Welcome to the Week in Review.
White House Announces Agreements With Eli Lilly & Novo Nordisk on Blockbuster Weight Loss Drugs
From the Oval Office on Thursday, President Trump announced lower prices on several blockbuster weight-loss drugs, including Ozempic, Wegovy, and Zepbound, for patients on Medicare, as well as for anyone who purchases them through the administration’s forthcoming TrumpRx direct-to-consumer website. Though many of the details have not been made public, including how the $50 cost-sharing proposal might work in Medicare and how it might affect current plan costs, the White House fact sheet outlined that TrumpRx will offer Ozempic and Wegovy for $350 and Zepbound for $346 per month. That’s a steep reduction from current list prices of between $1,000 and $1,350 per month, but still higher than prices for these drugs in other high-income nations. Additionally, Medicare will now cover these drugs for weight loss, expanding coverage and reducing the price to $245 per month. With Ozempic and Wegovy both included in the second round of Medicare negotiation, important questions remain about how these agreements will relate to the Medicare-negotiated prices and whether this new voluntary initiative will complement or complicate the savings patients are due to receive, especially given that Lilly and Novo have a long history of price-gouging American patients who take insulin and have consistently increased their prices in lockstep with one anotherStill, this announcement is welcome news for patients like Gloria, whose health and well-being depend on one of these life-changing but wildly overpriced drugs. — [White House, KFF, P4AD, Washington Post, STAT News, POLITICO, CBS News, Bloomberg, Washington Post, Wall Street Journal, Endpoints News, STAT News, ABC News, Reuters]
Novo Manipulates Searches to Push Ozempic
Ozempic manufacturer Novo Nordisk spent $7.5 million on paid keywords over the course of two years, according to a new analysis from JAMA, pushing direct-to-consumer advertisements to individuals searching the internet for weight loss solutions despite the drug not being FDA-approved for weight loss. Over 3,500 of the keywords didn’t even contain a mention of the drug, in what the researchers concluded was an attempt to influence consumers and even “potentially circumvent traditional advertising regulations.” Direct-to-consumer (DTC) drug ads are a practice largely unique to the U.S., and estimates have found that each 1.5% increase in DTC TV ad spending is associated with a 10% increase in sales. The Trump administration cracked down on misleading DTC ads with an executive order in September, organizations like Generation Patient have been working to fight DTC social media ads, and we’ve endorsed legislation like The No Handouts for Drug Advertisements Act that would eliminate a tax break that makes it cheap and easy for Big Pharma to flood the airwaves with ads. Internet searches are just another way pharmaceutical companies funnel misleading advertisements directly to consumers through less-regulated methods, and it’s time for the law to catch up. — [JAMA Network, STAT News, TIME, White House, Sen. Hawley, NPR]
AstraZeneca Downplays the Impact of MFN
Following its mid-October MFN drug pricing deal with the Trump administration, AstraZeneca executives are downplaying the financial impact. On Thursday, CFO Aradhana Sarin told Bloomberg that the company could fully “absorb” the cost of the agreement, while at the same time, CEO Pascal Soriot appeared on Bloomberg TV, warning that lower U.S. prices could harm an “environment that attracts investment from large pharma companies”. It’s a familiar contradiction: publicly warning that lower prices will devastate innovation while assuring investors that profits are secure. It’s the same playbook the industry has used with Medicare negotiation for years. Big Pharma has repeatedly claimed negotiation would stifle R&D and limit new cures, yet in shareholder meetings and earnings calls, pharmaceutical executives routinely emphasize that the impact on their bottom line will be minimal. This is an industry that could lose $1 trillion in revenue over a decade and remain one of the most profitable industries in the world, and these conflicting messages reveal what’s really at stake: not innovation, but preserving the system that allows drugmakers to charge whatever they want, for as long as they can. — [Bloomberg, TV Eyes, West Health]
