Latest News | Mar 14, 2025

RELEASE: Patients For Affordable Drugs Now Backs Bipartisan Crackdown On Big Pharma Patent Abuse

Senate Bills Take Aim At Drug Industry Tactics That Block Competition And Keep Prices High

WASHINGTON, D.C. — Patients For Affordable Drugs Now welcomes two bipartisan bills to curb some of Big Pharma’s abuses of the patent system in a renewed effort to lower prescription drug prices. The Affordable Prescriptions for Patients Act (S. 1041) targets patent thicketing, a tactic pharmaceutical companies use to block lower-cost biosimilars from entering the market. The second bill, newly introduced S. 1040, would prohibit product hopping, a shady practice drugmakers deploy to direct patients to a new brand-name drug to avoid facing generic competition. 

These legislative reforms are critical steps to reducing pharmaceutical industry abuses that delay competition and drive up costs, helping to bring more affordable alternatives to market and reducing prescription drug prices for millions of Americans.“For too long Big Pharma has rigged the system in its favor,” said Merith Basey, Executive Director of P4ADNow. “These bipartisan bills take direct aim at the pharmaceutical industry’s exploitation of our patent and regulatory systems — systems they manipulate to inflate drug prices and extend monopolies, costing patients and taxpayers billions every year. This is corporate greed at its worst and patients are paying the price. With nine out of 10 Americans demanding further action from Congress to rein in high drug prices, the Senate must advance these bipartisan measures and prioritize patients over the insatiable greed of pharma and their lobbyists.”

In the 118th Congress, these reforms were originally introduced as one 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. The patent thicketing bill was also included in a reintroduced health care package last week by Senators Sanders and Wyden. Now, in the 119th Congress, these reforms have been introduced by Senators Cornyn, Blumenthal, Grassley, and Durbin as two separate bills. 

BACKGROUND

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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.

Key Drug Price Reforms Reintroduced

Senators Bernie Sanders and Ron Wyden, Ranking Members of the Senate HELP and Senate Finance Committees, respectively, reintroduced a health package that includes key bipartisan reforms to lower drug prices by curbing some of the shady tactics used by pharma and pharmacy benefit managers to keep prices high for patients and taxpayers. These reforms were left out of the year-end package in 2024 due to last-minute political maneuvering, and their reintroduction provides a second chance to address manipulative tactics like patent thicketing on biologics, which block more affordable biosimilars from entering the market and keep prices high. In a statement, P4ADNow Executive Director Merith Basey called on Congress to “act swiftly to pass these measures and prove that [Congress’] priority is lowering costs for Americans – not caving to corporate interests.” Patients have been calling for these reforms for years, including Kaye Peterson, a P4AD patient advocate from Kentucky who lives with type 1 diabetes. In an LTE in The Lebanon Enterprise this week, Kaye highlighted the impact of patent thicketing on insulin prices and urged Congress to pass these reforms. With mounting pressure from patients and advocates alike, lawmakers must choose between protecting Pharma’s profits or delivering long-overdue relief to Americans struggling to afford their medications. – (The HillPoliticoCongress.govThe GuardianCongress.govP4ADNowThe Lebanon Enterprise)

Pharma-Backed Bills Seek to Undermine Medicare Negotiation

Big Pharma is escalating its campaign to undermine the 2022 prescription drug law – and they’ve found allies in Congress. Last week, the EPIC Act was reintroduced in the House to unnecessarily extend the Medicare negotiation exemption period for small-molecule drugs from nine to 13 years. On Wednesday, Senator Thom Tillis introduced a companion bill in the Senate, further escalating efforts to undermine the historic Medicare negotiation program. Meanwhile, the Maintaining Investments in New Innovation (MINI) Act was also reintroduced in the House this week by Rep. Don Davis – another bill aimed at creating loopholes for pharma by extending the exemption for genetically targeted therapies to 13 years – even though the current nine years is more than enough time for drugmakers to recoup investments. Yesterday, P4AD sent a letter to every Senator, urging them to oppose the EPIC Act, ORPHAN Cures Act, and MINI Act  – building on a similar letter sent to the full House last month. The 2022 prescription drug law already strikes a fair balance between encouraging innovation and lowering prices for patients. Lawmakers must decide whether they stand with patients or with Pharma’s profits. – (Congress.govInside Health PolicyCongress.govCongress.govP4ADNowP4ADNow)

