AstraZeneca Advances Legal Challenge, While New Report Shows How They Kept Blockbuster Drug Prices High for Years
On Monday, AstraZeneca revived one of its multiple lawsuits against Medicare negotiation, this time asking the Fourth Circuit to reverse a Maryland district court dismissal earlier this year. The legal challenge comes as new analysis from AARP’s Public Policy Institute examines AstraZeneca’s layered efforts to delay generic competition, offering a striking look at how drugmakers work to preserve pricing power throughout a drug’s lifecycle. To delay competition on its blockbuster inhaler Symbicort — which has generated more than $55 billion in lifetime global sales — the company accumulated more than 90 patents around the drug and shifted marketing to the newer, more expensive Breztri Aerosphere as Symbicort faced loss of exclusivity — a strategy known as product hopping. Taken together, the developments illustrate the multi-pronged strategy used by drugmakers to fight any constraints on their pricing power: using patent and product strategies to delay competition, while challenging Medicare’s new authority to negotiate prices in court. — [AstraZeneca, Law360, AARP]
PhRMA Files Lawsuit Against the Already Gutted GLOBE Model
PhRMA filed a lawsuit this week challenging the Trump administration’s GLOBE model, asking a D.C. federal court to declare the program unconstitutional. The challenge comes after the administration already substantially weakened GLOBE by allowing drugmakers with voluntary MFN agreements to receive waivers from the mandatory model, alongside additional drug category exemptions. GLOBE is now projected to save only 4% of what CMS originally projected, yet even still, PhRMA is seeking to invalidate what remains. That should be a warning for CMS as it develops GUARD, the corresponding model for Medicare Part D; exempting drugmakers from mandatory pricing policies in exchange for voluntary agreements does not guarantee industry acceptance of the underlying reforms. CMS should not repeat the same mistake by allowing voluntary agreements to hollow out another mandatory model. — [POLITICO, STAT News, Endpoints News, Medical Daily, Pharma Commerce]
Health Care Costs Remain at the Center of Americans’ Affordability Concerns
New KFF polling this week finds that health care costs remain one of voters’ top affordability concerns, exceeding worries about housing, food, utilities, and on par with concerns over gas and transportation costs. Eighty-two percent of voters polled say healthcare costs are extremely or very important for candidates to discuss, while 60% are worried about their ability to afford healthcare for themselves and their families — including insurance, office visits, and prescription drugs. Additionally, a new POLITICO poll also found that 34% of voters say health care costs are the main reason driving their vote this midterm, only second to 45% who listed broader concerns about “affordability and the economy.” These findings continue a pattern KFF has been tracking: policymakers looking to address Americans’ cost-of-living concerns must not overlook lowering prescription drug prices as an important piece of any broader affordability agenda. — [KFF, POLITICO]
ICYMI: Last week, tariffs on imported patented drugs and their ingredients expanded beyond the 17 large drugmakers who received letters from the Trump administration in July. But the policy’s impact will vary significantly: all 17 of those large drugmakers have since secured a 0% tariff through January 2029 under MFN pricing and U.S. manufacturing agreements, while other manufacturers could face rates as high as 100% depending on their products, manufacturing plans, and country of origin. — [Managed Healthcare Executive]
Administration Guts Mandatory GLOBE Drug Pricing Model with Pharma Carveouts
The finalized GLOBE model is now projected to save just $440 million — a staggering 96% decrease from CMS’s original projection of $11.9 billion. Central to the dramatic reduction is the administration’s decision to allow drugmakers participating in voluntary deals, including the GENEROUS model, to receive waivers from mandatory participation, a fact that we warned would drastically limit patient savings and impact. The administration moved forward with the carveout anyway, and today only a few drugmakers are included in GLOBE, down from an initial 19. A mandatory model only works if drugmakers are actually required to participate. The administration should reverse course on these pharma-friendly carveouts and ensure GLOBE delivers the savings it was designed to achieve for patients and taxpayers — and as CMS finalizes GUARD, its corresponding model for Medicare Part D, it should not repeat the same mistake. — [P4AD, STAT News, Bloomberg Law, Fierce Healthcare]
56 Members of Congress Side with Big Pharma to Weaken Medicare Negotiation