FDA Clears Way for Faster Personalized Gene Editing Therapy
The FDA is set to publish an outline for the agency’s new approach to simplifying custom gene-editing treatments this month, in an attempt to streamline the lengthy and expensive approval process. By allowing patients with related genetic disorders to be grouped into a combined trial, researchers say the cost for custom-made cell and gene treatments could reach a few hundred thousand dollars — still exorbitantly expensive, but a significant improvement over the current multimillion-dollar price tag. While gene and cell therapies have the potential to transform medicine and patients’ lives, offering cures for previously intractable diseases like sickle cell, leukemia, or lymphoma, the lack of a sustainable pricing model in the U.S. means that access is limited. Spain’s decentralized model for manufacturing CAR-T therapy has sped up production times at a cost of one third of the U.S. price, and a similar model was launched in Brazil in 2024 that’s also set to lower CAR-T’s cost. Cell and gene therapies are revolutionary and lifesaving treatments, but only if patients can afford to access them. — [Bloomberg, STAT News, Caring Cross]
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Patient Advocate Spotlight: Kaye Peterson
Background: 67-year-old retired librarian from Lebanon, Kentucky
Condition: Type 1 Diabetes and Polyneuropathy
Drug: Lispro ($639.59 / vial), Lantus ($649.75 / vial), Midodrine ($185.99). Kaye pays $35 per vial for Lispro and Lantus, and Midodrine is covered by her insurance.
In her words: “Even with good insurance coverage, prescription drug prices are still ridiculously high for patients who need them. A minor change in my insurance could leave me with soaring out-of-pocket costs.”
“I believe in lower prescription drug prices because I am way too tired to have to continue asking this question: How many people have to continue to die because they can’t afford their insulin and inhalers?”
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Welcome to the Week in Review.
FDA Announces Steps to Expedite Approval of Lower-Cost Biosimilars
The FDA took a significant step in accelerating biosimilar approvals this week, announcing a new draft guidance to cut unnecessary red tape and streamline duplicative clinical trial requirements. The change is designed to speed lower-cost treatments known as biosimilars to market for diseases like cancer, arthritis, and autoimmune conditions, delivering relief to patients who’ve waited too long for more affordable options. It’s a move we’ve long supported: the P4ADNow-endorsed Biosimilar Red Tape Elimination Act, introduced by Senators Lee, Hassan, Paul, and Lujan and Representatives Pfluger and Landsman, would codify the same commonsense reforms. While this is welcomed progress, there’s still an urgent need to address the patent abuses that big drug companies employ to block competition and keep lower-cost alternatives from reaching the market. That’s why we’re pushing for several bipartisan patent reform measures in Congress that would close these loopholes and complement the FDA’s announcement – ensuring faster access to affordable medicines for patients. — [C-SPAN, FDA, Congress, P4ADNow, New York Times, The Hill, Endpoints News, STAT News, Fierce Pharma, BioPharma Dive, Bio Space]
Senate HELP Hearing Highlights Need for Affordable Prescriptions
Amid growing bipartisan pressure to lower drug prices, the Senate Committee on Health, Education, Labor & Pensions (HELP) held a hearing this week on U.S. biotechnology that revealed familiar fault lines. While some lawmakers echoed industry talking points about the IRA’s impact on innovation, others pressed for action to make drugs more affordable. Dr. Aaron Kesselheim of Harvard Medical School and Dr. Reshma Ramachandran of the Yale School of Medicine cut through the noise — underscoring what patients and advocates have long known: innovation is useless if people can’t afford it.
The hearing made clear that while pharma continues to frame affordability as a threat to innovation, experts — and an increasing number of lawmakers on both sides of the aisle — are focused on the real issue: ensuring breakthroughs in medicine actually reach the patients who need them.
Cigna Ends Prescription Drug Rebates — Will Patients Benefit?
