STATEMENT: Patients For Affordable Drugs Now Strongly Opposes Reintroduction of Patent Bills That Protect Pharma Profits Over Patients
PREVAIL and PERA Bills Would Undermine Reforms, Extend Monopolies, and Keep Drug Prices High
WASHINGTON, D.C. — Patients For Affordable Drugs Now strongly opposes the reintroduction of two harmful patent bills — the PREVAIL Act and the Patent Eligibility Restoration Act — which would further enable abuse of the patent system and prolong monopolies on brand-name medications.
“These dangerous bills would further rig the patent system in favor of the pharmaceutical industry,” said Merith Basey, Executive Director of Patients For Affordable Drugs Now. “At a time when one in three Americans can’t afford their prescriptions, Congress should be working day and night to lower prices, but instead, Senators Tillis and Coons are siding with Big Pharma and helping the industry further entrench its power at the expense of patients”.
While nearly 90% of Americans say prescription drug prices are too high — and more than 9 in 10 voters across party lines believe Congress must act to lower them — these proposals move in the wrong direction. Today, 29 million Americans are considered “cost desperate,” struggling to afford the medications and care they need. Yet instead of reining in Big Pharma, Congress is poised to expand its power — even as nearly two-thirds of voters view pharmaceutical companies unfavorably and see them as one of the top drivers of high health care costs. A full 78% of voters believe drug companies are focused on profits, not patients. Advancing these bills would not only undermine popular reforms but also stifle competition and hand even more control to an industry voters know is rigging the system against them.
BACKGROUND
Americans already pay between four and eight times what people in other wealthy nations pay for the exact same brand-name drugs.
The PREVAIL Act would restrict key tools used to challenge weak or abusive pharmaceutical patents, weakening oversight and limiting the ability of the U.S. Patent and Trademark Office to ensure patent quality.
The PERA Act would open the door to even broader patent protections for drugs, diagnostics, and other products, further locking in monopolies and blocking competition.
Between 2005 and 2015, 74 percent of the new drug patents issued were for drugs already on the market. Of the roughly 100 best-selling drugs in another study, nearly 80 percent obtained an additional patent to extend their monopoly period.
In September 2024, P4ADNow sent a letter to all the members of the Committee urging them to vote against S. 2220.
In the House: H.R. 6986 to address patent thickets; H.R. 9070, the Affordable Prescriptions for Patients Act; H.R. 1717, the Interagency Patent Coordination and Improvement Act; and H.R. 5429, the Medication Affordability and Patent Integrity Act.
In the Senate: S. 142, to ban pay-for-delay agreements; S. 148 and S. 1067, to reform the citizen petition process; and S. 79, to establish a task force between USPTO and FDA to improve communication in the implementation of each agency’s patent-related activities.
The Senate has already unanimously passed an amended version of S. 150. These Senate bills are estimated to save taxpayers $4.5 billion over the next 10 years.
### 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.
NEW POLL: GOP Voters Overwhelmingly Back Medicare Negotiation
A major new poll from Republican polling firm Fabrizio Ward confirms what patients have long known: Voters overwhelmingly support bold action to lower drug prices, and their views are driven by their lived experiences. The survey shows 89% of American voters, including 89% of Trump voters, say prescription drug prices are too high. Nearly 60% have struggled to afford their medications, and a staggering 86% of all voters support Medicare negotiating prices for all prescription drugs by capping prices no higher than what other wealthy nations pay. Support for negotiation jumps to 72% among Republicans, while favorability for pharma is underwater among Trump voters at -43. With Republicans gaining 20 points on the generic ballot when they back Medicare negotiation, the takeaway is clear: Defending Medicare negotiation is not just good policy – it’s good politics. — [Arnold Ventures]
Pharma’s Record-Breaking Lobbying Spend