56 members of Congress signed a letter urging CMS to withdraw a proposed policy designed to close a loophole in the Medicare negotiation program. This is the tried-and-tested industry playbook: if they can’t defeat negotiation in the courtroom, they’ll try to chip away at it piece by piece on Capitol Hill. Under current policy, a drugmaker can combine an existing drug with an additional ingredient that is not biologically active against the disease and have the resulting fixed-dose combination treated as a separate drug when CMS determines eligibility for negotiation — potentially resetting the negotiation clock and giving the new product a later eligibility date. CMS has identified this technicality as a program integrity risk, warning that manufacturers could use minor changes to existing drugs to avoid selection for negotiation which would keep prices high for patients for longer. Its proposed policy for the 2029 negotiation cycle would address the loophole by putting certain fixed-dose combinations together with the original drug when determining negotiation eligibility. We strongly support CMS’s proposal and submitted comments in August urging the agency to stand firm against Big Pharma’s efforts to weaken negotiation. — [Fox News, P4AD]
Patients Respond — CBP Importation Change Threatens Low-Cost Medications
Lawmakers on both sides of the aisle are pushing back on an upcoming Customs and Border Protection (CBP) rule taking effect October 22 that would create a significant new hurdle for Americans who buy lower-cost medications from pharmacies outside the U.S. In an informal survey of just over 100 patients in our community, 52 respondents said they receive medication shipped from a pharmacy abroad — and among those patients, 94% are concerned the new requirements could affect their access to medication and 79% said their medication costs more in the U.S. Several even told us that losing self-importation would mean going without their medication altogether. No patient should have to look outside the U.S. to afford the medicine they need, but disrupting a pathway patients currently rely on without addressing the high U.S. prices that drove them there leaves some patients without an affordable way to access their medication. — [STAT News]
Former House Majority Leader Eric Cantor to Lead PhRMA
Eric Cantor, Former Republican House Majority Leader from 2011 to 2014, was named the next president and CEO of PhRMA, the pharmaceutical industry’s lobbying group. Cantor takes the helm as drugmakers face mounting pressure in Washington over high drug prices and policies aimed at lowering them, including Medicare negotiation. This is the second time PhRMA has chosen a former Republican House member as its leader, after Congressman Billy Tauzin ran the group from 2005 to 2010. As chair of the Energy and Commerce Committee, Tauzin played a leading role in securing the pharma-backed non-interference clause that stopped Medicare from negotiating drug prices for two decades. — [P4AD, STAT News, Endpoints News, Axios, POLITICO, The Hill, Pink Sheet]
ICYMI: New research in JAMA finds no evidence that the Inflation Reduction Act accelerated the trend of pharmaceutical companies setting and raising launch prices. Drug companies were launching drugs at increasingly unaffordable prices long before Medicare negotiation — and contrary to industry fearmongering, the IRA did not make the problem worse. However, median launch prices climbed from roughly $39,000 between 2008 and 2013 to $254,000 between 2020 and 2025. Now policymakers need to tackle the part of the pricing system the IRA largely left untouched: what drug companies can charge at launch. — [JAMA, Managed Healthcare Executive]
FOIA’d MFN Agreements Reveal New Details — But Key Terms Remain Secret
Newly released, heavily redacted Pfizer and Eli Lilly MFN agreements reveal concerning drug exclusions and terms while leaving key details about pricing and implementation unknown. That’s according to Public Citizen, which obtained the heavily redacted agreements through FOIA litigation. Eli Lilly’s deal, for example, excludes Mounjaro and Zepbound from certain MFN pricing requirements — undercutting one of the administration’s biggest selling points for the deals. According to Public Citizen, the exclusion could reduce potential first-year GENEROUS savings by up to $300 million. The documents also confirm that Pfizer’s agreement takes precedence over GENEROUS where the two agreements conflict, raising additional questions about the program’s potential long-term savings. Ultimately, these disclosures reinforce a central concern with these voluntary agreements: we still don’t know which drugs are covered, what prices manufacturers have agreed to, or how much savings they will actually deliver for patients and taxpayers. — [Public Citizen, Washington Post, PharmaPhorum, NBC Polling, STAT News]
Pharma Says the Quiet Part Out Loud on Innovation
At a specialty pharmacy conference this week, BRG executives spoke candidly about the financial calculations behind investment in new treatments, asking “why would you want to invest in this space to get your 10 to 20 adopted cell and gene therapies a year if you could invest in AI or a data center, where you have a more certain return?” It reveals what the pharmaceutical industry intends to protect when it warns that policies to lower drug prices could threaten innovation. In parallel, AbbVie EVP Perry Siatis claimed this week that Germany’s pricing and reimbursement policies “veer drastically” from incentivizing innovation. It’s rich that AbbVie is lecturing Germany on “fair contribution” while their blockbuster drug Humira is a textbook patent-thicketing case, preventing biosimilars from reaching the market in the U.S. for years longer than they did in Germany. Increasing competition is one of the primary ways to incentivize true innovation. — [Endpoints News, AJMC]
