The Week in Review in Prescription Drug Pricing: Senate HELP Advances P4ADNow-Backed Bills, Closing Negotiation Loops, and more
Welcome to the Week in Review.
Senate HELP Advances P4ADNow-Backed Bills
Yesterday, the Senate HELP Committee advanced two bipartisan and P4ADNow-supported bills: 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. P4ADNow has been in support of these bills for years, and we see opportunities for both to pass in a number of potential packages later this year. Additionally, The Ensuring Timely Access to Generics Act of 2025 (S. 3014), which targets sham citizen petitions that block generic entry, was amended to include the INSULIN Act and did not receive a vote. This is another P4ADNow-supported bill, and we anticipate it will be included in a forthcoming July markup. — [IP Watchdog, POLITICO
New Study Reaffirms the Broad Success of OOP Cost Caps
After out-of-pocket expenses were capped for patients on Medicare, their ability to both access and use costly medications increased. That’s according to a new study this week examining changes in prescription fills from 2022 to 2025 — before and after Medicare’s annual out-of-pocket spending caps were introduced. In the researcher’s words, “the policy substantially improved patient access.” After the implementation of the cap, patients had a pronounced increase in fill rates for high-cost drugs, such as treatments for cancer and pulmonary fibrosis. These results mirror what we’ve been hearing from members in our community, and it further reinforces the case for expanding similar caps past Medicare and to the commercial market in conjunction with mechanisms that tackle list price. — [JAMA]
ICYMI
P4AD CEO Merith Basey joined Laura Packard of Care Talk last week to discuss the recent Supreme Court decision to reject six of the largest pharmaceutical industry lawsuits against Medicare negotiation. You can watch the full episode below! — [Care Talk]
Patient Advocate Spotlight: Cheryl Jones
Condition: Thyroid Cancer
Drugs: Armour Thyroid (Over $100 per bottle), and other medications
Background: Patient advocate from Del City, Oklahoma
In Her Words: “For those of us on limited incomes and living off of Social Security benefits, such high costs hurt us badly. We are supposed to be living in our golden years, not dealing with fear and anxiety of where our next meal will come from. It ultimately comes down to the decision of buying prescription drugs or food to eat.
We should all have access to affordable prescription drugs in this country. Instead, the pharmaceutical companies keep raising their drug costs while insurance companies refuse to pay for varying degrees of a medication’s cost.”
WASHINGTON, D.C. — Just now, the Senate HELP Committee advanced two bipartisan bills, all supported by P4ADNow, that will help to increase competition and lower 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
The Medication Affordability and Patent Integrity Act (S. 2658), which would strengthen oversight of the patent system and close loopholes that delay competition
In response, P4ADNow CEO Merith Basey released the following statement:
“We applaud the Senate HELP Committee for standing with patients and cracking down on tactics deployed by the pharmaceutical industry that block cheaper biosimilars and generics from coming to market. At a time when nine in ten Americans are demanding Congress do more to lower prescription drug prices, there is both an urgent need and an opportunity to pass these bills as soon as possible. Patients cannot wait.”
P4ADNow has been in support of both these bills for years and our community has pushed hard to get them to this point — including sending nearly 1,500 letters to lawmakers on the Senate HELP Committee in the past four days alone. We see a real path forward for these bills to pass in a number of potential packages later this year.
The Ensuring Timely Access to Generics Act of 2025 (S. 3014), which targets sham citizen petitions that block generic entry, was amended and did not receive a vote today. This is another P4ADNow-supported bill, and we anticipate it will be included in a forthcoming July markup.
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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.
