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Posted

 

Food and Drug Administration v. Alliance for Hippocratic Medicine 

(consolidated with Danco Laboratories, L.L.C. v. Alliance for Hippocratic Medicine)

Date: June 13, 2024

Author: Kavanaugh

Split: 9-0

Dissent: N/A

Appeal From: Fifth Circuit

 

Basic Facts:

In 2000, the Food and Drug Administration approved a new drug application for mifepristone tablets marketed under the brand name Mifeprex for use in terminating pregnancies up to seven weeks. To help ensure that Mifeprex would be used safely and effectively, FDA placed additional restrictions on the drug’s use and distribution, for example requiring doctors to prescribe or to supervise prescription of Mifeprex, and requiring patients to have three in-person visits with the doctor to receive the drug. In 2016, FDA relaxed some of these restrictions: deeming Mifeprex safe to terminate pregnancies up to 10 weeks; allowing healthcare providers, such as nurse practitioners, to prescribe Mifeprex; and approving a dosing regimen that required just one in-person visit to receive the drug. In 2019, FDA approved an application for generic mifepristone. In 2021, FDA announced that it would no longer enforce the initial in-person visit requirement. Four pro-life medical associations and several individual doctors moved for a preliminary injunction that would require FDA either to rescind approval of mifepristone or to rescind FDA’s 2016 and 2021 regulatory actions. Danco Laboratories, which sponsors Mifeprex, intervened to defend FDA’s actions.

The District Court agreed with the plaintiffs and in effect enjoined FDA’s approval of mifepristone, thereby ordering mifepristone off the market. FDA and Danco appealed and moved to stay the District Court’s order pending appeal. As relevant here, this Court ultimately stayed the District Court’s order pending the disposition of proceedings in the Fifth Circuit and this Court. On the merits, the Fifth Circuit held that plaintiffs had standing. It concluded that plaintiffs were unlikely to succeed on their challenge to FDA’s 2000 and 2019 drug approvals, but were likely to succeed in showing that FDA’s 2016 and 2021 actions were unlawful. This Court granted certiorari with respect to the 2016 and 2021 FDA actions.

 

 

Issue:

Quote

 

Whether respondents have Article III standing to challenge FDA's 2016 and 2021actions.

Whether FDA's 2016 and 2021 actions were arbitrary and capricious.

Whether the district court properly granted preliminary relief.

 

 

Holding: Reversed and remanded.

Quote


Plaintiffs lack Article III standing to challenge FDA’s actions regarding the regulation of mifepristone.

 

 

 

Skinny: While consequential, this is again a procedural ruling. (It doesn't have anything to do with whether one thinks the drug — or abortion, in general — is good or bad.) The court notes that it's possible someone else might have standing to challenge the FDA's relaxed regulation of the drug, but the plaintiffs here cannot show that they suffer any injury from the FDA's actions (they're not required to use or prescribe the drug), and so they cannot properly challenge those actions. 

 

 

 

https://redstate.com/smoosieq/2024/06/13/the-skinny-on-scotus-n2175428

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Posted

What was the name of the DEM Pac that fought the state law and got row thrown out?  who funds them?

 

Center for Reproductive rights, but good luck finding the actual sources of revenue.

 

 

 

 

Posted

Infant deaths increased after Texas banned abortion in early pregnancy

 

“Since Texas’ ban on abortion went into effect, infant deaths in the state increased by nearly 13%, according to a new analysis published on Monday in JAMA Pediatrics. In the rest of the country, infant mortality increased less than 2% over the same period.”


***

 

”Among the causes of infant deaths, one increased the most: congenital abnormalities, which increased 22.9% in Texas in children between 2021 and 2022, while they decreased 2.9% in the rest of the country. That trend suggests that at least in some cases, parents were forced to carry a pregnancy to term while knowing their children had little to no chance of survival, said Gemmill.”

***
 

“Significant increases were also found in babies who died because of maternal complications of pregnancy; in Texas, those deaths increased by 18.2% between 2021 and 2022, compared to 7.8% in the rest of the country. Infant deaths caused by unintentional injuries, which can be associated with unwanted pregnancies, also increased by 20.7%, compared to a 1.1% increase elsewhere in the U.S.”