Big Pharma is spending more than ever to block reforms and protect its monopoly pricing power. PhRMA, the industry’s top lobbying group, reported a record $12.9 million in federal lobbying expenditures in Q1 of 2025 – the most it’s ever spent in a single quarter – to roll back provisions of the 2022 prescription drug law, secure carveouts like the EPIC Act, and keep prices high for patients. The surge in spending also reflects mounting pressure over Trump’s tariff threats, with companies like Pfizer and Eli Lilly sharply increasing their own lobbying budgets and hiring Trump-linked lobbyists to shape policy behind closed doors. Lilly nearly doubled its Q1 spending compared to last year, hitting $3.4 million, while Pfizer jumped to $4.2 million. As one in three Americans struggles to afford their prescriptions, the industry’s multimillion-dollar blitz to preserve its power speaks volumes. — [Endpoints, Sludge, POLITICO, POLITICO]
‘Most Favored Nation’ Pricing Floated For 2nd Time
The Trump administration is reportedly considering a “Most Favored Nation” (MFN) policy that would tie Medicare drug prices to those paid in other wealthy countries, where prices are often dramatically lower. Originally introduced during President Trump’s first term and blocked in court, the MFN proposal would prevent Medicare from paying more than the lowest price charged for a drug in peer nations, adjusted for economic factors. While the concept has some support, it remains deeply unpopular with pharmaceutical companies. Trump’s team is said to be weighing options for reviving the policy through a new Medicare demonstration model or legislation. No formal proposal has been released yet, but recent comments and documents suggest the idea is gaining traction once again. — [STAT News, Reuters, BioSpace, RAND]
Trump’s Executive Order Includes Massive Pharma Giveaway
President Trump’s new executive order (EO) on drug pricing proposes a sweeping change to the Medicare negotiation program that would delay negotiations for small-molecule drugs, typically lower-cost pills, by four years. This delay, which is a major win for drug companies, is outlined in the EPIC Act. If implemented, the policy would shield billions in pharma profits and gut the core of the 2022 prescription drug law’s widely popular cost-saving reforms. According to KFF, more than half of the drugs selected in the first two rounds of negotiation would have been ineligible under this proposal. The policy would have exempted from negotiation some of the most widely used and most expensive drugs covered by Medicare, like Eliquis, Jardiance, and Ozempic, for years longer than under current law, helping pharma to maintain their monopolies for longer at the expense of patients. The industry argues that small-molecule drugs are unfairly subject to negotiation sooner than biologics. But if the Trump Administration truly wants parity, as stated in the EO, it should align both at nine years – not extend monopoly pricing even further. Nine years is already a generous runway before Medicare can negotiate lower prices. The administration is clearly signaling that it sees high drug prices as an urgent issue – but if it’s serious about lowering costs, cutting off one of the most powerful tools in the toolbox is counterintuitive. With fewer high-priced drugs eligible for negotiation, achieving the administration’s stated goal of greater savings for Medicare and patients becomes significantly harder. — (New York Times, Fierce Pharma, The Hill, Healthcare Finance, MedCity News, KFF, Health Affairs, P4ADNow, BioCentury.
Yes, We’re Still Talking About Tariffs
The Trump administration has formally launched a national security investigation into imported pharmaceuticals and drug ingredients – a move that experts warn will raise prices and disrupt supply chains. While Big Pharma could absorb the costs, history shows they’ll pass them on to patients instead. Generics like heparin, which is used daily in hospitals, are especially vulnerable to tariffs due to reliance on raw materials from countries like China. As The Washington Postreports, patients like 66-year-old Wanda, who relies on daily infusions of heparin to survive, could face life-threatening disruptions if tariffs trigger major price hikes or shortages. Health economists warn that the U.S. system isn’t currently equipped to urgently replace global supply chains, and hospitals may be forced to make dangerous tradeoffs. Even as drug companies rush to announce increases in U.S. investment, this policy shift will hit patients long before any promised benefits materialize. As Trump doubles down and drugmakers continue to prioritize profits above all else, it’s patients who will end up paying the price. — (STAT News, POLITICO, Bloomberg, Washington Post, POLITICO, New York Times)