Upcoming CBP Drug Importation Change Could Harm Patients
A new Customs and Border Protection rule change taking effect October 22nd will require prescription drugs mailed from abroad to go through a formal customs entry process. In practice, this change will likely make the personal importation of lower-cost medicines from other countries very difficult and potentially impossible. An estimated 2.3 million Americans have purchased prescription drugs outside the U.S., and members of P4AD’s patient community could be directly affected. Maureen has purchased her brand-name seizure medications from Canada for years, while Darlene’s blood pressure drug costs five times more in the U.S. than in Canada. Even P4AD’s founder David Mitchell relied on Canadian pharmacies to purchase Eliquis when his Part D plan wouldn’t cover the drug — or allow him to pay out-of-pocket for it. At the time, he was able to purchase it for just a third of the US price. Patients shouldn’t have to look outside the U.S. to afford the medicines they need, but for those who already do, disrupting this pathway without addressing the high prices that drove them there could put their access to treatment at risk. — [Wall Street Journal]
ICYMI: Public Interest Patent Law Institute (PPLI) sent a letter to the House Judiciary Subcommittee this week highlighting how drugmakers use terminal disclaimers to accumulate multiple closely related patents on the same invention, creating costly legal hurdles for generic competitors. As PPLI put it, “a company holding dozens of them can turn one dispute into a war of attrition.” The bipartisan ETHIC Act would limit drugmakers to asserting one patent from a terminally disclaimed group against a generic or biosimilar competitor, reducing a barrier to lower-cost competition. — [PPLI]
POTUS Announcement — The State of GENEROUS and MFN
President Trump announced from the Oval Office that all 50 states have agreed to participate in the GENEROUS (GENErating cost Reductions fOr U.S. Medicaid) voluntary CMS model. But the announcement leaves significant questions unanswered. The administration has not disclosed which drugs are included, the prices Medicaid programs will pay, or the underlying deal terms needed to independently evaluate its savings projections, although the White House is claiming $64.3 billion in federal and state savings over the next decade. Medicaid already receives substantial statutory and supplemental rebates, and states can stick with previous agreements if they offer a better deal. Ultimately, the model’s success will depend not on how many states sign up, but on whether it delivers lower drug prices and improved access for patients on Medicaid — [White House, Semafor]
HHS Adviser Chris Klomp Faces Questions Over MFN Deals
Chris Klomp, the CMS Medicare Director who has played a key role in negotiating the administration’s MFN agreements with drugmakers, faced questions from two Senate committees this week as part of his Deputy HHS Secretary confirmation, with much of the scrutiny focused on the deals’ lack of transparency. Senator Wyden pressed Klomp over HHS Secretary Kennedy’s April commitment to provide Congress with the agreements, which have yet to be released, while Senator Warren pointed to drugmakers’ own statements that the deals are not expected to materially affect their financial outlook, and questioned what companies received in return. Klomp maintained that transparency is a core principle of the agreements, but their terms remain largely confidential, making it difficult to independently assess their impact. What has emerged publicly, including reports that some deals are structured to expire after three years and exclude key products, only adds to those concerns. The stakes of that opacity were underscored by a new study released the same week, which found that confidential exemption deals with an estimated 26 drugmakers could wipe out close to 80% of the Medicare savings projected under the administration’s GLOBE and GUARD models. A well-designed MFN policy has the potential to lower prices for patients, but voluntary time-limited agreements whose terms remain secret make it difficult to know whether these deals will deliver meaningful, lasting savings. — [P4AD, The Lancet]
ICYMI: The Congressional Black Caucus Foundation’s 55th Annual Legislative Conference took place this week, and P4AD was there representing patients with our “Guess The Price” booth. With a heavy pharmaceutical industry presence at the conference including drugmakers like Merck and Vertex, we made sure patients’ perspective was represented, challenging attendees to guess the sky-high price of drugs like Entresto and Casgevy — a sickle cell treatment. How many can you get right?
