Welcome to the Week in Review.
Pharma Launches New Lobbying Group
AstraZeneca, Bristol Myers Squibb, Eli Lilly, and Merck have launched a new lobbying group aimed squarely at undermining the popular Medicare Drug Price Negotiation Program — the most significant check on pharma’s monopoly power in decades. Since the law’s passage in 2022, the industry has poured billions into lobbying and filed numerous lawsuits to block this progress. But the courts continue to side with patients. Having failed in court 12 times, drug companies are doubling down on their legislative strategy, with record-breaking lobbying spends in Q1 and Q2 and the launch of this new front group. Yet momentum remains with patients: Medicare negotiation continues to move forward, with STAT News reporting that the administration may push for even lower prices in the next round of negotiation, another win for Americans who are tired of paying the highest drug prices in the world. — [STAT News, P4AD, Endpoints News, POLITICO Pro, STAT News, Bloomberg Law]
Eli Lilly’s Price Hikes Abroad
Eli Lilly has indicated plans to significantly raise drug prices in Europe, without making any commitment to reducing prices in the United States. The company, like other manufacturers, already earns healthy profits in every country where it operates, yet Americans pay four to eight times more than people in peer nations for the same medicines. Raising prices abroad will do nothing to make medicines more affordable for Americans. By moving forward with a Most Favored Nation-style approach, the administration has the potential to secure a better deal for U.S. patients, but only if it includes enforcement mechanisms to prevent pharma from gaming the system and shifting costs elsewhere. Pharma action alone will not lower prices. — [CNN, STAT News, BioPharma Dive, Reuters, CNBC, Inside Health Policy]
MAHA Takes Aim at Pharma DTC Advertising
On Wednesday, it was reported that leaked documents from the Make America Healthy Again (MAHA) Commission included plans to implement new oversight measures on pharma’s direct-to-consumer (DTC) advertising — specifically on “deceptive” marketing tactics. In recent months, we’ve seen a growing trend of legislation introduced that would target these practices, including the bipartisan and P4ADNow-endorsed No Handouts for Drug Advertisements Act, which would eliminate a tax break that allows Big Pharma to flood the airwaves and grow their influence at the expense of taxpayers. The U.S. is one of only two countries that allows DTC advertising for pharmaceutical drugs, and HHS Secretary RFK Jr. has long criticized this practice. Americans understand that pharma is the reason drug prices are high, and the desire to crack down on this practice shows there’s a real appetite for common sense industry reform. — [PharmaVoice, Washington Examiner, Hawley, X]
ICYMI
A new op-ed in Health Affairs this week highlighted Congress’s opportunity to crack down on patent thickets: a pharma tactic used to block competition in the drug market. The piece underscores the need for bipartisan bills like the Affordable Prescriptions for Patients Act, a bill unanimously passed by the Senate last year, which would limit the number of patents a drug company can assert on a biologic drug. — [HealthAffairs, P4ADNow]
Patient Advocate Spotlight: Jackie Trapp
Condition: Multiple Myeloma, an incurable blood cancer
Drug(s): Revlimid ($180k / year before the $2k cap) and Xarelto
Background: Former high school teacher from Muskego, WI
In her words:
“Since my diagnosis ten years ago, the price of my prescriptions has been a constant source of stress and instability in my life. We have decimated our life savings and equity and have put off appointments we deem less vital. I am grateful for the drug that has saved my life, but I am also resentful that the financial burden is draining my life at the same time. The out-of-pocket cap is life-changing for my husband and me. We are finally able to replenish our savings account and do things we have been putting off, like seeing the dentist — and I don’t have to worry about leaving my husband bankrupt.”
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Welcome to the Week in Review.