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Posted

 

https://www.washingtonpost.com/opinions/2024/07/18/abortion-vance-extremism-vice-president-trump-pick/

Republicans have a problem: Their base insists on a nationwide forced-birth law, but political realists in the party understand this is a hugely unpopular position, and one that might lead to electoral disaster. The tactical solution: Hide their abortion extremism while winking to the base.

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The Post reported, “The new Republican platform still includes language that links abortion to the 14th Amendment to the Constitution, leaving open a path to legislation or court decisions that would grant fetuses additional legal rights.”

 

The selection of Vance clarified the party’s absolutism. Mini Timmaraju, president and CEO of Reproductive Freedom for All, put out a statement following the Vance announcement: “Make no mistake, Trump picked him because of — not in spite of — his anti-abortion bona fides. … Vance has worked in lockstep with extremist Republicans in the Senate to undermine reproductive freedom — refusing to back down from the dangerous abortion bans and restrictions his party has engineered.” She then ticked off the list of his radical positions, which includes favoring an abortion ban without exceptions for rape or ***** and opposition to a bill protecting IVF.

 

In a Biden-Harris campaign press call after Vance was named, the campaign spokespeople’s focus on his radical abortion position was noteworthy. “He supports a nationwide ban on abortion, criticizes exceptions for rape and ***** survivors, actually saying ‘two wrongs don’t make a right’ [and] calling those circumstances ‘inconvenient,’” said reproductive rights advocate Amanda Zurawski.

The campaign put two prominent abortion advocates on the call. “When Donald Trump and J.D. Vance celebrate overturning Roe, they’re celebrating every single cruel abortion ban across the country, many of which have no exceptions for rape or *****,” Timmaraju said. “And, at the end of the day, we always knew Trump would pick someone just as committed to taking away reproductive freedom. But now that it’s official, it couldn’t be more clear.”

Posted
2 hours ago, Tiberius said:

 

https://www.washingtonpost.com/opinions/2024/07/18/abortion-vance-extremism-vice-president-trump-pick/

Republicans have a problem: Their base insists on a nationwide forced-birth law, but political realists in the party understand this is a hugely unpopular position, and one that might lead to electoral disaster. The tactical solution: Hide their abortion extremism while winking to the base.

Sign up for the Prompt 2024 newsletter for opinions on the biggest questions in politics

The Post reported, “The new Republican platform still includes language that links abortion to the 14th Amendment to the Constitution, leaving open a path to legislation or court decisions that would grant fetuses additional legal rights.”

 

The selection of Vance clarified the party’s absolutism. Mini Timmaraju, president and CEO of Reproductive Freedom for All, put out a statement following the Vance announcement: “Make no mistake, Trump picked him because of — not in spite of — his anti-abortion bona fides. … Vance has worked in lockstep with extremist Republicans in the Senate to undermine reproductive freedom — refusing to back down from the dangerous abortion bans and restrictions his party has engineered.” She then ticked off the list of his radical positions, which includes favoring an abortion ban without exceptions for rape or ***** and opposition to a bill protecting IVF.

 

In a Biden-Harris campaign press call after Vance was named, the campaign spokespeople’s focus on his radical abortion position was noteworthy. “He supports a nationwide ban on abortion, criticizes exceptions for rape and ***** survivors, actually saying ‘two wrongs don’t make a right’ [and] calling those circumstances ‘inconvenient,’” said reproductive rights advocate Amanda Zurawski.

The campaign put two prominent abortion advocates on the call. “When Donald Trump and J.D. Vance celebrate overturning Roe, they’re celebrating every single cruel abortion ban across the country, many of which have no exceptions for rape or *****,” Timmaraju said. “And, at the end of the day, we always knew Trump would pick someone just as committed to taking away reproductive freedom. But now that it’s official, it couldn’t be more clear.”

Did Wa Po actually let go of the guy journalist that published south Korean propaganda, from his Spy wife, yet?

Posted
1 minute ago, Tommy Callahan said:

Did Wa Po actually let go of the guy journalist that published south Korean propaganda, from his Spy wife, yet?

 

You mean, did they give Max...the Boot?

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Posted

According to Statista, from a YouGov survey, the most important issues to voters in the 2024 election are as follows:  inflation, healthcare, immigration, the economy, climate and the environment.   

 

https://www.statista.com/statistics/1362236/most-important-voter-issues-us/

 

The eight most important issue is Abortion rights, which is the most important issue to 5% of voters.  All those voters were going to vote for Harris anyway, whether Roe v. Wade was repealed or not.  Trump has also said that he's not in favor of imposing restrictions on abortion at the federal level.