Senate HELP Markup on Affordability Bills Next Week
The Senate HELP Committee is set to markup several bipartisan bills on Wednesday aimed at increasing competition and lowering drug prices. Among them are three P4ADNow-endorsed bills, including the Biosimilar Red Tape Elimination Act (S. 1954), which would reduce unnecessary regulatory hurdles that slow the adoption of lower-cost biosimilars, the Medication Affordability and Patent Integrity Act (S. 2658), which would strengthen oversight of the patent system and close loopholes that delay competition, and the Ensuring Timely Access to Generics Act of 2025 (S. 3014), which targets sham tactics that block generic entry. Patients in our community are actively urging lawmakers to support these measures, which would bring more affordable alternatives to market. We will be closely monitoring the markup and will share any updates as it moves forward. — [Congress, Congress, Congress]
Polling Shows Strong Demand for Lower Drug Prices — and Action from Congress
New polling shows overwhelming bipartisan support for lowering drug prices, with 91% of battleground voters backing policies to align U.S. prices with those in other countries and 9 in 10 saying it’s important for Congress to act. A majority (65%) support Congress passing legislation to codify a most-favored-nation approach. The findings reinforce what patients have been saying for years: Americans are tired of paying significantly more than people in other countries and want meaningful action to drive down prices. With U.S. brand-name drugs costing on average 4 times more than in other wealthy nations, a well-designed MFN policy has the potential to deliver lower prices for patients, but voluntary time-bound deals alone won’t get there. The current MFN agreements lack transparency and enforcement mechanisms. — [PRA, POLITICO]
New Op-Ed from P4AD’s Merith Basey: “Big Pharma lost in court. Congress shouldn’t bail them out.”
In a new op-ed in The Hill, P4AD CEO Merith Basey argues that after the Supreme Court rejected challenges from six major drugmakers seeking to overturn Medicare drug price negotiation, the industry will only increase their focus on Capitol Hill. The piece highlights the real-world impact of Medicare negotiation, including the story of Judy Aiken, a retired nurse from Maine whose monthly cost for Enbrel fell by 67 percent under the program. It also warns that industry-backed legislation, including the EPIC Act, would delay negotiation for many medicines and keep prices higher for patients. You can read the full op-ed at the link here. — [The Hill]
Insulin Cap Expansion Gains Bipartisan Momentum
Legislation to expand Medicare’s $35 monthly insulin cap to the commercial market is gaining traction, with four new bipartisan co-sponsors bringing the total to 22. The bill would extend the cap to employer and marketplace plans, and create a pilot program to provide low-cost insulin to uninsured patients. The push builds on the success of the Medicare cap, which has significantly reduced out-of-pocket costs for seniors, like Bob Parant, who have struggled with the high cost of their insulin for decades. Polling shows expanding the cap to people beyond Medicare is popular, and patients living with diabetes know relief from high insulin prices is well overdue. — [The Hill, P4AD, KFF]
Patient Advocate Spotlight
Name: Andrea Bertram
Condition: Multiple Sclerosis (MS) and Type 2 Diabetes
Drugs: Ocrevus ($63,000 / year) and Mounjaro
Background: Patient Advocate from Johnstown, Pennsylvania
In Her Words: “As the disease progressed, I became medically disabled and a victim of the outrageously high medical costs this condition carries. Unfortunately, every day is a new battle and a new test to maintain self-autonomy of my body and my brain.
“For three years now I have taken Ocrevus, a drug that carries a list price of over $21,700 per vial. I receive this medication every six months at the cost of $63,000 every year, which is thankfully covered by a grant from the manufacturer and previously covered by an income-dependent foundation grant. And this outrageously high price is even an improvement from my previous drug, Copaxone, which used to cost me $7,700 every month.
“I only live on an income of $30,000, and the high costs of both my medications have forced me to shuffle bills around to pay for my medication or just rack up debt on a credit card. Living life like this is not easy or fair. Patients deserve better treatment and more affordable drug prices.”
