STATEMENT: Senate HELP Advances P4ADNow-Backed INSULIN Act
WASHINGTON, D.C. — Today, the Senate Health, Education, Labor and Pensions (HELP) Committee advanced the INSULIN Act (S. 4189), a bipartisan bill which is supported by P4ADNow. The legislation would:
Establish a $35 monthly out-of-pocket cap for people with private insurance, limiting cost-sharing for insulin at $35 or 25% of a plan’s negotiated price, whichever is lower. Patients with Medicare have had such protections since 2022.
Crack down on pharmaceutical companies’ abuse of citizen petitions by allowing the FDA to reject petitions filed solely to delay generic or biosimilar competition.
The bill passed out of Committee with an added amendment to create a pilot program that would provide grants to states to provide insulin to uninsured patients.
In response, P4ADNow CEO Merith Basey released the following statement:
“The $35 insulin co-pay cap has successfully lowered monthly costs for patients on Medicare, and people with private insurance deserve the same protection from exorbitant prices. We applaud the HELP Committee for advancing the bipartisan INSULIN Act and urge Congress to get it across the finish line.”
P4ADNow sent a letter to the Committee yesterday ahead of the hearing in support of the INSULIN Act.
Today’s markup follows last month’s HELP Committee advancement of two other bipartisan bills aimed at increasing competition and lowering prescription drug prices: The Biosimilar Red Tape Elimination Act (S. 1954), which would reduce unnecessary regulatory hurdles that slow the adoption of lower-cost biosimilars, and the Medication Affordability and Patent Integrity Act (S. 2658), which would strengthen oversight of the patent system and close loopholes that delay competition.
###
Patients For Affordable Drugs Now is the only national, patient advocacy organization focused exclusively on policies to lower drug prices. We empower and mobilize patients and allies, hold accountable those in power, and fight to shape and achieve system-changing policies that make prescription drugs affordable for all people in the United States. P4ADNow is bipartisan and does not accept funding from organizations that profit from the development or distribution of prescription drugs. To learn more, visit: PatientsForAffordableDrugsNOW.org
Welcome to the Week in Review.
Growing Attention to Patent Reform on Capitol Hill
The Senate Judiciary Committee and the House Energy and Commerce Committee each held hearings this week on drug development and access, with lawmakers from both parties highlighting industry practices that keep prices high. Rep. Ocasio-Cortez (D-NY) pointed to a particularly egregious example of AstraZeneca’s use of patent thickets, highlighting how the manufacturer patented a minor redesign to its inhaler cap — not the medicine itself — to delay competition from coming to market. And Sen. Hawley (R-MO) criticized pharmaceutical companies for gaming the patent system, stating that innovation “doesn’t do much good” if people can’t access the medications. With 9 in 10 voters saying healthcare, including prescription drug costs, will influence their vote in the 2026 midterms, prescription drug pricing continues to emerge as a winning bipartisan issue. Elected officials who continue to align themselves with the pharmaceutical industry do so at their own political risk. — [Rep. Ocasio-Cortez, Sen. Hawley]
FTC Finalizes Third PBM Settlement
The FTC reached a settlement with CVS Caremark on Tuesday, marking the final of three settlements with the nation’s largest Pharmacy Benefit Managers (PBMs), and resolving claims that CVS Caremark, Cigna’s Express Scripts, and OptumRx generated $7.4 billion by artificially inflating insulin prices. Included in the settlements are reforms that delink PBM compensation from list prices, base patient cost-sharing on a drug’s net price, and ensure fairer reimbursement to community pharmacies — long-overdue systemic adjustments that will help to drive greater transparency and fairness. PBMs and drugmakers alike must be held accountable for their abusive practices that drive up costs for patients, and we welcome these three settlements as checks on the power of three companies that control roughly 80% of prescriptions filled in the United States. — [FTC, P4AD, Axios, STAT News, Healthcare Finance]
Pharma M&A Market Booming in 2026, Undercutting Industry Fearmongering
It’s been nearly four years since Medicare negotiation was enacted, and despite years of industry fearmongering about the program’s impact on innovation, the biopharma sector remains exceptionally strong. Pharmaceutical companies have maintained — and in some cases increased — R&D investment, while merger and acquisition activity has been “booming” this year, with nearly four dozen acquisitions in the first half of 2026 alone. Even as the first round of lowered prices take effect and additional rounds move forward, there is little evidence that the law has slowed innovation. The U.S. remains the most lucrative pharmaceutical market in the world — just this week, Johnson and Johnson announced a record high $49.4 billion in sales for the first half of the year, putting them on track to be the first drugmaker with over $100 billion in annual sales. Medicare negotiation preserves strong incentives for innovation, and corporations continue to profit massively while Americans struggle to pay for their essential medications. — [Endpoints News, Protect Our Care]
ICYMI: In a newly published op-ed in Spanish for El Tiempo Latino, P4ADNow CEO Merith Basey celebrates the Supreme Court’s decision to decline six drugmaker petitions against Medicare negotiation, and calls on Congress to similarly reject Big Pharma’s efforts to block key reforms. With patients finally seeing reduced prices on the first ten drugs and continued rounds of negotiations underway, now is the time to protect and strengthen the government’s ability to secure a better deal for patients. You can read the full op-ed at the link here. — [El Tiempo Latino]
Welcome to the Week in Review.