Cigna is the latest to promise lower drug prices — but whether patients will actually benefit remains an open question. On Monday, the Cigna Group, which owns pharmacy benefit manager (PBM) Express Scripts, announced plans to eliminate prescription drug rebates across many of its commercial health plans starting in 2027, claiming that the move will lower “monthly prescription drug prices by an average of 30% for those who pay full cost.” HHS Secretary RFK Jr. praised the move, saying it aligned with the administration’s “vision of empowering patients.” But the details matter. Previous efforts to pass rebates directly onto patients have often resulted in raised premiums or produced limited savings for most enrollees, especially those not paying full price for their drugs. In an interview with Bloomberg Radio, Cigna Express Scripts president Adam Kautzner said the company expects to “extract more value out of drug manufacturers” — and Cigna’s stock rose nearly 2% by midday of the announcement. Cigna’s move may grab headlines, but the real test is whether the savings reach patients, or just stay with insurers and manufacturers. — [Axios, Bloomberg, X.com, Bloomberg Radio, Endpoints News, Washington Post, STAT News]
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Patient Advocate Spotlight: Bob Parant
Background: New York resident, living with diabetes for 53 years
Condition: Type 1 Diabetes
Drug: Insulin ($825 per month, before the $35 cap) and Entresto ($765)
In his words: “I am thankful for the insulin that has been developed that I use to manage my disease, but the cost is inhumane. I need insulin to live, but far too often, the high prices of insulin stand in the way of patients accessing this essential drug.”
“The reforms passed in the Inflation Reduction Act make a huge difference in my life. The new $2,000 cap on out-of-pocket costs for my prescriptions, plus the $35 insulin copay caps, mean that I’ll spend much less each year on my drugs. With lower drug costs, I’ll be able to visit my grandchildren more and not worry as much about my retirement funds.”
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Welcome to the Week in Review.
ORPHAN Re-Score Explodes Cost ~$9 Billion, as P4ADNow & AARP Urge Congress Against EPIC
The re-score of the ORPHAN Cures Act by the Congressional Budget Office (CBO) confirmed what patients feared: the bill is even more expensive and more harmful than originally projected. The cost to taxpayers has jumped from $5 billion to $8.8 billion, after the first analysis failed to account for the exemption of blockbuster drugs like Keytruda, Opdivo, and Darzalex from Medicare negotiation. This week Senators Welch, Cortez Masto, and Wyden introduced legislation to repeal the provision in the One Big Beautiful Bill and replace it with a targeted policy: exempting only true rare-disease drugs that account for less than $400 million in annual Medicare spending, rather than the current $200 million threshold. The goal is to preserve incentives for genuine rare-disease innovation while ensuring overpriced blockbusters can still be negotiated. But even as legislators work to correct the damage from ORPHAN, Pharma is already pushing its next attack on Medicare negotiation — the EPIC Act, which would delay negotiation for small-molecule drugs, which make up 90% of all prescriptions. As reported exclusively by The Hill. P4ADNow and AARP sent a joint letter to congressional leadership opposing EPIC, warning that it would have disqualified more than half the drugs already selected for negotiation, including Eliquis, Jardiance, and Ozempic. The industry continues to look for more ways to roll back progress. — [CBO, POLITICO, Senator Welch, Axios, P4ADNow, The Hill, EPIC One-Pager, STAT News, Reuters, Endpoints News, POLITICO, Fierce Healthcare, Common Dreams, Healthcare Finance]
Big Pharma Smashed Yet Another Lobbying Record
PhRMA is continuing to buy influence on Capitol Hill, spending nearly $30 million on lobbying so far this year — with record-breaking individual totals in all three quarters. As the industry continues to lose both in court and in public opinion, it’s clear Pharma now views Congress as its last line of defense. But patients are fighting back: the P4AD community has already sent nearly 54,000 letters urging lawmakers to defend Medicare negotiation and stand with patients, not the industry. — [Washington Post, POLITICO, Endpoints News, POLITICO Pro, Endpoints News]
New I-MAK National Survey Proves Bipartisan Support for Drug Pricing Reform
The Initiative for Medicines, Access and Knowledge (I-MAK) released the findings from their recent survey, showing just how widespread the affordability crisis remains — and how strongly Americans across the political spectrum want change. The data reinforces what we hear from patients every day: the high cost of drugs affects everyone, regardless of party, and voters want lawmakers to act. Among the key takeaways:
The message is clear: lowering drug prices isn’t a partisan issue — it’s an American priority.