MFN Architect Chris Klomp to Testify
CMS Medicare director Chris Klomp will face back-to-back Senate confirmation hearings on Tuesday and Wednesday next week for the Deputy HHS Secretary role. Klomp is recognized as one of the primary architects behind the slate of MFN drugmaker deals introduced in the past year, and Klomp’s hearings will offer lawmakers a rare opportunity to press for further details on the deals. At present their terms remain largely confidential, several are structured to expire after just three years, and key products have reportedly been excluded altogether. Lasting savings require transparency and enforceability — and American patients struggling to afford their medications need Congress to deliver on both fronts. — [POLITICO, The Hill, Washington Post, Inside Health Policy]
INSULIN Act Introduced in House
Last week saw the introduction of the INSULIN Act by a bipartisan group of House lawmakers, legislation that would expand Medicare’s $35 monthly out-of-pocket cap on insulin to private and employer insurance plans. The bill is a companion to the Senate version that left committee earlier this summer, and while the House text doesn’t contain the same patent competition language as the Senate bill, similar provisions have already advanced out of the House Energy and Commerce Committee. Medicare’s $35 insulin cap has been delivering hundreds of dollars in savings each month for seniors since it went into effect in 2023, and while out-of-pocket caps don’t address the root cause of high list prices — the role of the pharmaceutical industry in setting prices — the continued growth in bipartisan support for out-of-pocket caps is a step that will benefit patients struggling with high insulin costs. — [POLITICO, Washington Post]
New Survey: Pharma Execs Game the System Against Reform
A new survey of 175 executives across 67 pharmaceutical companies found industry executives describing the current wave of drug pricing and market access changes as unlike anything they’ve experienced in decades. In particular, pharma executives revealed their attempts to rethink strategy and adjust to Medicare negotiation and most-favored-nation policies. It’s a telling admission from the industry: while drugmakers publicly warn that pricing reforms threaten innovation, the same executives are openly strategizing around how to preserve pricing power and shift costs by gaming the system — all at the expense of patients. — [Fierce Pharma]
ICYMI: In case you missed it last week, Patients For Affordable Drugs, We Are Más, and Brown University’s Information Futures Lab released The Price Patients Pay, a new report detailing how unaffordable prescription drugs shape the health, finances, and daily lives of Hispanic and Latino families. Drawing on five weeks of interviews and community discussions — most conducted in Spanish — the report documents patients rationing medication, taking on debt, and traveling abroad to afford the prescriptions they need, and offers recommendations for policymakers, providers, and advocates working to fix it. You can read the full report in English here, and in Spanish here.
P4AD Releases New Report on High Drug Prices in Hispanic and Latino Communities
Yesterday, P4AD, in collaboration with We Are Más, and Brown University’s Information Futures Lab released The Price Patients Pay: How Unaffordable Prescription Drugs Shape the Health, Finances, and Daily Lives of Hispanic and Latino Communities, a new report documenting how high prescription drug prices are forcing Hispanic and Latino patients to delay treatment, ration medications, take on debt, and travel abroad to access more affordable medicines. Drawing on five weeks of interviews, surveys, and community discussions — primarily conducted in Spanish — the report examines how unaffordable medicines affect patients’ health, finances, and daily lives and helps ensure the experiences of Hispanic and Latino patients inform the policy debate over how to lower drug prices. The report generated widespread coverage, reaching national and local outlets across the U.S. and Latin America, including Associated Press, Business Insider, USA Today, Infobae, Clarín, Yahoo Noticias, EFE, El Tiempo Latino, Hola News, and others. Read the full report in English and Spanish.