Gene Therapy Prices Soar & Access Remains Limited
Fierce Pharma’s latest ranking of the most expensive drugs in the U.S. underscores the rapid escalation in launch prices, driven primarily by gene therapies priced between $2.2 million and $4.25 million per dose. While some of these treatments face other hurdles to patient uptake, the price tag itself is a major barrier – especially when the same drugs often launch at significantly lower prices in countries like Spain and Brazil. P4AD has long pushed to rein in high launch prices so medical breakthroughs are affordable for the patients who need them. — [Fierce Pharma, P4AD]
Three Years of Drug Price Reforms
Tomorrow marks the third anniversary of the 2022 Prescription Drug Law — the historic law that, for the first time, gave Medicare the power to negotiate lower drug prices, capped insulin at $35 a month for Medicare beneficiaries, established a $2,000 annual out-of-pocket cap for Medicare drug costs, and made vaccines free for people with Medicare. Patients are already seeing the impact: over 10 million people received free vaccines in 2023, an estimated 1.5 million people benefited from the insulin cap in its first year, and more than 11 million people are expected to save in 2025 because of the out-of-pocket cap, and there are more savings to come. The first round of negotiated prices will take effect in January 2026, saving patients and taxpayers billions, with billions more in savings in subsequent years expected. However, Big Pharma continues to spend millions to overturn these monumental reforms — and P4AD is working alongside our patient community to defend them. What patients are saying about the law:
Lynn Scarfuto takes Imbruvica (drug included in the first round of negotiation) and reached the $2,000 cap: “I hit the $2,000 cap in January — and now I pay $0.”
Update On Imported Drugs Tariffs
The Trump administration’s probe into pharmaceutical imports and potential sector-specific tariffs — which could eventually reach 250% — is now likely weeks away, despite earlier timelines. Meanwhile, President Trump issued an executive order directing health officials to secure a six-month domestic supply of active pharmaceutical ingredients (APIs) for about 26 critical drugs, with plans to expand to a broader list of 86 essential medicines. Currently, only 10% of U.S. prescription drug APIs are made domestically, raising concerns about both supply chain security and potential impacts on drug prices and patients. — [Reuters, Axios]
In Case You Missed It
In July alone, drug companies hiked prices on 152 medications — and more than 60% of those increases were above the inflation rate. Some drugs, like Novartis’ gene therapy Zolgensma, increased by more than $119,000 in a single hike. Twenty drugs were hiked in both January and July, underscoring that price hikes aren’t about innovation; they’re about profit.
*Introducing a new weekly patient advocate spotlight. These advocates are the heart of our movement and courageously share their stories to drive change.
Patient Advocate Spotlight: Lisa McRipley, Michigan
Condition: Multiple Sclerosis (MS)
Drug(s): Kesimpta ($8,000/year). Lisa met the $2,000 out-of-pocket cap.
Background: Former Higher Education Administrator, and current caregiver to her mother.
In her words: “…the costs of the prescription medication to treat my symptoms add up to several thousand dollars a year, and living on a fixed income, I can’t afford it. My parents and siblings help pay for my groceries and meals to supplement my ability to pay for my medication.. Since [IRA’s] passage, I can see the light at the other end of the tunnel! … Now, I will pay no more than $2,000 a year!”
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Welcome to the Week in Review.
