Connect with us

Business

Column: A Trump judge slaps down Big Pharma's attack on Biden's drug price cuts

Published

on

Column: A Trump judge slaps down Big Pharma's attack on Biden's drug price cuts

The pharmaceutical industry’s all-out attack on President Biden’s drug negotiation initiative for Medicare — comprising nine federal lawsuits (so far) and lots of heavy breathing by lobbyists — has just run into a major snag.

That it came from a judge appointed by Donald Trump is just one of its man-bites-dog aspects. Another is the forceful skepticism expressed by a federal judge in normally business-friendly Delaware in his ruling, issued March 1 against the British drugmaker AstraZeneca.

“Understandably, drug manufacturers like AstraZeneca don’t like the IRA,” wrote Judge Colm F. Connolly, referring to the Inflation Reduction Act of 2022, which authorized Medicare to negotiate with drugmakers over how much it would pay for prescription drugs taken by its enrollees.

No one is entitled to sell the Government drugs at prices the Government won’t agree to pay.

— Federal Judge Colm F. Connolly

Advertisement

“Lower prices mean lower profits,” Connolly continued. “Drug manufacturers like AstraZeneca desire the old pricing regime, and they lobbied and perhaps expected Congress not to pass the IRA in 2022.”

However, he wrote, “No one is entitled to sell the Government drugs at prices the Government won’t agree to pay.”

Connolly tossed out the lawsuit by granting the government summary judgment. His opinion has no sway over the federal judges hearing the other lawsuits, which have been brought by Merck, Johnson & Johnson, Novo Nordisk, Bristol Myers Squibb, Novartis, Boehringer Ingelheim, the industry lobbying arm Phrma and the U.S. Chamber of Commerce.

But his opinion can serve as a window into how the other judges might view those lawsuits, most of which bear such strong resemblance to AstraZeneca’s that they might all have been spit out by ChatGPT if it were asked to draft any industry lawsuit over any distasteful government regulation.

That makes it a useful counterbalance to the claims in those cases, which I earlier described as “windows into the mind of Big Pharma, revealing the industry’s grotesque level of entitlement and its cynical exploitation of Americans’ desire for better healthcare in order to claim profits well beyond the level that any thinking person would consider moral.” Those cases have been filed in federal courts in Ohio, New Jersey and the District of Columbia.

Advertisement

So let’s take a closer look. First, a word about the judge. He doesn’t appear to be cut from the same cloth as some Trump-appointed judges who have given the federal judiciary something of a bozoid flavor, such as James Ho of the 5th Circuit Court of Appeals in New Orleans or Matthew Kaczmarek of the Northern District of Texas, sitting in Amarillo, who have riled the legal system with extreme right-wing rulings.

A former U.S. attorney in Delaware under George W. Bush, Connolly is the chief judge of his district. His ruling in the AstraZeneca case comes as a meticulously researched analysis of the issues and the legal background. That doesn’t mean it will stand up as higher courts ponder AstraZeneca’s inevitable appeal.

A quick primer on the IRA’s Medicare negotiation initiative will be useful here. This implemented a long-cherished idea of drug price reformers, which is to give Medicare, the largest buyer of prescription drugs, the right to dicker over prices with drugmakers, overcoming a prohibition that Congress imposed on Medicare in 2003, when it created Medicare’s Part D prescription drug benefit.

The negotiation system also applies to drugs administered to patients under Medicare Part B, which typically are administered in hospitals or doctors’ offices, not at home. Medicaid can also benefit from price cuts reached through the Medicare process. Here’s how it works:

In September, the Department of Health and Human Services compiled a list of 10 branded, non-generic drugs from the roster of those on which Medicare spends the most; 30 more drugs will be added in 2025 and 2026, and more in subsequent years.

Advertisement

Drug companies have 30 days after the selection to agree to negotiations on a price, which must be at least a 25% to 60% discount from a drug’s average price on the non-federal market. For the first round, the negotiation process will last through July, with prices to take effect in 2026.

Companies that refuse to participate in this process or reject Medicare’s designation of a “fair” price will be subject to an excise tax starting at 65% of a drug’s U.S. sales and rising over time to 95%. To avoid the penalty, those companies have the option of pulling out of Medicare and Medicaid entirely.

AstraZeneca filed its lawsuit in August 2023. That was before HHS named the first 10 drugs to be negotiated, so the company couldn’t assume it would be directly affected by the program.