P4AD hosted a press briefing with project partners and a patient participant to discuss the findings and answer questions from reporters.
White House Announces New MFN Deals With Drugmakers
The Trump administration announced voluntary agreements with nine additional drugmakers to provide most-favored-nation (MFN) pricing to state Medicaid programs, bringing the total number of companies with agreements to 26. While the administration has touted the deals as a major step toward aligning U.S. drug prices with those in peer countries, their impact on patients and taxpayers remains unclear. Medicaid already receives steep statutory discounts, states can choose whether to participate, and the terms of the agreements — including the actual prices — remain secret. The deals may also come with a significant benefit for drugmakers: several participating companies have said they expect to be exempt from the administration’s planned mandatory MFN pricing models in Medicare. In other words, manufacturers may be gaining relief from broader Medicare pricing requirements in exchange for offering lower prices in Medicaid, where drugs are already heavily discounted. According to a new analysis this week from a Dutch investment bank, these deals will have “limited” impact on drugmaker profits. Voluntary and confidential agreements are no substitute for robust, transparent and enforceable reforms that lower prices for patients across the system and hold drug companies accountable. — [USA Today, Washington Post, Common Dreams]
New Reporting Highlights Rising Cancer Drug Prices and Weak Industry Accountability
Two major stories this week underscored the consequences of unchecked pharmaceutical industry pricing power. The New York Times examined how annual prices approaching half a million dollars are becoming increasingly common for new cancer drugs, including a newly approved pancreatic cancer treatment priced at around $480,000 per year. Separately, an International Consortium of Investigative Journalists (ICIJ) analysis found that nearly $1.7 billion in fines and settlements against cancer drugmakers over 15 years amounted to just a fraction of the companies’ revenues. Together, the reporting illustrates a market in which drugmakers retain enormous power to set and increase prices while penalties intended to deter misconduct can amount to little more than a cost of doing business. The ICIJ analysis cited P4AD data on the rising price of Revlimid, which reached roughly $900 per pill by mid-2024. — [NYT, ICIJ]
ICYMI: A new analysis from the Campaign for Sustainable Rx Pricing (CSRxP) found that the ten largest U.S. drug companies spend three times more on profits, advertising, and overhead (53% of revenue) than on research and development (18%). Profits alone account for 25% of revenue — more than R&D — undermining the industry’s longstanding argument that policies to lower U.S. drug prices would threaten investment in innovation.
Bad Week for Pharma in Court!
Big Pharma suffered two more courtroom defeats this week, delivering the 24th and 25th legal victories for Medicare negotiation and the patients who fought to make it law. On Wednesday, a unanimous Fifth Circuit panel rejected a challenge from PhRMA, the industry’s trade association and a central player in its years-long campaign to dismantle negotiation. Two days earlier, Merck — the first drugmaker to file a lawsuit after Medicare negotiation became law in 2022 — lost its challenge in federal court in D.C. The losses add to an increasingly decisive legal record: courts have repeatedly rejected the industry’s attempts to overturn Medicare negotiation, and the Supreme Court declined to hear six additional drugmaker challenges earlier this year. Big Pharma has spent years and millions of dollars trying to protect its monopoly pricing power in court, but patients and Medicare negotiation keep winning. — [Merck Brief, PhRMA Brief, The Hill, Fierce Pharma, Bloomberg Law, Endpoints News, Law360]
Potential Drugmaker Deals Coming Soon
The White House is expected to announce a new round of most-favored-nation agreements with midsized biotech companies on Monday. According to reporting, participating drugmakers would offer discounts to state Medicaid programs based on prices paid abroad, in exchange for exemptions from forthcoming Medicare drug pricing models and, in some cases, potential tariff relief. Lower prices are welcome, but most of these discounts would flow to Medicaid programs that already receive substantial mandatory discounts, and participation would be optional for states — raising questions about how much additional savings the agreements will deliver. It’s also unclear whether the savings generated by these agreements will outweigh any savings forgone by exempting participating drugs from the forthcoming Medicare pricing models. Like other administration drug initiatives, these agreements could provide meaningful savings in some circumstances, but enforcement mechanisms are unclear and even in a best case scenario, they fall short of the transparent, system-wide reforms needed to bring down U.S. drug prices for patients across the market. — [Bloomberg, POLITICO]
