drug pricing

big-pharma’s-fight-against-drug-price-reforms-takes-weird,-desperate-turn

Big Pharma’s fight against drug price reforms takes weird, desperate turn

🙃 —

PhRMA claims price negotiations raise costs and that drug patents lower them.

Stephen Ubl, president and chief executive officer of Pharmaceutical Research and Manufacturers of America (PhRMA), speaks during a Bloomberg Live discussion in Washington, DC, in 2017.

Enlarge / Stephen Ubl, president and chief executive officer of Pharmaceutical Research and Manufacturers of America (PhRMA), speaks during a Bloomberg Live discussion in Washington, DC, in 2017.

After a series of decisive court losses, the pharmaceutical industry appears to be taking its fight against Medicare drug price negotiations directly to the people—and the White House is not impressed.

This week, the high-powered industry group PhRMA (the Pharmaceutical Research and Manufacturers of America) released two eye-catching attacks on federal efforts to lower America’s singularly astronomical drug prices. In a press release Tuesday, PhRMA announced an analysis suggesting that the Medicare drug price negotiations—part of the Biden administration’s 2022 Inflation Reduction Act—could actually cost some seniors and people with disabilities slightly more in out-of-pocket costs. The analysis, however, relies on a key—and questionable—assumption that the federal government will set price limits using the highest possible estimate for maximum fair prices in 2026.

Milliman, the consulting firm PhRMA commissioned to do the study, cautioned that the actual prices “will certainly vary due to differences in unit cost and utilization trend, 2026 benefit designs, and actual 2026 maximum fair prices.”

On Wednesday, PhRMA then announced an “educational campaign” on how the US intellectual property system “is actually the vehicle for lower [drug] costs.” The bold claim is likely jarring to the many critics of the pharmaceutical industry, who for years have noted how drug companies exploit double patenting or “patent thickets” to extend monopolies on drugs and hold off low-cost generics from entering the market.

“They’ll lose”

For instance, staunch drug pricing critic Sen. Bernie Sanders (I-Vt.) has railed against patent thickets in congressional reports, noting that companies often file dozens of patents for a single drug. Merck, for instance, has 168 patents on its cancer drug Keytruda, most of which were filed after the drug was approved by the Food and Drug Administration. Johnson & Johnson, meanwhile, filed 57 patents on arthritis treatment Stelara, 79 percent of which were filed after FDA approval.

Merck and Johnson & Johnson are both members of PhRMA, along with many other big-name drug companies, including Pfizer, Bayer, GSK, Lilly, Novo Nordisk, and Sanofi.

A 2022 study in Nature Biotechnology found that of 179 patents covering nine biologic drugs that were the focus of patent infringement lawsuits, 94 percent of the patents covered minor or peripheral aspects of a drug, such as manufacturing techniques. Only 11 of the 179 patents, 6 percent, were related to the actual active ingredient in a drug. However, these tangles of secondary patents effectively allowed drug companies to extend market exclusivity well beyond the 12-year period provided by federal laws.

In an attempt to uproot some of those thickets, the US Patent and Trademark Office proposed a rule last month that would affect certain add-on patents, called terminal disclaimers. Under the proposed rule, if a drug company puts a terminal disclaimer on several patents, and one of those patents gets invalidated for any reason, the drug company would agree not to enforce any of the other patents linked by the terminal disclaimer.

On Wednesday, the Biden administration hit back at PhRMA’s attacks on drug pricing reforms. In a statement that provided links to PhRMA’s efforts this week, White House spokesperson Andrew Bates called Big Pharma’s pricing on drugs “corporate rip-offs.” He noted that the pharmaceutical industry spent an “unprecedented $372 million lobbying against” drug pricing reforms but lost the fight against the passage of the Inflation Reduction Act.

“Now that President Biden is delivering real savings for the families who have been overcharged by Big Pharma for medicines they desperately need, they’re continuing to fight tooth and nail against the financial interests of American seniors,” Bates said. “They’ll lose this fight, too.”

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Drugmaker to testify on why weight-loss drugs cost 15x more in the US

On second thought —

Bernie Sanders cancels subpoena vote.

Lars Fruergaard Jorgensen, chief executive officer Novo Nordisk A/S, during an interview at the company's headquarters in Bagsvaerd, Denmark, on Monday, June 12, 2023.

Enlarge / Lars Fruergaard Jorgensen, chief executive officer Novo Nordisk A/S, during an interview at the company’s headquarters in Bagsvaerd, Denmark, on Monday, June 12, 2023.

