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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
“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.
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.
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.”
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.
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.)
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.
Scott Bessent, the billionaire hedge fund manager whom President-elect Donald J. Trump picked to be his Treasury secretary, plans to divest from dozens of funds, trusts and investments in preparation to become the nation’s top economic policymaker.
Those plans were released on Saturday along with the publication of an ethics agreement and financial disclosures that Mr. Bessent submitted ahead of his Senate confirmation hearing next Thursday.
The documents show the extent of the wealth of Mr. Bessent, whose assets and investments appear to be worth in excess of $700 million. Mr. Bessent was formerly the top investor for the billionaire liberal philanthropist George Soros and has been a major Republican donor and adviser to Mr. Trump.
If confirmed as Treasury secretary, Mr. Bessent, 62, will steer Mr. Trump’s economic agenda of cutting taxes, rolling back regulations and imposing tariffs as he seeks to renegotiate trade deals. He will also play a central role in the Trump administration’s expected embrace of cryptocurrencies such as Bitcoin.
Although Mr. Trump won the election by appealing to working-class voters who have been dogged by high prices, he has turned to wealthy Wall Street investors such as Mr. Bessent and Howard Lutnick, a billionaire banker whom he tapped to be commerce secretary, to lead his economic team. Linda McMahon, another billionaire, has been picked as education secretary, and Elon Musk, the world’s richest man, is leading an unofficial agency known as the Department of Government Efficiency.
In a letter to the Treasury Department’s ethics office, Mr. Bessent outlined the steps he would take to “avoid any actual or apparent conflict of interest in the event that I am confirmed for the position of secretary of the Department of Treasury.”
Mr. Bessent said he would shutter Key Square Capital Management, the investment firm that he founded, and resign from his Bessent-Freeman Family Foundation and from Rockefeller University, where he has been chairman of the investment committee.
The financial disclosure form, which provides ranges for the value of his assets, reveals that Mr. Bessent owns as much as $25 million of farmland in North Dakota, which earns an income from soybean and corn production. He also owns a property in the Bahamas that is worth as much as $25 million. Last November, Mr. Bessent put his historic pink mansion in Charleston, S.C., on the market for $22.5 million.
Mr. Bessent is selling several investments that could pose potential conflicts of interest including a Bitcoin exchange-traded fund; an account that trades the renminbi, China’s currency; and his stake in All Seasons, a conservative publisher. He also has a margin loan, or line of credit, with Goldman Sachs of more than $50 million.
As an investor, Mr. Bessent has long wagered on the rising strength of the dollar and has betted against, or “shorted,” the renminbi, according to a person familiar with Mr. Bessent’s strategy who spoke on condition of anonymity to discuss his portfolio. Mr. Bessent gained notoriety in the 1990s by betting against the British pound and earning his firm, Soros Fund Management, $1 billion. He also made a high-profile bet against the Japanese yen.
Mr. Bessent, who will be overseeing the U.S. Treasury market, holds over $100 million in Treasury bills.
Cabinet officials are required to divest certain holdings and investments to avoid the potential for conflicts of interest. Although this can be an onerous process, it has some potential tax benefits.
The tax code contains a provision that allows securities to be sold and the capital gains tax on such sales deferred if the full proceeds are used to buy Treasury securities and certain money-market funds. The tax continues to be deferred until the securities or money-market funds are sold.
Even while adhering to the ethics guidelines, questions about conflicts of interest can still emerge.
Mr. Trump’s Treasury secretary during his first term, Steven Mnuchin, divested from his Hollywood film production company after joining the administration. However, as he was negotiating a trade deal in 2018 with China — an important market for the U.S. film industry — ethics watchdogs raised questions about whether Mr. Mnuchin had conflicts because he had sold his interest in the company to his wife.
Mr. Bessent was chosen for the Treasury after an internal tussle among Mr. Trump’s aides over the job. Mr. Lutnick, Mr. Trump’s transition team co-chair and the chief executive of Cantor Fitzgerald, made a late pitch to secure the Treasury secretary role for himself before Mr. Trump picked him to be Commerce secretary.
During that fight, which spilled into view, critics of Mr. Bessent circulated documents disparaging his performance as a hedge fund manager.