Patient Advocate Spotlight: Mary Simmons
Background: Retired state government employee, from Henrico, Virginia
Condition: Acute Lymphoblastic Leukemia (ALL) and Diabetes
Drug: Methotrexate
In her words: “After my extended hospital stay, the medical upkeep and additional prescription and medical costs added up. Shortly after, I finally got social security disability insurance (SSDI) and have received more financial coverage and assistance from Medicare and my dual coverage of my husband’s insurance. Yet prescription copays remain at an all-time high, costing me several hundred dollars a month. Due to costs, I even tried switching my medication regimen from brand-name prescriptions to generics, which ultimately caused more problems, forcing me back on the expensive medications. Something needs to be done. Patients deserve lower prices without the stress of worrying how to pay for necessary things when their health is at a low. Big Pharma greed needs to stop!”
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AstraZeneca Strikes Deal with Trump, While Undermining Admin’s Powers Behind the Scenes
The Trump administration announced that AstraZeneca struck a deal to sell certain drugs to Medicaid at a discount, and committed to listing any new drugs it releases on the TrumpRx platform. It’s the third deal, and points to how the industry is performing the bare minimum with little actual substance to get on the administration’s good side. AstraZeneca CEO Pascal Soriot joined the White House rollout to praise the partnership, but behind the scenes, the company is pushing hard to block Trump’s ability to lower prices through Medicare, escalating its lawsuit against the Medicare Negotiation Program via a petition to the Supreme Court. AstraZeneca’s performative price reductions to win political points with the White House, while simultaneously fighting to maintain its monopoly pricing on its diabetes drug Farxiga aren’t fooling us. — [Washington Post, White House, STAT News, WBUR, The Hill, CMS, STAT News, Endpoints News, Healthcare Finance]
All Eyes On CMS
All eyes are on CMS as the agency prepares to announce the Maximum Fair Prices for the second round of Medicare drug negotiations. Wednesday marked the deadline for CMS to send offers to the manufacturers of the 15 high-cost drugs, after which manufacturers have until the end of the month to accept the new, lower prices, or withdraw from participation in federal health programs like Medicare and Medicaid. It’s a pivotal moment in the implementation of this historic reform, and will be proof that the Trump Administration is continuing the implementation of the program, launched under the previous administration. With round one prices taking effect on January 1st and the industry continuing to lose in court, this next phase shows that negotiating prices and standing with patients can transcend party politics and find widespread support among American voters. — [KFF, Arnold Ventures]
Pharma Fact Check
Big Pharma and its allies are recycling familiar talking points to justify monopolies and sky-high profits. A recent Pharmaceutical Executive article offers a snapshot of some of the industry’s most popular arguments, and why they fall apart under scrutiny:
Claim: “It is unfair to the pharma industry to put these kinds of limits and caps on what they’re doing. Making the pharma industry cap out costs could stifle innovation.”
Fact Check: Pharmaceutical companies still retain complete control over launch prices. Since the IRA passed, R&D spending has continued to grow, and CBO projects that Medicare negotiation will have less than a 1% impact on the number of new drugs developed over 30 years. The real threat to innovation isn’t fair pricing, it’s a system that lets companies profit from endless monopoly extensions. Meanwhile, every other service or medical product has a set price under Medicare. For years, pharma is the only part of our health care system that’s been gifted the ability to set their own prices.
Claim: “The pharma industry has helped to cure major diseases, like polio.”
Fact Check: The claim that “pharma cured polio” is misleading. The polio vaccine was developed in 1955 by Dr. Jonas Salk and his team at the University of Pittsburgh, with the support of public funding. Salk refused to patent the vaccine, famously saying, “Could you patent the sun?” and was committed to equitable access to the vaccine. National Institutes of Health (NIH) funding was involved in basic or applied research related to over 99% of drugs approved by the FDA from 2010 to 2019.