States Push Back on PBM Power Amid National Reform Debate
Momentum is building against the outsized influence of pharmacy benefit managers (PBMs), as 39 state attorneys general called on Congress to ban PBMs from owning pharmacies – a move they say would curb conflicts of interest and reduce drug costs. The plea follows Arkansas enacting the nation’s first law requiring PBMs to choose between operating as middlemen or owning pharmacies, a major step toward dismantling vertically integrated monopolies. Meanwhile, state audits, lawsuits, and a growing patchwork of legislation across the country highlight the urgent need for federal action to rein in PBM abuses and restore fair competition. – (STAT News, U.S. News & World Report, STAT News)
Pharma Tariffs Would Raise Drug Prices, Deepen Patient Struggles
Despite President Trump’s decision to pause broad-based tariffs on most countries, concerns are mounting as he continues to double down on potential pharmaceutical tariffs — a move that would drive up drug prices for Americans. The U.S. already pays the highest prescription drug prices in the world, and patients are worried. “Tariffs will exacerbate that problem,” Merith Basey, executive director of Patients For Affordable Drugs, told CNN. “Prescription drugs aren’t luxury goods; they’re essential to people’s health and survival.” New tariffs could increase manufacturing costs, worsen the ongoing drug shortage crisis, and make it harder for patients to access medications they need. With one in three Americans already struggling to afford their prescriptions, these added costs risk pushing more people to skip or ration their medications. P4AD will continue to monitor developments and speak out against any policy that would raise drug prices. — (POLITICO, The Hill, NBC5, CNN, POLITICO)
Courts Hear Arguments in Ongoing Lawsuits Against Medicare Negotiation
Last Friday, Boehringer Ingelheim faced a skeptical panel during oral arguments before the Second Circuit Court of Appeals, as judges questioned the company’s claims that the Medicare negotiation program imposes unconstitutional conditions. The government’s defense was so strong that the lawyer representing the case used only a fraction of their allotted time. On Tuesday, a Third Circuit panel heard challenges from Novartis and Novo Nordisk. The panel appeared unconvinced by Novartis’ argument that the program constitutes an unlawful “taking” under the Fifth Amendment. Novo Nordisk faced scrutiny over its claim that CMS unlawfully grouped six of its insulin products for negotiation. While judges appeared more engaged with Novo Nordisk’s arguments, the panel largely deferred to CMS’ authority under the law, suggesting the program remains on solid footing. These hearings mark the first time the Trump Administration has defended Medicare negotiation in court — and so far, the trend of judges remaining unconvinced by pharmaceutical corporations’ arguments is continuing. — (Bloomberg, Courthouse News, Endpoints, Inside Health Policy)
Medicare Coverage Expansion for Anti-Obesity Drugs Halted
The Trump administration has declined to finalize a Biden-era proposed rule that would have expanded Medicare coverage to include GLP-1 drugs like Ozempic and Wegovy for obesity. While the drugs remain covered for diabetes, heart disease, and sleep apnea, Medicare is still barred by law from covering them for obesity alone. The proposal’s estimated $40 billion price tag raised alarms, but the real scandal is why the drugs are priced so high to begin with. Studies show Ozempic can be manufactured for less than $5 a month, yet it carries a U.S. list price of nearly $1,000 a month – considerably higher than in comparable countries. – (Axios, CNBC, Peterson-KFF)
ICYMI: A new report from I-MAK reveals how drugmakers Novo Nordisk and Eli Lilly are abusing the patent system to extend monopolies on blockbuster GLP-1 drugs like Ozempic, Wegovy, Mounjaro, and Zepbound. It’s a clear reminder why Congress must urgently pass bipartisan patent reform to restore competition, end monopoly abuse, and lower drug prices.
