Welcome to the Week in Review.
Round 2 Medicare Negotiation Prices Announced
Last Tuesday, the Centers for Medicare and Medicaid Services (CMS) announced new lower prices for the second round of Medicare drug price negotiations. It’s a major milestone for the program that’s delivering continued savings for patients and taxpayers. Over 5 million patients on Medicare take one of the 15 drugs included in this round, which accounted for $42.5 billion in Medicare Part D spending from November 2023 to October 2024. The announced prices are consistent between both rounds, and according to CMS, Medicare savings will double to $12 billion in 2027, due in part to the inclusion of five additional drugs this round and significant discounts on high-cost GLP-1s. Patients on these 15 drugs have struggled to afford them for years — including patients in our community like Aarolyn from Michigan, and Janet from South Carolina. If these new prices had already been in effect in 2024, patients would have saved $685 million in out-of-pocket costs. For patients who’ve been forced to work multiple jobs, cut pills in half, or choose between filling a prescription and buying groceries, these lower prices will bring long-overdue relief, flexibility, and stability. — [CMS, P4AD, The Hill, CBS News, STAT News, Inside Health Policy, Healthcare Finance]
Entresto, Stelara, and Xarelto to be Removed from Negotiations
In another significant shift for the Medicare negotiation program, CMS announced that Entresto, Stelara and Xarelto will be removed in 2027 after determining that the drugs now face generic or biosimilar competition. These three drugs were included in round one of Medicare negotiations, and their lower negotiated prices will take effect in less than a month, meaning that these prices will be in place for only one year. Medicare negotiation was established as a check on pharma’s monopoly power, specifically targeting drugs that have evaded competition and kept Americans paying between 4 and 8 times more than patients in other high-income countries. One of the criteria for a drug to be included in the program is being single-source, meaning that the product doesn’t have generic or biosimilar versions available in the same class and therefore no bona fide competition on the market. While we don’t yet know the extent to which the new competition will lower the prices for these three drugs — the main concern for the patients who need them — incentivizing generic or biosimilar rivals to enter the market is a win that has historically lowered prices and benefited patients. — [CMS, Inside Health Policy, POLITICO]
Pharma Celebrates New U.S. & U.K. Deal
The U.K. has committed to increasing its spending on new drugs, entering an agreement with the U.S. after facing pressure from the Trump administration and potential pharmaceutical tariffs. The U.K’s National Institute for Health and Care Excellence (NICE) will increase its cost-effectiveness threshold by 25 percent to £35,000 per quality adjusted life year (QALY), meaning that the National Health Service (NHS) will pay more for medicines. This is a massive win for pharma, and predictably the industry’s lobbyists quickly responded by urging other European countries to mirror the agreement. Imposing higher prices on patients in other countries does nothing to reduce the burden on Americans who are forced to decide between paying rent and obtaining life-saving medications. Indeed, the Pharma CEOs that testified at a Senate Finance Committee hearing in 2019, confirmed under oath that they make a profit in every country where they sell their drugs. Hiking expenditures for the U.K. government only boosts the bottom line for one of the most profitable industries on the planet. — [POLITICO, STAT News, POLITICO]
ICYMI
Eli Lilly has officially hit $1 trillion in value — the first “healthcare” company to reach this milestone. Like nearly all pharmaceutical companies industry-wide, Eli Lilly has consistently complained that transformative programs like Medicare negotiation and reforms to rein in drug monopolies will force them to scale back innovation and R&D investment, preferring instead to promote voluntary, one-off agreements, like last month’s GLP-1 deal with the Trump administration. The news of Eli Lilly’s record-high valuation makes their arguments against lowering prices offensive, particularly when 1 in 3 Americans can’t afford the cost of their prescription drugs. — [New York Times, CNBC, Reuters, BioPharma Dive]
Patient Advocate Spotlight: Joe Kerrigan
Background: Patient advocate from Myrtle Beach, South Carolina
Drug: Janumet ($740 per 60-day supply)
In the words of his wife Janet: “Janumet is not just helpful — it’s necessary. But the cost is outrageous. Merck charges our insurance $740 for a 60-day supply. Even with coverage, we end up paying anywhere between $324 and $631, depending on which pharmacy we go to. That’s on top of our $185 monthly Medicare premium. My husband lives on $14,000 a year from Social Security – once we pay for his medicine, we have less than $10,000 left to live on for the year. We’ve come close to bankruptcy — not once, but multiple times — just trying to afford the medications that keep us alive.”
