now, allies say his actions are primed to win the primary over Trump, and he'll worry about a general election later." Fla. Gov. DeSantis is now looking to overhaul the state's colleges and universities - "DEI, diversity equity and inclusion programs, and CRT, critical race theory, are two phrases that come up a lot now in DeSantis' news conferences. He's required all public colleges and universities to report on how much they spend on DEI programs. DeSantis says the Republican-controlled legislature will soon bring him a bill outlawing them in Florida." (previously)

When One Party Controls State Government - "We're one country, but increasingly, we experience two different Americas."[2,3]
posted by kliuless (22 comments total) 21 users marked this as a favorite
 
… well that’s a little bit terrifying.
posted by From Bklyn at 12:31 AM on February 11, 2023 [8 favorites]


wtf.

That is distressing for sure.
posted by many-things at 1:30 AM on February 11, 2023 [1 favorite]


The majority of voters in Texas and Florida have made it more than clear they would happily drag us into open civil war, if it would bring back the era of women and Black people as chattel. We should listen to them.
posted by They sucked his brains out! at 2:03 AM on February 11, 2023 [12 favorites]


>The majority of voters in Texas and Florida

A gentle reminder that the elected get to influence who votes. Do not confuse the voters of a state with the residents. Every state has significant populations that agree or disagree with whatever position you hold. Fight the politicians and policies, not an entire constituency in one brush.
posted by persona at 3:06 AM on February 11, 2023 [42 favorites]


Abortions rights being controlled by who holds the presidency sounds perfect for both the DNC and RNC.
posted by jeffburdges at 3:41 AM on February 11, 2023 [4 favorites]


Fight the politicians and policies, not an entire constituency in one brush.

My co-chair at my former synagogue made a similar argument with me. The executive committee had refused to put up LGBTQ safe space stickers or a Pride flag, and I was ready to resign from the board and leave. The co-chair had been there during the fight for marriage equality, and for many others through the years, and said that the only way we got queer rights was with allies. They were right.

I still left. There are those of us - closeted trans women like me in my situation, and people threatened by restrictions on abortion access in this one - who have to choose between staying and fighting in places like Texas or Florida, or fleeing persecution. I guess the best I can say here is, those who can fight, do - and help those who cannot hide elsewhere until the battle is won.
posted by Flight Hardware, do not touch at 4:32 AM on February 11, 2023 [15 favorites]


This is, of course, yet another route to dismantling the federal government. Imagine if it’s decided that a single lawsuit can overturn FDA approval of a drug nationwide. If this lawsuit works, I believe this will be the route taken to outlaw contraceptive drugs, which is the next big target for far-right evangelicals.
posted by Thorzdad at 6:30 AM on February 11, 2023 [18 favorites]


I understand that people are sensitive to the fact that not all residents of the separatist states are fascists — I mean, I live in separatist state — but I think the point of, "We should listen to them," is that it already will take federal troops to restore order.
posted by ob1quixote at 6:33 AM on February 11, 2023 [13 favorites]


Can’t this judge be arrested for practicing medicine without a license? As well as state legislators, and governors?
posted by njohnson23 at 9:18 AM on February 11, 2023 [5 favorites]


With nationwide injections, to pass a law, you need to get it by the the House, the Senate, the President - and then every district court judge in America.

It’s not sustainable. There are 677 of them.
posted by kerf at 9:28 AM on February 11, 2023 [1 favorite]


We have a court system that already acts as an extra-constitutional super legislature (implementing policies like Qualified Immunity) and now where convenient members of the judiciary would like to be extra-constitutional super executives, taking administrative actions (deeming drug products unsafe).

We really need a state or the executive to loudly, persistently undermine the ongoing case by asking if (or declaring that) the conduct doesn't meet the Article 3 Good Behavior requirements. Actual Constitutional Crisis steps can happen after but the court has not (in almost a century) actually been threatened and the lack of fear is showing.

They are supposed to be a co-equal branch of government, that they're a place to beg for desired political outcomes outside normal process is wrong.

We have gotten a handful of good things (marriage equality) and a metric shit ton of bad (dark money, eroded right to vote, expanded right to guns, torture is OK, and a hundred minor little nicks on things like the separation of church and state).