But it plainly had an inkling that its diabetes and kidney disease drug Farxiga would be on the list, because Medicare was spending about $3.3 billion a year to provide it to about 800,000 patients, so it mentioned the drug in its legal complaint, almost in passing. When Farxiga indeed was named as one of the first 10 drugs, the company amended its complaint with a three-word change to bring it up to date. About a week later, the company agreed to participate in the negotiation process, though it continued to pursue the lawsuit. I believe this is known in courthouse corridors as “hedging your bets.”

In its lawsuit, AstraZeneca asserts that the negotiation process hurts it in several ways — assertions aimed at showing that the company suffered concrete injuries from the IRA, the threshold established by the Constitution for allowing lawsuits to be heard in federal court — the principle known as “standing.”

Advertisement

The company claimed that the government’s plan to treat all permutations of a drug, including the conditions it can be used to treat, as a single drug will sap it of the incentive to search for new uses, “which in turn will narrow patient access to new treatments.” It also said that its “decision-making about other drugs” will be affected by the government’s negotiation rules, in part because how the negotiations will unfold is so uncertain “we don’t know the impact” of the process “on our ability to negotiate.”

Connolly found both claims to be too vague to give AstraZeneca standing. In any event, he wrote, AstraZeneca plainly does know how the negotiations will be conducted, since it described the process in detail in its 44-page legal complaint and 100 pages of briefs.

“The only uncertainty,” Connolly found, “comes from the filing of this lawsuit,” which calls for the IRA to be found unconstitutional. That won’t do, he observed. “A plaintiff,” he wrote, “cannot create standing to file a suit by filing the suit.”

The meat of AstraZeneca’s case is its contention that the negotiation provision of the IRA represents government coercion — that the threat of penalizing drugmakers with steep taxes for not coming to the negotiating table is tantamount to “a gun to the head.”

Connolly dismissed that out of hand by pointing to a flaw in the argument remarked on by other legal experts: For drug companies, selling their products to Medicare is an entirely voluntary choice. No law requires them to participate.

Advertisement

It’s true, as he noted, that by commanding 40% of the prescription drug market in the U.S. — nearly 50%, including Medicaid — Medicare is a customer crucial, perhaps even indispensable, to every drug company’s business model.

But here’s the trade-off: Reaching the 49 million Medicare and Medicaid members provides an incentive that the government is fully within its rights to use to extract better prices from the manufacturers. There’s “nothing sinister” about it, Connolly wrote.

He’s right, of course. It’s not as if drug companies themselves haven’t used their monopoly rights over blockbuster drugs to demand parasitic prices for those products. That’s the impulse, after all, that drove Gilead Sciences in 2015 to demand $100,000 per treatment for Harvoni, its miracle cure for hepatitis C, when it could have made a healthy profit at half that price, or less. AstraZeneca, by the way, reported an operating profit of $14.5 billion in its 2023 fiscal year on revenue of nearly $46 billion.

Aware that Connolly’s ruling might be used as a road map by the judges hearing the other drug industry lawsuits, HHS Secretary Xavier Becerra made sure that it was entered into the record in the other courts. One can expect the other plaintiffs to do what they can to distinguish their claims from AstraZeneca’s.

Merck, which was the first to sue to overturn the IRA, responded promptly. On Monday, it notified the judge in its case that it “does not assert a right to sell its drugs to Medicare at a market price; rather, it asserts a right not to be compelled to sell its drugs to Medicare at the government-dictated price.” (Emphasis Merck’s.)

Advertisement

To non-lawyers, this may seem to cut the baloney mighty thin. To lawyers, perhaps it cuts to the essence of the case. One way or another, it’s a signal that the pharmaceutical industry isn’t about to give up. Why would it, with billions of dollars at stake, never mind access to life-giving drugs for millions of Americans.

Business

U.S. Space Force awards $1.6 billion in contracts to South Bay satellite builders

Published

on

U.S. Space Force awards .6 billion in contracts to South Bay satellite builders

The U.S. Space Force announced Friday it has awarded satellite contracts with a combined value of about $1.6 billion to Rocket Lab in Long Beach and to the Redondo Beach Space Park campus of Northrop Grumman.

The contracts by the Space Development Agency will fund the construction by each company of 18 satellites for a network in development that will provide warning of advanced threats such as hypersonic missiles.