President Trump, Negotiate A “Better Deal” For Americans
P4AD launched a new national TV ad this week, airing on Fox & Friends, urging President Trump to continue defending Medicare’s ability to negotiate lower drug prices and deliver a better deal for American patients. The 30-second spot entitled “Better Deal” highlights Trump’s own statements supporting the need for Medicare to negotiate and calls on him to stand with patients, not Big Pharma lobbyists, as the second round of negotiations is underway. The ad aired amidst ongoing legal challenges from drug companies seeking to block the program, and as Trump’s DOJ has begun defending the law in court. Watch the ad below! – (Axios, YouTube)
Uncertainty Around Trump Tariffs Raises Concerns for Patients
President Trump’s newly announced tariffs have sparked growing concerns about the potential impact on drug prices and patient access. While pharmaceuticals were temporarily exempted from the latest round of tariffs, the administration has signaled that industry-specific tariffs targeting the sector are still under consideration. If implemented, these tariffs would likely increase manufacturing costs and further drive up prescription drug prices for Americans, one in three of whom are already struggling to afford their medications. We have already heard from patients anxious about rising prices and wondering if they should rush to stock up on the medications they rely on. P4AD will continue to monitor developments closely and amplify the voices of patients whose health and financial well-being hang in the balance. — (Bloomberg, Reuters, Fierce Pharma, USA Today)
Patent Bills Pass Through Committee Once Again
The Senate Judiciary Committee advanced a slate of bipartisan, pro-competition bills this week aimed at curbing patent abuses and lowering prescription drug prices. These bills – S.1040, S.1041, S.1096, S.1095, and S.1097 – would address anti-competitive tactics including product hopping, patent thicketing, pay-for-delay deals, and abuses of the FDA’s citizen petition process. The legislation would also improve coordination and communication between the FDA and the United States Patent and Trademark Office (USPTO) regarding each agency’s drug patent-related activities. The five bills have been championed by patients in our community since July 2023 and are projected to save taxpayers nearly $5 billion over the next decade. This latest vote marks an important step toward advancing reforms that promote competition and deliver long-overdue relief to patients and taxpayers. — (PatientsPushForCompetition.org)
Affordability Crisis Hits New High
A new Gallup-West Health report finds that nearly 29 million Americans are now “Cost Desperate” – unable to afford or access the care and medicine they need. The percentage of Americans struggling to pay for healthcare is at its highest level since 2021, with the burden falling hardest on Black, Latino, and low-income families. The research shows that the gap between those who can afford care and those who can’t is now wider than ever — and high drug prices are a key driver of this growing crisis. It’s yet another stark reminder that patients need relief now, and are demanding lawmakers act to rein in Big Pharma’s unchecked pricing power. – (Gallup)
ICYMI
This week, P4AD launched a new Spanish-language website to ensure Latino and Spanish-speaking communities, who are disproportionately harmed by high drug prices, are not only included in the fight for lower cost drugs they also have the tools to amplify their voices and take action.
President Trump confirmed this week that pharmaceutical tariffs remain on the table as part of a broader trade package. If imposed, tariffs of 25% or more on imported medicines and ingredients would disrupt the global supply chain, and patients would be left footing the bill. The U.S. already pays between 4-8 times what similar high-income nations pay for the same brand-name drugs. Adding tariffs would raise costs further, especially for generic medications, which account for 90% of all prescriptions in the US. New data from the Biotechnology Innovation Organization (BIO) suggests that proposed tariffs on the EU could jeopardize innovation and slow the development of new treatments for patients, as biotech companies could be left scrambling for new research and manufacturing partners. Some major drug companies have recently announced new U.S. manufacturing investments, likely in anticipation of future trade penalties. But reshoring takes years; in the meantime, patients would face higher prices and greater uncertainty. Pharma, meanwhile, could use the disruption to raise prices – exploiting chaos while continuing to fight efforts to lower costs and reform the patent system. Regardless of the policy intent, it’s patients who will bear the cost of pharmaceutical tariffs. – (Politico, Axios, Fierce Pharma, Global Trade Magazine, Desert Sun, BIO, Reuters, Forbes)
Judiciary Committee to Markup Pro-Competition Drug Pricing Bills
This Thursday, the Senate Judiciary Committee will mark up a slate of bipartisan, pro-competition bills aimed at curbing patent abuses and lowering prescription drug prices. The legislation targets tactics like patent thicketing, product hopping, and pay-for-delay deals that allow brand-name drug companies to extend monopolies and block generics and biosimilars. Previous versions of these bills – S.1040, S.1041, S.1096, S.1095, and S. 1097 – have been championed by patients in our community since July 2023. They have not only passed through Committee with bipartisan support but are projected to save taxpayers nearly $5 billion over the next decade. With one in three Americans struggling to fill their prescriptions due to cost, the Committee has a critical opportunity to advance reforms that promote competition and deliver relief to patients and taxpayers. — (Senate Judiciary Committee, PatientsPushForCompetition.org)
AFPI Outlines Drug Pricing Policies in Report
The America First Policy Institute (AFPI), a think tank founded by former Trump officials, released a new policy paper last week signaling that Trumpworld is serious about addressing the fact that Americans pay far more for prescription drugs than people in other countries. The paper revives ideas from Trump’s first term that were never implemented, and offers a more detailed roadmap than anything seen so far from the administration. While lowering prices for Americans is mentioned, the paper’s main focus is on preventing other countries from “freeloading” off U.S. investments in R&D. While we don’t share all of AFPI’s assumptions, the paper represents a notable shift and raises the prospect of potential drug pricing reforms under President Trump. (Axios, Endpoints)
ICYMI
The FTC’s lawsuit against the three largest PBMs is now in jeopardy after two commissioners were fired, raising legal questions about whether the case can proceed. We’re closely monitoring this development, which could undermine efforts to hold PBMs accountable for inflated insulin prices and restricted patient access.