The ETHIC Act & P4AD Joint Letter with AARP & ERISA Industry Committee
This week, Patients For Affordable Drugs Now, AARP, and the ERISA Industry Committee (ERIC) sent a joint letter to congressional leadership urging Congress to pass the ETHIC Act. The bipartisan bill would curb patent thickets by allowing generic drugmakers to challenge one patent per patent family – lowering barriers to entry for lower-cost competition while preserving protections for true innovation. The letter comes as the House Judiciary Subcommittee on Courts, Intellectual Property, Artificial Intelligence and the Internet will hold a hearing on June 4th on how intellectual property policy impacts prescription drug competition and patient access. A new article from the Epoch Times, featuring three P4AD patient advocates, highlights how brand-name drugmakers build these dense patent thickets, forcing generic competitors to challenge dozens of patents to enter the market. — [P4AD, POLITICO, Congress, House, Epoch Times]
MFN Deals Put to the Test
The administration’s most-favored-nation deals are about to face their first real test, as several new drugs from AstraZeneca, Novo Nordisk, and Pfizer, prepare to launch in the U.S. While the agreements touted requirements for new drugs to be launched in the U.S. at prices aligned with other peer nations, none of the companies would confirm to STAT News whether these drugs would be subject to the MFN deal terms. The lack of clarity and secrecy around these agreements makes it difficult to assess scope, enforceability, and real-world impact. There may be significant gaps in how broadly the agreements apply, raising questions about whether patients will truly see the lower-cost drugs they’ve been promised. — [STAT News]
New AARP Report: U.S. Drug Prices Continue to Rise, Despite Falling Abroad
Prices for the 25 top-selling brand-name prescription drugs have increased by an average of 81% in the U.S., while falling by 13% in other high-income countries. That’s according to a new report from AARP this week. The gap is stark: Eli Lilly’s Trulicity rose 106% in the U.S. while falling 16% abroad, Merck’s Januvia rose 126% in the U.S. while dropping 40% elsewhere, and Amgen’s Enbrel surged 873% despite declining 27% internationally. The findings highlight a key driver of America’s high drug costs: unlike peer nations, drugmakers face few constraints on raising prices over time — leaving patients exposed to unchecked price increases. — [AARP]
ICYMI: With more than 130 patents and a yearly cost of $77,000, AbbVie’s Humira remains a leading example of how patent thickets delay competition. In a new STAT News op-ed, I-MAK founder and CEO Tahir Amin details how overlapping patents and aggressive tactics have extended exclusivity and kept prices high — reinforcing the need for reforms like the ETHIC Act. You can read the full piece here.