The longer the relevant powers wait to tell the courts "No" the more the water we're in boils and the more we start to see extreme things as normal judiciary actions.
posted by Slackermagee at 9:30 AM on February 11, 2023 [7 favorites]


Black market.
posted by aiq at 9:35 AM on February 11, 2023


Black market?
posted by tiny frying pan at 9:43 AM on February 11, 2023


There already is a black market for abortion pills: the New Yorker within the last few months had a long piece about women in Texas transporting pills back from Mexico, where they are much easier to obtain.
posted by suelac at 10:06 AM on February 11, 2023 [6 favorites]


The private prison industry will be glad to provide government-funded lodging for all those Texas women smuggling "deadly" drugs into the state.
posted by tigrrrlily at 10:19 AM on February 11, 2023 [9 favorites]


My point was...what about a black market? We need the real market. For real healthcare. Abortion.
posted by tiny frying pan at 10:43 AM on February 11, 2023 [12 favorites]


I know this makes me a terrible person but the more these assholes push their fascist agenda, the more I miss the Weather Underground.
posted by evilDoug at 11:30 AM on February 11, 2023 [12 favorites]


This case is a reason I refuse to go to any state that is restricting trans health care and HRT. I actually worry that if I go to Texas or Florida in the future, and they check my medication container, they will confiscate it and arrest me for the crime of being trans.

If this passes, the worst case scenario is going to be these states doing the “we can be more restrictive than the feds, go ahead and fight us” and I believe that Abbott and DeSantis wouls be more than happy to pick that fight.
posted by mephron at 1:01 PM on February 11, 2023 [13 favorites]


Why An Abortion Drug Approved 20 Years Ago Might Get Yanked From The Market - "It's less about science, and more about philosophy — particularly that of the Trump-appointed judge poised to rule on the approval."

also btw... posted by kliuless at 10:19 AM on February 25, 2023 [2 favorites]


Some key sections of yesterday's Washington Post profile of the Trump judge: The Texas judge who could take down the abortion pill

Why activists are filing cases in Amarillo:
Because Amarillo is a federal district with a single judge, plaintiffs know their arguments will be heard by Kacsmaryk — who, like any federal judge, is positioned to issue rulings with nationwide implications. Appeals from Kacsmaryk’s district follow a path that has regularly yielded favorable outcomes for conservatives — reviewed first by the U.S. Court of Appeals for the 5th Circuit, which upheld a strict Texas abortion ban long before Roe v. Wade was overturned, then ultimately by the conservative-controlled Supreme Court.
Quotes from a letter to the editor written while an undergraduate at Abilene Christian University make his philosophy clear:
“The Democratic Party’s ability to condone the federally sanctioned eradication of innocent human life is indicative of the moral ambivalence undergirding this party,” Kacsmaryk wrote, endorsing a Republican Party platform that would grant a fetus the full legal protections of a person.
From the same letter to the editor:
"Perhaps more than any other national institution, the liberal Democratic Party and its ideological affiliates have facilitated the demise of America's Christian heritage ... Clinton's repeal of the bans on homosexuals in the military and fetal tissue research are tantamount to a blatant and contemptuous assault on the traditional family."
In December:
Kacsmaryk sided with a Christian father who did not want his daughters to access birth control without his permission, challenging a federal program that provides low-cost or free contraception, including to teens without parental consent. Kacsmaryk agreed with the father that a provision of Title X violates the constitutional right of parents to “direct the upbringing of their children.”
posted by pjenks at 5:58 AM on February 26, 2023 [2 favorites]


And in case you think that this case might be decided on the merits, their entire argument is:
... the FDA lacked the authority to approve the drug, did not adequately study the medication and that the drug is unsafe ... The suit said the agency erred in approving the drug under an expedited process that is intended to speed consideration of therapies for life-threatening illnesses, not a condition like pregnancy.
This for a drug that: was approved in France in 1990, the UK in 1991, by the US FDA in 2000; was re-approved by the US in generic form in 2019; and has a rate of complications (requiring hospitalization) of less than 1% (more details can be found in the comprehensive review of medical abortion performed by the National Academies of Science, Engineering, and Medicine).
posted by pjenks at 6:25 AM on February 26, 2023 [2 favorites]


The Latest Attack on the Abortion Pill Is Forty Years in the Making [ungated] - "If a Texas lawsuit prevails, mifepristone will no longer be available anywhere in the nation, even in states where abortion is legal."

The Abortion Pill Fight [ungated] - "Since Roe v. Wade ended, the battle over legal abortion has largely shifted to access to pills."

also btw...
What Happens If More Red States Ban Abortion? - "Where is the nearest abortion clinic? Our interactive map shows the distance a woman may need to travel to reach an abortion provider if proposed abortion restrictions pass."
posted by kliuless at 10:06 PM on March 9, 2023 [1 favorite]


« Older Violent Femmes on the local news   |   ChatGPT is a Blurry JPEG of the Web Newer »


This thread has been archived and is closed to new comments