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Patients on Medicare will see an average list price reduction of 62% percent on the 15 included drugs.
WASHINGTON, D.C. — The Centers for Medicare and Medicaid Services (CMS) has announced the new lower prices from the second round of Medicare drug price negotiations, building on the previous administration’s inaugural first round, and delivering significant savings for patients on Medicare.
In 2024, about 5.3 million patients on Medicare used one of the 15 drugs included in this round, which accounted for $42.5 billion in Medicare Part D spending. The newly negotiated drugs include treatments for diabetes, cancer, heart disease, respiratory illnesses, and autoimmune conditions — some of the most common and costly chronic diseases affecting patients on Medicare.
If the new prices had already been in effect in 2024, patients would have saved an estimated $685 million in out-of-pocket costs, while taxpayers would have saved an estimated $12 billion, according to CMS. You can find the full list of price reductions here.
Merith Basey, Executive Director of Patients For Affordable Drugs, issued the following statement:
“The Medicare Negotiation Program changed the trajectory of drug pricing in the United States, helping to reduce Big Pharma’s monopoly pricing power, which dictated prices to Americans on Medicare for two decades. This second round of negotiations — now under President Trump — marks another major milestone, delivering continued savings for patients and taxpayers.”
“The lower negotiated prices are more than numbers on a page. For patients who’ve been forced to work multiple jobs, cut pills in half, or choose between filling a prescription and buying groceries, these lower prices will bring long-overdue relief, flexibility, and stability.”
“As we celebrate this moment, we know the work is far from finished. At a time when 47% of Americans are concerned about their ability to pay for a health-related cost next year, we must keep pushing to ensure Pharma’s attacks to undermine the program fail. Patients fought hard for these reforms, and Americans overwhelmingly support expanding the program — including to the millions of patients in the commercial market still awaiting relief. Today’s announcement is proof that lasting change can happen when patients demand it.”
“The reduced cost of Ozempic is such great news for patients like me who constantly worry about the many expenses in our lives,” said Aarolyn McCullough from Michigan. “I have been a substitute teacher a couple of days a week to bring in extra income and take care of bills. The savings from Ozempic’s reduced price may finally allow me to stop substitute teaching or reduce the number of days I need to.” In 2027, the negotiated list price for Ozempic will be reduced to $274 per month – a 71% list price reduction.
“The reduced price of Otezla is promising news that will allow me to afford the medication, pay down debt, and buy more groceries,” said Mary Schmidt from Texas. “I live on a strict budget and need money for other products to help my autoimmune condition, so these savings really matter to me. People with chronic conditions should not have to suffer.” In 2027, the negotiated list price for Otezla will be reduced to $1,650 per month – a 65% price reduction.
“My husband and I are barely surviving, trying to stay alive, paying exorbitant amounts for medication,” said Janet Kerrigan from South Carolina. “My husband Joe is diabetic, and he depends on his Janumet to keep him in control of his blood sugars. His Social Security is $15,000/year, and the price for Janumet is $500-$700/month. Medicare takes out $185/month, which leaves him with around $7,000 a year to live on. The lowering of Janumet would allow us not to worry if we can afford the medication that is keeping him alive.” In 2027, the negotiated list price for Janumet will be reduced to $80 per month – an 85% price reduction.
Lowering drug prices isn’t a partisan goal — it’s an American one, and Medicare negotiation remains one of the most popular reforms in recent history. Polling this year shows that 96% of voters across party lines say it’s important for the government to negotiate with drug companies – and two-thirds support allowing Medicare to negotiate the prices of all prescription drugs. As Big Pharma’s public favorability continues to fall, the success of negotiation demonstrates strong bipartisan momentum to expand these reforms and deliver further relief to patients.