Three Major Defeats to Pharma’s Legal Campaign Against Medicare Negotiation
This week saw three blows to pharma’s multi-million dollar legal campaign against the Medicare Negotiation Program. On Wednesday, the Sixth Circuit U.S. Court of Appeals blocked a legal challenge brought by various Chambers of Commerce. The case was originally dismissed in August 2024 by a federal district judge in Ohio, with this week’s decision upholding the lower court’s ruling. Less than 24 hours later, the Second Circuit U.S. Court of Appeals denied Boehringer Ingelheim’s attempt to stop the program in its tracks. The three-judge panel — which included two judges appointed by President Trump and one Clinton appointee — affirmed last July’s lower court decision that the Medicare Negotiation Program is fully constitutional and lawful. Finally, the U.S. District Court for the Western District of Texas rejected a sweeping constitutional challenge from PhRMA, affirming that the program is a lawful and appropriate exercise of congressional authority. These decisions mark the 10th, 11th, and 12th court rulings in favor of patients and against the industry’s attacks on Medicare negotiation. — [The Hill, U.S. Court of Appeals, P4AD, Litigation Tracker, First Word Pharma, FightPharma, Public Citizen, Fierce Healthcare, IP Watchdog, Bloomberg Law, Endpoints News, POLITICO, Bloomberg Law, Healthcare Finance, The Hill, POLITICO, Inside Health Policy]
ORPHAN Cures Gets A Re-Score – and it’s Even Worse Than What We Thought
Last weekend, The Wall Street Journal revealed that the Congressional Budget Office (CBO) will be re-scoring the ORPHAN Cures Act to account for its impact on even more blockbuster drugs than previously anticipated, meaning its already massive $5 billion price tag is set to grow. When first scored, the ORPHAN Cures Act was projected to cost taxpayers nearly $5 billion over the next decade, allowing drugmakers to reap the rewards of a weakened Medicare Negotiation Program. This policy change is not needed, as Medicare negotiation already preserves all the incentives for rare disease research under the 42-year-old Orphan Drug Act. With the upcoming re-score revealing the full scale of this pharma-backed carveout, patients have already been mobilizing to stop another potential pharma giveaway: the harmful EPIC Act, which would further undermine the negotiation program’s ability to lower drug prices. — [Wall Street Journal, P4AD, Congress]
PhRMA Hits New Q2 Lobbying Record
After breaking the record for the most spent in a single quarter with $12.9 million in Q1, PhRMA followed it up with $7.58 million last quarter, the highest Q2 spend in its history. This investment is being deployed in an attempt to roll back provisions in the 2022 prescription drug law and keep prices extortionately high for patients. At the same time, drugmakers are ramping up efforts to deflect blame for high drug prices onto pharmacy benefit managers (PBMs). With three lobbyists per member of Congress, the pharmaceutical industry is only escalating its campaign to drown out the voices of patients — but P4ADNow continues fighting to elevate the voices of our advocates and continue fighting back against pharma’s monopoly. — [POLITICO, Endpoints, Sludge, WSJ, KFF Health News]
Cystic Fibrosis Medication Medication Price Gouging
Pharma’s mid-year price hikes are hurting patients across the country. This week, we’re highlighting one particularly egregious example: Vertex Pharmaceuticals raised prices on its two flagship cystic fibrosis (CF) medications, Trikafta and Kalydeco, to over $28,400 per month — a hike more than 2.5 times the rate of inflation. Trikafta is Vertex’s top-selling drug by far, with the company stating that its 2024 revenue of over $11 billion is “primarily driven by [Trikafta’s] continued performance.” Vertex has long been under fire from patients and doctors for its predatory pricing practices, and it’s the sole manufacturer of drugs that can add years to the life expectancy of people with CF. They’re choosing to maximize profits by drastically hiking prices on vulnerable patients with no other alternatives to fight their rare disease. — [Vertex, Boston Globe, BioPharma Dive, Fierce Pharma]
In Case You Missed It
New reporting from the Washington Post revealed that the Trump administration is planning a five-year experiment to cover GLP-1 weight loss drugs under Medicare and Medicaid. According to documents from CMMI, the proposed plan would allow state Medicaid and Medicare plans to cover drugs like Ozempic, Wegovy, Mounjaro, and Zepbound for weight management purposes. — [Washington Post]
*Introducing a new weekly patient advocate spotlight. These advocates are the heart of our movement and courageously share their stories to drive change.
Nicholas from Ellenton, Florida
Condition: Multiple Sclerosis (MS)
Drug: Vumerity ($1,949/month)
In his wife Diane’s words: “Due to the high cost charge differences and bills, between our insurance and Medicare Part D, Nicholas has not been able to get Vumerity and has seen his health decline. As a retired nurse, I just can’t let this happen, but the entire situation has consumed my life, from looking for other grants, reaching out to organizations, and calling our insurance plan to dispute the coverage.”
“We hope that the Medicare Negotiation Program will continue to lower the costs of selected medications, and hopefully include MS drugs in the negotiation process.”