After some persuasion from Sen. Bernie Sanders (I-Vt.), the CEO of Novo Nordisk will testify before lawmakers later this year on the “outrageously high cost” of the company’s diabetes and weight-loss drugs—Ozempic and Wegovy—in the US.

CEO Lars Jørgensen will appear before the Senate Committee on Health, Education, Labor, and Pensions (HELP), which is chaired by Sanders, in early September. The agreement came after a conversation with Sanders in which the CEO reportedly “reconsidered his position” and agreed to testify voluntarily. As such, Sanders has canceled a vote scheduled for June 18 on whether to subpoena Novo Nordisk to discuss its US prices, which are considerably higher than those of other countries.

The independent lawmaker has been working for months to pressure Novo Nordisk into lowering its prices and appearing before the committee. In April, Sanders sent Jørgensen a letter announcing an investigation into the prices and included a lengthy set of information requests. In May, the committee’s investigation released a report suggesting that Novo Nordisk’s current pricing threatens to “bankrupt our entire health care system.”

Sanders has repeatedly hammered not only the high prices of Novo Nordisk’s two blockbuster drugs but also the huge disparity between US prices and those in other countries.

Up to 15x more in the US

“Novo Nordisk currently charges Americans with type 2 diabetes $969 a month for Ozempic, while this same exact drug can be purchased for just $155 in Canada and just $59 in Germany,” Sanders wrote in April. “Novo Nordisk also charges Americans with obesity $1,349 a month for Wegovy, while this same exact product can be purchased for just $140 in Germany and $92 in the United Kingdom.”

Yale researchers, meanwhile, published a study in JAMA in March estimating that both drugs could be manufactured for less than $5.

In May, Novo Nordisk responded with a letter to Sanders, arguing that blame for high prices in the US lies with the country’s complex health system and with middle managers who take cuts, according to Bloomberg. Novo Nordisk said in the letter that it is prepared to address “systemic issues so that everyone who can benefit from its medicines is able to get them,” the outlet reported. The company also said it has spent over $10 billion on research and development to bring Wegovy and Ozempic to the market.

Still, that number is small in comparison to the projected revenue from the drugs. Bloomberg noted that analysts estimate that Novo Nordisk will make $27 billion from the two drugs this year alone. The May analysis by the HELP committee found that if just half of the adults in the US with obesity start taking a new weight-loss drug, such as Wegovy, the collective cost would be around $411 billion per year. Another report by the Congressional Budget Office found that the drugs’ costs are so high that they will not be offset by any financial gains from improved health outcomes.

“The Committee looks forward to Mr. Jørgensen explaining why Americans are paying up to 10 or 15 times more for these medications than people in other countries,” Sanders said last week.

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Medicare forced to expand forms to fit 10-digit bills—a penny shy of $100M

more zeros —

Previously, some doctors had to divide bills by 10 and submit 10 claims to get costs covered.

High angle close-up view still life of an opened prescription bottles with pills and medication spilling onto ae background of money, U.S. currency with Lincoln Portrait.

In a disturbing sign of the times, Medicare this week implemented a change to its claims-processing system that adds two extra digits to money amounts, expanding the fields from eight digits to 10. The change now allows for billing and payment totals of up to $99,999,999.99, or a penny shy of $100 million.

In a notice released last month, the Centers for Medicare & Medicaid Services (CMS) explained the change, writing, “With the increase of Part B procedures/treatments exceeding the $999,999.99 limitation, CMS is implementing the expansion of display screens for monetary amount fields related to billing and payment within [the Fiscal Intermediary Shared System (FISS)] to accept and process up to 10 digits ($99,999,999.99).”

The FISS is the processing system used by hospitals and doctors’ offices to process Medicare claims.

Stat news, which first reported the update, noted that it’s not the first time CMS has struggled to make room for ever-increasing drug and treatment prices in its claims processing systems. In 2022, the agency had to give technical advice to doctors submitting claims for chimeric antigen receptor (CAR) T-cell therapy, which is used to treat blood cancers. CAR T-cell therapies run around half a million dollars, or eight digits. But in a different claims processing system, called the Multi-Carrier System (MCS), the money amount fields only included seven digits. In that case, rather than expanding the field, the CMS requested that doctors divide the bill by either five or 10, depending on the size, and then bill Medicare five or 10 separate times for a single claim.