Mr. Bessent’s most recent hedge fund, Key Square Capital, launched to much fanfare in 2016, garnering $4.5 billion in investor money, including $2 billion from Mr. Soros, but manages much less now. A fund he ran in the early 2000s had a similarly unremarkable performance.
When devastating wildfires erupted across Los Angeles County this week, David Torgerson’s team of firefighters went to work.
The thousands of city, county and state firefighters dispatched to battle the blazes went wherever they were needed. The crews from Torgerson’s Wildfire Defense Systems, however, set out for particular addresses. Armed with hoses, fire-blocking gel and their own water supply, the Montana-based outfit contracts with insurance companies to defend the homes of customers who buy policies that include their services.
It’s a win-win if the private firefighters succeed in saving a home, said Torgerson, the company’s founder and executive chairman. The homeowner keeps their home and the insurance company doesn’t have to make a hefty payout to rebuild.
“It makes good sense,” he said. “It’s always better if the homes and businesses don’t burn.”
Torgerson’s operation, which has been contracting with insurance companies since 2008 and employs hundreds of firefighters, engineers and other staff, highlights a lesser-known component of fighting wildfires in the U.S. Along with the more than 7,500 publicly funded firefighters and emergency personnel dispatched to the current conflagrations, which have burned more than 30,000 acres and destroyed more than 9,000 structures, a smaller force of for-hire professionals is on the fire lines for insurance companies, wealthy individual property owners or government agencies in need of additional hands.
Their presence isn’t without controversy. Private firefighters hired by homeowners directly have drawn criticism for heightening class divides during disasters. This week, a Pacific Palisades homeowner received backlash for putting a call out on X, the social media site formerly named Twitter, for help finding private firefighters who could save his home.
“Does anyone have access to private firefighters to protect our home in Pacific Palisades? Need to act fast here. All neighbors houses burning,” he wrote in the since-deleted post. “Will pay any amount.”
“The epitome of nerve and tone deaf!” someone replied.
In 2018, Kim Kardashian and Kanye West credited private firefighters for saving their $60-million home in the Santa Monica mountains during a wildfire. But those who serve wealthy clients make up only a small fraction of nonpublic firefighters, according to Torgerson.
“Contract firefighters who are hired by the government are the vast majority,” he said. The federal government has been hiring private firefighters since the 1980s to support its own forces. According to the National Wildfire Suppression Assn., there are about 250 private sector fire response companies under federal contract, adding about 10,000 firefighters to U.S. efforts.
Some private firefighting companies, including Wildfire Defense Systems, are known as Qualified Insurance Resources and are paid by insurance companies to protect the homes of their customers. Wildfire Defense Systems refers to its on-the-ground forces as private sector wildfire personnel.
Wildfire Defense Systems only works with the insurance industry, but other privately held firefighting companies contract with industrial clients such as petrochemical facilities and utility providers. Wildfire Defense Systems declined to disclose company revenue or what it charges for its services.
Allied Disaster Defense, a company that has sent personnel to the fires in Los Angeles, offers services to both property owners and insurance companies. Its website says its services will “enhance the insurability of properties” and “contribute to reduced claims.”
The website also has a page dedicated to services for private clients, which include emergency response and assistance with insurance claims for “high net-worth and celebrity” customers. The company does not list prices for its services and has nondisclosure agreements with its private clients.
Several other private firefighting companies are based in California, including Mt. Adams Wildfire, which contracts with government agencies, and UrbnTek, which serves Los Angeles, Orange County and San Diego among other areas. Along with spraying fire retardant on trees and brush to stop an advancing fire, the company offers “a double layer of protection by wrapping a structure with our fire blanket system.”
Torgerson, a civil engineer with 34 years in emergency services, said he has been struck by the speed of the current wildfires. While typically it takes two to 10 minutes for a fire to sweep through a home, he said, the Palisades fire is traveling at higher speeds.
“It’s moving so fast, it’ll likely take one to two minutes for these fires to pass over the properties,” he said.
He said his company responded to all 62 of the wildfires that threatened structures in California in 2024 and didn’t lose a property.
This year just got started, but it is already shaping up nicely for U.S. airlines.