Claim: On tariffs: “Will there potentially be an increase in cost? There could be. How much will get passed down to the patient? That remains to be seen.”
Fact Check: Raising import costs is expected to increase prices, and history shows that drugmakers will pass those costs to patients, rather than absorb them. In reality, only 10% of the active pharmaceutical ingredients (APIs) used in U.S medicines are produced domestically. Additionally, Trump’s proposed 100% tariff would only apply to brand-name drugs, which already make up three quarters of drug spending despite only being 10% of prescriptions — meaning the patients who rely on these drugs would be hit the hardest.
In Case You Missed It
On Saturday, P4AD advocate Janet Kerrigan joined NewsNation to discuss her struggles with high drug prices. In the decade since her diagnosis with Multiple Myeloma, an incurable blood cancer, Janet has been through chemotherapy, a transplant, years of high-priced prescription drugs, and, most recently, CAR-T treatment — and she’s still fighting to lower drug prices for patients. You can watch the full interview here.
Patient Advocate Spotlight: Jacquie Persson
Background: Graphic designer and marketing manager in Waterloo, Iowa
Condition: Crohn’s Disease
Drug: Otulfi ($3,619 / month)
In her words: “Since my diagnosis, I have been fortunate enough to have good insurance, making all of the medications that I need within reach. Even with my exceptional coverage, not a day goes by that I do not stress about the what-ifs. What if I lose my job? What if my employer changes our insurance plan and my treatment is no longer affordable or covered? What if I am sick enough that I need extended time off from work? To make matters worse, stress is my number one trigger when it comes to my Crohn’s disease flare-ups, so living with these what ifs can just make me sicker.”
Jacquie recently spoke with Reuters about her struggles with high drug prices.
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Amgen Follows Pfizer — What That Means For Patients
Nearly two weeks after President Trump’s TrumpRx announcement, Amgen unveiled its own direct-to-consumer (DTC) program, announcing a discounted price for its cholesterol drug, Repatha, at $239 per month, which the company says is “nearly 60% lower than the current U.S. list price.” This is the latest move as drug manufacturers race to align with the administration’s pressure campaign. But while framed as progress, these piecemeal discounts underscore the limits of voluntary action: $239 a month remains impossible for many patients, and Repatha is only one of the dozens of drugs Amgen sells at high prices. Real affordability will require systemic reforms – not temporary, corporate-driven programs that leave patients dependent on goodwill. — [White House, Amgen, STAT News, POLITICO, Endpoints News, Reuters]
Big Pharma’s Legal Campaign Continues
Pharma’s courtroom losing streak continued this week, marking the industry’s 15th defeat. On Monday, the U.S. Court of Appeals For The Third Circuit unanimously rejected Novo Nordisk’s challenge to the Medicare Negotiation Program, dismissing claims that the law violates the First and Fifth amendments. The next day, the Fifth Circuit heard oral arguments in PhRMA’s lawsuit, where the government’s lawyer faced sharp questioning from one judge who appeared sympathetic to PhRMA’s position. The panel’s other two judges were more measured, one even noting the absence of any amicus briefs supporting PhRMA, compared to several backing the government. The court may wait for related filings in the upcoming Supreme Court case before ruling, but the trend remains clear: Pharma continues to challenge Medicare’s authority to negotiate, and patients’ advocates continue to defend it. — [P4AD, U.S. Court of Appeals, U.S. Court of Appeals]
Colorado Becomes First State to Cap the Price of a Prescription Drug
Colorado patients and advocates scored a major victory this week as the state’s Prescription Drug Affordability Review Board (PDAB) set the nation’s first price cap on a prescription drug, limiting the cost of Enbrel to $600 per weekly dose. This milestone was years in the making — and it happened because patients spoke up. P4AD patient advocates in Colorado supported the effort, sending letters and sharing their stories to illustrate the need for reform. Enbrel, approved more than 25 years ago, has seen its price rise by more than 1,500% and is protected by at least 57 separate patents that block generic competition. As expected, manufacturer Amgen and the broader industry are threatening lawsuits and reviving familiar claims about “innovation.” But with $3.2 billion in annual sales, Amgen has long recouped its investment — this fight is about protecting profits, not progress. — [Denver 7, Washington Post, Colorado Sun]
P4AD Defends Patients’ Voices at GW Law’s IRA Conference
