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"Caremark, ESI, and Optum—as medication gatekeepers—have extracted millions of dollars off the backs of patients who need lifesaving medications," said one agency leader.
The Federal Trade Commission on Friday initiated a legal process against middlemen that collectively administer about 80% of all prescriptions in the United States, accusing them of artificially inflating the list price of insulin drugs and blocking patients from accessing cheaper products.
The FTC action targets the "Big Three" pharmacy benefit managers (PBMs): CVS Health's Caremark Rx, Cigna's Express Scripts (ESI), and UnitedHealth Group's OptumRx. It also involves their affiliated group purchasing organizations (GPOs): Zinc Health Services, Ascent Health Services, and Emisar Pharma Services.
"Millions of Americans with diabetes need insulin to survive, yet for many of these vulnerable patients, their insulin drug costs have skyrocketed over the past decade thanks in part to powerful PBMs and their greed," said Rahul Rao, deputy director of the FTC's Bureau of Competition.
"Caremark, ESI, and Optum—as medication gatekeepers—have extracted millions of dollars off the backs of patients who need lifesaving medications," Rao continued. "The FTC's administrative action seeks to put an end to the Big Three PBMs' exploitative conduct and marks an important step in fixing a broken system—a fix that could ripple beyond the insulin market and restore healthy competition to drive down drug prices for consumers."
The FTC's vote to begin the legal process by filing a complaint was 3-0. Led by Chair Lina Khan, the Democrats supported the move while the two Republicans, Commissioners Melissa Holyoak and Andrew N. Ferguson, recused.
The American Prospect executive editor David Dayen noted that "the complaint, which was filed in an administrative court, has not yet been made public, as it is undergoing redactions. Agency officials expect it to be made public on Monday."
However, in a statement after the vote, the FTC shared some details about the complaint's arguments that "Caremark, ESI, and Optum and their respective GPOs engaged in unfair methods of competition and unfair acts or practices under Section 5 of the FTC Act by incentivizing manufacturers to inflate insulin list prices, restricting patients' access to more affordable insulins on drug formularies, and shifting the cost of high list price insulins to vulnerable patient populations."
Rao emphasized that while the commission on Friday "exercised its discretion to move forward with suing only the PBMs and GPOs now, FTC staff's investigation has also shed light on the concerning and active role that the insulin manufacturers—Eli Lilly, Sanofi, and Novo Nordisk—play in the challenged conduct."
"All drug manufacturers should be on notice that their participation in the type of conduct challenged here can raise serious concerns, with a potential for significant consumer harm, and that the Bureau of Competition reserves the right to recommend naming drug manufacturers as defendants in any future enforcement actions over similar conduct," he said.
Emma Freer, senior policy analyst for healthcare at the American Economic Liberties Project, pointed out that "the FTC's case adds to the mounting, bipartisan criticism of the 'Big Three' PBMs, which for far too long have exploited their monopoly power to inflate drug prices and enrich shareholders at the expense of patients' health and pocketbooks."
"The lawsuit also exposes their industrywide abuse, using insulin—the price of which has soared over 1,200% since 1999—as a flagship example of how PBMs' rebate schemes distort markets and drive up costs for lifesaving drugs," Freer said. "While PBMs bear much of the blame, the FTC is right to also put brand-name manufacturers like Eli Lilly, Novo Nordisk, and Sanofi on notice for their role in this crisis. We're thrilled to see the commission bring this long overdue challenge against healthcare's most notorious middlemen, and hope to see it result in concrete reform and accountability."
As The New York Times reported:
Just weeks before the presidential election, the agency is tackling an issue that Vice President Kamala Harris has signaled an interest in. Campaigning at a community college in Raleigh, North Carolina, in August, Ms. Harris promised to "demand transparency from the middlemen who operate between Big Pharma and the insurance companies, who use opaque practices to raise your drug prices and profit off your need for medicine."
Former President Donald J. Trump has not campaigned on the issue, but in 2018, his administration proposed a sweeping change that would have threatened the benefit managers' business model. The proposal was never enacted. Mr. Trump's administration also created a model for capping Medicare patients' out-of-pocket costs for some insulin products that was later expanded under President [Joe] Biden.