Medicare Negotiation Moves Forward Despite Industry Attacks
The Centers for Medicare and Medicaid Service (CMS) has announced that all 12 manufacturers of the 15 drugs selected for the second round of the Medicare negotiation program have voluntarily agreed to participate. Overshadowing this key moment however is the fact that six of the drug manufacturers previously filed lawsuits between June 2023 and January 2025 to halt the program — which, if successful, would block significant price reductions for patients and billions in potential taxpayer savings. But these legal attacks aren’t the only threat to the popular program. Three bills have been re-introduced in Congress — The Orphan CURES Act, The EPIC Act, and the MINI Act — unnecessary giveaways to Big Pharma that would create new loopholes for drug companies to avoid negotiation for longer and for more drugs. These attacks, both in the courts and in Congress, make it clear that Big Pharma’s lobbyists and lawyers are doing everything they can to undermine the reforms patients fought hard to achieve. But there is also reason for some hope. At his confirmation hearing last week, likely CMS Administrator Dr. Mehmet Oz, pledged to “defend” and “use” the program when asked whether he would protect Medicare negotiation in court. With the law under attack from multiple fronts, P4AD remains committed to holding leaders accountable and ensuring the Medicare negotiation program is successfully implemented and able to deliver real relief to patients. — (CMS, P4AD, Fightpharma.org, P4ADNow, P4AD, P4ADNow, Drug Topics, Axios, P4AD)
PBMS Under Fire For Driving Up Drug Prices
Pharmacy benefit managers (PBMs) continue to face scrutiny for their role in driving up prescription drug prices. At the Managed Health Care Associate’s 2025 Business Summit this week, P4ADNow Executive Director Merith Basey exposed how PBM’s opaque and anti-competitive practices inflate drug prices. Highlighting findings from the Federal Trade Commission’s (FTC) report, Merith shared how PBMs manipulate formularies to favor high-cost brand-name drugs over lower-cost generics and biosimilars while pocketing massive rebates from manufacturers – with patients bearing the brunt of these practices. Bert in Pennsylvania, saw his PBM suddenly stop coverage of his Symbicort inhaler, forcing him to alternatives that caused severe side effects. In Michigan, Stacey’s PBM refused to cover her husband’s life-saving insulin, leaving them scrambling for options. With growing bipartisan momentum in Congress to address the shady practices of PBMs, there is an opportunity to drive overdue reforms that prioritize patients. P4ADNow supports efforts to end the PBM black box by increasing transparency, holding PBMs accountable for manipulating formularies to prioritize higher-cost drugs, and reining in vertical integration. — (P4ADNow, Federal Trade Commission, Commonwealth Fund)
DTC Ads Drive Up Costs For Taxpayers
The 10 largest drug companies in the U.S. spent a staggering $13.8 billion on direct-to-consumer (DTC) advertising in 2023 — and because this spending is tax-deductible, it effectively shifts the financial burden to taxpayers. A new analysis from the Campaign for Sustainable Rx Pricing (CSRxP) found that eliminating this tax break or banning DTC ads could raise federal revenues by up to $1.7 billion. DTC ad spending also directly contributes to higher drug prices. The analysis also highlighted that, according to the Congressional Budget Office, a 10% increase in DTC ads leads to a 2.3% rise in drug spending. The U.S. is one of only two countries in the world – alongside New Zealand – that allows DTC prescription drug ads, and Americans pay between four to eight times more for prescription drugs compared to people in other high-income nations. While some lawmakers are pushing for greater transparency in pharmaceutical advertising, more action is needed to address DTC ads and Big Pharma’s tactics that lead to higher drug prices. — (Tech Target, Campaign for Sustainable Rx Pricing, Politico, Congressional Budget Office, USC Schaffer, RAND)