CMS found that, in 2024, the 15 selected drugs earned over $65 billion in combined total global revenue:
The Medicare Drug Price Negotiation Program was established through the 2022 Prescription Drug law, allowing the federal government to negotiate directly with drug manufacturers for lower prices on the most expensive medications covered under Medicare. The first round of negotiated prices, taking effect in January 2026, covered drugs used by 8.8 million people on Medicare, with list price reductions ranging from 38-79%. Medicare Negotiation will save taxpayers nearly $99 billion over the next decade and prevent more than 656,967 premature deaths over seven years due to improved treatment adherence and affordability.
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Patients For Affordable Drugs Now is the only national, patient advocacy organization focused exclusively on policies to lower drug prices. We empower and mobilize patients and allies, hold accountable those in power, and fight to shape and achieve system-changing policies that make prescription drugs affordable for all people in the United States. P4ADNow is bipartisan and does not accept funding from organizations that profit from the development or distribution of prescription drugs. To learn more, visit: PatientsForAffordableDrugsNOW.org
Welcome to the Week in Review.
New USPTO Proposal Could Undermine Biosimilar Competition
The United States Patent and Trademark Office (USPTO) is considering a new rule that would make it harder for biosimilar manufacturers and patient advocacy groups to challenge drug patents through the Patent Trial and Appeal Board (PTAB) — a process that is faster and more cost-efficient than lengthy court battles. Increased competition through the introduction of generic drugs and biosimilars into the market is one of the most effective tools for lowering the price of prescription drugs, but the difficulty of challenging bad or frivolous patents is one of the biggest barriers to getting these drugs onto the market. Between May and September of this year, the USPTO denied 60% of PTAB challenges, tripling historical rates. If finalized, the new proposed rule would make those denials standard practice. That shift would extend drugmakers’ monopolies and keep prices high for longer, particularly for biologics, which make up just 2% to 5% of prescriptions but accounted for half of all pharmaceutical company revenue in 2024. With patients depending on affordable alternatives, maintaining a strong and accessible PTAB process is critical to protecting competition and ensuring lower prices for consumers. P4AD will be submitting comments urging the USPTO to protect access to this process. — [HealthAffairs, Health Affairs Scholar, GoozNews, KFF Health News]
Fake “Patient Advocacy” Group Backs PERA and Drug Monopolies
A new letter from The Alliance for Aging Research (AFAR) is circulating in support of the Patent Eligibility Restoration Act (PERA), a harmful bill that would broaden what can be patented, allowing drugmakers to claim new protections for minor tweaks to existing drugs. It’s no surprise who’s behind the push. Despite its branding, AFAR is a pharma-funded front group that P4AD exposed in a report earlier this year. They receive significant funding from industry-tied donors in exchange for doing their bidding on Capitol Hill, most recently by supporting the harmful EPIC Act that would undermine Medicare Negotiation. The industry’s renewed promotion of PERA is a last-ditch effort to secure another handout before lawmakers head home for the holidays. — [Congress, P4AD, P4ADNow, Economic Liberties]
GLP-1 Prices Are Driven by Corporate Strategy, Not Patient Impact
After Trump announced deals to bring Novo Nordisk and Eli Lilly’s blockbuster GLP-1 drugs to TrumpRx at discounted prices, Novo quickly moved to undercut Lilly by dropping its own prices even earlier through its direct-to-consumer website. For patients paying cash directly to Novo, Ozempic and Wegovy will cost $199 for the first two months before rising to $349 — the same price point planned for TrumpRx. This response is a critical reminder: these companies can lower their prices at any time, because the list prices for GLP-1s bear no relation to their production costs – Ozempic costs only $5 to manufacture. While the recent voluntary deals we’ve seen do have the potential to save money for a select group of patients, they rely on the goodwill of drug companies and therefore can be taken away at any time. We need system-level reform to ensure lower prices for all Americans, not just for patients covered by a one-off deal or a temporary competitive maneuver. — [CNN, The Hill, Axios, Endpoints News]
DC District Court Rejects Teva Pharmaceuticals’ Challenge to Medicare Negotiation