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WASHINGTON, D.C. — The ORPHAN Cures Act is proving even more destructive than initially reported. Over the weekend, The Wall Street Journal revealed that the Congressional Budget Office (CBO) will re-score the bill to account for its impact on even more blockbuster drugs, meaning its already massive $5 billion price tag is set to grow.
When first scored, the ORPHAN Cures Act was projected to cost taxpayers nearly $5 billion over the next decade, allowing drugmakers to reap the rewards of a weakened Medicare Negotiation Program. But that initial estimate understated the damage: major high-cost drugs, including blockbusters like Keytruda, weren’t counted in the original analysis. With a new CBO score underway, the full scale of this pharma-backed carveout will soon be clear — and it’s worse than anyone thought.
This carveout is a blatant loophole designed for Big Pharma to protect its monopolies and keep prices artificially high. Pharma’s claim that ORPHAN is necessary to protect rare disease innovation doesn’t stand up to scrutiny either, since Medicare negotiation already preserves all the incentives for rare disease research under the 42-year-old Orphan Drug Act.
This should serve as a warning to Congress: the ORPHAN Cures Act is already funneling billions more to Big Pharma than lawmakers originally understood, doing even greater damage to Medicare negotiation. The last thing patients and taxpayers can afford is another pharma-backed giveaway like the EPIC Act that would hand the industry even more money and further undermine the program’s ability to lower drug price
The Wall Street Journal: Why Drug Prices for Some Big Medicines Will Remain High for a Longer Time
Joseph Walker | August 3, 2025
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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.
Pharma’s Mid-Year Money Grab
Despite one in three Americans being unable to afford their prescription drugs, pharma companies raised prices in July on over 150 brand-name medications as part of their mid-year price hikes. The majority of hikes were increases above the rate of inflation. A few lowlights: Novartis raised the price of its spinal muscular atrophy gene therapy, Zolgensma, by $119,585, the highest singular price increase on an already wildly expensive drug sold at over $2.5 million. And the largest percentage was for the osteoporosis drug Ibandronate Sodium, which was increased by 359% for three tablets. This is business as usual for Pharma: hiking prices and squeezing patients, regardless of the crushing financial burden they face.
Trump Administration Re-Ups MFN with New Letters to Pharma
On Thursday, President Trump sent letters to 17 major pharmaceutical companies ratcheting up his Most Favored Nation (MFN) drug pricing strategy. Americans shouldn’t be paying between four and eight times what other high-income nations pay for the very same brand-name drugs, and the president is recognizing that drug companies gaming the system are to blame. However, the letters still leave far too much room for the industry to protect its profits by raising prices for patients abroad — in line with their track record of exploiting even the most well-intentioned plans to maintain its monopolies at the expense of patients. It’s critical that any MFN plan contains safeguards to prevent pharmaceutical companies from simply raising prices in other countries instead of lowering them in the U.S., in addition to clearly defined ways for the administration to monitor and enforce compliance. — [White House, P4AD, NYT, POLITICO, Reuters, Inside Health Policy, Axios, The Hill, STAT News, CNBC, Bloomberg Law]
Tariffs Will Devastate Patients
Sunday’s EU trade deal will set a 15% tariff on imported pharmaceuticals from Europe, affecting a wide range of drugs, including blockbusters Ozempic and Keytruda. With Wall Street analysts predicting that the deal will cost the pharma industry $19 billion, P4AD is once again sounding the alarm that manufacturers will pass any new costs onto patients, raising prices and increasing drug shortages. Even if companies invest in reshoring, new price hikes will likely hit long before any potential benefits, harming the most vulnerable patients already struggling to afford their prescription drugs. — [White House, Reuters, Bloomberg, NYT, Axios, Endpoints, STAT News, Inside Health Policy]
Pharma Executives Push For Yet Another Handout
The Maintaining Investments in New Innovation Act, or MINI, is back in the news, with the CEO of Alnylam Pharmaceuticals penning an op-ed in support of this harmful bill. MINI would extend the exclusivity period for genetically targeted technologies (GTTs) to 11 years, further restricting them from negotiation and ensuring manufacturers can price-gouge patients for longer while increasing costs for taxpayers. If a drug company CEO is lobbying for a bill like MINI, you can bet it’s bad for patients. We urge Congress to put patients above industry interests — particularly after the industry was already handed a $5 billion handout with the ORPHAN Cures Act last month. — [Congress, STAT News, P4ADNow]
*Introducing a new weekly patient advocate spotlight. These advocates are the heart of our movement and courageously share their stories to drive change.
