Latest News | May 16, 2025

This Week in Drug Pricing: Trump Revives Global Drug Pricing Debate, Another Win for Patients and Another Warning For Big Pharma In Court, The ORPHAN Cures Act Would Undermine Patient Savings, Endorsing the No Handouts for Drug Advertisements Act, and ICYMI

Welcome to the Week in Review.

Trump Revives Global Drug Pricing Debate

This week, President Trump issued an Executive Order (EO) focused on addressing the high cost of prescription drugs. One key provision aims to align U.S. prices with those in other high-income nations — a concept referred to as “Most Favored Nation” (MFN). Right now, Americans pay the highest drug prices in the world for two main reasons: U.S. policy allows drug companies to set launch prices and raise them at will, and unlike other countries that negotiate prices for nearly all prescription drugs, the U.S. only recently began limited negotiation for a small set of expensive drugs through Medicare. That’s why international reference pricing frameworks like MFN are worth exploring — but only if they’re done right. P4ADNow supports pursuing a better deal for Americans — including through the widely popular Medicare Negotiation program — however, any MFN policy must meaningfully lower prices for U.S. patients, without driving up costs or limiting access abroad, and should include strong guardrails to prevent drug companies from exploiting new loopholes. Check out P4ADNow’s Executive Director Merith Basey’s interview on the EO on Univision. — [New York TimesForbesEpoch TimesCitelineHealthcare FinanceSTAT NewsEndpoints NewsReutersPOLITICOWashington PostBloomberg LawUSA Today

Another Win for Patients and Another Warning For Big Pharma In Court

Patients netted a massive victory this week, after the U.S. Court of Appeals for the Third Circuit rejected AstraZeneca’s challenge to the Medicare Drug Price Negotiation Program in a unanimous ruling — affirming that Medicare can and should be negotiating lower drug prices on behalf of seniors and people with disabilities. This ruling marks the first appellate decision evaluating and upholding the negotiation program’s core framework, and it serves as a warning to other drug companies attempting to protect their outrageous profits through the court. As Michael Lieberman of Fairmark Partners — the firm representing P4AD in amicus briefs — told Inside Health Policy, the decision is a “positive sign for the government regarding how the Third Circuit might rule in other cases.” To date, P4AD has submitted four amicus briefs on behalf of patients and has signed onto seven amicus briefs in our campaign to challenge Big Pharma’s attempts to undermine Medicare negotiation through the U.S. legal system. — [Endpoints NewsInside Health PolicyP4ADPink SheetBloomberg LawReutersFirstWord PharmaLaw360]

The ORPHAN Cures Act Would Undermine Patient Savings

On Wednesday, the House Energy and Commerce Committee advanced the ORPHAN Cures Act (H.R. 946), which was included in a larger reconciliation bill largely focused on Medicaid. Driven predominantly by the pharmaceutical industry and its allies, ORPHAN Cures would create an unnecessary loophole in the Medicare Negotiation Program, allowing even more drugs to avoid price negotiation — including those indicated for multiple rare diseases — right before the first round of negotiated prices takes effect in January. Medicare negotiation is on the verge of delivering $1.5 billion in savings to nine million patients and $6 billion in taxpayer savings, so the last thing Americans need is a new loophole for the pharmaceutical industry to exploit. Thousands of P4ADNow patient advocates have sent letters demanding Congress vote no on ORPHAN Cures, and P4ADNow is urging Congress to side with patients and stop the progression of this harmful bill. — [Congress.govCMS]

Endorsing the No Handouts for Drug Advertisements Act

On Wednesday, Senator Jeanne Shaheen (D-NH) and Senator Josh Hawley (R-MO) introduced the No Handouts for Drug Advertisements Act to eliminate a tax break that fuels the flood of prescription drug ads designed to boost profits for Big Pharma and drive up prices for patients. The U.S. is one of just two countries that even allows direct-to-consumer (DTC) drug advertising — there’s no reason taxpayers should be footing the bill for it. We’re proud to support Senators Shaheen and Hawley’s common-sense reform to put patients before pharma profits. — [Inside Health Policy]

ICYMI

Patients For Affordable Drugs’ founder and president, David Mitchell, has been included in Washingtonian’s Washington DC’s 500 Most Influential People of 2025 for the third year in a row. David’s commitment to reforming the drug price system without taking a penny from industry has made him one of the most trusted and influential voices on this issue.