ICYMI: A growing number of U.S. employers are planning to drop coverage of GLP-1 weight-loss drugs in 2027 as healthcare costs continue to rise. The share of employers covering GLP-1s for obesity fell from 72% in 2025 to 60% in 2026, while 14% said they already have or plan to eliminate coverage in 2027. As the high price of these medicines puts increasing pressure on employer health plans — the most common way that Americans have medical insurance — patients risk losing access to treatments that can significantly improve their health. — [Reuters]
New Video: Your Voice Is Your Power
In honor of National Patient Advocacy Day on Wednesday, P4AD released a new video, Your Voice Is Your Power, following patient advocates Kris Garcia, Sarah Wisniewski, and Amelia Schachter as they travel to Capitol Hill to share their experiences with high prescription drug costs directly with lawmakers. None of them set out to become advocates — their experiences struggling to access and afford the medicines they need compelled them to speak up. As Kris says in the video, “They might have all that money, but we have our stories.” Their experiences are a powerful reminder that while the pharmaceutical industry has enormous resources and influence, patients have the power to change policy by making their voices heard. Watch and share the full video here. — [P4AD]
Drug Prices Fall as IRA Reforms Take Hold
Prescription drug prices fell 0.8% in July and 3.1% over the past year — the steepest year-over-year decline since 1963. While that’s encouraging news, the CPI measures what pharmacies receive from insurers and consumers rather than what patients pay out of pocket, meaning millions of Americans are still facing unaffordable costs at the pharmacy counter. The Trump administration has credited TrumpRx and its most-favored-nation agreements for the decline, but the general consensus from drug pricing experts is that the evidence points elsewhere. The administration’s GLOBE and GUARD MFN models have not yet taken effect, and the impact of TrumpRx on the index remains unclear given the paucity of data. In terms of robust policy measures, this is the first year that lower prices negotiated under the Inflation Reduction Act are in effect for some of Medicare’s highest-spending drugs. Further, the law’s inflation rebates are designed to discourage excessive pharma price hikes, while growing generic and biosimilar competition is beginning to bring down prices for some blockbuster drugs. No single policy can explain the entire decline, but the data is a promising sign that reforms designed to rein in drug prices and increase competition are working. The answer now is to build on that progress — not weaken the policies helping deliver it. — [PBS, Endpoints News, U.S. Bureau of Labor Statistics]
Another Legal Win for Medicare Negotiation
The pharmaceutical industry suffered another legal defeat this week after the D.C. Circuit rejected Teva Pharmaceuticals’ core challenges to Medicare drug price negotiation. The court upheld CMS’s decision to treat Austedo and Austedo XR as a single drug for negotiation and rejected Teva’s constitutional claim that the program deprived the company of a protected property interest. One narrow issue involving when generic competition is sufficient to exclude a drug from negotiation was sent back to the lower court for consideration. P4AD filed an amicus brief in the case defending the program and bringing patient voices directly into the appeal. Coming just three months after the Supreme Court declined to hear six additional industry challenges, the decision adds to the overwhelming body of rulings rejecting Big Pharma’s years-long campaign to dismantle a program that is already lowering prices for patients. — [Bloomberg, Fierce Pharma, P4AD]
Big Pharma’s Banner Year Continues
According to Protect Our Care, ten of the top publicly traded drugmakers brought in nearly $300 billion in global revenue during the first half of 2026 — $24 billion more than during the same period last year — while returning $63 billion to shareholders through dividends and stock buybacks. Meanwhile, nearly 6 in 10 Americans say they are worried about being able to afford their prescription drugs. The contrast is stark: the pharmaceutical industry continues to generate enormous revenues while millions of patients ration medications, leave prescriptions unfilled, or sacrifice other necessities to afford them. Big Pharma has the ample resources to invest in research and develop the treatments patients are waiting for without charging Americans an average of four to eight times what they charge in other high-income nations for the very same brand-name drugs.