The Supreme Court denied petitions from six major drugmakers — AstraZeneca, Bristol Myers Squibb, Janssen, Novartis, Novo Nordisk, and Boehringer Ingelheim— leaving in place lower court rulings that rejected their challenges to the Medicare Drug Price Negotiation Program. After 16 losses for the industry in court, these pharmaceutical companies asked the Supreme Court to step in, and it declined. It’s the end of the line for these six drugmakers, and Medicare can continue delivering lower drug prices for patients without interruption, exactly what patients fought for. P4AD has been in this fight from the beginning, advocating for the program’s protection through amicus briefs, and this ruling vindicates that work. Four cases remain in the lower courts, from AbbVie, Merck, Teva, and PhRMA, but they rest on many of the same arguments courts have now repeatedly rejected. Pharma is running out of legal options. We’ll keep watching and keep pushing for the full implementation and expansion of Medicare negotiation. — [POLITICO, Epoch Times, AP, Endpoints News, STAT News, The Hill, CNN, Axios]
P4AD and Social Security Works’ joint mobile billboard traveled around D.C. on Monday, celebrating the news: Patients won, and Big Pharma lost.
TrumpRx Expansion: What It Is and Isn’t
President Trump announced this week that over 600 generic drugs are being added to TrumpRx, the administration’s direct-to-consumer discount website. The rollout is being billed by the administration as a major new affordability initiative, but in practice the platform aggregates and links to existing cash-discount programs available to patients through GoodRx, Amazon Pharmacy, and Mark Cuban’s Cost Plus Drugs. From what we’ve seen thus far, many of the coupon prices — including many from the original set of discounts — can only be fulfilled at large chain pharmacies like CVS and Walgreens that have the infrastructure to honor them. Patients who rely on independent pharmacies (including the nearly 20% of Americans reliant on rural pharmacies) or have insurance plan restrictions may not be able to access these prices at all. While TrumpRx may help some patients navigate existing options, it does nothing to address list prices, manufacturer pricing power, or the structural conditions that allow drug companies to price-gouge Americans for their essential medicines. — [New York Times, Rural Health Medicine, Washington Post, Reuters, USA Today]
Takeda Pharmaceutical Sued for Pay-For-Delay
A U.S. judge found Takeda Pharmaceutical liable for $885 million in damages this week after the company paid competitor Par Pharmaceutical to delay launching a generic version of the constipation drug Amitiza. The deal, struck in 2014, kept the generic off the market for seven years — leaving patients with no lower-cost alternative until 2021. Pay-for-delay deals let drug companies pay off competitors to stay out of the market, abusing the patent system to protect profits at patients’ expense. Takeda’s case is a win, but one verdict doesn’t fix a systemic problem. Congress needs to pass the bipartisan Preserve Access to Affordable Generics and Biosimilars Act to rein in these types of deals. The stakes are real: when one generic alternative enters the market prices can drop by 39%, and multiple can lead to a 95% reduction in price. — [Reuters, Fierce Pharma, Congress, FDA]
ICYMI: Virginia Governor Spanberger vetoed the state’s Prescription Drug Affordability Board (PDAB) this week — in a win for industry. Colorado became the first state to cap a prescription drug price through its PDAB last October, using it to lower the cost of the blockbuster drug Enbrel. — [VA Governor, Denver 7, Virginia Mercury, Virginia Scope]
Over the last two weeks, P4AD patient advocates from across the country traveled to Washington, D.C., to share what high drug prices mean in real terms — skipped doses, delayed care, and impossible financial tradeoffs. They met directly with lawmakers on both sides of the aisle to urge action on reforms like the ETHIC Act, a bipartisan bill that would curb pharma patent abuses and help bring lower-cost generic and biosimilar alternatives to market faster. During meetings with lawmakers, patient advocates also described how the Medicare Negotiation Program is already improving their lives and how bills like EPIC would undermine hard-won progress. With nine in ten Americans calling on Congress to do more, theirstories make clear what’s at stake — and why action can’t wait.
