Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Tuesday, September 23, 2025

Trump v Tylenol

 Another batshit crazy presser.


LOL.  No doubt.




You talk a lot of nonsense.


Fight like hell not to take it?  Is Tylenol trying to ram itself down your throat?


Will they never tell him?

He won't get an argument from me on that.







In short:





Bobby K sure is fidgety.


Yeah, and we're going to pay for it.

Aside from the fact that it's hard for him to say acetaminophen, why is he destroying Tylenol?  

If he had a functioning brain cell in his head, he would have let Bobby stand up there alone and make a fool of himself about Tylenol.  For some reason, he needed to be part of it.

Maybe...


Or maybe...


UPDATE 09:46 am:




Wednesday, July 30, 2025

The most incompetent administration in history

By design.




Marty Malarky, more like.  "Listening tour?"  He's listening to the wrong people.

Actually, I think RFKJ is in charge, but I take the point.  This clown heads the FDA.

Friday, April 18, 2025

Food Safety important to you?

 


There's a small matter of funding.  And of political ideology.  Red states would have more lax regulations for both reasons.  And they'll have fewer, less well equipped medical facilities.



Tuesday, April 1, 2025

Unfuckingbelievable

 There's more than one way to kill an agency.


They'll do what they damn well please, and you can't even communicate with them, much less get any information from them, as your rights permit.



DOGE at work

 






They don't.





UPDATE 11:36 am:




Tuesday, February 18, 2025

Tuesday, February 11, 2025

Another judge's order to ignore

A federal judge on Tuesday ordered the nation’s premier health agencies to restore online access to several websites that monitor HIV, health risks for youths and assisted reproductive technologies, which were abruptly taken offline to ensure they complied with President Donald Trump’s recent executive order on gender.

U.S. District Judge John D. Bates granted a temporary restraining order requested by the nonprofit advocacy group Doctors for America, directing the administration to bring back public information maintained by the Centers for Disease Control and Prevention and the Food and Drug Administration while a lawsuit challenging the administration’s decision to remove it is pending.

[...]

About a dozen public health websites, some of which had been online since the 1990s, were pulled from the internet late last month after Trump signed an executive order directing federal agencies to recognize only male and female genders, and the Office of Personnel Management issued a memorandum saying agency heads should “end all agency programs that use taxpayer money to promote or reflect gender ideology.” A Justice Department attorney representing the health agencies said they needed to review the sites’ content for compliance with the order.

Doctors for America, whose members practice medicine in all 50 states, said the removals went beyond the terms of Trump’s executive order and have left the public exposed to a broad swath of health risks.

  MSN


Tuesday, November 12, 2024

Saturday, April 15, 2023

In the battle for women's health

Earlier this month, U.S. District Judge Matthew Kacsmaryk issued a preliminary injunction to vacate the FDA's approval of the drug [mifepristone] altogether.

The FDA responded by requesting an emergency stay of the decision, elevating the case for the Fifth Circuit Court of Appeals to weigh in.

The appellate panel then issued a complicated ruling on the injunction, siding in part with the FDA and part with the anti-abortion coalition.

[...]

Supreme Court Justice Samuel Alito has placed a hold on a lower court ruling that restricts access to the abortion drug mifepristone until Wednesday night. Alito also instructed that any responses be filed by April 18 at noon.

[...]

Portions of a Texas district court's order that limits the drug would have otherwise taken effect April 15, but Alito's order put it on pause.

[...]

The administration brief calls the lower court rulings "unprecedented" and says they "unleashed regulatory chaos" by suspending the existing FDA-approved conditions of use for mifepristone."

[...]

"The district court countermanded the scientific judgment the FDA has maintained across five administrations; nullified the approval of a drug that has been safely used by millions of Americans over more than two decades; and upset reliance interests in the health care system that depends on the availability of mifepristone as an alternative to surgical abortion for women who choose to lawfully terminate their early pregnancies." The administration said those harms would be felt throughout the nation because mifepristone has lawful uses in every state, regardless of whether abortion is legal, for instance, to treat women who have miscarried.