Patient Advocate Spotlight: Steven Hadfield, 73, North Carolina
Condition: Rare Blood Cancer and Type 2 Diabetes
Drugs: Brukinsa ($15,744), Januvia ($527), Dupixent ($7,987), Metformin, Gabapentin, and Repaglinide, totalling roughly $24,221/month. Thankfully, Steven met the IRA’s $2,000 out-of-pocket cap this year.
This week, Steven participated in a press conference urging the repeal of the ORPHAN Cures Act. Here’s some of what Steven had to say:
“I used to take Imbruvica — a cancer drug priced at nearly $17,000 a month. I had to get grants to pay for it because it was simply unaffordable. Now, because it’s part of Medicare negotiation, in January that price will be cut by 40 percent — but if the ORPHAN Cures Act had been passed into law earlier, Imbruvica would not have been eligible for negotiation, leaving thousands of patients paying a higher price indefinitely… Patients like me fought hard to win Medicare negotiation. We cannot let Pharma gut that victory. It’s time to repeal the Orphan Cures Act and stand with patients — not Big Pharma’s profits.”
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WASHINGTON, D.C. — Patients For Affordable Drugs Now Executive Director Merith Basey issued the following statement in response to letters sent by President Trump to 17 major pharmaceutical companies regarding his Most Favored Nation drug pricing strategy:
“American patients deserve real relief from paying between four and eight times what other high-income nations pay for the very same brand-name drugs, and we welcome efforts to hold drug corporations accountable for their price-gouging and blame-shifting tactics. Yesterday’s letters make clear that the administration recognizes that drug companies are gaming the system to keep prices high here in the U.S.; however, the letters still leave far too much room for the industry to protect its profits while also raising prices for patients abroad.
Americans overwhelmingly understand that drug corporations are the root cause of high drug prices. And based on the industry’s track record, without proper enforcement and penalties, Big Pharma will exploit even well-intentioned plans to maintain its monopolies at the expense of patients.”
REMAINING 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.
Welcome to the Week in Review.
Details Emerge in FDA Voucher Program
The FDA is continuing to build out its new priority review voucher program, now formally adding “affordability” as one of the priority criteria when considering vouchers. According to new guidance, companies could potentially be eligible for a voucher if they lower U.S. brand-name drug prices to match those in comparable high-income nations – a nod to President Donald Trump’s ‘Most Favored Nation’ pricing proposal. While we are encouraged to see affordability being raised, without congressional authorization and with only five vouchers available in the pilot year, it raises serious questions about the program’s viability. As always, we know pharma will find ways to abuse even the best-intentioned programs. P4AD will continue to monitor this program as it develops. — [CNBC, Endpoints]
Pharma’s Silence Gives The Game Away
Pharma loves to claim that the popular Medicare Negotiation Program will devastate innovation – but when a CBO report found that a 10% cut to the NIH budget would result in more than four times the harm to new drug development, the industry has largely remained quiet. Why? Because pharma’s fearmongering about the IRA isn’t really about innovation – it’s about protecting their monopoly pricing power. According to the CBO, NIH cuts would result in 53 fewer drugs coming to market over the next 30 years, compared to just 13 from Medicare negotiation. — [CBO, KFF]
AstraZeneca Begins Reshoring But Patients Still Get Squeezed
With 200% tariffs on pharmaceutical products still being considered by President Trump, AstraZeneca announced a $50 billion investment this week in U.S. manufacturing. But let’s be clear; reshoring won’t happen overnight, and drugmakers will pass any increased import costs onto patients long before domestic supply chains can catch up. And while AstraZeneca is using this announcement to cozy up to the administration, its CEO is also using the spotlight for attacking potentially transformative drug pricing reforms like Most Favored Nation – a reminder that Big Pharma’s top priority remains protecting profits, not patients. — [Bloomberg, STAT News]
In Case You Missed It
A new report commissioned by the Association for Accessible Medicines claims that Medicare negotiation will harm generic competition and drive up drug prices. But a closer look reveals that their entire argument is based on faulty assumptions and ignores key facts, including inaccurately suggesting that Medicare negotiation is a substitute for market-based competition, conveniently overlooking that generic or biosimilar competition is already ineligible for negotiation.