CAR T-cell therapies aren’t the only treatments with eye-popping price points these days. Just last month, the drug Lenmeldy, a lifesaving gene therapy for a tragic childhood condition, set the current record for the highest drug price in the world at $4.25 million. Before Lenmeldy arrived, the hemophilia B drug Hemgenix held that record, with its price set at $3.5 million.

While these advanced therapies come with mind-boggling prices, prescription drug costs in the US are a problem across the board. In a KFF poll published in August, 28 percent of US adults reported difficulty affording their prescription medication, while 31 percent reported not taking their medicine as prescribed in the past year due to the cost. A federal report from 2022 found that Americans pay nearly three times more for prescription drugs than people in 33 other wealthy countries.

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lifesaving-gene-therapy-for-kids-is-world’s-priciest-drug-at-$4.25m

Lifesaving gene therapy for kids is world’s priciest drug at $4.25M

promising but pricey —

It’s unclear if government and private insurance plans can cover the costs.

A mother with her twin 6-year-old boys who have metachromatic leukodystrophy, a genetic disease that leaves them unable to move. Photo taken on September 3, 2004.

Enlarge / A mother with her twin 6-year-old boys who have metachromatic leukodystrophy, a genetic disease that leaves them unable to move. Photo taken on September 3, 2004.

In a medical triumph, US Food and Drug Administration on Monday approved a gene therapy that appears to trounce a rare, tragic disease that progressively steals children’s ability to talk, move, and think, leading to a vegetative state and death. For those who begin to slip away in infancy, many die by age 5. But, with the new therapy, 37 children in an initial trial were all still alive at age 6. Most could still talk, walk on their own, and perform normally on IQ tests, which was unseen in untreated children. Some of the earliest children treated have now been followed for up to 12 years—and they continue to do well.

But, the triumph turned bittersweet today, Wednesday, as the company behind the therapy, Lenmeldy, set the price for the US market at $4.25 million, making it the most expensive drug in the world. The price is $310,000 higher than what experts calculated to be the maximum fair price for the lifesaving drug; the nonprofit Institute for Clinical and Economic Review, or ICER, gave a range last October of between $2.29 million to $3.94 million.

The price raises questions about whether state, federal, and private health insurance plans will be able to shoulder the costs. “Unless states have allocated appropriately for it, and looked at the drug pipeline, they may not be prepared for what could be significant cost spikes,” Edwin Park, a research professor at the McCourt School of Public Health at Georgetown University, told CNN.

It’s also unclear whether the drug can reach the children who need it in time. Lenmeldy must be given before symptoms develop or early on in symptom development in children. However, diagnosis of the rare genetic condition can be slow, and many children treated so far were identified because older siblings, now too old for treatment, developed the condition first.

Devastating disease

Stat, for instance, spoke with the mother of an 8-year-old with the condition, who can no longer talk or move, has frequent seizures, and requires a feeding tube and 28 different medications. Meanwhile, her 3-year-old brother, who has the same genetic mutation, is a typical toddler—he was able to get the new treatment when he was six months old. To get it, the family flew him to Milan, Italy, where Lenmeldy was first developed. It was approved for use in Europe in 2021.

The condition Lenmeldy treats is called metachromatic leukodystrophy (MLD), which occurs in about 40 children in the US each year. MLD is caused by a mutation in the gene that codes for the enzyme arylsulfatase A (ARSA). Without this enzyme, the body can’t break down sulfatides, a fatty substance that then builds up to toxic levels in the brain and peripheral nervous system. Sulfatides are essential components of myelin, the fatty insulation on nerve cells critical for quick transmission of electrical impulses. But, too much sulfatides leads to a loss of myelin, which gradually destroys myelin producing cells and leads to nervous system damage.

Lenmeldy prevents that damage by giving the body a working copy of the ARSA gene. In a one-time infusion, patients are given a dose of their own blood stem cells that have been genetically engineered to contain a functional ARSA gene. Patients undergo chemotherapy to clear out their own stem cells from bone marrow so the genetically modified cells can replace them. The engineered stem cells then produce myeloid cells that travel around the body in the blood, producing ARSA enzyme that can halt progression of MLD.

It’s unknown how long the therapy lasts, but it’s clearly buying children time and giving them hope for a full, normal life.

“MLD is a devastating disease that profoundly affects the quality of life of patients and their families,” Nicole Verdun, director of the FDA’s Office of Therapeutic Products, said in a statement. “Advancements in treatment options offer hope for improved outcomes and the potential to positively influence the trajectory of disease progression.”