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P4ADNOW urges Congress to Reject The Pharma-Backed Bill and Protect Key Drug Pricing Reforms 

WASHINGTON, D.C. — Today, the House Energy and Commerce Committee advanced the ORPHAN Cures Act (H.R. 946) through their markup. This legislation, driven predominantly by the pharmaceutical industry and its allies, would create an unnecessary loophole in the Medicare Negotiation Program — allowing even more drugs to avoid price negotiation, including those indicated for multiple rare diseases — right before the first round of negotiated prices take effect in January. Patients For Affordable Drugs Now urges Congress to stop progression of this harmful bill.

“The overwhelmingly popular Medicare negotiation program is on the verge of delivering savings to nine million patients, and the last thing patients and the taxpayers need is a new loophole for the pharmaceutical industry to exploit,” said Merith Basey, Executive Director of P4ADNOW. “The Orphan Cures Act is yet another industry handout designed to protect corporate monopolies while undermining widely popular drug pricing reforms and overdue relief for patients”

An orphan drug designation applies to a treatment for conditions affecting fewer than 200,000 people in the United States. However, many drugs with multiple orphan indications reach much larger patient populations and are highly profitable for pharmaceutical manufacturers. The industry has spent millions of dollars misleading patients by falsely claiming that allowing multi-orphan drugs to remain eligible for price negotiation will harm innovation. The reality is the 2022 prescription drug law maintains all existing incentives for the development of orphan drugs, and only a small percentage of drugs approved for more than one orphan disease gross over $200 million under Medicare each year, the threshold for negotiation eligibility. Instead, the ORPHAN Cures Act will ensure prices are kept artificially high, unjustly undermining the victories that patients fought for.

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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.

WASHINGTON, D.C. – Patients For Affordable Drugs Now Executive Director Merith Basey issued the following statement in response to President Trump’s new Executive Order (EO) on drug pricing:

“We completely agree with President Trump that Americans shouldn’t be paying the highest drug prices in the world for the exact same brand-name prescription drugs. And we broadly support international reference pricing — including ‘Most Favored Nation’ style policies — that, if well designed, could help rein in inflated drug prices and deliver savings for patients.

This Executive Order is a step in the right direction, but without additional guardrails, it leaves room for pharmaceutical companies to continue gaming the system at the expense of patients. The reality is: drug companies set high prices in the U.S. because U.S. policy lets them – unlike other high income countries that negotiate lower prices. 

With nearly nine in ten Americans demanding lower prices and greater accountability from drugmakers, the administration can pursue an even better deal, in line with other high income nations, including through the popular Medicare Negotiation program. 

While outstanding questions remain, P4AD is committed to working to ensure this executive order is implemented in a way that delivers lower drug prices for patients. We’ll continue to monitor implementation closely and urge the administration to stay focused on patient-centered reforms that hold the true driver of high drug prices accountable: drug corporations.”

BACKGROUND

Several aspects of the EO raise immediate questions:

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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.

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Growing Momentum Around International Reference Pricing

Senators Josh Hawley (R-MO) and Peter Welch (D-VT) unveiled a bipartisan bill that would bar drug companies from charging Americans more than the international average price for a specific prescription drug, adding to growing momentum around international reference pricing. Meanwhile, the Trump administration is considering a separate proposal that would tie Medicaid drug payments to foreign prices as part of broader budget reconciliation legislation, with new reports that Trump is expected to sign an executive order pursuing the initiative as soon as Monday. P4AD supports the principle that Americans shouldn’t be paying up to eight times more than patients in other countries, and we’re encouraged to see bipartisan efforts to lower drug prices through mechanisms such as international reference pricing. These proposals have the potential to deliver real relief for patients, but ultimately, the devil will be in the details. We’ll be watching closely to ensure any final plan truly lowers prices without restricting access here or abroad. — [POLITICOStat NewsAxiosEndpoints NewsBloombergPOLITICO]

P4AD Holds Community Town Hall

On Tuesday, we hosted a live Town Hall to answer questions from our community and shared the latest in our fight to stop pharma, its lobbyists, and allies from rolling back the progress we’ve made to lower drug prices. We covered everything from the threats to Medicare negotiation, to the potential harm of tariffs, to recent competition bills progressing through Congress, to efforts to reform the PBM system. Thank you to our community members who joined us live and to those of you who wrote to us with close to 600 questions! If you missed it, check out the video here!

