Mr. Jones Is Already Back In His Seat, Today — In Tennessee, Mr. Pearson Will Be Voted Back In… Tomorrow.

And so… despite all the GOP’s Klux-Klanning, down there in Nashville — the whole thing is… all but over (except for the shouting).

It was however a very clear demonstration of “what Hinderaker’s GOP has become” (or perhaps reverted back into), though.

I know John is embarrassed by it — and his party’s devolvement… into pre-Reconstruction era politicking.

But he cannot say so, for being labeled disloyal to the Klanners in the party.

D a m n.

Good luck ever winning another national election, son.

The “Good Guys'” Amici Briefs Are Already On The Docket, In The 5th Cir.: Opposing Any Implementation of Kacsmaryk’s Loony Texas Order… Is Docketed.

As Hinderaker whines impotently about taxes on his own personal wealth (so big of him!)… we are pleased to offer some sanity — against Matthew Kacsmaryk’s lunacy down in Texas of last Friday night.

Do go read the brief. All of it.

After Dobbs, the Supremes made plain that it is to be a state by state decision, within the first two trimesters, as to whether a given state chooses to continue to allow abortion, and on what parameters. Of course, Matthew Kacsmaryk’s unhinged order of last Friday purports to take that right away from all states, nation wide — for at least half of all such procedures, since about 52% overall are now by pill, not invasive scrape. [And that pill is by far the safer way to go, not incidentally. A safer side effect profile, overall, than over-the-counter Tylenol.]

So the states have today filed in the Fifth Circuit, to join HHS, and explain that Kacsmaryk’s ruling ignores the plain commands of Dobbs, from the Supremes, last term.

You may read it all, here — but there is essentially zero chance, once the dust settles, that this nutty opinion will stand. I wanted to get out some solid legal arguments, as to why that is so — so that you all may repeat them to your friends who might claim the “right to life” is all that young Matthew Kacsmaryk sought to protect in Texas. That is simply… a lie. Here’s a bit:

…Although the Supreme Court, reversing longstanding precedent, concluded that the U.S. Constitution does not protect the right to obtain an abortion [in Dobbs], the Court endorsed the States’ authority to safeguard access to abortion for their residents, explaining that it was “return[ing] the issue of abortion to the people’s elected representatives.” Id. at 2243. The district court’s order could eviscerate the sovereign decisions of many amici States by disrupting access to mifepristone across the country, including in States where abortion is lawful….

Medication abortion promotes access to early abortion, when it is safest and least expensive, thereby reducing complication rates, decreasing costs, and easing burdens on the health care system overall. Medication abortion can also safely be provided in a variety of contexts and practice areas — for example, in a private physician’s office, an ob-gyn or family practice setting, or even at home with appropriate medical supervision. The availability of medication abortion within mainstream medical settings not only lifts constraints on access but also offers added privacy and security for both patients and providers — benefits that are particularly critical given persistent and escalating violence at abortion clinics….

[B]ecause carrying a pregnancy to term is 14 times more risky than early abortion [See National Acads. of Scis., Eng’g & Med., The Safety and Quality of Abortion Care in the United States 10, 55 (2018)], curtailing access to medication abortion would likely lead to a steep rise in birth-related mortality rates, worsening a crisis already disproportionately faced by Black women….

Let ALL our voices be clear as a ringing bell — in this night of one-eyed ignorance, and myopia: this is an e pluribus unum nation (many voices, one FDA).

We are not a nation ruled by a single, backward state (Texas and one judge’s supposed Roman Catholic religion… entering his chambers — and appearing in his judicial opinions) to effectively rule us all (just as young USDC Judge Bruce Drew Tipton had to learn two years ago, out of Texas, on dead hand provisions, on immigration). Each of the states have an equal, independent right to decide; and the FDA has nation-wide authority to allow doctors in every state to have access to abortion medications. Out.

नमस्ते

With A Likely Multi-Billion Dollar Zetia® Antitrust Trial Looming, Glenmark Said To Consider (Again) Selling Its API Businesses…

We are now less than two weeks away (with likely a week’s time, in court after official opening day — to get all the way to the opening of the first bits of actual evidence — and beyond just preliminaries and opening arguments) from what will almost certainly be a multi-billion dollar civil antitrust class action trial against Glenmark, and Merck — in what is alleged as a “pay to delay” scheme.

In this decade long action, Glenmark was an API supplier, and a potential generic market entrant, that agreed to delay its US entry with a ezetimibe agent — in return for hundreds of millions, from Merck (and earlier, legacy Schering-Plough).

This morning we read that Glenmark may exit its API business in total, to pay down debt coming due, in India. Here is Fierce Pharma’s latest — ever on the case — on it all:

…Facing a debt problem in 2019, Glenmark considered selling off its active pharmaceutical ingredient (API) business before opting instead for a spinoff.