Patients For Affordable Drugs Now released a new video featuring patient advocates and staff highlighting the bipartisan ETHIC Act ahead of this week’s House Judiciary hearing on patent law and prescription drug access. Introduced by Sens. Peter Welch, Josh Hawley, and Amy Klobuchar, the bipartisan ETHIC Act would make it easier for generic manufacturers to challenge duplicative patents — lowering barriers to entry and helping drive down costs for patients as well as taxpayers. The bill is gaining traction as lawmakers increasingly focus on how patent thickets delay competition. To date, P4ADNow has mobilized nearly 16,000 patient advocates to contact Congress in support of ETHIC and submitted written testimony to a House Judiciary Subcommittee hearing on ETHIC Thursday. AARP and the ERISA Industry Committee also joined P4ADNow in a joint letter to Congressional leadership urging action. — [P4AD, Testimony, Joint Letter]
SCOTUS Protects Generic Competition
The Supreme Court unanimously ruled in favor of generic drugmaker Hikma Pharmaceuticals, preserving a critical pathway that allows lower-cost alternatives to come to market. The case focused on “skinny labeling,” which lets generics launch for unpatented uses, without waiting for every patent on a drug to expire. Had the court ruled the other way, generic manufacturers could have faced increased legal risk when following the rules established by Congress and the FDA — meaning delayed competition, and higher drug prices for patients and taxpayers. Competition is one of the most effective mechanisms for lowering prescription drug prices. — [SCOTUS, Fierce Pharma, IP Watchdog, POLITICO, STAT News, Endpoints News]
New TrumpRx Drugs Don’t Fix Existing Problems
Despite the Trump administration billing the 160 new medications coming to TrumpRx as new deals, these — like last month’s announcement of 600 generic drugs — are instead simply links to existing cash-discount programs already available to patients. While TrumpRx may help some patients navigate existing options, it does not address the underlying drivers of high costs — including the structural conditions that allow drug companies to price-gouge Americans for their essential medicines. — [Washington Times]
ICYMI: The FDA released new draft guidance allowing developers to leverage existing scientific and manufacturing knowledge (from past studies, similar therapies, or their own previous work) to streamline the development of cell and gene therapies. The move is part of a broader effort to reduce regulatory friction and speed approvals of these complex treatments. While faster development can improve access, it does not necessarily translate to lower prices, particularly with therapies that already launch at extremely high costs, such as a treatment for sickle cell disease that costs $2.2 million per patient. — [Endpoints News, Axios]
Patient Advocate Spotlight
Name: Mary Schmidt
Condition: Pityriasis Rubra Pilaris (PRP) Drugs: Prescribed Otezla ($3,000 / month) but is unable to afford the cost Background: Patient Advocate from Devine, Texas
In Her Words: “When I was first prescribed Otezla, it worked very well. In an attempt to continue the medication, I applied to the drugmaker’s assistance program because I knew it was very expensive. I attempted to prove to them that I was on a limited income. I even had to apply for Extra Help via Texas’s Health and Human Services which sent me a letter saying I could get $1,600 of additional coverage, but that would still be way too expensive.
As a result, I had to go on Methotrexate — a drug that has the potential to do more harm than good for me. I had to have my blood drawn regularly and would bruise badly because of my condition. Next, I was put on Skyrizi and was accepted into their assistance program for a year — but it then came time to renew, and I haven’t been able to get back into the program again.
This has been an ongoing issue, and I’ve done everything possible on my part. In the meantime, I’m forced to call my dermatologist and ask if they have a sample, simply to get my next dose. Otezla and Skyrizi cost thousands of dollars that I do not have. Medication for profit is really sad and life-threatening to patients like me.”
WASHINGTON, D.C. — Today, Patients For Affordable Drugs Now released a new video featuring patient advocates and P4ADNow staff highlighting the bipartisan ETHIC Act and how the legislation would help curb one of Big Pharma’s most common tactics for blocking lower-cost competition to keep drug prices high.
The ETHIC Act would address patent thickets — a practice in which brand-name drugmakers accumulate dozens, and sometimes hundreds, of overlapping patents on a single medicine. These patent thickets can be used to block generic and biosimilar competition through costly litigation, entrenching monopolies and forcing patients to pay higher prices for brand-name medications for longer.