Northrop Grumman has been awarded contracts for prior phases of the Proliferated Warfighter Space Architecture, a planned network of missile defense and communications satellites in low Earth orbit.

The contract announced Friday is valued at $764 million, and the company is now set to deliver a total of 150 satellites for the network.

Advertisement

The $805-million contract awarded to Rocket Lab is its largest to date. It had previously been awarded a $515 million contract to deliver 18 communications satellites for the network.

Founded in 2006 in New Zealand, the company builds satellites and provides small-satellite launch services for commercial and government customers with its Electron rocket. It moved to Long Beach in 2020 from Huntington Beach and is developing a larger rocket.

“This is more than just a contract. It’s a resounding affirmation of our evolution from simply a trusted launch provider to a leading vertically integrated space prime contractor,” said Rocket Labs founder and chief executive Peter Beck in online remarks.

The company said it could eventually earn up to $1 billion due to the contract by supplying components to other builders of the satellite network.

Also awarded contracts announced Friday were a Lockheed Martin group in Sunnyvalle, Calif., and L3Harris Technologies of Fort Wayne, Ind. Those contracts for 36 satellites were valued at nearly $2 billion.

Advertisement

Gurpartap “GP” Sandhoo, acting director of the Space Development Agency, said the contracts awarded “will achieve near-continuous global coverage for missile warning and tracking” in addition to other capabilities.

Northrop Grumman said the missiles are being built to respond to the rise of hypersonic missiles, which maneuver in flight and require infrared tracking and speedy data transmission to protect U.S. troops.

Beck said that the contracts reflects Rocket Labs growth into an “industry disruptor” and growing space prime contractor.

Advertisement
Continue Reading

Business

California-based company recalls thousands of cases of salad dressing over ‘foreign objects’

Published

on

California-based company recalls thousands of cases of salad dressing over ‘foreign objects’

A California food manufacturer is recalling thousands of cases of salad dressing distributed to major retailers over potential contamination from “foreign objects.”

The company, Irvine-based Ventura Foods, recalled 3,556 cases of the dressing that could be contaminated by “black plastic planting material” in the granulated onion used, according to an alert issued by the U.S. Food and Drug Administration.

Ventura Foods voluntarily initiated the recall of the product, which was sold at Costco, Publix and several other retailers across 27 states, according to the FDA.

None of the 42 locations where the product was sold were in California.

Ventura Foods said it issued the recall after one of its ingredient suppliers recalled a batch of onion granules that the company had used n some of its dressings.

Advertisement

“Upon receiving notice of the supplier’s recall, we acted with urgency to remove all potentially impacted product from the marketplace. This includes urging our customers, their distributors and retailers to review their inventory, segregate and stop the further sale and distribution of any products subject to the recall,” said company spokesperson Eniko Bolivar-Murphy in an emailed statement. “The safety of our products is and will always be our top priority.”

The FDA issued its initial recall alert in early November. Costco also alerted customers at that time, noting that customers could return the products to stores for a full refund. The affected products had sell-by dates between Oct. 17 and Nov. 9.

The company recalled the following types of salad dressing:

  • Creamy Poblano Avocado Ranch Dressing and Dip
  • Ventura Caesar Dressing
  • Pepper Mill Regal Caesar Dressing
  • Pepper Mill Creamy Caesar Dressing
  • Caesar Dressing served at Costco Service Deli
  • Caesar Dressing served at Costco Food Court
  • Hidden Valley, Buttermilk Ranch
Continue Reading

Business

They graduated from Stanford. Due to AI, they can’t find a job

Published

on

They graduated from Stanford. Due to AI, they can’t find a job

A Stanford software engineering degree used to be a golden ticket. Artificial intelligence has devalued it to bronze, recent graduates say.

The elite students are shocked by the lack of job offers as they finish studies at what is often ranked as the top university in America.

When they were freshmen, ChatGPT hadn’t yet been released upon the world. Today, AI can code better than most humans.

Top tech companies just don’t need as many fresh graduates.

“Stanford computer science graduates are struggling to find entry-level jobs” with the most prominent tech brands, said Jan Liphardt, associate professor of bioengineering at Stanford University. “I think that’s crazy.”

Advertisement

While the rapidly advancing coding capabilities of generative AI have made experienced engineers more productive, they have also hobbled the job prospects of early-career software engineers.