The Times also noted that "some Republicans in Congress have proposed curbing some of the benefit managers' business practices. But other top Republicans have defended PBMs and said the FTC is overreaching."
Among the GOP's critics of PBMs is House Committee on Oversight and Accountability Chairman James Comer (R-Ky.), who highlighted his panel's investigations into the companies and praised the FTC move.
Another leading congressional critic of PBMs—and the country's failing for-profit healthcare system more broadly—is Senate Committee on Health, Education, Labor, and Pensions (HELP) Chair Bernie Sanders (I-Vt.), who caucuses with Democrats.
After a public pressure campaign led Eli Lilly, Novo Nordisk, and Sanofi to cut list prices of insulin products last year, Sanders held a hearing with their CEOs as well as PBM executives. At the time, he welcomed the voluntary reductions but also stressed that as "Americans pay outrageously high prices for prescription drugs, the pharmaceutical industry and the PBMs make enormous profits."
While the FTC's Friday action was widely praised—other than by the PBMs, who denied the allegations—some advocates hope the commission and other decision-makers will go even further in the future.
Stacy Mitchell, co-executive director of the Institute for Local Self-Reliance, called PBMs "some of the most predatory corporations in healthcare" and highlighted that "these companies have incredibly long rap sheets and convictions at the state level."
"I'm thrilled the FTC is going after these criminal enterprises," she said. "I hope this lawsuit, with its focus on kickbacks, is just the beginning. We also need action on how PBMs harm local pharmacies. Ultimately, these corporations need to be broken up."
"Why? Excessive corporate greed," said Sen. Bernie Sanders.
U.S. Sen. Bernie Sanders called out the pharmaceutical giant Novo Nordisk on Tuesday for charging American patients more than $900 a month for the increasingly popular diabetes drug Ozempic, even though generic manufacturers are willing to sell the medication for significantly less.
During a panel discussion with experts, Sanders (I-Vt.) said he and his staff have been in contact with the top executives of major drug makers who say they could sell a generic version of Ozempic for less than $100 a month—and still turn a profit. A recent study found that the drug can be manufactured for less than $5 a month.
"Novo Nordisk, which has made nearly $50 billion in sales off of Ozempic and Wegovy, charges Americans almost $1,000 a month—the highest prices in the world," Sanders, the chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, said Tuesday. "Why? Excessive corporate greed."
Ozempic and Wegovy are part of a class of treatments known as GLP-1s. Wegovy, a weight-loss drug that Novo Nordisk sells for $1,349 a month in the U.S., contains the same active ingredient as Ozempic, which is approved only for people with Type 2 diabetes.
The drugs' growing popularity in the U.S. has drawn greater scrutiny to Novo Nordisk's pricing. Sanders' office noted Tuesday that the company's price tag for Wegovy is $186 in Denmark, $140 in Germany, and $92 in the United Kingdom.
Novo Nordisk's high prices for the drugs in the U.S. could have far-reaching impacts on the nation's healthcare system. A group of economists wrote in a recent op-ed for The New York Times earlier this year that "under reasonable assumptions and at current prices, making this class of drugs available to all obese Americans could eventually cost over $1 trillion per year," which is "almost as much as the government spends on the entire Medicare program and almost one-fifth of the entire amount America spends on healthcare."
Sanders warned Tuesday that if the prices of Ozempic and Wegovy aren't reined in, Medicare premiums could surge.
"Our healthcare system, I think most people understand, is in crisis," Sanders said during the panel discussion. "The business model of the pharmaceutical industry is unsustainable."
Over the course of our investigation into the outrageous cost of Ozempic and Wegovy in the U.S., I spoke with the CEOs of major generic pharmaceutical companies who confirmed:
They can sell a generic version of Ozempic for $100/mo. https://t.co/XDHdBRPIcM
— Bernie Sanders (@SenSanders) September 17, 2024
Peter Maybarduk, director of the Access to Medicines Program at Public Citizen, said in a statement Tuesday that "all we need to make Ozempic for $100 a reality is to overcome Novo's patent monopoly, which the government has the power to do any time."