Regeneron is the latest drugmaker to reach a most-favored-nation (MFN) pricing agreement with the Trump administration, part of a broader set of voluntary deals aimed at bringing U.S. drug prices in line with those in other high-income countries. The company was the last of the 17 corporations that received letters in July 2025. The White House announced the agreement alongside the expedited approval of Regeneron’s new gene therapy, Otarmeni, to treat a rare genetic form of hearing loss. The treatment was expedited through the FDA’s National Priority Voucher program. According to Regeneron, it will be available in the United States at no direct cost to patients. While we are thrilled for the families able to access this treatment for free, voluntary, company-by-company agreements do not change the fundamental dynamic that gives Big Pharma the power to set and raise prices at will. — [White House, White House]
Pharma Tops Q1 Healthcare Lobbying
New disclosures show the pharmaceutical industry continuing to outpace the rest of the health sector in lobbying spending. PhRMA reported $12.2 million in Q1 — more than $4 million higher than any other health care organization — already putting it on track to approach its record $38 million spend in 2025. Several major drugmakers, including Pfizer, Merck, Novartis, Genentech (Roche), and Eli Lilly also ranked among the top 10 highest spenders on health care lobbying. Collectively, these five companies reported a staggering $323.5 billion in 2025 revenue. The spending comes as Congress continues to weigh drug pricing policies, highlighting the scale of industry influence aimed at shaping, and in many cases slowing, efforts to lower prices. — [OpenSecrets, Washington Post, Fierce Pharma]
Bipartisan Hill Pharma Probe
Sens. Maggie Hassan (D-NH) and Chuck Grassley (R-IA) this week called on the Government Accountability Office to investigate how pharmaceutical companies use coupons, including whether they steer patients toward higher-cost brand-name drugs instead of lower-cost generics. Drugmakers deploy these coupons to maintain market share and blunt competition from generics, offering short-term discounts that can obscure true costs and keep patients on more expensive medications. When those coupons expire, patients can face sudden spikes in out-of-pocket costs. The probe reflects growing bipartisan scrutiny of industry practices that drive up costs and limit competition. — [Sen. Hassan, POLITICO]
BALANCE Model Delayed As Insurers Decline To Participate
The Trump administration has indefinitely delayed the Part D component of the BALANCE model, a pilot designed to test Medicare coverage of GLP-1 drugs like Ozempic for weight loss, after failing to secure sufficient participation from insurers. CMS will still launch a smaller, temporary program to run from July 2026 through 2027 to provide the treatment to some Medicare patients at $50 per month. This initiative will exist outside of the Part D coverage benefits, with the government absorbing the cost of expanded coverage. While Medicare patients may still access these medications in the near term, the path forward remains uncertain and costly. When drug prices are set at such high levels, they create pressure throughout the system — shaping coverage decisions and ultimately determining who can access treatment. — [Axios, Washington Post]
ICYMI: Senate Democrats are introducing legislation to require HHS to disclose the terms of its most-favored-nation drug-pricing deals, which remain largely confidential. Public Citizen is also seeking information through FOIA requests. — [Axios, Public Citizen]
Patient Advocate Spotlight: Don Kreis and his daughter Rose
Condition: Cystic Fibrosis
Drugs: Trikafta (Over $300,000 / year)
In His Words: “My daughter Rose is living and thriving with cystic fibrosis. Last year, the more routine set of drugs Rose currently takes to treat her CF costs upwards of $160,000. Fortunately, my employer has a good health insurance plan, so our family paid very little of that out-of-pocket.
Vertex has a real-life monopoly on expensive CF drugs, and the next iteration could keep my daughter out of the hospital. These drugs could save her life. When she no longer has dad’s insurance plan, in the not so distant future, will she be able to weather hundreds of thousands of dollars in medication costs? We must do more as a society to make sure that my daughter and others like her can always afford the prescription drugs they need.”