Four years later, with the same debt issues, Glenmark is taking another look at selling its stake in the API business, called Glenmark Life Sciences. The Indian pharma company has contacted potential buyers and has hired Kotak Mahindra Capital to oversee the potential sale, sources told news outlet Mint.

Glenmark is looking to sell off a majority stake in the API subsidiary. The company owns 82% of the business. The company was already required to sell a part of Glenmark Life Sciences by August of 2024, according to Mint, to reach a 75% ownership threshold required by Indian regulators….

Now you know… time for another warm sunny bike ride, by the clear lake waters… smile.

नमस्ते

Hinderaker Again, Knifing Tangerine, Tonight. Delicious.

I will just drop a link to this one, and… laugh. No sane human thought it would end any other way.

Which is why Hinderaker thought he was… a serious preznit.

Few others ever did (privately).

That is now plain.

But they ALL rode him — to their deplorable ends. Especially the Powerline boys.

Now Trump is solely burnt flesh — by his own career of endless… criminality.

So to quickly pivot away from his own awful judgment, Hinderaker goes on to complain about… the Fed.

What a feckless… tool. Damn.

Hilarious.

If The Settlement Discussions Aren’t Finalized By Then, A “FINAL” Pretrial Conference Will Be Held Before The Judge On July 6, 2023 In Lanham Act: Merck v. Merck.

The parties here have been discussing settlement on and off, for over two years now.

But no signed agreements have resulted — despite numerous conferences, in person — with the able Magistrate in NJDC. So, to move them along, the court has set a July 6, 2023 pretrial date. That would be the moment when each side must answer “ready for trial” — or explain why, after nearly a decade in motion practice… one or the other is NOT ready.

Indeed, this is mostly just to impress on both sides… that a trial will occur this summer if they don’t come to terms, and soon. So this was entered this afternoon, on the federal docket, in Newark:

…TEXT ORDER:

Final Pretrial Conference set for 7/6/2023 at 11:00 a.m. in Newark – Courtroom 2C. Trial counsel must be present at the conference. The parties shall jointly file a proposed final pretrial order by 6/22/2023. The parties shall mail a tabbed courtesy copy to Chambers by 6/22/2023. Please mark your calendar accordingly.

So Ordered by Magistrate Judge Michael A. Hammer on 4/10/2023….

Onward, grinning on a lovely Spring afternoon — to now ride a mountain bike, by the crystal clear lake waters. First of the season!

नमस्ते

Hinderaker: That “Structural Advantage”? It Is… Saner, More Humane… Policies. Period.

This afternoon, Hinderaker whines that the Democratic Party in the US has an unfair “structural” advantage. He means that there are more people — especially young people — registering as new Democrats, than GOP members. In fact, many GOP party members are… dying off.

But again — senile, bitter old John lacks reasoning capacity: the “root cause” of that state of affairs… is the GOP’s five decades now of intentional cruelty.

Cruelty, and failed fiscal management.

A lethal combination.

So… get used to… losing, Hinderaker. And losing… a lot, more. [I’ve graciously ignored all the typos in his quoted source — his own 501(c)(3) / hard right think tank. Here’s a hint — “don’t use possessive when you mean the plural case. It is difficult to take such ignorance seriously, on any point of policy, then.” Cheers.]

Out.

The Letter, In Full — As Signed By Merck And Pfizer CEOs: In Support Of FDA — Given Kacsmaryk’s Crazy Texas Ruling Friday.

At the moment, around 2:20 pm Eastern on Monday, there are over 500 signatures to the letter, from all corners of the life sciences industry, in the US and globally.

Of course, the CEOs are the headliners, and both Merck and Pfizer have confirmed their CEOs signatures are genuine. Here’s that letter, in full. [Along with many other life science attorneys, I have also added my name.]

…In Support of FDA’s Authority to Regulate Medicines

On Friday, April 7, a federal judge with no scientific training fundamentally undermined the bipartisan authority granted by Congress to the Food and Drug Administration to approve and regulate safe, effective medicines for every American.

District Judge Matthew Kacsmaryk issued a decision that overturns the FDA’s 23-year old approval of mifepristone, the primary medicine used in abortion and miscarriage care, and which has been proven by decades of data to be safer than Tylenol, nearly all antibiotics and insulin.

The decision ignores decades of scientific evidence and legal precedent. Judge Kacsmaryk’s act of judicial interference has set a precedent for diminishing FDA’s authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry. As an industry we count on the FDA’s autonomy and authority to bring new medicines to patients under a reliable regulatory process for drug evaluation and approval. Adding regulatory uncertainty to the already inherently risky work of discovering and developing new medicines will likely have the effect of reducing incentives for investment, endangering the innovation that characterizes our industry.

