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The FDA took a significant step in accelerating biosimilar approvals this week, announcing a new draft guidance to cut unnecessary red tape and streamline duplicative clinical trial requirements.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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WASHINGTON, D.C. — In response to today’s announcement from the Food and Drug Administration (FDA) on new draft guidance to accelerate biosimilar approvals, Patients For Affordable Drugs Now executive director Merith Basey released the following statement:
“We welcome the administration’s commitment to increasing biosimilar competition to lower drug prices for American patients. Expediting the biosimilar approval process – by cutting unnecessary red tape and streamlining duplicative clinical trials – will help speed lower-cost treatments to market for diseases like cancer, arthritis, and autoimmune conditions, delivering relief to patients who’ve waited too long for more affordable options.”
“To build on this effort, Congress must tackle the patent abuses that allow big drug companies to block competition even after FDA approval. Bipartisan patent reform measures currently in Congress would crack down on these patent abuses and close regulatory loopholes. Together, these actions can help restore fairness and accountability to a system that has favored pharmaceutical monopoly power for too long.”
The FDA’s new draft guidance would streamline the process for approving biosimilars, which are more affordable than their biologic reference products. The proposal would remove unnecessary human trials, known as interchangeability studies, when advanced testing already shows that a biosimilar works the same as the brand-name drug and would make it easier for doctors and pharmacists to substitute lower-cost biosimilars, much like generic drugs.
In announcing the new draft guidance, Health and Human Services Secretary Robert F. Kennedy Jr. underscored the human cost of high drug prices and the role pharmaceutical lobbying played in maintaining monopolies: “Across our country, millions of Americans struggle to afford essential medicines. Families are rationing prescriptions, seniors are skipping doses, and parents are facing heartbreaking choices,” he later added that “when Congress wrote the Biologics Price Competition and Innovation Act, the pharmaceutical industry rigged the rules…They claimed that biologics were too delicate, that they were too mystical to allow true generics… it was all clever marketing, none of it was based on science. Then, to block pharmacists and doctors from switching patients to lower-cost options, the lobby invented a fake distinction between biosimilars and interchangeable biosimilars. The result has been sky-high costs, endless red tape, and a biosimilar market that still lags far behind Europe’s.”
FDA commissioner Dr. Marty Makary also highlighted how biologics are driving drug spending and stressed the importance of accelerating competition: “We can create more intense competition and let market forces do their work. When Humira had its biosimilar come out seven years later, it should have been closer to two years — or even one year, as we often see in Europe. When there’s that kind of gap, it means a longer period with no competition and higher prices. We want to see more competition, and we want to see more innovation
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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.
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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What was once a $5 billion Big Pharma giveaway has exploded to $8.8 billion – a windfall for drug corporations at the expense of patients and taxpayers.
WASHINGTON, D.C. — Patients For Affordable Drugs Now and AARP sent a joint letter to Congressional leadership opposing the EPIC Act (S.832/H.R.1492), warning that the bill would delay Medicare’s ability to negotiate lower prices for small-molecule drugs by an additional four years – threatening one of the most popular and effective drug price reforms in recent history.
Since small molecule drugs make up 90% of prescriptions, if enacted before the passage of the 2022 prescription drug law, EPIC would have disqualified more than half of the drugs selected for negotiation, including Eliquis, Jardiance, and Ozempic, commonly used to treat diabetes, blood clots, heart and kidney diseases.
The truth is, this isn’t about innovation – it’s about protecting monopoly profits. The industry itself lobbied for a longer negotiation timeline for biologics, and now it’s seeking the same delay for small-molecule drugs. If parity is the goal, both drug types should be subject to negotiation after nine years, not 13.
Further, since the law was passed in 2022, drug company investment and R&D increased. In the nine months following the passage, big drug companies acquired more small-molecule drugs than in the nine months prior.
EPIC would come on the heels of another massive industry giveaway, with the industry netting a $9 billion handout with the ORPHAN Cures Act. With PhRMA ramping up its lobbying machine and spending $9 million in Q3 alone — its most expensive third quarter to date — we know that EPIC is the next attempt to roll back progress and squeeze patients and taxpayers even further.
But Americans aren’t fooled. Nine in ten Americans want Congress to do more to lower drug prices, and a strong majority supports the government negotiating a better deal for patients. Patients are fighting back. Already, more than 34,000 patients have sent letters to Congress demanding that they oppose the EPIC Act and defend Medicare negotiation.