It “has the potential to stop or slow the progression of this devastating childhood disease with a single treatment, particularly when administered prior to the onset of symptoms,” Bobby Gaspar, CEO of Lenmeldy’s maker, Orchard Therapeutics, said in a statement Wednesday. “We are committed to enabling broad, expedient, and sustainable access to this important therapy for eligible patients with early-onset MLD in the US.”

The company is working on expanding newborn screening to include tests for MLD, to try to find children early, Orchard reported. Still, with such a rare condition, it’s unclear if the pricey drug will be a moneymaker for the company. Stat notes that Orchard has previously abandoned four therapies for other rare genetic conditions because of the difficulty in meeting regulatory standards for essentially custom therapies and questions about whether health plans will pay the steep, multimillion-dollar prices. In April of last year, Belgium, Ireland, and the Netherlands walked away from price negotiations with the company, saying they couldn’t come to an agreement on this “extremely expensive therapy.”

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judge-tosses-big-pharma-suit-claiming-drug-price-negotiation-is-unconstitutional

Judge tosses Big Pharma suit claiming drug price negotiation is unconstitutional

tossed —

The judge ruled that the court lacks jurisdiction.

Stephen Ubl, president and chief executive officer of Pharmaceutical Research and Manufacturers of America (PhRMA), speaks during a Bloomberg Live discussion in Washington, DC, on Tuesday, Sept. 19, 2017.

Enlarge / Stephen Ubl, president and chief executive officer of Pharmaceutical Research and Manufacturers of America (PhRMA), speaks during a Bloomberg Live discussion in Washington, DC, on Tuesday, Sept. 19, 2017.

A federal judge in Texas dismissed a lawsuit Monday brought by a heavy-hitting pharmaceutical trade group, which argued that forcing drug makers to negotiate Medicare drug prices is unconstitutional.

The dismissal is a small win for the Biden administration, which is defending the price negotiations on multiple fronts. The lawsuit dismissed Monday is just one of nine from the pharmaceutical industry, all claiming in some way that the price negotiations laid out in the Inflation Reduction Act of 2022 are unconstitutional. The big pharmaceutical companies suing the government directly over the negotiations include Johnson & Johnson, Bristol Myers Squibb, Novo Nordisk, Merck, and AstraZeneca.

Last month, a federal judge in Delaware heard arguments from AstraZeneca’s lawyers, which reportedly went poorly. AstraZeneca argued that Medicare’s new power to negotiate drug prices violates the company’s rights under the Fifth Amendment’s due process clause. The forced negotiations deprive the company of “property rights in their drug products and their patent rights” without due process, AstraZeneca claimed. But Colm Connolly, chief judge of the US District Court of Delaware, was skeptical of how that could be the case, according to a Stat reporter who was present for the hearing. Connolly noted that AstraZeneca doesn’t have to sell drugs to Medicare. “You’re free to do what you want,” Connolly reportedly said. “You may not make as much money.”

At a later point, Connolly bluntly commented: “I don’t find their argument compelling.”

Though the plaintiffs in the now-dismissed Texas also made an argument based on the Fifth Amendment’s due process clause, the case didn’t make it that far. US District Judge David Ezra in Austin, Texas, dismissed the case brought by one of the case’s three plaintiffs, saying the court lacked jurisdiction. And, because that one plaintiff is the only one based in the Western District of Texas, where the lawsuit was filed, he dismissed the case completely.

The three plaintiffs in the case were PhRMA, a powerful drug industry trade group representing high-profile drug makers, including Pfizer, GSK, Eli Lilly, and Sanofi; the Global Colon Cancer Association (GCCA); and the Texas-based National Infusion Center Association (NICA). Lawyers for the Biden administration filed a motion to dismiss the case, arguing that NICA is not a proper plaintiff.

Ezra found that for NICA to bring constitutional claims against Medicare’s price negotiations in a court, it is first required under federal rules to bring those claims through an administrative review process under the Medicare Act or the Centers for Medicare and Medicaid Services. Without a prior administrative review, the court has no jurisdiction.

“The Court lacks jurisdiction over NICA’s claims because the claims here ‘arise under’ the Medicare Act and the claims do not fall under the exception carved out for when claims may completely avoid judicial or administrative review. Therefore, NICA’s claims are dismissed without prejudice,” Ezra wrote in his ruling.

And, with the one Texas-based plaintiff, NICA, knocked out of the case, the Western Texas district is now the “improper venue” for a case brought by the remaining two plaintiffs, PhRMA and GCCA.