 

So you may want to think twice about making this your party's main issue.  

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Posted
10 minutes ago, Artful Dodger said:

According to Statista, from a YouGov survey, the most important issues to voters in the 2024 election are as follows:  inflation, healthcare, immigration, the economy, climate and the environment.   

 

https://www.statista.com/statistics/1362236/most-important-voter-issues-us/

 

The eight most important issue is Abortion rights, which is the most important issue to 5% of voters.  All those voters were going to vote for Harris anyway, whether Roe v. Wade was repealed or not.  Trump has also said that he's not in favor of imposing restrictions on abortion at the federal level.

 

So you may want to think twice about making this your party's main issue.  

Are you for a federal law giving women the right to their own choice on reproductive rights? Or are you against it? 

Posted
1 minute ago, Tiberius said:

Are you for a federal law giving women the right to their own choice on reproductive rights? Or are you against it? 

 

No.  I think that it should be in the hands of the states.  After all this shakes out, I suspect that most or all of the states will have laws that make abortion legal through four months or so, which is comparable to the status quo in most European countries and is where most voters are.   It will be messy getting there, but when it does, the issue will cease to be controversial and will no longer be politically salient for either party.  

 

But, frankly, it's not an important issue to me.  And the polling suggests that compared to inflation or immigration or health care costs, it's not an important issue to most Americans.  

Posted
1 minute ago, Artful Dodger said:

 

No.  I think that it should be in the hands of the states.  After all this shakes out, I suspect that most or all of the states will have laws that make abortion legal through four months or so, which is comparable to the status quo in most European countries and is where most voters are.   It will be messy getting there, but when it does, the issue will cease to be controversial and will no longer be politically salient for either party.  

 

But, frankly, it's not an important issue to me.  And the polling suggests that compared to inflation or immigration or health care costs, it's not an important issue to most Americans.  

Good, so there is a difference between the parties. Harris should push for this national right. Trump will of course oppose this right. We have a choice! 

 

Good, that's what elections are about 

Posted
2 minutes ago, Tiberius said:

Good, so there is a difference between the parties. Harris should push for this national right. Trump will of course oppose this right. We have a choice! 

 

Good, that's what elections are about 

 

I guess it will gin up her base who are included in that 5% of people who think that abortion is the most important issue and who are already in a frenzy to vote against Trump.   But most of the rest of the country wants to hear what she's going to do about the cost of living and uncontrolled immigration and so on.  Insofar as she's talking about abortion, she's not talking about those things.  

Posted
11 minutes ago, Artful Dodger said:

 

No.  I think that it should be in the hands of the states.  After all this shakes out, I suspect that most or all of the states will have laws that make abortion legal through four months or so, which is comparable to the status quo in most European countries and is where most voters are.   It will be messy getting there, but when it does, the issue will cease to be controversial and will no longer be politically salient for either party.  

 

But, frankly, it's not an important issue to me.  And the polling suggests that compared to inflation or immigration or health care costs, it's not an important issue to most Americans.  

I simply cannot believe the new Trump stance on abortion. The "leave it to the states; everyone's happy" stance.

 

There were more abortions in America in the first post-Dobbs year than in the year before Dobbs.

If you believe that abortion is actually the taking of an innocent human life (I respect that position; I think it's wrong, but I respect it), how can you live with this? How can you "take the win" and say, oh well, at least we've made abortion a little less convenient for women in the southern U.S. We'll stop now.

 

No. The Christian Right did a lot to get Trump nominated again, and they'll do a lot to try to get him elected again. They will not stop. The drive will begin with an attempt to kill "medication abortion" - Trump's FDA will be a Trump-controlled FDA, and they'll try to ban it on bogus "not safe and effective" grounds. There will be proposed legislation to ban abortion, at least post-15/16 week abortions, at a national level.

 

We are in a Missouri Compromise moment on abortion. Hey look, we've finally settled that pesky slavery question! Except we hadn't. We might have made it worse, even more divisive. The issue will not go away.

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Posted

There were more abortions in America in the first post-Dobbs year than in the year before Dobbs.