Introduced by Sens. Peter Welch, Josh Hawley, and Amy Klobuchar, the bipartisan ETHIC Act would require generic manufacturers to challenge only one patent per patent family rather than litigating against dozens of duplicative patents. The reform would preserve legitimate patent protections while helping prevent abuse of the system to delay competition.
Patent-protected brand-name drugs only make up about 10% of prescriptions, but account for three-quarters of drug spending in the U.S. On average, there are 74 patents per top-selling drug, and when challenged, more than two-thirds of secondary patents are invalidated.
Kris Garcia, Patient Advocate: “Americans pay the highest drug prices in the world.”
Lisa Ann Trainor:“A big reason why is because branded drug companies game the patent system to block patients from accessing lower-cost generics and biosimilars.”
Sarah Wisniewski, Patient Advocate: “One of the ways they do this is by amassing dozens, often hundreds, of patents on a single drug. Then their lawyers use these patents to sue competitors when they try to launch lower-cost generics.”
Alejandra Borbolla Diaz:“Often, brand-name drug companies aren’t even necessarily trying to win the lawsuit. They just want to tie their competitors up in court so they can’t launch their products.”
Merith Basey:“The ETHIC Act is a bipartisan bill introduced by three Senators: Peter Welch, Josh Hawley, and Amy Klobuchar. If passed, this bill would help stop big pharma from bombarding competitors with frivolous patent lawsuits that delay them from launching generics and biosimilars.”
Emma Sands:“So, the ETHIC ACT. It’ll rein in these patent games, which will lead to more competition, which will lead to lower drug prices.”
Kris Garcia:“That’s good for patients. Really good for patients. That’s why we’re fighting to pass the ETHIC Act. Get involved at www.patientsforaffordabledrugsnow.org.”
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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.
Patent Barriers Delay Generic Ozempic in the U.S.
Generic versions of semaglutide – the active ingredient in Ozempic and Wegovy – are beginning to enter the market in countries such as India and Canada. At the same time, Americans may not see a generic version until at least 2031, and potentially much later. The gap reflects how the U.S. patent system allows manufacturers to layer dozens of additional patents on top of a single drug — delaying competition and extending monopoly pricing. Ozempic can still cost up to $1,000 per month in the U.S., putting it out of reach for many patients. As lower-cost alternatives expand globally, the contrast highlights the need for patent reforms to ensure generics can enter the market sooner and patients aren’t left waiting years longer for affordable options. — [NBC News]
Bipartisan Push Targets Pharmacy-PBM Integration
A bipartisan group of lawmakers reintroduced legislation this week that would forbid large health care companies that own pharmacy benefit managers, or insurance companies, from directly owning pharmacies. If passed the bill would give companies a year to sell their pharmacies. The Patients Before Monopolies Act reflects growing scrutiny of vertically integrated firms like CVS, UnitedHealth, and Cigna, which control key parts of the drug supply chain. The proposal underscores rising frustration in Congress over the complexity and opacity of the system. Following the PBM reforms that passed earlier this year, vertical integration is receiving more scrutiny as a way to lower prices for patients and the system as a whole. — [USA Today, Fierce Healthcare]
Tariff Policy Drives Industry Workarounds – Not Lower Prices
As the Trump administration moves toward potential 100% tariffs on imported drugs, companies are already adjusting – with larger manufacturers better positioned to navigate the policy framework than smaller firms. The early response makes one thing clear: tariffs are reshaping how companies operate, but not addressing the root causes of high drug prices. For patients, the risk is that added costs and disruption will be absorbed into the system–and undoubtedly passed on to themat the pharmacy counter.— [Fierce Pharma, Endpoints News]
ICYMI: Sen. Peter Welch (D-Vt.) said this week he would “actively and aggressively” support a most-favored-nation drug pricing policy, pointing to growing bipartisan interest in aligning U.S. prices with those in other countries. His comments come as questions remain about the scope and transparency of the administration’s current MFN deals. Senator Welch is a co-sponsor on an International Reference Price bill with Sen. Hawley (R-MO).