High Cost of GLP-1 Drugs Forces Some States to Scale Back Coverage
The high cost of GLP-1 drugs are increasing pressure on state Medicaid programs — and in response, some cities and states are beginning to restrict or eliminate coverage. In the U.S., drugs like Ozempic cost more than eight times what they do in peer countries such as the U.K., France, and Australia. Despite those elevated prices, manufacturer Novo Nordisk hiked the price of both Ozempic and Rybelsus above the inflation rate at the start of the year. The downstream impact is clear: when manufacturers set and raise prices at these levels, payers limit coverage, and for patients who rely on these medications to manage diabetes and related conditions, that can mean losing access to essential treatment. — [The Guardian, Healthline]
Expanding Access to Cash-Pay Drugs, Not Lower Prices
New legislation introduced this week by Rep. Greg Murphy (a champion of the pharma-backed EPIC Act) would require insurers to count drug purchases made through direct-to-consumer platforms like TrumpRx towards a patient’s deductible and out-of-pocket maximum — a change that could make these programs more usable for insured patients. The proposal reflects a recognition that cash-pay models, while sometimes cheaper, have limited reach and appeal when they exist outside the insurance system. The change could benefit patients in cases where cash prices undercut insurance costs, particularly for those enrolled in high-deductible plans. But it has tradeoffs: requiring plans to integrate these purchases could lead to higher premiums, and the TrumpRx model still depends on a narrow set of drugs and voluntary, time-limited pricing arrangements that have yet to deliver savings across the board. While some policymakers are looking for ways to expand access to lower-cost options within the current system, these approaches do not replace the need for reforms that address high list prices and drugmakers’ pricing power directly. — [Axios, Inside Health Policy]
LTE: High Medication Costs Harm Latinos
In a new letter to the editor published in the Washington Times, P4AD advocate Sonia Vega pushed back on industry claims that lowering drug prices would harm innovation, highlighting instead how high costs are already affecting patients. The letter was in response to a March op-ed claiming that reforms to bring U.S. prices in line with those of other high-income countries would lessen R&D investment from the pharmaceutical industry, ultimately harming Hispanic patients. In response, Sonia points out that presenting efforts to lower drug prices as a threat to innovation and new-drug development ignores the real patient experience. The Hispanic community is disproportionately burdened by chronic disease, meaning they’re also disproportionately burdened by the high cost of prescription drugs — nearly 70% of Hispanic adults report being worried about affording their medications. As she writes, “for Hispanic patients like me, the real risk isn’t reform; it’s a system where lifesaving medications remain out of reach because of the cost.” — [Washington Times]
ICYMI: Senate Democrats released a report this week finding that drugmakers with Most Favored Nation deals have continued to raise prices on drugs, raising questions about the impact of the arrangements. The report points to drugs like Keytruda, Kesimpta, and Opdivo that continue to see price hikes despite their manufacturers signing MFN agreements. The long-term viability of these deals is also in question, as at least 16 are set to expire after three years — and the exact terms of the agreements are not public. — [Senate HELP, NBC News, STAT News]
Patient Advocate Spotlight: Gail DeVore
Condition: Type 1 Diabetes
Drugs: Insulin
In Her Words: “For the last 45 years, I have seen the invention of home glucose meters, insulin pumps, better insulin, continuous glucose monitors (CGM), and many other new and advancing treatment options for type 1 diabetics. These are not “special devices” or extraordinary treatment options. The ability to constantly monitor our blood sugar levels is critical to saving our lives.
However, it all comes with a very high price. A single bottle of insulin costs about $350. Many diabetics need multiple bottles per month to simply stay alive. Supplies can also cost about $1,000 per month on top of that, despite insurance coverage and prescription benefits. These costs are exorbitant. Considering the risks diabetics like myself face, the costs are absolutely unacceptable.”
WASHINGTON, D.C. — Yesterday, the Federal Trade Commission (FTC) announced a settlement with Cigna’s Express Scripts, resolving claims that the pharmacy benefit manager engaged in practices that artificially inflated insulin prices and harmed patients.
In response to the settlement, Merith Basey, CEO of Patients For Affordable Drugs, released the following statement:
“Patients have been price-gouged for decades by shady PBMs whose business models have been intentionally structured to push patients toward higher-priced drugs. This settlement includes welcome reforms that aim to prevent Express Scripts from favoring higher-priced drugs, delink PBM compensation from list prices, allow patient cost-sharing to be based on a drug’s net price, and ensure fairer reimbursement to community pharmacies — long-overdue steps that move the system in the right direction. Ultimately, patients will judge progress by what they pay at the pharmacy counter.While PBM reform remains a top priority, Big Pharma should not be let off the hook. We will continue pressing for systemic reforms that hold drug manufacturers and PBMs accountable and deliver lower drug prices for patients.”
The public now has 30 days to submit comments on the proposed settlement, followed by a final FTC approval vote. The FTC’s cases against the other two dominant pharmacy benefit managers — CVS Caremark and OptumRx — remain ongoing. In September 2024, the FTC sued the nation’s three largest PBMs following a bipartisan report exposing secret agreements with drug manufacturers that incentivized higher list prices and restricted access to cheaper generics and biosimilars. Together, CVS Caremark, Express Scripts, and OptumRx control roughly 80% of prescriptions filled in the U.S. A subsequent FTC report found PBMs generated $7.4 billion by inflating the prices of 51 lifesaving drugs between 2017 and 2022, driving up patient costs across conditions including cancer, HIV, and heart disease.