After several setbacks, the industry ended 2024 in a fairly strong position because of healthy demand for tickets and the ability of several airlines to control costs and raise fares, experts said. Barring any big problems, airlines — especially the largest ones — should enjoy a great year, analysts said.
“I think it’s going to be pretty blue skies,” said Tom Fitzgerald, an airline industry analyst for the investment bank TD Cowen.
In recent weeks, many major airlines upgraded forecasts for the all-important last three months of the year. And on Friday, Delta Air Lines said it collected more than $15.5 billion in revenue in the fourth quarter of 2024, a record.
“As we move into 2025, we expect strong demand for travel to continue,” Delta’s chief executive, Ed Bastian, said in a statement. That put the airline on track to “deliver the best financial year in Delta’s 100-year history,” he said.
The airline also beat analysts’ profit estimates and said it expected earnings per share, a measure of profitability, to rise more than 10 percent this year.
Delta’s upbeat report offers a preview of what are expected to be similarly rosy updates from other carriers that will report earnings in the next few weeks. That should come as welcome news to an industry that has been stifled by various challenges even as demand for travel has rocketed back after the pandemic.
“For the last five years, it’s felt like every bird in the sky was a black swan,” said Ravi Shanker, an analyst focused on airlines at Morgan Stanley. “But it appears that this industry does have its ducks in a row.”
That is, of course, if everything goes according to plan, which it rarely does. Geopolitics, terrorist attacks, air safety problems and, perhaps most important, an economic downturn could tank demand for travel. Rising costs, particularly for jet fuel, could erode profits. Or the industry could face problems like a supply chain disruption that limits availability of new planes or makes it harder to repair older ones.
Early last year, a panel blew off a Boeing 737 Max during an Alaska Airlines flight, resurfacing concerns about the safety of the manufacturer’s planes, which are used on most flights operated by U.S. airlines, according to Cirium, an aviation data firm.
The incident forced Boeing to slow production and delay deliveries of jets. That disrupted the plans of some airlines that had hoped to carry more passengers. And there was little airlines could do to adjust because the world’s largest jet manufacturer, Airbus, didn’t have the capacity to pick up the slack — both it and Boeing have long order backlogs. In addition, some Airbus planes were afflicted by an engine problem that has forced carriers to pull the jets out of service for inspections.
There was other tumult, too. Spirit Airlines filed for bankruptcy. A brief technology outage wreaked havoc on many airlines, disrupting travel and resulting in thousands of canceled flights in the heart of the busy summer season. And during the summer, smaller airlines flooded popular domestic routes with seats, squeezing profits during what is normally the most lucrative time of year.
But the industry’s financial position started improving when airlines reduced the number of flights and seats. While that was bad for travelers, it lifted fares and profits for airlines.
“You’re in a demand-over-supply imbalance, which gives the industry pricing power,” said Andrew Didora, an analyst at the Bank of America.
At the same time, airlines have been trying to improve their businesses. American Airlines overhauled a sales strategy that had frustrated corporate customers, helping it win back some travelers. Southwest Airlines made changes aimed at lowering costs and increasing profits after a push by the hedge fund Elliott Management. And JetBlue Airways unveiled a strategy with similar aims, after a less contentious battle with the investor Carl C. Icahn.
Those improvements and industry trends, along with the stabilization of fuel, labor and other costs, have created the conditions for what could be a banner 2025. “All of this is the best setup we’ve had in decades,” Mr. Shanker said.
That won’t materialize right away, though. Travel demand tends to be subdued in the winter. But business trips pick up somewhat, driven by events like this week’s Consumer Electronics Show in Las Vegas.
The positive outlook for 2025 is probably strongest for the largest U.S. airlines — Delta, United and American. All three are well positioned to take advantage of buoyant trends, including steadily rebounding business travel and customers who are eager to spend more on better seats and international flights.
But some smaller airlines may do well, too. JetBlue, Alaska Airlines and others have been adding more premium seats, which should help lift profits.
While he is optimistic overall, Mr. Shanker acknowledged that the industry was vulnerable to a host of potential problems.
“I mean, this time last year you were talking about doors falling off planes,” he said. “So who knows what might happen.”
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