Monitoring Potential Impact of New Tariffs

Newly announced tariffs on pharmaceutical imports from China are raising important concerns about potential drug price increases and supply shortages. While it is premature to assess the full impact on patients, in particular since the recent tariffs levied on Mexico and Canada were delayed yesterday, we’re closely monitoring the situation. Any measure that could drive up drug costs for patients is a serious concern. We’ll continue to track developments and advocate for solutions that protect patients from higher prices. – (ForbesBloomberg LawNBC News)

Attorneys Recalled to Defend Medicare Negotiation

At least two attorneys involved in defending Medicare’s drug price negotiation program have been recalled to their positions – after being caught up in the widespread layoffs across the government. This is a promising sign that the administration is committed to upholding the 2022 prescription drug law. This follows the DOJ’s recent brief defending Medicare negotiations in the case brought by Novartis to undermine the program. Additionally, last Friday marked the deadline for drugmakers to agree to participate in the next round of negotiations. While only a handful of companies have publicly confirmed their participation, none have publicly refused – an encouraging sign that the program could continue to move forward as planned. We remain hopeful that all manufacturers will negotiate in good faith and that the second round of negotiations will deliver significant savings – in line with the 62% average list price reduction achieved in the first round of negotiations. – (STAT NewsBloombergInside Health PolicyEndpoints NewsFierce HealthcareInside Health PolicyEndpoints News)

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Bipartisan Measures Aim to Curb Big Pharma’s Greed, Lower Drug Prices for Americans, and Save Taxpayers Billions

WASHINGTON, D.C. — Patients For Affordable Drugs Now applauds the reintroduction of key bipartisan drug price reforms that were left out of the end-of-year package in 2024 due to last-minute political maneuvering. A health package that includes these measures was reintroduced this afternoon by Senators Bernie Sanders and Ron Wyden.

These reforms represent an urgent opportunity to lower prescription drug prices by tackling the pharmaceutical industry’s shady tactics, anti-competitive practices, and patent abuses that keep more affordable generics off the market at the expense of patients and taxpayers.

“Congress now has a second chance to address one of the most pressing needs of Americans: lowering prescription drug costs,” said Merith Basey, Executive Director of P4ADNow. “The reintroduction of these reforms is a necessary step toward ending the unchecked greed of industries that profit from the development or distribution of prescription drugs. With nine out of 10 Americans demanding Congress do more to lower drug prices, P4ADNow is calling on Congress to act swiftly to pass these measures and prove that their priority is lowering costs for Americans – not caving to corporate interests.”

The reintroduced package includes:


In July 2023, P4ADNow launched the “Push for Competition to Lower Drug Prices” campaign to highlight the harmful impact of Big Pharma’s anti-competitive practices. The campaign included digital ads, an online advocacy hub, and videos urging Congress to pass bipartisan bills like S.150 and Q1/Q2 to promote generic and biosimilar competition. Over the last 20 months, key efforts by patients and advocates have included:

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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.