Executive Director Merith Basey joined GW Law’s Inflation Reduction Act conference for a panel focused on the law’s most pressing questions, threats, and challenges around drug pricing. In a room dominated by industry representatives and economists, Merith made sure patients’ voices were heard – pushing back when affordability was dismissed and reminding the audience that these policies aren’t theoretical, but affect real people. While much of the discussion rehashed the same tired industry arguments about innovation and investment, Merith cut through the noise – emphasizing that it’s about balance and patients need both. As she noted, our founder, David Mitchell’s story (who lives with a rare blood cancer) shows that innovation is essential, but it means nothing if patients can’t afford it. — [GWU]
In Case You Missed It
Senators Grassley (R-IA) and Hassan (D-NH) reintroduced the bipartisan Open Payments Expansion Act, which would reveal the financial ties between drug companies and the tax-exempt patient advocacy groups they fund. As P4AD’s Hidden Hand reports have shown, these front groups often claim to represent patients while defending drug industry interests. The bill would bring long-overdue transparency to those relationships — ensuring lawmakers and the public can see who’s really behind campaigns that seek to undermine drug pricing reform. — [Sen. Grassley, P4AD]
Patient Advocate Spotlight: Janet Kerrigan
Background: Retired critical care nurse living in Myrtle Beach, SC
Condition: Multiple Myeloma, an incurable blood cancer
Drug: Revlimid ($800 per daily capsule, or $24,000 in monthly copays)
In her words: “I relied on grants to help cover these astronomical expenses, and the uncertainty of their availability meant living in a constant state of worry, wondering if the drugs that were keeping me alive would be covered… No one should have to face bankruptcy or fear losing access to life-saving medications.”
This week, Janet spoke with the New York Post about her struggles with high drug prices and President Trump’s recent DTC announcements. You can read the full article here.
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TrumpRx Announced
Even in a crowded week of news, prescription drug pricing remained prominent with President Trump’s announcement of TrumpRx — a new government direct-to-consumer platform — alongside a deal with Pfizer to offer Medicaid prescriptions at most-favored-nation (MFN) prices. The rollout underscores that drug pricing is a top administration priority, but key questions remain about the program: Which drugs will be covered? Will patients see any savings? And who ultimately benefits? The program does cut out middlemen, but also allows pharma to continue setting prices at will. Pfizer’s prominent role in the announcement signals that drugmakers expect to come out ahead. The reality is clear: drug companies — not PBMs or pharmacies — dictate launch prices, and that’s the root cause of unaffordable medicines. While DTC programs may offer limited relief to some patients, only structural reforms like Medicare negotiation can rein in monopoly pricing power and deliver lasting affordability. P4AD patient advocate Sarah Wisniewski underscored that point on BBC World Business Report and with CBS, sharing her own struggles with high drug costs and what these announcements could mean for patients like her. — [White House, BBC, CBS, POLITCO, Inside Health Policy, The Hill, Bloomberg, STAT News, Axios, Pink Sheet, Endpoints News, Fierce Pharma, Washington Examiner, Barron’s]
ORPHAN Re-score Anticipated Soon
The Congressional Budget Office (CBO) is still working on a re-score of the ORPHAN Cures Act, but we’re expecting a number well beyond the original $5 billion estimate, which failed to include a range of blockbuster drugs, including Keytruda. Championed by the pharmaceutical industry, ORPHAN exempts many high-cost drugs from negotiation, keeping prices artificially higher even longer. Lawmakers should learn from this mistake and reject pharma’s next push for carveouts through bills like EPIC and MINI. — [KFF, Congress, Congress]
New Profile on P4AD Patient Advocates
The Epoch Times published a profile of three P4AD patient advocates — Sarah, Beth, and Sanie — who traveled from across the country to D.C to share their firsthand experiences with the crushing cost of prescription drugs. During their meetings with lawmakers they pressed Congress to rein in patent abuse and protect Medicare negotiation. Their stories are powerful: spending thousands each month on treatments, rationing doses of life-saving medication, and navigating endless hurdles just to maintain coverage. Sadly, these experiences are all too common in our broken drug pricing system. With one in three Americans struggling to afford their prescription drugs, and nine in ten demanding action on the issue, the message to Congress couldn’t be clearer: it’s time to act. You can read the full profile here. — [Epoch Times]
In Case You Missed It
P4AD Executive Director Merith Basey will be joining GW Law’s Inflation Reduction Act event next Friday for a panel on the bill’s most urgent questions, threats, and challenges around drug pricing.