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October 20, 2025
Dear Majority Leader Thune, Minority Leader Schumer, Speaker Johnson, and Minority Leader Jeffries:
We write to you on behalf of the millions of Americans who want real relief from outrageous prescription drug prices and are urging Congress to protect them from higher costs. Costly legislation like S.832/H.R. 1492 – the Ensuring Pathways to Innovative Cures (EPIC) Act – does not serve the American taxpayers and would instead block or delay patients’ access to lower prescription drug prices at a time when the overwhelming majority support granting Medicare the power to negotiate lower prices for more drugs.
Simply put, the EPIC Act would give drug companies even more time to charge Americans the same or even higher prices for their medications – all by extending the Medicare drug price negotiation exemption period for small molecule drugs (pills) from nine to 13 years. That’s four more years where patients and taxpayers would continue bearing the burden of high prices, with billions in additional costs. In real terms, taxpayers could face close to 10 billion dollars in unnecessary spending at a time when fiscal responsibility is paramount, while patients face impossible choices like whether to fill their prescriptions or purchase groceries.
The pharmaceutical industry’s claim that current law is stifling the development of small-molecule drugs is not supported by objective evidence. Since Medicare drug price negotiation became law in 2022:
Moreover, only the highest expenditure drugs can be selected for negotiation. To be eligible, products must gross at least $200 million per year from Medicare alone. Coupled with the number of years before Medicare-negotiated drug prices become available, drugs that are eligible for negotiation are well-positioned to recover all of their R&D costs within the existing nine-year window based solely on Medicare revenue. It is also important to note that the pharmaceutical industry does not undertake R&D alone. Taxpayers help underwrite medical innovation: the NIH contributed funding to over 99 percent of drugs approved between 2010 and 2019.
Americans deserve a government that prioritizes their needs over unfounded complaints from drug companies. We urge you to stand with patients and older Americans by protecting access to affordable medicines and ensuring taxpayer dollars are used wisely. Please oppose any legislation that would make it harder for struggling patients to gain affordable access to the medications they need, including the EPIC Act (S.832/H.R.1492).
Sincerely,
AARP
Patients for Affordable Drugs Now
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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
What was once a $5 billion Big Pharma giveaway has exploded to $8.8 billion – a windfall for drug corporations at the expense of patients and taxpayers.
WASHINGTON, D.C. — The Congressional Budget Office (CBO) has re-scored the pharmaceutical carveout known as the ORPHAN Cures Act, and the results confirm what patients feared: it’s even more expensive – and more harmful – than originally thought.
The new score reveals the bill will cost taxpayers $8.8 billion, up from a massive $5 billion initially. The CBO’s earlier analysis failed to fully account for the impact of exempting blockbuster drugs like Keytruda, Brukinsa, and Jakafi from Medicare price negotiations – a change that funnels billions in savings away from patients and straight into Big Pharma’s pockets.
“The ORPHAN Cures Act is a wildly expensive handout to Big Pharma that will harm patients, drain taxpayer dollars, and weaken the government’s ability to rein in high drug prices,” said Merith Basey, executive director of Patients For Affordable Drugs Now. “And yet, the insatiable pharmaceutical industry continues to demand more – spending record sums this year to advance additional carveouts like the EPIC Act, which would exempt even more blockbuster drugs from negotiation. Any support for these bills goes against the will of the 90% of Americans who want Congress to go further to lower drug prices – not facilitate another handout to Big Pharma.”
The ORPHAN Cures Act exempts drugs approved for two or more rare diseases from Medicare negotiation, including blockbuster medicines that already generate billions. If drugs have both orphan and non-orphan designations, ORPHAN resets their negotiation timeline to the date of their newest approval, even if they’ve been on the market for years. Rare disease research incentives have existed in the U.S. under the Orphan Drug Act for more than 40 years, and investment in drug R&D has hit record levels since the Inflation Reduction Act was passed, directly contradicting the industry’s fearmongering about innovation.
Following the ORPHAN Cures Act, two additional industry-backed bills – the EPIC Act and MINI Act – threaten to further weaken Medicare’s negotiating power and inflate drug costs:
Both rely on debunked claims that negotiation stifles innovation – and both would sabotage President Trump’s ability to secure a better deal for Americans.
Across the country, patients are mobilizing against these industry giveaways. Collectively, P4ADNow’s community has sent 53,886 letters urging lawmakers to reject carveouts like ORPHAN, EPIC, and MINI and protect Medicare’s power to negotiate lower prices.
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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.
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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Welcome to the Week in Review.
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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Welcome to the Week in Review.
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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