[...]

Meanwhile, a competing ruling out of Washington state could limit the Texas injunction's reach.

The final ruling from the appellate panel led the DOJ to appeal even higher to the Supreme Court in hopes of ensuring access to the drug is fully restored.

  NPR
What isn't explained in this article is the extreme bullshit of having the original suit brought by some doctors who claimed standing to sue by virtue of the fact that someone might some day come to them for treatment after having had complications from the use of mifepristone. (Additionally, they called the cramping and expulsion of uterine material "side effects" of the drug. That's not side effects, that's effects. That's what the drug is supposed to do. That's how a pregnancy ends.)

And never mind that this situation has never been presented to them, and is unlikely to ever be presented to them due to the drug's safety record (safer than Tylenol), and the probability that if someone did have complications they would go to the doctor who prescribed mifepristone to them in the first place and not to these assholes.

...but hey, do what you want...you will anyway.

UPDATE 02:58 pm:  Well, lookie here...


So much slime in the "conservative" world.

Friday, January 27, 2023

"Uterus Inquisition Squad"

Access to medicine shouldn’t be controversial, and it wouldn’t be but for the Christian fundamentalist forces who’ve been emboldened by the right-wing takeover of the Judicial Branch and the Supreme Court’s revocation of reproductive rights. Now, at the very moment mifepristone has become one of the few means of securing widespread abortion access, these people have targeted it for destruction. Back in November, the inaccurately named Alliance Defending Freedom (ADF) brought a lawsuit against the FDA challenging its initial approval of mifepristone. The ADF claims that the FDA did not follow its own procedures when it approved the drug.

The lawsuit is so ridiculous that it hardly warrants discussion on the merits. First of all, the statute of limitations allows challenges to FDA procedures for only six years and mifepristone has been approved for over 20. Moreover, Congress passed an amendment to the Food and Drug Act in 2007 that revised the FDA’s procedures and deemed any drug previously approved by the agency to be in compliance with the new rules. There are also jurisdictional problems with the lawsuit. But even if you overlook all these technical legal hurdles, the ADF’s core argument—that the FDA failed to consider the dangers of mifepristone—is wrong. Mifepristone is safe, and no amount of Gregorian chanting from the self-appointed Uterus Inquisition Squad can prove it otherwise.

Unfortunately, we have to treat this incoherent nonsense masquerading as a lawsuit as a serious threat to abortion drugs because of the judge who recently got hold of the case: Matthew Kacsmaryk. Kacsmaryk is a Trump-appointed district court judge in Texas.

[...]

He was an anti-gay crusader for a Christian right law firm before Trump raised him up to be a judge. He claims that homosexuality is a “disorder.” He’s attacked the right to contraception and denounced the “sexual revolution” of the 1960s and ’70s.

[...]

[This case has] not ended up in front of Kacsmaryk by accident or bad luck. Right-wingers have actively sought out Kacsmaryk for their most dubious legal claims by means of the 21st-century version of “forum shopping.”

[...]

In the past, one of the more popular forms of forum-shopping saw lawyers trying to game out whether a state court or federal one would lead to a better outcome. They could do this because many state and federal laws overlap, and many corporations (and the federal government) can be sued in any state they do business in.

[...]

The Supreme Court tried to put a stop to this kind of forum shopping in 1938, in a case called Erie Railroad v. Tompkins. The so-called Erie Doctrine required that in cases where there is a question of whether to apply federal or state law, a federal judge must apply the law as it would be understood in the states where the judge resides.

[...]

You’ll never see a challenge to federal gun regulations filed in California, or a lawsuit against the fossil-fuel industry filed in Texas. Lawyers will always seek to take advantage of the laws most favorable to their clients or positions, wherever those laws happen to exist.

[...]

[L]awyers Steven Vladek and Max Wolson point out that Texas regularly removes cases to federal court to get specific judges, and it works.

[...]