Patient Advocate Spotlight: Sarah Wisniewsi
Condition: Multiple Sclerosis (MS)
Drug: Kesimpta, and a range of immunotherapy drugs
In her words: ““No one can afford to pay for this drug when the monthly out of pocket cost is $8,736!”
“Even though my disease remains active, I am still able to work at a good job and remain a productive, tax paying member of society, but that will not be the case if I have to shoulder the cost of the Kesimpta on top of everything else. I don’t want to have to go on disability just so I can survive and hopefully get my medication paid for.”
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P4AD Files 5th Amicus Brief as Pharma Petitions SCOTUS
On Wednesday, P4AD filed its fifth patient-centered amicus brief defending the Medicare Negotiation Program, this time against PhRMA’s appeal to the Fifth Circuit. A Texas district court denied the group’s claims in August, adding to the industry’s 14 defeats. On the same day, AstraZeneca petitioned the Supreme Court to hear its appeal after losing its own case in 2024, seeking to block the price reduction of its diabetes drug, Farxiga, when lower negotiated prices take effect on January 1. While this marks a new escalation, it’s one we’ve long expected and prepared for. P4AD will continue elevating the voices of patients and highlighting the real-world benefits of negotiation, including the $99 billion in taxpayer savings and 656,967 lives projected to be saved over the next seven years. Medicare negotiation is here to stay. — [P4AD, P4AD, SCOTUS, CNN, The Hill, CBO, CIDSA]
Pharma Hikes Abroad ≠ Lower U.S. Prices
With the September 29 deadline approaching for drug manufacturers to respond to President Trump’s demands to reduce U.S. drug prices, BMS is following in Eli Lilly’s footsteps and raising prices in the U.K., claiming the move will somehow “improve affordability in the U.S.” But basic math shows that shifting costs overseas won’t bring down drug prices for Americans, even if some discounts are provided to lessen the inflated sticker price. Pharma has proven time and again that they can’t self-regulate, creating a dangerous crisis for patients who rely on their life-saving drugs but can’t afford them. It’s time for tangible and effective enforcement measures if drugmakers fail to meet the approaching deadline. — [White House, CNN, Pink Sheet, Axios, Inside Health Policy]
100% Pharmaceutical Tariffs Coming Next Month
In a Truth Social post on Thursday, President Trump announced tariffs of up to 100% on “any branded or patented Pharmaceutical Product” starting October 1 — unless the company is already building facilities in the U.S. Reshoring can’t happen overnight, and in the meantime, drugmakers will pass higher import costs directly onto patients. Today, only 10% of the active pharmaceutical ingredients used in U.S medicines are produced domestically. Doubling the cost of importing the remaining 90% would mean higher prices for patients already struggling to afford their prescriptions. — [CNBC, POLITICO, Bloomberg]
New KFF Analysis Slams the ORPHAN Cures Act
New analysis from KFF this week confirms what patients already know: the ORPHAN Cures Act will keep prices artificially increased for people on Medicare for longer, leading to higher out-of-pocket costs at a time when 29 million Americans are already “cost-desperate” when it comes to paying for their medications. The paper also reinforces earlier reporting that the CBO’s $5 billion score vastly underestimates the bill’s true cost for taxpayers, which will skyrocket once blockbuster drugs like Keytruda are factored in. By exempting these medicines from negotiation, ORPHAN hands pharma a massive windfall while weakening one of the most popular cost-cutting programs in the country. Lawmakers should take this as a warning and reject future carveouts like the EPIC and MINI Acts that would further undermine Medicare negotiation. — [KFF, Gallup, WSJ, Congress, Congress]
In Case You Missed It
Administration officials are floating the possibility of a government-run online pharmacy, dubbed TrumpRX. While an HHS characterized the idea as “internal deliberations” and “pure speculation,” it comes in the context of President Trump’s ongoing MFN pricing push and discussions with large U.S. drugmakers. — [Inside Health Policy, Bloomberg, Independent]
Patient Advocate Spotlight: Sa’Ra Skipper
Condition: Type 1 Diabetes
Drug: Insulin
Background: Student from Indiana. Sa’Ra joined former President Biden in 2021 and shared remarks on the high cost of prescription drugs.