Ezra noted that in such situations, a judge can transfer the case to a court that would be considered a proper venue. But Ezra declined, noting that neither the plaintiffs nor defendants suggested a proper venue. And, even if they did, it likely wouldn’t matter, Ezra reasoned, because PhRMA and GCCA also haven’t gone through an administrative review.

“[T]he same federal jurisdictional defect likely exists for PhRMA and GCCA, as nothing suggests that either party has presented its claims to the [Health] Secretary,” Ezra wrote.

Ezra dismissed the case “without prejudice,” meaning the claims could be refiled. A spokesperson for PhRMA told FiercePharma: “We are disappointed with the court’s decision, which does not address the merits of our lawsuit, and we are weighing our next legal steps.”

Meanwhile, the first round of Medicare drug price negotiations is underway. Earlier this month, the federal government sent out its opening offers in the price negotiation process for the first 10 drugs selected. The bargaining will continue through the coming months, with an ending deadline of August 1, 2024. The prices will go into effect at the beginning of 2026.

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big-pharma-spends-billions-more-on-executives-and-stockholders-than-on-r&d

Big Pharma spends billions more on executives and stockholders than on R&D

Greed —

Senate report points to greed and “patent thickets” as key reasons for high prices.

Big Pharma spends billions more on executives and stockholders than on R&D

When big pharmaceutical companies are confronted over their exorbitant pricing of prescription drugs in the US, they often retreat to two well-worn arguments: One, that the high drug prices cover costs of researching and developing new drugs, a risky and expensive endeavor, and two, that middle managers—pharmacy benefit managers (PBMs), to be specific—are actually the ones price gouging Americans.

Both of these arguments faced substantial blows in a hearing Thursday held by the Senate Committee on Health, Education, Labor and Pensions, chaired by Sen. Bernie Sanders (I-Vt.). In fact, pharmaceutical companies are spending billions of dollars more on lavish executive compensation, dividends, and stock buyouts than they spend on research and development (R&D) for new drugs, Sanders pointed out. “In other words, these companies are spending more to enrich their own stockholders and CEOs than they are in finding new cures and new treatments,” he said.

And, while PBMs certainly contribute to America’s uniquely astronomical drug pricing, their profiteering accounts for a small fraction of the massive drug market, Sanders and an expert panelist noted. PBMs work as shadowy middle managers between drugmakers, insurers, and pharmacies, setting drug formularies and consumer prices, and negotiating rebates and discounts behind the scenes. Though PBMs practices contribute to overall costs, they pale compared to pharmaceutical profits.

Rather, the heart of the problem, according to a Senate report released earlier this week, is pharmaceutical greed, patent gaming that allows drug makers to stretch out monopolies, and powerful lobbying.

On Thursday, the Senate committee gathered the CEOs of three behemoth pharmaceutical companies to question them on the drug pricing practices: Robert Davis of Merck, Joaquin Duato of Johnson & Johnson, and Chris Boerner of Bristol Myers Squibb.

“We are aware of the many important lifesaving drugs that your companies have produced, and that’s extraordinarily important,” Sanders said before questioning the CEOs. “But, I think, as all of you know, those drugs mean nothing to anybody who cannot afford it.”

America’s uniquely high prices

Sanders called drug pricing in the US “outrageous,” noting that Americans spend by far the most for prescription drugs in the world. A report this month by the US Department of Health and Human Services found that in 2022, US prices across all brand-name and generic drugs were nearly three times as high as prices in 33 other wealthy countries. That means that for every dollar paid in other countries for prescription drugs, Americans paid $2.78. And that gap is widening over time.

Focusing on drugs from the three companies represented at the hearing (J&J, Merck, and Bristol Myers Squibb), the Senate report looked at how initial prices for new drugs entering the US market have skyrocketed over the past two decades. The analysis found that from 2004 to 2008, the median launch price of innovative prescription drugs sold by J&J, Merck, and Bristol Myers Squibb was over $14,000. But, over the past five years, the median launch price was over $238,000. Those numbers account for inflation.

The report focused on high-profit drugs from each of the drug makers. Merck’s Keytruda, a cancer drug, costs $191,000 a year in the US, but is just $91,000 in France and $44,000 in Japan. J&J’s HIV drug, Symtuza, is $56,000 in the US, but only $14,000 in Canada. And Bristol Myers Squibb’s Eliquis, used to prevent strokes, costs $7,100 in the US, but $760 in the UK and $900 in Canada.