More than 40,000 vetted patient stories are now featured on P4AD’s interactive map, representing every state and congressional district and documenting the harm of high drug prices. What began with one story – from founder David Mitchell – has grown into a nationwide movement of patients pushing for policies that lower drug prices. The sobering milestone underscores both the scale of the crisis, which spans every congressional district, and its impact across communities. — [P4AD]
White House MFN Savings Estimates Raise Questions
The administration’s projected savings from its most-favored-nation (MFN) deals rely heavily on modeling and a series of optimistic assumptions rather than observed policy outcomes. The estimates span all payers — including Medicare, Medicaid, and commercial insurance — even though the underlying agreements are limited in scope and largely confidential, making it difficult to verify the White House’s projections. The analysis assumes codification of the deals, a 30% reduction in U.S. drug prices over time, broad and sustained manufacturer participation, and even global price shifts – all of which are uncertain. It also counts significant savings from applying MFN pricing to future drugs that don’t yet exist, based on historical data projected forward. The projections also hinge on the passage of a bill that would allow people with employer-based insurance to apply expenditures through direct-to-consumer purchasing programs to their deductible. Early disclosures further complicate the picture: filings from companies like Merck and Sanofi indicate that some high-cost and newly launched drugs are excluded, while others suggest agreements may expire after three years – raising questions about how long any savings would last. Taken together, the estimate reflects a potential future scenario rather than a clear picture of what patients are likely to experience in the near term. [White House, STAT News, Forbes]
New Report Highlights Growing Use of Patent Tactics to Delay Competition
A new report from Generation Patient finds that pharmaceutical companies are increasingly using a mechanism called terminal disclaimers to build patent thickets that delay generic competition and keep drug prices high. Nearly 70% of drug patents filed between 2017 and 2021 included terminal disclaimers, up from 36% in the early 2000s. These patents are also appearing more frequently in litigation, with 74% of drug patent cases filed in 2020 involving them. The findings add to growing evidence that brand-name manufacturers are layering patents to stymie the entry of lower-cost generics. For patients – particularly those managing chronic conditions – that means artificially prolonged periods of high prices and limited access to affordable alternatives. The report strengthens the case for the bipartisan ETHIC Act, which would limit how these terminally disclaimed patents can be used to block competition and is designed to address one of the key structural drivers of high drug prices. — [Generation Patient]
TrumpRx Drugmakers Boost Lobbying as Program Took Shape
Pharmaceutical companies participating in TrumpRx increased their federal lobbying spending by nearly 23% in 2025, outpacing the broader industry as the program was negotiated behind the scenes. The 17 companies collectively spent over $130 million – more than a quarter of total industry lobbying – while securing key policy concessions tied to the program. At the same time, many of these companies intensified lobbying on policies that would delay Medicare price negotiation and expand coverage of high-cost drugs like GLP-1s. The overlap highlights a broader dynamic: even as companies participate in high-profile pricing initiatives, they continue to invest heavily in maintaining their monopoly power at the expense of American patients. — [OpenSecrets]
ICYMI: In a new contribution to a broader report on Medicare reform, P4AD CEO Merith Basey pushes back on pharmaceutical industry arguments to roll back drug price negotiation and advocates for an expansion of the program. She highlights that since the policy was enacted, R&D spending has increased, and it is projected to save taxpayers $98.5 billion through 2031, with minimal impact on new drug development.