But that’s not what right-wingers are doing now. Instead, they are “judge shopping”—trying to take advantage of the fact that the judges themselves apply the laws differently based on which party appointed them and whether they have even a basic grasp of logic or fairness.

[...]

In the North District of Texas, judges are assigned based on their “divisions,” which break the region down to places like Dallas, Lubbock, and Amarillo. Kacsmaryk is the district judge for Amarillo and, by rule, is assigned every single federal case filed there. If you bring a federal case in Amarillo, you are guaranteed to get Judge Kacsmaryk. As Ian Milihiser put it on Vox, this rule makes Judge Kacsmaryk “one of the most consequential public officials in modern-day America.”

[...]

Meanwhile, Texas Attorney General Ken Paxton regularly files suit in the Southern District of Texas, Victoria Division, where the case is guaranteed to end up in front of Judge Drew Tipton, another Trump appointee who is a virulent anti-immigration crusader. Paxton did it again this week to challenge another Biden immigration policy.

[...]

There are no laws, rules, or doctrines to stop this kind of behavior. Arguably, both conservative and liberal lawyers can (and do) engage in judge shopping at some level. What’s supposed to make the process fruitless are the circuit courts of appeal and, ultimately, the Supreme Court.

  The Nation
So much for any liberal lawyer's hopes of judge or forum shopping advantage.
[C]ertain courts of appeal, like that of the Fifth Circuit that presides over Texas, have been captured by right-wing extremists just like the rest of the Republican Party. More problematically, we’ve seen the Supreme Court act quickly to overrule liberal district court judges on emergency appeal but leave in place rulings from conservatives for at least as long as it takes for their cases to make it all the way up to the highest court through normal order. That’s a process that can take years, and sometimes span presidential administrations.

[...]

When you file a lawsuit, the judge should be picked from a pool of all federal judges in a state, and if we’re talking about a federal law, any judge in the country should be in the hopper.

[...]

The circuits exist so that travel wouldn’t be too taxing for the judges, who lived in some central region of the district. But judges no longer need to take two horses and a palanquin hoisted by slaves to get from New Orleans to Amarillo. A Delta flight and an Uber can get anybody anywhere in this country in under 12 hours.
...but hey, do what you want...you will anyway.

UPDATE 04/13/2023:  The Texas judge ruled as expected.  Scrambling ensued.


Still ridiculous.

Wednesday, January 11, 2023

No surprise here

One week after the federal government made it easier to get abortion pills, Alabama Attorney General Steve Marshall said Tuesday that women in Alabama who use those pills to end pregnancies could be prosecuted.

That’s despite wording in Alabama’s new Human Life Protection Act that criminalizes abortion providers and prevents its use against the people receiving abortions. Instead, the attorney general’s office said Alabama could rely on an older law, one initially designed to protect children from meth lab fumes.

“The Human Life Protection Act targets abortion providers, exempting women ‘upon whom an abortion is performed or attempted to be performed’ from liability under the law,” Marshall said in an emailed statement. “It does not provide an across-the-board exemption from all criminal laws, including the chemical-endangerment law—which the Alabama Supreme Court has affirmed and reaffirmed protects unborn children.”

[...]

Lawmakers passed the chemical endangerment law in 2006 to protect small children from fumes and chemicals from home-based meth labs. District attorneys soon began applying the law to protect the fetuses of women who used various drugs during pregnancy. Justices on the Alabama Supreme Court upheld and affirmed prosecutions of pregnant people in 2013 and 2014.

Since then, the law has been used against more than a thousand Alabama women who used drugs during pregnancy.

  AL.com
Unfuckingbelievable.

And they're not "abortion pills".  They're pregnancy prevention pills.  They're contraception.  This may well go to the Supreme Court, where it will be used to chip away at contraception rights.  