 

And if this ruling did little to stop abortions, it becomes an even less salient issue, except for extremists on the right and on the left as a way to get the base riled up.  Restricting all abortions is unpopular, even in red states.  For example, both Kansas and Ohio held referendums where voters established a constitutional right to an abortion.  And once that's done, the issue was off the table in those states.  Many politicians are not bright, but they do have a keen survival instinct, and they want to be where most of their voters are.   There's no chance any legislation will succeed on the national level.  I completely disagree that this issue is not going away.  It's already going away, which is why only 5% of voters consider it the most important issue.  

 

The polling data suggests that the country knows that it has much bigger problems to worry about.  To me, centering one's campaign around this issue either illustrated the essential unseriousness of a candidate or else the fact that they know they can't win on other more important issues.  

Posted
13 minutes ago, The Frankish Reich said:

I simply cannot believe the new Trump stance on abortion. The "leave it to the states; everyone's happy" stance.

 

There were more abortions in America in the first post-Dobbs year than in the year before Dobbs.

If you believe that abortion is actually the taking of an innocent human life (I respect that position; I think it's wrong, but I respect it), how can you live with this? How can you "take the win" and say, oh well, at least we've made abortion a little less convenient for women in the southern U.S. We'll stop now.



Had this discussion many times within my own Church - how can you sign a bill that limits it to 12 weeks for example. 
 

The answer is you are saving lives - it could be worse and you know that’s all you can do for now - it’s ultimately NOT your decision.  You are saving lives bc the alternative is worse.  That’s also why we support policies that give woman as much info as possible before killing the baby.  
 

Some Ds pre Obama used to be in this place to.  Safe rare legal and didn’t support late term abortions.  
 

Now it’s to the end.  And don’t even want the woman to hear about alternatives or ramifications etc there is no justification for that. 

 

 

13 minutes ago, The Frankish Reich said:

 

No. The Christian Right did a lot to get Trump nominated again, and they'll do a lot to try to get him elected again. They will not stop. The drive will begin with an attempt to kill "medication abortion" - Trump's FDA will be a Trump-controlled FDA, and they'll try to ban it on bogus "not safe and effective" grounds. There will be proposed legislation to ban abortion, at least post-15/16 week abortions, at a national level.

 

We are in a Missouri Compromise moment on abortion. Hey look, we've finally settled that pesky slavery question! Except we hadn't. We might have made it worse, even more divisive. The issue will not go away.


 

Abortion is never ever going away at the state level.  The SCOTUS had a chance to do that by just making it illegal and didn’t.  
 

If you think it isn’t settled you just want abortions nationwide right up to birth - that wasn’t even what Roe said.  

Posted
4 minutes ago, Artful Dodger said:

There's no chance any legislation will succeed on the national level.

Let's say the election plays out like Dems feared it would about a week ago.

Trump wins.

The Republicans increase their majority in the House, and they retake the Senate.

How long will it take for Senate Republicans to kill the filibuster? I'd give it a month or two.

What happens to medication abortion with an anti-abortion activist put in place at the FDA?

Will Trump really refuse to sign a 15-week abortion ban that sails through the House and Senate?

I see what you're saying. The issue is not front and center with most voters now. But I also think you need to game plan this through... it will be Kamala's job to make the case. We will see whether she is able to do it.

Posted
3 minutes ago, The Frankish Reich said:

Let's say the election plays out like Dems feared it would about a week ago.

Trump wins.

The Republicans increase their majority in the House, and they retake the Senate.

How long will it take for Senate Republicans to kill the filibuster? I'd give it a month or two.

What happens to medication abortion with an anti-abortion activist put in place at the FDA?

Will Trump really refuse to sign a 15-week abortion ban that sails through the House and Senate?

I see what you're saying. The issue is not front and center with most voters now. But I also think you need to game plan this through... it will be Kamala's job to make the case. We will see whether she is able to do it.

 

There's never been any evidence that the Republican Senate has desired to kill the filibuster; most of the calls for that have been from the Left.  Perhaps now that Mitch McConnell's gone that may change, but there's no reason so far to think that it will.  Unless there's a Republican landslide this fall, which seems very unlikely, there won't be enough support in either the House or the Senate for an abortion ban.  As I've suggested, most legislators know that's not what their constituents want.  

 

I think you have a better case with your point about an anti-abortion activist in place at the FDA. But recent Supreme Court rulings have greatly diminished the power of administrative agencies to issue regulations and make laws without legislation.  That ruling applies to Republican governments as well as Democratic governments.

 

You do make an excellent case for divided government.  Neither party can be trusted.  

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