Stanford students describe a suddenly skewed job market, where just a small slice of graduates — those considered “cracked engineers” who already have thick resumes building products and doing research — are getting the few good jobs, leaving everyone else to fight for scraps.

“There’s definitely a very dreary mood on campus,” said a recent computer science graduate who asked not to be named so they could speak freely. “People [who are] job hunting are very stressed out, and it’s very hard for them to actually secure jobs.”

The shake-up is being felt across California colleges, including UC Berkeley, USC and others. The job search has been even tougher for those with less prestigious degrees.

Eylul Akgul graduated last year with a degree in computer science from Loyola Marymount University. She wasn’t getting offers, so she went home to Turkey and got some experience at a startup. In May, she returned to the U.S., and still, she was “ghosted” by hundreds of employers.

Advertisement

“The industry for programmers is getting very oversaturated,” Akgul said.

The engineers’ most significant competitor is getting stronger by the day. When ChatGPT launched in 2022, it could only code for 30 seconds at a time. Today’s AI agents can code for hours, and do basic programming faster with fewer mistakes.

Data suggests that even though AI startups like OpenAI and Anthropic are hiring many people, it is not offsetting the decline in hiring elsewhere. Employment for specific groups, such as early-career software developers between the ages of 22 and 25 has declined by nearly 20% from its peak in late 2022, according to a Stanford study.

It wasn’t just software engineers, but also customer service and accounting jobs that were highly exposed to competition from AI. The Stanford study estimated that entry-level hiring for AI-exposed jobs declined 13% relative to less-exposed jobs such as nursing.

In the Los Angeles region, another study estimated that close to 200,000 jobs are exposed. Around 40% of tasks done by call center workers, editors and personal finance experts could be automated and done by AI, according to an AI Exposure Index curated by resume builder MyPerfectResume.

Advertisement

Many tech startups and titans have not been shy about broadcasting that they are cutting back on hiring plans as AI allows them to do more programming with fewer people.

Anthropic Chief Executive Dario Amodei said that 70% to 90% of the code for some products at his company is written by his company’s AI, called Claude. In May, he predicted that AI’s capabilities will increase until close to 50% of all entry-level white-collar jobs might be wiped out in five years.

A common sentiment from hiring managers is that where they previously needed ten engineers, they now only need “two skilled engineers and one of these LLM-based agents,” which can be just as productive, said Nenad Medvidović, a computer science professor at the University of Southern California.

“We don’t need the junior developers anymore,” said Amr Awadallah, CEO of Vectara, a Palo Alto-based AI startup. “The AI now can code better than the average junior developer that comes out of the best schools out there.”

To be sure, AI is still a long way from causing the extinction of software engineers. As AI handles structured, repetitive tasks, human engineers’ jobs are shifting toward oversight.

Advertisement

Today’s AIs are powerful but “jagged,” meaning they can excel at certain math problems yet still fail basic logic tests and aren’t consistent. One study found that AI tools made experienced developers 19% slower at work, as they spent more time reviewing code and fixing errors.

Students should focus on learning how to manage and check the work of AI as well as getting experience working with it, said John David N. Dionisio, a computer science professor at LMU.

Stanford students say they are arriving at the job market and finding a split in the road; capable AI engineers can find jobs, but basic, old-school computer science jobs are disappearing.

As they hit this surprise speed bump, some students are lowering their standards and joining companies they wouldn’t have considered before. Some are creating their own startups. A large group of frustrated grads are deciding to continue their studies to beef up their resumes and add more skills needed to compete with AI.

“If you look at the enrollment numbers in the past two years, they’ve skyrocketed for people wanting to do a fifth-year master’s,” the Stanford graduate said. “It’s a whole other year, a whole other cycle to do recruiting. I would say, half of my friends are still on campus doing their fifth-year master’s.”

Advertisement

After four months of searching, LMU graduate Akgul finally landed a technical lead job at a software consultancy in Los Angeles. At her new job, she uses AI coding tools, but she feels like she has to do the work of three developers.

Universities and students will have to rethink their curricula and majors to ensure that their four years of study prepare them for a world with AI.

“That’s been a dramatic reversal from three years ago, when all of my undergraduate mentees found great jobs at the companies around us,” Stanford’s Liphardt said. “That has changed.”

Advertisement
Continue Reading

Trending