UPDATE:


This is silly, but it's also indicative of how loose our laws and regulations can be.  The HOV lanes are meant as a measure to cut down on carbon emissions from automobiles on the highway.  The only way it does that is if the two or more people in the vehicle have driver's licenses and therefore could otherwise be driving a separate vehicle.  But any two people apparently give cover to drive in the HOV lane.  I guess it would be too hard to enforce if they had to know whether the other people were licensed drivers.  But we can be damned sure the other "person" in a pregnant woman's car isn't.

Thursday, January 5, 2023

Working around Dobbs

This week, the Food & Drug Administration made a small legal change in its classification of the drug mifepristone, and the Department of Justice confirmed that the drug can be sent through the mail.

Mifepristone is a drug that can be used for the treatment of high blood sugar, but it can also be used off-label to inhibit the hormone progesterone, which is necessary for maintaining pregnancies. Along with another drug, misoprostol, which causes contractions, it can be used to medically induce abortions. The mifepristone-misoprostol combination is already used in over half of abortions performed in the United States, with demand only increasing since the Supreme Court adopted Christian fundamentalist theory crafting and revoked the right to abortion last June.

Mifepristone has been used in Europe since the 1980s (my generation called it “RU-486,” and every sex-ed teacher reminded us that it “does not prevent AIDS”). [...] But until now it had only been available in-person at a clinic or doctor’s office.

This week, the FDA abandoned that restriction and instituted a change that will allow the pill to be obtained at local pharmacies, or by mail, with an ordinary prescription.

  Elie Mystal @ The Nation
Assume GOP state legislatures will go to work to stop that ASAP, if they haven't already.
In forced-birth states, many of the bans targeting abortion providers also prohibit the use of abortion drugs like mifepristone. One challenge for the big-chain pharmacies that might carry the drugs, like CVS or Walgreens, is that they will likely need to have different rules for different states.

[...]

Part of the agreement with the drug’s manufacturers includes pharmacies’ not publishing the names of doctors who prescribe the medication, to protect those doctors’ safety. But that also means that pharmacies cannot list the names of prescribing doctors in their nationwide databases, which they commonly do. And that doesn’t even get into the threats that these companies might face if they provide the medication, including in states where it is legal.
Sounds like mail order will be the best way to get the drug.
The Office of Legal Counsel issued a memo at the request of the DOJ saying that shipping abortion medication through the mail is legal, even after the Supreme Court’s ruling in Dobbs. The memo related to a provision of the Comstock Act that prohibits the mailing of any “article or thing designed, adapted, or intended for producing abortion, or for any indecent or immoral use.” The Comstock Act was passed in 1873 at the behest of a self-styled anti-vice crusader named Anthony Comstock. It’s essentially an anti-“obscenity” law—because Comstock was one of those dudes who was willing to throw away freedom and liberty every time he saw an exposed nipple—but it has been regularly used by conservative forces to curtail access to abortion and contraceptive medications. The Comstock Act was once used to prevent the distribution of birth control pills, but it was defanged by the Supreme Court case that recognized a right to privacy and a right to contraception, Griswold v. Connecticut.

[...]

The OLC memo provides some cover to out-of-state activists who are trying to get medicine into the hands of those who need it.

[...]

No legal workaround can replace a constitutional right. Women and pregnant people will be at risk as long as the fundamentalist Supreme Court and Republican lawmakers are allowed to be in charge of reproductive health. But after decades of Republican politicians restricting abortion access and Democratic politicians failing to do enough to restore them, it feels like the Democrats have at least joined the battle.
I fully expect this Supreme Court to accept a lawsuit that will attack Griswold

UPDATE 1/11:  Alabama AG plans to prosecute women who use these pills under an Alabama chemical-endangerment law intended to protect children from meth lab fumes.

Friday, January 1, 2021

WTF?

[T]he Food and Drug Administration (FDA) said that any distillery that had switched to producing hand sanitizer during the pandemic this year would owe thousands of dollars in fees, and could be charged twice if they do not cease production immediately.

  The Hill
WTF?