House Reintroduces The EPIC Act

Big Pharma is at it again. This week, the House reintroduced the EPIC Act (H.R. 1492), a pharma-backed bill that would extend the Medicare negotiation exemption period for small molecule drugs from nine years to 13 years, forcing patients and taxpayers to pay higher prices for longer. The truth is, this bill is nothing more than a giveaway to the pharmaceutical industry. The 2022 prescription drug law already strikes the right balance to ensure innovation we need at prices we can afford. The law allows Medicare to negotiate after drugs have been on the market for several years while still allowing drugmakers to set prices and raise them in early years. Lawmakers who truly stand with patients must reject this dangerous bill and any other attempts to weaken Medicare negotiation, as extending drugmakers’ monopoly pricing power would only hurt patients and taxpayers. — (Inside Health PolicySTATCongress.govP4ADNow

P4AD Files Fourth Amicus Brief Defending Medicare Negotiations

This week, Patients For Affordable Drugs (P4AD) filed an amicus brief in the Third Circuit Court of Appeals, defending Medicare’s ability to negotiate lower drug prices against a lawsuit brought by Novartis. This marks the fourth patient-centered amicus brief filed as part of P4AD’s US v. Pharma campaign, pushing back on the industry’s baseless claims that Medicare negotiation will stifle innovation and limit patient access. The brief highlights the experience of Bob Parant, a P4AD patient advocate, who has been living with type 1 diabetes for more than 50 years and began taking Entresto after emergency triple bypass surgery. As a patient on Medicare who needed both Entresto and insulin, Bob wasn’t able to afford both medications until key reforms in the historic prescription drug law went into effect. Prior to the law taking effect, Bob was forced to switch to a cheaper insulin that he found to be less-effective while posing potential risk to his longterm health. Last week, the Department of Justice filed its brief defending Medicare negotiations in the Novartis case. This was the first government brief of the Trump administration and marked an important moment as questions loomed over whether the new administration would defend the program in the courts. Today’s deadline for drugmakers to agree to enter into negotiations for the next 15 drugs is another key test – both for the administration’s commitment to lower prices and for Pharma’s willingness to engage rather than obstruct. — (P4ADIP WatchdogFightpharma.orgP4ADCommonwealth FundSTAT)

Push To Revive PBM Reforms

Pharmacy benefit managers (PBMs) are black boxes in the drug supply chain that operate in secrecy. On Wednesday, the House Energy and Commerce Health Subcommittee held a hearing on the role of PBMs in driving up prescription drug costs. Lawmakers on both sides of the aisle called out the shady middlemen for their anti-competitive practices, highlighting how the three largest PBMs control 80% of the prescription drug market and use their dominance to manipulate formularies – prioritizing high-cost drugs while blocking lower-cost generics and biosimilars. And patients are the ones left paying the price. Stacy in Michigan shared with P4AD that her PBM refused to cover her husband’s life-saving insulin, even after changing jobs for better insurance coverage. Stories like hers are all too common as PBMs restrict access, inflate prices, and profit at the expense of patients. Congress has a critical opportunity to revive long-overdue reforms to increase transparency within the PBM industry that were excluded from the year-end funding deal in December. Patients are counting on Congress to hold PBMs accountable. — (House Energy and Commerce Health Subcommittee, AxiosModern Healthcare

In Case You Missed It
According to an HHS Office of Inspector General report, Medicare spending on 10 diabetes drugs, including seven GLP-1 treatments, increased 364% over four years from $7.7 billion in 2019 to $35.8 billion in 2023. Rising spending on these high-cost treatments raises serious concerns about the financial strain on patients and our health care system.

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Welcome to the Week in Review.

DOJ Defends Medicare Negotiations

The Trump Department of Justice (DOJ) took the first step in defending Medicare negotiation in court. On Wednesday, the DOJ filed a brief in the Third Circuit Court of Appeals in the Novartis case, maintaining the government’s legal defense of the Medicare negotiation program – for now. Notably, this is the first DOJ brief under the Trump Administration, and it remains largely unchanged from previous filings, signaling that the government is standing with the program against Big Pharma’s multi-million dollar legal assault. This is an encouraging sign for the nine million patients on Medicare who are expected to save at least $1.5 billion out-of-pocket in the first year. However, this fight is far from over. Several industry-backed lawsuits still threaten the program, and with a critical February 28th deadline approaching for drugmakers to agree to negotiate in the next round, PhRMA’s pressure campaign is in full force. Patients fought hard for this law – and we will continue to hold the administration accountable to ensure it delivers the savings millions of Americans are counting on. — (PoliticoO’Neill InstituteInside Health PolicySTATAxiosFightPharma.orgP4AD