*Introducing a new weekly patient advocate spotlight. These advocates are the heart of our movement and courageously share their stories to drive change.
Patient Advocate Spotlight
Elaine Kniepfel, 83, Kansas
Condition: Multiple Sclerosis
Drugs: Copaxone ($100,000/year), Provigil ($8,000/month)
Background: Retired educator with 47 years of service as a teacher and administrator
In her words: “Even with Medicare, the $2,000 cap is too much for retired people on fixed incomes. It’s abhorrent that drug companies charge so much to the people who need medicine most.”
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Welcome to the Week in Review.
CMS Model Could Expand Access to Sickle Cell Therapy
This week, CMS announced that 33 states, DC, and Puerto Rico will join an initiative intended to improve access and lower costs for gene therapies for sickle cell disease (SCD), a condition that disproportionately impacts Black and Latino communities. A continuation of the Biden administration’s model, the Cell & Gene Therapy Access model ties payment to clinical outcomes, aiming to expand access while holding drug companies accountable. With a massive price tag upwards of $2.8 million for SCD treatments, we’re encouraged to see CMS working to make these life-changing therapies more affordable and more widely accessible for patients. — [CMS, NIH, CMS, BioPharma Dive, Fierce Healthcare, BioPharma Dive, Pink Sheet, Healthcare Finance]
Big Pharma’s Discount Won’t Cut It
Bristol-Myers Squibb (BMS) and Pfizer announced a new direct-to-patient program this week, offering a “discounted” price on their blockbuster blood thinner Eliquis. While marketed as a win for patients, the new discounted price is still higher than what patients on Medicare will pay under the new Medicare Negotiation Program and will still be too high for many patients. In the wake of growing public and political pressure, this announcement comes just weeks after the Trump administration issued an executive order reviving the idea of ‘Most Favored Nation’ pricing including calling for direct-to-consumer sales at a lower price, and at a time when patients and the majority of Americans demand more action to lower drug prices. At the same time, BMS is actively trying to weaken Medicare negotiation, asking for the “maximum level of flexibility”. Make no mistake, pharma is looking for ways to stay ahead of reforms that threaten their pricing power. — [WSJ, Reuters, Endpoints]
FDA Proposes Tying Priority Approval Vouchers to Drug Affordability
In an interview with CNBC late last week, FDA Commissioner Makary said the agency would consider drug affordability as a factor in its new priority review voucher program. This announcement comes after the department introduced the new program last month, stating that its goal is to “reduce inefficiencies” and expedite decision-making. Though some experts have claimed the new voucher program doesn’t hold up to legal scrutiny, Makary and the FDA have stated they’re aiming to use the program as an incentive for companies that commit to lowering their drug prices — though we’re always on the lookout for pharma to try and game the system here too. — [CNBC, FDA, Inside Health Policy, BioSpace]
In Case You Missed It
A new study found that just 2.5% of nearly 10,000 patents on small-molecule drugs cite government funding, despite the fact that 99% of drugs approved from 2010 to 2019 originated through NIH-funded research. It’s yet another example of a rigged system: Taxpayers fund the science, but pharma patents the profits. — [Nature Biotech, JAMA, Endpoints]
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