In her words: “As a diabetic, you have to fight so hard physically and mentally just to survive. There shouldn’t be a price tag on my life, and I shouldn’t have to decide if I’m going to pay for living expenses or pay for insulin.”
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14th Court Victory
In a unanimous decision, the Third Circuit U.S. Court of Appeals rejected Novartis’ challenge and stood with Medicare negotiation, exactly one week after the same court delivered a similar defeat to Bristol Myers Squibb (BMS) and Janssen. The judges — appointees from Presidents Trump, Biden, and Bush — once again upheld the constitutionality of Medicare negotiation, and went one step further to rule that Novartis didn’t have legal grounds to sue. One major component of this case was the amicus brief P4AD submitted on behalf of patients, elevating the testimony of three patient advocates. Despite the back-to-back defeats of their tired legal arguments, the industry continues to funnel lawyers and millions in an attempt to roll back Medicare negotiation, and P4AD will be fighting them every step of the way. — [U.S. Courts, HHS, P4AD, Inside Health Policy, Fierce Pharma, Endpoints News, Bloomberg Law, FirstWord Pharma, Pharma Letter, Law360]
Most Favored Nation letters Deadline Approaches
In late July, President Trump sent letters to 17 large pharmaceutical corporations demanding they take steps to bring drug costs in line with comparable countries as part of his Most Favored Nation (MFN) pricing plan. The September 29th deadline is fast approaching, and in the weeks since, pharma has continued to show their disdain for MFN. Pfizer’s Albert Bourla claimed the letter “asks a lot,” referring to the requirements as a mere starting point for negotiations, and Eli Lilly responded with plans to significantly raise drug prices in Europe without making any commitment to reducing prices in the U.S. Despite this, new reporting this week shows that interest in MFN and other price reforms continues to grow across the aisle on Capitol Hill. P4AD patient advocates raised MFN with their representatives during our fly-in day last week, and our community continues to push for concrete action that will lead to lower prices for American patients. — [White House, President Trump, Axios, CNN, STAT News]
In Case You Missed It
In a New York Times op-ed, FDA Commissioner Marty Makary condemned what he calls “a nonstop bombardment of ads.” Direct-to-consumer (DTC) drug ads are a practice largely unique to the U.S., and are immensely profitable for drugmakers — estimates have found that each 1.5% increase in DTC ad spending is associated with a 10% increase in sales. Commissioner Makary is exactly right when he writes that “the billions of dollars drug companies spend on advertising would be better spent on lowering drug prices for American consumers.” — [New York Times, TIME]
Patient Advocate Spotlight: Ginny Boynton
Condition: Lambert-Eaton Myasthenic Syndrome (LEMS)
Drug: Ruzurgi ($250,000)
Background: Pennsylvania resident and retired lawyer
In her words:
“I’m lucky to have insurance coverage through my husband’s work that helps me afford my medications, but I worry about the strain these prices put on other LEMS patients and the system as a whole. I don’t know how a patient without insurance coverage could afford the astronomical price tag for these drugs.”
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