Sanders asked Bristol Myers Squibb’s CEO Boerner if the company would “reduce the list price of Eliquis in the United States to the price that you charge in Canada, where you make a profit?” Boerner replied that “we can’t make that commitment primarily because the prices in these two countries have very different systems.”

The powerful pharmaceutical trade group PhRMA, published a blog post before the hearing saying that comparing US drug prices to prices in other countries “hurts patients.” The group argued that Americans have broader, faster access to drugs than people in other countries.

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big-pharma-hiked-the-price-of-775-drugs-this-year-so-far:-report

Big Pharma hiked the price of 775 drugs this year so far: Report

up and up —

Meanwhile, Senate to consider subpoenas to force pharma CEOs testify on prices.

Sen. Bernie Sanders (I-Vt.).

Enlarge / Sen. Bernie Sanders (I-Vt.).

Pharmaceutical companies have raised the list prices of 775 brand-name drugs so far this year, with a median increase of 4.5 percent, exceeding the rate of inflation, according to an analysis conducted for the Wall Street Journal.

Drugmakers typically raise prices at the start of the year, and Ars reported on January 2 that companies had plans to raise the list prices of more than 500 prescription medications. The updated analysis, carried out by 46brooklyn Research, a nonprofit drug-pricing analytics group, gives a clearer picture of pharmaceutical companies’ activities this month.

High-profile drugs Ozempic (made by Novo Nordisk) and Mounjaro (Eli Lilly), both used for Type II diabetes and weight loss, were among those that saw price increases. Ozempic’s list price went up 3.5 percent to nearly $970 for a month’s supply, while Mounjaro went up 4.5 percent to almost $1,070 a month. The annual inflation rate in the US was 3.4 percent for 2023.

The asthma medication Xolair (Novartis) and the Shingles vaccine Shingrix (GlaxoSmithKline) saw price increases above 7.5 percent, the Wall Street Journal noted. The highest prices were around 10 percent. For some drugs, the single-digit percentage increases can equal hundreds or even thousands of dollars. For instance, the cystic fibrosis treatment Trikafta (Vertex Pharmaceuticals) went up 5.9 percent to $26,546 for a 28-day supply. And the psoriasis therapy Skyrizi (AbbVie) saw an increase of 5.8 percent, bringing the price to $21,017.

Lawmakers’ responses

The list price is typically not the price that people and health insurance plans pay, and pharmaceutical companies say they sometimes don’t make more money from raising list prices. Instead, they argue that the higher list prices allow them to negotiate large discounts and rebates from pharmacy middle managers, whose revenue and dealings are opaque. Drugmakers who spoke with the Wall Street Journal attributed this year’s price hikes to market conditions, inflation, and the value the drugs provide. Overall, the tactics increase the cost of health care.

The hefty hikes come as the federal government is trying to crack down on the high prices of drugs in the US, which pays far more for prescription medications than other high-income countries. Last year, Medicare began, for the first time, negotiating the prices of 10 costly drugs. The negotiations were a provision of the 2022 Inflation Reduction Act. And a provision in 2021’s American Rescue Plan Act now forces drugmakers to pay Medicaid large rebates if their drug price increases outpace inflation.

But, it’s not enough to provide Americans with relief from high drug prices. On Thursday, Stat reported that Senate health committee chair Bernie Sanders (I-Vt) took steps to subpoena pharmaceutical CEOs regarding a Congressional investigation on high drug prices. Sanders invited Johnson & Johnson CEO Joaquin Duato, Merck CEO Robert Davis, and Bristol Myers Squibb CEO Chris Boerner to testify—but only Boerner agreed, and only on the condition that he would not be the only CEO testifying. The trio were invited to a hearing titled “Why Does the United States Pay, By Far, The Highest Prices In The World For Prescription Drugs?,” which was originally scheduled for January 25. Now, Sanders will hold a committee vote on January 31 on whether to issue subpoenas for the CEOs of Johnson & Johnson and Merck. If the committee votes in favor, it will be the first time it has issued a subpoena in more than 40 years.

All three companies have sued the federal government over the new regulations requiring them to negotiate prices with Medicare. J&J and Merck accused Sanders of calling them to testify as retribution for their legal action.

“You have opted not for the most effective way of securing information relevant to the Committee’s important work on drug prices, but for a broad-ranging public spectacle, with witnesses you can question on pending litigation you disagree with,” Merck wrote to Sanders.

Sanders called the two CEOs’ refusal to testify “absolutely unacceptable.”

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