Push For Competition Bills & Defending Medicare Negotiations

With a new Congress in session, there is a critical opportunity to continue to advance reforms that lower drug prices. Last Congress, P4AD championed a slate of bipartisan bills to curb anti-competitive practices by drug companies and pharmacy benefit managers (PBMs), including:

Millions of patients are counting on lawmakers to revive these reforms and pass them into law to rein in the skyrocketing cost of prescription drugs and reduce taxpayer spending. At the same time, Big Pharma and its allies are aggressively pushing legislation to undermine Medicare negotiations. The recently re-introduced Orphan CURES Act would expand the Medicare negotiation exemption beyond drugs with a single orphan disease designation to those with multiple indications, giving drugmakers more power to inflate prices. Meanwhile, the EPIC Act, which is expected to be re-introduced, would extend the negotiation exemption period for small-molecule drugs from nine to 13 years – keeping prices high for longer. Pharma is framing both bills as pro-innovation, but in reality, they are blatant attempts to protect monopoly pricing at the expense of patients. Lawmakers must reject these industry-backed measures and instead deliver the bold reforms that Americans overwhelmingly support. — (Congress.govCBOCongress.govCBOCongress.govP4ADNowCongress.govSTATP4ADNow)

Drugmakers Meet With President Trump — Patients Excluded

Big Pharma is cozying up to President Trump while patients are shut out. Yesterday, drug industry executives from PhRMA sat down with President Trump for a third time to push their agenda to weaken the 2022 prescription drug law and keep drug prices high. Meanwhile, patients who are most harmed by drug pricing policy have yet to be granted a seat at the table. Make no mistake: PhRMA’s so-called commitment to “innovation and affordability” is nothing more than a smokescreen for their all-out assault on the drug price provisions in the IRA which they’ve openly declared is their top priority, The drug industry has spent millions buying access to the administration, but patients won’t stop fighting to protect the reforms they fought for — and we’re watching to see whether Trump follows through on his promise to lower drug prices or caves to Big Pharma’s influence. — (ReutersFierce HealthcareThe Wall Street JournalMedPage Today

In Case You Missed It
At a White House event yesterday, following President Trump’s meeting with PhRMA executives, Pfizer CEO Albert Bourla was met with loud boos from the audience as he was introduced. One can safely assume this reaction underscores the deep frustration Americans feel toward Big Pharma’s greed, as drug companies continue to prioritize profits over patients while millions struggle to afford their medications.

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Welcome to the Week in Review.

P4AD Report Debunks Drug Industry Myths About IRA

This week, P4AD released a report dismantling Big Pharma’s false claims about the 2022 prescription drug law, highlighting how the law is already lowering costs for patients and taxpayers. The report reveals PhRMA, the drug industry’s largest lobbying arm, spent more than $235,800 on social media ads over a four month period spreading misinformation about the law’s “unintended consequences” as it relates to patient costs, access, and future innovation. The report rebutted each of PhRMA’s claims with data and evidence – proving that the industry’s assertions are misleading at best and outright false at worst. At a press briefing on Wednesday, P4AD’s president and founder David Mitchell, and AARP’s prescription drug policy principal Leigh Purvis, debunked these claims, calling out the industry’s desperate attempt to regain its complete monopoly pricing power. They underscored how the law is delivering tangible savings to millions of Americans while ensuring fair profits for the industry and safeguarding future innovation. After decades of Big Pharma’s unchecked pricing power, the 2022 prescription drug law is reining in drug costs, and patients remain committed to defending this progress. — (P4ADYoutube)

RFK Jr. Selected As HHS Secretary

Robert F. Kennedy Jr. was confirmed yesterday as the Secretary of the Department of Health and Human Services (HHS), but after two Senate hearings last week, he offered little clarity on how he plans to lower prescription drug prices – raising concern for patients who urgently need access to affordable medications. With bipartisan interest in reducing skyrocketing drug costs and nine in 10 voters – on both sides of the aisle – demanding action, all eyes are on Secretary Kennedy. Will he champion reforms that put patients first or side with Big Pharma? — (Fierce Healthcare, P4ADNowP4ADNow)

Rising Cost of Cell And Gene Therapies

New gene therapies are hitting the market with staggering price tags based on what the market can bear – not development costs. An investigation by ProPublica focused on one such treatment, Zolgensma, a $2.1 million gene therapy for children born with spinal muscular atrophy (SMA), which has become a prime example of how Big Pharma sets drug prices. Despite critical early grassroots fundraising and taxpayer-funded grants from the National Institute of Health (NIH), Zolgensma’s price was driven by Wall Street projections and a calculated pricing strategy. Novartis leveraged value-based pricing studies that floated prices as high as $5 million, helping to condition the market toward accepting an astronomical price tag. The final $2.1 million price was framed as a “compromise,” even though it had little to do with actual R&D costs and everything to do with maximizing profits for investors. This approach has set a dangerous precedent: new gene therapies can now leverage these prior launch prices as justification for setting even higher ones. Since Zolgensma’s debut, cell and gene therapies like Hemgenix ($3.5M) and Lenmeldy ($4.25M) have pushed the ceiling higher, straining public programs like Medicaid and Medicare. As P4AD’s David Mitchell told ProPublica, “every time the benchmark moves up, they think, ‘Well, we can get away with more.” Without reforms to rein in high launch prices, patients and taxpayers will continue to pay the price for Pharma’s unchecked greed. — (Drug Discovery TrendsProPublica)

In Case You Missed It
Payouts to shareholders of major drug companies like Merck, Johnson & Johnson, and Pfizer more than tripled over the past two decades, according to a new study published in JAMA. Meanwhile, patients continue to struggle to afford their essential medicines as a result of Big Pharma’s anti-competitive tactics. 

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WASHINGTON, D.C. — Following a narrow Senate vote, Robert F. Kennedy Jr., was confirmed today as Secretary of the Department of Health and Human Services (HHS).

P4ADNow Executive Director, Merith Basey, released the following statement:

“Secretary Kennedy has a critical opportunity – and responsibility – to build on existing measures to rein in Big Pharma’s price-gouging and lower drug costs for patients. We are ready to work with him to ensure Medicare drug price negotiations continue, out-of-pocket costs are reduced, and competition in the marketplace is increased through reforms to end abusive pharmaceutical monopolies that harm patients.

“But make no mistake: patients fought hard to secure the 2022 prescription drug law, and we will fiercely oppose any efforts to weaken it. We stand ready to help make America healthy again by making prescription drugs affordable. Nine out of ten Americans think lowering prescription drug costs should be a top priority – and they are counting on Secretary Kennedy to deliver.”

Background

—During back-to-back confirmation hearings, RFK Jr. provided limited details on plans to lower drug prices and defend Medicare negotiations — a critical issue for millions of American families.

—Americans pay three to eight times more than people in other wealthy nations pay for the exact same brand-name drugs.

—In 2023, about three in 10 adults reported not taking their prescription medicines due to the high cost.

—84% of voters on both sides of the aisle support allowing Medicare to negotiate directly with big drug companies over the prices of some drugs to bring down costs.

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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.