This settlement follows bipartisan action by Congress earlier this week, when lawmakers passed a government funding package that included new restrictions on PBM business practices, including changes to how PBMs are compensated in Medicare. Together, legislative and enforcement efforts signal growing momentum to rein in middleman practices that have contributed to unaffordable drug costs, while underscoring the need for continued oversight to ensure reforms deliver real savings for patients.
PBMs, however, are not the only bad actors in this system. Insulin manufacturers, led by the Big Three: Eli Lilly, Novo Nordisk, and Sanofi, have repeatedly raised list prices in lock-step, knowing those increases would be rewarded through rebate-driven arrangements. Any serious effort to lower drug costs must address both the practices of PBMs that profited from inflated prices and the manufacturers that set those prices.
###
Patients For Affordable Drugs Now is the only national, patient advocacy organization focused exclusively on policies to lower drug prices. We empower and mobilize patients and allies, hold accountable those in power, and fight to shape and achieve system-changing policies that make prescription drugs affordable for all people in the United States. P4ADNow is bipartisan and does not accept funding from organizations that profit from the development or distribution of prescription drugs. To learn more, visit: PatientsForAffordableDrugsNOW.org
Welcome to the Week in Review.
Uncertainty Around MFPs with Recent Trump GLP-1 Deal
With President Trump’s GLP-1 pricing deals dominating headlines, the ongoing Medicare negotiation program appears to have taken a backseat — despite the fact that the second round of maximum fair prices (MFPs) is required to be announced by the end of November. The new prices, which cover 15 drugs including Ozempic and Wegovy, are expected to take effect in 2027 and should deliver significant savings for millions of patients on Medicare. Despite broad support from Americans on both sides of the aisle, the president has said little about the program in recent months. Instead, the administration has leaned on voluntary agreements with drugmakers. And while those deals are highly visible and offer potentially quick wins, the Medicare Negotiation Program remains the nation’s most consequential and durable tool for lowering prescription drug prices. Patients are eagerly awaiting the new, lower negotiated prices. — [White House, AV, NBC News, P4AD]
Congress Is Back — Here’s What We’re Watching
There are only a few weeks of session left this year, and we’re closely monitoring any movement on drug pricing legislation and keeping the pressure up for lawmakers to stand behind patients. In addition, the newly-enacted Continuing Resolution (CR) runs through January 30, which creates an opportunity for a health extenders package come January. Here’s what our community is pushing for
✅ The Affordable Prescriptions for Patients Act: Passed the Senate unanimously last year, and would limit the number of patents a drug company can assert on a biologic drug. It’s a key reform to stop Big Pharma from blocking biosimilar competition through patent thickets and keeping prices high.
✅ The ETHIC Act: Bipartisan measure that would streamline the patent process and limit drug companies to one patent at a time, making the harmful practice of patent thicketing significantly harder.
✅ The Biosimilar Red Tape Elimination Act and Q1/Q2, a provision of the Lower Costs, More Transparency Act: Policies that would streamline approvals processes by deeming biosimilars interchangeable with FDA approval and simplifying rejections — making it easier for generic alternatives and biosimilars to come to market and saving taxpayers millions.
And here’s what patients are focused on stopping:
🛑 The EPIC Act and The MINI Act: Industry-backed proposals that would delay Medicare negotiation for small-molecule drugs and genetically targeted technologies (GTTs) for an additional four years. Both would drive up costs for patients and taxpayers — echoing the same pharma giveaways seen in the recently passed $8.8 billion ORPHAN Cures Act.
Patient Advocate Spotlight: Emmabella Rudd Background: Florida State University student, documentary producer, and insulin accessibility advocate since her diagnosis at 5 years old. Condition: Type 1 Diabetes Drug: Insulin ($3,000 per year)
In her words: “It’s frustrating to see pharmaceutical companies bask in the protection of numerous patents around their insulin products. They’re interested in appearing concerned about drug affordability, but their efforts are always superficial and short-lived. Drug companies need to remember that their actions affect real human lives, and at the end of the day, the people will have the power.”