Fortunately, HHS is against it.
The Department of Health and Human Services (HHS) on Thursday said it is taking action to prevent distilleries that produce hand sanitizer during the pandemic from being hit with an unexpected $14,000 fee.Many craft-brewing distilleries switched production to non-consumable alcohol in response to the COVID-19 pandemic and a shortage of the product's availability in the spring.

HHS officials said they first became aware of the fees this week and held an emergency meeting in response. They later instructed the FDA not to collect the fees.

[...]

Under the now-voided rule, distilleries would have been forced to shut down production of hand sanitizer on Thursday and notify the federal government of their change in status in order to avoid paying the same fee in 2022 as well.

“Given all that’s happened in 2020, the timing of this news could not be worse. The $14,000 fee being assessed could certainly put many of these small family owned businesses out of business," he said.

“Everyone was totally blindsided by FDA’s announcement and as a result, craft distillers across the country are scrambling to understand and respond," McDaniel added.
...but hey, do what you want...you will anyway.

Saturday, December 12, 2020

Don't trust the FDA under Trump

The White House chief of staff, Mark Meadows, has reportedly told the head of the US Food and Drug Administration to authorize Pfizer’s coronavirus vaccine on Friday or prepare to resign.

Meadows leaned on [Stephen] Hahn during a phone conversation on Friday, according to the Washington Post. It came after Donald Trump tweeted that the FDA was “a big, old, slow turtle”, and told FDA commissioner Stephen Hahn to “get the dam vaccines out NOW”.

The warning from Meadows led the FDA to speed up its timetable for potential emergency approval of the Pfizer/BioNTech vaccine from Saturday morning to later on Friday, according to the Post.

  Guardian
Friday...


Biden should replace Hahn.  I doubt he will.

...but hey, do what you want...you will anyway.

Tuesday, October 6, 2020

Your life is a pawn in Trump's game

Top White House officials are blocking strict new federal guidelines for the emergency release of a coronavirus vaccine, objecting to a provision that would almost certainly guarantee that no vaccine could be authorized before the election on Nov. 3, according to people familiar with the approval process.

Facing a White House blockade, the Food and Drug Administration is seeking other avenues to ensure that vaccines meet the guidelines. That includes sharing the standards — perhaps as soon as this week — with an outside advisory committee of experts that is supposed to meet publicly before any vaccine is authorized for emergency use. The hope is that the committee will enforce the guidelines, regardless of the White House’s reaction.

[...] 

The vaccine guidelines carry special significance: By refusing to allow the Food and Drug Administration to release them, the White House is undercutting the government’s effort to reassure the public that any vaccine will be safe and effective, health experts fear.

[...] 

A main sticking point has been the recommendation that volunteers who have participated in vaccine clinical trials be followed for a median of two months after the final dose before any authorization is granted, according to a senior administration official and others familiar with the situation, who spoke on the condition of anonymity. Given where the clinical trials stand, that two-month follow-up period would all but preclude any emergency clearance before Election Day.

[...]

Mr. Trump has repeatedly misrepresented how quickly a vaccine might be available to most Americans, promising a major breakthrough in vaccine development as early as this month. No clinical trial in the United States has yet advanced far enough to prove that any vaccine is safe and effective, although Pfizer, one vaccine developer, is hoping for interim results soon from its trial.

[...]

The Food and Drug Administration submitted the guidelines to the Office of Management and Budget for approval more than two weeks ago, but they stalled in the office of Mark Meadows, the White House chief of staff. Their approval is now seen as highly unlikely. 

  NYT

Let's revisit that story on Mark Meadows.
In addition to the two-month follow-up period, the guidelines stated that there should be at least five cases of severe infection in the placebo group as evidence that a vaccine is effective in preventing more than just mild to moderate illness. About 10 percent of Covid-19 cases are considered severe.

The guidelines also laid out the agency’s expectation that vaccine makers would continue to assess the long-term safety and efficacy of the drug, if granted emergency use authorization.

[...]

Some vaccine makers, including Johnson & Johnson, have publicly indicated that they will follow the agency’s recommendations, regardless of the White House’s actions.
Caveat emptor.

UPDATE: