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One critic charged that Trump's earlier deals with pharmaceutical companies "just nibble around the margins in terms of what is really driving high prices for prescription drugs in the US."
President Donald Trump in recent months has made ludicrously false claims about his administration slashing prescription drug prices in the US by as much as 600%, which would entail pharmaceutical companies paying people to use their products.
In reality, reported Reuters on Wednesday, drugmakers are planning to raise prices on hundreds of drugs in 2026.
Citing data from healthcare research firm 3 Axis Advisors, Reuters wrote that at least 350 branded medications are set for price hikes next year, including "vaccines against COVID, RSV, and shingles," as well as the "blockbuster cancer treatment Ibrance."
The total projected number of drugs seeing price increases next year is significantly higher than in 2025, when 3 Axis Advisors estimated that pharmaceutical companies raised prices on 250 medications.
The median price increase for drugs next year is projected at 4%, roughly the same as in 2025.
Reuters also found that some of the companies raising prices on their drugs are the same ones who struck deals with Trump to lower the costs of a limited number of prescriptions earlier this year, including Novartis, Pfizer, Boehringer Ingelheim, and GSK.
In announcing the deals with the pharmaceutical companies, Trump declared that "starting next year, American drug prices will come down fast and furious and will soon be the lowest in the developed world."
But Dr. Benjamin Rome, a health policy researcher at Brigham and Women's Hospital in Boston, told Reuters that the projected savings for Americans under the Trump deals are a drop in the bucket compared with the continued price hikes on other drugs.
"These deals are being announced as transformative when, in fact, they really just nibble around the margins in terms of what is really driving high prices for prescription drugs in the US," Rome explained.
Merith Basey, CEO of Patients For Affordable Drugs Now, a patient advocacy organization focused exclusively on lowering the cost of medications, also said she was unimpressed by Trump's deals with drugmakers.
"Voluntary agreements with drug companies—especially when key details remain undisclosed—are no substitute for durable, system-wide reforms," she said earlier this month. "Patients are overwhelmingly calling on Congress to do more to lower prescription drug prices by holding Big Pharma accountable and addressing the root causes of high drug prices, because drugs don’t work if people can’t afford them."
"You owe the American public an explanation for why you took part in PhRMA's influence-peddling events with President Trump," wrote Sens. Elizabeth Warren, Ron Wyden, and Bernie Sanders.
A group of progressive U.S. senators on Monday pushed Robert F. Kennedy Jr., secretary of the Health and Human Services Department, to disclose what he and President Donald Trump discussed with pharmaceutical executives at recent private dinners as the industry pressures the new administration to end Medicare drug price negotiations.
In a letter to Kennedy, Sens. Elizabeth Warren (D-Mass.), Ron Wyden (D-Ore.), and Bernie Sanders (I-Vt.) pointed to Wall Street Journal reporting from last month on the millions of dollars that healthcare industry executives spent to dine with Trump at his Mar-a-Lago club in Florida ahead of his inauguration.
Kennedy, according to the Journal, "attended several of the dinners, but largely stayed quiet as Trump and others talked."
Warren, Wyden, and Sanders wrote to Kennedy that "the dinners may have served as an opportunity for Big Pharma to gain insider access to both you and President Trump" and asked the HHS chief to reveal information about the meetings with industry executives, including how many there have been since the November election and whether Medicare drug price negotiations or other critical matters were discussed.
"Big Pharma stands to profit immensely from a second Trump administration, especially if they can convince you and President Trump to abandon policies like Medicare drug price negotiations and patent reform that would save Americans hundreds of billions of dollars on lifesaving drugs," the senators wrote. "Indeed, the executives that attended these dinners have called on him to 'pause drug negotiations'—negotiations that are expected to save taxpayers $100 billion by 2032."
"You owe the American public an explanation for why you took part in PhRMA's influence-peddling events with President Trump, what happened at these meetings, and whether they will affect your commitment to ensuring that Americans receive the relief they deserve from high drug prices," the senators added.
RFK Jr. said he'd "clean up corruption" as HHS Secretary. So why'd he have dinner with Big Pharma executives at Mar-a-Lago with Trump? The American people deserve to know what kind of deals might have been made at those "million-dollar" dinners.
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— Elizabeth Warren (@warren.senate.gov) March 10, 2025 at 7:29 PM
The Journal reported that the CEO of Pfizer, which pumped $1 million into Trump's inaugural committee, was among the executives who attended the private Mar-a-Lago dinners. Eli Lilly's chief executive also joined at least one of the dinners.
Though Kennedy, an anti-vaccine conspiracy theorist, has vocally criticized Big Pharma and its political influence, the industry did not lobby against his nomination to lead HHS, which oversees the Medicare drug price negotiations that began during the Biden administration.
Last month, the head of the pharmaceutical industry's biggest lobbying group and several pharma CEOs met with Trump as part of a campaign to weaken the price negotiations, which threaten drugmakers' ability to jack up prices at will.
The negotiations have yielded significant results, but Trump's Centers for Medicare and Medicaid Services—an agency within HHS—has signaled it is open to altering the program.
"The Trump administration's statement is far from an embrace of drug price negotiation," Wyden and other senators warned earlier this year, "and appears to be opening the door to changes that could undermine Medicare's ability to get the best price possible on drugs."
"For the first time, Medicare isn't just accepting whatever prices the drug corporations set for expensive and widely used drugs," said one campaigner.
The Biden administration announced Thursday that it made its opening bids as part of Medicare's historic drug price negotiation program, which major pharmaceutical companies are working hard to kill in court.
The initial offers, which were not made public, were sent to the manufacturers of the 10 drugs that the Biden administration selected for the initial round of price negotiations. Additional medicines will be subject to price negotiations in later years.
The companies—including Merck, Johnson & Johnson, Pfizer, and Amgen—have 30 days to either accept Medicare's proposed maximum fair price for the selected medicines or put forth a counteroffer. Over the coming spring and summer, Biden administration officials will hold negotiation meetings with drug company representatives to resolve price disputes if the government doesn't accept the drugmakers' counters.
In September, the Centers for Medicare and Medicaid Services (CMS) will publish the negotiated prices, which won't take effect until 2026.
Margarida Jorge, the head of Lower Drug Prices Now, said in a statement Thursday that "for the first time, Medicare isn't just accepting whatever prices the drug corporations set for expensive and widely used drugs in Part D like Xarelto and Eliquis—instead, the agency, newly empowered under the new Medicare negotiations law, will propose lower prices for 10 of the most expensive drugs in Medicare Part D to kick off the negotiations process."
Jorge noted that around 9 million seniors on Medicare "spent an estimated $3.4 billion out-of-pocket on these ten drugs in 2022 to treat blood clots, cancer, diabetes, arthritis and other common conditions."
"Big Pharma made record profits by using their monopoly power to set prices and keep them high, forcing many Medicare patients to forgo other necessities, incur debt, or go without medicine because the prescriptions were not affordable," Jorge added. "Now, despite a barrage of lawsuits, paid ads, and threatening prognostications from the drug corporations, Medicare is on track to implement the new reforms that will lower prices, make costs affordable, and save taxpayers billions over the next decade."
"We are moving ahead to help people in spite of pharma's efforts to block negotiation in the courts."
The list prices of the drugs chosen for the initial round of negotiations range from around $7,000 a year in the case of Johnson & Johnson's Xarelto to over $133,000 annually for AbbVie and Johnson & Johnson's Imbruvica.
Lawrence Gostin, faculty director of the O'Neill Institute for National and Global Health Law at Georgetown University, said he expects the price negotiations to be "tense and hostile" given that the "stakes are huge for industry and the administration."
"It'll end up at SCOTUS and become a central issue in the 2024 presidential election," Gostin predicted.
A majority of the initial 10 drugs are made by companies that are currently suing the Biden administration in an effort to strike down the price negotiation program, which represents a serious challenge to the industry's ability to drive up prices at will.
According to government data, the selected drugs accounted for roughly 20% of total Medicare Part D spending between June 1, 2022 and May 31 of last year.
An analysis released earlier this month by the Commonwealth Fund found that list prices for the 10 drugs are three times higher on average in the U.S. than in other rich countries.
David Mitchell, founder of Patients for Affordable Drugs, said Thursday that the Biden administration's opening offers mark a "big step forward to lower drug prices."
"We are moving ahead to help people in spite of pharma's efforts to block negotiation in the courts," Mitchell added. "A good day for America."
"Handing exclusive rights to publicly-funded vaccines and medicines to just a few companies simply does not work—for rich countries or poorer ones," said an adviser to the People's Vaccine Alliance.
Vaccine equity campaigners on Monday condemned European Union nations for hoarding Covid-19 vaccine doses at the expense of low-income countries after a new Politico analysis estimated that the bloc's members have thrown out at least €4 billion—roughly $4.4 billion—worth of the lifesaving shots.
That equates to around 215 million coronavirus vaccine doses—very likely an undercount, given that Politico wasn't able to obtain waste numbers from every E.U. member country.
"Calculations based on available data show that E.U. countries have discarded an average of 0.7 jabs for every member of their population," the outlet reported. "Top of the scale is Estonia, which binned more than one dose per inhabitant, followed closely by Germany, which also threw away the largest raw volume of jabs."
Piotr Kolczyński, E.U. health policy adviser at the People's Vaccine Alliance and Oxfam International, said in a statement that the new analysis is "further proof that the E.U. wasted millions of its Covid-19 vaccines, hoarded early in the pandemic, as it locked poorer countries out of access."
"The appalling waste in the world's pandemic response was disastrous," said Kolczyński. "Handing exclusive rights to publicly-funded vaccines and medicines to just a few companies simply does not work—for rich countries or poorer ones."
Politico attributed much of the waste to the E.U.'s massive 2021 deal with Pfizer and BioNTech, which agreed to sell 1.1 billion doses of their mRNA jab to members of the bloc as low-income countries struggled to obtain shots for their populations.
"Despite considering a significant reform to reign in pharmaceutical waste and profiteering within its borders, the EU fails to support similar efforts on the global stage."
E.U. members—Germany in particular—pushed back aggressively against the India and South Africa-led call for a Covid-19 vaccine patent waiver, which proponents said would have lifted key barriers to expanding vaccine manufacturing and access. Germany alone has wasted 83 million vaccine doses, according to Politico.
The pharmaceutical industry, for its part, lobbied aggressively to preserve its monopoly control over vaccine recipes and production, focusing significant attention on the European Commission.
With the global health emergency formally over, countries are currently negotiating the terms of a pandemic agreement that would govern how the international community responds to the next global crisis.
Reuters reported in September that "governments remain divided, failing to agree on some of the basics needed to strengthen health systems worldwide."
"Those basics, all issues that hindered a coordinated global response to the Covid-19 outbreak, include the sharing of information, costs, and vaccines," Reuters added. "The divisions arose anew in June, when the European Union negotiated new agreements with pharmaceutical companies to reserve vaccines for future pandemics. The agreements led critics to accuse the bloc of 'vaccine apartheid.'"
Last month, 18 members of the European Parliament wrote to the Council of the European Union and the European Commission expressing "concerns about the E.U.'s negotiating position."
"It proposes to continue relying solely on voluntary measures in the deployment of key public health interventions, such as the transfer of technology, know-how and 'trade secrets,' or the removal of intellectual property barriers," the lawmakers wrote. "In the meantime, the E.U. avoids specific commitments for equitable access to pandemic products."
As the People's Vaccine Alliance noted Monday, the E.U.'s latest proposed text "suggests removing transparency and equity measures."
"Despite considering a significant reform to reign in pharmaceutical waste and profiteering within its borders, the E.U. fails to support similar efforts on the global stage," said Kolczyński. "It is one rule for the E.U. and another for everyone else."
"Pfizer treats Paxlovid like a Prada handbag; a luxury for the few rather than a treatment for the many," said one consumer advocate.
U.S. consumer watchdog Public Citizen on Thursday excoriated Pfizer after the pharmaceutical giant announced it would more than double the price of a lifesaving Covid-19 treatment, which will soon sell for an estimated 100 times the cost of production.
Pfizer said Wednesday that it will price its patented Covid treatment nirmatrelvir-ritonavir—sold under the brand name Paxlovid—at $1,390 for a five-day course. Researchers Melissa J. Barber and Dzintars Gotham recently estimated it costs Pfizer $13 to produce five days' worth of the drug, which is taken in three-pill doses.
"Pfizer's new price is an estimated 100 times the cost of production," Peter Maybarduk, director of Public Citizen's Access to Medicines program, said in a statement.
"Pfizer chose to double its U.S. price just as pandemic funding falters and the precarious winter viral season begins."
It's also more than 2.5 times the federal government's purchase price for Paxlovid. The government has bought and distributed the antiviral drug to the public free of charge since December 2021, when the U.S. Food and Drug Administration approved the treatment. Starting next year, Pfizer will sell Paxlovid directly to health insurance companies.
"Pfizer has made tens of billions in Paxlovid sales, largely through major government purchases," Maybarduk noted. "Pfizer could choose now to support the fight against Covid and ease treatment access by lowering its already inflated prices."
"Instead, Pfizer chose to double its U.S. price just as pandemic funding falters and the precarious winter viral season begins," he continued. "This will strain health budgets and contribute to further treatment rationing."
"Pfizer treats Paxlovid like a Prada handbag; a luxury for the few rather than a treatment for the many," Maybarduk added. "For shame."
Medical professionals and patient advocates have voiced concerns that increasing the price of Paxlovid could leave at-risk people without access to the lifesaving drug, which is proven to reduce the risk of death or severe illness from Covid-19 for patients with weakened immune systems or ailments like diabetes and heart conditions.
News of the Paxlovid price hike came a day after Public Citizen and the Health Global Access Project (Health GAP) published an analysis revealing that more than 8 million people with high-risk Covid-19 infections in low- and middle-income nations could not access the drug last year, leaving over 90% of the need for the treatment unmet.
"At a minimum, 10 times more people needed Paxlovid than had any chance to receive it in developing countries, and that almost certainly significantly understates the problem," Maybarduk said on Tuesday.
In addition to Paxlovid, Pfizer manufactures one of the two available mRNA vaccines for Covid-19. The company reported $56 billion in sales of its Covid-19 vaccine and Paxlovid last year. However, projecting a sales slump in 2023, Pfizer late last year announced a plan to significantly hike the price of its publicly funded Covid-19 shot.
Pfizer reported profits of $31.4 billion in 2022, a 43% increase over the previous year. Pfizer CEO Albert Bourla took home $33 million in compensation last year, a 36% raise from 2021.
"Millions of Americans' lives are affected by this report and it's crucial that the report tell the truth to American people and it's not degraded into another sales pitch for Big Food and Big Pharma."
Nearly half the members of the U.S. government panel that helps draft dietary guidelines for Americans have ties to the food, pharmaceutical, or weight loss industry, a report released this week revealed.
"Food and pharmaceutical industry actors have historically sought to influence the U.S. Dietary Guidelines for Americans (DGA), and have had financial ties to nutrition experts on the Dietary Guidelines Advisory Committee (DGAC), which reviews the latest science on diet, nutrition, and health outcomes to make recommendations for the DGA," states the report, which was authored by researchers at the advocacy group U.S. Right to Know.
"We found that 13 of 20 DGAC members had high-risk, medium-risk, or possible conflicts of interest with industry actors," the authors wrote.
Of these, nine were high- or medium-risk conflicts with companies and industry groups including Coca-Cola, the Nestlé Nutrition Institute, National Dairy Council, Weight Watchers International, Beyond Meat, the California Walnut Commission, and the National Egg Board. Big Pharma giants including Pfizer, Abbott, Novo Nordisk, and Eli Lilly are also named in the report.
U.S. Right to Know executive director Gary Ruskin told The Guardian that revelations like those in the report erode consumer confidence in government dietary guidelines.
"Millions of Americans' lives are affected by this report and it's crucial that the report tell the truth to American people and it's not degraded into another sales pitch for Big Food and Big Pharma," Ruskin said.
The report also notes some "encouraging findings," including that "seven members had no relationships in the past five years that met our definition" of conflicts of interest, and that "four members only had one instance" of possible conflicts.
"Surely, there is room for further improvement," the publication states. "With high-risk conflicts of interest still present on the DGAC,
the public cannot have confidence that the official dietary advice of the U.S. government is free from industry influence."
The report's authors offer recommendations for the U.S. Department of Health and Human Services and U.S. Department of Agriculture, including:
The group also called on Congress to expand the Physician Payments Sunshine Act to cover the nutrition field.
"Public funding delivers incredible medical advances and that should be a priority for all countries, but pharmaceutical companies cannot be trusted to share technology with the world."
Scientists Katalin Karikó and Drew Weissman were awarded the Nobel Prize in Physiology or Medicine on Monday for research that paved the way for the messenger RNA vaccines against Covid-19—critical work that, as campaigners quickly pointed out, benefited from substantial U.S. government funding.
Dr. Mohga Kamal-Yanni, policy co-lead for the People's Vaccine Alliance, said in a statement that "this award challenges the claim that it was solely big pharmaceutical companies who saved the world from Covid-19."
"Just like the Oxford-AstraZeneca vaccine, Karikó and Weissman's groundbreaking work on mRNA vaccines received a huge amount of public funding," said Kamal-Yanni. "Pharmaceutical companies have refused to share mRNA technologies with developers and researchers in developing countries."
The Nobel Prize committee credited Karikó and Weissman with fundamentally changing "our understanding of how mRNA interacts with our immune system."
"The laureates contributed to the unprecedented rate of vaccine development during one of the greatest threats to human health in modern times," the committee said.
As The Washington Post summarized, the pair "discovered how to chemically tweak messenger RNA, turning basic biology into a technology ready to change the world when the pandemic struck. Their discovery is incorporated into the coronavirus vaccines made by Moderna and Pfizer and its German partner, BioNTech, which have now been given billions of times."
But the Post and other major outlets covering Karikó and Weissman's Nobel prize-winning contributions did not emphasize—or even mention—that some of the scientists' work was funded by the National Institutes of Health. Karikó and Weissman patented their findings in 2006 and later licensed the patents to Moderna and BioNTech, Pfizer's coronavirus vaccine partner.
According to an analysis by Knowledge Ecology International (KEI), Weissman "appears as the principal investigator on a total of 42 projects funded by the National Institutes of Health (NIH) between 1998 and 2020, representing $18,323,060 in costs."
"Karikó was the principal investigator of four projects funded by the NIH between 2007 and 2011, totaling $1,234,462 in costs," KEI observed. "In other words, the United States government funded and has certain rights over at least some of the foundational Karikó and Weissman patents directed to mRNA discoveries."
"As governments discuss how to prepare for the next pandemic, they should learn from the story of mRNA."
Throughout the pandemic and into the present, vaccine makers such as Pfizer and Moderna have opposed global calls to share their vaccine recipes and technology with the world, fiercely clinging to their monopoly control over production and using that control to force governments into one-sided contracts favorable to the pharmaceutical industry—even though their vaccines were developed with massive public support.
A
study published in The BMJ earlier this year estimated that the U.S. government pumped nearly $32 billion into the development, production, and purchase of mRNA coronavirus vaccines.
The Biden administration, meanwhile, has declined to use its ownership of key patents or the leverage provided by public funding to force pharmaceutical companies to do everything they can to ensure the equitable distribution of lifesaving vaccine technology.
Kamal-Yanni of the People's Vaccine Alliance said Monday that "fortunately, Weissman is helping a WHO-backed mRNA program which aims to develop mRNA technology in lower-income countries, even while pharmaceutical companies refuse to share their know-how."
"As governments discuss how to prepare for the next pandemic, they should learn from the story of mRNA," said Kamal-Yanni. "Public funding delivers incredible medical advances and that should be a priority for all countries, but pharmaceutical companies cannot be trusted to share technology with the world."
Peter Maybarduk, director of the Access to Medicines program at Public Citizen, echoed that message, saying in a statement that "today's Nobel must ring as a call for equity and health justice, and a call to change a massively unjust pharmaceutical industry."
"Moderna, Pfizer, and BioNTech still largely control the available vaccines and in some countries have significantly increased their price, despite the billions in public funding on which the vaccines rely," said Maybarduk. "By supporting initiatives to share science and technology, and by funding vaccine infrastructure, governments can help blunt the effects of disease, and bring a coda of justice to a terribly unjust time."
This story has been updated to include a statement from Public Citizen.
"Cancer patients—the majority of whom are on Medicare—can face annual out-of-pocket costs of more than $16,500."
Major pharmaceutical companies are
profiting immensely from the second-leading cause of death in the United States by saddling cancer patients with tens of thousands of dollars in out-of-pocket costs, often forcing them to choose between treatment and other basic necessities.
But many people living with cancer in the U.S. will soon see long-overdue relief thanks to provisions of the Inflation Reduction Act (IRA), a law that the pharmaceutical industry lobbied aggressively against and is still fighting tooth and nail.
According to a report published Wednesday by Patients for Affordable Drugs, cancer patients will benefit substantially from the IRA's $2,000 cap on annual out-of-pocket medicine spending for Medicare Part D enrollees—a limit that's set to take effect in 2025.
Of the nearly 62,000 people on traditional Medicare who receive a brand-name cancer drug through Medicare Part D, 99% will see savings from the out-of-pocket spending cap, said Patients for Affordable Drugs, which partnered with the National Opinion Research Center (NORC) at the University of Chicago on the new analysis.
On average, that population will see savings of more than $7,500 once the spending cap is in place in 2025. Some will see savings of over $19,000 in 2025.
"To afford it, I have fundraised, searched for grants, sold furniture and my husband's truck, and zeroed out our savings."
The coming savings highlight the extent to which cancer patients and the Medicare program are currently being gouged by cancer drug manufacturers, which often raise prices on their products annually after developing them with government support.
"Between 2017 and 2021, the average initial price of a new Part D cancer drug rose by more than 25% to over $235,000 yearly when adjusted for inflation," Patients for Affordable Drugs noted in its new report, citing a recent investigation by Rep. Katie Porter's (D-Calif.) office. "Pharmaceutical companies then raise the prices on these drugs year after year."
David Mitchell, the founder of Patients for Affordable Drugs and a blood cancer patient whose medications come with a list price of more than $900,000 a year, said in a statement Wednesday that "cancer patients—the majority of whom are on Medicare—can face annual out-of-pocket costs of more than $16,500."
"The historic Inflation Reduction Act includes policies that will bring needed relief to millions of patients, especially older Americans with cancer," said Mitchell. "We've been waiting for this relief for far too long."
The new report spotlights several high-priced brand-name cancer medications sold by Pfizer, Bristol Myers Squibb (BMS), Johnson & Johnson, and other major pharmaceutical companies.
Pfizer has hiked the price of Ibrance, a breast cancer medication, every year since it came to market in 2015. Today, the list price is "more than $15,000 per bottle," Patients for Affordable Drugs observed.
"Celgene/BMS has almost tripled the price of Revlimid—a drug to treat multiple myeloma—since it came to market in 2006," the group added. "Despite being on the market for more than 15 years, the drug remains one of the best-selling products in the world. Much of these sales are paid for by taxpayers, with Medicare Part D spending over $5.8 billion on the drug in 2021 for 45,601 beneficiaries."
Jackie Trapp, a multiple myeloma patient in Wisconsin, told Patients for Affordable Drugs that Revlimid costs her "$20,000 each year on Medicare."
"To afford it, I have fundraised, searched for grants, sold furniture and my husband's truck, and zeroed out our savings," she said. "The price of Revlimid has had real impacts on my husband and my quality of life. It is already unfair that I am likely to leave my husband all alone sooner than I would like, but now I fear of leaving him bankrupt as well."
Trapp's case is hardly an outlier.
A recent American Cancer Society Cancer Action Network survey of 1,218 cancer patients and survivors found that "more than 70% of respondents said they made significant lifestyle changes in order to afford care, including delaying major purchases (36%), depleting most or all of their savings (28%), going into more credit card debt (28%), and borrowing money from relatives and friends (20%)."
Trapp said the $2,000 out-of-pocket spending cap "will be huge," helping "bring me and my husband peace of mind, knowing that my portion of my sky-high drug prices will be lower than it is now and that we'd have a reasonable limit if I lost my grant."
The new report comes as the Biden administration is facing pressure to build on the Inflation Reduction Act, which will also require Medicare to negotiate the prices of a small number of high-cost prescription drugs.
Merck, whose cancer drug Keytruda carries an annual list price of $175,000, sued the Biden administration last week in an attempt to block the price negotiation provision.
Patients for Affordable Drugs pointed out that Keytruda and Revlimid are in the top ten drugs for U.S. sales in 2021 and their manufacturers have applied for more than 180 patents on each drug."
"Research shows that when drug corporations amass dozens of patents, competition from lower-priced generics and biosimilars is delayed, leaving patients and taxpayers footing the bill for billions in unjust profits," the group said. "Fortunately, there are bills in the 118th Congress that crack down on abuse of the patent and regulatory system. If these bills become law, they will enable more affordable drugs to come to market more quickly, providing relief for patients struggling to pay for overpriced medications."
Rep. Pramila Jayapal (D-Wash.) and Sen. Elizabeth Warren (D-Mass.) have also outlined steps the United States Patent and Trademark Office can take immediately and unilaterally to curb abuses of the patent system.
"For decades," the lawmakers wrote in April, "powerful pharmaceutical companies and other large corporate actors have repeatedly abused the patent system to stifle competition and prolong their market power, showing no regard for the harm done to patients through sustained high prices."
"We request HHS to consider this appeal directly... because the NIH has repeatedly demonstrated its unwillingness to even acknowledge that the Bayh-Dole Act includes an obligation to make products invented with federal funds 'available to the public on reasonable terms.'"
Two days after President Joe Biden's administration rejected a petition asking federal regulators to use their authority to lower the astronomical price of a lifesaving prostate cancer drug developed entirely with public funds, petitioners on Thursday filed an administrative appeal.
At issue is enzalutamide, a drug the Japanese pharmaceutical giant Astellas and its U.S. counterpart Pfizer sell under the brand name Xtandi. Although Xtandi owes its existence to U.S. taxpayers, who bankrolled 100% of its development, an annual supply of the drug costs $189,900 in the United States—three to six times more than its list price in other wealthy nations.
In late 2021, prostate cancer patients Robert Sachs, Clare Love, and Eric Sawyer petitioned the U.S. Department of Health and Human Services (HHS) to exercise its "march-in rights" against Xtandi. Under the Bayh-Dole Act, the federal government can reclaim and redistribute patents for inventions created with public funding—enabling generic competitors to produce cheaper versions—when "action is necessary to alleviate health or safety needs" or when an invention's benefits are not being made "available to the public on reasonable terms."
HHS Secretary Xavier Becerra referred the petition to the National Institutes of Health (NIH), whose acting Director Lawrence Tabak argued in a Tuesday letter that "Xtandi is widely available to the public on the market," citing Astellas' estimate that "more than 200,000 patients were treated with Xtandi from 2012 to 2021."
Even with insurance, co-pays for Xtandi are sky-high. Medicare recipients, for example, are expected to pay roughly $10,000 per year for the medicine. Especially for the millions of uninsured and underinsured people in the U.S., Xtandi remains completely out of reach.
Tabak's letter went on to say that Xtandi's "practical application is evidenced by the 'manufacture, practice, and operation' of the invention and the invention's 'availability to and use by the public….'" As Knowledge Ecology International executive director James Love lamented, the NIH completely elided any mention of "reasonable terms," editing out that key phrase from Bayh-Dole.
In their appeal, the petitioners wrote: "The petition focused on a single issue: the reasonableness of charging U.S. cancer patients three to six times more than residents of other high-income countries for the drug Xtandi."
"There is no dispute about the following facts," the appeal continues. "Xtandi was invented on grants from the U.S. Army and the NIH at UCLA, a public university. The patents were licensed eventually to Astellas, a Japanese drug company, with a partnership share now held by Pfizer, following its 2016 $14 billion acquisition of Medivation, UCLA's original licensee, that occurred just after the NIH rejected an earlier march-in request on Xtandi. The prices in the United States have consistently been far higher than the prices in other high-income countries."
Prior to the 2021 petition, Clare Love and prostate cancer patient David Reed filed a petition, later joined by Sachs, with the U.S. Department of Defense (DOD) after the Senate Armed Services Committee instructed the Pentagon to initiate march-in proceedings when the price of a drug created with a DOD grant exceeds the median price in seven large high-income nations. The Pentagon, however, has yet to acknowledge or act on the petition submitted to it in February 2019.
"If you consider both of these requests together, a petition to exercise the government's march-in or other rights in the Xtandi patents has been pending before the federal government for more than four years," Thursday's appeal states. "The HHS petition was filed 16 months ago."
It continues:
The petitions were filed with the DOD and HHS instead of the NIH because the NIH has repeatedly demonstrated its unwillingness to even acknowledge that the Bayh-Dole Act includes an obligation to make products invented with federal funds 'available to the public on reasonable terms.' This is demonstrated by a track record of dismissing multiple requests to use the government's Bayh-Dole safeguard to address pricing abuses and access restrictions, including those concerning the federal government's march-in rights under 35 USC § 203, and the federal government's global royalty-free license, under 35 USC § 202(c)(4). There are also extensive email records between Mark Rohrbaugh, currently NIH special adviser for technology transfer who is a long-time agency official, and lobbyists for drug companies and university rights holders, obtained through Freedom of Information Act requests, which not only express opposition to any safeguards regarding unreasonable pricing but organize public relations efforts against using a march-in request to address the pricing of products.
"HHS chose to assign to the NIH the evaluation of our petition regarding Xtandi," says the appeal. "We request HHS to consider this appeal directly, and not assign NIH to review its own decision. The latter would be tantamount to no review at all."
Since Bayh-Dole was enacted in 1980, "march-in rights have never been used... and NIH has repeatedly rejected the idea that affordability is a reasonable term," The American Prospect reported Wednesday. With Xtandi, "advocates thought they found the perfect test case for a new administration that paid lip service to lowering prescription drug costs."
As The Lever noted on Wednesday, the NIH's decision this week was consistent with Biden's track record:
Biden was vice president when the Obama administration rejected congressional Democrats' demand that the government use the same power to lower the skyrocketing prices of medicine in America.
As a senator in 2000, Biden was one of just eight Democrats who helped pharmaceutical lobbyists kill a measure spearheaded by Sen. Paul Wellstone (D-Minn.) and then-Rep. Bernie Sanders (I-Vt.) that would have reinstated the Reagan-era requirement that drug companies sell medicines developed with public money at a reasonable price.
That requirement was repealed by the Clinton administration in 1995, following pressure by drugmakers.
But Becerra's acquiescence to Big Pharma was more surprising. Prior to joining the Biden administration, the HHS secretary had expressed support for wielding the executive branch's authority to rein in soaring drug prices.
As the attorney general of California in the summer of 2020, "Becerra demanded the Trump administration use existing law to lower the price of medicines that were originally developed at taxpayer expense," The Lever reported. "As a member of Congress in 2016, Becerra signed on to a letter to the Obama Department of Health and Human Services calling on officials to broadly use 'march-in rights' to lower the cost of prescription drugs—including 'specialty drugs, like those to treat cancer, which are frequently developed with taxpayer funds.'"
Despite pressure from numerous members of Congress and medicine affordability advocacy groups, the NIH declared Tuesday that it "does not believe that use of the march-in authority would be an effective means of lowering the price of the drug."