Judicial activism will not stop here. If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone. While the drug development, approval and monitoring process is not perfect, the Agency’s framework has resulted in decades of unsurpassed medical innovation and in statutory mechanisms to remove drugs from the market if, among other reasons, they fail to maintain the anticipated safety and efficacy profile.

As an industry dedicated to improving human health, and as members of the biopharma industry, we add our signatures to this letter and stand together to unequivocally support the continued authority of the FDA to regulate new medicines.

In the face of laws and rulings that aim to undermine the evidence-based and legislatively sanctioned authority of federally mandated institutions such as FDA to protect public interests, and by putting an entire industry focused on medical innovation at risk, we cannot stay quiet. We call for the reversal of this decision to disregard science, and the appropriate restitution of the mandate for the safety and efficacy of medicines for all with the FDA, the agency entrusted to do so in the first place….

Now you know — J&J and Lilly and Amgen are also confirmed as signers, this afternoon. Onward.

नमस्ते

I Think The Boys Have Now Written… At Least FIVE Pieces, On Which Watered-Down Beer Is… Ideologically Acceptable.

Tell me you have become an irrelevant old whyte men’s embittered media outlet, without telling me you’re now an irrelevant old whyte men’s embittered media outlet department:

The boys have at least five posts up, about the unmitigated horrors of Bud Light… being inclusive.

Okay. You guys are so… um… badass! Or… not.

Steve even went so far as to recommend Coors Light, as a more philosophically-pure version of watered down swill — encouraging a brand switch… somewhere on the site (can’t find it now, nor will I waste another second looking for it).

Which is particularly hilarious — because Coors Light is a very proud sponsor of both the NY version and the Chicago version of Gay Pride each year.

All of which brings me to my only real point here: these embittered old jumokes will soon not have a single national brand of soft drinks, clothing, shoes, hats, cars, toothpastes, beers or wines… or for that matter… toilet paper and bedding… they deem “acceptable“.

What then?

Will the boys and their chuckleheaded followers… knit their own clothes from raw wool from sheep raised exclusively on Posse Committatus land, and beef, fed only non-industrial / Cargill feed, in mountainous Idaho and Washington State? Will only Neo-Nazi goods and services suffice?! Will they distill their own moonshine and brew their own bathtub beers?! Will they only watch Soviet sporting events?!

I know. They won’t. But… they will die off, soon enough. Or be put in nursing homes, by their now middle aged adult offspring — who will have grown utterly exasperated with their lunacy and senility.

And that… will be a form or rough justice, boys.

Out.

“Two-For-One!”: Mirengoff’s Off His Nut Tonight, Too!

This must be the Easter / Passover “reckoning effect” — for both Hinderaker and Mirengoff, just under differing covenants of faith, having heard from their respective preacher / rabbi this weekend — about what they each owe their fellow humans (under each covenant).

Charming; the previous one below was on John — while these two topics are… Paul’s (as at right, and below). Mirengoff leaves his readers with the false impression tonight that the Biden administration is considering ignoring the moronic ruling at right. That is false.

The government has already appealed it; and the USDC Judge stayed his own ruling, in any event — on his own. Moreover, the state of Washington and at least 20 other states will abide by a federal court ruling there affirming that the FDA is indeed empowered to regulate 23 year old on market drugs, not Texas nut jobs in robes — who’ve benefited wildly from forum shopping. So — shut it Paul.

Next he complains that the Vice President is supporting acts that are inconsistent with prosecuting insurrection.

D A M N.

Again, Paul — these were legislators. They were ELECTED by the people of Tennessee. Their job is to protest for more responsible laws, from the GOP super-majority there.

You and Scott and John and Steve would take that right from them, primarily because the gun lobby pays you malignant idiots too much.

I know you know better. You well know that the floors of legislatures are among the purest of free expression zones in the nation. And you know that one cannot “break and enter” there, when it is in session… AND ALL THREE WERE MEMBERS in good stead. This is quite different from a riot where Ashli Babbitt was killed by mob felony murder, while vigilantes stormed our Capitol.

These elected reps will be reseated again, within a few weeks. It is the job the people elected them to do — to oppose super-majority tyranny.

You did see that at least one liberal activist is going to release the details of each GOP members’ mistresses and affair partners… (having received the same in Tennessee) should the GOP try to oppose the two young mens’ re-appointment to their seats… you saw that, right?

To be clear… I don’t approve.

But I understand. When the (national and Tennessee) GOP goes low… like last week… it must notice that not all local Democrats will be as gracious as Michelle Obama, and go high.

So — yes, keep up with the false analogies. See where it gets you, oh Tennessee GOP-ers. Besides divorce court, and about ten years of alimony payments.