"States and clinicians are asking the feds for help," said Maybarduk. "We estimate taking action on Novo's patents could save Medicare more than $14 billion in the first two years of competition, while making diabetes and obesity drugs affordable."
Last month, Public Citizen delivered a petition to U.S. Health and Human Services Secretary Xavier Becerra urging him to use existing law to "authorize generic competitors to Ozempic and Wegovy."
"Novo Nordisk’s outrageous pricing of [Ozempic and Wegovy] threatens to break the coffers of federal health programs," the group wrote. "Pursuant to 28 U.S.C. § 1498, the administration should authorize use of any and all patents necessary to allow manufacturers to produce generic alternatives to these treatments on behalf of the United States government, which can be used to supply Medicare, Medicaid, and other federal health programs. This will facilitate competition and make the treatments more affordable and accessible for patients."
The CEO of Novo Nordisk, which has spent aggressively on lobbying this year, is scheduled to testify before the Senate HELP Committee next week.
"We must question why Bavarian Nordic refuses to adjust its unconscionable approach to pricing and access," wrote the director of Public Citizen's Access to Medicines program.
A U.S.-based watchdog group on Friday called out what it described as the "profiteering approach" taken by one of the only companies in the world with an approved vaccine for mpox, an infectious disease whose rapid spread in the Democratic Republic of Congo prompted the World Health Organization to declare a global emergency earlier this month.
Peter Maybarduk, the director of Public Citizen's Access to Medicines program, wrote a letter to the Danish pharmaceutical giant Bavarian Nordic expressing deep concern that the company "may be exploiting the latest global health crisis, putting profits over people."
A spokesperson for Bavarian Nordic, the maker of the mpox vaccine Jynneos, told STAT in a recent interview that the firm doesn't "tend to talk about price," a lack of transparency that set off alarm bells amid a pressing international crisis. Mpox has spread to the DRC's neighboring countries, and Thailand and Sweden each recently reported a case.
Maybarduk elaborated on his concerns:
In 2022, the Pan American Health Organization (PAHO) resolved to procure mpox vaccines despite Bavarian Nordic’s refusal to provide a single low price for all PAHO Member States. Consequently, the vaccine costs much more than any of the other vaccines available through the Revolving Fund, PAHO's bulk vaccine purchaser. In negotiations with manufacturers, the Revolving Fund usually seeks to obtain a supplier's lowest available price to ensure that all PAHO Member States can access affordable vaccines, regardless of size or level of development.
Given Bavarian Nordic's troubling approach to pricing with PAHO then, we remain concerned about pricing implications now for group procurement by Africa CDC and multilateral purchasers such as Gavi, as well as wider ramifications for the global public health response.
"While many actors have roles to play in ensuring a coordinated international effort to contain the spread of mpox, including how best to make use of vaccines," Maybarduk added, "we must question why Bavarian Nordic refuses to adjust its unconscionable approach to pricing and access."
The WHO's emergency declaration and the lack of vaccine access in the countries most affected by mpox has sparked concerns of a repeat of the vaccine apartheid that undermined the global response to Covid-19, with deadly consequences.
Lawrence Gostin, Sam Halabi, and Alexandra Finch, experts at the O'Neill Institute for National and Global Health Law at Georgetown University, wrote in a New York Times op-ed earlier this week that "we shouldn't discount the pandemic potential of mpox."
"Africa CDC has estimated that it needs 10 million doses to stop the current outbreak. But as was the case with the Covid vaccines, mpox vaccines are in the hands of the world's richest countries and companies," the experts wrote. "An agreement between Africa CDC, the European Union, and Bavarian Nordic has already been reached for the procurement and rapid distribution of about 200,000 doses, but many more are needed. The United States has said it will donate 50,000 doses to Congo from its stockpile. But this still leaves Africa nowhere near the 10 million doses needed."
"Bavarian Nordic says that by the end of this year it could manufacture two million more doses, and then eight million doses next year, if purchase orders are made," they added. "But there is no clear commitment to make these doses affordable for African countries."