Big Pharma has spent decades exploiting loopholes in the patent system to extend monopolies, block competition, and keep drug prices high. Senators Cornyn, Blumenthal, Grassley, and Durbin took a step to curb these abuses this week by reintroducing the Affordable Prescriptions for Patients Act (S.1041) – previously S.150 – a bipartisan bill to help crack down on “patent thicketing” by limiting the number of patents pharmaceutical companies can assert on biologic drugs. The bill is predicted to save taxpayers $1.8 billion over a decade. The same senators also introduced S.1040 to prohibit product-hopping – an anti-competitive strategy where a brand-name drug company switches patients to a “newer” version of an existing drug without generic competition just when the older version is about to face competition. In the 118th Congress, these reforms were originally introduced as one combined bill under the Affordable Prescriptions for Patients Act. However, during markup, the product hopping provision was removed, allowing the remaining patent thicketing portion of the bill to advance and ultimately pass the Senate unanimously in July 2024. Now, in the 119th Congress, these reforms have been re-introduced as two separate bills. The momentum behind these reforms has been powered by patients who sent over 40k letters and made over 30k calls to Congress demanding action. The Senate must act now to pass these crucial reforms that will help bring down costs for patients and taxpayers, increase competition, and deliver relief to Americans struggling with high drug prices. — (P4ADNow, Politico, Congress.gov, Congress.gov, P4ADNow)
CMS Ends Innovative Payment Models
On Wednesday, CMS announced it will not move forward with two prescription drug payment demonstration programs proposed under the previous administration. While these models were not yet in effect, the Medicare $2 Drug List Model would have capped the copay for certain generic drugs covered by Medicare at $2 a month, and the Accelerating Clinical Evidence Model would have incentivized the completion of confirmatory trials for drugs with accelerated FDA approval. However, CMS is, for now, continuing the Cell and Gene Therapy Access Model to help Medicaid patients, starting with those living with sickle cell disease, by increasing access to potentially transformative treatments and reducing health care costs and burdens to state Medicaid programs. With one in three Americans struggling to afford their prescription drugs and nine in 10 voters calling for Congress to prioritize further action to lower drug costs, it is concerning that CMS has chosen to halt the implementation of two of these models that could have provided relief to patients. — (Inside Health Policy, Axios, CMS, CMS, Politico, KFF, P4ADNow)
Novo Nordisk Ramps Us Lobbying
Novo Nordisk is bolstering efforts to protect its massive profits by hiring a lobbyist who previously worked to weaken key provisions in the 2022 prescription drug law. The company has become a poster child for pharmaceutical industry greed, raking in billions from its expensive GLP-1 treatments while aggressively lobbying against drug price reforms. In 2024, the company shattered its own record, spending $5.8 million on lobbying, much of which was used to oppose legislative solutions to lower drug prices. But its efforts don’t stop there. The company is also waging a legal battle. Determined to maintain its monopoly pricing power over its drugs, Novo Nordisk is one of eight companies that have filed lawsuits to block the implementation of the Medicare negotiation program which could reduce prices on several of the company’s blockbuster drugs over the next two years. But patients are fighting back. P4AD filed an amicus brief in the case amplifying the voices of those who urgently need lower negotiated prices and would suffer if Novo Nordisk was successful in the courtroom. It’s US v. Pharma: patients fought hard for these reforms, and they won’t let Big Pharma strip them away. — (NPR, Open Secrets, Politico, The Lever, KFF, Pew Research, P4AD, Fightpharma.org)
Attorneys Recalled to Defend Medicare Negotiation
Eli Lilly’s massive profits from GLP-1 treatments Mounjaro and Zepbound contributed to CEO David Ricks’ staggering $114 million salary in 2024. Whether drug industry executives take home $20 million or $100 million, it’s a stark reminder of who it is that foots the bill: patients and taxpayers.