Yesterday, the U.S. District Court for the District of Columbia rejected Teva Pharmaceuticals’ challenge to the Medicare Drug Price Negotiation Program — marking the 16th defeat against the industry’s nationwide legal campaign to prevent the law from lowering prices. Teva manufactures Austedo and Austedo XR — used to treat involuntary movements associated with Huntington’s disease and tardive dyskinesia — which are included in the second round of negotiation. The deadline for the second round of lower negotiated prices to be announced is November 30th. The court dismissed both Teva’s Fifth Amendment argument as well as the company’s attempt to challenge the law’s grouping of multiple products under a single negotiation unit. Austedo and AustedoXR share the same active ingredient and differ only in delivery mechanism, undermining the company’s claim that the drugs should be treated as separate. The ruling reaffirmed the constitutionality of the historic medicare negotiation program, which is supported by more than 80% of Americans. — [DC District Court, AV]
New Public Citizen Report Exposes Pharma Lobbying
A new report from Public Citizen has revealed the scale of Big Pharma’s lobbying campaign to undermine the Medicare price negotiation program. The analysis found 545 lobbyist-client relationships tied to the ORPHAN Cures Act, EPIC Act, and MINI Act. The findings come as PhRMA reported spending a record-breaking $30 million in the first three quarters of the year. For an industry that continues to claim it can’t afford lower prices, pharma continues to prove it has no trouble paying to protect its profit machine and undermine the will of the American people. — [Washington Post, Public Citizen]
ICYMI
P4AD’s Merith Basey and Fairmark Partners LLC’s Michael Lieberman joined the McGill Journal of Law and Health podcast to discuss pharma’s ongoing legal crusade against drug price negotiations, and how patient advocates are fighting back. You can listen to their conversation here.
Patient Advocate Spotlight: John Aadland
Background: Patient advocate living with COPD in Central Point, OR.
Drug: Trelegy ($300 per month)
In her words: “Even with insurance, my Trelegy prescription costs me more than $300 a month. This forces me to have a friend in Mexico buy it for me at less than a quarter of the price I have to pay here in the United States. A lower price on the medication would allow me to buy it here in the U.S. and avoid the workarounds to be able to access my medication.”
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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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WASHINGTON, D.C. — The White House announced agreements today with pharmaceutical giants Eli Lilly and Novo Nordisk to lower the prices of their blockbuster weight-loss drugs Ozempic, Wegovy, and Zepbound for patients on Medicare, as well as for anyone who purchases them through the administration’s new TrumpRx direct-to-consumer program, expected to launch in January 2026.
Under the deals, for which few details have been made public, patients will be able to purchase Ozempic and Wegovy for $350 and Zepbound for $346 per month through TrumpRx — a steep reduction from current list prices of between $1,000 and $1,350 per month, though still higher than prices in other high-income nations like Canada, Germany, and Japan.
For the first time, Medicare will also expand coverage of these drugs for weight loss, expanding beyond previous coverage for heart disease and diabetes, at a reduced price of $245 a month.
“If you are a patient whose health and well-being depends on one of these life-changing but wildly overpriced drugs, today’s announcement is welcome news,” said Merith Basey, Executive Director of Patients For Affordable Drugs Now. “We commend the Trump administration for continuing to take steps that can bring much-needed relief to Americans who have been price-gouged for decades by pharmaceutical giants like Eli Lilly and Novo Nordisk. Patients are overwhelmingly calling on the Administration and Congress to hold Big Pharma to account at a time when almost 60% of patients have skipped or delayed a prescription because of cost. Any voluntary deal with Big Pharma must be complemented with legislation that tackles the root causes of high drug prices.”
The news comes just days before Medicare’s second round of negotiated drug prices is expected to be announced under the 2022 Prescription Drug Law — a round that includes both Ozempic and Wegovy. While Administration officials have shared that the new deals are separate from those negotiations, the overlap raises important questions about how these agreements will relate to the binding Medicare-negotiated prices and whether this new voluntary initiative will complement or complicate the savings patients are due to receive under the law.
High costs for drugs like Ozempic and Wegovy have forced patients to skip doses, go into debt, or look abroad for affordable options. Lower prices could bring these medications within reach for people like:
The drug companies’ CEOs joined the President in the Oval Office for the announcement. Stock prices for both companies rose following early reports of the deal.
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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.
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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