New Bills Attempt To Weaken The IRA

P4AD sent a letter to all members of the House of Representatives yesterday, opposing two bills that would weaken the Medicare Drug Price Negotiation Program – a critical lever that will lower drug prices for millions of Americans on Medicare. The letter makes it clear: the 2022 prescription drug law was designed to balance innovation with fairer pricing, ensuring drug companies can profit while preventing unnecessary price hikes that leave patients struggling to afford their medications. One bill, the ORPHAN Cures Act, would expand Medicare’s negotiation exemption beyond drugs approved for a single orphan disease to those with multiple indications—providing a loophole for drugmakers to extend unwarranted monopolies and inflate prices indefinitely. Orphan drugs with multiple indications already generate significant revenue from expanded patient populations, in both public and private markets, and don’t need additional exemptions to remain profitable. The second bill, the Ensuring Pathways to Innovative Cures (EPIC) Act, which is expected to be reintroduced, would extend the negotiation exemption for small molecule drugs from nine to thirteen years, forcing patients to pay higher prices for longer. This change is unnecessary, as the current law gives drugmakers ample time to recover R&D costs. Companies can still set launch prices and raise them in subsequent years – Medicare negotiation simply ensures they can’t keep hiking prices unchecked. These bills aren’t about innovation – they’re about protecting pharma’s profits and undermining the law at the expense of patients. Any members who are committed to lowering drug prices should oppose these harmful bills and reject industry-backed efforts to weaken the law. — (P4ADNowKFFSTATBIO)

Price Hikes On 15 Drugs Selected For Medicare Negotiation

The drugmakers behind the 15 drugs selected for the second round of Medicare negotiation have spent years rapidly hiking prices. Cancer drugs on the list lead the pack: Pomalyst, a multiple myeloma treatment, has soared in price by 130% since its launch in 2013, while Ibrance, a breast cancer medication, has increased by 62% over the 10 years its been on the market. Novo Nordisk has hiked prices on expensive GLP-1 treatments Ozempic and Rybelsus every single year since 2021. Meanwhile, GlaxoSmithKline’s (GSK) inhaler Trelegy is up 24% since 2017 and Breo Ellipta has jumped 52% since 2013. Many of these drugs have also been shielded from competition by layers of patents, extending Pharma’s monopolies long past the dates they should have faced lower-cost alternatives. Austedo, a drug used to treat movement disorders like Huntington’s disease, has 28 active patents, while Ozempic and Trelegy each hold 20 active patents—ensuring prices stay high while patients foot the bill. — (NBCAARPPharsightPharsight, Pharsight)

Americans Demand Health Care Affordability

A new Gallup and Emory University poll found that more than half of Americans ranked improving access and lowering costs as one of their top three concerns – cutting across party lines and underscoring the mounting frustration over soaring prices. Big Pharma has rigged the system to put excessive profits over patients, driving up prices and leaving one in three Americans struggling to afford their medicines. With public demand for reform at an all-time high and nine out of 10 Americans in agreement that Congress needs to do more to lower drug costs, the question is no longer whether drug prices need to come down—it’s whether lawmakers will stand with patients or protect Pharma’s bottom line. — (Gallup/Emory UniversityAxiosKFF)

Big Pharma’s Big Earnings

Quarterly earning reports from 2024 are rolling in and unsurprisingly, Big Pharma has once again come out on top. Pfizer beat expectations and raked in $17.76 billion in fourth-quarter revenue, a 22% increase from the same period last year. Novo Nordisk reported revenue of $12.26 billion in the period, largely driven by skyrocketing sales of its pricey GLP-1 drug Wegovy. Meanwhile, GSK pulled in $10.4 billion in revenue, as it continues to charge more than $11,000 for its endometrial cancer treatment, Jemperli, among other medications. These earnings are a blunt reminder: Big Pharma is swimming in cash and can afford to lower prices. Instead, they continue to hike drug costs while lobbying to block reforms—putting profits over patients at every turn. — (CNBCThe Washington PostFierce PharmaThe Washington Post)

In Case You Missed It
Ranking Members of the House Committee on Energy and Commerce, the House Education and Workforce Committee, and the House Ways and Means Committee wrote a letter to the Government Accountability Office requesting that they monitor the Medicare Drug Price Negotiation Program to ensure the new Trump administration upholds its promise to lower prescription drug prices and drive down taxpayer spending.

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