Instead, the agency vowed to "pursue a whole-of-government approach informed by public input to ensure the use of march-in authority is consistent with the policy and objective of the Bayh-Dole Act," a move that progressive advocates denounced as a "pathetic" attempt to deflect criticism of its failure to use or threaten to use its legal power.
“This is a drug that was invented with taxpayer dollars by scientists at UCLA and can be purchased in Canada for one-fifth the U.S. price," Sanders said Tuesday. "The Japanese drugmaker Astellas, which made $1 billion in profits in 2021, has raised the price of this drug by more than 75%."
"How many prostate cancer patients will die because they cannot afford this unacceptable price?" asked Sanders, chair of the Senate Committee on Health, Education, Labor, and Pensions.
During a Wednesday hearing, Sanders made the case for changing "the current culture of greed into a culture which understands that science and medical breakthroughs should work for ordinary people, and not just enrich large corporations and CEOs."
"This decision effectively rubber-stamps continued Big Pharma abuse," said one Democratic lawmaker.
Patient advocates on Tuesday blasted the Biden administration's refusal to compel the manufacturer of a lifesaving prostate cancer drug developed completely with public funds to lower its nearly $190,000 annual price tag.
In 2021, prostate cancer patient Eric Sawyer petitioned U.S. Health and Human Services (HHS) Secretary Xavier Becerra to grant march-in rights—under which the government can grant patent licenses to companies other than a drug's manufacturer—for enzalutamide, which is sold under the brand name Xtandi by Pfizer and Japanese pharmaceutical giant Astellas.
The drug's development was 100% taxpayer-funded. Yet a one-year supply of Xtandi currently costs $189,800 in the United States, or up to five times more than its price in other countries.
HHS' National Institutes of Health (NIH) said Tuesday that it "does not believe that use of the march-in authority would be an effective means of lowering the price of the drug."
"What the Biden administration is saying is that charging U.S. residents three to six times more than any other high-income country is reasonable."
The agency added that it "will pursue a whole-of-government approach informed by public input to ensure the use of march-in authority is consistent with the policy and objective of the Bayh-Dole Act," a reference to legislation meant to promote the commercialization and public availability of government-funded inventions.
James Love, director of the Washington, D.C.-based advocacy group Knowledge Ecology International, called the administration's rejection "appalling."
"What the Biden administration is saying is that charging U.S. residents three to six times more than any other high-income country is reasonable," he wrote.
U.S. Senate Health, Education, Labor, and Pensions Committee Chair Bernie Sanders (I-Vt.) said in a statement that he is "extremely disappointed that the Biden administration denied a petition by prostate cancer patients to substantially reduce the price of Xtandi."
"This is a drug that was invented with taxpayer dollars by scientists at UCLA and can be purchased in Canada for one-fifth the U.S. price," Sanders added. "The Japanese drugmaker Astellas, which made $1 billion in profits in 2021, has raised the price of this drug by more than 75%... How many prostate cancer patients will die because they cannot afford this unacceptable price?"
Rep. Lloyd Doggett (D-Texas), the ranking member of the House Ways and Means Health Subcommittee, said in a statement:
Today's decision is a blow to prostate cancer patients, their families, and taxpayers. Developed with U.S. taxpayer research dollars, Xtandi costs American patients $180,000 a year—as much as six times as much as patients in other countries. This excessive price gouging cost taxpayers $2 billion to cover Medicare beneficiaries' treatment in 2020 alone. The Biden administration has missed yet another opportunity to do something meaningful to lower prescription drug costs and protect taxpayer investments.
The administration's position "protects monopolists over taxpayers and patients, despite clear statutory authority and reasonableness to intervene," Doggett added. "This decision effectively rubber-stamps continued Big Pharma abuse."
In a move that Public Citizen president Robert Weissman called "pathetic," HHS and the Department of Commerce announced Tuesday that they would "pursue a whole-of-government approach to review... march-in authority as laid out in the Bayh-Dole Act" by forming an interagency working group.
The group "will develop a framework for implementation of the march-in provision that clearly articulates guiding criteria and processes for making determinations where different factors, including price, may be a consideration in agencies' assessments."
In a statement, Becerra said that the administration is "committed to increasing access to healthcare and lowering costs."
"March-in authority is a powerful tool designed to ensure that the benefits of the American taxpayers' investment in research and development are reasonably accessible to the public," he added. "We look forward to updates from the Bayh-Dole Interagency Working Group, and at my direction, HHS will review the findings, engage the public, and better define how HHS could effectively utilize our authority moving forward."