Patient Advocate Spotlight: Aarolyn McCullough
Condition: Diabetes
Drugs: Everolimus, Zortress, and Ozempic ($2,000 / month before her former employer’s assistance)
Background: Retired liver transplant survivor living in Oak Park, MichiganIn her words: “I can thankfully afford my prescriptions due to manufacturer assistance and health coverage benefits I receive through my former employer: the United States Postal Service. But without such assistance, a situation which I have faced before, I would be paying about $2,000 per month for all of my medications… As a retired individual, this should not be my reality. As an American citizen, I believe we deserve lower-cost prescription drugs because we are simply overpaying compared to the rate other countries pay for the same or equivalent medications.” You can read more about Aarolyn and her story in her recent interview here.
SCOTUS Examines Skinny Labels that Drive Low-Cost Generics to Market
The Supreme Court heard arguments this week in a case that could limit how and when lower-cost generics come to market. The case, Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., focuses on “skinny labeling,” which allows generics to launch for off patent uses of a drug while brand-name manufacturers retain patents on other indications — providing a key pathway for earlier competition that saves patients and taxpayers billions annually. While justices appeared skeptical of their case, a ruling for Amrin could significantly limit that pathway by exposing generic manufacturers to liability based on routine marketing, creating a chilling effect that delays or deters generic entry across multiple drug classes. The stakes for patients are significant, given that a single generic can reduce drug prices by 39%, and multiple competitors can lower prices by as much as 95%. A decision is expected in June. — [SCOTUS, NPR, SCOTUS Blog, FDA, JD Supra, Endpoints News, Reuters]
Delayed Competition for Pfizer’s Vyndamax Raises Concerns
Pfizer struck agreements this week with three generic drugmakers to delay competition for its blockbuster heart drug Vyndamax until 2031, two years later than previously expected. Vyndamax, which treats a serious and potentially fatal condition, carries a list price of approximately $23,000 per month for 30 capsules. Artificially extending the monopoly on the drug means patients will face high prices for longer without meaningful competition or pricing relief. While the terms remain secret, these types of settlements raise familiar concerns about “pay-for-delay” arrangements where brand-name manufacturers compensate generic competitors for postponing market entry of lower-cost alternatives. Policymakers have increasingly scrutinized these practices, and P4ADNow has endorsed the bipartisan Preserve Access to Affordable Generics and Biosimilars Act to curb them. — [Endpoints News, Congress, Sen. Klobuchar]
Healthcare Costs — and Rx Prices — Remain A Top Voter Concern
NewKFF polling shows affordability remains a top concern for Americans, with 64% of adults worried about the cost of health care, on par with concerns about gas and transportation costs amidst the U.S. conflict with Iran. Prescription drug costs remain a key driver, as insured adults overwhelmingly point to lowering out-of-pocket costs as their top priority.The political implications are clear: nearly 9 in 10 voters say healthcare costs will influence their vote in the 2026 midterm. High drug prices are a central political issue, and lawmakers should be feeling the pressure to legislate against pharmaceutical industry greed. — [KFF]
ICYMI: CMS extended the deadline for applications to the GENEROUS Model for a second time this week, from April 30th to June 11th, stating that they’re looking to give “potentially interested” drug manufacturers additional time to engage. Even if the model is able to eventually achieve broad drugmaker participation, its impact on patient costs is likely limited. — [CMS, Fierce Healthcare]
Patient Advocate Spotlight: Harold Brown
Condition: Type 2 diabetes, high blood pressure, and heart failure
Drugs: Entresto ($700 / month), among other prescriptions
Background: Retired, worked at the Cleveland Electric Illuminating Company for 27 years
In His Words: “As a patient with Medicare coverage through United Healthcare, I am thankful for having a majority of my health care costs covered. But there were instances in which my Entresto prescriptions were costing me hundreds of dollars a month before getting into a patient assistance program, which I have to apply to each year and see if I am approved. This is just not right.
If I had to pay out of pocket for my heart medication, I would just have to go without it and trust in God for my life. I mean this. I have already had to decline to purchase prescription medications because I couldn’t afford them, and I wish not to do so again. But the truth of the matter is, as Americans, it shouldn’t have to be this way.”