Drug Spending Hits Record High As Patients Struggle to Afford Medications

According to Axios’ coverage of a new IQVIA report, Americans’ out-of-pocket spending on prescription drugs has surged 25% over the last five years, reaching a historic high of $98 billion last year. Even though total net medicine spending rose 11.4% last year, hitting a massive $487 billion, more than one-quarter of new prescriptions went unfilled — largely because they aren’t covered by insurance. It’s no surprise that nearly 90% of voters, including 89% of Trump voters, say prescription drug prices are too high, with nearly 60% of Americans reporting struggling to afford their medications in the last 12 months. Americans – who pay between four and eight times more than people in other wealthy countries – are urgently demanding that the White House and Congress do more to address this crisis of high drug prices. — [AxiosArnold Ventures]

ICYMI

In a powerful report for ProPublica, David Armstrong reflects on the cancer drug Revlimid — the same drug that helped treat his own multiple myeloma — and the industry tactics that kept its price high for years. The piece, which includes reflections from P4AD’s David Mitchell, who is also a multiple myeloma patient, captures both the human stakes and the corporate strategies that put profit above patients.

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Welcome to the Week in Review.

P4AD and AARP Push Back Against Pharma’s EPIC Act

In an exclusive first reported by The Hill, P4ADNow and AARP sent a joint letter to top House committee leaders urging them to reject the EPIC Act (H.R. 1492) — a pharmaceutical industry-backed bill that would delay Medicare drug price negotiation for small-molecule drugs from 9 to 13 years. The move comes as lawmakers consider what to include in the upcoming reconciliation package, where the drug industry is pushing for the bill’s inclusion. The letter argues that if Congress wants to “align” timelines for biologics and pills, as President Trump recently suggested, it should do so at 9 years, not 13, to protect savings for patients and taxpayers. Blocking earlier negotiation would mean drugs like Eliquis and Jardiance, which were negotiated in the first round, would not be eligible, costing Americans billions in higher prices. – [P4ADNowThe HillAxiosAARP]

Pharma-Backed Patent Bills Return

Yesterday, Senators Thom Tillis and Chris Coons reintroduced two harmful bills — the PREVAIL Act and PERA — that would entrench pharma monopolies and block lower-cost competition. P4ADNow strongly opposes both bills, which would weaken key patent oversight tools and expand patent protections that keep drug prices high. Patients helped defeat these harmful proposals in the last Congress, and are ready to do it again. With 78% of voters saying drug companies are focused on profits over people, advancing these bills isn’t just bad policy — it’s bad politics. – [P4ADNowArnold Ventures]

Pharma Opposes Tariffs — They Prefer to Hike Prices Themselves

The Trump administration’s investigation into pharmaceutical imports has raised the possibility of a 25% tariff on drugs and ingredients. A new PhRMA-commissioned report warns tariffs could raise U.S. drug prices by nearly 13% and cost Americans $51 billion annually — but let’s be clear: drug companies set drug prices, and while we agree tariffs would drive up costs and threaten access, Big Pharma’s warning is more about protecting its bottom line than protecting patients. As P4AD’s Merith Basey told The Lancet Oncology, it’s patients who would suffer the most, facing higher prices, potential shortages, and threats to the progress made under Medicare drug price negotiation. – [ReutersConsumer AffairsPharmaphorumThe Lancet Oncology]

Pharma’s Scapegoat: Inside the $31M Campaign to Shift Blame

A new Wall Street Journal article reveals how Big Pharma’s $31 million lobbying blitz last year, plus another $13 million in Q1 2025, helped shift blame for high drug prices onto pharmacy benefit managers (PBMs). From funding minority-led nonprofits to underwriting conservative media campaigns, the piece exposes how drug companies are shaping the narrative to deflect scrutiny. It’s a calculated strategy that makes strange bedfellows — and while P4AD supports genuine reforms to rein in PBMs, it’s clear the drug industry is more focused on shifting blame and protecting profits than fixing the system. – [The Wall Street Journal]

ICYMI

P4AD released an open letter to our community – on the 100th day of President Trump’s second term – reaffirming our commitment to lowering drug prices. While Pharma ramps up lobbying and pushes carveouts like the EPIC Act, patients are organizing, fighting back, and driving progress. The fight continues.

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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

P4ADNow supports the following patent reform bills;

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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.

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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]

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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 Post reports, 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)

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